PD-1 AND PD-L1 INHIBITOR MARKET ANALYSIS

Market Size and Trends

The PD-1 and PD-L1 inhibitor market is estimated to be valued at USD 52.51 Bn in 2024 and is expected to reach USD 170.01 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 18.3% from 2024 to 2031.

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The market is witnessing positive growth due to increasing demand for immunotherapies for treatment of various cancer types. PD-1 and PD-L1 inhibitors have demonstrated high efficacy in treatment of lung cancer, kidney cancer, melanoma and other cancers. These drugs have better side effect profile compared to conventional chemotherapy. Ongoing clinical trials evaluating efficacy of PD-1 and PD-L1 inhibitors for new cancer indications such as gastric cancer, cervical cancer and pancreatic cancer are also boosting the market. Moreover, approval of combination therapies of PD-1 and PD-L1 inhibitors with other immunotherapies is further driving the market growth. However, high cost of therapy is one of the factors hindering widespread adoption of PD-1 and PD-L1 inhibitors.

Increase in cancer incidence

The rise in incidence/prevalence of cancer across the globe is expected to boost growth of the global PD-1 and PD-L1 inhibitor market during the forecast period. For instance, PD-1/PD-L1 inhibitors are important immune checkpoint inhibitors (ICIs) used as front-line treatments for several types of cancer. According to the World Health Organization (WHO) February 2022 press release, cancer was one of the leading causes of death worldwide, accounting for around ten million deaths in 2020, or nearly one in six deaths. The most common cancers are breast, lung, colon and rectum and prostate cancers. Thus, there is an increase in demand for PD-1 and PD-L1 inhibitors worldwide.

Market Concentration and Competitive Landscape

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Growing geriatric population around the world is expected to augment growth of the global PD-1 and PD-L1 inhibitor market during the forecast period. For instance, according to the Union for International Cancer Control (UICC), elderly (people aged 65 years and more) are 11 times more likely to develop cancer, compared to younger people. According to the United Nations January 2023 press release, there are over 761 million people aged 65 or older in 2021, a number that is projected to reach 1.6 billion by 2050.

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The unsustainably high cost of cancer treatment is a major restraint on the growth of the PD-1 and PD-L1 inhibitor market. Cancer treatments have become exorbitantly expensive over the past few decades, to the point where they cause financial distress for many patients and their families . Healthcare systems and insurance companies around the world struggle with providing coverage and reimbursement for such expensive therapies. Many are unable to bear the brunt of the costs, leaving patients in the lurch.

Market Opportunities: Rise in the research and development activities

Rise in research and development activities are expected to offer significant growth opportunities for players in the PD-1 and PD-L1 inhibitor market. For instance, market players are increasingly investing in research and development activities to meet the increasing demand. Researchers at Johns Hopkins Kimmel Cancer Center are leading the way in developing novel immunotherapies called anti-PD-1 and anti-PD-L1 for people with advanced melanomas. The aim of the therapy is not to kill cancer cells directly, but to block a pathway that protects tumor cells from components of the immune system that are capable and ready to fight cancer.

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The type of inhibitor segment includes PD-1 Inhibitors and PD-L1 Inhibitors. PD-1 Inhibitors is anticipated to hold 61.8% of the market share in 2024 due to their versatility in treating various cancer types. By blocking the PD-1 receptor, these inhibitors help unleash the immune system’s attack on cancer cells. This targeted approach offers more precision than conventional treatments while reducing side effects like nausea, hair loss or organ damage from chemotherapy. A key factor driving the demand for PD-1 inhibitors is their approval for treating various cancers beyond their pioneering use in melanoma. FDA approvals for diseases like lung cancer, lymphoma and head & neck cancer have expanded the eligible patient population manifold. Developers are continually exploring new cancer candidates as well, holding promise to enlarge approved use in the future. Furthermore, early success rates from clinical trials have encouraged oncologists to prescribe PD-1 inhibitors as the first line of treatment in multiple settings.

Insights, By Cancer Type: Growing prevalence of lung cancer across the globe

The cancer type segment includes kidney, melanoma, bladder, non-small cell lung cancer, liver, head & neck, and others. Non-small cell lung cancer holds the highest share of the PD-1 and PD-L1 inhibitor market and is projected to hold 31.1% of the market share in 2024. This is primarily because lung cancer remains the leading cause of cancer-related deaths globally with a poor five-year survival rate of less than 20%. Most diagnoses still occur in advanced stages when surgical options are limited. However, immunosuppressive PD-1/PD-L1 inhibitors have shown promising results even in late-stage non-small cell lung cancer patients who failed previous treatments. They work by suppressing mechanisms enabling cancer to hide from immune surveillance. Post-approval studies continue to validate efficacy across histological subtypes as well as in biomarker-selected patient groups. This expands the addressable population for second- and third-line usage of such drugs.

Insights, By Distribution Channel: Convenience and Compliance drives hospital pharmacies growth

The distribution channel segment includes hospital pharmacies, retail pharmacies, online pharmacies. Hospital pharmacies accounts for the highest share of the PD-1 and PD-L1 inhibitor market and is projected to hold 39.2% of the market share in 2024. Hospital visits allow for integrated care where a dedicated oncology team closely monitors therapy progress and addresses any side effects promptly. Patients find this reassuring especially during initial doses when most adverse reactions occur. It also aids compliance as hospital staff can directly supervise administering intravenous medications on schedule. Moreover, hospital pharmacies are better equipped than retail setups to safely handle riskier substances like immunotherapies requiring refrigeration or preparation under sterile conditions. They facilitate direct billing of treatments to insurance, reducing co-pay hassles as well. The growing trend of hospitals providing cancer centers and infusions under one roof enhances this value proposition significantly.

Regional Insights

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North America dominates the global PD-1 and PD-L1 inhibitor market and is expected to continue its stronghold over the forecast period. North America is estimated to hold 43.8% of the market share in 2024 owing to a highly developed healthcare sector and large cancer patient pool in the region. Players in this region have extensively invested in R&D and are constantly launching innovative drug formulations with better efficacy and fewer side effects. This has resulted in rapid adoption of immune checkpoint inhibitors across various cancer indications in the country. Additionally, supportive regulatory guidelines and favorable reimbursement policies have encouraged pharmaceutical manufacturers to seek early market approvals for drug candidates. This has ensured high commercial availability and affordability of approved therapies, driving the regional market. Furthermore, higher per capita healthcare expenditure has empowered cancer patients to opt for premium treatment options like immune checkpoint inhibitors.

The Asia Pacific region has emerged as the fastest growing market for PD-1 and PD-L1 inhibitors globally. Rapid economic development, growing geriatric population susceptible to cancer and rising healthcare investments are some of the key factors propelling the Asia Pacific market. Nations like China, Japan and South Korea have well-established pharmaceutical industries that are investing heavily in innovation and manufacturing of biosimilars. This has made immune checkpoint therapies more affordable for local patients compared to imported brands.

Market Report Scope

Key Developments

• On February 07, 2024, Bristol Myers Squibb, a multinational pharmaceutical company, announced two regulatory approvals for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC)
• On January 25, 2024, LAVA Therapeutics N.V., a clinical-stage biotechnology company, announced that it had entered into a clinical trial collaboration and supply agreement with Merck, a multinational pharmaceutical company, to evaluate its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with LAVA-1207, a Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).
• On January 12, 2024, Merck announced that the U.S. Food and Drug Administration (FDA) had approved Merck's anti-PD-1 medication, KEYTRUDA, in combination with chemoradiotherapy (CRT), for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.
• On January 08, 2024, Medison Pharma, a global pharmaceutical company, announced that it had signed an exclusive multi-national agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., a leading biotechnology company, to commercialize Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in select European markets and other markets worldwide.

*Definition:The PD-1 and PD-L1 inhibitor market refers to drugs and therapies that target the immune checkpoint receptors PD-1 (programmed cell death protein 1) and PD-L1 (programmed death-ligand 1). These receptors, when activated, help cancer cells avoid detection and destruction by the immune system. PD-1 and PD-L1 inhibitors work by blocking these receptors and thereby helping the immune system recognize and attack cancer cells.

Market Segmentation

• Type of Inhibitor Insights (Revenue, USD BN, 2019 - 2031)
  • PD-1 Inhibitors 
  • PD-L1 Inhibitors
• Cancer Type Insights (Revenue, USD BN, 2019 - 2031)
  • Kidney
  • Melanoma
  • Bladder
  • Non-small Cell Lung Cancer
  • Liver
  • Head & Neck
  • Others
• Distribution Channel Insights (Revenue, USD BN, 2019 - 2031)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
    • Pradeep Tripathi
• Key Players Insights
  • Pfizer Inc.
  • Novartis AG
  • AstraZeneca PLC
  • Gilead Sciences Inc.
  • Amgen Inc.
  • Sanofi AG
  • F. Hoffmann-La Roche AG
  • Merck & Co.
  • Bristol-Myers Squibb Company
  • Regeneron Pharmaceuticals Inc.
  • Merck & Co.
  • GSK plc
  • Ono Pharmaceutical Co., Ltd.
  • Eli Lilly and Company
  • BeiGene LTD