Review of Key Criteria for the Successful Development of the Biomedical Sector Presented by Frost & Sullivan’s Biotechnology Team 15th November 2010
Table of Contents Key success factors for biotech clusters 1 A look at International + Singapore Biotech Clusters 2 Benchmarking with International Clusters 3
Research Objectives Analysis of Best Practices Activity in Developing Bioclusters Identify world-wide some of the developmental efforts related to developing and growing the Biomedical sector. This includes overall strategy, financial and non-financial incentives, and other assistance that public sector/ non-profit organizations offer to biomedical companies, especially SMEs. Key successful bioclusters in comparable and competitive economies will serve as benchmark for this study. Identify Strengths and Weaknesses in the Singapore Biocluster Understand key challenges faced by biomedical companies, review infrastructure and assistance available in Singapore for biomedical companies, comparing them to the bioclusters identified above. To also identify key gaps, outlining recommended approaches that SPRING can embark on to build capabilities of local biomedical players.
Identify actionable recommendations and policies to foster the Singapore SME growth in the biomedical sector
Identify the key success factor and learning from the International clusters
Examples of key biotech clusters Medicon Valley
Zealand in Denmark and Scania in South Sweden
Greater Boston Area including Providence and Worcester
Jerusalem, Tel Avi and Haifa triangle
Across the country
San Francisco Bay Area in North California
Los Angeles, Orange County, Riverside and San Diego in South California
Singapore Boston and California clusters are leading, mature and old clusters, Medicon Valley is among the successful clusters in Europe. Israel and Korea are two growing clusters with strong government support and strength in research
Setting the stage… 1 Industry Maturity, Medical Centre and University Maturity, Funding Availability and Regulatory and Business Environment are four key attributes of a bio medical cluster 2 Singapore performance in the last 10 years has been appreciated by the industry and foreign participants. It compares well on the Business environment. However, it needs to progress on other 3 parameters 3 To improve Industry Maturity– we need to focus on medical devices, faster commercializable research, proven technologies, clinical trials to leverage healthcare infrastructure 4 To improve University and Medical Centre maturity More collaboration activities, TTOs and incubators, More commercial exposure to scientists and international tieupsare needed 5 Promotion of SMEs, Improving skill base and promoting entrepreneurship are desirable to improve the business environment in the overall cluster 6 Pre seed funding and steps to develop VC need to be taken to improve funding availability for companies 7 Ways to Promote Entrepreneurship, run TTOs, increase International affiliations, attracting VC can be learned from other international clusters
The Magic of Boston and California ClustersStrong science base. Established institutions, Funds from government and VC, strong industry associations and a spirit of entrepreneurship make them sustainable clusters Strong Science Base Funding Availability Business Environment for Biotech
30+ years of history in Biotech
100+ years of successful research at MIT, Harvard, Stanford, UCSF
Efficient TLO and networks to drive commercialization
Boston and California face competition from Texas, Los Angeles, Philadelphia for funds. Companies locating manufacturing facilities elsewhere for low real estate costs, higher tax benefits etc.
Continuous need to Provide space, talent, funds for the expanding cluster
Needs to continue focus on scientific collaboration and innovation
Emerging clusters pose competition due to low cost, high growth potential for companies
The Secret Sauce of Israel Strong in Research,TTOsandincubators to promote startups, developed VC industry and an entrepreneurship spirit characterize Israel Strong in Technology/Research Govt Support Business Environment for Biotech
Developed IT industry ; Defense;
Notable pharma products from Hebrew, Technion universities
Israel economy is classified as Innovation based economy by WEF
Physicians are early adopter as well as develop technology
2nd in per capita patents granted by USPTO in biotechnology
The Medicon Valley StoryBenefitted from integrated presence of leading companies and good healthcare infrastructure. The cluster is becoming complacent now Niche Development Business Environment for Biotech
Key Capabilities Singapore can look forward to become a partner in the Life Science Ambassador Program
Collaboration between universities, hospitals and institutions need to be improved
Lack of capital at later stages recently; Improvement needed to tap US capital markets
The cluster is said to be a little complacent .Not many cluster development efforts specifically
Taxes and an unfavorable weather; high cost of services are growing concerns
The Growth of Korea Educated and experienced manpower, success in research and clinical trials and the biomedical infrastructure created by the government are the key reasons for growth Strong Science Base Business Environment for Biotech
Biotechnology-related Departments in 40 Universities
Around 40 technologies or drug candidates were licensed out to Big Pharma during 1986-2008 and over 100 new drugs or lead candidates are under development.
Govt. creating research institutes, 25 biotechnology centers acting as incubators, specialized biotech parks, providing funds
The first initiative started in late 1980’s, continued effort in 1994 and 2006
government investments have grown from $311mn in 2001 to $721mn in 2007. This represents a CAGR of 15%.
Korea is ranked as 19 by WF Global Competitiveness Report 2009-10
The Bio-Vision initiative started in 2006 out with a budget of $720 million for R&D and $230 million for infrastructure in 2007, with a projected rise to $1.67 billion for R&D and $690 million for infrastructure by 2016. The total budget for nine years is projected at $15.56 billion
Pharmaceutical companies do not have strong experience to enter global markets
3rd in WEF Global Competitiveness Report 2009-10
Indications of developing medical devices and clinical trials segment
Limited Pre Seed Funding Available, Not sufficient for startup needs
VC investment in the sector less than $200mn annually. Preference given to other sectors, projects with certain product development plans and clear revenue generation strategy
Low levels of Entrepreneurship even though the business climate is quite suitable. Preference of Singaporeans towards professional careers and limited need to pursue risky opportunities
Need for improvement in commercialization and collaboration activities of research institutes
Less than 25 startups being created in the sector annually
Potential improvements in availability of experienced top management and in skill base of local workers
Improvements needed in international affiliations and collaboration of SMEs
Key Issues Higher Focus on Areas of Improvement
Key Success Factors for Biotech ClustersCompany Base, Science Base and Funding Availability are key capabilities for biomedical clusters Description Example clusters Company Base Boston, California
Thriving spin-out and start up companies.
Presence of companies to support research, clinical trials and manufacturing
Leading research organizations: University departments, hospitals/medical schools and charities
Critical mass of researchers, World leading scientists, Both industry driven and independent research
2 California Availability of Finance
Venture capitalists, Business angels, Developed public markets
Availability of cash at all stages of business like venture formation, pre-seed, seed, second round, mezzanine and opportunities for IPO
3 Source: Frost & Sullivan analysis
Key Success Factors for Biotech ClustersInfrastructure, supportive policy and business support services are strongly needed during the cluster start and growth phase Description Example clusters Premises & Infrastructure All
Incubators available close to research organizations
Premises with wet labs and flexible leasing arrangements
Space to expand, Motorways, Rail, International airport
4 US, Singapore Supportive Policy Environment
National and sector promotion policies, Long term planning
Specialist business, legal, patent, recruitment, property advisors, Large companies in related sectors (healthcare, chemical, agrifood)
6 Source: Frost & Sullivan analysis
Key Success Factors for Biotech ClustersSkilled workforce, entrepreneurial culture and effective networking develop as clusters mature and are important for sustainability Description Example clusters Skilled Workforce Boston, Israel
Skilled workforce, Training courses at all levels
7 Entrepreneurial Culture Boston, Israel
Commercial awareness and entrepreneurship in Universities and research institutes, presence of anchor companies
Role models and recognition of entrepreneurs, Presence of Second generation entrepreneurs
8 Ability to attract key staff Singapore. California
Critical mass of employment opportunities, Other living amenities
Image/Reputation as biotechnology cluster, Climate conditions
Attractive place to live. Good remuneration. Presence of similar intellectual class
9 Effective collaboration Boston. California 10
Shared aspiration to be a cluster. Regional trade associations.
Key Attributes of Biotech Clusters Ten factors have been combined into four attributes for simplicity, measurement and to do comparison across clusters. These include all stakeholders and all activities in the value chain Industry Maturity University/Medical Centre Maturity
Presence and nature of biotech companies (e.g. Startup, early stage, late development, mature commercial, enabling service)
Quantity and diversity of lifesciences stakeholders (e.g. R&D, medical devices, clinical trials and manufacturing, supporting industries)
Growth in Output – stagnated growth, slow growth or faster than industry
Strong research universities and academic medical centers, supported by effective technology transfer offices, as a key source of innovation and talent
Collaborative relationships between research universities and academic medical centers to sustain invention and innovation
Areas of Research and Commercialization Success
Funding Availability Regulatory and Business Environment
Availability of funding to support early stage company research
Funding for established biotech companies to invest in additional infrastructure and clinical research to move products into the market place
Regulatory and Business Environment comprises other seven factors
Source: Frost & Sullivan analysis
Cluster Current Positioning and Outlook LARGE California Boston
California life sciences $ 75bn in 2008 with a growth of 2% over 2007
Israel life sciences export were $6.5bn in 2008 and they tripled from 2004 levels
Singapore $15bn in 2009 growing at a CAGR of 14% during 2000-2009
Korea pharmaceutical was around $14bn in 2008 growing at a rate of 8-10%
Medicon Valley Size Korea Singapore Israel SMALL Cluster Capability World Class Emerging
Revenues for Boston and Medicon valley clusters not available. Their positioning is approximate in terms of size
Industry maturity – Focus on medical devices, faster commercializable research, proven technologies, clinical trials to leverage healthcare infrastructure
Funding availability – Higher efficiency of grants being disbursed, development of VC funds
University/Medical Center maturity – More collaboration activities, TTOs and incubators, More commercial exposure to scientists
Source: Frost & Sullivan Analysis Note : Two similar circles may not denote complete equality on the parameter.
Table of Contents Key success factors for biotech clusters 1 A look at International + Singapore Biotech Clusters 2 Benchmarking with International Clusters 3
Boston ClusterStrong Research base, effective networks and entrepreneurship culture leads to startup companies which leverage the available funding and other stakeholders’ support to develop successful products Diverse Companies Entrepreneurship Culture . Experienced Talent and Effective Networks Strong Research Base 30 +Years of history Funding Avalability Strong Research base, effective networks and entrepreneurship culture leads to startup companies which leverage the available funding and other stakeholders’ support to develop successful products Source: Frost & Sullivan Analysis
Evolution of Boston ClusterGovernment funding promoted research leads to formation of biotech startups that tie up with big pharmaceutical companies. World-class universities and research hospitals (M.I.T., Whitehead, Harvard, Massachusetts General Hospital, Brigham & Women’s Hospital, Beth Israel Hospital, Boston University, etc., etc.)- Harvard university since 1640 and MIT since 1865 Longwood Medical Center in Boston/Brookline started with 26acres in 1906 and grew up around Harvard Medical School . Kendell Square in Cambridge began in 1915 when MIT moved its campus there. In 1962, Massachusetts Medical Center was found in Worcester. In 1978, Biogen, first biopharma of the region was founded In 1980 Bayh-Dole Act Gave universities title to their patents from federally funded research Allowed universities to grant licenses, including exclusive licenses Allowed universities to take royalties (and legislated sharing of royalties with inventors.) In 1985, Genzyme had its first drug Ceradase to treat Gaucher disease In 1996, Wyeth acquires Genetic Institute and became the first large pharma company to establish manufacturing in the region In 2005, NIH research grants to the region reach $2.2bn Source: Press Articles
Boston ClusterMature Industry–big and small, across sectors and across the value chain; presence of leading medical institutions, venture capital firms and industry associations make it an integrated and mature cluster 72000 employees
Boston ClusterStrong Academic Science; Entrepreneurship culture and TLO efforts move products from mind to market MIT Statistics
20+ companies formed using MIT IP every year
Genzyme, Repligen, Biogen and Amgen founded by MIT faculty or alumni
$83 mn available to facilitate the commercialization of novel technology and intellectual property licensed from universities to small high technology firms employing less than 500 people
Boston ClusterRecent Initiatives in the Cluster
$500 million is earmarked for the Massachusetts Life Sciences Investment Fund
$250 million for the award of grants and $250 million in tax credits.
Tax incentives for companies to embark on expansions or new initiatives ;
Provide seed money to develop new ideas and provide financial aid for graduate students.
Money for the state's vocational and technical high schools and colleges to purchase new equipment to train life sciences workers.
Retain Researchers, Develop Stem Cell bank, fund equipment purchase, commercialization
$1 billion Life Sciences Initiative by State over 10 years 2015 Strategic Plan Development by MassBio Six Focus Areas for MassBiotech Association Company Recruitment and Retention Provision of Business Services Promote Scientific Collaboration and Innovation Improve Industry Representation Develop talent at all levels Improve access to capital Other Initiatives
Bio Ready Community –Communities ready for labs or manufacturing plants.
Life Science Talent Initiative -Promote biotechnology methods and inspire scientific curiosity and understanding at the high school level
Two very well known innovations emerged from Rafael, Israel Armament Development Authority: PillCamTM, a video capsule endoscope (developed by Given Imaging) and cryotherapy for the treatment of cancer (developed by Galil Medical).
Defense Community Source: Israel Export and International Cooperation Institute
Israel ClusterStrong in Medical devices ; Biotech Research; Small companies in early research phases Source: Israel Export and International Cooperation Institute, Israel Biotechnology Sector Paper by Alastair Bell
Israel ClusterBrief Snapshot of Various Sectors Medical Devices Therapeutics and Stem Cells
Ranked 2nd for Medical Devices solution
Therapeutic devices–both implantable and disposable–comprise the largest subsector
Insightec works on MRI guided non invasive surgical procedures
DeepBreeze provides physicians with a dynamic functional image of the lungs.
Sialo Technology presents an advanced endoscope system and tools for root canal “direct vision”
17% annual growth of biotechnology sector in last decade
Smart Biotech stimulates antibody production (in vitro) for early and more complete detection of HIV
Exalenz Bioscience assess a range of liver and gastrointestinal disorders via molecular analysis of the patient’s breath.
Source: Israel Export and International Cooperation Institute
Singapore StrengthsGovt. Support, Healthcare Infrastructure and Friendly Business Environment are key strengths. However, entrepreneurial culture needs to be encouraged. Source: Frost & Sullivan Primary Research
SPRING Policies & InitiativesFinancing Schemes and Capability Building Schemes for SMEs Source: http://www.spring.gov.sg/entrepreneurship/fs/pages/programmes-start-ups.aspx
SPRING Policies & InitiativesTechnology Innovation Schemes and Business Leadership Development Schemes Source: http://www.spring.gov.sg/entrepreneurship/fs/pages/programmes-start-ups.aspx
Singapore–Opportunities and ThreatsOpportunities in individual sectors; threats from neighboring clusters Opportunities Threats
Biogenerics and vaccines are the key growth areas in pharmaceuticals. Other opportunities are Volume manufacturing of commodities, translational medical research and the generic drugs market.
For biotech, stem cell research, genetic screening and gene therapy are promising areas for the future.
Healthcare services industry can see growth in medical tourism and chronic diseases.
Government focus on clinical trials to drive CRO growth
In the medical devices section do it at home products and development of measurement devices for the affluent section of the people holds significant potential.
China’s health biotech segment had maintained an annual growth rate of 30% since 2005
Biopharmaceutical production rose from US$860 million in 2000 to US$4.2 billion in 2005, and is forecast to exceed US$12.5 billion in 2015
Venture capitalists committed US$337 million to Chinese life sciences projects during 2008.
Indian biotech sector could reachUS$5 billion by 2010
Biopharmaceutical segment has more than 40% of the 325 biotech companies in India
Few larger Indian companies have begun acquiring foreign entities in the US and Europe to better retail their products
Singapore is rated high in Business Environment. It needs to improve on Industry Maturity, Funding Availability, and University & Medical Centre maturity.
Singapore is a young cluster compared to other clusters. So, this comparison is indicative when compared with other clusters. The industry has lauded Singapore’s’ biomedical progress over the last ten years
Source: Frost & Sullivan Analysis
Comparative Analysis- Industry Maturity (1/2)Successful clusters have critical mass; strong in research; successful in commercialization and have companies across the value chain Source: Frost & Sullivan Analysis
Comparative Analysis- Industry Maturity (2/2)Singapore needs critical mass of companies; focus on medical devices, clinical trials increase research commercialization; continue on its growth path Source: Frost & Sullivan Analysis
Comparative Analysis- Funding Availability (1/2)Successful clusters have developed private funding channels with strong government support for research and starting up; funding across value chain Source: Frost & Sullivan Analysis
Comparative Analysis- Funding Availability (2/2)Singapore needs to improve its private funding, pre-seed funding for enterprises Source: Frost & Sullivan Analysis
Comparative Analysis- University/Medical Centre Maturity (1/2)Successful clusters have startups and products emerging from universities; besides noble laureates, efficiently running TTOs and incubators Source: Frost & Sullivan Analysis
Comparative Analysis- University/Medical Centre Maturity (2/2)Singapore needs to focus on research commercialization; have efficient TTOs and incubators; continue its focus on research excellence Source: Frost & Sullivan Analysis
Comparative Analysis- Business Environment(1/2)Successful clusters have associations, steady stream of workers; high diffusion of knowledge; infrastructure in place and supporting business policies Source: Frost & Sullivan Analysis
Comparative Analysis- Business Environment(2/2)Singapore can improve on knowledge diffusion; availability of more skilled workers Source: Frost & Sullivan Analysis
Develop private VC industry in long term – Learning from Israel professional funds with government participation Yozma program in Israel started in 1992 with a govt. funding of $100 mn ($80 mn in 10 startup focused VC funds and $20mn as direct investments in startups. Target Level of Capital Aimed was 200-250M$ (Government Support- 100M$)- this was the ‘Critical Mass’ of effort required for VC industry ‘emergence’ Israel Yozma Program to develop local VC industry Each fund managed by a local management company& involving at least one Reputable Foreign Financial Institution (and one important Domestic Financial Institution) Government Participation in each Fund-8 million dollars (in most Funds this represented 40% of the 20 M$ raised) Strong Incentive to the “Upside”- the possibility, within a 5 year period, of purchasing Government’s share at approx. at cost with 5-7% interest rate(all Funds except 3 made use of this option). There was no downside 'guarantee‘.
Rapid entry of non Yozma VC funds was seen in Israel in1996
Significant increase in number of startups seen in Israel
Growth of (gross) accumulated numbers of new VC-backed SU companies from 110 in 1993 to 730 in 1998
Source: Ministry of Finance, Israel Presentation on Life Science Funds Dec 2009, Venture Capital Policy in Israel , A paper by Gil AvniMelech, Hebrew University 2002
Two round of reviews; Scoring Criteria established for determining scientific and technical merit; Applications receive a written critique, Interviews of key people – Learning from US Small Business Grants Criteria Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Does the proposed project have commercial potential to lead to a marketable product, process or service? Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for (1) Protections for Human Subjects, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Source: http://grants.nih.gov/grants/funding/sbirsttr_ReviewCriteria.htm
Proactive commercialization in Research and Academic Centers – Learning from Yale University Technology Transfer at Yale University Impact
High support–high selectivity policies needed for entrepreneurially underdeveloped environments
Provided facilities like creation of business plan, providing mentoring support, promotion of success stories, having entrepreneurial courses in curriculum, incentives for starting up, getting entrepreneurs to set up in the region and chasing VCs
Gregory Gardiner, a former Pfizer executive took charge of Office of Cooperative Research in 1982
An important goal for the Yale OCR was to identify new ideas, cultivate venture funding for them, and facilitate their development into companies that become part of the New Haven economy.
Increased exposure of researchers to commercial ideas
The renewed OCR established direct contacts with venture capital firms. The goal was not only to persuade venture capital firms of the relevance of university technology but also to convince them to create ventures in New Haven
The hard work of seeking appropriate investors eventually paid off, and in 1998, after two years of effort, the first round of financing was concluded with $20 million for five companies.
Today the Connecticut cluster employs 17,985 people directly and 35,857 through indirect and induced employment. It consists of 49 biotechnology companies. Five of the biotech companies are publicly traded: Alexion Pharmaceuticals, Neurogen, Curagen, Gennesiance, and Vion Pharmaceuticals. Of the biotech companies, 24 companies, or 49%, of the biotechnology cluster in New Haven were created after 1996 with technology, ideas, or founders from Yale and with the help of the OCR.
Source: University Commercialization Strategies in the Development of Regional Bioclusters , Shiri M. Breznitz, Rory P. O’Shea, and Thomas J. Allen published in Journal of Product Innovation Management 2008
THANK YOU Rhenu Bhuller Vice President Frost & Sullivan Biotechnology Group rbhuller@ frost.com Contact: +65 6890 0986