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Small and Medium Biopharmaceutical Enterprises in North America and Europe - Biotechnology Clusters, Funding Characteristics and Regulatory Landscape

Summary

This pharmaceutical and healthcare report provides an overview of the small and medium biopharmaceutical enterprises in the North American and European regions. The report provides an insight in to the importance of Small and Medium Enterprises (SME) in the biotechnology industry. It covers market characterization, geographical spread of SMEs, drivers and restraints, regulatory scenarios and funding challenges faced by the biotechnology SME industry. The study reviews the role of SMEs in driving the pipeline within the biotechnology industry, the role of governments in promoting the sector, as well as potential gaps. It provides a comprehensive analysis of the deals in the SME sector and also provides competitive benchmarking to understand how SMEs compete.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis.

Scope

The scope of this report includes:

Biotechnology SME composition in North America, and Europe. In North America, the US (United States) and Canada are covered. The report covers European countries such as the UK (United Kingdom), Germany, Canada, France, Sweden, Switzerland, Denmark, the Netherlands and Belgium.

Pipeline analysis data for the two geographies to provide an understanding of the contribution of biotechnology SMEs in the pipeline of the industry.

Qualitative analysis of market drivers and restraints and funding for SMEs. Funding structure for biotechnology SMEs and issues faced in funding.

Analysis of deals involving biotechnology SMEs.

Competitive landscape covering key players Clovis Oncology, Pacific Biosciences, ActoGeniX, Aileron, BioVex, AC Immune, Avila Therapeutics, Chroma Therapeutics, KaloBios, Achaogen.

Reasons to buy

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

Develop an understanding of the SME biotechnology sector and the role played by them in driving innovation in the pharmaceutical and biotechnology industries.

Understand the funding related issues that SMEs face and make use of the potential solutions.

Exploit in-licensing and out-licensing opportunities by identifying the key areas of licensing activities of SME biotechnology firms.

Understand and exploit M&A opportunities present in the biotechnology SME landscape.

Develop a clear knowledge & understanding of how SMEs are supported in North America and Europe.

Identify key players best positioned to take advantage of the emerging market opportunities.

Table of Contents

1 Table of contents 5

• 1.1 List of Tables 7
• 1.2 List of figures 8

2 Introduction 9

• 2.1 Research Report Guidance 9

3 Small and Medium Biopharmaceutical Enterprises - Overview of the Present Biotechnology SME Sector 11

• 3.1 Small and Medium Enterprise Characteristics 11
  • 3.1.1 SMEs Across Different Industries and Geographies are Small Enterprises 11
  • 3.1.2 SMEs Have an Entrepreneurial Management Structure in Place with Central Leadership Allowing Quick Decision Making 12
  • 3.1.3 Biotechnology SMEs are Non-Profit Making Companies Due to a Lack of a Marketed Product Portfolio 12
  • 3.1.4 SMEs Lack Commercialization Capabilities and Should Focus on Industry Partnerships and Outsourcing 13
• 3.2 Lifecycle of a Small and Medium Enterprise 13
• 3.3 Small and Medium Enterprise and Patents 14
• 3.4 Biotechnology Clusters and Role in Development of SME 15
  • 3.4.1 European Clusters 15
  • 3.4.2 North American Clusters 17
  • 3.4.3 Success Factors for Clusters 19

4 Small and Medium Biopharmaceutical Enterprises – Market Characterization 21

• 4.1 Composition of the Biotechnology Industry: Small and Medium Enterprises Dominate 21
  • 4.1.1 Composition of SMEs by Geography: North America has Higher Proportion of Biotechnology Companies 22
  • 4.1.2 Composition of SMEs by Size: The Majority of SMEs are Small, Employing Less than 250 Employees 24
  • 4.1.3 Composition of SMEs by Therapeutic Class: Most SMEs are Active in Cancer Research 24
  • 4.1.4 Biotechnology Drug Pipeline: SME Contribution Important 26
• 4.2 Drivers and Restraints 27
  • 4.2.1 Drivers 27
  • 4.2.2 Restraints/Challenges 28

5 Small and Medium Biopharmaceutical Enterprises – Funding Scenario 30

• 5.1 SME Lifecycle and Sources of Funding 30
  • 5.1.1 Pre-Seed and Seed Stage: Angel Investor and Government Grants are the Key Sources of Finances 31
  • 5.1.2 Start up Stage: Venture Capital Firms Provide Major Funding 31
  • 5.1.3 Early Growth and Expansion: SMEs Feel Funding Pressure, Big Pharmaceutical and Biotechnology Companies Take an Interest 31
• 5.2 Funding Activities of SMEs 31
  • 5.2.1 Venture Capital Firms: In the Absence of Exit Opportunities they are Unable to Raise Sufficient Funds for New SMEs 33
  • 5.2.2 Initial Public Offerings: Slowdown in IPO Market Impacts Availability of Growth Stage Capital 33
  • 5.2.3 Mergers and Acquisitions 34
• 5.3 The Future Funding Scenario of Biotechnology SMEs Looks Balanced 36
• 5.4 Gaps in SME Funding 36
• 5.5 Filling the Funding Gap 37
  • 5.5.1 Government Support: Need to Increase Focus on Growing SMEs 38
  • 5.5.2 Industry Players: Need to Invest Early in SMEs 38
  • 5.5.3 VC and Angel Investors: To Continue their Support 38

6 Small and Medium Biopharmaceutical Enterprises – Regulatory Environment and Government Support 39

6.1.1 Overview of Regulatory Environment 39

6.1.2 Regulatory Environment and Small and Medium Enterprises 40

6.2 The Current State of Support for SMEs – Europe 41

• 6.2.1 Hard Initiatives: Grants and Funding 42
• 6.2.2 Soft initiatives – Guidance and Advice 44

6.3 Current State of Support for SMEs – North America 45

• 6.3.1 Funding and Assistance Structures Present in North America 45
• 6.3.2 Hard Initiatives: Grants and Funding 46
• 6.3.3 Soft Initiatives – Guidance and Advice 49

7 Small and Medium Biopharmaceutical Enterprises – Deals Analysis 50

• 7.1 Mergers and Acquisitions of SMEs in North America and Europe 50
  • 7.1.1 Sciele Pharma acquired Addrenex 52
  • 7.1.2 Celldex Therapeutics acquired CuraGen Corporation 52
  • 7.1.3 Affitech AS merged with Pharmexa A/S 52
  • 7.1.4 Cell Genesys and BioSante merged to form BioSante 52
  • 7.1.5 Johnson & Johnson acquires Cougar Biotechnology 52
  • 7.1.6 Takeda acquires IDM Pharma 53
  • 7.1.7 Merck acquires Insmed's follow-on biologics platform 53
  • 7.1.8 Bristol-Myers Squibb acquires Medarex 53
• 7.2 Licensing Activities: SME Pipeline Targeted for In-licensing 53
  • 7.2.1 Preclinical 55
  • 7.2.2 Phase I 59
  • 7.2.3 Phase II 61
  • 7.2.4 Phase III 63
  • 7.2.5 Approved 65
• 7.3 Out Licensing of Biotechnology SMEs to Large Pharmaceutical Companies 67

8 Small and Medium Biopharmaceutical Enterprises in North America and Europe – Competitive Landscape 69

• 8.1 Competitive Benchmarking 69
• 8.2 Key Player Profiles 70
  • 8.2.1 Clovis Oncology 70
  • 8.2.2 Pacific Biosciences 70
  • 8.2.3 ActoGeniX 71
  • 8.2.4 Aileron 72
  • 8.2.5 BioVex 73
  • 8.2.6 AC Immune 74
  • 8.2.7 Avila Therapeutics 74
  • 8.2.8 Chroma Therapeutics 75
  • 8.2.9 KaloBios 76
  • 8.2.10 Achaogen 77

9 Small and Medium Biopharmaceutical Enterprises in North America and Europe - Conclusion 79

10 Appendix 80

• 10.1 Market Definitions 80
• 10.2 Abbreviations 80
• 10.3 Research Methodology 81
  • 10.3.1 Coverage 82
  • 10.3.2 Secondary Research 83
  • 10.3.3 Primary Research 83
  • 10.3.4 Expert Panel Validation 83
• 10.4 Contact Us 83
• 10.5 Disclaimer 84
• 10.6 Sources 84

1.1 List of Tables

• Table 1: Definition of Small and Medium Enterprises in Key Countries 12
• Table 2: Country Break-up of Healthcare Biotechnology SMEs in North America and Europe, 2009 24
• Table 3: Biotechnology SMEs, Key M&A activities in 2009 51
• Table 4: Biotechnology SMEs, Licensing Agreements for Drugs in the Preclinical Stage, 2009 56
• Table 5: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase I Stage, 2009 59
• Table 6: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase II Stage, 2009 61
• Table 7: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase III Stage, 2009 63
• Table 8: Biotechnology SMEs, Licensing Agreements for Approved Drugs, 2009 65
• Table 9: Benchmarking of Key Biotechnology SMEs, 2009 69

1.2 List of figures

• Figure 1: Lifecycle of an SME, 2010 14
• Figure 2: Number of Clusters and Networks by Country in Europe, 2010 16
• Figure 3: Key Biotechnology Clusters in Europe, 2010 16
• Figure 4: Key Biotechnology Clusters in the US, 2010 18
• Figure 5: Key Biotechnology Clusters in Canada, 2010 18
• Figure 6: Factors for Success of Biotechnology Clusters, 2010 19
• Figure 7: Composition of the European and North American Biotechnology Industry, Number of Companies, 2009 21
• Figure 8: Composition of the European and North American Biotechnology Industry, 2009 22
• Figure 9: Number of SMEs by Geography, 2009 23
• Figure 10: Break-up of SME Sector by Country, 2009 23
• Figure 11: SME by Size of Companies, 2009 24
• Figure 12: Number of SMEs by Therapeutic Areas, 2009 25
• Figure 13: Therapeutics Areas of Focus for SMEs, 2009 26
• Figure 14: Number of Drugs in the Pipeline in the Biotechnology Industry, 2009 27
• Figure 15: Sources of SME funding at Different Stages of its Lifecycle, 2010 30
• Figure 16: Financing Activities: Biopharmaceutical and Pharmaceutical Industry, 2006-2009 32
• Figure 17: Financing Activities: Biotechnology SMEs, 2006-2009 32
• Figure 18: Number of Companies Receiving VC Funding, Biotechnology SMEs, 2006- 2009 33
• Figure 19: Number of IPOs/Offerings, Biotechnology SMEs, 2006-2009 34
• Figure 20: Number of Companies Acquired, Biotechnology SMEs, 2006-2009 35
• Figure 21: Trends in Funding, 2008-2009 36
• Figure 22: Filling the Funding Gap for SMEs, 2008 37
• Figure 23: Decline in NME Approvals by the FDA, 1996–2008 40
• Figure 24: European Union Funding for the Development of SMEs and Innovation, 2010 42
• Figure 25: FP7 Funding Activities, 2008-2013 44
• Figure 26: Government Support for SMEs, the US, 2010 46
• Figure 27: Government Support for SMEs, Canada, 2010 46
• Figure 28: SBIR Program Grants for Different Stages of Development of Innovation, 2010 48
• Figure 29: Licensing Activity by Licensor Type, 2008-2009 54
• Figure 30: Licensing Activity of Biotechnology and Pharmaceutical Companies, 2009 55
• Figure 31: Licensing Activity of Biotechnology SMEs by Stage of Development, 2009 55
• Figure 32: Licensing Activity of Top Ten Pharmaceutical Companies, 2004-2009 67
• Figure 33: Licensing Activity of Top Ten Pharmaceutical Companies, 2004-2009 68
• Figure 34: Clinical Trials Analysis for ActoGenix, 2008 72
• Figure 35: Clinical Trials Analysis for BioVex, 2008 73
• Figure 36: Clinical Trials Analysis for AC Immune, 2008 74
• Figure 37: Clinical Trials Analysis for Chroma Therapeutics, 2008 76
• Figure 38: Clinical Trials Analysis for KaloBios, 2008 77
• Figure 39: Clinical Trials Analysis for Achaogen, 2008 78
• Figure 40: Research Methodology 82

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