Immune Checkpoint Inhibitors Market By Drug TypePD-1 Inhibitors, PD-L1 Inhibitors, CTLA-4 Inhibitors), 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, Others), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Immune Checkpoint Inhibitors Market accounted for USD 52.3 Billion in 2024 and is expected to reach USD 288.65 Billion by 2035, growing at a CAGR of around 16.8% between 2025 and 2035.  The checkpoint inhibitor market is one of the subsectors of the pharmaceutical industry that specializes in developing drugs to enhance the activity of the immune system in fighting cancer. It functions by blocking some proteins that would otherwise restrict an immune reaction, allowing the immune system to detect and fight cancer cells more effectively. Key players in the market are Bristol-Myers Squibb, Merck, and Roche, whose products treat different cancers, including melanoma and lung cancer. With the growth of cancer and research on new therapies-mostly combination treatments-it is proliferating. Overall, it's a significant area of innovation for cancer treatment.

Report Scope:

Market Dynamics

• Rising Cancer Prevalence Driving Demand for Immunotherapies

The steady increase in cancer cases globally has tremendously increased the demand for effective treatments, including immunotherapy like checkpoint inhibitors. The WHO states that, in 2020, cancer was attributed to about 10 million deaths, with new cases projected at 19.3 million that year. While other conventional treatments such as chemotherapy have had adverse effects on the patients, the employment of immunotherapy has been demonstrated to improve survival rates.

England Journal of Medicine report, states the survival of patients with advanced melanoma who had received pembrolizumab, also branded as Keytruda, to be approximately 34% at five years of survival. Secondly, investments in cancer studies, in particular over $6 billion in immunotherapy invested by NIH, confirm that its potential recognition has exponentially increased. Given these challenges, global health initiatives have underscored the need to have effective treatments that necessarily require the use of immunotherapy in this fight against cancer.

• Advancements in Research and Clinical Trials Boosting Market Growth

Research and clinical trials are constantly evolving, and this is primarily contributing to the growth of checkpoint inhibitors. In fact, according to ClinicalTrials.gov, with a clear surge in active clinical studies for immunotherapies, there were over 1,500 active studies specifically conducted on checkpoint inhibitors in 2022. This reflects the increasing interest in these therapies and their exploration of various types of cancers. The American Society of Clinical Oncology has proven that checkpoint inhibitors are now put under the test to determine their novel uses, such as cervical, pancreatic, and gastric cancer, hence, their market scope is increasing. These therapies have had expedited approvals by agencies like the FDA. There were over 20 new indications that were granted approval from 2015 through to 2021.

The NIH received its appropriations for $44.96 billion for 2021–2022. It also received $6.9 billion just to give to NCI to fund basic research and clinical trials. Median overall survival in patients with metastatic non-small cell lung cancer treated with nivolumab (Opdivo) was seen to be increased at 16.8 months. This mutualism between academics and big pharma makes innovative trials and combinatorial therapies more likely to occur. These advances, in themselves, form the necessary steps that fuel the ever-increasing application and efficacy of checkpoint inhibitors, thus sustaining the growth trajectory of the market.

• High Costs of Checkpoint Inhibitors Limiting Accessibility

The expense of checkpoint inhibitors significantly limits accessibility and uptake, thus becoming a barrier between patients and healthcare systems. Such therapies can cost more than $100,000 per patient per year, and drugs such as pembrolizumab (Keytruda) and nivolumab (Opdivo) can cost an average of $12,500 per month. A study published in the Journal of Clinical Oncology found that some 33% of cancer patients experience financial toxicity from these treatments because they are extremely pricey, forcing them to make tough choices on whether they continue therapy. According to the American Cancer Society, insurance plans typically charge extremely high copays or restrict coverage of these medications, making it not fiscally possible for up to around 20% of patients to continue treatment. Many, then, would end up taking inferior conventional therapies, where survival chances would be greatly affected.

The World Health Organization states that such financial barriers lead to huge disparities in access, especially in low- and middle-income countries, where checkpoint inhibitors may not be accessible. The cost of care is also focusing on the increasing expenses involved in cancer care, which translates to a tremendous financial burden on health systems and leaves less money to spend on other services. This challenge concerning costs must be positively addressed at the policy level and through better insurance provisions for equity to access these vital therapies for every client.

• Biomarker Identification and Validation Enhancing Treatment Outcomes and Market Potential

Biomarkers identification and validation represent an important opportunity for treatment outcome and market potential expansion for the therapy using checkpoint inhibitors. Biomarkers are useful for identifying patients who are likely to benefit from particular therapies. In turn, such optimizes treatment strategies. According to NCI, the application of biomarkers in oncology improves the outcomes of the patients by allowing more personalized treatment plans. For instance, a patient with very high expression of the biomarker for checkpoint inhibitors, PD-L1, tends to have a better response to pembrolizumab or Keytruda.

According to a study published by the Journal of Clinical Oncology, patients who have tumors with PD-L1 experienced a 44% response rate to pembrolizumab while those who had low expression had only 16%. Along with this, proper funding at all levels is also given to the importance of precision medicine, in 2023, the NIH committed around $1.5 billion to efforts into precision medicine. Therefore, the value it will bring to the treatment process goes hand in hand with "fueling market growth through increased investments and potential for closer collaboration between pharmaceutical companies and research institutions leading to the development of precise therapies for targeted patient groups."

• Innovations in Drug Delivery Systems Improving Patient Convenience and Adherence

Advancements in drug delivery systems have a huge scope for enhancing the patients' convenience and their adherence to checkpoint inhibitors. Some advanced methods of delivery include easier administration through subcutaneous injections and implantable devices that reduce the need to visit hospitals. According to the NIH, such innovations can improve patient compliance even further, even in a chronic condition like cancer, because the complexity of the regimens may be required. As reported by the Centers for Disease Control and Prevention (CDC), approximately 125,000 deaths annually in the United States are attributed to drug nonadherence and 33% to 69% of hospital admissions related to medications are due to poor adherence.

Published in the Journal of Clinical Oncology, it has been established that patients who receive subcutaneous formulation of cancer therapies have higher adherence and satisfaction rates than intravenous treatments. If the delivery is accessible to users, pharmaceutical companies will benefit through improvement in the treatment outcome and expansion of the market scope, thus making checkpoint inhibitors more accessible and integrating them into daily life more conveniently.

Industry Experts Opinion

“I think the ability to create new therapies that benefit more patients is here right now,”

• Philip D. Greenberg, MD at editor-in-chief of the AACR journal Cancer Immunology Research

"It's very clear we're seeing long-term survival. It's really changed things dramatically,"

• Dr. David Hogg, a melanoma specialist at Princess Margaret Cancer Centre.

Segment Analysis

Based on product type, The Immune Checkpoint Inhibitors Market is segmented into three subsegments like PD-1 inhibitors, PD-L1 inhibitors, and CTLA-4 inhibitors. PD-1 inhibitors include pembrolizumab known as Keytruda and nivolumab known as Opdivo. This former tends to block the PD-1 receptor, while the latter targets the ligand. CTLA-4 inhibitors include drugs like ipilimumab known as Yervoy. They inhibit another crucial immune checkpoint pathway, hence expanding treatment options for cancer.

Based on application, the Immune Checkpoint Inhibitors Market is classified into lung cancer, breast cancer, bladder cancer, melanoma, cervical cancer, Hodgkin lymphoma, colorectal cancer, and others. Each application highlights how checkpoint inhibitors enhance the immune response against specific tumors, with notable use in lung cancer and melanoma treatments.

Regional Analysis

North America with the U.S. being the key player in the Immune Checkpoint Inhibitors Market, driving through a sound healthcare infrastructure and significant investments in the study of cancer disease has marked the market in its approximate $17 billion value in the year 2022. The region has been poised by high incidence rates of lung and melanoma cancers. The National Cancer Institute reported 1.9 million new cases of cancer in the United States in 2022, while an estimated 609,000 cancer deaths stress the demand for better treatments. Many of the world's most known biotechnology and pharmaceutical companies are headquartered in the United States, and many more work toward developing new immunotherapies, over 20 checkpoint inhibitors have been FDA-approved for clinical use.

Favorable regulatory frameworks also speed up approval processes for novel therapies to market, thereby improving access for patients. Advanced healthcare facilities, increased awareness among doctors, and patients are other factors that help in increasing the uptake of checkpoint inhibitors. Ongoing research and development by academic collaborations with industry players ensure a steady stream of innovative products in the pipeline. This is one of the main reasons why North America continues to be the prime market for checkpoint inhibitors.

Asia-Pacific region is set to follow a steep growth curve in the Immune Checkpoint Inhibitors Market, based on the rising incidence of cancer and growth in healthcare infrastructure. Companies like China and Japan are heavily investing in research on oncology. High incidence of cancer in the country has also made China one of the largest markets for immunotherapy. In the China scenario, reported in 2021, the nation is said to account for close to 18% of all new cancer diagnoses. Such a surge has brought to the fore an urgent need for effective treatments of such patients. The drug regulatory landscape, too, is in a state of evolution as, for example, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) sets out actively to facilitate the approval of new therapies, including multiple checkpoint inhibitors.

Besides, increased cooperation between local biotechnology companies and international pharmaceutical corporations increases the inputs of research and development. Increased awareness and education of healthcare professionals in immunotherapy also propels the uptake of checkpoint inhibitors. This trend is poised to expand the market in Asia-Pacific considerably, providing an opportunity to address a critical need in the region: innovative cancer therapies.  

Competitive Landscape

The checkpoint inhibitors are highly having Amgen Inc., Novartis AG, Pfizer Inc., Boehringer Ingelheim GmbH, and Bristol-Myers Squibb Company. The company Amgen recently announced that it would collaborate with BeiGene in co-developing immunotherapy treatments to expand its presence in the oncology market. Novartis has also been active, enhancing its pipeline through the strategic acquisition of a biotech firm focused on immune modulation. Meanwhile, Pfizer and Merck formed a collaboration about researching combination therapies that apply their combined checkpoint inhibitors to enhance the therapeutic effects of treatments against various cancers. Collaboration is a characteristic indication of market dynamics through efforts by the companies to keep up and build and expand their portfolios of therapeutic offerings as cancer incidence grows and progresses through treatment.

Immune Checkpoint Inhibitors Market, Company Shares Analysis, 2024

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Recent Developments:

• In April 2024, ImmunityBio announced FDA approval of ANKTIVA®, a first-in-class IL-15 receptor agonist, for treating BCG-unresponsive non-muscle invasive bladder cancer. This approval marks a significant advancement in immunotherapy, offering a new treatment option for patients facing this challenging condition.
• In March 2024, the FDA approved nivolumab (Opdivo) with cisplatin and gemcitabine as a first-line treatment for unresectable or metastatic urothelial carcinoma, based on the Phase 3 CheckMate-901 trial results.

Report Coverage:

By Drug Type

• PD-1 Inhibitors
• PD-L1 Inhibitors
• CTLA-4 Inhibitors

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

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Sanofi
• F. Hoffmann-La Roche Ltd.
• Merck & Co.
• Bristol-Myers Squibb Company
• Eli Lilly and Company
• Regeneron Pharmaceuticals Inc.
• AstraZeneca PLC
• Shanghai Jhunsi Biosciences Ltd
• Immutep Ltd
• BeiGene Ltd
• GlaxoSmithKline PLC
• Amgen Inc.
• Novartis AG
• Pfizer Inc.
• Boehringer Ingelheim GmbH

Frequently Asked Questions (FAQs)