Gosset Breaking the Monopoly:
How New Players Are Reshaping the $45B PD-1/PD-L1 Market
The Rise of Challengers in Cancer Immunotherapy's Most Lucrative Arena
Last Updated: June 23, 2025
Market Size
While Keytruda remains the undisputed leader with $25 billion in sales, a diverse ecosystem of competitors now commands nearly half the market. The era of monopolistic dominance is giving way to a more dynamic competitive landscape, with Chinese biotechs, late entrants, and niche players all carving out profitable positions.1
PD-1/PD-L1 Market Landscape
This visualization reveals how the market has evolved beyond a simple duopoly. While Keytruda maintains its crown, the "Others" segment has grown from negligible to nearly 20% of the market, driven by new approvals and geographic expansion.
Growth Trajectories
This chart compares the growth rates of established giants versus emerging players. Note how newer entrants like Serplulimab (230% growth) and Dostarlimab (>100% growth) are expanding rapidly from smaller bases.1
Top PD-1/PD-L1 Revenue Generators
| Rank | Drug (Brand) | Company | Target | 2023 Revenue | YoY Growth | Market Share | Key Differentiator | First Approval |
|---|---|---|---|---|---|---|---|---|
| 1 | Pembrolizumab (Keytruda) | Merck & Co. | PD-1 | $25.01B3 | +19%3 | 55.3% | First-mover advantage; broadest label | 20142 |
| 2 | Nivolumab (Opdivo) | Bristol Myers Squibb | PD-1 | $9.01B4 | +9%4 | 19.9% | Strong combo data with ipilimumab | 20142 |
| 3 | Durvalumab (Imfinzi) | AstraZeneca | PD-L1 | $4.20B5 | +52%1 | 9.3% | Stage III NSCLC monopoly (PACIFIC) | 20172 |
| 4 | Atezolizumab (Tecentriq) | Roche | PD-L1 | $4.19B6 | +8%1 | 9.3% | First PD-L1; strong in HCC, SCLC | 20162 |
| 5 | Cemiplimab (Libtayo) | Regeneron | PD-1 | $869M7 | +50%7 | 1.9% | Cutaneous squamous cell carcinoma leader | 20182 |
| 6 | Tislelizumab (Tevimbra) | BeiGene | PD-1 | $537M8 | +27%8 | 1.2% | First Chinese PD-1 with FDA approval | 20192 |
| 7 | Dostarlimab (Jemperli) | GSK | PD-1 | $175M9 | >100%9 | 0.4% | dMMR/MSI-H focus; late entry success | 20212 |
| 8 | Serplulimab (Hetronifly) | Henlius | PD-1 | $159M10 | +230%10 | 0.4% | First PD-1 for 1L ES-SCLC globally | 20222 |
| 9 | Toripalimab (Loqtorzi) | Junshi/Coherus | PD-1 | $130M11 | +25%1 | 0.3% | First China-developed PD-1 in US12 | 20182 |
This table shows verified 2023 revenues. Access comprehensive competitive intelligence on all 20+ approved PD-1/PD-L1 inhibitors, including emerging biosimilars and next-generation bispecifics.
Get Market Intelligence / Book a CallRecently Approved & Emerging Players
| Drug (Brand) | Company | Approval Year | Status | 2023 Revenue/Status | Key Strategic Advantage | Market Entry Strategy |
|---|---|---|---|---|---|---|
| Retifanlimab (Zynyz) | Incyte | 2023 (FDA)2 | Launching | Minimal (new launch)13 | Merkel cell carcinoma niche | Ultra-rare indication focus |
| Cosibelimab (Unloxcyt) | Checkpoint Therapeutics | 2024 (FDA)2 | Pre-launch | $0 (not yet launched)14 | Cutaneous SCC specialty | Dermatology-focused |
| Envafolimab (Enweida) | Alphamab/3D Medicines | 2021 (China)2 | China only | Not disclosed | World's first SC PD-L115 | Convenience differentiation |
| Sugemalimab (Cejemly) | CStone/Pfizer | 2021 (China)2 | Expanding | $4.5M (royalties to CStone)16 | Pfizer partnership in China17 | Big pharma collaboration |
| Ivonescimab | Akeso/Summit | 2024 (China)18 | Pipeline | $500M licensing deal19 | PD-1/VEGF bispecific | Next-gen technology |
| Cadonilimab | Akeso | 2022 (China)15 | China approved | Growing rapidly | PD-1/CTLA-4 bispecific | Single molecule combo |
Breaking Down the Monopoly: Three Key Disruption Strategies
The Niche Domination Play
- Target ultra-specific patient populations overlooked by giants
- Achieve rapid approval with smaller, focused trials
- Build from $100-200M niche to broader indications
The Geographic Arbitrage
- Develop in cost-efficient China market first
- Use domestic revenue to fund global expansion
- Partner with Western companies for market access
The Technology Leap
- Move beyond monoclonal antibodies to bispecifics
- Offer superior efficacy or convenience
- Command premium pricing and partnerships
Why Late Entrants Are Still Winning
The $20 Billion Opportunity Outside Keytruda
While Keytruda dominates with 55% market share, the remaining 45% represents a $20+ billion opportunity.1 This "non-Keytruda" market is growing faster than Keytruda itself, driven by:
New approvals in previously untapped cancer types
Emerging markets adoption
Novel pairings that enhance efficacy
Positioning for the post-2028 patent cliff20
The Power of Being Second (or Tenth)
Late market entry, once considered fatal in pharma, has proven viable in PD-1/PD-L1:
Now approaching $1B despite being 5th to market7
Achieved >100% growth by targeting dMMR niche9
230% growth via first-in-class SCLC indication10
The Chinese Disruption: From Copycats to Innovators
Chinese PD-1/PD-L1 developers have transformed from fast followers to global innovators in just 5 years:
The Next Chapter: Beyond Monoclonal Antibodies
Near Term (2025-2027)
The market shifts from single agents to combinations
- PD-1/PD-L1 + ADC combinations dominate
- Bispecifics gain significant share
- Biomarker-driven patient selection
Patent Cliff (2028-2030)
Keytruda's expiry reshapes the entire market
- Biosimilars capture 70%+ of Keytruda volume20
- Innovation focus shifts to next-gen IO
- Chinese companies become global leaders
Investment Focus
Where smart money should look
Best bets: Bispecific platforms, combination enablers
Avoid: Me-too monoclonal antibodies
Watch: Biosimilar developers preparing for 2028
Key Strategic Takeaways
The Market Is No Longer Winner-Take-All
With 45% of revenues flowing to non-Keytruda products and growing, the era of monopolistic dominance is ending. Multiple players can thrive with the right strategy.1
Late Entry ≠ Lost Opportunity
Dostarlimab, Serplulimab, and others prove that focused strategies can drive explosive growth even years after the pioneers. The key is differentiation, not timing.
The Future Belongs to Innovators, Not Imitators
Bispecifics, novel delivery methods, and intelligent combinations will define the next decade. The $500M ivonescimab deal shows the premium for true innovation.19
References
- Gosset.ai revenue database.
- Gosset.ai assets database.
- Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results. Keytruda global sales: $25.011 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "Pembrolizumab (Keytruda)".
- Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023. Opdivo revenue: $9.009 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "Nivolumab (Opdivo)".
- AstraZeneca 2023 Results. Imfinzi sales: $4.2 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "The PD-L1 Incumbents".
- Roche 2023 Annual Report. Tecentriq global sales: $4.19 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "The PD-L1 Incumbents".
- Regeneron Reports Fourth Quarter and Full Year 2023 Financial Results. Libtayo sales: $869 million. PD-1/PD-L1 Drug Sales Analysis, Section: "Cemiplimab (Libtayo)".
- BeiGene Reports Fourth Quarter and Full Year 2023 Financial Results. Tislelizumab sales: $536.6 million. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
- GSK Q4 2023 Announcement. Jemperli sales: £141 million (~$175 million USD). PD-1/PD-L1 Drug Sales Analysis, Section: "Dostarlimab (Jemperli)".
- Henlius 2023 Annual Results. Serplulimab revenue: RMB 1.120 billion (~$159 million USD), 230.2% YoY growth. PD-1/PD-L1 Drug Sales Analysis, Section: "Serplulimab (Hansizhuang)".
- Junshi Biosciences 2023 Annual Report. Toripalimab China sales: RMB 919 million; Coherus US sales: $0.6 million. PD-1/PD-L1 Drug Sales Analysis, Section: "Toripalimab".
- Rapid Global Expansion of Chinese PD-1/PD-L1 Key Players. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
- Incyte Reports 2023 Fourth Quarter Financial Results. Zynyz initial sales minimal. PD-1/PD-L1 Drug Sales Analysis, Section: "Other Marketed Agents".
- Checkpoint Therapeutics Reports Full-Year 2023 Financial Results. No product sales in 2023. PD-1/PD-L1 Drug Sales Analysis, Section: "Other Marketed Agents".
- China's 20th PD-(L)1 drug. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
- CStone Pharmaceuticals 2023 Annual Results. Sugemalimab royalty income: RMB 31.4 million. PD-1/PD-L1 Drug Sales Analysis, Section: "Sugemalimab (Cejemly)".
- Pfizer gains rights to CStone's PD-L1 antibody sugemalimab in China. PD-1/PD-L1 Drug Sales Analysis, Section: "Global Commercialization Models".
- Ivonescimab approved in China 2024. PD-1/PD-L1 Drug Sales Analysis, Table 2.
- Summit Therapeutics Financial Results Q1 2023. $500 million upfront payment for ivonescimab licensing. PD-1/PD-L1 Drug Sales Analysis, Section: "Ivonescimab".
- The Approaching Patent Cliff and the Future of the Market. PD-1/PD-L1 Drug Sales Analysis. Keytruda patent expiry 2028-2032.
- China's Domestic PD-1/PD-L1 Inhibitors. NRDL inclusion price cuts up to 80%. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
Disclaimer
This report is for informational purposes only and should not be considered investment advice. Revenue figures are based on company-reported data and third-party estimates where noted. Market dynamics can change rapidly, and past performance does not guarantee future results. Always conduct your own due diligence before making investment or business decisions.