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Biosimilar Opportunities: Pipelines and Companies
Decision Resources, Inc, Sep 2011
The multibillion dollar biosimilars opportunity is an extremely attractive commercial prospect. A considerable volume of biosimilars research is under way in emerging markets. More global business development will be triggered by key patent expiries in the major markets and more products reaching later stages of development. The lure of biosimilars is also enticing companies outside the pharmaceutical arena to develop biosimilars capabilities - an interest that emphasizes the potential size of the biosimilars market. However, successful biosimilars commercialization will be a marathon, not a sprint, and prospective market players must commit to the long term when they enter the biosimilars arena. In this report, we analyze the biosimilars pipelines of more than 30 companies and discuss business strategies in the evolving biosimilars space. The biosimilars race is heating up, and our analysis is important to understanding the future competitive landscape for many biologics.
Questions answered in this report:
- The timeline of patent expiry for originator brand patents typically opens the door for the development of biosimilars. Which biosimilars have been approved? Which have been approved in more than one region? What companies are developing biosimilars, and what is the extent of their biosimilars pipelines?
- The number of pipeline biosimilars varies significantly among companies. How many development programs can a company support? How do companies choose which biosimilars to develop?
- Amgen’s management has said the company is confident it can hold 80% to 85% of its core base business through 2015. What is the basis of this confidence? What are Amgen’s plays for developing its own biosimilars?
- Teva Pharmaceutical Industries intends to aggressively increase its market share with ambitions to become a world leader in biosimilars. What strategies is the company employing? What company is its major competitor? What are the biosimilars pipelines of these companies?
- Merck’s CEO recently told analysts that biosimilars can provide a solid return on investment with less product development risk relative to an unproven mechanism. What is Merck’s game plan for success in biosimilars markets? How does its strategy compare with those of other Big Pharma companies interested in biosimilars?
- Hospira’s CFO recently told analysts that his company is leveraging its existing specialized salesforces and minimizing risk by focusing on oncology and strategic collaborations and acquisitions. Why are partnerships so important in developing biosimilars markets? What is the timeline of expected development in different market types? What deals have recently taken place?
- Celltrion’s management has said that there is a limited window of opportunity to build an early position in biosimilars markets. What is this window? Why will it be open for only a limited time? What is Celltrion’s global market strategy?
- Watson Pharmaceuticals’ CEO told investors that his company does not want to enter biosimilars markets where it would be the fifth or sixth player in those markets. What are Watson’s goals in biosimilars markets? What strategies does it plan to use to reach these goals?
Scope:
Biologics: Human growth hormone, erythropoietin, granulocyte colony-stimulating factor (G-CSF), low-molecular-weight heparins (LMWHs), tumor necrosis factor (TNF)-alpha-Fc fusion protein, Factor VIII, follicle-stimulating hormone (FSH), insulin/insulin analogues, streptokinase, anti-CD20 antibody, glucocerebrosidase, monoclonal antibodies (MAbs), recombinant proteins, enzyme replacement therapies, interferon-beta-1a, interferon-beta-1b, interferon-alfa-2b, alpha-galactosidase A, iduronate-2-sulfatase, choriogonadotropin.
Biosimilars markets: Combined 2010 sales of biologics brands facing patent expiry, 72 approved biosimilars by market, approvals by market, approvals by molecule type, sales leaders, biosimilars pipelines of more than 30 companies, number of patent expiries by year for key biologics in 2010-2026.
Types of companies: Big Pharma, innovative brand manufacturers, global generics manufacturers, small biotechs, MAb startups, contract research organizations (CROs), domestic companies in emerging markets, non-pharmaceuticals players, partners, acquisitions, subsidiaries, contract manufacturing organizations (CMOs).
Geographies: China, India, South Korea, emerging markets, Europe, Japan, North America, Turkey, Malaysia, Brazil, Argentina, Middle East and North Africa (MENA), Spain, Australia, Canada, Europe, Japan, New Zealand, the United States, Taiwan, Indonesia, Commonwealth of Independent States, Chile, Peru, Venezuela, Israel.
Company strategies: Mitigating risk, early market entry, market access tactics, leveraging existing strengths, role of partnerships, balancing strategies, market barriers, level of exposure to biosimilars.
Exhibits: 12 data-rich tables and figures.
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