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

Published by: GBI Research

Published: Feb. 1, 2010 - 84 Pages


Table of Contents


1 Table of contents
1 Table of contents
1.1 List of Tables
1.2 List of figures
2 Introduction
2.1 GBI Research Report Guidance
3 Small and Medium Biopharmaceutical Enterprises - Overview of the Present Biotechnology SME Sector
3.1 Small and Medium Enterprise Characteristics
3.1.1 SMEs Across Different Industries and Geographies are Small Enterprises
3.1.2 SMEs Have an Entrepreneurial Management Structure in Place with Central Leadership Allowing Quick Decision Making
3.1.3 Biotechnology SMEs are Non-Profit Making Companies Due to a Lack of a Marketed Product Portfolio
3.1.4 SMEs Lack Commercialization Capabilities and Should Focus on Industry Partnerships and Outsourcing
3.2 Lifecycle of a Small and Medium Enterprise
3.3 Small and Medium Enterprise and Patents
3.4 Biotechnology Clusters and Role in Development of SME
3.4.1 European Clusters
3.4.2 North American Clusters
3.4.3 Success Factors for Clusters
4 Small and Medium Biopharmaceutical Enterprises - Market Characterization
4.1 Composition of the Biotechnology Industry: Small and Medium Enterprises Dominate
4.1.1 Composition of SMEs by Geography: North America has Higher Proportion of Biotechnology Companies
4.1.2 Composition of SMEs by Size: The Majority of SMEs are Small, Employing Less than 250 Employees
4.1.3 Composition of SMEs by Therapeutic Class: Most SMEs are Active in Cancer Research
4.1.4 Biotechnology Drug Pipeline: SME Contribution Important
4.2 Drivers and Restraints
4.2.1 Drivers
4.2.2 Restraints/Challenges
5 Small and Medium Biopharmaceutical Enterprises - Funding Scenario
5.1 SME Lifecycle and Sources of Funding
5.1.1 Pre-Seed and Seed Stage: Angel Investor and Government Grants are the Key Sources of Finances
5.1.2 Start up Stage: Venture Capital Firms Provide Major Funding
5.1.3 Early Growth and Expansion: SMEs Feel Funding Pressure, Big Pharmaceutical and Biotechnology Companies Take an Interest
5.2 Funding Activities of SMEs
5.2.1 Venture Capital Firms: In the Absence of Exit Opportunities they are Unable to Raise Sufficient Funds for New SMEs
5.2.2 Initial Public Offerings: Slowdown in IPO Market Impacts Availability of Growth Stage Capital
5.2.3 Mergers and Acquisitions
5.3 The Future Funding Scenario of Biotechnology SMEs Looks Balanced
5.4 Gaps in SME Funding
5.5 Filling the Funding Gap
5.5.1 Government Support: Need to Increase Focus on Growing SMEs
5.5.2 Industry Players: Need to Invest Early in SMEs
5.5.3 VC and Angel Investors: To Continue their Support
6 Small and Medium Biopharmaceutical Enterprises - Regulatory Environment and Government Support
6.1.1 Overview of Regulatory Environment
6.1.2 Regulatory Environment and Small and Medium Enterprises
6.2 The Current State of Support for SMEs - Europe
6.2.1 Hard Initiatives: Grants and Funding
6.2.2 Soft initiatives - Guidance and Advice
6.3 Current State of Support for SMEs - North America
6.3.1 Funding and Assistance Structures Present in North America
6.3.2 Hard Initiatives: Grants and Funding
6.3.3 Soft Initiatives - Guidance and Advice
7 Small and Medium Biopharmaceutical Enterprises - Deals Analysis
7.1 Mergers and Acquisitions of SMEs in North America and Europe
7.1.1 Sciele Pharma acquired Addrenex
7.1.2 Celldex Therapeutics acquired CuraGen Corporation
7.1.3 Affitech AS merged with Pharmexa A/S
7.1.4 Cell Genesys and BioSante merged to form BioSante
7.1.5 Johnson & Johnson acquires Cougar Biotechnology
7.1.6 Takeda acquires IDM Pharma
7.1.7 Merck acquires Insmed's follow-on biologics platform
7.1.8 Bristol-Myers Squibb acquires Medarex
7.2 Licensing Activities: SME Pipeline Targeted for In-licensing
7.2.1 Preclinical
7.2.2 Phase I
7.2.3 Phase II
7.2.4 Phase III
7.2.5 Approved
7.3 Out Licensing of Biotechnology SMEs to Large Pharmaceutical Companies
8 Small and Medium Biopharmaceutical Enterprises in North America and Europe - Competitive Landscape
8.1 Competitive Benchmarking
8.2 Key Player Profiles
8.2.1 Clovis Oncology
8.2.2 Pacific Biosciences
8.2.3 ActoGeniX
8.2.4 Aileron
8.2.5 BioVex
8.2.6 AC Immune
8.2.7 Avila Therapeutics
8.2.8 Chroma Therapeutics
8.2.9 KaloBios
8.2.10 Achaogen
9 Small and Medium Biopharmaceutical Enterprises in North America and Europe - Conclusion
10 Appendix
10.1 Market Definitions
10.2 Abbreviations
10.3 Research Methodology
10.3.1 Coverage
10.3.2 Secondary Research
10.3.3 Primary Research
10.3.4 Expert Panel Validation
10.4 Contact Us
10.5 Disclaimer
10.6 Sources
1.1 List of Tables
Table 1: Definition of Small and Medium Enterprises in Key Countries
Table 2: Country Break-up of Healthcare Biotechnology SMEs in North America and Europe, 2009
Table 3: Biotechnology SMEs, Key M&A activities in 2009
Table 4: Biotechnology SMEs, Licensing Agreements for Drugs in the Preclinical Stage, 2009
Table 5: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase I Stage, 2009
Table 6: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase II Stage, 2009
Table 7: Biotechnology SMEs, Licensing Agreements for Drugs in the Phase III Stage, 2009
Table 8: Biotechnology SMEs, Licensing Agreements for Approved Drugs, 2009
Table 9: Benchmarking of Key Biotechnology SMEs, 2009
1.2 List of figures
Figure 1: Lifecycle of an SME, 2010
Figure 2: Number of Clusters and Networks by Country in Europe, 2010
Figure 3: Key Biotechnology Clusters in Europe, 2010
Figure 4: Key Biotechnology Clusters in the US, 2010
Figure 5: Key Biotechnology Clusters in Canada, 2010
Figure 6: Factors for Success of Biotechnology Clusters, 2010
Figure 7: Composition of the European and North American Biotechnology Industry, Number of Companies, 2009
Figure 8: Composition of the European and North American Biotechnology Industry, 2009
Figure 9: Number of SMEs by Geography, 2009
Figure 10: Break-up of SME Sector by Country, 2009
Figure 11: SME by Size of Companies, 2009
Figure 12: Number of SMEs by Therapeutic Areas, 2009
Figure 13: Therapeutics Areas of Focus for SMEs, 2009
Figure 14: Number of Drugs in the Pipeline in the Biotechnology Industry, 2009
Figure 15: Sources of SME funding at Different Stages of its Lifecycle, 2010
Figure 16: Financing Activities: Biopharmaceutical and Pharmaceutical Industry, 2006-2009
Figure 17: Financing Activities: Biotechnology SMEs, 2006-2009
Figure 18: Number of Companies Receiving VC Funding, Biotechnology SMEs, 2006- 2009
Figure 19: Number of IPOs/Offerings, Biotechnology SMEs, 2006-2009
Figure 20: Number of Companies Acquired, Biotechnology SMEs, 2006-2009
Figure 21: Trends in Funding, 2008-2009
Figure 22: Filling the Funding Gap for SMEs, 2008
Figure 23: Decline in NME Approvals by the FDA, 1996-2008
Figure 24: European Union Funding for the Development of SMEs and Innovation, 2010
Figure 25: FP7 Funding Activities, 2008-2013
Figure 26: Government Support for SMEs, the US, 2010
Figure 27: Government Support for SMEs, Canada, 2010
Figure 28: SBIR Program Grants for Different Stages of Development of Innovation, 2010
Figure 29: Licensing Activity by Licensor Type, 2008-2009
Figure 30: Licensing Activity of Biotechnology and Pharmaceutical Companies, 2009
Figure 31: Licensing Activity of Biotechnology SMEs by Stage of Development, 2009
Figure 32: Licensing Activity of Top Ten Pharmaceutical Companies, 2004-2009
Figure 33: Licensing Activity of Top Ten Pharmaceutical Companies, 2004-2009
Figure 34: Clinical Trials Analysis for ActoGenix, 2008
Figure 35: Clinical Trials Analysis for BioVex, 2008
Figure 36: Clinical Trials Analysis for AC Immune, 2008
Figure 37: Clinical Trials Analysis for Chroma Therapeutics, 2008
Figure 38: Clinical Trials Analysis for KaloBios, 2008
Figure 39: Clinical Trials Analysis for Achaogen, 2008
Figure 40: GBI Research Methodology

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.


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