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

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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

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									    Small and Medium Biopharmaceutical Enterprises in North
     America and Europe - Biotechnology Clusters, Funding
           Characteristics and Regulatory Landscape
 Reference Code: GBIHC012MR                                                                             Publication Date: February 2010

                                     Small and Medium Biopharmaceutical Enterprises - Executive Summary
   SMEs and big players in           GBI Research’s analysis suggests that small and medium biopharmaceutical companies will form
   the biopharmaceutical             strategic partnerships with pharmaceutical and biotechnology companies to deliver synergy,
   industries will form              innovation, and high value business transactions despite being faced by a challenging market
   strategic partnerships to         environment, uncertain competitive positioning, and unstructured funding options. The Small and
   overcome individual               Medium Enterprises (SMEs) contribute to the majority of biopharmaceutical research and
   challenges of funding and         development programs indicating the strength of the biopharmaceutical SME pipeline. Big
   R&D productivity                  pharmaceutical companies are facing challenges such as the patent expiry of blockbuster drugs
   respectively.                     and low R&D productivity. These two factors will be the prime factors driving partnerships between
                                     biopharmaceutical SMEs and bigger companies in the pharmaceutical and biotechnology
                                     industries. These partnerships are a win-win situation for both parties. This is because the
                                     biotechnology SMEs are faced with a challenging market due to the lack of internal
                                     commercialization skills and other management skills which make them ill equipped to compete
                                     with bigger players in a strict regulatory environment. In addition, the SMEs have access to
                                     fragmented funding which depends on multiple sources and factors. The importance of SMEs in
                                     driving innovation in the industry will encourage an increased number of Mergers & Acquisitions
                                     (M&As) involving biopharmaceutical and biotechnology SMEs. The small biotechnology companies
                                     are highly focused on fulfilling the unmet need in the market. This helps SMEs to attract funding
                                     from different sources and also compete with bigger players.
                                     The Biopharmaceutical and Biotechnology Small and Medium Enterprises will Drive
                                     Innovation in the Pharmaceutical Industry Through Strategic Partnerships
                                     GBI Research’s analysis suggests that research intensive biopharmaceutical and biotechnology
                                     SMEs will contribute to the innovative pipeline of pharmaceutical and biotechnology companies
                                     through licensing agreements and research collaborations. Biotechnology SMEs focus primarily on
                                     research and development activities. The biotechnology SMEs play an important role in the
                                     industry by enhancing the product pipeline of the industry through their innovative ideas and
                                     products. SMEs have very few commercialized products and are valued based on the potential of
                                     their products in the pipeline. Almost all the resources and employees in a biotechnology SME are
                                     dedicated to research and development. In addition, the close association of SMEs with academic
                                     research enhances the innovative potential of the sector. Many of the biotechnology SMEs have
                                     been established as spin-offs from university research departments. GBI Research’s study of more
                                     than 3,000 pipeline products revealed that biotechnology SMEs account for more than 87% of the
                                     biotechnology pipeline. This indicates that a majority of the new compounds under development in
                                     the biotechnology industry belong to SMEs.
                                     The larger pharmaceutical and biotechnology companies also benefit from the innovation of SMEs.
                                     The bigger companies enter into strategic collaborations with biotechnology SMEs in order to
                                     enhance their pipeline. Licensing agreements with SMEs provide bigger companies access to
                                     novel compounds under development. In addition, bigger companies also enter into research
                                     collaborations with smaller companies to leverage the innovative ideas of smaller companies. Big
                                     pharmaceutical and biotechnology companies also consider SMEs to be important M&A targets
                                     due to their ability to expand their pipeline.
                                     The strategic collaborations between SMEs and bigger companies provide advantages to both
                                     parties. SMEs often have limited access to resources and funding, and enter into licensing and
                                     M&A agreements with bigger companies to enable them to continue R&D activities. Similarly, big
                                     organizations benefit by expanding their depleting pipeline. GBI Research’s analysis suggests that
                                     SMEs and big pharmaceutical and biotechnology companies will continue to collaborate for their
                                     mutual benefit in order to bring novel therapies to market.




Small and Medium Biopharmaceutical Enterprises in North                                                   GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                              Page 1
                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                      Biopharmaceutical and Biotechnology SMEs, Contribution to Industry Innovation, 2010

                                                                                                  SMEs



                                                                                                                                 Biotech SMEs bring
                                                                                                Innovative                       innovative product to
                                                                Technology                  products/research                    industry pipeline
                                                                interactions
                                                                                                        Funding
                                                                                                        interactions
                                              Partnership with pharma                    Outlicensing to pharma                    Acquisition by pharma
                                                  and big biotech                            and big biotech                          and big biotech
                                                    companies                                  companies                                companies




                                                  Collaboration using big                Receive funding to carry                  Ensure regular funding
                                                  pharma technology and                    out development of                         for its innovative
                                                  resources with biotech                    innovative drugs                                pipeline
                                                     SME innovation


                                              •     SMEs drive the industry’s innovative pipeline by improving competition, providing the industry with
                                                    access to innovative drugs, and enhancing the R&D capabilities of pharma and biotech companies by
                                                    being acquired by these companies
                                              •     In turn, the biotech companies seek regular funding for their activities, which is the main driver for
                                                    research collaborations, licensing and M&A activities of biotech SMEs

                                      Source: GBI Research



                                     Biotechnology SMEs and big companies collaborate in order to enhance the industry
                                     pipeline.
                                     Biotechnology SME’s Organizational Structure Focuses Primarily on Research which
                                     Exposes them to Many Challenges
                                     The top management in biotechnology SMEs are research oriented but may have limited exposure
                                     to business related aspects of running a company. Many SMEs originate as spin-offs from
                                     universities and are therefore founded and headed by experts from research backgrounds. As a
                                     result, a focus on research and development is built into the culture of biotechnology SMEs. This
                                     encourages innovation but can lead to a limited exposure to marketing, production, and
                                     commercialization experience. Although SMEs are not required to handle commercialization
                                     activities in the initial stages of their development, such exposure can be helpful in financing their
                                     research and crossing regulatory hurdles more quickly. Bigger companies on the other hand are
                                     much more organized and experienced in handling these business challenges and are strong
                                     competition to smaller biotechnology companies. Most biotechnology SMEs are acquired by bigger
                                     companies once they approach the commercialization stage which allows them to leverage the
                                     experience of bigger companies. In addition, SMEs need to enter into marketing and distribution
                                     agreements with bigger companies due to their lack of distribution expertise. Therefore,
                                     biotechnology SMEs rely on the bigger companies in order to survive while at the same time
                                     competing with them.
                                     SMEs Face a Challenging Funding Environment Due to the Unstructured Nature of Funding
                                     Sources
                                     The funding for biotechnology SMEs is unstructured as they depend on many different funding
                                     sources at different stages of their lifecycle. The funding depends on internal factors such as the
                                     pipeline strength of biotechnology SMEs and external factors such as economic conditions. The
                                     traditional sources of funding for SMEs are under pressure due to the Impact of the economic
                                     recession. The biotechnology SMEs differ in their funding model from pharmaceutical companies.
                                     Big pharmaceutical companies rely on the revenue and profits from their products in order to invest
                                     in various activities. SMEs do not have revenue generating drugs and therefore depend on Venture
                                     Capital (VC) financing. An analysis of the funding activities of biotechnology SMEs reveals that all
                                     their traditional sources of finances have taken a hit due to the recession. The total number of initial
                                     public offering (IPO) and VC financing activities declined in 2008 by 18% as compared to an
                                     increase of 10% in 2007. This decline in the VC and IPO markets is likely to have a major impact
                                     on the biotechnology SME sector which is dominated by small companies incapable of surviving for


Small and Medium Biopharmaceutical Enterprises in North                                                                     GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                                                     Page 2
                                                                                 © GBI Research. This is a licensed product and is not to be photocopied
                                     long periods of time without funding. If such a scenario persists, these small companies will not be
                                     able to develop their pipelines any further and will eventually face extinction if they are not acquired
  Their small size places            by bigger companies or receive government aid.
  SMEs at a disadvantage
  while carrying out                  Financing Activities: Biotechnology SMEs, 2006-2009
  regulatory processes and
  exposes them to a                                                                                         Impact of recession is seen on
                                                          180
                                                                                                            total financing activities in
  challenging funding                                                                                       2008. Number of
  environment.                                            160                                               IPOs/offerings have
                                                                                                            substantially declined in 2008.
                                                                                                            Considerable improvement was
                                                          140                                               seen in the number of financing
                                                                                                            activities in 2009
                                                          120
                                        Number of Deals


                                                                                                                                                 111
                                                          100       71                        74

                                                          80                                                          74


                                                          60
                                                                                              16

                                                          40        39
                                                                                                                                                 24
                                                                                              26                      21
                                                          20                                                          9                          17
                                                                    20                        20
                                                                                                                      13                          9
                                                           0         3
                                                                   2006                      2007                   2008                        2009

                                                                Financing Agreements      IPO's/Offerings    Mergers and Acquisitions         VC Financing
                                      Source: GBI Research



                                     Biotech SMEs rely on M&A activities, VC funding, and IPOs for their financing needs.
                                     However, the number of these activities have declined in the recent in the recent years
                                     indicating greater challenges for SME.s
                                     SMEs are Challenged by a Strict Regulatory Scenario Due to Their Small Size and Few
                                     Resources
                                     The regulations for drug development and approval in the US and Europe are stringent with many
                                     processes. Industry players are required to adhere to regulatory guidelines at every stage of
                                     research and development. The players are also required to maintain extensive records for
                                     regulatory authorities. This requires considerable expertise and experience. Relatively new SMEs
                                     have limited exposures to such processes and generally find it difficult to adhere to all standards
                                     without impacting the productivity of other departments. Therefore, with very little expertise in areas
                                     other than research, SMEs find it difficult to handle the regulatory requirements in North America
                                     and Europe. While the bigger players are experienced in taking their drugs through the various
                                     stages of regulatory approval, smaller companies struggle due to their limited experience in this
                                     field. This makes the regulatory landscape challenging for SMEs.
                                     Biotechnology SMEs will Continue to be Targets for Acquisition by Big Pharmaceutical and
                                     Biotechnology Companies
                                     Biotechnology SMEs are considered important targets for M&As and partnerships by the bigger
                                     pharmaceutical and biotechnology companies. The collaboration with biotechnology SMEs enables
                                     the pharmaceutical industry to tackle challenges such as patent expiry of key blockbusters and low
                                     R&D productivity that it faces. These issues have left the major pharmaceutical companies with
                                     unproductive pipelines, and therefore in-licensing new drug candidates from smaller innovative
                                     firms is considered as an important strategy to enhance the R&D pipelines. Licensing activities not
                                     only provide big pharmaceutical companies with the essential boost to their R&D pipeline, but also
                                     help the smaller companies to finance their research and development activities. In addition to
                                     licensing activities, biotechnology SMEs will continue to be a target for acquisition by bigger
                                     biotechnology or pharmaceutical companies. Recent acquisitions of small biotechnology
                                     companies indicate that these smaller companies will continue to attract buyers or partners
                                     because of their innovative pipelines. Small biotechnology companies and academic research

Small and Medium Biopharmaceutical Enterprises in North                                                                     GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                                                     Page 3
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                     organizations have been the targets in the majority of the licensing activities since 2008. Therefore,
                                     even as traditional sources of funding such as VCs and IPOs remain under pressure, biotechnology
                                     SMEs will increase their reliance on other big pharmaceutical and biotechnology companies for
                                     their funding needs.
                                     Biotechnology SMEs’ Competitive Positioning is Based on a Strong Pipeline and Bringing
                                     New Products to Serve Areas of Unmet Needs
                                     Biotechnology companies compete in the market by positioning themselves as players in niche
                                     segments with areas of unmet need. This allows biotechnology companies to develop first-in-class
                                     medicines in different disease indications. Most of the SMEs focus on one or two therapy areas,
                                     unlike the big pharmaceutical companies which have a diversified R&D pipeline focusing on
                                     multiple therapy areas. This limited focus helps SMEs to optimize their limited resources and
                                     effectively engage in R&D activities for finding innovative therapies. Success for these
                                     biotechnology companies is measured in terms of the patent portfolio and the product pipeline of
                                     company at any given time. Biotechnology SMEs with strong products in the pipeline find it easier
                                     to attract VC funding and partner with bigger pharmaceutical and biotechnology companies. In
                                     some cases SMEs license some of their products while retaining the rights to other products in their
                                     pipeline. Such a strategy is used by smaller firms in order to leverage the experience of big
                                     companies to enhance the quality of their pipeline and also to gain experience in handling clinical
                                     trials related information. Biotechnology SMEs have few resources but they utilize them to compete
                                     in niche segments with other SMEs and big pharmaceutical and biotechnology companies.




Small and Medium Biopharmaceutical Enterprises in North                                                    GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                               Page 4
                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                     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 Dominate21
                                            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

Small and Medium Biopharmaceutical Enterprises in North                                                                                 GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                                                                       Page 5
                                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                           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




Small and Medium Biopharmaceutical Enterprises in North                                                                                    GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                                                                          Page 6
                                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                     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




Small and Medium Biopharmaceutical Enterprises in North                                                                             GBIHC012MR /Published FEB 2010
America and Europe - Biotechnology Clusters, Funding
Characteristics and Regulatory Landscape                                                                                                                                    Page 7
                                                                                   © GBI Research. This is a licensed product and is not to be photocopied
                                     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 Devel
								
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