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From Blockbuster to Nichebuster: Changing Markets and Firm Strategies in the Pharmaceutical Industry
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Abstract:
The global pharmaceutical landscape is being transformed, moving away from the blockbuster drug era—where high-revenue drugs targeted vast patient populations—toward a “nichebuster” strategy focused on high-value products for much smaller market segments. This has been driven by the growth of so called “orphan” drugs for rare diseases, named after the 1983 US Orphan Drug Act, which introduced major incentives for firms to invest in these products. This has turned what was once a neglected market into a thriving one. As a result, FDA orphan drug approvals surged from just a handful per year in the 1980s to nearly 100 annually after 2020, now constituting more than half of all new drugs approved by the US FDA. Despite targeting very small patient groups many of these now rank among the industry's top-selling products due to their very high prices and collectively constitute nearly 25% of global pharmaceutical sales. However, there are major differences in the pattern of orphan drug approvals between the US and Europe, a range of technology and business strategies adopted by firms and growing criticism of the perverse incentives arising from these regulatory incentives as the average launch price of a new orphan drug has climbed to over $250,000 a year.
Drawing on analysis of a longitudinal data set, company case studies and drug approvals in different jurisdictions this presentation will explore this major shift in the products and markets created by the pharmaceutical industry over the last 40 years as a result of this important regulatory and policy change. What is the technological foundation of the move towards orphan drugs and where has this knowledge come from? What impact has this had on industry structure and firm strategy? How have different regulatory systems shaped the market for orphan drugs? What are the implications for the long-term sustainability of the industry and healthcare systems?
Bio:
Jin Ding: https://www.sheffield.ac.uk/socstudies/people/academic-staff/jin-ding
Paul Martin: https://www.sheffield.ac.uk/socstudies/people/academic-staff/paul-martin