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Reportlinker Adds Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment
Date:3/29/2011

NEW YORK, March 29, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

http://www.reportlinker.com/p0464103/Biosimilars-Approval-Pathways-in-the-US-and-Europe---Development-and-Approval-of-Biosimilar-mABs-May-Face-Tough-Regulatory-Environment.html

Biosimilars Approval Pathways in the US and Europe - Development and Approval of Biosimilar mABs May Face Tough Regulatory Environment

Summary

GBI Research, the leading business intelligence provider, has released its latest report, "Biosimilars Approval Pathways in the US and Europe – Development and Approval of Biosimilar mAbs May Face Tough Regulatory Environment" that provides key data, information and analysis of the major trends and issues affecting the global biosimilar market. The report provides a comprehensive insight into the biosimilar market. It offers geography-wise as well as category-wise market forecasts for biosimilars and provides the drivers and restraints affecting the biosimilars market. The report also talks about the business environment and the key success factors in the global biosimilar industry. The report also describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. At the end, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that took place in the industry.

Scope

The report covers -

- Data and analysis on the biosimilar market in the leading geographies of the world – the US, the UK, Germany, France, Italy, Spain, and Japan.

- Market forecast for global biosimilar market from 2009 to 2016, geography-wise as well as product category-wise.

- Key drivers and restraints that have had a significant impact on the market globally as well as at national level.

- The regulatory environment for biosimilars in the US, the EU and in Japan.

- Analysis of competitive environment in the industry, profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddy's, Biocon, Watson Pharmaceuticals, Biopartners, Reliance Life Sciences, Stada, Intas, Celltrion and 3S Bio.

- Key M&A activities and Licensing Agreements that took place between 2008 and 2010 in the global biosimilar market.

Reasons to buy

The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to -

- Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.

- Identify the key areas of deal making through thorough understanding of the deals landscape in the global biosimilar market.

- Build effective strategies to launch the pipeline products by identifying potential geographies.

- Identify the companies from emerging nations for collaborations along with their key capabilities.

- Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.

Table of Contents

1 Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 7

2 Biosimilars Approval Pathways in the US and Europe – Introduction 10

2.1 GBI Research Report Guidance 10

3 Biosimilars Approval Pathways in the US and Europe – Market Overview 11

3.1 Overview of the Biopharmaceutical Industry 11

3.2 Biosimilars and their Significance 19

3.3 Comparison of Biosimilars with Generics 22

3.4 Biopharmaceutical Manufacturing Process 24

4 Biosimilars Approval Pathways in the US and Europe – Market Characterization 26

4.1 Global Biosimilar Market Size and Forecast 26

4.2 The US Biosimilars Market Size and Forecast 27

4.3 Europe Biosimilar Market Size and Forecast 28

4.4 Japan Biosimilars Market Size and Forecasts 30

4.5 Market Forecasts for Biosimilars 31

4.5.1 Human Growth Hormone (hGH) Biosimilars Markets 31

4.5.2 Erythropoietin (EPO) Biosimilars Markets 33

4.5.3 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets 35

4.6 Opportunity Analysis 37

4.6.1 Interferon alfa Biosimilars 37

4.6.2 Interferon beta Biosimilars 38

4.6.3 Insulin and Insulin Analogs Biosimilars 40

4.6.4 TNF alfa Inhibitor Biosimilars 42

4.6.5 Biosimilars for Monoclonal Antibodies against Cancer 43

5 Biosimilars Approval Pathways in the US and Europe – Industry Dynamics 45

5.1 Key Success Factors in the Biosimilar Industry 45

5.1.1 Long Term Strategy 45

5.1.2 Sound Financial Structure 46

5.1.3 Comprehensive Competitive Intelligence 46

5.1.4 Biomanufacturing Competencies 46

5.1.5 Clinical Development and Regulatory Expertise 46

5.1.6 Marketing, Sales and Distribution Capabilities 46

5.2 Participants in the Biosimilar Industry 47

5.3 Suppliers 48

5.3.1 Clinical Trial Capability Providers 48

5.3.2 Manufacturing Capacity Providers 48

5.3.3 Media and Reagents Providers 48

5.4 Innovators 49

5.5 Stakeholders 49

5.5.1 Regulators 49

5.5.2 Payers 49

5.5.3 Physicians 50

5.5.4 Patients and Patient Groups 50

6 Biosimilars Approval Pathways in the US and Europe – Drivers and Restraints 51

6.1 Drivers 52

6.1.1 Need to Cut Healthcare Costs in Developed Economies 52

6.1.2 Lower Development Costs and Regulatory Costs Compared to a New Biologic Drug 54

6.1.3 Lower Overall Cost of Treatment Using Biosimilar Drugs Compared to Biologics 55

6.1.4 Patent Expiry for Blockbuster Biologics 55

6.1.5 Increasing Uptake of Biologic Drugs 56

6.1.6 More Profitable than Generic Drugs 56

6.2 Restraints 56

6.2.1 Absence of Automatic Substitution 56

6.2.2 Higher Development and Manufacturing Costs Compared to Generics 57

6.2.3 High Entry Barriers 58

6.2.4 Threat from Second Generation Biologic Drugs 58

6.2.5 Patent Protection Around Biologic Drugs 58

7 Biosimilars Approval Pathways in the US and Europe – Regulatory Landscape 59

7.1 Regulatory Landscape in the US 60

7.1.1 Regulatory Framework for Biopharmaceutical Industry 60

7.1.2 Evolution of Regulatory Pathways for Biosimilars 62

7.1.3 BPCIA and the Pathway for Approval of Biosimilar Products 65

7.2 FDA's Public Meeting on Biosimilars 70

7.2.1 Data requirement to Demonstrate Biosimilarity 71

7.2.2 The Standard for Interchangeability 71

7.2.3 Naming for Biosimilars 71

7.2.4 Extrapolation 71

7.2.5 Foreign Studies 71

7.2.6 Other Issues 71

7.2.7 Drivers and Barriers 72

7.3 Regulatory Landscape in Europe 73

7.3.1 Regulatory Framework for Biopharmaceutical Industry 73

7.3.2 Evolution of Regulatory Pathways for Biosimilars 74

7.3.3 Current Position on Biosimilars 75

7.3.4 The Bolar Type Provision 80

7.3.5 The Comparability Exercise 81

7.3.6 Biosimilars Approvals and Applications 82

7.3.7 EMEA Guidelines for Biosimilar mAb 84

7.3.8 Issues Facing the European Biosimilars Industry 84

7.3.9 Drivers for the European Biosimilars Market 85

7.3.10 Barriers for the European Biosimilars Market 86

7.3.11 Country Analysis – The UK 87

7.3.12 Country Analysis – Germany 88

7.3.13 Country Analysis – France 90

7.3.14 Country Analysis – Spain 91

7.3.15 Country Analysis – Italy 93

7.4 Regulatory Landscape in Japan 94

7.4.1 Regulatory Framework for Biopharmaceutical Industry 94

7.4.2 Evolution of Regulatory Pathways for Biosimilars 94

7.4.3 Current Position on Biosimilars 95

7.4.4 Drivers and Barriers 96

8 Biosimilars Approval Pathways in the US and Europe – Competitive Landscape 97

8.1 Profiles of Major Biosimilar Players 97

8.1.1 Sandoz 97

8.1.2 Teva Pharmaceuticals Ltd 100

8.1.3 Hospira Inc 102

8.1.4 Dr. Reddy's Laboratories 104

8.1.5 Biocon Ltd 106

8.1.6 Biopartners 108

8.1.7 Watson Pharmaceuticals 110

8.1.8 STADA Arzneimittel AG 112

8.1.9 Reliance Life Sciences 114

8.1.10 Intas Biopharmaceuticals 116

8.1.11 Celltrion Inc. 118

8.1.12 3SBio Inc. 120

9 Biosimilars Approval Pathways in the US and Europe – Strategic Consolidations 122

9.1 M&A Deals 122

9.1.1 Pfizer–Biocon Deal 122

9.1.2 Teva Acquired Ratiopharm 122

9.1.3 Watson–Itero Deal 122

9.1.4 Biocon and Mylan Strategic Collaboration 122

9.1.5 Merck Acquired Insmed's Follow-On Biologics for $130m 122

9.1.6 Teva and Lonza JV Targets Biosimilars 123

9.1.7 GTC Enters Follow-On-Biologic Founder Development Collaboration with Ag Research 123

9.1.8 Apotex–Intas Deal 123

9.1.9 Teva Acquires CoGenesys 123

9.2 R&D Licensing Deals 124

9.2.1 Innogene Seals Deal With CIMAB to Market Biosimilars 124

9.2.2 Abraxis Licenses Rights to Biosimilar from Indian Firm Biocon 124

10 Biosimilars Approval Pathways in the US and Europe – Appendix 125

10.1 Market Definitions 125

10.2 Abbreviations 126

10.3 Research Methodology 128

10.3.1 Coverage 128

10.3.2 Secondary Research 128

10.3.3 Primary Research 129

10.3.4 Expert Panel Validation 129

10.4 Contact Us 129

10.5 Sources 130

10.6 Disclaimer 130

List of Tables

1.1 List of Tables

Table 1: Biosimilars Approval Pathways in the US and Europe, Medicare Formulary Coverage for Top-Selling Biologics 20

Table 2: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 2009–2016 26

Table 3: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 2009–2016 28

Table 4: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 2009–2016 29

Table 5: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 2009–2016 30

Table 6: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 2009–2016 31

Table 7: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 2009–2016 33

Table 8: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 2009–2016 35

Table 9: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 2009–2016 37

Table 10: Biosimilars Approval Pathways in the US and Europe, Global, Interferon-beta Biosimilar Market Opportunity Analysis, ($m), 2009–2016 39

Table 11: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 2009–2016 40

Table 12: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis, ($m), 2009–2016 42

Table 13: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 2009–2016 44

Table 14: Biosimilars Approval Pathways in the US and Europe, Cost-Sharing Practices by Health Insurers in the US, 2009 50

Table 15: Biosimilars Approval Pathways in the US and Europe, Comparison for a Biosimilar, 2010 54

Table 16: Biosimilars Approval Pathways in the US and Europe, Patent Expiry for Major Biologic Drugs, 2010–2016 55

Table 17: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars By Cell Culture Type, ($m), 2010 57

Table 18: Biosimilars Approval Pathways in the US and Europe, Europe, Existing Guidelines for Biosimilars, 2010 75

Table 19: Biosimilars Approval Pathways in the US and Europe, Biosimilar Approvals, 2010 82

Table 20: Biosimilars Approval Pathways in the US and Europe, Europe, Applications Rejected or Withdrawn, 2010 83

List of Figures

1.2 List of Figures

Figure 1: Biosimilars Approval Pathways in the US and Europe, Global Biologics Market Forecast, ($bn), 2007–2016 11

Figure 2: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Therapeutic Class, 2009 12

Figure 3: Biosimilars Approval Pathways in the US and Europe, Growth for Biologics, 2010 13

Figure 4: Biosimilars Approval Pathways in the US and Europe, Share of Top 25 Biologics By Production System, 2008 14

Figure 5: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Therapeutic Class, Global, 2008 15

Figure 6: Biosimilars Approval Pathways in the US and Europe, Biologics Under Development by Disease Category, Global, 2008 16

Figure 7: Biosimilars Approval Pathways in the US and Europe, Comparison of Small Molecule Drugs and Biologics 17

Figure 8: Biosimilars Approval Pathways in the US and Europe, Difference Between the Distribution Chains for Small Molecule and Biologic Drugs 18

Figure 9: Biosimilars Approval Pathways in the US and Europe, Medicare Coverage for Biologic Drugs, 2009 19

Figure 10: Biosimilars Approval Pathways in the US and Europe, Imminent Biosimilar Opportunities, 2010 21

Figure 11: Biosimilars Approval Pathways in the US and Europe, Comparison of Biosimilars With Generics, 2010 22

Figure 12: Biosimilars Approval Pathways in the US and Europe, Development Costs and Timelines for a Biosimilar, 2010 23

Figure 13: Biosimilars Approval Pathways in the US and Europe, Challenges and their Solutions in Biopharmaceutical Manufacturing, 2010 24

Figure 14: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), 2009–2016 26

Figure 15: Biosimilars Approval Pathways in the US and Europe, the US, Market Forecasts, ($m), 2009–2016 27

Figure 16: Biosimilars Approval Pathways in the US and Europe, Europe, Market Forecasts, ($m), 2009–2016 28

Figure 17: Biosimilars Approval Pathways in the US and Europe, Japan, Market Forecasts, ($m), 2009–2016 30

Figure 18: Biosimilars Approval Pathways in the US and Europe, Global, hGH Biosimilars Market Forecasts, ($m), 2009–2016 31

Figure 19: Biosimilars Approval Pathways in the US and Europe, Global, EPO Biosimilars Market Forecasts, ($m), 2009–2016 33

Figure 20: Biosimilars Approval Pathways in the US and Europe, Global, G-CSF Biosimilars Market Forecasts, ($m), 2009–2016 35

Figure 21: Biosimilars Approval Pathways in the US and Europe, Global, Interferon alfa Biosimilar Market Opportunity Analysis, ($m), 2009–2016 37

Figure 22: Biosimilars Approval Pathways in the US and Europe, Global, Interferon beta Biosimilar Market Opportunity Analysis, ($m), 2009–2016 38

Figure 23: Biosimilars Approval Pathways in the US and Europe, Global, Insulin and Insulin Analogs Biosimilar Market Opportunity Analysis, ($m), 2009–2016 40

Figure 24: Biosimilars Approval Pathways in the US and Europe, Global, TNF alfa Inhibitor Biosimilar Market Opportunity Analysis,($m), 2009–2016 42

Figure 25: Biosimilars Approval Pathways in the US and Europe, Global, Monoclonal Antibodies Against Cancer Biosimilar Market Opportunity Analysis, ($m), 2009–2016 43

Figure 26: Biosimilars Approval Pathways in the US and Europe, Global, Expected Market Split in 2016 44

Figure 27: Biosimilars Approval Pathways in the US and Europe, Key Success Factors in the Biosimilar Industry, 2010 45

Figure 28: Biosimilars Approval Pathways in the US and Europe, Comparison of Capabilities of Market Entrants, 2010 47

Figure 29: Biosimilars Approval Pathways in the US and Europe, Drivers and Restraints, 2010 51

Figure 30: Biosimilars Approval Pathways in the US and Europe, Rising Expenditure on Pharmaceuticals, 2010 52

Figure 31: Biosimilars Approval Pathways in the US and Europe, Increase in Elderly Population Indicates Rising Healthcare Expenses, 2010 53

Figure 32: Biosimilars Approval Pathways in the US and Europe, Inflation in Prescription Drug Prices in the US , 2010 54

Figure 33: Biosimilars Approval Pathways in the US and Europe, Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, ($m), 2010 57

Figure 34: Biosimilars Approval Pathways in the US and Europe, Objectives of Biosimilar Legislation and Regulatory Frameworks, 2010 59

Figure 35: Biosimilars Approval Pathways in the US and Europe, the US, Regulatory Bodies for Biologics, 2010 60

Figure 36: Biosimilars Approval Pathways in the US and Europe, Drug Development and Approval Process, 2010 61

Figure 37: Biosimilars Approval Pathways in the US and Europe, the US, Evolution of Regulatory Pathway, 2010 62

Figure 38: Biosimilars Approval Pathways in the US and Europe, the US, Impact of Data Exclusivity Period on Biosimilars Development, 2010 63

Figure 39: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA – Round 1, 2010 66

Figure 40: Biosimilars Approval Pathways in the US and Europe, the US, Patent Litigation Provisions in BPCIA – Round 2, 2010 68

Figure 41: Biosimilars Approval Pathways in the US and Europe, Key Issues Discussed at FDA's Public Hearing on Biosimilars, 2010 70

Figure 42: Biosimilars Approval Pathways in the US and Europe, the US, Drivers and Barriers for the Biosimilars Market, 2009–2016 72

Figure 43: Biosimilars Approval Pathways in the US and Europe, Europe, Drug Approval Process, 2010 73

Figure 44: Biosimilars Approval Pathways in the US and Europe, Europe, Evolution of Regulatory Pathway for Approval of Biosimilars, 2010 74

Figure 45: Biosimilars Approval Pathways in the US and Europe, Europe, General and Product Specific Guidelines for Biosimilars, 2010 77

Figure 46: Biosimilars Approval Pathways in the US and Europe, Europe, Approval Process for Biosimilars, 2010 78

Figure 47: Biosimilars Approval Pathways in the US and Europe, Europe, Data and Market Exclusivity Periods, 2010 79

Figure 48: Biosimilars Approval Pathways in the US and Europe, Europe, Comparability Exercises, 2010 81

Figure 49: Biosimilars Approval Pathways in the US and Europe, Europe, Number of Biosimilar Applications, 2004–2009 83

Figure 50: Biosimilars Approval Pathways in the US and Europe, Europe, Key Issues Facing Biosimilars Market, 2010 84

Figure 51: Biosimilars Approval Pathways in the US and Europe, Europe, Drivers and Barriers for the Biosimilars Market, 2009–2016 85

Figure 52: Biosimilars Approval Pathways in the US and Europe, the UK, Drivers and Barriers for the Biosimilars Market, 2009–2016 88

Figure 53: Biosimilars Approval Pathways in the US and Europe, Germany, Drivers and Barriers for the Biosimilars Market, 2009–2016 89

Figure 54: Biosimilars Approval Pathways in the US and Europe, France, Drivers and Barriers for the Biosimilars Market, 2009–2016 91

Figure 55: Biosimilars Approval Pathways in the US and Europe, Spain, Drivers and Barriers for the Biosimilars Market, 2009–2016 92

Figure 56: Biosimilars Approval Pathways in the US and Europe, Italy, Drivers and Barriers for the Biosimilars Market, 2009–2016 93

Figure 57: Biosimilars Approval Pathways in the US and Europe, Japan, Evolution of Regulatory Pathway, November 2009 95

Figure 58: Biosimilars Approval Pathways in the US and Europe, Japan, Drivers and Barriers for the Biosimilars Market, 2009–2016 96

Figure 59: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, 2010 97

Figure 60: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Sandoz, SWOT, 2010 99

Figure 61: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, 2010 100

Figure 62: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Teva, SWOT, 2010 101

Figure 63: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira Inc, 2010 102

Figure 64: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Hospira, SWOT, 2010 103

Figure 65: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddy's Laboratories, 2010 104

Figure 66: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Dr. Reddy's Laboratories, SWOT, 2010 105

Figure 67: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, 2010 106

Figure 68: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biocon, SWOT, 2010 107

Figure 69: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, 2010 108

Figure 70: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Biopartners, SWOT, 2010 109

Figure 71: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, 2010 110

Figure 72: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Watson Pharmaceuticals, SWOT, 2010 111

Figure 73: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, 2010 112

Figure 74: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, STADA Arzneimittel AG, SWOT, 2010 113

Figure 75: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, 2010 114

Figure 76: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Reliance Life Sciences, SWOT, 2010 115

Figure 77: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, 2010 116

Figure 78: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Intas Biopharmaceuticals, SWOT, 2010 117

Figure 79: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, 2010 118

Figure 80: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, Celltrion Inc, SWOT, 2010 119

Figure 81: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, 2010 120

Figure 82: Biosimilars Approval Pathways in the US and Europe, Major Biosimilar Players, 3SBio Inc, SWOT, 2010 121

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