High-volume, big-population drugs have fueled the industry’s growth over the past 15 years. But with increasing uncertainty about the ROI of primary care drug development, big pharma is looking for additional avenues of growth. Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade is a window into the complex world of specialty medicine: its stakeholders, its evolving regulatory environment, and its economics. Based on extensive thought-leader interviews, this report is both a manual and a guidebook to competing and prospering in the world of specialty pharmaceuticals. Specifically, it provides:

Strategies for . . .

• Sustaining a specialty franchise by building relationship equity with specialists
• Identifying and communicating with hard-to-reach patient populations
• Generating referrals, raising awareness, working with disease associations and patient groups

Data that capture . . .

• Cost, time, and approval rate comparisons between specialty and primary care R&D
• Trends in specialty drug sales, pricing, and health care expenditures
• Specifics about the large- and small-molecule specialty pipelines in big pharma

Insight into . . .

• Pricing and uptake prospects for biogenerics and orally delivered proteins
• The impact on practice economics of Medicare CAP and the shift away from buy-and-bill
• Positioning specialty products for managed care

Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade delivers the case studies, the recommendations, and the insider insights to help you navigate the shifting terrain of specialty markets: the gathering cost pressures, rising competitive heat, disruptive technologies, changing regulatory guidelines, new reimbursement paradigms, and more. The report also drills down into two specialty disease commercial opportunities -- pulmonary arterial hypertension and scleroderma -- detailing the epidemiology, the drugs in development, and the opportunities for improving on the current standard of treatment.

Sector Drivers of Increased Focus on the Specialist

Big pharma has awakened to the specialty opportunity, and is busy filling its pipelines and aligning its organizations in order to bring to market novel drugs for small but desperately needy patient populations. Lilly currently has 14 proteins in development targeting specialty diseases, constituting about 30% of its early stage pipeline. And Pfizer’s new CEO Jeffrey Kindler boasted in his first major presentation since assuming office that Pfizer, with 35 protein projects in R&D, was on course to generate $1.5 billion in protein therapeutics in 2006, and would triple that number by 2010. Biotech companies, which already dominate most specialty disease categories, are capitalizing on the shifting momentum with the hope of vaulting into the ranks of the top 10 pharma companies.

The phenomenal productivity of specialty drug R&D and the impressive commercial performance of a growing stable of specialty products beg a larger question: will big pharma be able to synergize both its specialty and primary care sales forces and to navigate the looming challenges of pricing, biogenerics, and tightening regulations in order to meet the challenge of building a prosperous specialty business?

About the Author

Michael Goodman is general manager of CHI Insight Pharma Reports. He brings 16 years of experience as an analyst and program manager at leading pharmaceutical research and advisory firms. As Director of Decision Resources’ Spectrum Advisory Service and DR Reports, Michael set the strategic direction for two industry-leading business intelligence services. At Fuld & Company, he provided competitive analysis in the areas of product development, organizational models, and disease management strategies to major pharmaceutical and biotechnology clients. At Arthur D. Little, Michael led an information service focused on consumer health markets across the food/drug continuum. Michael received a BA from the State University of New York at Stony Brook. He can be reached at  mgoodman@healthtech.com