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Big Pharma’s New Licensing Strategies

Decision Resources, Inc, Oct 2011


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Licensing strategies have never been more important to the pharmaceutical industry. Companies are competing on multiple fronts; they are inlicensing or acquiring innovative new drug candidates, accessing enabling technologies, balancing small-molecule and biologics drug development, and staking a larger claim in emerging markets. In this report, we discuss 15 opportunities of importance to the industry and analyze the strategies that companies are using to take advantage of those opportunities.

Questions answered in this report:

- Biologics markets are growing faster than other technology sectors in the global pharmaceutical market. What five major strategies are companies focusing on to take advantage of biologics markets? What are the leading recombinant protein therapy companies? What are the advantages of enzyme replacement therapy (ERT) development? Even given the enormous commercial success of monoclonal antibodies (MAbs), what still needs to be done in this market sector?

- Successful biosimilars commercialization will be a marathon, not a sprint. When is the burst in the number of biosimilars launching around the world expected? How is Teva positioning itself to become a biosimilars leader? What biosimilars strategies are other companies employing?

- Having a tool belt of different protein-improvement technologies will be critical for future success in mixed biologics markets. What are biobetters? What technological advances exist for designing new and improved recombinant protein and MAb therapies?

- Rare diseases have emerged as an attractive drug development opportunity. What are the advantages of rare disease drug development? What companies are active in this arena? What programs has the U.S. government established?

- Data mining in claims databases represents a new opportunity in drug discovery and development. Why are these databases so valuable? What recent deals have occurred between health benefit companies and Big Pharma companies?

- Licensing deals continue to trend toward earlier-stage deals. Of 73 deals analyzed from September 2010 to September 2011, what proportion were for discovery and preclinical stage programs? Were companies willing to pay more or less for early-stage deals?

- Sanofi was able to acquire Genzyme when it agreed to a $20.1 billion price plus a contingent value right (CVR) potentially worth another $3.8 billion. What are CVRs? What is the nature of the Genzyme CVR, and how has its price recently traded on the NASDAQ stock exchange?

- Partnerships between Big Pharma companies are logically compelling to solve some of the industry’s problems. What Big Pharma-Big Pharma deals took place in 2011? What are the advantages of such deals? How might this strategy benefit companies trying to expand in emerging markets?

- Most multinational corporations (MNCs) are already selling innovative brands into large urban areas in emerging markets. New market expansion and growth will come from penetrating rural markets. What are the characteristics of rural markets in developing Asian countries? What strategies are companies using to penetrate rural markets in India?

- Branded generics portfolios are key to penetrating emerging markets and capturing market share that can be used to help promote innovative brands. Why is a pure generics strategy difficult for MNCs in emerging markets? Which companies are bulking up their branded generics portfolios?

- Outsourcing is evolving into more extensive investments in emerging markets. Which MNCs are establishing R&D centers in markets such as China? What other local operations are being moved to China?

- Emerging markets, such as Russia, are requiring local manufacturing as a means to develop the domestic pharmaceutical industry and decrease reliance on costly imported brands. Which Western companies have already begun the process of transforming from an import-driven strategy to a local manufacturing strategy in Russia? Who is building facilities? Who is licensing/partnering with local manufacturers? What is the nature of the facility: packaging, formulations, full-scale manufacturing?

Scope:

Biologics: Recombinant proteins, monoclonal antibodies (MAbs), size and growth rate of technology sectors in the global pharmaceutical market, biologics strategies, leading recombinant protein companies, enzyme replacement therapies (ERTs), world’s most expensive drug therapy, blockbuster MAbs, risk evaluation and mitigation strategies (REMs), biosimilars, period of brand patent expiry, number of biosimilar approvals by region, biosimilars pipeline by phase and number of molecules, biosimilars strategies, biobetters, life-cycle management, mixed biologics markets, plethora of protein improvement technologies, antibody-based therapeutics.

Rare diseases: Reasons for attraction in drug development, technology convergence, new federal programs and database, rare disease strategies.

Recent licensing deals: Prescription claims databases, unique disruptor in healthcare services, claims database mining, recent deals, pharmacy benefit manager, comparative effectiveness research, evidence-based medicine, real-world evidence, top value of recent licensing deals, trend toward earlier-stage deals, use of contingent value rights (CVRs) in acquisitions, collaborations between Big Pharma companies, four Big Pharma-Big Pharma deals in 2011.

Emerging markets: Accessing and penetrating rural markets, healthcare expenditures in developing Asian markets, rural market strategies in India, branded generics strategy, recent branded generics deals in India, R&D investments in China, strategies to address local manufacturing requirements, new Russian manufacturing model.

Exhibits: 14 data-rich tables and figures



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