Immune Checkpoint Inhibitors Market – By Type (CTLA-4 Inhibitors, PD-1 Inhibitors, PD-L1 Inhibitors), By Indication (Lung cancer, Bladder cancer, Melanoma, Hodgkin lymphoma, Others), By End-User (Hospitals, Speciality clinics, Academic & Research Institutions), By Region (North America, Europe, Asia Pacific, Latin America, Middle East and Africa) – Industrial Analysis From 2025 to 2033

Updated On: June, 2024
ID: 14602
Pages: 150

Global Immune Checkpoint Inhibitors Market Size

The global immune checkpoint inhibitors market size was valued at USD 52.45 billion in 2024 and is projected to reach USD 196.40 billion by 2033 from USD 60.74 billion in 2025, growing at a CAGR of 8.3% during forecast period.

Immune checkpoint inhibitors (ICIs) are therapies that use checkpoint inhibitors to stimulate the body’s immune system to fight cancer. Immune checkpoint inhibitors include monoclonal antibodies such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy) which have received approval for various cancers, including melanoma, non-small cell lung cancer (NSCLC), and bladder cancer. Furthermore, the global market is expected to expand as more drugs are developed and approved which leads to broader indications and combination therapies. For example, Keytruda (pembrolizumab), one of the leading ICIs that generated $17 billion in sales in 2022, makes it the top-selling immuno-oncology drug. The ICI market is further supported by ongoing clinical trials. Over 1,000 active clinical trials exploring immune checkpoint inhibition therapies were reported in 2023 which reflects the growing interest in expanding the potential applications of ICIs in cancer treatment.

MARKET DRIVERS

Rising Cancer Incidence

The increasing prevalence of cancer globally is one of the primary drivers of the immune checkpoint inhibitors (ICIs) market. According to the World Health Organization (WHO), cancer was responsible for nearly 10 million deaths worldwide in 2020 and the number expected to rise to 16.4 million by 2040. The growing prevalence of cancer drives increasing demand for effective treatments like ICIs. For instance, Keytruda and Opdivo have been approved for multiple types of cancers which is reflecting a growing clinical need for immunotherapy treatments that can offer improved survival rates compared to traditional therapies.

Advancements in Immunotherapy Research

Ongoing advancements in immuno-oncology research are significantly driving the market. The National Cancer Institute (NCI) states that immunotherapies, particularly checkpoint inhibitors, have transformed cancer treatment which are leading to improved long-term survival rates in cancers like melanoma and lung cancer. The approval of additional ICIs and their combination with other therapies have broadened the applications of these treatments. In 2024, more than 1,000 clinical trials are exploring ICIs for various cancers and this pipeline of therapies promises further market expansion as new drugs and combinations reach the market.

MARKET RESTRAINTS

High Treatment Costs

One of the major restraints in the Immune Checkpoint Inhibitors (ICIs) market is the high cost of therapy. ICIs, such as pembrolizumab and nivolumab can cost between $100,000 to $150,000 per year for a patient which is creating significant barriers to access and especially in low-income regions. According to the Centers for Medicare & Medicaid Services (CMS), cancer treatment expenditures in the U.S. accounted for nearly $50 billion in 2021, with a significant portion spent on expensive immunotherapies. This high cost can limit access to treatments and particularly in developing countries and is impacting market growth and patient access.

Immune-Related Adverse Effects (irAEs)

Immune checkpoint inhibitors can cause severe immune-related adverse effects, including inflammation in organs like the lungs, liver, and colon which can lead to hospitalization or even death. The National Institutes of Health (NIH) states that approximately 30% to 40% of patients on ICIs experience moderate to severe side effects. These adverse reactions limit the widespread use of ICIs and necessitate additional management strategies, including immunosuppressive treatments. This burden on healthcare systems and the risk of serious complications restrain the adoption of ICIs and is especially in patients with preexisting conditions or compromised immune systems.

MARKET OPPORTUNITIES

Expanding Use in Combination Therapies

One of the key opportunities in the Immune Checkpoint Inhibitors (ICIs) market lies in their use in combination therapies. Combining ICIs with other treatment modalities such as targeted therapies, chemotherapy, or radiation has shown promising results in improving efficacy and overcoming resistance. According to the National Cancer Institute (NCI), the combination of nivolumab and ipilimumab has been shown to significantly improve overall survival in patients with advanced melanoma, with a 5-year survival rate of 52% compared to 43% for monotherapy. This creates an opportunity to expand ICI applications across multiple cancer types that is driving market growth.

Potential in Expanding Indications for Rare and Hard-to-Treat Cancers

Another significant opportunity is the expanding use of ICIs in rare and hard-to-treat cancers. Clinical trials are increasingly focusing on less common cancers, including esophageal cancer, cervical cancer, and endometrial cancer. The FDA has granted breakthrough therapy designations for several ICI drugs such as Keytruda and Opdivo for cancers like non-small cell lung cancer (NSCLC). According to the American Cancer Society, the incidence of these hard-to-treat cancers is rising by creating an untapped market for ICIs. Expanding their use in these areas could significantly boost market opportunities.

MARKET CHALLENGES

Immune-Related Adverse Events (irAEs)

One of the major challenges in the Immune Checkpoint Inhibitors (ICIs) market is the occurrence of immune-related adverse events (irAEs), which can arise due to the activation of the immune system against healthy tissues. These side effects can range from mild to severe, including colitis, pneumonitis, and hepatitis. According to the U.S. Food and Drug Administration (FDA), approximately 20-30% of patients undergoing ICI treatment experience significant adverse reactions and thereby leading to discontinuation of therapy in some cases. Managing these side effects remains a major challenge, as their unpredictability complicates treatment plans and patient management.

High Treatment Costs and Accessibility

The high costs of immune checkpoint inhibitor therapies present a significant barrier to widespread adoption. Drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo) can cost patients between $100,000 and $150,000 annually. According to the Centers for Medicare & Medicaid Services (CMS), such expenses can impose a substantial financial burden on healthcare systems, particularly in low-resource settings. These costs hinder patient access to cutting-edge treatments, especially in developing countries, where healthcare infrastructure and insurance coverage may be limited. Reducing costs and improving accessibility is essential for expanding the reach of ICIs globally.

REPORT COVERAGE

REPORT METRIC

DETAILS

Market Size Available

2024 to 2033

Base Year

2024

Forecast Period

2025 to 2033

Segments Covered

By Type, Indication, End-Use, and Region

Various Analyses Covered

Global, Regional and Country Level Analysis, Segment-Level Analysis, Drivers, Restraints, Opportunities, Challenges; PESTLE Analysis; Porter's Five Forces Analysis, Competitive Landscape, Analyst Overview of Investment Opportunities

Regions Covered

North America, Europe, Asia Pacific, Latin America, Middle East & Africa.

 

SEGMENTAL ANALYSIS

By Type Insights

The PD-1/PD-L1 inhibitors segment held 40.4% of the global market share in 2024. The PD-1/PD-L1 inhibitors segment includes monoclonal antibodies such as pembrolizumab (Keytruda) and nivolumab (Opdivo) which have been approved for various cancer types, including melanoma, non-small cell lung cancer, and bladder cancer. The widespread clinical applications and proven efficacy of these therapies contribute to their substantial market share. For example, studies show that the use of PD-1/PD-L1 inhibitors has led to a 30-40% improvement in overall survival rates for patients with metastatic non-small cell lung cancer (NSCLC). Additionally, clinical trials involving these inhibitors are being expanded to include over 20 different cancer types by demonstrating their broad potential. Data from the American Cancer Society highlights that these inhibitors have been approved for more than 5 types of cancer over the last 5 years alone.

The CTLA-4 inhibitors segment in the immune checkpoint inhibitors market is projected to grow at a CAGR of 13.7% in the coming years. The segment encompasses agents like ipilimumab (Yervoy) and is recognized for its significant role in cancer immunotherapy. It has a smaller market share compared to the PD-1/PD-L1 segment but is experiencing the fastest growth rate. This rapid expansion is attributed to ongoing clinical trials and research initiatives exploring the efficacy of CTLA-4 inhibitors in various cancer types. The increasing number of approved antibody therapies targeting CTLA-4 and the development of combination therapies are expected to drive this growth.

By Application Insights

The lung cancer segment held a dominating position in the global immune checkpoint inhibitors market in 2024 and accounted for 25.1% of the global market share due to its high incidence and mortality rates worldwide. It’s projections indicating a CAGR of 13.7% for the estimation period. In 2023, the United States reported 238,340 new lung cancer diagnoses having approximately 127,070 fatalities. The significant burden of lung cancer coupled with the proven efficacy of ICIs in improving patient outcomes and thereby contributes to the segment's substantial market share. The approval of PD-1 inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo) for non-small cell lung cancer (NSCLC) has been a pivotal factor in this growth. These therapies have demonstrated significant improvements in overall survival rates which is leading to their widespread adoption in clinical practice.

The breast cancer segment is growing promisingly and is anticipated to post a CAGR of 16.8% in the foreseen years. The rapid expansion of the breast cancer segment is driven by ongoing clinical trials and research initiatives exploring the efficacy of ICIs in various subtypes of breast cancer including triple-negative breast cancer (TNBC). The increasing number of approved antibody therapies targeting breast cancer and the development of combination therapies are expected to drive this growth. Additionally, breast cancer remains the most prevalent type of cancer among women globally, accounting for 28.2% of all female cancers in India, with an estimated 216,108 cases by 2022, as per the KNOCKSENSE.

By Distribution Channel Insights

The hospital pharmacy segment led the immune checkpoint inhibitors (ICIs) market with a significant share of 57% in the global market in 2024 owing to the centralized administration of ICIs in hospital settings, where patients receive comprehensive cancer care. Hospitals are equipped with specialized facilities and healthcare professionals trained to manage complex cancer treatments including the administration of ICIs. This centralized approach ensures proper monitoring and management of potential side effects associated with ICIs, thereby enhancing patient safety and treatment efficacy. Hospital settings enable real-time monitoring for side effects and immediate intervention if necessary, enhancing patient safety and treatment success. The same study noted that slightly over 70% of patients were discharged within 7 days of ICI administration by indicating the importance of timely and effective inpatient care, as per the ASCO PUBLICATIONS.

The retail pharmacy segment is expected to experience the fastest CAGR of 11.1% over the forecast period. The rapid expansion of the Retail Pharmacy segment is driven by the increasing availability of ICIs through outpatient settings and allows patients to access treatments closer to home. Retail pharmacies offer convenience and accessibility which are crucial for patients requiring ongoing cancer therapy. The growth of this segment reflects a shift towards more patient-centric care models where treatments are administered in community-based settings and thereby reducing the need for prolonged hospital stays.  As of 2024, there are approximately 23,384 independent pharmacies and 36,209 chain pharmacies in the United States, totaling around 59,593 retail pharmacies, according to PCMA NET.

REGIONAL ANALYSIS

North America dominated the market and occupied 55.5% of the global market share in 2024. The United States in particular is a significant contributor. It remains the leading region for immune checkpoint inhibitors which is driven by the advanced healthcare systems in the United States and Canada. The region is home to world-class research institutions and healthcare providers, and the United States alone contributes to more than 50% of global cancer treatment expenditure. According to the National Cancer Institute, about 1.9 million new cancer cases are expected to be diagnosed in 2024. The U.S. healthcare spending, which includes oncology treatments is expected to surpass $4.5 trillion by 2024 and highlights the importance of cancer therapeutics in the region.

Europe is expected to hold a witness a CAGR of 28.2% during the forecast period. The region has seen substantial adoption of ICIs due to strong regulatory support from the European Medicines Agency (EMA) and well-established healthcare infrastructure. Cancer is the second most common cause of death in the European Union having over 3.5 million new cancer diagnoses projected for 2024, according to the World Health Organization (WHO). The European Union has a significant focus on cancer research and treatment access with numerous member states investing in innovative therapies and healthcare accessibility.

Asia-Pacific is growing significantly and is estimated to be the fastest growing region in the global market for the forecast period. Particularly China and Japan are becoming a growing market for ICIs. China with its rapidly aging population and increasing cancer incidence (over 4.5 million new cases projected by the WHO in 2024) and is driving demand for advanced cancer therapies. Japan also faces a high cancer burden, with nearly 1 million new cancer cases expected in 2024. The region benefits from expanding healthcare coverage and public-private partnerships aimed at increasing access to innovative treatments.

The immune checkpoint inhibitors market in Latin America is estimated to account for a substantial share of the global market during the forecast period. Cancer rates in this region are rising with the Pan American Health Organization (PAHO) highlighting that cancer is the second leading cause of death in the region. In 2022, more than 78,000 women were diagnosed with cervical cancer, and more than 40,000 died from the disease in the Region of the Americas, as per the Pan American Health Organization. Additionally, in 2020, there were more than 210,000 new diagnoses of breast cancer in Latin America and the Caribbean, and nearly 68,000 deaths according to Pan American Health Organization.

The immune checkpoint inhibitors market in Middle East is expected to grow at a steady CAGR during the forecast period. The MEA region while currently holding a smaller share of the global ICI market is witnessing significant improvements in cancer care. It is driven by increasing clinical trials and research initiatives. The region currently holding a smaller share of the global immune checkpoint inhibitors market and is witnessing significant improvements in cancer care. The World Health Organization (WHO) has highlighted that cancer is the second leading cause of death globally and the MEA region is experiencing a rising cancer burden, with a projected 1.8-fold increase in diagnoses by 2030. In 2020, Africa reported over 1 million new cancer cases and nearly 711,000 cancer-related deaths. Saudi Arabia and South Africa are among the key countries focusing on enhancing healthcare infrastructure, with investments in oncology care and collaboration with international organizations. For instance, Saudi Arabia has committed substantial financial resources to advance cancer treatment and is benefiting both local and global populations.

KEY MARKET PLAYERS AND COMPETITIVE LANDSCAPE

Bristol Myers Squibb Company, Regeneron Pharmaceuticals Inc, AstraZeneca plc, Merck & Co. Inc, Hoffmann-La Roche AG, NewLink Genetics Corporation, Novartis International AG, ImmunOs Therapeutics are some of the key market players in the Immune Checkpoint Inhibitors.

The competition in the Immune Checkpoint Inhibitors (ICIs) market is fierce, with a growing number of pharmaceutical companies vying for dominance. The market is currently led by major players such as Merck & Co. and Bristol-Myers Squibb, with their flagship drugs Keytruda (pembrolizumab) and Opdivo (nivolumab), respectively. These two drugs dominate the market, driving substantial revenue through approvals across multiple cancer types, including melanoma, lung cancer, and urothelial carcinoma.

However, other pharmaceutical companies are actively developing competitive ICIs, creating a dynamic and rapidly evolving market. Roche's Tecentriq (atezolizumab) and AstraZeneca's Imfinzi (durvalumab) are among the notable competitors, each with a growing footprint in the oncology space. These companies are focusing on expanding the range of cancers treated and pursuing combination therapies, which are expected to drive future market growth.

Additionally, smaller biotech firms and emerging players are developing next-generation immune checkpoint inhibitors and combination therapies. Companies like Regeneron Pharmaceuticals and AstraZeneca are advancing innovative treatments to compete with the established market leaders, while numerous clinical trials continue to explore the efficacy of ICIs in new indications.

With the continuous development of more personalized and combination therapies, the competition will intensify, making this market highly competitive and innovative.

RECENT MARKET DEVELOPMENTS

  • In July 2024, Boehringer Ingelheim acquired Nerio Therapeutics for up to $1.3 billion. This acquisition aimed to bolster Boehringer's immuno-oncology pipeline by integrating Nerio's preclinical small molecules targeting immune checkpoint proteins PTPN1 and PTPN2.
  • In November 2024, BioNTech announced the acquisition of Biotheus, a clinical-stage biotechnology company specializing in novel antibody development. This acquisition provided BioNTech with full global rights to BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A, with the potential to replace current checkpoint inhibitor standard-of-care treatments for solid tumors. 

MARKET SEGMENTATION

This research report on the immune checkpoint inhibitors market has been segmented and sub-segmented based on the type, indication, end-use, and region.

By Type

  • PD-1
  • PD-L1
  • CTLA-4
  • Others

By Application

  • Lung Cancer
  • Breast Cancer
  • Bladder Cancer
  • Melanoma
  • Cervical Cancer
  • Hodgkin Lymphoma
  • Colorectal Cancer
  • Others

By Distribution Channel

  • Hospital Pharmacy
  • Retail Pharmacy
  • Online Pharmacy

By Region

  • North America
  • Europe
  • Asia Pacific 
  • Latin America
  • Middle East and Africa

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Anil Kumar P is research manager at Market Data Forecast and responsible for Healthcare Domain.

Author

Anil Kumar P (Research Manager - Healthcare)

Anil Kumar P is the lead author of this report and the manager of the team responsible for authoring healthcare reports at Market Data Forecast. He holds a Bachelor’s degree in Pharmacy (Hons.) from BITS Pilani, one of India’s premier institutions. Over the past seven years, Anil has gained extensive experience working with multiple market research companies, where he has collaborated with a diverse range of clients—from innovative startups to Fortune 500 companies—delivering data-driven insights and strategic advice that drive business growth.

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Frequently Asked Questions

What is the current status of the Immune Checkpoint Inhibitors market?

The ICI market has witnessed significant growth in recent years, with several ICIs receiving regulatory approval for various cancer indications. The market is dynamic, with ongoing research and development efforts to expand the range of treatable cancers.

What are the main challenges in the Immune Checkpoint Inhibitors market?

Challenges include identifying biomarkers to predict patient response, managing immune-related adverse events, and exploring combination therapies to improve overall response rates. Additionally, the cost of ICIs can be a barrier to widespread access.

What are the potential side effects of Immune Checkpoint Inhibitors?

Common side effects include fatigue, skin rash, and gastrointestinal issues. However, ICIs can also lead to immune-related adverse events affecting various organs, which require careful monitoring and management.

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