PD-1およびPD-L1阻害薬：競合情勢 (2025年)

当レポートは、180社以上、200種類以上のPD-1およびPD-L1阻害薬に関する包括的な洞察を提供しています。当レポートでは、製品タイプ、開発ステージ、投与経路、分子タイプ別に治療薬の評価を行っています。また、この分野における開発中止または非アクティブなパイプライン製品についても取り上げています。

当レポートでは、収載されている医薬品について、商業的評価を深く掘り下げており、コラボレーション、契約、ライセンス供与、買収に関する取引金額の動向も網羅されています。

レポートハイライト：

• 2025年2月、Innovent Biologicsは、IBI363が米国FDAより2回目のファストトラック指定 (FTD) を受けたことを発表しました。今回の指定は、抗PD-(L)1免疫チェックポイント阻害療法およびプラチナ製剤を用いた化学療法後に進行した切除不能な局所進行性または転移性扁平上皮非小細胞肺癌 (sqNSCLC) の治療を対象としています。
• 2025年2月、Shanghai Henlius Biotechは、同社のPD-L1抗体薬物複合体 (ADC) であるHLX43について、第II相臨床試験における初回被験者への投与を無事完了したことを発表しました。
• 2025年1月、Pfizerは、sasanlimabとBacillus Calmette-Guerin (BCG) の併用療法に関する重要な第III相CREST試験のトップライン結果が良好であったことを発表しました。本試験では、主要評価項目であるイベントフリー生存期間 (EFS) が治験責任医師の評価により達成され、臨床的に有意かつ統計的にも有意な改善が示されました。
• 2024年12月、AstraZenecaは、抗癌剤 Rilvegostomig (AZD2936) 注射液 (濃度50 mg/mL、750 mg/バイアル) に関する第III相臨床試験の実施について、インドの中央標準管理機構 (CDSCO) 傘下の専門委員会 (SEC) から承認を取得しました。
• 2024年8月、米国FDAはJemperli (dostarlimab) をカルボプラチンおよびパクリタキセルとの併用療法 (化学療法) に続き、Jemperli単剤療法を原発性進行・再発子宮内膜癌の成人患者に対する治療薬として承認しました。今回の承認により、従来のジェンペリ＋化学療法の適応が拡大され、子宮内膜癌と診断された患者の70～75％を占め、治療選択肢が限られているミスマッチ修復能 (MMRp) ／マイクロサテライト安定 (MSS) 腫瘍の患者にも適応が拡大されました。 2024年8月、米国FDAは、Jemperli (dostarlimab) を、carboplatinおよびpaclitaxel (化学療法) との併用、その後の単剤投与による一次進行性または再発性子宮内膜癌の成人患者の治療薬として承認しました。今回の承認により、Jemperliと化学療法の併用療法の適応は、ミスマッチ修復機能正常 (MMRp)/マイクロサテライト安定型 (MSS) 腫瘍を有する患者にも拡大されました。これらの患者は子宮内膜癌と診断される全体の約70～75%を占めており、治療選択肢が限られています。

企業および製品プロファイル：上市済み薬

1. Merck

2. GSK

企業および製品プロファイル：パイプライン薬

1. AstraZeneca

2. Pfizer

3. Incyte Corporation

4. Suzhou Zelgen Biopharmaceuticals

5. ImmVira Pharma

目次

イントロダクション

エグゼクティブサマリー

PD-1およびPD-L1阻害薬：概要

• 構造
• 作用機序
• プログラム細胞死1受容体
• 用途

PD-1およびPD-L1阻害薬 - 分析的視点：詳細な商業的評価

• PD-1およびPD-L1阻害薬の企業間連携分析

競合情勢

• 企業の比較評価 (治療法、開発ステージ、技術別)

治療評価

• 製品タイプ別
• ステージ・製品タイプ別
• 投与経路別
• ステージ・投与経路別
• 分子タイプ別
• ステージ・分子タイプ別

PD-1およびPD-L1阻害薬：企業および製品プロファイル：上市済み薬

Merck

• 企業概要

KEYTRUDA

• 製品説明
• 研究開発活動
• 製品開発活動

PD-1およびPD-L1阻害薬：企業および製品プロファイル：パイプライン薬

後期ステージの製品 (フェーズIII)

• 比較分析

AstraZeneca

• 企業概要

Rilvegostomig

• 製品説明
• 研究開発活動
• 製品開発活動

中期ステージの製品 (フェーズII)

• 比較分析

Suzhou Zelgen Biopharmaceuticals

• 企業概要

ZG005

• 製品説明
• 研究開発活動
• 製品開発活動

初期ステージの製品 (フェーズI)

• 比較分析

ImmVira Pharma

• 企業概要

C5252

• 製品説明
• 研究開発活動
• 製品開発活動

前臨床および探索ステージの製品

• 比較分析

企業名

• 企業概要

製品名

• 製品説明
• 研究開発活動
• 製品開発活動

非アクティブな製品

• 比較分析

PD-1およびPD-L1阻害薬：アンメットニーズ

PD-1およびPD-L1阻害薬：市場促進要因・阻害要因

List of Tables

• Table 1 Total Products for PD-1 and PD-L1 Inhibitors
• Table 2 Late Stage Products
• Table 3 Mid Stage Products
• Table 4 Early Stage Products
• Table 5 Pre-clinical & Discovery Stage Products
• Table 6 Assessment by Product Type
• Table 7 Assessment by Stage and Product Type
• Table 8 Assessment by Route of Administration
• Table 9 Assessment by Stage and Route of Administration
• Table 10 Assessment by Molecule Type
• Table 11 Assessment by Stage and Molecule Type
• Table 12 Inactive Products

List of Figures

• Figure 1 Total Products for PD-1 and PD-L1 Inhibitors
• Figure 2 Late Stage Products
• Figure 3 Mid Stage Products
• Figure 4 Early Stage Products
• Figure 5 Preclinical and Discovery Stage Products
• Figure 6 Assessment by Product Type
• Figure 7 Assessment by Stage and Product Type
• Figure 8 Assessment by Route of Administration
• Figure 9 Assessment by Stage and Route of Administration
• Figure 10 Assessment by Molecule Type
• Figure 11 Assessment by Stage and Molecule Type
• Figure 12 Inactive Products

DelveInsight's, "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.

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-Guerin (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.

PD-1 and PD-L1 Inhibitors Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: PD-1 and PD-L1 Inhibitors Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• 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

Table of Contents

Introduction

Executive Summary

PD-1 and PD-L1 Inhibitors: Overview

• Introduction
• Structure
• Mechanism of Action
• Programmed cell death 1 receptor
• Applications

PD-1 and PD-L1 Inhibitors -Analytical Perspective: In-depth Commercial Assessment

• PD-1 and PD-L1 Inhibitors Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

Merck

• Company Overview

KEYTRUDA

• Product Description
• Research and Development Activities
• Product Developmental Activities

PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

AstraZeneca

• Company Overview

Rilvegostomig

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Suzhou Zelgen Biopharmaceuticals

• Company Overview

ZG005

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

ImmVira Pharma

• Company Overview

C5252

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical and Discovery Stage Products

• Comparative Analysis

Company Name

• Company Overview

Product Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Inactive Products

• Comparative Analysis

PD-1 and PD-L1 Inhibitors- Unmet needs

PD-1 and PD-L1 Inhibitors - Market drivers and barriers