Biopharma Confronts Dual Challenges: Massive Patent Cliff and Imminent Price Controls

Biopharma Confronts Dual Challenges: Massive Patent Cliff and Imminent Price Controls

June 26, 2023 : The biopharmaceutical industry has achieved remarkable productivity recently, approving 287 new medicines from 2017 to 2022. These include treatments for various diseases such as cancers, rare diseases, diabetes, obesity, and even Alzheimer’s. Moreover, the industry played a pivotal role in combatting the COVID-19 pandemic by developing vaccines and therapeutics. These achievements have positively impacted billions of people worldwide.

Despite these successes, the biopharma sector faces two significant threats that could hinder its future potential. The first challenge is the looming patent cliff, the largest in the industry’s history. According to PharmaVoice’s Meagan Parrish, by 2030, 190 drugs, accounting for $236 billion in sales, will lose their patent exclusivity. Notable drugs include Humira by AbbVie, Keytruda by Merck, and Trulicity by Lilly.

While patent expirations are common in the industry, the scale of this upcoming cliff is unprecedented. Biopharma companies must continually reinvent their product portfolios by replacing older drugs with new ones to sustain and grow their sales. This poses a daunting challenge for research and development (R&D) heads responsible for driving pipeline innovation. Unfortunately, the public often underestimates the finite nature of a company’s product portfolio. Paradoxically, while many advocates for price controls, they fail to recognize that patent expirations already act as a form of price control. As Peter Kolchinsky highlights in his book, “The Great American Drug Deal,” proprietary drugs are the only healthcare component where prices dramatically decline after approximately twelve years. In contrast, hospital procedures like hip or knee replacements cost $40,000 annually and continue to increase indefinitely.

The second major crisis confronting biopharma is the implementation of price controls through the Inflation Reduction Act (IRA). Under the IRA, the government will set prices for specific Medicare-covered medicines. Vital Transformation (VT), an independent healthcare think tank, has assessed the IRA’s impact on biopharma regarding revenue and new drug output. VT’s findings are striking. Their analysis of the top 200 biologic and small molecule medicines covered by Medicare Parts B and D reveals that 92 drugs from 41 biopharma companies will be affected over the next decade. Biologics are projected to experience an average revenue reduction of $4.9 billion per therapy, while small molecules will face a $4 billion decline. These cumulative impacts are estimated to exceed $400 billion.

Critics of the industry may argue that these revenue reductions are insignificant, considering the pharmaceutical sector’s profitability. However, VT challenges this notion by referencing data from NYU Stern, which shows that the pharma sector ranks 92nd overall in net profit margin at 18%. This margin falls below that of banks, railroads, oil/gas, tobacco, and semiconductors. It is closer to that of the soft drink industry (15%). Such a comparison is sobering, considering that sodas do not offer protection against COVID-19.

As a result, the industry will be compelled to make substantial cuts to its R&D operations. Research sites may be scaled back or closed, therapeutic areas could be abandoned, and job losses will occur. This scenario had previously unfolded when Pfizer’s blockbuster drug Lipitor faced patent expiration in 2007. Sales of Lipitor, which once reached $12.9 billion, plummeted by over 90% within 12 months. Research sites in Ann Arbor, France, and Japan were shut down, therapeutic areas were discontinued, and hundreds of R&D positions were eliminated. Considering the potential impact of similar actions across the biopharmaceutical sector is crucial.

Despite new medicines saving more in hospital costs than the spending on drugs, the industry continues to face unjustified criticism. The implementation of price controls will erode the industry’s ability to introduce breakthrough therapies that save lives and reduce overall healthcare expenses. This outcome is regrettable and poses a challenge to the advancement of medical science.