PD-1 and PD-L1 Inhibitors Market Report and Forecast 2025-2034

The global PD-1 and PD-L1 inhibitors market was valued at USD 54.90 Billion in 2024, driven by the incidence of cancer across the globe. The market is anticipated to grow at a CAGR of 16.10% during the forecast period of 2025-2034 to achieve a value of USD 244.28 Billion by 2034.

PD-1 and PD-L1 Inhibitors Market Overview

PD-1 and PD-L1 inhibitors are checkpoint inhibitors used to block the activity of PD-1 and PDL1 immune checkpoint proteins, commonly present on the surface of cells. These inhibitors play a pivotal role in offering immunotherapy to cancer patients. The interaction of these cell surface proteins is also engaged in the immune system suppression and occurs following infection to restrain the killing of bystander host cells and avoid autoimmune disease.

PD-1 and PD-L1 Inhibitors Market Growth Drivers

Rising Adoption of Immunotherapies and Regulatory Approvals to Drive Market Growth

The increasing prevalence of non-small cell lung cancer (NSCLC) and the growing emphasis on early-stage cancer treatment are key drivers of the market. For instance, in August 2024, results from the AEGEAN Phase III trial showed that an Imfinzi (durvalumab)-based regimen reduced the risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone. Following these findings, the U.S. FDA approved Imfinzi in combination with chemotherapy for adult patients with resectable early-stage (IIA-IIIB) NSCLC without EGFR mutations or ALK rearrangements. This approval is expected to strengthen market growth by expanding the use of PD-L1 inhibitors in early-stage cancer management, increasing demand for immunotherapies, and encouraging further research into combination regimens that improve patient outcomes.

Expanding Treatment Options to Impact PD-1 and PD-L1 Inhibitors Market Value

The demand for effective therapies in metastatic cancers and the expansion of immunotherapy indications are significant market growth drivers. For instance, in March 2024, BeiGene, Ltd announced that the U.S. FDA had approved TEVIMBRA (tislelizumab-jsgr) as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who had previously undergone systemic chemotherapy without a PD-(L)1 inhibitor. TEVIMBRA is set to launch in the U.S. in the second half of 2024, expanding treatment options for ESCC patients. This approval is expected to boost the PD-1 and PD-L1 inhibitors market by increasing accessibility to immunotherapies, driving competitive advancements, and encouraging pharmaceutical companies to invest in developing novel PD-1 and PD-L1 inhibitors across multiple oncology indications.

Global PD-1 and PD-L1 Inhibitors Market Trends

The market is witnessing several trends and developments to improve the current scenario. Some of the notable trends are as follows:

Liquid Biopsy Advancements to Drive Market Growth

In November 2023, Angle launched its Portrait PD-L1 test, a liquid biopsy diagnostic test that evaluates PD-L1 protein expression on circulating tumour cells (CTCs). This innovation enhances non-invasive biomarker detection, improving patient selection for PD-1 and PD-L1 inhibitors. The increasing adoption of liquid biopsies is expected to drive market growth by enabling precision oncology, expanding patient accessibility, and accelerating drug development. With liquid biopsy solutions gaining regulatory approvals and clinical acceptance, the market is poised for significant expansion in the coming years.

Adoption of Immunotherapy and mRNA-Based Innovations to Boost PD-1 and PD-L1 Inhibitors Market Demand

In October 2024, Merck and Moderna initiated INTerpath-009, a pivotal Phase 3 trial evaluating V940 (mRNA-4157) with KEYTRUDA for non-small cell lung cancer (NSCLC) patients. This study explores the synergy between PD-1 inhibitors and mRNA-based neoantigen therapies, advancing personalised immunotherapy. With global recruitment underway, this trend is expected to enhance treatment efficacy, drive investment in mRNA-immune checkpoint inhibitor combinations, and expand PD-1 inhibitor indications. The increasing focus on personalised immunotherapy is set to bolster market growth and redefine oncology treatment landscapes.

Surge in FDA Approvals to Expand PD-1 and PD-L1 Inhibitors Market Value

In December 2024, Checkpoint Therapeutics received FDA approval for UNLOXCYT (cosibelimab-ipdl), the first PD-L1 blocking antibody for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). Approved based on strong response rates in Study CK-301-101, this milestone expands PD-L1 inhibitors' clinical applications. The approval is expected to drive market expansion by increasing competition, boosting drug accessibility, and encouraging further research into PD-L1-targeted therapies for other solid tumours, strengthening the market landscape.

Subcutaneous Immunotherapy Advancements to Enhance PD-1 and PD-L1 Inhibitors Market Size

In December 2024, Bristol Myers Squibb secured FDA approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), a subcutaneous PD-1 inhibitor formulation for various solid tumours. Based on the Phase 3 CheckMate-67T trial, this approval enables a more convenient, non-inferior alternative to intravenous administration. The development of subcutaneous immunotherapies is expected to enhance patient compliance, reduce treatment burden, and expand the adoption of PD-1 inhibitors, driving market growth and accessibility in the forecast period.

PD-1 and PD-L1 Inhibitors Market Segmentation

PD-1 and PD-L1 Inhibitors Market Report and Forecast 2025-2034 offers a detailed analysis of the market based on the following segments:

Market Breakup by Type of Inhibitors

• PD-1 Inhibitors
• PD-L1 Inhibitors

Market Breakup by Application

• Hodgkin Lymphoma
• Melanoma
• Kidney Cancer
• Non-Small Cell Lung Cancer
• Others

Market Breakup by Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Market Breakup by Region

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

PD-1 and PD-L1 Inhibitors Market Share

PD-1 Inhibitors to Dominate the Segmentation by Type

PD-1 inhibitors are expected to hold the largest market share due to their widespread adoption across multiple cancer types and superior clinical efficacy. Leading drugs such as KEYTRUDA and Opdivo have demonstrated strong survival benefits, driving their demand. The increasing approvals of PD-1 inhibitors for new indications and their combination with emerging immunotherapies further strengthen their dominance. With ongoing clinical trials and expanding patient accessibility, the segment is set to propel market growth, supported by rising cancer incidence and advancements in personalised medicine during the forecast period.

Non-Small Cell Lung Cancer to Lead the PD-1 and PD-L1 Inhibitors Market Segmentation by Application

Non-small cell lung cancer (NSCLC) is poised to dominate the market due to the high global prevalence of lung cancer and the significant clinical success of PD-1 and PD-L1 inhibitors in this indication. According to Expert Market Research, the small cell lung cancer (SCLC) market is anticipated to grow at a CAGR of 8.3% during the forecast period of 2025-2034. Drugs like Imfinzi, KEYTRUDA, and Opdivo have become standard treatments for NSCLC, supported by robust clinical trials and regulatory approvals. Increasing adoption of immunotherapy in first-line treatment and advancements in biomarker-driven therapies will further drive market growth. With expanding research into combination therapies, the NSCLC segment is expected to contribute significantly to market expansion in the forecast period.

Hospital Pharmacies to Hold a Substantial PD-1 and PD-L1 Inhibitors Market Value for Segmentation by Distribution Channel

Hospital pharmacies are expected to maintain the largest market share due to the high administration of PD-1 and PD-L1 inhibitors in clinical settings. These immunotherapies are primarily used for cancer treatment, necessitating hospital-based infusion facilities. The growing number of oncology treatment centres and increasing hospital-based immunotherapy adoption further support this segment’s dominance. Additionally, streamlined distribution networks, hospital collaborations with pharmaceutical companies, and improved patient access to advanced therapies will continue to drive market growth. With the rising burden of cancer, hospital pharmacies are set to remain the primary distribution channel for PD-1 and PD-L1 inhibitors.

PD-1 and PD-L1 Inhibitors Market Analysis by Region

North America is poised to hold the largest market share, driven by strong regulatory support, high adoption of immunotherapies, and extensive clinical research. The United States leads in PD-1 and PD-L1 inhibitor approvals, with major pharmaceutical players continuously expanding their oncology pipelines. Recent FDA approvals, such as Imfinzi’s expanded indication, reinforce market dominance. Europe follows closely, supported by growing reimbursement policies and advancements in personalised medicine. Asia-Pacific is experiencing rapid growth due to increasing cancer prevalence and rising investments in biopharmaceutical innovation. Meanwhile, Latin America and the Middle East and Africa witness gradual adoption, hindered by limited healthcare access and regulatory challenges, though improving infrastructure is expected to enhance market penetration.

Leading Players in the PD-1 and PD-L1 Inhibitors Market

The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:

Bristol Myers Squibb

Bristol Myers Squibb, headquartered in New York, USA, was established in 1887. The company is a global biopharmaceutical leader, focusing on oncology, immunology, and cardiovascular diseases. It has a strong portfolio of immunotherapy drugs, including Opdivo (nivolumab), a key PD-1 inhibitor used in multiple cancer treatments. With a commitment to innovation, the company continues to expand its pipeline, integrating advanced biologics and personalised medicine approaches to enhance cancer treatment outcomes worldwide.

Merck & Co., Inc

Merck & Co., Inc., was founded in 1891 and is headquartered in Rahway, New Jersey, USA. It is a pioneer in immuno-oncology, with Keytruda (pembrolizumab) leading the PD-1 inhibitors market. The company’s oncology portfolio spans lung, melanoma, and other cancers, alongside a strong focus on vaccine and antiviral development. Merck’s ongoing research and strategic collaborations continue to strengthen its position in precision medicine and next-generation cancer treatments.

F. Hoffmann-La Roche Ltd

Roche, headquartered in Basel, Switzerland, was established in 1896 and is a global leader in pharmaceuticals and diagnostics. Its oncology division includes leading PD-L1 inhibitors like Tecentriq (atezolizumab), which has revolutionised cancer immunotherapy. Roche integrates advanced molecular diagnostics with its therapies, driving personalised medicine advancements. The company’s robust research pipeline and strategic collaborations reinforce its position as a key player in immuno-oncology, offering innovative solutions for cancer treatment across various tumour types.

AstraZeneca plc

AstraZeneca, founded in 1999 and headquartered in Cambridge, UK, is a global biopharmaceutical company with a strong focus on oncology. Its PD-L1 inhibitor, Imfinzi (durvalumab), has gained significant regulatory approvals for multiple cancer indications. The company’s research spans immunotherapy, targeted therapies, and combination treatments, enhancing survival outcomes in lung and other cancers. AstraZeneca’s dedication to precision medicine and extensive global clinical trials position it as a leading innovator in the PD-1 and PD-L1 inhibitors market.

Other key players in the market include Pfizer, Inc., Sanofi, Regeneron Pharmaceuticals, Inc., Novartis AG, Ottobock Healthcare and Jiangsu Hengrui Medicine Co., Ltd

Key Questions Answered in the PD-1 and PD-L1 Inhibitors Market

• What was the global PD-1 and PD-L1 inhibitors market value in 2024?
• What is the global PD-1 and PD-L1 inhibitors market forecast outlook for 2025-2034?
• What is market segmentation based on the type of inhibitors?
• What is market segmentation based on application?
• What is market segmentation based on distribution channels?
• What are the major factors aiding the global PD-1 and PD-L1 inhibitors market demand?
• How has the market performed so far and how is it anticipated to perform in the coming years?
• What are the market's major drivers, opportunities, and restraints?
• What are the major global PD-1 and PD-L1 inhibitors market trends?
• Which type of inhibitors will lead the market segment?
• Which application will lead the market segment?
• Which distribution channel will lead the market segment?
• Who are the key players involved in the global PD-1 and PD-L1 inhibitors market?
• What is the patent landscape of the market?
• What are the current unmet needs and challenges in the market?
• How are partnerships, collaborations, mergers, and acquisitions among the key market players shaping the market dynamics?​

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