Immune Checkpoint Inhibitors in Oncology Markets

Immune Checkpoint Inhibitors in Oncology: Market Forecast, Competitive Landscape and Strategic Opportunities, 2027–2031

Global forecasts by indication, target, product, molecule format and treatment setting, with country and regional breakouts and 25 company profiles.

Our Take

The checkpoint inhibitor market is about to stop growing in its core. Keytruda and Opdivo begin losing exclusivity from 2028, and we forecast the market to peak at $75.7 billion in 2028 before biosimilars pull it down. The winners of the next five years will be the challengers with early-stage labels, not the incumbents, and PD-(L)1/VEGF bispecifics remain an expensive, unproven bet rather than the next standard backbone.

Situation Analysis: what is really happening

• The patent cliff arrives in 2029. Keytruda and Opdivo lose exclusivity from 2028 and the first Keytruda biosimilar filing was accepted in October 2026. We expect brand erosion to start earlier than the 2033 timing many analysts assume.
• Biosimilars become a major segment. Pembrolizumab and nivolumab biosimilars go from nothing to one of the largest product segments by 2031, with Samsung Bioepis and Formycon/Zydus first in line.
• Growth moves earlier and to the challengers. Perioperative and first-line use grow while later-line use shrinks. Imfinzi, Libtayo, Opdualag and China-originated PD-1s are the growth brands, and bladder cancer is the fastest-growing indication.
• The bispecific money arrived before the proof. PD-(L)1/VEGF licensing deals exceed $25 billion in headline value, but the HARMONi-3 interim miss leaves the class unproven globally. The November 14 FDA decision on ivonescimab is the next test.
• 

Company Analysis: who is positioned, who is exposed

• Merck & Co.: Keytruda carries about half of Merck's revenue into the patent cliff. Keytruda Qlex and the Padcev combination slow the loss but do not stop it.
• Bristol Myers Squibb: The next most exposed, with Opdivo eroding. Opdualag, Opdivo Qvantig and the BioNTech bispecific pumitamig are its bridge.
• AstraZeneca: Imfinzi is the biggest brand winner, built on curative-intent indications and a later loss of exclusivity than its rivals.
• Summit Therapeutics / Akeso: Ivonescimab is the single most important test of the bispecific thesis; the FDA decision and global HARMONi-3 data decide its value.
• Roche: Tecentriq holds its niches, but the TIGIT failure left Roche without a next-generation checkpoint.
• Samsung Bioepis: First with global Phase 3 data for a Keytruda biosimilar, positioning it as an early winner from the cliff, subject to litigation with Merck.

Plus 19 more company profiles covering big pharma, China-originated developers, biosimilar makers and technology licensors.

Questions this report answers

• When will Keytruda and Opdivo biosimilars launch, and how fast will brand sales fall?
• Which checkpoint brands keep growing through the patent cliff?
• Will PD-1/VEGF bispecifics replace PD-1 as the standard backbone?
• How much revenue moves into perioperative and adjuvant use?
• How are China-originated checkpoint inhibitors changing price and competition?
• How will Medicare price negotiation affect Keytruda and Opdivo?

What’s inside

• 183 pages, 23 chapters
• 25 company profiles with technology, pipeline, strategy and risks
• Forecasts 2027–2031 from a 2026 base (actual) year, by indication, target, product, molecule format and treatment setting, for 14 countries and regions
• Approved product registry and 2025 sales benchmarks
• Patent cliff and biosimilar readiness, Medicare negotiation, and a China ecosystem chapter
• Delivered as 3 files: full report PDF, Situation Analysis PDF, and Excel workbook of all charts and tables
• Download the Table of Contents (PDF)

Who buys this report

• Business development and licensing teams: track the bispecific race and find in-licensing candidates.
• Investors and equity analysts: model the patent cliff and judge who holds value.
• Biosimilar developers and manufacturers: size the opportunity and plan launch timing.
• Oncology drug developers: choose a checkpoint backbone and combination partners.

Licences and support

Your order is delivered to your inbox immediately. Every licence includes unlimited questions to the analyst and custom data breakouts, including any country not shown. Single User, Five User and Enterprise licences contain the same report; they differ only in how many people may use it.

About the author

Greg Powell, B.Sc., M.B.A., has worked in laboratory testing and management for more than 20 years, with executive training at Harvard Business School and the Burke Institute.