This publication has been discontinued on September 9, 2011.
Abstract
Small and Medium Biopharmaceutical Enterprises in North America and Europe -
Biotechnology Clusters, Funding Characteristics and Regulatory Landscape
Summary
GBI Research, the leading business intelligence provider, has released its
latest research, “Small and Medium Biopharmaceutical Enterprises in
North America and Europe - Biotech Clusters, Funding Characteristics and
Regulatory Landscape.” 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 by GBI
Research’s team of industry experts.
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
1 Table of contents 5
1.1 List of Tables 7
1.2
List of figures 8
2 Introduction 9
2.1 GBI 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: GBI Research
Methodology 82
