Immune Checkpoint Inhibitors Market Size, Share & Trends Analysis Report By Type (PD-1 Inhibitor, PD-L1 Inhibitor, CTLA-4 Inhibitor, Others), By Applications (Lung Cancer, Breast Cancer, Bladder Cancer, Melanoma, Colorectal Cancer, Hodgkin Lymphoma, Cervical Cancer, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Immune Checkpoint Inhibitors Market Size

The global immune checkpoint inhibitors market size was valued at USD 62.51 billion in 2024 and is projected to reach from USD 76.61 billion in 2025 to USD 189.40 billion by 2033, exhibiting a CAGR of 11.98% during the forecast period (2025-2033).

ICIs are a class of cancer immunotherapies that help the immune system recognize and attack cancer cells more effectively. Normally, immune checkpoints are regulators that prevent the immune system from attacking normal cells in the body. However, cancer cells can exploit these checkpoints to avoid detection by the immune system. ICIs work by blocking these checkpoints, allowing immune cells to identify and destroy cancer cells.

The major factors propelling the ICI market expansion are rising cancer cases, the availability of advanced screening technologies for early cancer detection, and the growing demand for effective cancer drugs. For instance, the World Health Organization (WHO) reported that 20 million new cancer cases were diagnosed in 2022, with lung, breast, and colorectal accounting for 33.6% of the cases.

Additionally, expanding approvals and the increasing use of ICIs for various cancers, such as lung, melanoma, and cervical, are fueling demand in global healthcare settings. Moreover, the growing number of clinical trials for ICIs worldwide highlights the increasing interest in enhancing the therapeutic potential of these treatments.

The graph below depicts the number of ICI clinical trials for major locations.

Source: Clinical Trials, Whitepapers, and Straits Analysis

Immune Checkpoint Inhibitors Market Trends

Adoption of combination therapies

There is a growing market trend of using immune checkpoint inhibitors (ICIs) in combination with other treatment therapies such as chemotherapy, targeted therapies, or other immunotherapies. Combination treatments have been shown to enhance the efficacy of cancer-directed therapies by attacking cancers through multiple mechanisms.

• For example, pembrolizumab (Keytruda, a PD-1 inhibitor), in combination with chemotherapy, improved the overall survival of non-small cell lung cancer (NSCLC) patients who had not previously received treatment for their advanced disease compared with chemotherapy alone.
• Ipilimumab (CTLA-4 inhibitor) combined with nivolumab (PD-1 inhibitor) has been shown to be effective in treating advanced melanoma.

Thus, the adoption of ICIs in combination with other treatment therapies is driving the market, along with exploring novel combinations.

Shift towards biomarker-based treatment approaches

An emerging practice in cancer treatment involves the use of biomarkers to help personalize immune checkpoint inhibitor (ICI) therapies, increasing their precision and effectiveness. By analyzing certain markers such as PD-L1 expression or tumor mutation burden (TMB), physicians can determine who will likely respond best to ICIs.

• For example, pembrolizumab (Keytruda) is indicated for patients with high PD-L1 levels in non-small cell lung cancer (NSCLC).

Thus, the adoption of such an approach increases success by concentrating on the most appropriate patients, reducing toxicity, and streamlining treatment.

Immune Checkpoint Inhibitors Market Growth Factors

High efficacy and durable responses of icis

ICIs have shown substantial efficacy, particularly in difficult-to-treat cancers such as melanoma and non-small cell lung cancer (NSCLC). Their ability to provide durable responses in patients, even leading to long-term remission in some cases, fuels their demand.

• For example, according to a press release from Merck & Co., Inc. in September 2024, ten-year data from the KEYNOTE-006 trial demonstrated that KEYTRUDA (pembrolizumab) exhibits high efficacy in advanced melanoma. The 10-year overall survival (OS) rate for KEYTRUDA was 34.0%, compared to 23.6% for ipilimumab.
• KEYTRUDA reduced the risk of death by 29% (HR=0.71) and more than doubled the median OS, achieving 32.7 months versus 15.9 months for ipilimumab, underscoring its long-term effectiveness.

Thus, the capacity of ICIs to provide long-lasting clinical benefits and durable responses is significantly driving their adoption and growth in the oncology industry.

Increasing global cancer prevalence

The increasing global prevalence of cancer is a significant driver in the immune checkpoint inhibitor (ICI) market. As cancer cases continue to rise, particularly in major markets like the U.S., China, India, and Europe, the demand for effective and targeted treatments such as ICIs grows. These therapies offer promising outcomes for hard-to-treat cancers, making them a critical part of oncology care.

The graph below illustrates the cancer incidence rate per 100,000 individuals across various regions, providing insights into the global burden of the disease.

Source: International Agency for Research on Cancer, Globocan, Straits Analysis

Thus, the rising incidence of cancers, such as lung, melanoma, and renal, amplifies the need for innovative therapies, thereby boosting the adoption of ICIs in clinical practice worldwide.

Restraining Factor

High cost of icis

The high cost of ICIs is a significant restraining factor impacting market dynamics. ICIs, while highly effective, come with a steep price that can limit accessibility for many patients.

• For example, the cost of KEYTRUDA (pembrolizumab) is $11,564.16 per dose when administered every three weeks and $23,138.32 per dose when given every six weeks.

Such high price points can create financial barriers, leading to challenges in insurance coverage and reimbursement. As a result, many patients may struggle to afford these treatments, restricting the broader adoption of ICIs in healthcare settings.

Market Opportunities

Development of novel icis targeting new pathways

While current ICIs primarily target pathways such as PD-1, PD-L1, and CTLA-4, researchers are now exploring additional immune checkpoints, such as LAG-3, TIM-3, and TIGIT. These new targets offer promising opportunities for therapeutic development and could broaden the scope of cancer treatment options. Early clinical trials involving inhibitors of these novel checkpoints have shown potential, expanding the horizon of ICIs.

• For example, relatlimab, a LAG-3 inhibitor, has proven effective in combination with nivolumab in treating melanoma.

Thus, the development of such novel ICIs will provide more treatment options for patients who are resistant to current therapies, along with offering new avenues for companies to expand their ICI portfolios.

Regional Insights

North america: dominant region with 55.50% market share

North America holds a dominant position in the ICI market, accounting for the largest revenue share. This leadership can be attributed to several key factors, including a well-established healthcare infrastructure, substantial investments in research and development, and a high prevalence of cancer. The presence of major industry players such as Bristol-Myers Squibb Company, Merck & Co., Inc., and Regeneron Pharmaceuticals, Inc., alongside favorable regulatory support, further enhances the market’s growth potential in the region.

Asia-pacific: rapid growth in china, japan, and india

The Asia-Pacific region is projected to experience the fastest compound annual growth rate (CAGR) during the forecast period. This rapid growth is driven by increasing cancer incidence, heightened awareness of advanced cancer therapies, and growing investments in healthcare infrastructure across countries like China, Japan, and India.

Additionally, improving regulatory frameworks and an increase in partnerships between local and global pharmaceutical companies are facilitating greater access to ICI treatments, contributing to the region's rapid market expansion. These dynamics position the Asia-Pacific region as a key area of growth in the global ICI market.

Countries insights

• U.S. – The U.S. continues to lead the ICI market due to its robust healthcare system and substantial investment in cancer research. The high prevalence of cancer cases further drives the demand for advanced therapies. For instance, the National Cancer Institute projects that 2,001,140 new cancer cases will be diagnosed in the U.S. in 2024, with the number expected to rise to 29.9 million by 2040. Additionally, strong support from regulatory agencies such as the U.S. FDA expedites the approval of novel treatments, enhancing patient access to these advanced therapies.

• Canada - In Canada, the strong emphasis on personalized medicine and precision oncology significantly propels market growth. The Canadian healthcare system prioritizes access to cutting-edge cancer therapies, and increasing public and private funding for cancer research fosters innovation. Moreover, the growing prevalence of cancer, combined with supportive regulatory policies, enhances the adoption of ICIs, establishing Canada as a key market for these therapies.
• Germany – Germany's well-established healthcare system and commitment to medical innovation are key drivers for the ICI market. The country is known for its high standards of patient care and a strong focus on research and development in oncology. Moreover, the increasing incidence of cancer and growing awareness of ICIs among healthcare professionals contribute to growth, supported by favorable reimbursement policies for innovative cancer therapies.
• UK - The United Kingdom's National Health Service (NHS) plays a significant role in driving the market growth. The NHS's commitment to providing access to innovative cancer therapies supports the integration of ICIs into standard treatment protocols. Moreover, ongoing clinical trials and research collaborations between academic institutions and pharmaceutical companies contribute to the development of new ICI therapies, enhancing the country's position in the global market.
• France - In France, the government's commitment to improving cancer care and increasing funding for oncology research drives the ICI market. The French healthcare system emphasizes the integration of innovative therapies into treatment protocols, enhancing patients' access to ICIs. Moreover, strong collaboration between pharmaceutical companies and academic institutions fosters the development of new ICI therapies, further supporting market expansion.
• China - In China, a rapid increase in cancer incidence is the major driver in the ICI market. The country faces significant public health challenges due to the high burden of cancer cases, prompting increased investments in oncology research and drug development. For instance, according to the World Health Organization (WHO) 2023, 48,24,703 new cancer cases were reported in 2022.
• India - In India, the increasing incidence of cancer and rising awareness of advanced treatment options drive the demand for ICIs. The growing emphasis on improving healthcare infrastructure, coupled with government initiatives to enhance cancer care, creates a favorable environment for the ICI market. Moreover, the influx of foreign investments in India's biotechnology sector stimulates research and development activities, further propelling the market's growth.
• Australia - In Australia, the increasing incidence of cancer and a strong commitment to advancing cancer care drive the market. The Australian healthcare system supports access to innovative therapies, with strong government initiatives promoting research and development in oncology. Moreover, the collaboration between academic institutions and pharmaceutical companies fosters the development of new ICIs, enhancing the market's growth potential.

Analyst Opinion

As per our analyst, the immune checkpoint inhibitors (ICIs) market is experiencing rapid expansion driven by several pivotal factors. The increasing global prevalence of cancer, along with the growing number of approvals for ICIs across various cancer types, significantly propels market growth. Furthermore, a surge in clinical trials exploring new indications and combination therapies enhances the therapeutic landscape, offering more options for patients.

Advancements in biomarker-driven treatment approaches and the development of next-generation inhibitors are also crucial in fueling market progress. Strong investments in oncology research and development, coupled with government initiatives aimed at improving cancer care, create a favorable environment for innovation and accessibility.

Additionally, the expanding adoption of ICIs in emerging markets and the growing availability of advanced treatment options in hospital settings contribute to the market's swift growth trajectory. Collectively, these factors position the ICI market for continued expansion in the foreseeable future.

Immune Checkpoint Inhibitors Market Segmentation Analysis

By product type

The market is segmented into PD-1 inhibitors, PD-L1 inhibitors, CTLA-4 inhibitors, and others. The PD-1 inhibitor segment leads the market due to its high efficacy in treating various cancers, such as non-small cell lung cancer, esophageal cancer, and melanoma, along with ongoing advancements in clinical trials and expanding indications for these therapies across global markets.

• For instance, in March 2024, BeiGene received U.S. Food and Drug Administration (FDA) approval for its PD-1 inhibitor TEVIMBRA (tislelizumab-jsgr) for the treatment of advanced/metastatic esophageal squamous cell carcinoma after prior treated with chemotherapy.

By application

The market is segmented into lung cancer, breast cancer, bladder cancer, melanoma, cervical cancer, colorectal cancer, Hodgkin lymphoma, and others. The lung cancer segment dominates the global market due to the high prevalence and mortality rates associated with the disease, making it a major focus for treatment advancements. Immune checkpoint inhibitors, particularly PD-1/PD-L1 inhibitors such as pembrolizumab and nivolumab, have demonstrated significant efficacy in improving survival rates for patients with non-small cell lung cancer (NSCLC).

Additionally, the increasing adoption of these therapies as a first-line treatment and the growing number of approvals for ICIs in various lung cancer subtypes further contribute to the segment's dominance.

• For example, in January 2023, Merck & Co., Inc., announced that the FDA has approved KEYTRUDA, its anti-PD-1 therapy, as an adjuvant treatment for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC) following surgery and platinum-based chemotherapy.

By indication

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment holds a dominant position in the market, primarily due to their essential role in administering complex cancer therapies like ICIs. Hospitals serve as the primary centers for cancer treatment, where ICIs are frequently prescribed and closely monitored by specialized healthcare professionals.

Moreover, hospital pharmacies are equipped to ensure the proper storage and handling of these biological drugs, which often require stringent conditions to maintain their efficacy. They also provide comprehensive patient support, including education on treatment protocols and management of side effects.

This combination of factors significantly enhances the market share of hospital pharmacies in the distribution of ICIs, solidifying their critical role in delivering effective cancer therapies.

Company Market Share

Key players in the immune checkpoint inhibitors market are pursuing strategic collaborations, acquisitions, and partnerships to enhance their product offerings and broaden their market reach.

Immutep Ltd: An emerging provider

Immutep Ltd is an emerging player in the market, known for its innovative LAG-3 immunotherapies, which target a novel checkpoint pathway, positioning the company as a key player in advancing next-generation cancer treatments.

Recent Development

• In September 2024, Immutep Ltd. announced topline results from the TACTI-003 Phase IIb trial evaluating eftilagimod alfa (efti) in combination with Merck & Co., Inc., anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC).

Recent Developments

• September 2024- BeiGene, Ltd. announced that the Israeli Ministry of Health has approved TEVIMBRA (tislelizumab) as a monotherapy for adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC) following prior systemic chemotherapy.