Pharma Faces $236 Billion Patent Cliff by 2030: Key Drugs and Companies at Risk

The global pharmaceutical industry is heading toward a $236 billion patent cliff between 2025 and 2030, as patents on blockbuster drugs expire, exposing nearly 70 high-revenue products to competition. This wave threatens significant revenue losses for major players like Bristol-Myers Squibb, AbbVie, and Novartis. Unlike the 2008 cliff, this period features a higher share of biologics, which face slower but substantial erosion from biosimilars, driven by faster regulatory approvals from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

These expirations will reshape markets for critical treatments, including cancer and diabetes drugs, while forcing companies to adapt swiftly. Here’s a breakdown of the stakes, the hardest-hit firms, and their strategies to weather the storm.

Revenue Drop Looms as Patents Expire

When patents lapse, generics and biosimilars enter with lower prices, slashing sales of branded drugs. Small-molecule drugs typically lose 90% of their market share within months, while biologics decline by 30% to 70% in the first year due to complex production and slower adoption. By 2030, 190 drugs will lose protection, including 69 blockbusters generating over $1 billion annually. This puts nearly half the 2021 sales of the top 10 biologic firms—totaling $512 billion—at risk. According to a report by Deloitte, this accounts for approximately 46 percent of sales at risk for the top ten pharmaceutical companies over the next decade.

Companies and Treatments Most Exposed

Leading the losses are drugs like Merck’s Keytruda, with $25 billion in 2023 sales, set to expire in 2028, and Bristol-Myers Squibb’s Eliquis, at $12 billion, due by 2027 or 2028. These hits will strain financials and R&D budgets, particularly for companies with weak pipelines.

Aside form BMS, AbbVie, and Novartis face the steepest challenges. BMS risks losses from Eliquis, Opdivo ($9 billion), and Revlimid ($6 billion), while AbbVie’s Stelara ($10.9 billion) and Novartis’s portfolio are also vulnerable. By 2026, eight of the 13 largest pharma firms—representing 55% of global market value—could see 30% or more of their revenue jeopardized. Losses may range from $6 billion to $38 billion per company, with five of the top 10 facing over 50% exposure.

Key therapeutic areas include oncology, type 2 diabetes, COPD, HIV, and lung cancer. Oncology, currently 22% of global drug revenue and projected to reach 27% by 2030, will see intensified competition as drugs like Keytruda and Opdivo lose patents. Chronic disease markets, serving millions, will also shift as affordable alternatives emerge.

Major Drugs Approaching Expiration

The following table highlights key drugs nearing patent expiry:

Note: Dates are subject to change pending legal or extension outcomes.

Industry Response: R&D, Deals, and Restructuring

Pharmaceutical companies are responding with a mix of strategies aimed at mitigating revenue losses. Research and development is shifting toward AI-driven efficiency, as traditional returns on investment (ROI) have declined to around 2% by 2020. Companies that specialize in high-growth therapeutic areas, such as oncology, are seeing an annualized growth rate of 7%, compared to just 0.2% for diversified firms. This trend is pushing large pharmaceutical players to narrow their focus and deepen investments in core areas with strong long-term potential.

Mergers and acquisitions (M&A) have also surged as companies look to biotech innovation to replenish their pipelines. The top 12 firms collectively hold approximately $180 billion in cash reserves, fueling a wave of acquisitions and licensing deals. “With about $180 billion in ‘dry powder’ sitting with the top 12 companies alone, we can anticipate more M&A activity,” said Maria Whitman, global head of ZS Associates’ pharmaceutical and biotech practice.

Beyond acquisitions, firms are rethinking their business models. Some are pivoting toward operational efficiencies, leveraging digital tools to streamline processes and reduce costs. Others are evaluating local market strategies, with a focus on balancing regional operations with centralized support. European drugmakers, for instance, are advocating for streamlined pricing and reimbursement filings across all EU member states within two years of market authorization to accelerate patient access to new therapies.

The integration of artificial intelligence (AI) and data analytics is also transforming pipeline decision-making. AI tools are increasingly being used to assess potential drug candidates, predict regulatory success, and optimize commercial strategies. In oncology trials, for example, AI-driven predictions have proven highly accurate in forecasting drug approval outcomes, helping companies make more informed investment decisions.

Broader Impact: Access and Innovation

Despite these efforts, the challenge remains formidable. Recent data shows that more than half of all drug launches between 2019 and 2021 failed to meet expectations, underscoring the difficulties of replacing lost revenue with new products. Companies are now focusing on launching smaller, high-impact drugs that reach peak sales more quickly, shifting away from the traditional blockbuster model.

The cliff will lower drug prices as generics and biosimilars proliferate, boosting access—especially in lower-income regions—and easing healthcare budgets. However, reduced R&D funding could slow new drug development. Meanwhile, reliance on external innovation may empower biotech startups, reshaping the industry’s ecosystem.

As the $236 billion patent cliff nears, the pharmaceutical industry must adapt quickly. The companies that successfully navigate this transition will shape the competitive landscape for the next decade, determining which of today’s industry leaders will still dominate in 2030.

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Author

Bernice Lottering