This “PD-1 and PD-L1 Inhibitors - Competitive landscape, 2025,” report provides comprehensive insights about 180+ companies and 200+ drugs in PD-1 and PD-L1 Inhibitors Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
PD-1 inhibitors block the PD-1 receptor, while PD-L1 inhibitors block the PD-L1 ligand, both effectively preventing the interaction that leads to immune suppression. This blockade allows T cells to recognize and destroy cancer cells more effectively, leading to improved outcomes in several types of cancer, including melanoma, non-small cell lung cancer, and renal cell carcinoma.
The mechanism of action of PD-1 and PD-L1 inhibitors revolves around blocking the inhibitory pathway that tumors use to evade the immune system. PD-1, a receptor on T cells, interacts with PD-L1, a ligand on tumor cells and other cells in the tumor microenvironment, to downregulate immune responses and promote immune tolerance.
PD-1 inhibitors, such as nivolumab and pembrolizumab, bind to the PD-1 receptor on T cells, while PD-L1 inhibitors, like atezolizumab and durvalumab, bind to the PD-L1 ligand on tumor cells. By blocking this interaction, these inhibitors prevent the "off" signal from being sent to T cells, thus enhancing T cell activation and proliferation. This reactivation of T cells enables them to recognize and destroy cancer cells more effectively, leading to improved anti-tumor immune responses. This blockade effectively disrupts the tumor's ability to hide from the immune system, restoring the immune system's capability to target and kill cancer cells. As a result, PD-1 and PD-L1 inhibitors have become critical components in the treatment of various cancers, demonstrating significant clinical benefits and improved patient outcomes.
The structure of PD-1 and PD-L1 inhibitors typically involves monoclonal antibodies designed to bind specifically to their targets. PD-1 inhibitors, such as nivolumab and pembrolizumab, are antibodies that bind to the PD-1 receptor on T cells, preventing its interaction with PD-L1. Similarly, PD-L1 inhibitors like atezolizumab and durvalumab are antibodies that bind to the PD-L1 ligand on tumor cells. These antibodies are large, Y-shaped proteins composed of two heavy chains and two light chains, featuring variable regions that recognize and attach to specific epitopes on PD-1 or PD-L1. This precise binding blocks the inhibitory signaling pathway, thereby reactivating T cell activity against cancer cells.
Keytruda has received approval for advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, microsatellite-instability-high cancer, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Small Cell Lung Cancer (SCLC), Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma and advanced urothelial bladder cancer.
In September 2014, US Food and Drug Administration (FDA) approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This includes patients with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Additionally, Jemperli is indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response.
Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist.
Currently, the drug is in the Phase III stage of its development for the treatment of Biliary cancer. The drug is also under development for the treatment of solid tumors, advanced or metastatic squamous or non-squamous non-small cell lung carcinoma, squamous or non-squamous non-small cell lung cancer and locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, cholangiocarcinoma and gallbladder cancer.
Incyte emphasizes precision medicine approaches, aiming to target disease mechanisms with greater specificity and efficacy. In addition to its in-house R&D capabilities, the company actively engages in strategic collaborations and licensing agreements to strengthen its portfolio and expand its global presence. Through continuous investment in science and innovation, Incyte strives to deliver meaningful therapeutic advances to patients worldwide.
Zelgen follows a vertically integrated model, encompassing drug discovery, clinical development, manufacturing, and commercialization within China’s rapidly evolving healthcare landscape. With a commitment to scientific innovation and patient-centric development, the company aims to advance therapies that improve outcomes and expand treatment options in China and potentially global markets.
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Geography Covered
- Global coverage
PD-1 and PD-L1 Inhibitors: Understanding
PD-1 and PD-L1 Inhibitors: Overview
PD-1 and PD-L1 inhibitors are classes of immunotherapy drugs designed to enhance the immune system's ability to fight cancer. The PD-1 receptor, found on the surface of T cells, and its ligand, PD-L1, present on tumor cells and some normal cells, play a crucial role in downregulating immune responses and promoting self-tolerance by suppressing T cell inflammatory activity. Cancer cells often exploit this pathway to evade immune detection.PD-1 inhibitors block the PD-1 receptor, while PD-L1 inhibitors block the PD-L1 ligand, both effectively preventing the interaction that leads to immune suppression. This blockade allows T cells to recognize and destroy cancer cells more effectively, leading to improved outcomes in several types of cancer, including melanoma, non-small cell lung cancer, and renal cell carcinoma.
The mechanism of action of PD-1 and PD-L1 inhibitors revolves around blocking the inhibitory pathway that tumors use to evade the immune system. PD-1, a receptor on T cells, interacts with PD-L1, a ligand on tumor cells and other cells in the tumor microenvironment, to downregulate immune responses and promote immune tolerance.
PD-1 inhibitors, such as nivolumab and pembrolizumab, bind to the PD-1 receptor on T cells, while PD-L1 inhibitors, like atezolizumab and durvalumab, bind to the PD-L1 ligand on tumor cells. By blocking this interaction, these inhibitors prevent the "off" signal from being sent to T cells, thus enhancing T cell activation and proliferation. This reactivation of T cells enables them to recognize and destroy cancer cells more effectively, leading to improved anti-tumor immune responses. This blockade effectively disrupts the tumor's ability to hide from the immune system, restoring the immune system's capability to target and kill cancer cells. As a result, PD-1 and PD-L1 inhibitors have become critical components in the treatment of various cancers, demonstrating significant clinical benefits and improved patient outcomes.
The structure of PD-1 and PD-L1 inhibitors typically involves monoclonal antibodies designed to bind specifically to their targets. PD-1 inhibitors, such as nivolumab and pembrolizumab, are antibodies that bind to the PD-1 receptor on T cells, preventing its interaction with PD-L1. Similarly, PD-L1 inhibitors like atezolizumab and durvalumab are antibodies that bind to the PD-L1 ligand on tumor cells. These antibodies are large, Y-shaped proteins composed of two heavy chains and two light chains, featuring variable regions that recognize and attach to specific epitopes on PD-1 or PD-L1. This precise binding blocks the inhibitory signaling pathway, thereby reactivating T cell activity against cancer cells.
Report Highlights
- In February 2025, Innovent Biologics announced that IBI363 had received its second Fast Track Designation (FTD) from the US Food and Drug Administration (FDA). This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.
- In February 2025, Shanghai Henlius Biotech announced that its PD-L1 antibody-drug conjugate (ADC), HLX43 had successfully completed the first patient dosing in a Phase II clinical trial.
- In January 2025, Pfizer announced positive topline results from its pivotal Phase III CREST trial evaluating sasanlimab in combination with Bacillus Calmette-Guérin (BCG). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement.
- In December 2024, AstraZeneca got approval from the Subject Expert Committee (SEC) functional under the Central Standard Control Organization (CDSCO) to conduct a Phase III clinical study of the anticancer drug Rilvegostomig (AZD2936) concentrate for solution for infusion, 50 mg/mL (750 mg/vial).
- In August 2024, the US Food and Drug Administration approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options.
PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)
1. Company Overview: Merck
Merck & Co., Inc., known as MSD outside the United States and Canada, is a global healthcare company headquartered in Rahway, New Jersey. The company is engaged in the research, development, manufacture, and marketing of a broad range of pharmaceutical products, vaccines, and animal health solutions. Merck is widely recognized for its contributions in oncology, particularly through its immunotherapy drug Keytruda, as well as for its efforts in infectious diseases, cardiometabolic conditions, and vaccines. With a strong commitment to scientific innovation and global health, Merck invests heavily in R&D and pursues strategic partnerships to address some of the world’s most pressing health challenges.Product Description: KEYTRUDA
Pembrolizumab is the active ingredient of Keytruda, which is a humanized monoclonal antibody that binds to the programmed cell death - 1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. Pembrolizumab is an IgG4 kappa immunoglobulin and has an approximate 149 kDa molecular weight.Keytruda has received approval for advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, microsatellite-instability-high cancer, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Small Cell Lung Cancer (SCLC), Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma and advanced urothelial bladder cancer.
In September 2014, US Food and Drug Administration (FDA) approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
2. Company Overview: GSK
GSK (GlaxoSmithKline) is a global biopharmaceutical company focused on developing innovative medicines and vaccines to improve health outcomes worldwide. With a strong presence in infectious diseases, HIV, oncology, immunology, and respiratory conditions, GSK leverages cutting-edge science and advanced technology to deliver transformative healthcare solutions. The company combines a robust R&D pipeline with strategic collaborations to address some of the world’s most pressing health challenges, aiming to positively impact the lives of billions of people.Product Description: JEMPERLI
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes.In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This includes patients with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.
Additionally, Jemperli is indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response.
Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist.
PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)
1. Company Overview: AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company headquartered in Cambridge, United Kingdom, specializing in the discovery, development, and commercialization of prescription medicines. The company focuses on three main therapy areas: oncology; cardiovascular, renal and metabolism (CVRM); and respiratory and immunology. AstraZeneca is also expanding its presence in rare diseases through its acquisition of Alexion Pharmaceuticals. With a strong commitment to innovation and sustainability, AstraZeneca invests significantly in R&D and leverages advanced technologies to accelerate drug development. The company operates in over 100 countries and aims to deliver life-changing medicines that improve patient outcomes globally.Product Description: Rilvegostomig
Rilvegostomig (AZD-2936) is a bi-specific antibody acts by targeting T cell immunoreceptor with Ig and ITIM domains (TIGIT) and programmed cell death protein 1 (PD1). It is derived from COM902 (anti-TIGIT antibody). It is administered through Intravenous route.Currently, the drug is in the Phase III stage of its development for the treatment of Biliary cancer. The drug is also under development for the treatment of solid tumors, advanced or metastatic squamous or non-squamous non-small cell lung carcinoma, squamous or non-squamous non-small cell lung cancer and locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, cholangiocarcinoma and gallbladder cancer.
2. Company Overview: Company Overview: Pfizer
Pfizer Inc. is a global biopharmaceutical company headquartered in New York City, dedicated to discovering, developing, and delivering innovative medicines and vaccines. The company has a broad portfolio spanning oncology, immunology, rare diseases, inflammation, internal medicine, and vaccines. Pfizer gained worldwide recognition for its role in developing one of the first mRNA-based COVID-19 vaccines in partnership with BioNTech. Committed to improving global health, Pfizer invests significantly in research and development and actively engages in collaborations to advance science and expand access to its therapies across diverse markets.Product Description: Sasanlimab
Sasanlimab is an investigational humanized IgG4 monoclonal antibody developed by Pfizer that targets programmed death-1 (PD-1), an immune checkpoint receptor expressed on T cells and other immune cells. By binding PD-1, sasanlimab blocks its interaction with PD-L1 and PD-L2, thereby restoring T-cell activation and enhancing anti-tumor immune responses. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Non-muscle Invasive Bladder Cancer.3. Company Overview: Incyte Corporation
Incyte Corporation is a biopharmaceutical company headquartered in Wilmington, Delaware, focused on the discovery, development, and commercialization of innovative therapeutics in oncology and inflammation. The company has established a diverse pipeline of small molecules and biologics, addressing both solid tumors and hematologic malignancies, as well as immune-mediated conditions.Incyte emphasizes precision medicine approaches, aiming to target disease mechanisms with greater specificity and efficacy. In addition to its in-house R&D capabilities, the company actively engages in strategic collaborations and licensing agreements to strengthen its portfolio and expand its global presence. Through continuous investment in science and innovation, Incyte strives to deliver meaningful therapeutic advances to patients worldwide.
Product Description: INCB 099280
INCB099280 is an orally administered small-molecule inhibitor of programmed cell death ligand 1 (PD-L1), developed by Incyte Corporation, designed to disrupt the PD-1/PD-L1 interaction, which is a key immune checkpoint pathway exploited by tumors to evade immune surveillance. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Cutaneous Squamous Cell Carcinoma.4. Company Overview: Suzhou Zelgen Biopharmaceuticals
Suzhou Zelgen Biopharmaceuticals is a China-based biopharmaceutical company focused on the research, development, and commercialization of innovative therapies across oncology, immunology, and hematology. The company integrates small molecules and biologics into its pipeline, targeting unmet medical needs with a focus on differentiated mechanisms of action.Zelgen follows a vertically integrated model, encompassing drug discovery, clinical development, manufacturing, and commercialization within China’s rapidly evolving healthcare landscape. With a commitment to scientific innovation and patient-centric development, the company aims to advance therapies that improve outcomes and expand treatment options in China and potentially global markets.
Product Description: ZG005
ZG005 is a bispecific monoclonal antibody developed by Suzhou Zelgen Biopharmaceuticals that targets both PD-1 and TIGIT immune checkpoints. This dual targeting aims to synergistically activate T cells and enhance the anti-tumor activity of natural killer (NK) cells, making it a promising immunotherapy for various solid tumors. ZG005 is currently being evaluated in Phase II for the treatment of Hepatocellular Carcinoma.5. Company Overview: ImmVira Pharma
ImmVira Pharma is a biotechnology company based in China that focuses on the development of next-generation oncolytic virus therapies for cancer treatment. The company leverages its proprietary OvPENS platform to design genetically engineered herpes simplex virus (HSV)-based therapies that selectively target and destroy tumor cells while stimulating anti-tumor immune responses. ImmVira’s pipeline includes candidates for a variety of solid tumors, including those with limited treatment options. By combining viral oncology with immunotherapy, the company aims to create potent, targeted therapies that enhance efficacy and safety in cancer care.Product Description: C5252
Leveraging ImmVira's OvPENS development platform, MVR-C5252 is designed specifically for the treatment of malignant glioma. This product has been further genetically engineered on the basis of MVR-T3011 (also known as T3011) by specific attenuation to achieve on-target malignant gliocyte killing while maintaining safety profile. MVR-C5252 also carries exogenous genes that express IL-12 and PD-1 mAb to promote the immune response of tumor microenvironment for further anti-tumor activity. C5252 is currently being evaluated in Phase I for the treatment of Glioblastoma.Further product details are provided in the report
PD-1 and PD-L1 Inhibitors Analytical Perspective
- In-depth Commercial Assessment: PD-1 and PD-L1 Inhibitors Collaboration Analysis by Companies
PD-1 and PD-L1 Inhibitors Competitive Landscape
The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).PD-1 and PD-L1 Inhibitors Report Assessment
- Company Analysis
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing PD-1 and PD-L1 Inhibitors drugs?
- How many PD-1 and PD-L1 Inhibitors drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of PD-1 and PD-L1 Inhibitors?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bispecific antibody therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Bispecific antibody and their status?
- What are the key designations that have been granted to the emerging and approved drugs?
Key Players
- GSK
- Roche
- Merck
- Pfizer
- CStone Pharmaceuticals
- Astrazeneca
- Incyte Corporation
- Agenus
- ImmVira Pharma
- Suzhou Zelgen Biopharmaceuticals
Key Products
- JEMPERLI
- TECENTRIQ
- KEYTRUDA
- Sasanlimab
- Sugemalimab
- Rilvegostomig
- INCB 099280
- Balstilimab
- C5252
- ZG005
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Table of Contents
IntroductionExecutive SummaryPD-1 and PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)PD-1 and PD-L1 Inhibitors- Unmet needsPD-1 and PD-L1 Inhibitors - Market drivers and barriersAppendix
PD-1 and PD-L1 Inhibitors: Overview
PD-1 and PD-L1 Inhibitors -Analytical Perspective: In-depth Commercial Assessment
Competitive Landscape
Therapeutic Assessment
Merck
KEYTRUDA
Late Stage Products (Phase III)
AstraZeneca
Rilvegostomig
Mid Stage Products (Phase II)
Suzhou Zelgen Biopharmaceuticals
ZG005
Early Stage Products (Phase I)
ImmVira Pharma
C5252
Preclinical and Discovery Stage Products
Company Name
Product Name
Inactive Products
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- GSK
- Roche
- Merck
- Pfizer
- CStone Pharmaceuticals
- Astrazeneca
- Incyte Corporation
- Agenus
- ImmVira Pharma
- Suzhou Zelgen Biopharmaceuticals
