Immune Checkpoint Inhibitors Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Immune Checkpoint Inhibitors Market is Segmented by Inhibitor Type (CTLA-4 Inhibitors, PD-1 Inhibitors, and More), Indication (Non-Small Cell Lung Cancer, and More), Route of Administration (Intravenous and Sub-Cutaneous), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Immune Checkpoint Inhibitors Market Size and Share

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Immune Checkpoint Inhibitors Market Analysis by Mordor Intelligence

The Immune Checkpoint Inhibitors Market size is estimated at USD 50.29 billion in 2025, and is expected to reach USD 107.86 billion by 2030, at a CAGR of 16.49% during the forecast period (2025-2030).

Growth rests on broadening regulatory approvals, rapid uptake of combination regimens, and next-generation targets such as LAG-3, TIGIT, and TIM-3. Subcutaneous formulations that free up infusion chairs, AI-guided biomarker discovery that lifts response rates, and the shift of therapies into perioperative settings continue to expand eligible patient pools. Mounting M&A activity, exemplified by Sun Pharmaceutical’s USD 416 million acquisition of Checkpoint Therapeutics, underscores the strategic importance of late-stage assets. Asia’s accelerating adoption, tight U.S. pricing dynamics, and the arrival of biosimilars will reshape competitive tactics through 2030.

Key Report Takeaways

  • By inhibitor type, PD-1 molecules led with 61.56% revenue share of the immune checkpoint inhibitors market in 2024, while LAG-3 assets are projected to expand at a 17.81% CAGR to 2030.
  • By indication, non-small cell lung cancer held 26.86% of the immune checkpoint inhibitors market share in 2024, whereas small cell lung cancer is advancing at a 23.04% CAGR through 2030.
  • By route of administration, intravenous delivery accounted for 68.67% of the immune checkpoint inhibitors market size in 2024; subcutaneous formats are set to grow at 25.93% CAGR to 2030.
  • By distribution channel, hospital pharmacies retained 57.45% share of the immune checkpoint inhibitors market size in 2024; online pharmacies post a 20.26% CAGR forecast to 2030.
  • By region, North America captured 37.33% share in 2024, while Asia–Pacific is projected to expand at 19.85% CAGR through 2030.

Segment Analysis

By Inhibitor Type: Next-Generation Targets Challenge PD-1 Dominance

PD-1 agents delivered 61.56% of immune checkpoint inhibitors market revenue in 2024, underpinned by Keytruda and Opdivo franchises. LAG-3 molecules such as relatlimab exhibit a 17.81% CAGR, supported by melanoma uptake. PD-L1 products gain from tissue-agnostic labels, while CTLA-4 checkpoints shift to combination partner roles. TIGIT and TIM-3 pipelines progress unevenly, reflecting nuanced biology and mixed readouts. Bispecific antibodies that bridge PD-1 with LAG-3 or VEGF targets may offset monotherapy plateaus and refresh intellectual-property clocks.

A widening array of oral LAG-3 small molecules under investigation underscores demand for cost-efficient oral immunomodulation. This diversification of modalities broadens prescriber choice and mitigates resistance patterns inherent in single-checkpoint blockade.

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Note: Segment shares of all individual segments available upon report purchase

By Indication: SCLC Emerges as High-Growth Opportunity

Non-small cell lung cancer controlled 26.86% of immune checkpoint inhibitors market revenue in 2024, retaining front-line dominance. Small cell lung cancer delivers the fastest expansion at 23.04% CAGR, buoyed by limited historical options and durable benefits from anti-PD-L1 plus chemotherapy combinations. Melanoma sustains steady uptake through LAG-3 combination approvals. Renal cell carcinoma and hepatocellular carcinoma respond well to IO-VEGF pairings. Urothelial cancer leverages antibody–drug conjugate synergies, with enfortumab vedotin plus pembrolizumab doubling overall survival versus chemotherapy.

Precision medicine drives differentiation as microsatellite instability status, tumor mutational burden, and PD-L1 expression refine therapeutic choices. Earlier-stage interventions shift volume from metastatic to adjuvant settings, altering oncology workflow and resource allocation.

By Route of Administration: Subcutaneous Revolution Addresses Infrastructure Constraints

Intravenous infusion generated 68.67% of immune checkpoint inhibitors market revenue in 2024, favored by established protocols and reimbursement familiarity. Subcutaneous formats grow at 25.93% CAGR as two-minute pushes replace thirty-minute infusions. Hyaluronidase-enabled high-volume delivery expands to community practices, lowering indirect costs like chair time and nursing labor. 

Monthly subcutaneous options such as crovalimab illustrate the patient convenience premium. Device-integrated autoinjectors under development promise at-home administration, potentially shifting volumes toward ambulatory care pathways.

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Note: Segment shares of all individual segments available upon report purchase

By Distribution Channel: Digital Transformation Reshapes Access Models

Hospital pharmacies retained 57.45% of immune checkpoint inhibitors market revenue in 2024, reflecting close monitoring needs. Online players post a 20.26% CAGR, fueled by maturing cold-chain logistics and tele-oncology adoption. 

Retail pharmacies broaden specialty units to capture spill-over business from hospital outsourcing. Value-based contracts require sophisticated adherence tracking, prompting platform investments in real-time analytics and adverse-event reporting.

Geography Analysis

North America held 37.33% of immune checkpoint inhibitors market revenue in 2024, supported by favorable reimbursement and trial density. Asia–Pacific rises at 19.85% CAGR on the back of regulatory convergence and local manufacturing incentives. China’s National Medical Products Administration authorized Keytruda for neoadjuvant NSCLC, highlighting regional agility. Japan benefits from domestic innovators like Ono Pharmaceutical in immuno-oncology. 

Europe demonstrates steady growth through harmonized regulatory pathways and value-based healthcare adoption, with the European Medicines Agency's multiple 2024-2025 approvals for checkpoint inhibitor combinations indicating continued market expansion. The region's emphasis on health technology assessment and cost-effectiveness analysis shapes market access strategies and pricing negotiations. Middle East and Africa represent emerging opportunities with significant unmet medical needs, yet face affordability challenges that limit widespread adoption of premium-priced immunotherapies. South America's growth potential centers on Brazil and Argentina, where regulatory improvements and healthcare infrastructure investments create opportunities for market expansion. The geographic landscape's evolution reflects broader economic development patterns and healthcare system maturation, with emerging markets increasingly demanding local manufacturing capabilities and technology transfer agreements to ensure sustainable access to innovative cancer therapies.

Growth Rate by Region
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Competitive Landscape

The immune checkpoint inhibitors market is moderately concentrated yet fiercely contested by multinational incumbents and venture-backed challengers. Merck’s Keytruda aims for USD 22.2 billion sales in 2025, while Bristol Myers Squibb’s Opdivo franchise produced USD 2.39 billion in Q2 2024. Leaders extend lifecycles through subcutaneous reformulations, novel combinations, and biomarker partnerships. Sun Pharmaceutical’s USD 416 million purchase of Checkpoint Therapeutics following Unloxcyt approval illustrates acquisitive moves to secure first-in-class assets.

Bispecific programs advance, typified by BNT327 (PD-1/VEGF) in Phase III trials and ivonescimab (PD-1/VEGF) outperforming Keytruda head-to-head. AI-enabled biomarker firms square off with in-house diagnostics as precision prescribing becomes a revenue lever. Biosimilar entrants in Asia undercut price but must prove interchangeability and secure payer confidence. Market participants prioritize vertical integration that links drug, diagnostic, and digital patient-support assets into an ecosystem that preserves share despite price compression.

Immune Checkpoint Inhibitors Industry Leaders

  1. Bristol Myers Squibb Company

  2. Regeneron Pharmaceuticals Inc

  3. F. Hoffmann-La Roche AG

  4. AstraZeneca

  5. Merck & Co.

  6. *Disclaimer: Major Players sorted in no particular order
Immune Checkpoint Inhibitors Market Concentration
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Recent Industry Developments

  • June 2025: Bristol Myers Squibb partnered with BioNTech to develop BNT327, a bispecific cancer drug targeting PD-1 and VEGF pathways, entering Phase III trials across multiple cancer types and representing a strategic shift toward multi-target immunomodulation approaches
  • May 2025: The FDA approved retifanlimab-dlwr (Zynyz) for treating inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal, both as combination therapy with carboplatin and paclitaxel and as monotherapy, demonstrating median progression-free survival of 9.3 months versus 7.4 months for placebo
  • April 2025: Bristol Myers Squibb reported Q1 2025 revenues of USD 11.2 billion with Growth Portfolio generating USD 5.6 billion, up 16%, driven by Opdivo sales of USD 2.3 billion and raised full-year guidance to USD 45.8-46.8 billion
  • February 2025: The FDA accepted a supplemental biologics license application for nivolumab plus ipilimumab combination as first-line treatment for unresectable/metastatic MSI-H/dMMR colorectal cancer, with target action date of June 23, 2025, based on CheckMate 8HW trial results

Table of Contents for Immune Checkpoint Inhibitors Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Investments In R&D and Clinical Trials
    • 4.2.2 Increased Product Approvals & Special Designations
    • 4.2.3 Expansion of ICIs into Earlier-Line & Adjuvant Settings
    • 4.2.4 AI-Powered Biomarker Discovery Raising Response Rates
    • 4.2.5 Growth of Sub-Cutaneous ICI Formulations Easing Infusion Capacity
    • 4.2.6 Local-Manufactured Biosimilars Driving Affordability
  • 4.3 Market Restraints
    • 4.3.1 High Treatment Cost & Reimbursement Hurdles
    • 4.3.2 Immune-Related Adverse Events and Safety Concerns
    • 4.3.3 Adaptive Resistance in “Cold” Tumours Limiting Durability
    • 4.3.4 Price Erosion from Incoming ICI Biosimilars Reducing ROI
  • 4.4 Porter’s Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value in USD)

  • 5.1 By Inhibitor Type
    • 5.1.1 CTLA-4 Inhibitors
    • 5.1.2 PD-1 Inhibitors
    • 5.1.3 PD-L1 Inhibitors
    • 5.1.4 LAG-3 Inhibitors
    • 5.1.5 TIGIT Inhibitors
    • 5.1.6 TIM-3 & Other Next-Gen Checkpoints
  • 5.2 By Indication
    • 5.2.1 Non-Small Cell Lung Cancer (NSCLC)
    • 5.2.2 Small Cell Lung Cancer (SCLC)
    • 5.2.3 Melanoma
    • 5.2.4 Renal Cell Carcinoma
    • 5.2.5 Head & Neck Cancers
    • 5.2.6 Urothelial & Bladder Cancer
    • 5.2.7 Hepatocellular Carcinoma
    • 5.2.8 Hodgkin Lymphoma
    • 5.2.9 Other Cancers
  • 5.3 By Route of Administration
    • 5.3.1 Intravenous
    • 5.3.2 Sub-cutaneous
  • 5.4 By Distribution Channel
    • 5.4.1 Hospital Pharmacies
    • 5.4.2 Retail Pharmacies
    • 5.4.3 Online Pharmacies
  • 5.5 By Geography
    • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
    • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
    • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
    • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
    • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Bristol-Myers Squibb
    • 6.3.2 Merck & Co.
    • 6.3.3 F. Hoffmann-La Roche
    • 6.3.4 Regeneron Pharmaceuticals
    • 6.3.5 AstraZeneca
    • 6.3.6 Eli Lilly
    • 6.3.7 Sanofi
    • 6.3.8 BeiGene
    • 6.3.9 Junshi Biosciences
    • 6.3.10 GlaxoSmithKline
    • 6.3.11 Innovent Biologics
    • 6.3.12 Novartis
    • 6.3.13 Incyte
    • 6.3.14 Exelixis
    • 6.3.15 Gilead Sciences
    • 6.3.16 Ono Pharmaceutical
    • 6.3.17 Zai Lab
    • 6.3.18 Shanghai Henlius
    • 6.3.19 Iovance Biotherapeutics
    • 6.3.20 MacroGenics

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Immune Checkpoint Inhibitors Market Report Scope

As per the scope of the report, immune checkpoint inhibitors are anticancer drugs used in immunotherapy, which enhance the immune response to detect and target cancer cells. These drugs are widely accepted as a standard treatment for advanced-stage cancers due to their proven efficiency and positive patient responses with a lower incidence of side effects compared to conventional chemotherapy. 

The immune checkpoint inhibitors market is segmented by type of inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, and other types of inhibitors), application (Hodgkin lymphoma, kidney cancer, melanoma, non-small cell lung cancer, and other applications), distribution channel (hospital pharmacies, retail pharmacies, and online pharmacies), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Inhibitor Type CTLA-4 Inhibitors
PD-1 Inhibitors
PD-L1 Inhibitors
LAG-3 Inhibitors
TIGIT Inhibitors
TIM-3 & Other Next-Gen Checkpoints
By Indication Non-Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)
Melanoma
Renal Cell Carcinoma
Head & Neck Cancers
Urothelial & Bladder Cancer
Hepatocellular Carcinoma
Hodgkin Lymphoma
Other Cancers
By Route of Administration Intravenous
Sub-cutaneous
By Distribution Channel Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
By Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Inhibitor Type
CTLA-4 Inhibitors
PD-1 Inhibitors
PD-L1 Inhibitors
LAG-3 Inhibitors
TIGIT Inhibitors
TIM-3 & Other Next-Gen Checkpoints
By Indication
Non-Small Cell Lung Cancer (NSCLC)
Small Cell Lung Cancer (SCLC)
Melanoma
Renal Cell Carcinoma
Head & Neck Cancers
Urothelial & Bladder Cancer
Hepatocellular Carcinoma
Hodgkin Lymphoma
Other Cancers
By Route of Administration
Intravenous
Sub-cutaneous
By Distribution Channel
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
By Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What is the current value of the immune checkpoint inhibitors market?

The immune checkpoint inhibitors market stands at USD 50.29 billion in 2025 and is projected to more than double by 2030.

Which inhibitor class holds the largest market share?

PD-1 inhibitors account for 61.56% of revenue, anchored by Keytruda and Opdivo.

Why are subcutaneous formulations important?

Subcutaneous delivery cuts administration time to minutes, eases infusion capacity constraints, and supports outpatient treatment models.

Which cancer type is growing fastest for checkpoint inhibitors?

Small cell lung cancer posts the highest CAGR at 23.04% through 2030 due to limited historical options and new combination approvals.

How will biosimilars affect prices?

Medicare data show reference checkpoint products can face 30%-plus price cuts within five years of biosimilar entry, pressuring margins and accelerating value-based contracting.

What role does AI play in this market?

AI enhances biomarker discovery and patient stratification, raising response rates and lowering late-stage trial failures for next-generation inhibitors.

Page last updated on: July 8, 2025

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