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

2023 Global Market

$45.2B

Total PD-1/PD-L1 Market1

Non-Keytruda Revenue

$20.2B

44.7% of Total Market1

New Entrants Since 2021

8+

FDA/EMA Approvals2

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

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Top PD-1/PD-L1 Revenue Generators

RankDrug (Brand)CompanyTarget2023 RevenueYoY GrowthMarket ShareKey DifferentiatorFirst Approval
1Pembrolizumab (Keytruda)Merck & Co.PD-1$25.01B3+19%355.3%First-mover advantage; broadest label20142
2Nivolumab (Opdivo)Bristol Myers SquibbPD-1$9.01B4+9%419.9%Strong combo data with ipilimumab20142
3Durvalumab (Imfinzi)AstraZenecaPD-L1$4.20B5+52%19.3%Stage III NSCLC monopoly (PACIFIC)20172
4Atezolizumab (Tecentriq)RochePD-L1$4.19B6+8%19.3%First PD-L1; strong in HCC, SCLC20162
5Cemiplimab (Libtayo)RegeneronPD-1$869M7+50%71.9%Cutaneous squamous cell carcinoma leader20182
6Tislelizumab (Tevimbra)BeiGenePD-1$537M8+27%81.2%First Chinese PD-1 with FDA approval20192
7Dostarlimab (Jemperli)GSKPD-1$175M9>100%90.4%dMMR/MSI-H focus; late entry success20212
8Serplulimab (Hetronifly)HenliusPD-1$159M10+230%100.4%First PD-1 for 1L ES-SCLC globally20222
9Toripalimab (Loqtorzi)Junshi/CoherusPD-1$130M11+25%10.3%First China-developed PD-1 in US1220182

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.

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Recently Approved & Emerging Players

Drug (Brand)CompanyApproval YearStatus2023 Revenue/StatusKey Strategic AdvantageMarket Entry Strategy
Retifanlimab (Zynyz)Incyte2023 (FDA)2LaunchingMinimal (new launch)13Merkel cell carcinoma nicheUltra-rare indication focus
Cosibelimab (Unloxcyt)Checkpoint Therapeutics2024 (FDA)2Pre-launch$0 (not yet launched)14Cutaneous SCC specialtyDermatology-focused
Envafolimab (Enweida)Alphamab/3D Medicines2021 (China)2China onlyNot disclosedWorld's first SC PD-L115Convenience differentiation
Sugemalimab (Cejemly)CStone/Pfizer2021 (China)2Expanding$4.5M (royalties to CStone)16Pfizer partnership in China17Big pharma collaboration
IvonescimabAkeso/Summit2024 (China)18Pipeline$500M licensing deal19PD-1/VEGF bispecificNext-gen technology
CadonilimabAkeso2022 (China)15China approvedGrowing rapidlyPD-1/CTLA-4 bispecificSingle molecule combo

Breaking Down the Monopoly: Three Key Disruption Strategies

1

The Niche Domination Play

Dostarlimab (dMMR/MSI-H)Retifanlimab (Merkel cell)
  • Target ultra-specific patient populations overlooked by giants
  • Achieve rapid approval with smaller, focused trials
  • Build from $100-200M niche to broader indications
Result: GSK's Jemperli grew >100% YoY despite late entry9
2

The Geographic Arbitrage

TislelizumabToripalimabSerplulimab
  • Develop in cost-efficient China market first
  • Use domestic revenue to fund global expansion
  • Partner with Western companies for market access
Result: 8+ Chinese PD-1s now seeking FDA/EMA approval12
3

The Technology Leap

Ivonescimab (PD-1/VEGF)Cadonilimab (PD-1/CTLA-4)
  • Move beyond monoclonal antibodies to bispecifics
  • Offer superior efficacy or convenience
  • Command premium pricing and partnerships
Result: Summit paid $500M upfront for ivonescimab rights19

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:

→
Indication expansion

New approvals in previously untapped cancer types

→
Geographic growth

Emerging markets adoption

→
Combination strategies

Novel pairings that enhance efficacy

→
Biosimilar preparation

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:

Cemiplimab2018

Now approaching $1B despite being 5th to market7

Dostarlimab2021

Achieved >100% growth by targeting dMMR niche9

Serplulimab2022

230% growth via first-in-class SCLC indication10

Learning advantage: Later entrants avoid early mistakes, target proven indications

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:

2018-2019

Domestic Flood

4 PD-1s approved within 12 months2

2020-2022

Price Collapse

80% price cuts force global expansion21

2023-2024

Global Entry

First FDA approvals & Western deals12

2025+

Innovation Lead

Bispecifics competing with giants

20+Chinese PD-1/PD-L1s approved15
$500MSummit's upfront for ivonescimab19
8Seeking FDA/EMA approval12

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

1

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

2

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.

3

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

  1. Gosset.ai revenue database.
  2. Gosset.ai assets database.
  3. 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)".
  4. 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)".
  5. AstraZeneca 2023 Results. Imfinzi sales: $4.2 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "The PD-L1 Incumbents".
  6. Roche 2023 Annual Report. Tecentriq global sales: $4.19 billion. PD-1/PD-L1 Drug Sales Analysis, Section: "The PD-L1 Incumbents".
  7. Regeneron Reports Fourth Quarter and Full Year 2023 Financial Results. Libtayo sales: $869 million. PD-1/PD-L1 Drug Sales Analysis, Section: "Cemiplimab (Libtayo)".
  8. 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".
  9. GSK Q4 2023 Announcement. Jemperli sales: £141 million (~$175 million USD). PD-1/PD-L1 Drug Sales Analysis, Section: "Dostarlimab (Jemperli)".
  10. 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)".
  11. 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".
  12. Rapid Global Expansion of Chinese PD-1/PD-L1 Key Players. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
  13. Incyte Reports 2023 Fourth Quarter Financial Results. Zynyz initial sales minimal. PD-1/PD-L1 Drug Sales Analysis, Section: "Other Marketed Agents".
  14. Checkpoint Therapeutics Reports Full-Year 2023 Financial Results. No product sales in 2023. PD-1/PD-L1 Drug Sales Analysis, Section: "Other Marketed Agents".
  15. China's 20th PD-(L)1 drug. PD-1/PD-L1 Drug Sales Analysis, Section: "The Chinese Biopharma Vanguard".
  16. CStone Pharmaceuticals 2023 Annual Results. Sugemalimab royalty income: RMB 31.4 million. PD-1/PD-L1 Drug Sales Analysis, Section: "Sugemalimab (Cejemly)".
  17. Pfizer gains rights to CStone's PD-L1 antibody sugemalimab in China. PD-1/PD-L1 Drug Sales Analysis, Section: "Global Commercialization Models".
  18. Ivonescimab approved in China 2024. PD-1/PD-L1 Drug Sales Analysis, Table 2.
  19. Summit Therapeutics Financial Results Q1 2023. $500 million upfront payment for ivonescimab licensing. PD-1/PD-L1 Drug Sales Analysis, Section: "Ivonescimab".
  20. The Approaching Patent Cliff and the Future of the Market. PD-1/PD-L1 Drug Sales Analysis. Keytruda patent expiry 2028-2032.
  21. 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.