Trends in Market Access for Specialty Biologics: Challenges & Promises


  • Sanjay Kumar Rao Vice President CRA International Washington DC



Specialty Biologics, Market Access, Commercialization, Distribution, Marketing, Pricing, Reimbursement


Specialty biologics are the fastest growing class of bio/pharmaceutical products in terms of the number of new brand launches and rates of health care spending in the U.S. and globally. Innovative biologics meant to treat a range of hitherto untreatable conditions in oncology, inflammation, CNS, endocrinology and other chronic conditions seek to offer radical improvements in efficacy and patient well-being. Such products can command premium prices, often costing over $100K per year per patient - triggering a raft of challenges to ensuring that eligible patients have adequate access.

 This article outlines important trends impacting market access to specialty biologics in the U.S. and globally. Particular importance is placed on evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access. The reshaping of the specialty product market access landscape in the U.S. through the availability of oral biologic formulations distributed to patients via high-touch, high-involvement specialty pharmacies is examined. The rising role of risk sharing between specialty product manufacturers and insurers as a way to balance rewards of access with the risks inherent in radical new specialty therapeutics is discussed. Challenges posed by specialty biosimilars to traditional ways of ensuring market access and fair reimbursement are outlined. The impact of health care reforms on market access for specialty biologics in the U.S. is discussed in the context of the growing need for comparative outcomes research and the application of the principles of health technology assessments - adapted, in part from their apparent success in ensuring equitable and cost-effective access to biologics in the E.U.

Author Biography

Sanjay Kumar Rao, Vice President CRA International Washington DC

Sanjay K. Rao, Ph.D., is Vice President in the Life Sciences practice at CRA’s Washington, DC office. Since 1990, his projects have impacted product and portfolio development strategy, clinical trial investments, pharmaceutical brand development, new product commercialization, clinical and geographic market development, sales force design and optimization, product life cycle management, and new product and portfolio pricing, access and evolution strategies. In a special management consulting supplement, the Nov 2007 Issue of Pharmaceutical Executive profiles Sanjay as one the leading strategy consultants in the global bio/pharmaceutical industry.

His publications have appeared in The Journal of Business Strategy, The Journal of Commercial Biotechnology, The Journal of New Product Innovation Management, Marketing Research, Marketing Insights, Marketing Health Services, Product Management Today, The Journal of Pharmaceutical Development & Regulation, SCRIP—Issues in Pharmaceutical Perspectives, PM360, The Pharmaceutical World Directory, Pharmaceutical Executive, Journal of Medical Marketing, Pharmaceutical Executive Europe and proceedings of the PMRG, the PMRG Institute, the PMSA, EPhMRA and the Oxford Outcomes PRO Conference. Sanjay has a Ph.D. in Marketing from The Wharton School of the University of Pennsylvania.


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