Bharat Book Bureau

This report analyzes the global pharmaceutical market in terms of market size, key drivers and resistors, trends and competitive positioning. It includes profiles of the top ten companies in the industry along with 5-year financial analysis and in-depth SWOT analysis.

Scope

* Performance of the global pharmaceutical market on the basis of sales, volume and respective growth patterns over the past five years
* Obtain descriptive profiles of the top ten leading players including strategic initiatives undertaken in the last 12 months
* Analysis of the Strengths, Weaknesses, Opportunities and Threats of the top 10 pharmaceutical companies along with business overview and financials
* Benchmark the performance of the top 10 players for the past five years; includes revenue comparison, profitability analysis, industry-specific ratios

Highlights

The global pharmaceutical market generated total revenues of $615.1 billion in 2008, representing a compound annual growth rate (CAGR) of 4.7% for the period spanning 2004-2008.

The cardiovascular segment was the market’’s most lucrative in 2008, generating total revenues of $121.7 billion, equivalent to 19.8% of the market’’s overall value.

The performance of the market is forecast to decelerate, with an anticipated CAGR of 3.6% for the five-year period 2008-2013, which is expected to drive the market to a value of $734 billion by the end of 2013.

Reasons to Purchase

* Save time, money and resources on analyzing the top 10 pharmaceutical companies using this report
* Analyze the global pharmaceutical market with key industry metrics including market value, market volume, and growth forecasts
* Assess the intensity of competition based on the 5-forces model including degree of rivalry, substitutes, new entrants, buyer power and supplier power

Table of Contents:

Table of Contents 2
FIGURES 3
Tables 4
Executive Summary 5
Industry analysis 5
Industry definition 5
Research highlights 5
Top 10 companies landscape 5
Market value 7
Market forecast 8
Market segmentation-product 9
Market segmentation-geographic 10
Five Forces Analysis 11
Summary 11
Buyer power 12
Supplier power 13
New entrants 14
Substitutes 15
Rivalry 16
Top 10 Companies Landscape 17
Overview 17
Pfizer 18
GlaxoSmithKline 18
F, Hoffmann-La Roche 19
Novartis 19
Sanofi-Aventis 19
AstraZeneca 19
Abbott Laboratories 19
Merck & Co. 19
Wyeth 20
Bristol-Myers Squibb Company 20
Revenue analysis 21
Financial performance analysis 23
Operating profit analysis 24
Net profit analysis 25
Ratio analysis 26
Company Reports 28
Pfizer Inc 28
Company overview 28
Business description 28
SWOT analysis 29
Strengths 29
Weaknesses 29
Opportunities 30
Threats 31
Recent developments 32
GlaxoSmithKline Plc 34
Company overview 34
Business description 34
SWOT analysis 35
Strengths 35
Weaknesses 36
Opportunities 37
Threats 38
Recent developments 38
F. Hoffmann-La Roche 40
Company overview 40
Business description 40
SWOT analysis 41
Strengths 41
Weaknesses 41
Opportunities 42
Threats 43
Recent developments 43
Novartis 45
Company overview 45
Business description 45
SWOT analysis 46
Strengths 46
Weaknesses 47
Opportunities 47
Threats 48
Recent developments 48
Sanofi-Aventis 50
Company overview 50
Business description 50
SWOT analysis 50
Strengths 50
Weaknesses 52
Opportunities 53
Threats 54
Recent developments 55
AstraZeneca 57
Company overview 57
Business description 57
SWOT analysis 58
Strengths 58
Weaknesses 59
Opportunities 60
Threats 62
Recent developments 62
Abbott Laboratories 64
Company overview 64
Business description 64
SWOT analysis 65
Strengths 65
Weaknesses 66
Opportunities 67
Threats 67
Recent developments 68
Merck & Co., Inc. 70
Company overview 70
Business description 70
SWOT analysis 71
Strengths 71
Weaknesses 71
Opportunities 72
Threats 74
Recent developments 74
Wyeth 77
Company overview 77
Business description 77
SWOT analysis 78
Strengths 78
Weaknesses 78
Opportunities 79
Threats 79
Recent developments 79
Bristol-Myers Squibb Company 82
Company overview 82
Business description 82
SWOT analysis 83
Strengths 83
Weaknesses 84
Opportunities 84
Threats 85
Recent developments 86
Five Year Financial Information 88
Pfizer 88
GlaxoSmithKline 91
F. Hoffman-La Roche 94
Novartis 97
Sanofi-Aventis 100
AstraZeneca 103
Abbott Laboratories 106
Merck & Co. 109
Wyeth 112
Bristol-Myers Squibb Company 115
APPENDIX 118

List of Tables
Table 1: Global pharmaceutical market, $ billion, 2004-2008 7
Table 2: Global pharmaceuticals market forecast, $ billion, 2008-2013 8
Table 3: Global pharmaceuticals market segmentation-product , % share 2008* 9
Table 4: Global pharmaceuticals market segmentation-geography, % share 2008* 10
Table 5: Revenues of global top 10 pharmaceutical companies, $ million, FY2008 17
Table 6: Revenue growth of global top 10 pharmaceutical companies, 2006-2008 21
Table 7: Key financials of global top 10 pharmaceutical companies, FY2008 23
Table 8: Key industry specific ratios-FY2008 26
Table 9: Pfizer-Financial and operational highlights, 2004-2008 ($ million) 88
Table 10: Pfizer-Key industry specific ratios, 2004-2008 90
Table 11: GlaxoSmithKline-Financial and operational highlights, 2004-2008 ($ million) 91
Table 12: GlaxoSmithKline-Key industry specific ratios, 2004-2008 93
Table 13: F. Hoffman-La Roche-Financial and operational highlights, 2004-2008 ($ million) 94
Table 14: F. Hoffman-La Roche-Key industry specific ratios, 2004-2008 96
Table 15: Novartis-Financial and operational highlights, 2004-2008 ($ million) 97
Table 16: Novartis-Key industry specific ratios, 2004-2008 99
Table 17: Sanofi-Aventis-Financial and operational highlights, 2004-2008 ($ million) 100
Table 18: Sanofi-Aventis-Key industry specific ratios, 2004-2008 102
Table 19: .Part (1) AstraZeneca-Financial and operational highlights, 2004-2008 ($ million) 103
Table 20: Part (2) AstraZeneca-Financial and operational highlights, 2004-2008 ($ million) 104
Table 21: AstraZeneca-Key industry specific ratios, 2004-2008 105
Table 22: Part(A) Abbott Laboratories-Financial and operational highlights, 2004-2008 ($ million) 106
Table 23: Part(B) Abbott Laboratories-Financial and operational highlights, 2004-2008 ($ million) 107
Table 24: Abbott Laboratories-Key industry specific ratios, 2004-2008 108
Table 25: Merck & Co.-Financial and operational highlights, 2004-2008 ($ million) 109
Table 26: Merck & Co.-Key industry specific ratios, 2004-2008 111
Table 27: Wyeth-Financial and operational highlights, 2004-2008 ($ million) 112
Table 28: Wyeth-Key industry specific ratios, 2004-2008 114
Table 29: Bristol-Myers Squibb Company-Financial and operational highlights, 2004-2008 ($ million) 115
Table 30: Bristol-Myers Squibb Company-Key industry specific ratios, 2004-2008 117

List of Figures
Figure 1: Global pharmaceuticals market, $ billion, 2004-2008 7
Figure 2: Global pharmaceuticals market forecast, $ billion, 2008-2013 8
Figure 3: Global pharmaceuticals market segmentation-product, % share 2008* 9
Figure 4: Global pharmaceuticals market segmentation-geography, % share 2008* 10
Figure 5: Forces driving competition in the global pharmaceuticals market 11
Figure 6: Drivers of buyer power in the global pharmaceuticals market 12
Figure 7: Drivers of supplier power in the global pharmaceuticals market 13
Figure 8: Factors influencing the likelihood of new entrants in the global pharmaceuticals market 14
Figure 9: Factors influencing the threat of substitutes in the global pharmaceuticals market 15
Figure 10: Drivers of degree of rivalry in the global pharmaceuticals market 16
Figure 11: Revenues of global top 10 pharmaceutical companies, $ million, FY2008 18
Figure 12: Revenue growth of global top 10 pharmaceutical companies, 2006-2008 22
Figure 13: Operating performance analysis, FY2008 24
Figure 14: Net profit analysis, FY2008 25

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Worldwide Market for Drug-Eluting, Bare and Other Coronary Stents, 2008-2017

This report details the worldwide market for the use of alternative stent devices in the treatment of coronary artery disease. The report assesses the treatment of coronary artery disease by alternative treatment methodologies (percutaneous intervention with or without stenting, coronary artery bypass grafting alternatives and other medical/surgical treatment options), with estimated current/forecast caseload across treatment types.

The report provides full year (actual) 2008 market size and share data, with forecast market data to 2017, for the U.S., Europe, Asia/Pacific and Rest of World.

The report details currently approved coronary stents, providing data on current and forecast impact on the market. The report also details the current state of product development in bare stents, drug-coated or drug-eluting stents and bioabsorbable stents in coronary applications and details the products under development, the anticipated timeline and impact of their market introduction. The report assesses the current and ten-year forecast global market for coronary stents, with segmentation by U.S., Europe, Asia/Pacific and Rest of World. The report provides competitor market shares by these geographic regions. The leading and key emerging coronary stent manufacturers are profiled with current product offerings, development status and market strengths/advantages.

Table of Contents:

EXECUTIVE SUMMARY

SECTION 1:   CLINICAL BACKGROUND

1.1       Cardiovascular Disorders Applicable for Stent Implantation
1.1.1    Acute Closure
1.1.2    Restenosis After Angioplasty
1.2       Risk Factors for Coronary Heart Disease
1.3       Stenting vs. CABG and Angioplasty
1.4       Alternative Therapies for Coronary Atherosclerosis
1.4.1    Angioplasty With or Without Stenting
1.4.2    Atherectomy
1.4.3    Coronary Artery Bypass Graft (CABG)
1.4.3.1 Open CABG
1.4.3.2 Off-Pump Coronary Artery Bypass (OPCAB)
1.4.3.3 MIDCAB (Minimally Invasive Direct Coronary Bypass)
1.4.3.4 RACAB (Robotic Assisted Coronary Artery Bypass)
1.4.3.5 Other Forms of CABG
1.4.4    Transmyocardial Laser Revascularization (TMR)
1.4.5    Genetic Therapies
1.4.6    HDL Therapy
1.4.7    Drug-Eluting Balloons
1.4.8    Nanoparticles and Other Agents
1.5       Incidence and Prevalence of Cardiovascular Stenting Procedures
1.6       Complications Related to Cardiovascular Stents

SECTION 2:   PRODUCTS, TECHNOLOGIES
2.1       Materials Used in Cardiovascular Stents
2.2       Various Stent Shapes and Resulting Impact
2.3       FDA Approval of Cardiovascular Stents
2.4       Reimbursement of Drug-Eluting Stents
2.5       Bare Metal Stents
2.6       Drug-Eluting Stents
2.6.1    Abbott Vascular
2.6.2    Boston Scientific
2.6.3    Johnson & Johnson/Cordis
2.6.4    Medtronic
2.6.5    Other Drug-Eluting Stent Companies
2.7       Bioabsorbable Stents
2.8       Other Types of Stents
2.9       Legal Proceedings
2.10     Key Clinical Trials
2.10.1  HORIZONS AMI
2.10.2  SYNTAX
2.10.3  SPIRIT
2.10.4  COURAGE
2.10.5  PROTECT
2.10.6  ENDEAVOR
2.10.7  FAME
2.10.8  SORT OUT III
2.10.9  DAPT
2.10.10  ZEST

SECTION 3:   MARKETS FORECASTS AND COMPETITOR SHARES
3.1       Worldwide Market for Coronary Stents
3.1.1    Worldwide Market for Drug-Eluting Coronary Stents
3.1.2    Worldwide Market for Bare Metal Coronary Stents
3.1.3    Worldwide Market for Absorbable Coronary Stents
3.2       U.S. Market for Coronary Stents
3.2.1    U.S. Market for Drug-Eluting Coronary Stents
3.2.2    U.S. Market for Bare Metal Coronary Stents
3.2.3    U.S. Market for Absorbable Coronary Stents
3.3       European Market for Coronary Stents
3.3.1    European Market for Drug-Eluting Coronary Stents
3.3.2    European Market for Bare Metal Coronary Stents
3.3.3    European Market for Absorbable Coronary Stents
3.4       Asia/Pacific Market for Coronary Stents
3.4.1    Asia/Pacific Market for Drug-Eluting Coronary Stents
3.4.2    Asia/Pacific Market for Bare Metal Coronary Stents
3.4.3    Asia/Pacific Market for Absorbable Coronary Stents
3.5       Rest of World (ROW) Market for Coronary Stents
3.5.1    ROW Market for Drug-Eluting Coronary Stents
3.5.2    ROW Market for Bare Metal Coronary Stents
3.5.3    ROW Market for Absorbable Coronary Stents

SECTION 4:   COMPANY PROFILES
4.1       Aachen Resonance GmbH
4.2       Abbott Vascular
4.3       AdvanSource Biomaterials Corporation
4.4       Aeon Bioscience
4.5       Allvivo Vascular, Inc.
4.6       Amaranth Medical, Inc.
4.7       amg International GmbH
4.8       Arterial Remodeling Technologies (ART)
4.9       Atrium Medical
4.10     Avantec Vascular
4.11     B. Braun Melsungen
4.12     Balton Ltd.
4.13     Bioabsorbable Therapeutics, Inc.
4.14     Bioring SA
4.15     Biosensors International
4.16     Biotronik
4.17     Blue Medical Devices B.V.
4.18     Boston Scientific
4.19     Caliber Therapeutics
4.20     Cappella Inc.
4.21     CardioMind, Inc.
4.22     CeloNova BioSciences, Inc.
4.23     CID S.r.l. (Formerly Sorin Vascular Therapy)
4.24     Cinvention AG (Formerly Blue Membranes)
4.25     CorNova
4.26     CV Therapeutics/Gilead Inc.
4.27     Devax
4.28     DISA Vascular
4.29     Elixir Medical Corp.
4.30     Estracure Inc.
4.31     eucatech AG
4.32     Genesis Technologies, LLC
4.33     Global Therapeutics (Cook Medical)
4.34     Hexacath
4.35     ICON Interventional (Formerly ICON Medical Corp.)
4.36     InspireMD
4.37     InTek Technology
4.38     Invatec s.r.l.
4.39     ITGI Medical Ltd.
4.40     Johnson & Johnson
4.40.1  Cordis
4.40.2  Conor Medsystems (J&J)
4.41     JW Medical Systems / Biosensors International
4.42     Kaneka Corporation
4.43     Kyoto Medical Planning Co., Ltd.
4.44     Lepu Medical
4.45     Lutonix, Inc.
4.46     Medinol/ARIAD Pharmaceuticals
4.47     Medlogics Device Corporation (MDC)
4.48     Medtronic Vascular
4.49     Miami Cardiovascular Innovations
4.50     Micell Technologies
4.51     MicroPort Scientific Corporation
4.52     Minvasys
4.53     MIV Therapeutics
4.54     mNEMOSCIENCE GmbH
4.55     MoBeta, Inc.
4.56     NanoInterventions, LLC
4.57     Neovasc, Inc.
4.58     Nexeon MedSystems, Inc.
4.59     Opto Circuits (India) Ltd.
4.59.1  EuroCor GmbH
4.60     OrbusNeich
4.61     Palmaz Scientific, Inc.
4.62     Picarus NV
4.63     Possis Medical (Bayer)
4.64     Prescient Medical
4.65     Relisys Medical Devices
4.66     REVA Medical
4.67     Sahajanand Medical Technologies
4.68     Stentys SAS
4.69     Terumo
4.70     Translumina
4.71     TriReme Medical
4.72     Tryton Medical
4.73     Vascular Concepts
4.74     VasoTech, Inc.
4.75     X-Cell Medical
4.76     Xtent, Inc. (August 3, 2009:  Xtent shareholders approve plan to dissolve and liquidate company after it is unable to raise the necessary funds to continue its stent development.)

APPENDIX I:  SELECTED CLINICAL TRIALS

ABSORB
ARRIVE II Registry
ARTS
AXXESS PLUS
BASKET
BBC ONE
CARE
COREL
COSTAR
COURAGE
CUSTOM
DEScover Registry
DIRECT
DIVERGE
e-HEALING
EASTER Registry
ENDEAVOR
ETHOS
EuroSTAR
EVENT Registry
FAME
GENESIS
FOCUS
HEALING
HORIZONS-AMI
ISAR, ISAR-TEST-2
LONG DES
NOBLESS
NOBORI
NORDIC
OLYMPIA Registry
PASSION
PREPARE
PROGRESS
RESOLUTE
RESORB
REWARD Registries
SERIES
SIMPLE Registries
SIRIUS, E-SIRIUS, C-SIRIUS
SORT-OUT III
SPIRIT
STEALTH
STEMI
STENT Registry
SVELT
TAXUS
TYPHOON
ZEST-AMI
ZOMAXX
APPENDIX II:  COMPANY DIRECTORY

List of Exhibits

Exhibit ES-1: Types of Cardiovascular Disease and Incidence in the United States, 2006
Exhibit ES-2: Prevalence, Mortality and Hospital Discharges for Cardiovascular Disease Patients in the United States
Exhibit ES-3: Potential Complications Related to Implantation of Cardiovascular Stents
Exhibit ES-4: Types of Coronary Stents and Selected Anti-Restenosis Devices
Exhibit ES-5: Worldwide DES Market by Company, Calendar 4th Quarter, 2008
Exhibit ES-6: Worldwide Market for Coronary Stents, by Type, Revenue Forecast, 2008–2017
Exhibit ES-7: Worldwide Market for Drug-Eluting Coronary Stents, by Region, Revenue Forecast, 2008–2017
Exhibit ES-8: Worldwide Market for Bare Metal Coronary Stents, by Region, Revenue Forecast, 2008–2017
Exhibit ES-9: Worldwide Market for Absorbable Coronary Stents, by Region, Revenue, 2012–2017

Exhibit 1-1: Types of Cardiovascular Disease and Incidence in the United States, 2006
Exhibit 1-2: International Death Rates Per 100,000 Population for Total Cardiovascular Disease and Coronary Heart Disease for the Top 20 Countries
Exhibit 1-3: Prevalence, Mortality and Hospital Discharges for Cardiovascular Disease Patients in the United States
Exhibit 1-4: Drug-Eluting Balloon Catheters
Exhibit 1-5: Estimated Inpatient Cardiovascular Procedures, U.S., 2006 (000)
Exhibit 1-6: Number of Discharges, Coronary Atherosclerosis, U.S.
Exhibit 1-7: National Healthcare Cost and Utilization Project Statistics: Mean Charges and In-Hospital Death Rates for Various Cardiovascular Procedures, U.S.
Exhibit 1-8: Total Number of Cardiac Revascularization Discharges and Mean Charges, U.S., 1993–2006
Exhibit 1-9: Total Number of Discharges for PCI Procedures with Non-Drug-Eluting Stents and Mean Charges, U.S., 2002–2006
Exhibit 1-10: Total Number of Discharges for PCI Procedures with Drug-Eluting Stents and Mean Charges, U.S., 2002–2006
Exhibit 1-11: Total Number of Discharges for PCI Procedures with Non-Drug and Drug-Eluting Stent Discharges and Mean Charges, U.S., 2002–2006

Exhibit 2-1: Competitors in the Market for Bare Metal Stents
Exhibit 2-2: Competitors in the Market for Drug-Eluting Stents
Exhibit 2-3: Competitors in the Market for Bioresorbable Stents
Exhibit 2-4: Competitors in the Market for Novel Stent Technologies

Exhibit 3-1: Worldwide Coronary Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-2: Worldwide Drug-Eluting Coronary Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-3: Revenues for Leading Drug-Eluting Stent Market Competitors, Worldwide, 2008
Exhibit 3-4: Worldwide Coronary Bare Metal Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-5: Worldwide Coronary Absorbable Stent Market, Unit and Revenue Forecast, 2012-2017
Exhibit 3-6: U.S. Market for Coronary Stents, by Type, Revenue Forecast, 2008-2017
Exhibit 3-7: U.S. Coronary Drug-Eluting Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-8: Revenues for Leading Drug-Eluting Stent Market Competitors, United States, 2008
Exhibit 3-9: U.S. Coronary Bare Metal Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-10: U.S. Coronary Absorbable Stent Market, Unit and Revenue Forecast, 2013-2017
Exhibit 3-11: European Coronary Stent Market, by Type, Revenue Forecast, 2008-2017
Exhibit 3-12: European Drug-Eluting Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-13: European Coronary Bare Metal Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-14: European Coronary Absorbable Stent Market, Unit and Revenue Forecast, 2013-2017
Exhibit 3-15: Asia/Pacific Market Forecasts for Coronary Stents, by Type, Revenue Forecast, 2008-2017
Exhibit 3-16: Asia/Pacific Drug-Eluting Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-17: Asia/Pacific Coronary Bare Metal Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-18: Asia/Pacific Coronary Absorbable Stent Market, Unit and Revenue Forecast, 2012-2017
Exhibit 3-19: Rest of World Coronary Stent Market, by Type, Revenue Forecast 2008-2017
Exhibit 3-20: Rest of World Drug-Eluting Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-21: Rest of World Coronary Bare Metal Stent Market, Unit and Revenue Forecast, 2008-2017
Exhibit 3-22: Rest of World Coronary Absorbable Stent Market, Unit and Revenue Forecast, 2012-2017

Exhibit 4-1: AdvanSource Biomaterials Third Quarter Financial Results ($000s)
Exhibit 4-2: Medtronic Financial Data, Third Quarter 2009 ($millions)
Exhibit 4-3: Medtronic’s Coronary Stent Revenues, FY 2008 & 2009 ($millions)
Exhibit 4-4: Xtent Financial Data, Fourth-Quarter 2008 ($millions)

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Impending patent expiries, increasing competition and changes in legislation: where will generics go from 2009 onwards? Our new report - World Generics Market 2009-2024 - explains the opportunities and challenges there

The generic pharmaceuticals sector has been expanding strongly in recent years as the need for cheaper medicines worldwide has increased. The next five years from 2009 will see more leading drugs going off patent, thus increasing opportunities for generics producers. Regulations favouring generic products give cause for optimism in the generics sector, while still leaving scope for novel branded drugs. We predict that total revenues in the generics market will continue to increase in the years ahead.

Major players have been moving into the generic drugs market - spearheaded by leading pharma companies and specialist pharma organisations. Established generics companies, such as Teva, are increasing in commercial prominence and international reach. There are many rising challengers in developed and developing countries, inspired by patent expiry on major drugs. What will be the main challenges and the main opportunities in this market from 2009 onwards? Our new report, World Generics Market 2009-2024, investigates such questions in depth, providing you with the information that you need.

This report reveals forecasted sales in the world generics market and in leading national markets, providing detailed quantitative and qualitative data. In particular, World Generics Market 2009-2024 includes generics market forecasts for:

• The US
• Europe (with special focus on Germany, France, the UK, Italy and Spain)
• Japan
• China
• India
• Russia.

Our report also gives in-depth profiles of the five leading generic manufacturers: Teva, Sandoz, Mylan, Watson and Ratiopharm.

Comprehensive analysis of the global generics sector

World Generics Market 2009-2024 examines that sector critically, through a comprehensive review of information sources. This report provides detailed sales forecasts, discussions of developments and analyses of commercial drivers and restraints, including a SWOT analysis. There are 61 tables and figures and a full interview with an expert in the sector. The result is a comprehensive market- and industry-centred report, with detailed analyses and informed opinion to benefit your work.

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In this report you will receive the following benefits in particular:
• You will receive an appraisal of the current world generics market
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• You will receive analyses of the most-promising areas for generic drug development and marketing
• You will receive forecasts for principal geographical markets, especially those with high growth potential
• You will examine strengths and weaknesses of the worldwide generics sector from 2009 onwards, especially commercial drivers and restraints
• You will discover expert opinion from our industry survey.

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Nobody with an interest in the generics sector can afford to overlook this new market study. The market environment in many countries will change, especially with the further rise in economic power of China and India. With an increasing focus on lowering healthcare costs, widening treatment access and patent expiries, this sector holds the potential for high, growing revenues from 2009 onwards. Do you want to know more about the rising generics market? You can stay ahead by ordering this report today.

Table of Contents:

1 Executive Summary
1.1 Aims of This Report
1.2 Chapter Overview

2 Overview of the World Generics Market
2.1 Generic Drugs: An Introduction
2.1.1 Authorised, Branded and True Generics
2.2 Evergreening
2.3 Limited Growth in the World Pharmaceutical Market
2.4 Branded Pharmaceuticals: Is the Business Model Crumbling?
2.5 US Regulations
2.5.1 Obtaining FDA Approval: NDAs and ANDAs
2.5.2 The Hatch-Waxman Act: Promotion of Generic Drugs
2.5.3 The Hatch-Waxman Act: Incentives for the Branded Industry
2.5.4 Consequences of the Hatch-Waxman Act
2.5.5 Me First: Timing as a Key Factor
2.6 European Regulations
2.6.1 Generics Entry into the European Markets
2.6.2 Further Protection of Branded Products in the European Market
2.6.3 Variations Between European Countries
2.6.4 Moving Towards Standardisation
2.6.5 The 8+2+1 Rule
2.7 Japanese Regulations
2.8 Compulsory Licensing
2.9 Generic Drugs: An Overview

3 Generic Products World Market Forecast 2009-2024
3.1 Generic Products Versus Branded Pharmaceuticals
3.2 Sales Forecast 2009-2024
3.3 Blockbuster Patent Expiries: The Fall of Giants
3.4 Implications of the Current Financial Climate
3.5 Key Patent Expiries: An Overview 2009-2014
3.5.1 Expected Key Patent Expiries in 2009
3.5.2 Expected Key Patent Expiries in 2010
3.5.3 Expected Key Patent Expiries in 2011
3.5.4 Expected Key Patent Expiries in 2012
3.5.5 Expected Key Patent Expiries in 2013
3.5.6 Expected Key Patent Expiries in 2014
3.5.7 Expected Key Patent Expiries 2009-2014: A Summary
3.6 Big Pharma Enters the Generics Market
3.7 Major Geographical Markets
3.7.1 A Shift in Market Share?
3.8 Key Therapeutic Areas

4 The US Generics Market 2009-2024
4.1 Analysis of the Current Market
4.2 Sales for the US Generics Market: Forecast 2009-2024
4.3 Is Market Penetration Reaching a Saturation Point?
4.4 Growing Consumer Acceptance of Generic Medicines
4.5 The ANDA Backlog
4.6 Declining Market Share
4.7 Regulatory Environment
4.8 Concluding Remarks

5 The European Generics Market 2009-2024
5.1 Analysis of the Current Generics Market in Europe
5.2 Sales for the European Generics Market: Forecast 2009-2024
5.2.1 The Generics Market Varies Within the EU
5.2.2 Pricing and Reimbursement
5.2.3 Key Challenges to Generic Medicines in Europe
5.3 The German Generics Market
5.3.1 Sales for the German Generics Market: Forecast 2009-2024
5.3.2 High Public Acceptance of Generic Products
5.3.3 “Aut Idem” Regulations Encourage Generics Substitution
5.3.4 The Future of the German Generics Market
5.4 The French Generics Market
5.4.1 Sales for the French Generics Market: Forecast 2009-2024
5.4.2 The Future of the French Generics Market
5.5 The UK Generics Market
5.5.1 Sales for the UK Generics Market: Forecast 2009-2024
5.5.2 Generics Prescribing Due to Increasing Cost Pressures
5.5.3 Reducing Generics Prices: the Drug Tariff System
5.5.4 The Increasing Role of Pharmacists
5.5.5 Easy Entry, Strong Price Competition
5.5.6 The Future of the UK Generics Market
5.6 The Spanish Generics Market
5.6.1 Sales for the Spanish Generics Market: Forecast 2009-2024
5.6.2 Low Price Differences Between Generic and Originator Drugs
5.6.3 Prescribing Practices are Limiting Growth
5.6.4 The Future of the Spanish Generics Market
5.7 The Italian Generics Market
5.7.1 Sales for the Italian Generics Market: Forecast 2009-2024
5.7.2 Steps Towards Higher Generics Penetration
5.7.3 Intellectual Property in Italy
5.8 Concluding Remarks

6 The Japanese Generics Market 2009-2024
6.1 Analysis of the Current Market
6.2 Sales for the Japanese Generics Market: Forecast 2009-2024
6.3 The Regulatory Environment
6.3.1 Boosting Generic Products
6.4 Prescribers’ Attitude is a Major Obstacle
6.5 Mergers and Acquisitions
6.6 Concluding Remarks

7 Emerging Generics Markets 2009-2024
7.1 Increased Economic Power
7.2 India
7.2.1 Sales for the Indian Generics Market: Forecast 2009-2024
7.2.2 India’s Patent Law
7.2.3 Section 3(d) of the Indian Patents Act
7.2.4 International Success of India’s Pharmaceutical Industry
7.3 China
7.3.1 Sales for the Chinese Generics Market: Forecast 2009-2024
7.3.2 Pricing and Reimbursement
7.3.3 Patent Law
7.3.4 China or India?
7.4 Russian Federation
7.4.1 Sales for the Russian Federation Generics Market: Forecast 2009-2024
7.4.2 Imported Versus Domestic Pharmaceuticals
7.4.3 Pharmaceutical Distribution and Financial Strains
7.4.4 Per Capita Consumption Rates are Low
7.4.5 Prospects for the Russian Market
7.5 Concluding Remarks

8 Leading Generics Companies
8.1 Teva Pharmaceutical Industries
8.1.1 World Sales for Teva in 2008
8.1.2 Geographical Breakdown of Sales
8.2 Novartis’ Sandoz
8.2.1 Sales and Presence in the Major Geographical Regions
8.3 Mylan Inc
8.3.1 Acquisitions
8.3.2 International Presence
8.4 Watson Pharmaceuticals
8.4.1 International Presence
8.5 Ratiopharm
8.5.1 International Presence
8.5.2 The Future for Ratiopharm

9 Market Drivers and Restraints
9.1 Primary Drivers
9.1.1 The Ageing Population: Opportunities for Growth
9.1.2 Healthcare on a Budget
9.1.3 Generics Penetration Rates in the Developed World
9.1.4 Opportunities in the Emerging Markets
9.1.5 Supergenerics
9.1.6 Generics Companies: Bulking Up
9.1.7 Mergers and Acquisitions
9.2 Primary Restraints
9.2.1 Dependency on Branded Pharmaceuticals
9.2.2 Branded Resistance
9.2.3 Biogenerics: Not as Easy as Small Molecules
9.2.4 Rigid Intellectual Property Laws

10 Expert Opinion
10.1 Charlie Mayr, GPhA
10.1.1 The Value of the Generics Market
10.1.2 Main Challenges for the US Generics Market
10.1.3 On Authorized Generic Products
10.1.4 On Biogeneric Products

11 Conclusions
11.1 Generics Penetration Reaching Maturity?
11.2 Patent Expiries: A Key Growth Driver
11.3 Dependence on the Brands: A Thinning Pipeline
11.4 Price Declines and Volume Increases
11.5 Summary of Forecasts
11.6 Concluding Remarks

List of Tables
Table 3.1 Generics World Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 3.2 Major Patent Expiries by World Sales ($bn), 2009-2014
Table 3.3 Patent Expiries by Number, 2009-2014
Table 3.4 Expected Key Patent Expiries, 2009
Table 3.5 Expected Key Patent Expiries, 2010
Table 3.6 Expected Key Patent Expiries, 2011
Table 3.7 Expected Key Patent Expiries, 2012
Table 3.8 Expected Key Patent Expiries, 2013
Table 3.9 Expected Key Patent Expiries, 2014
Table 3.10 Major Generics Markets, Market Share (%), 2008
Table 3.11 Major Therapeutic Areas in the Generics Market, Market Share (%), 2008
Table 4.1 US Generics Market, Sales ($bn) and Growth (%), 2008 -2014, 2019, 2024
Table 5.1 European Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.2 Key Challenges Affecting EU Generics Markets
Table 5.3 German Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.4 French Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.5 UK Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.6 UK Department of Health Classes of Generic Drugs
Table 5.7 Spanish Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 5.8 Italian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 6.1 Japanese Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.1 Indian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.2 Chinese Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 7.3 Russian Generics Market, Sales ($bn) and Growth (%), 2008-2014, 2019, 2024
Table 8.1 Leading Companies in the Generics Market, World Sales ($bn) and Market Share (%), 2008
Table 8.2 Teva World Sales ($bn) by Therapeutic Class
Table 8.3 Teva Top Selling Products, World Sales ($bn), 2008
Table 8.4 Teva Sales ($bn) by Geographical Region, 2008
Table 8.5 Mylan World Sales ($bn) by Therapeutic Class, 2008
Table 8.6 Mylan Inc Sales Share (%) by Geographical Region, 2008
Table 8.7 Watson Pharmaceuticals World Sales ($bn) by Therapeutic Class, 2008
Table 8.8 Ratiopharm World Sales ($bn) by Therapeutic Class, 2008
Table 8.9 Ratiopharm Sales ($m) and Sales Share (%) by Geographical Region, 2008
Table 9.1 SWOT Analysis for The World Generics Market, 2009

List of Figures
Figure 3.1 Generic Products Versus Branded Pharmaceuticals, Market Share (%), 2008
Figure 3.2 Generics World Market Sales ($bn), 2008-2024
Figure 3.3 Expected Key Patent Expiries by Sales ($bn), 2009-2014
Figure 3.4 Major Generics Markets, Market Share (%), 2008
Figure 3.5 Key Generics Markets, Market Share (%), 2009
Figure 3.6 Key Generics Markets, Market Share (%), 2014
Figure 3.7 Key Generics Markets, Market Share (%), 2019
Figure 3.8 Key Generics Markets, Market Share (%), 2024
Figure 3.9 Major Therapeutic Areas in the Generics Market, Market Share (%), 2008
Figure 4.1 US Generics Market Sales ($bn), 2008-2024
Figure 5.1 European Generics Market Sales ($bn), 2008-2024
Figure 5.2 German Generics Market Sales ($bn), 2008-2024
Figure 5.3 French Generics Market Sales ($bn), 2008-2024
Figure 5.4 UK Generics Market Sales ($bn), 2008-2024
Figure 5.5 Spanish Generics Market Sales ($bn), 2008-2024
Figure 5.6 Italian Generics Market Sales ($bn), 2008-2024
Figure 6.1 Japanese Generics Market Sales ($bn), 2008-2024
Figure 7.1 Indian Generics Market, Sales ($bn), 2008-2024
Figure 7.2 Chinese Generics Market, Sales ($bn), 2008-2024
Figure 7.3 Russian Generics Market, Sales ($bn), 2008-2024
Figure 7.4 Chinese, Indian and Russian Generics Markets, Growth (%), 2009, 2014, 2019, 2024
Figure 7.5 Chinese, Indian and Russian Generics Markets, Market Share (%), 2009, 2014, 2019, 2024
Figure 8.1 Leading Companies in the Generics Market, Market Share (%), 2008
Figure 8.2 Teva Sales Share (%) by Geographical Region, 2008
Figure 8.3 Divisions of Novartis by Sales ($bn), 2008
Figure 8.4 Mylan Inc Sales Share (%) by Geographical Region, 2008
Figure 8.5 Ratiopharm Sales Share (%) by Geographical Region, 2008

Companies Listed

Abbott
Actavis
Apotex
Arrow Group (Watson Pharmaceuticals)
AstraZeneca
Aurobindo (Pfizer)
Barr Pharmaceuticals (Teva)
Bayer
Blue Cross Blue Shield Association
Boehringer Ingelheim
Bristol-Myers Squibb
British Generics Manufacturers Association (BGMA)
Centers for Medicare and Medicaid Services
Daiichi-Sankyo
Dr. Reddy’s Laboratories
Eisai
Eli Lilly
European Generic Medicines Association (EGA)
European Medicines Agency (EMEA)
Food and Drug Administration (FDA)
Generic Pharmaceuticals Association (GPhA)
German Pharmacy Association
GlaxoSmithKline
Greenstone (Pfizer)
Hospira
International Federation of Pharmaceutical Manufacturers Associations
Italian Generics Association (Assogenerici)
Johnson & Johnson
Kowa Company Ltd
Lundbeck
Merck & Co
Millennium Pharmaceuticals (Takeda)
Mylan Inc
National Health Service (NHS)
Novartis
Otsuka
Pfizer
Procter & Gamble
Purdue/Mundipharma
Ranbaxy
Ratiopharm
Roche
Sandoz (Novartis)
Sanofi-Aventis
Schering-Plough
Sciele Pharma (Shionogi)
Shionogi
Shire
Spanish Association of Generic Medicines
Stada Healthcare
Sun Pharma
Takeda
Teva Pharmaceutical Industries
UCB
Watson Pharmaceuticals
World Trade Organization (WTO)
Wyeth

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Medical Nanotechnology Markets

Nanotechnology has reached critical mass. Nowhere is this more evident than in medicine. Rising medical costs, demands for less-invasive procedures and pressures for immediate feedback of medical conditions, all point to nanotechnology as offering a new approach in healthcare. According to U.S. National Science Foundation estimates, by 2015 the annual global market for nano-related goods and services will top $1 trillion, thus making it one of the fastest-growing industries in history. Assuming that these figures prove to be accurate, nanotechnology will emerge as a larger economic force than the combined telecommunications and information technology industries at the beginning of the technology boom of the late 1990s.

This TriMark Publications report covers the specific segments of the medical nanotechnology markets, with particular emphasis on those segments where this emerging technology is or shows the potential to be most impactful. Nanotechnology, a field of science and technology that aims to control matter at the atomic, molecular and macromolecular level, potentially has far-reaching and paradigm-shifting implications for biology, drug discovery and medical technologies. The discipline has already yielded healthcare discoveries that have been used for drug delivery and diagnostic purposes. In this study, we describe various nanotechnologies under development for biological and medical purposes and assess their potential. Moreover, this analysis is arranged to provide an overview of the regulatory issues faced by the medical nanotechnology industry and focuses on how specific segments within the industry are poised for high future growth.

Table of Contents:

1 Overview 6
1.1 Statement of Report 6
1.2 About This Report 6
1.3 Scope of the Report 8
1.4 Methodology 8
1.5 Executive Summary 10

2 Medical Products (Drugs, Devices and Nutraceuticals) Nanotechnology Markets 13
2.1 Background 13
2.2 Market Calculations 13
2.3 Market Demands 14
2.4 Market Overview 18
2.4.1 The Role of Nanotechnologies in Medicine 18
2.4.2 Nanotechnology Sector Challenges 21
2.4.3 Nanotechnology Sector Drivers 21
2.4.4 Nanotechnology Sector Restraints 21
2.5 Nanotechnology Medical Product Market Segments 21
2.5.1 Overview 21
2.5.2 World Markets 22
2.5.3 U.S. Market 24
2.5.4 European Market 25
2.5.5 Japanese Market 26
2.5.6 Asian Market 27
2.5.7 Middle East 29
2.5.8 ROW 30

3 Medical and Life Science Nanotechnology Markets 32
3.1 Nano-Particles 33
3.2 Market for Nano-Particles in Life Sciences and Medicine 34
3.2.1 Key Players 34
3.2.2 Application Manufacturers 36
3.3 Dendrimers 36
3.3.1 PAMAM Dendrimers 36
3.3.2 Market for Nanocapsules in Life Sciences and Healthcare 37
3.3.3 Key Players 37
3.4 Market for Nanoporous and Nanostructured Materials in Life Sciences and Healthcare 37
3.4.1 Key Players 37
3.4.2 Nanofiltration 38
3.5 Nanodevices, Nanosensors and Quantum Dots 38
3.5.1 Sector Overview 38
3.5.2 Market for Quantum Dots in Life Sciences and Medicine 39
3.5.3 Commercial Applications for Quantum Dots 39
3.5.4 Key Players 40
3.5.5 Nanomaterials Suppliers 41
3.5.6 Application Manufacturers 41
3.6 Nanocoatings 42
3.7 Nanocomposites 42
3.8 Nanoarrays 42
3.8.1 Bead NanoArrays: A High-Sensitivity Detection System 43
3.9 Fullerenes 43
3.9.1 Key Applications and Market Opportunities 44
3.9.2 Medical Market Uses for Carbon Nanotubes 44
3.9.3 Key Players, Including Application Manufacturers, End Users and Nanomaterials Suppliers 45
3.10 Liposome-like Nano-Particles 45
3.10.1 Nanostructured Lipid Carriers 46
3.10.2 DauxoXome® Liposomal Formulation 46
3.11 Nanosensors 46
3.11.1 Microcantilever Sensors and Photonic Sensors 46
3.11.2 Field-Effect Nanoplate Devices 46
3.11.3 Electrochemical-Transducing Electrode Systems 47

4 Technology Issues 48
4.1 Nanotechnology in Drug Delivery and Development 48
4.1.1 Drug Delivery Using Nanotechnology 50
4.1.2 Design of Nanotechnology-Based Drug Delivery Systems 52
4.1.3 Using Magnetic Nano-Particles in Targeted Drug Delivery 53
4.1.4 Cancer Drug Delivery 53
4.1.5 Nano-Particle-Mediated Delivery of siRNA 55
4.1.6 Targeting Angiogenesis with Nano-Particles 55
4.1.7 Nanosystems and Inflammation 56
4.1.8 The Chiral Drug Development Process 56
4.1.9 Reasons Why the Drug Delivery Market is Rapidly Expanding 57
4.2 Categories of Medical Nanotechnology Products 57
4.2.1 Surgical Steel Devices 58
4.2.2 Contrast-Enhancing Agents for MRI (Magnetic Resonance Imaging) 58
4.2.3 Wound Dressings / Anti-Microbial Textiles 59
4.2.4 Nanocoated Surgical Blades 59
4.2.5 Suture Needles and Microneedles 59
4.2.6 Catheters for Minimally-Invasive Surgery 59
4.2.7 Optical Nanosurgery 59
4.2.8 Nanocoated or Nanocontoured Implant Surfaces 60
4.3 Biosensors and Biodetection 60
4.3.1 Cantilever Arrays 60
4.3.2 Nanosensors 60
4.3.3 Optical Sensors 60
4.3.4 Nano-Particle Sensors and Detectors 61
4.3.5 In Vitro Diagnostics 61
4.3.6 Imaging, In Vivo Diagnosis and Theranostics 64
4.4 Vaccines-Virus-Like Particles (VLPs) 65
4.5 Transdermal Drug Delivery 65
4.6 Phage Microarrays 65
4.7 Neuroscience 66
4.8 Nanotechnology Materials for Medical Products 67
4.8.1 Dental Materials 67
4.8.2 Bone Replacement 68
4.8.3 Contact Lenses 68
4.9 New Drug Development 68
4.10 Future Directions 69
4.10.1 Sources of Nano Development 69
4.10.2 Commercialization 70
4.10.3 Current/Pending Clinical Trials on New Products and Emerging Technologies 70
4.10.4 Future Directions 72
4.11 Key Technology Findings for Medical Uses of Nanotechnology 72

5 Business Trends 74
5.1 Market Forces 74
5.1.1 Market Drivers 74
5.1.2 Market Restraints 74
5.1.3 Medical / Clinical Studies 74
5.1.4 Demographics 75
5.2 Market Prospects 75
5.3 Marketing and Distribution 75
5.4 Competitive Landscape 76
5.5 Business Developments 76
5.5.1 Drug Pedigrees 76
5.6 Acquisitions and Partnerships 77
5.7 Key Players 77
5.8 Patent Climate 77
5.9 Investment Climate 78
5.9.1 U.S. Government 79
5.9.2 Europe 80
5.10 Venture Capital Environment 80
5.10.1 Medical and Health Nanotech Venture Companies 81
5.10.2 Pharma and Biotech Nanotech Venture Companies 83
5.11 Business Strategies for Medical Nanotechnology 88
5.12 Nanotechnology Questions 90
5.12.1 What Are the Near-Term Business Opportunities in the Medical Nanotechnology Markets? 90
5.12.2 What Are the Business Models Currently Used by Companies in the Medical Nanotechnology Markets? 90
5.12.3 How Will Manufacturers, Researchers, Physicians, Patients and Payers Influence the Medical Nanotechnology Markets? 91
5.12.4 What Are the Drivers and Bottlenecks Influencing the Medical Nanotechnology Markets? 91
5.12.5 What Are the Current and Emerging Technologies used in the Medical Nanotechnology Markets? 91
5.12.6 Who Holds the Proprietary Rights to the Medical Nanotechnology Markets, Especially in such a Multidisciplinary Environment? 92
5.12.7 What Are Current Applications of These Technologies? 92
5.12.8 What Regulatory Processes Must Medical Nanotechnology Undergo in the U.S., Japan and Europe? 92
5.12.9 How Will New or Emerging Medical Nanotechnologies Change Treatment and Payment Paradigms? 92
5.12.10 How Will Medical Nanotechnologies Reduce Adverse Clinical Reactions and Decrease Total Patient Care Cost? 93
5.12.11 How Will Medical Nanotechnology Reduce Healthcare Expenditures? 93
5.12.12 How Will Medical Nanotechnology Decrease Patient Diagnostic Testing Costs? 93
5.12.13 What is the Role of Nanotechnology in Drug Development? 93
5.12.14 Which Medical Nanotechnology Product Categories Are Driving Growth? 94
5.12.15 How Are Biomarkers Being Developed Using Nanotechnology? 94
5.12.16 What Companies Are Developing Nanotechnology Drug Delivery Systems? 94
5.12.17 How Are Nano-Optical Tagging Technologies Used in Animal Drug Safety Assessment Studies? 94
5.12.18 What Nanotechnology Platforms Are Being Used in Point of Care Diagnostic Testing? 95

6 Technology Assessment 96
6.1 Current Technologies for Nano 96
6.1.1 Nanodiagnostics 96
6.1.2 Competitive Analysis of Nano-Particle Assays 99
6.1.3 In Vivo Imaging 99
6.1.4 In Vitro Clinical Diagnostics 99
6.2 Future Technologies 101
6.3 Technology Accelerators, Roadblocks and Challenges 103
6.3.1 Technology Accelerators 103
6.3.2 Technology Roadblocks and Challenges 103
6.3.3 Public Awareness 104
6.4 Nanotechnology Product Trends and New Concepts for Medical Applications 106
6.4.1 Market Trends-Diagnostics 106
6.4.2 Market Trends-Therapies 115
6.4.3 Market Trends-Preventive and Other 120
6.4.4 Nanofibers in Medical Applications 124
6.4.5 Dental Applications 125
6.4.6 Optical Applications 126
6.5 Production Methods 126

7 Medical Nanotechnology Market Regulation and Reimbursement 128
7.1 Market Segments 128
7.1.1 Diagnostics 128
7.1.2 Therapies 128
7.1.3 Preventive 128
7.2 Customer Needs 128
7.3 Competitor Analysis 128
7.4 Pricing Pressures 129
7.5 U.S. Medicare and Other Government Agency Issues 129
7.6 Third-Party Reimbursement 129
7.7 Regulatory Trends 129
7.7.1 Regulatory Policy for Nanotechnology Drugs and Medical Devices 130
7.7.2 Current Good Manufacturing Practices (cGMPs) 133
7.7.3 Current Progress 134
7.7.4 Future Regulatory Trends 134
7.7.5 Key Issues 136
7.7.6 Labeling Requirements 136
7.8 Government Initiatives 136
7.8.1 NNI Research Centers 137
7.8.2 NNI Centers and Networks of Excellence 137
7.8.3 FDA’s Nanotechnology Task Force 137
7.8.4 Dutch Government Nano Action Plan 138
7.8.5 Other Research Centers 138
7.9 Medical Regulatory and cGMPs Issues 139
7.10 New Technology Concerns 140
7.11 Use Environment 141
7.11.1 Cancer 141
7.11.2 Medical Review 141
7.12 Risk Assessment 141
7.12.1 Risk Management (ISO 14971:2007) 141
7.12.2 Toxicology Assessment 141
7.12.3 Safety Evaluation 142
7.13 Cautions for Medical Nanotechnology Platforms 144
7.13.1 ETUC Precautionary Principle Applied to Nanotechnologies 145
7.13.2 Possible Risks to Human Health from Nanotechnology Products 145

8 Corporate Profiles 146
8.1 Abbott Laboratories 146
8.2 Abraxis Biosciences 146
8.2.1 NDA Pipeline 147
8.3 Aduro BioTech 148
8.4 Advanced Magnetics (AMAG Pharmaceuticals) 148
8.5 Alnis BioSciences 149
8.6 APP Pharmaceuticals 149
8.7 Arrowhead Research Corporation 150
8.8 Baxter International 151
8.9 Bristol-Myers Squibb 151
8.10 Caliper 151
8.11 Capsulution NanoScience AG 152
8.12 CytRx Corporation 152
8.13 Dendritech, Inc. 152
8.14 Dendritic Nanotechnologies, Inc. 152
8.15 Dow Chemical 153
8.16 DuPont 153
8.16.1 The Framework 155
8.17 Elan Drug Delivery (see also Bristol-Myers Squibb) 156
8.18 Evident Technologies 157
8.19 Evolved Nanomaterial Sciences (ENS) 157
8.20 Flamel Technologies 157
8.21 General Electric 160
8.22 GlaxoSmithKline 160
8.23 Honeywell International 160
8.24 Invitrogen 161
8.25 Nano-C 162
8.26 Nanocyl SA 163
8.27 Nanogen, Inc. 163
8.28 Nanolab Systems 164
8.29 NanoPass Technologies, Ltd. 164
8.30 Nanophase Technologies Corporation 164
8.31 Nanospectra Biosciences 165
8.32 Nanosphere, Inc. 165
8.33 Nanosys 166
8.34 New England Precision Grinding (NEPG) 166
8.35 Novartis 167
8.36 Novavax 167
8.37 Nucryst (Westaim) Pharmaceuticals 168
8.38 Orthovita 168
8.39 Phillips 168
8.40 pSivida Corporation 169
8.41 Quantum Dot Corporation 169
8.42 Roche 170
8.43 Sandvik Bioline 170
8.44 Starpharma Holdings, Limited 171
8.45 Sigma Aldrich 172
8.46 Wyeth Pharmaceuticals 173

9 Appendix: Nanotechnology References 174

10 Appendix: Glossary of Terms in Nanotechnology 175
10.1 Bionanotechnology 175
10.1.1 Nanopore Sequencing 175
10.1.2 Cantilevers with Functionalized Tips 175
10.1.3 Microneedles 175
10.1.4 Microchips for Drug Delivery 175
10.1.5 Nucleic Acid Lattices and Scaffolds 176
10.1.6 Nanofibers as Biomaterials 176
10.1.7 Carbon Nanotubes 177
10.2 Definition of Nano-Particles with Biological and Medical Applications 177
10.2.1 Superparamagnetic Iron Oxide Crystals 177
10.2.2 Quantum Dots 178
10.2.3 Dendrimers 178
10.2.4 Polymeric Micelles 178
10.2.5 Liposomes 178
10.2.6 Nanospheres 179
10.2.7 Aquasomes (Carbohydrate-Ceramic Nano-Particles) 179
10.2.8 Polyplexes/Lipopolyplexes 179

11 Appendix: NNI Centers and Networks of Excellence 180
11.1 National Science Foundation 180
11.2 Department of Energy 181
11.3 Department of Defense 181
11.4 National Aeronautics and Space Administration (NASA) 182
11.5 National Institute for Occupational Safety and Health 182
11.6 National Institute of Standards and Technology 182
11.7 National Institutes of Health 182

List of Figure :

Figure 2.1: End-User Markets for Nanotechnology, 2007 15
Figure 2.2: Nanometer Scale 18
Figure 2.3: International Per Capita Healthcare Spending by Country, 2006 22
Figure 2.4: World Nanomedical Market Shares, 2007 23
Figure 2.5: Total Spending on Healthcare in the U.S., 1960 to 2007 24
Figure 3.1: Nanotechnology Applications 33
Figure 3.2: Carbon Nanotubes 44
Figure 4.1: Depiction of nab Technology 49
Figure 7.1: FDA Product Validation Chart 133
Figure 7.2: FDA Product Lifecycle Model 135
Figure 8.1: Sigma Aldrich Sales Distribution 172

List of Table :

Table 2.1: Global Market for Nanotechnology Products, 2005 to 2013 15
Table 2.2: Nanotechnology Materials for Consumer Products, 2005 to 2013 16
Table 2.3: Nanotechnology Markets Worldwide by Industry, 2002 to 2015 16
Table 2.4: Nanotechnology Development Worldwide by Region, 2002 to 2015 16
Table 2.5: Currently-Growing Nanofabrication Techniques 18
Table 2.6: Global Nanomedicine Market, 2004 to 2013 22
Table 2.7: Nanomedicine Market Revenues by Product Segment, 2007 23
Table 2.8: Global Nanomedicine Market by Geographic Segment, 2004 to 2013 23
Table 2.9: U.S. Nanomedicine Market, 2004 to 2013 24
Table 2.10: European Nanomedicine Market, 2004 to 2013 25
Table 2.11: Japanese Nanomedicine Market, 2004 to 2013 26
Table 2.12: Japanese Nanotechnology Product Market Forecast 27
Table 2.13: Government Funding for Nanotechnology Research and Development, 1997 to 2008 30
Table 2.14: Global Nanotechnology R&D Spending, 1997 to 2013 30
Table 2.15: Global Growth in Nanotechnology R&D, 1997 to 2013 31
Table 3.1: Global Market for Nanotechnology Applications in the Life Sciences, 2005 to 2012 32
Table 3.2: Market for Nano-Particles in Life Sciences and Medicine, 2004 to 2012 34
Table 3.2: Market for Nanostructured Materials in Life Sciences and Medicine, 2004 to 2012 37
Table 3.4: Market for Nanodevices in Life Sciences and Medicine, 2004 to 2012 39
Table 3.5: Commercial Applications of Quantum Dots 40
Table 3.6: Market for Nanocomposites in Life Sciences and Medicine, 2004 to 2012 42
Table 3.7: Liposomal Formulations Used in Nanotechnology 45
Table 3.8: Types of Nanoparticulate Drug Delivery Systems 47
Table 4.1: FDA-Approved Drugs Developed with Nanotechnology-Based Formulations 49
Table 4.2: Key Effectors of Drug Delivery Using Nanomaterials 50
Table 4.3: Nanoscale Applications for Drug Delivery in Pharmaceutical Drug Development 51
Table 4.4: Drug Delivery Nanotechnology Market Drivers Ranked in Order of Impact 51
Table 4.5: Drug Delivery Nanotechnology Market Restraints Ranked in Order of Impact 51
Table 4.6: Anti-Cancer Drugs Formulated Using Nanomaterials 54
Table 4.7: Nanomaterials for in vitro RNAi Delivery 54
Table 4.8: Use of Peptide-Based Nanotubes for Biological Active Targets 55
Table 4.9: Lab-on-Chip and Microfluidic Chip Technology Innovations 62
Table 4.10: Diagnostic Nanotechnology Market Drivers Ranked in Order of Impact 63
Table 4.11: Diagnostic Nanotechnology Market Restraints Ranked in Order of Impact 63
Table 4.12: FDA-Approved In Vivo Imaging Materials Developed with Nanotechnology-Based Formulations 64
Table 4.13: Application Areas for Phage Nanotechnology Platforms 66
Table 4.14: Application Areas for Neuroscience Nanotechnology Platforms 66
Table 4.15: Nanotechnology Application Areas for Medical Nanomaterials 67
Table 4.16: FDA-Approved Dental Biomaterials Developed with Nanotechnology-Based Formulations 68
Table 4.17: Drug Discovery Nanotechnology Market Drivers Ranked in Order of Impact 68
Table 4.18: Drug Discovery Nanotechnology Market Restraints Ranked in Order of Impact 68
Table 4.19: Examples of Proposed U.S. NNI Interagency Collaborative Activities 70
Table 5.1: Medical Nanotechnology Market Drivers-Global, 2008 to 2016 75
Table 5.2: Medical Nanotechnology Market Restraints-Global, 2008 to 2016 75
Table 5.3: U.S. Nanotechnology Patents Issued per Year, 1996 to 2006 78
Table 5.4: Sources of Nanotechnology Funds 79
Table 5.5: National Government Funding Leaders for Nanotechnology, 2007 79
Table 5.6: Total Investments in Venture-Backed Nanotechnology Companies, 1997 to 2008 81
Table 5.7: Leading Nanotechnology Start-Up Companies 81
Table 6.1: Summary of Key Advantages for Nanotechnology 96
Table 6.2: Nanotechnology Platforms Used for Diagnostics and Imaging 96
Table 6.3: FDA-Approved In Vitro Diagnostics Developed with Nanotechnology-Based Formulations 97
Table 6.4: Applications of Veridex Nanotechnology Platform for Diagnostic Assays 98
Table 6.5: Characteristics of Gold Nano-Particle Technology for Diagnostic Testing 100
Table 6.6: Overview of Future Nanomedical Technology Development 101
Table 6.7: Recent Developments in Nanotechnology for Drug Delivery and Drug Discovery 101
Table 6.8: Recent Developments in Nanomaterials and Nanotechnology-Based Devices 102
Table 6.9: Recent Nanotechnology Applications in Diagnostics 102
Table 6.10: Future Nanomedical Technology Platforms 102
Table 6.11: Additional Global Market Trends 127
Table 8.1: AMAG Nanotechnology Products and Candidates 149

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Human embryonic stem cells (hESCs) are stem cells derived from the inner cell mass of a blastocyst, which is a stage reach 4-5 days post fertilization. hESCs are the most pluripotent of all stem cell types and can develop into over 200 different cell types of the human body.

hESCs were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman, and independently by Gail R. Martin. In 1995, the first successful culturing of embryonic stem cells from non-human primates occurred at the University of Wisconsin-Madison. Another breakthrough followed at the University of Wisconsin-Madison in November 1998 when a group led by Dr. James Thomson developed a technique to isolate and grow hESCs derived from human blastocysts. Federal funds to support hESC research became available on August 9, 2001, when President Bush announced his decision regarding federal funding for hESC research.

Because of their plasticity and unlimited capacity for self-renewal, hESCs have been proposed for use in wide range of applications, including toxicology testing, tissue engineering, cellular therapies, and basic stem cell biology research. Of particular interest to the medical community is the potential for use of hESCs to heal tissues with naturally limited capacity for renewal, such as the human heart, liver and brain.

This market report recognizes that a wide range of products and services are needed to support this active and well-funded research community. Thus, this report provides:

* Discussion of key advances in hESC research
* A breakdown of hESC research applications, including shared priorities and priorities by segment
* hESC patent analysis
* Historical and future growth projections for the hESC market
* Competitive analysis of providers of hESC research tools
* Overview of specialty pharma companies developing hESC therapies
* Overview of toxicology testing legislation impacting use of hESC in toxicology applications
* A breakdown of hESC research product categories
* Suggestions for novel NSC research products, including cells, kits, assays, media and reagents
* Guidance for companies that wish to offer hESCs products
* And more…

Table of Contents:

I. Background

A. Human Embryonic Stem Cells (hESC)
B. Brief History
C. Use in Treatment of Disease
D. Human Embryonic Stem Cell Line Availability

II. Available Stem Cell Lines

A. NIH Registry Approved
B. Sources of Additional Published hESC Lines
C. Sources of Additional Unpublished hESC Lines

III. Applications

A. Basic Stem Cell Biology
B. Cellular Therapies

1. Overview
2. Heart Regeneration
3. Pancreatic Islet Cell Replacement
4. Neural Regeneration

C. Tissue Engineering
D. Toxicology Testing

IV. Application Priorities

A. Overall

1. Cell-Based Therapies: Greatest shared priority across research community

a. Beneficial hESC Characteristics
b. hESC Safety Concerns
c. hESC Characterization in Vitro
d. hESC Characterization in Vivo

2. Toxicology Assessment: Another area of huge potential

a. Overview
b. Commercial Interest

B. By Segment

1. Academic
2. Biotech
3. Pharma

V. Patents

A. Key U.S. Neuronal Stem and Progenitor Cell Patents

B. Additional Key U.S. Patents

1. Geron Corporation
2. Regents of the University of California
3. BresaGen Inc.
4. Regeneron Pharmaceuticals, Inc.
5. Vanderbuilt University

C. Additional Key European Patents

1. ES Cell International PTE Ltd.
2. DNAVEC Research Inc.
3. University of Edinburgh

VI. Historical and Future Growth Projections

A. PubMed Analysis

1. Historical Analysis (Trailing 10 Years)
2. Future Growth Predictions (5-Year Forecasts)
3. Breakdown of ESC Research by Species

B. CRISP Analysis
C. Patent Analysis

1. All Fields
2. Abstract Only

VII. hESC PRODUCT COMPETITORS

A. Cellartis AB

1. Human embryonic stem cell lines
2. Monoclonal Antibodies for hESC Research
3. Differentiated Cell Products
4. Associated hESC products

B. Vitrolife

C. Tataa Biocenter

D. Invitrogen

1. hESC Culture Media & Reagents
2. hESC-qualified Basement Membrane Extract
3. hESC cDNA Libraries
4. hESC Reporter Cells
5. hESC PCR Kits
6. hESC Stem Cell Antibodies
7. hESC Stem Cell Growth Factors

E. Stem Cell Technologies

1. hESC Culture Media & Reagents
2. hESC Primary & Secondary Antibodies

F. BD Biosciences

G. Chemicon

1. hESC Culture Media and Reagents
2. hESC Lines
3. hESC Kits
4. hESC Antibodies

H. R&D Systems

I. SA Biosciences

J. Thermo Scientific

K. Australian Stem Cell Centre

VIII. Specialty Pharmaceutical Companies developing hESC Therapies

A. Geron
B. Novocell
C. Cell Cure Neurosciences Ltd
D. Cell Dynamics International
E. Advanced Cell Technology

IX. Featured Labs (Potential Customers)

A. Academic Labs
B. Private Labs
C. Government Labs
D. International Labs

X. Toxicology Testing Legislation

1. European Union to Ban Animal-Testing for Cosmetic Development in 2009

2. Responses to the European Ban on Animal Testing for Cosmetic Development

a. Overview
b. Skin Irritation
c. Eye Irritation
d. Skin Sensitisation
e. Mutagenicity/Genotoxicity
f. Reproductive Toxicity

3. EU Legislation Regarding Animal-Based Testing for Drug Discovery

XI. Product Development Suggestions

A. Product Categories

1. hESCs
2. hESC Derivative Cells
3. hESC Reporter Cells
4. hESC Antibodies
5. hESC Characterization & PCR Kits
6. hESC Qualified BME
7. hESC cDNA Libraries
8. hESC Growth Factors
9. hESC Media and Culture Reagents

B. Product Ideas & Suggestions

1. Areas of Underdeveloped Competition
2. Mouse ESC Products
3. iPS Cells Products
4. Non-animal-derived Culture Reagents for hESCs
5. Strategic Collaborations
6. Products for generating Pure ESC populations
7. hESC Toxicity Assay Kit

XII. Events of Interest

For more information kindly visit
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According to “Ukraine Pharma - New Opportunities for Growth”, a new research report, Ukraine promises to be one of the most lucrative pharmaceutical markets in the world. In 2007, the Ukrainian pharmaceutical market grew by nearly 21% to register revenues in excess of US$ 2 Billion. The market is characterized by an increasing proportion of imported and high-priced drugs. In 2007, the average unit price of drugs sold in Ukraine increased by nearly 20%, strongly pushing the value of pharmaceutical sales, despite a relatively ordinary growth in sales volume.

The future outlook of the industry also seems very positive as the market is expected to be driven by a number of reforms recently proposed by the government. Factors such as increasing penetration of health insurance and increasing disposable incomes of consumers will also fuel growth. The lack of effective price controls and high margins are also expected to lure foreign players in this market. The country’s unstable political environment, however, will be the biggest hurdle for investments. But overall, the market is expected to grow strongly, exceeding US$ 4.5 Billion in revenues by 2012.

This report gives an extensive and objective analysis on the pharmaceutical market of Ukraine. It investigates both the past and present trends in the market, with its main focus on the future trends shaping the industry. The study discusses the performance of both the retail and hospital segments of the pharmaceutical market in detail and based on various present and future indicators, analyzes the future of these segments. This report gives valuable information to manufacturers/investors planning to enter the Ukrainian pharmaceutical market.

The Report Provides Forecasts on

*Macroeconomic Indicators
*Healthcare Indicators
*Population & Demographics
*Disease Profiles
*Total Pharmaceutical Market
*Retail Pharmaceutical Market
*Hospital Pharmaceutical Market

Key Player Profiling

Ukraine Pharma - New Opportunities for Growth” provides brief profiling on key players, both domestic and foreign, currently operating in the Ukraine pharmaceutical market. This section describes the revenues and growth of players in the total pharmaceutical market, retail market and hospital market. Performance of key drugs in various segments of the market has also been evaluated. Business profiles of top five players, Berlin Chemie, Sanofi Aventis, Novartis, Arterium and Darnitsa, have also been discussed in this report.

Table of Contents:

1. Analyst View
2. What Makes Ukraine so Lucrative
2.1 Robust Economic Growth
2.2 Improved Investment Climate
2.3 Growth of High-priced Drugs
2.4 Healthcare Infrastructure
3. Population & Demographics
4. The Pharmaceutical Market
4.1 Market Size
4.2 Imported & Domestically Manufactured Drugs
4.3 Leading Domestic & Foreign Manufacturers
4.4 Leading Pharmaceutical Distributors
5. The Retail Market
5.1 Market Size
5.2 Prescription & OTC Sales
5.3 Therapeutic Segmentation
5.4 Leading Domestic & Foreign Players
5.5 Leading Drugs
5.6 Price Characteristics of Drug Consumption
6. The Hospital Market
6.1 Market Size
6.2 Prescription & OTC Sales
6.3 Therapeutic Segmentation
6.4 Leading Domestic & Foreign Players
6.5 Leading Drugs
6.6 Price Characteristics of Drug Consumption
7. Opportunities
7.1 Clinical Trials Market
7.2 Contract Manufacturing
7.3 Medical Devices Market
8. Roadblocks
8.1 Unstable Political Environment
8.2 Declining Population
8.3 Lack of Effective Reimbursement System
8.4 Opaque Tax System
9. Forecasts
9.1 Critical Success & Risk Factors Shaping the Future
9.1.1 Critical Success Factors
9.1.2 Critical Risk Factors
9.2 Pharmaceutical Market
9.2.1 Retail Market
9.2.2 Hospital Market
10. Key Company Profiles
10.1 Berlin-Chemie
10.2 Sanofi-Aventis Group
10.3 Novartis
10.4 Arterium
10.5 Darnitsa Pharma

List of Figures:
Figure 2-1: Ukraine - Nominal GDP (in Billion US$), 2001-2007 & 2012F
Figure 2-2: Ukraine - Disposable Income per Head (in US$), 2001-2007E & 2012F
Figure 2-3: Ukraine - Healthcare Expenditure per Head (in US$), 2001-2007E & 2012F
Figure 2-4: Ukraine - Hospital Beds (per ‘000 Population), 2001-2007E & 2012F
Figure 2-5: Ukraine - Doctors (per ‘000 Population), 2002-2007E & 2012F
Figure 3-1: Ukraine - Population (in Million), 2001-2007E & 2012F
Figure 3-2: Ukraine - Population Breakup by Age Group (%), 2005-2007E & 2012F
Figure 3-3: Ukraine - Leading Causes of Death (%), 2005
Figure 3-4: Ukraine - Deaths due to Leading Causes (in Number), 2005
Figure 3-5: Ukraine - Forecast for Leading Causes of Death (%), 2030
Figure 3-6: US - Forecast for Deaths due to Leading Causes (in Number), 2030
Figure 4-1: Ukraine - Pharmaceutical Market (in Million US$), 2006 & 2007
Figure 4-2: Ukraine - Pharmaceutical Market (in Million Units), 2006 & 2007
Figure 4-3: Ukraine - Proportion of Generic & Branded Drugs (%)
Figure 4-4: Ukraine - Share of Retail & Hospital Segment in Pharmaceutical Market by Sales Value (%), 2006 & 2007
Figure 4-5: Ukraine - Share of Retail & Hospital Segment in Pharmaceutical Market by Sales Volume (%), 2006 & 2007
Figure 4-6: Ukarine - Pharmaceutical Imports (in Billion US$), 2005-2007E
Figure 4-7: Ukarine - Share of Imported & Domestically Manufactured Drugs in Pharmaceutical Market by Sales Value (%), 2006 & 2007E
Figure 4-8: Ukarine - Top 5 Pharmaceutical Importing Countries (in ‘000 Units) 2006 & 2007
Figure 5-1: Ukraine - Retail Pharmaceutical Market (in Million US$), 2006 & 2007
Figure 5-2: Ukraine - Retail Pharmaceutical Market (in Million Units), 2006 & 2007
Figure 5-3: Ukraine - Share of RX & OTC Drugs in Retail Pharmaceutical Market by Sales Value (%), 2006 & 2007
Figure 5-4: Ukraine - Share of RX & OTC Drugs in Retail Pharmaceutical Market by Sales Volume (%), 2006 & 2007
Figure 5-5: Ukraine - Retail Pharmaceutical Market by Therapeutic Area (%), 2007
Figure 6-1: Ukraine - Hospital Pharmaceutical Market (in Million US$), 2006 & 2007
Figure 6-2: Ukraine - Hospital Pharmaceutical Market (in Million Units), 2006 & 2007
Figure 6-3: Ukraine - Share of RX & OTC Drugs in Hospital Pharmaceutical Market by Sales Value (%), Q1-Q3 2007
Figure 6-4: Ukraine - Share of RX & OTC Drugs in Hospital Pharmaceutical Market by Sales Volume (%), Q1-Q3 2007
Figure 6-5: Ukraine - Hospital Pharmaceutical-Market by Therapeutic Area (%), Q1-Q3 2007
Figure 7-1: Ukraine - Medical Devices Market (in Million US$), 2007E & 2012F
Figure 9-1: Ukraine - Forecast for Pharmaceutical Market (in Million US$), 2008-2012
Figure 9-2: Ukraine - Forecast for Share of Retail & Hospital Segment in Pharmaceutical Market by Sales Value (%), 2008-2012
Figure 9-3: Ukraine - Forecast for Retail Pharmaceutical Market (in Million US$), 2008-2012
Figure 9-4: Ukraine - Forecast for Hospital Pharmaceutical Market (in Million US$), 2008-2012

List of Tables:
Table 2-1: Ukraine - Average Price per Trading Unit of Pharmaceuticals (in US$), 2006 & 2007
Table 2-2: Ukraine - Hospital Beds & Doctors w.r.t. Developed Countries (per ‘000 Population), 2007E
Table 4-1: Ukraine - Statistics of Top Players in Pharmaceutical Market (2007)
Table 4-2: Ukraine - Market Share of Top Pharmaceutical Distributors (%), 2006 & 2007
Table 5-1: Ukraine - Statistics of Top Players in Retail Pharmaceutical Market (2007)
Table 5-2: Ukraine - Statistics of Top 10 Drugs in Retail Pharmaceutical Market (2007)
Table 5-3: Ukraine - Price Characteristics of Drug Consumption in Retail Pharmaceutical Market
Table 6-1: Ukraine - Statistics of Top Players in Hospital Pharmaceutical Market (2007)
Table 6-2: Ukraine - Statistics of Top 20 Drugs in Hospital Pharmaceutical Market (Q1-Q3 2007)
Table 6-3: Ukraine - Average Retail Price per Drug in Hospital Pharmaceutical Market (in US$), Q1-Q3 2006 & Q1-Q3 2007
Table 9-1: Ukraine - Critical Sucess Factors for Pharmaceutical Market
Table 9-2: Ukraine - Critical Risk Factors for Pharmaceutical Market

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Forecast Insight: Depression - Generic induced brand erosion leads to market decline

The depression market was valued at around $11.04 billion in 2007 across the seven major markets. Following marginal growth to 2011 ($12.01 billion), the market is forecast to decline in value through to 2017 ($9.81 billion) when brand erosion due to generic incursion affecting all major drug classes used to treat depression finally outweighs the success of reformulations and follow-on products.

Scope of this research

This report gives a strategic analysis of the likely impact that recent events will have on the future depression market
Includes depression-specific sales forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2017
Provides a global depression-market snapshot, and analysis of growth trends in key markets outside of the seven major pharmaceutical markets

Conclusions are supported by key opinion leader comment

Research and analysis highlights
Datamonitor has upgraded its depression-specific Abilify and Seroquel forecasts following positive clinical trial data in depression for both atypical antipsychotics, and the observation that regulatory approval of Abilify as an adjunct to antidepressants in depression resulted in an increase in the brand’s quarterly sales growth rate.

Servier and Novartis’s Valdoxan has emerged as the most promising pipeline depression drug following failure of several late-stage candidates. Prescribing for depression patients suffering from comorbid sleep disorders will drive sales over the forecast period.

Datamonitor forecasts moderate uptake of saredutant in refractory depression patients as an add-on therapy. While the drug failed to show efficacy as a monotherapy in clinical trials published over the last year, Sanofi-aventis is continuing to develop saredutant with two add-on therapy trials ongoing.

Key reasons to purchase this research

Quantify the current size of the global major depressive disorder market
Assess the impact of recent and anticipated events (patent expiries, new product launches, regulatory approval) on depression-specific brand sales
Understand the country-specific impact of key events in the major depressive disorder market during the forecast period 2008 to 2017

Table of Contents:

EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor insight into the depression market
Related reports

MARKET DEFINITION AND OVERVIEW
Market definition for this report
Countries and regions included in this report
Seven major market assessment
Seven major market dynamics
5EU (France, Germany, Italy, Spain and the UK) market dynamics
Japanese market dynamics
Comparison with previous forecast
Global sales and rest of the world snapshot
Rest of the world is a multi-billion dollar market
Rest of the world depression sales have grown rapidly over the last 4 years
Dynamics in the rest of the world

BRAND DYNAMICS
Overview of competitive landscape
Leading brands across the seven major pharmaceutical markets
Key pipeline drugs
Updated key marketed brand dynamics
Zoloft (sertraline, Pfizer)
Abilify (aripiprazole, Bristol-Myers Squibb and Otsuka Pharmaceutical)
Pristiq (desvenlafaxine succinate extended release, Wyeth)
Wellbutrin XL (bupropion extended-release; GlaxoSmithKline)
Effexor XR
Updated key pipeline drug assumptions
Valdoxan (agomelatine, Servier and Novartis)
Seroquel XR (quetiapine extended-release, AstraZeneca)
Vilazodone (Clinical Data Inc)
Saredutant (Sanofi-Aventis)
DDS-04A (once-daily formulation of trazodone, Labopharm)
Lu AA21004 (Lundbeck)
Corlux (mifepristone, C-1073, Corcept)
Key project discontinuations
Amibegron – project terminated
Gepirone ER – project terminated

BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports

APPENDIX A – MARKET ASSUMPTIONS
New product launches
Patent expiry dates
Data definitions, limitations and assumptions
Standard units
Japanese market data
Derivation of sales forecasts and pricing trends
Forecast methodology

APPENDIX B
Contributing experts
Report methodology

TABLES
Table: Depression-specific sales forecasts in the seven major markets ($m), 2007–2017
Table: Depression-specific sales revenue for the top eight ranked brands across the seven major markets, 2004–2017
Table: Key products in late-stage of development for depression , 2008
Table: Key products in Phase II development for depression , 2008
Table: Abilify (aripiprazole) recommended doses across indications, 2008
Table: Datamonitor’s estimated launch dates for key depression products in the seven major markets, 2008–2017
Table: Patent expiry dates for the key depression brands in the seven major markets, 2007–2018

FIGURES
Figure: Depression-specific sales ($ billion) by country, 2004–2017
Figure: Regional share of the total major depressive disorder market, 2007–2017
Figure: Depression-specific sales revenue ($ billion) in US, 2004–2017
Figure: 5EU major depressive disorder market value and forecast ($ billion), 2004–2017
Figure: Japanese major depressive disorder market value and forecast ($ billion), 2004–2017
Figure: Percentage of major drug class sales revenue in major depressive disorder, 2004–2017
Figure: Atypical antipsychotic sales revenue from major depressive disorder across the seven major markets, 2004–2017
Figure: Comparison of depression-specific forecasts in the seven major markets, 2006–2017
Figure: The global major depressive disorder market split by region, 2007
Figure: The global major depressive disorder market growth trends ($ billion) split by region, 2004–08
Figure: Regional major depressive disorder market value ($m), 2004–07
Figure: Latin American major depressive disorder market ($m), 2004–07
Figure: Top eight depression-specific brands on value ($m) across the seven major markets, 2004–2017
Figure: Generic incursion on Zoloft (sertraline) depression-specific sales in the US ($m)
Figure: Switch in sertraline IMS Standard Units sold in the US, Q1 2006 to Q2 2008
Figure: Zoloft (sertraline) branded depression-specific sales revenue ($m) in the US, 2005–07
Figure: Depression-specific Zoloft (sertraline) historical and forecast sales revenue ($m), seven major markets, 2004–2017
Figure: Depression-specific Abilify (aripiprazole) sales revenue across the seven major markets, 2006–2017
Figure: Depression-specific sales of key atypical antipsychotic brands across the seven major markets, 2006–07
Figure: Change in quarterly total brand IMS Standard Units (SU) sold for Abilify (aripiprazole) in the US, Q3 2006 to Q2 2008
Figure: Depression-specific Pristiq forecast sales revenue ($m), seven major markets, 2008–2017
Figure: Depression-specific Wellbutrin XL (bupropion extended-release) historical and forecast sales revenue ($m), seven major markets, 2004–2017
Figure: Depression-specific Cymbalta historical and forecast sales revenue ($m), seven major markets, 2004–2017
Figure: Depression-specific Effexor XR historical and forecast sales revenue ($m), seven major markets, 2004–2017
Figure: Depression-specific Valdoxan (agomelatine) forecast sales revenue ($m), seven major markets, 2008–2017
Figure: Depression-specific Seroquel IR and Seroquel XR historical (2004–07) and forecast (2008–2017) sales revenue ($m), seven major markets
Figure: Depression-specific Seroquel franchise (IR + XR) historical (2004–07) and forecast (2008–2017) sales revenue ($m), seven major markets
Figure: Off-label depression-specific sales of Seroquel (quetiapine) IR+XR, 2004–07
Figure: Percentage of total Seroquel brand sales attributed to depression, 2005–07
Figure: Quarterly US total brand sales ($m) for Seroquel IR and Seroquel XR, Q3 2007 to Q2 2008
Figure: Depression-specific vilazodone forecast sales revenue ($m), seven major markets, 2010–2017
Figure: Depression-specific saredutant forecast sales revenue ($m), seven major markets, 2008–2017
Figure: Depression-specific DDS-04A (trazodone once daily) forecast sales revenue ($m), seven major markets, 2008–2017

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The Russian Clinical trials market has always enjoyed good returns since its inception, but its growth has been especially significant over the past few years, and is expected to post major growth in the future says our new report “Clinical Trials Market in Russia”.

The number of Clinical trials conducted in Russia increased to 615 in 2008, which is an increase of around 9% over 2007. The country has a highly centralized healthcare system. It implies that the country has highly specialized medical units that deliver healthcare services to all the patients with common symptoms under one roof. The patients normally follow the references for the tests and treatments given by the doctors. These references are to the highly specialized doctors in the big hospitals.

The Russian Clinical Trials have been enjoying significant foreign investments and accounts for more than two-third of the total clinical trials across the world. Russia sponsored 201 clinical trials in 2008, followed by American sponsors who conducted 145 clinical trials during the year. The clinical trials conducted by Russia include various therapy areas such as oncology, cardiology, pulmonology, etc. The country has large number of physicians who are willing to work as Clinical Research Investigators, to enhance their knowledge in their fields of specialization and earn a subsidiary income.

The government is also taking vital steps to bring healthcare reforms and to encourage the Russian drug makers having well-laid plans for the development of innovative drugs, especially vaccines to compete in the market at par with the foreign players. It has recently invested US$ 3.4 Billion to improve the utilization of resources in the Russian Clinical Trials Market.

Our report is the outcome of the extensive research and thorough analysis of the Russia Clinical Trials Market. It covers the various market dynamics that play upon the performance of the Russia Clinical Trials Market. The report will also help the client to assess the future outlook of the industry based on the government initiatives, regulatory framework and the growth pattern of the pharmaceutical industry.
Table of Contents:

1. Analyst View
2. Clinical Trials Market Overview
3. Russian Clinical Trials Market
3.1 Foreign Participation
3.2 Clinical Research Outsourcing
4. Market Performance and Forecast
4.1 Clinical Trials
4.2 Global Clinical Trial Study
4.3 Trials in Advanced Phases
4.4 Trials under Major Therapy Areas
4.5 Multi-national Sponsors
5. Patient Enrolment
5.1 Population
5.2 Disease Profile
5.3 Patient Recruitment
5.4 Patient Recruitment Rate
6. Regulatory Environment
7. Cost Analysis
7.1 Lab Fees
7.2 Hourly Rate of CRO
8. Clinical Trials and New Drugs Approval
8.1 FDA Inspections
8.2 FDA Approved Drugs
8.3 EMEA Approved Drugs
9. Key Market Trends
10. Industry Restraints
11. Key Players
11.1 Biocad
11.2 Novartis
11.3 Sanofi-Aventis
11.4 GlaxoSmithKline plc (GSK)
11.5 Pfizer

List of Tables

Table 2-1: Drug Discovery, Development and Approval Process
Table 4-1: Number of Clinical Trials by Top Five Sponsors (2008)
Table 4-2: Clinical Trials by Top Five International Study Sponsors (2008)
Table 4-3: Clinical Trials by Top Five Russian Study Sponsors (2008)
Table 5-1: Patient Recruitment Rates in Top Five Therapeutic Areas
Table 7-1: Lab Fees Comparison with UK and US (US$)
Table 7-2: Fees Charged by Local CROs in Comparison to International CROs (US$/Hour)
Table 8-1: New Drugs Approved by FDA in Q4 2008
Table 8-2: New Drugs approved by EMEA in Q4 2008
Table 9-1: Patient Investigator Fees in Comparison to India, US and Europe (US$)
Table 9-2: Population and City Distribution by Federal Region
Table 9-3: Top Ten Emerging Cities/Region by Number of New Sites (2008)

List of Charts

Figure 2-1: Share of Europe in Global Clinical Trials Market (2008)
Figure 2-2: European Clinical Trials Market by Player (%), 2008
Figure 2-3: European Clinical Research Outsourcing Market (Billion Euro) 2008 & 2012
Figure 2-4: Share of Eastern and Western Europe in Clinical Trials Market (2008 & 2012)
Figure 3-1: Share of Russian & International Sponsors in Clinical Trials (2007 & 2008)
Figure 3-2: Clinical Trials by Type of Operator (%)
Figure 4-1: Number of Clinical Trials (2005-2008)
Figure 4-2: Forecast for Number of Clinical Trials (2009-2012)
Figure 4-3: Share of Study Type in Clinical Trials (2004 to 2007)
Figure 4-4: Share of Study Type in Clinical Trials (2007 & 2008)
Figure 4-5: Number of Clinical Trials by Phase (2007 & 2008)
Figure 4-6: Clinical Trials by Therapy Area (%) 2007 & 2008
Figure 4-7: Phases of Clinical Trials by International Sponsors (Q3 2008)
Figure 5-1: Comparison of Population with Ukraine (Million) 2007 & 2008
Figure 5-2: Population Breakup by Age Group (%), 2008
Figure 5-3: Share of Population and Clinical Trials by Region
Figure 5-4: Leading Causes of Death (%) 2005 & 2030
Figure 5-5: Patient Recruitment by Phase of Study (%), 2008
Figure 8-1: Number of FDA Inspections since 1995 to 2008
Figure 8-2: FDA Inspection Results (%), 1995 to 2007
Figure 8-3: FDA Inspection Results (%), 2008
Figure 9-1: Qualified Specialists by Type (Thousand)
Figure 9-2: Urban & Rural Population Breakup (%) 2008
Figure 9-3: Pharmaceutical Market (Billion US$) 2007-2009
Figure 9-4: Forecast for Pharmaceutical Market (Billion US$), 2010-2012
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An overview on Pharmaceutical companies in the Middle East and Africa

Bharatbook.com included a book that provides detailed information on the pharmaceutical companies in the Middle East and Africa. The pharma company profiles in the Middle East & Africa are discussed.

Multinational Pharmaceuticals & Healthcare Companies in Middle East & Africa Directory includes pharma company profiles from major sub-sectors, including prescription, over-the-counter and generic drugs manufacturers.

The Middle East & Africa Pharmaceuticals and Healthcare Directory and CD-Rom 2007 is a researched company database of pharma companies in the Middle East & Africa: a powerful database for pharma competitor analysis, market assessment and marketing, sales and recruitment leads with which to grow your pharma business.

The Middle East & Africa Pharmaceuticals and Healthcare Directory and CD-Rom 2007 features 2,032 fully researched, top decision makers at 615 multinational pharma companies in the Middle East & Africa.

The Middle East & Africa Pharmaceuticals and Healthcare Directory and CD-Rom 2007 features leading pharma companies from Algeria, Bahrain, Botswana, Egypt, Greece, Iran, Jordan, Kuwait, Lebanon, Libya, Morocco, Mozambique, Namibia, Oman, Qatar, Saudi Arabia, South Africa, Syria, Tunisia, Turkey, UAE, Yemen, Zambia and Zimbabwe, plus pharma parent company head offices.

The key benefits of this directory are:

• Generate new customers and sales leads for your pharma business
• Explore new Middle East & Africa pharma markets
• Source a comprehensive range of pharma products and services from leading pharma manufacturers and suppliers
• Find and compare Middle East & Africa pharma suppliers and manufacturers of specialist pharma equipment and services
• Research your competitors and potential partners in the Middle East & Africa’s pharma industry
• Create your own marketing and sales database of international pharma decision makers

Bharat Book Bureau provides strategic information tools to the executives, business analysts, and knowledge managers that will help them to probe into and support critical, timely business decisions and strategies. Bharat Book Bureau facilitates companies to take the lead of their industry with best practice business strategies and intelligence, through a unique combination of published reports, databases, country reports, company profiles and customized research services.

For further information visit:
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This report discusses US implantable and transdermal drug delivery systems for the years 2001 and 2006, with forecasts for 2011. Topics covered include market size, product and end-use segmentation, technology and product development, market environment, product and end-use forecasts, industry composition and leading participants. Product segments cover implantable systems (including drug-eluting coronary stents and other implantable systems) and transdermal patches (including central nervous system [CNS] patches and other transdermal patches). End-use applications include cardiovascular agents, central nervous system [CNS] agents, hormones and related agents, and other agents. This 20 page report also includes a highlights summary and a resources section.
 
 Companies Profiled
 
 Boston Scientific
 
 Johnson & Johnson
 
 Medtronic Incorporated
 
 Table of Contents
 
 HIGHLIGHTS
 
 INDUSTRY OVERVIEW
 Market Size
 Materials Segmentation
 Applications Segmentation
 
 INDUSTRY TRENDS & FORECASTS
 Market Environment
 Materials Forecasts
 Applications Forecasts
 
 INDUSTRY STRUCTURE
 Industry Composition
 Industry Leaders
 
 RESOURCES
 
 Focus Report Overview
 
 Each Freedonia Focus provides access to a wealth of industry insights and analysis including:
 
 Market size
 Product segmentation
 Market segmentation
 Product forecasts
 Market forecasts
 Industry composition
 Market leaders
 Business trends

To know more and to buy a copy of your report feel free to visit:  http://www.bharatbook.com/productdetail.asp?id=81621

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Bharat Book Bureau
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