In the increasingly crowded PD-(L)1 inhibitors market, KEYTRUDA maintains a dominant position, holding more than 50% market share in 2023 it is deeply entrenched with approval across 20 indications. Among the 10 approved drugs, early entrants OPDIVO and KEYTRUDA continue to command a major share of the market.
LAS VEGAS, July 2, 2024 /PRNewswire/ -- DelveInsight's PD-(L)1 Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging PD-(L)1 inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the PD-(L)1 Inhibitors Market Report
- According to DelveInsight's analysis, the market size of PD-(L)1 inhibitors in the 7MM was nearly USD 36 billion in 2023, and the largest market size was generated by the United States.
- In the competitive landscape of PD-1 inhibitors, KEYTRUDA dominates the US market, while OPDIVO leads in Japan.
- LIBTAYO is the market leader for non-melanoma skin cancers, such as cutaneous squamous cell carcinoma and basal cell carcinoma, and is expected to maintain its dominance in the coming years. TECENTRIQ holds the leading position in small-cell lung cancer.
- NSCLC is the leading indication for PD-(L)1 inhibitors in the 7MM with total incident cases of nearly ~200,000 in 2023, which is expected to increase by 2034 in the US.
- Leading PD-(L)1 inhibitor companies such as EQRx, CStone Pharmaceuticals, Pfizer, Novartis, Arcus Biosciences, Agenus, Tracon Pharmaceuticals, Shanghai Henlius Biotech, Incyte Corporation, and others are developing novel PD-(L)1 inhibitors that can be available in the PD-(L)1 inhibitors market in the coming years.
- The promising PD-(L)1 inhibitors in the pipeline include sugemalimab, sasanlimab, spartalizumab, zimberelimab, balstilimab, envafolimab, HLX10, INCB099280, and others.
- InApril 2024, Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) recommended approval of OPDIVO in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission will review the CHMP recommendation. The final EC decision is expected in June 2024.
- In March 2024, Chugai Pharmaceutical filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) for TECENTRIQ IV infusion 1,200 mg for an additional indication of alveolar soft part sarcoma.
Discover which therapies are expected to grab the major PD-(L)1 inhibitors market share @ PD-(L)1 Inhibitors Market Report
PD-(L)1 Inhibitors Overview
PD-(L)1 inhibitors are a class of immunotherapy drugs that have transformed the treatment landscape for various cancers. The "PD" stands for programmed death, and "L1" refers to its ligand, PD-L1. These inhibitors work by blocking the interaction between PD-1, a checkpoint protein on T cells, and PD-L1, a protein expressed in cancer cells and some immune cells. Under normal conditions, this interaction helps maintain immune homeostasis and prevent autoimmunity. However, many cancers exploit this pathway to evade immune detection by upregulating PD-L1, thereby "turning off" T cells and preventing them from attacking the tumor. By inhibiting this interaction, PD-(L)1 inhibitors reinvigorate T cells, allowing them to recognize and destroy cancer cells more effectively.
The advent of PD-(L)1 inhibitors has significantly improved the prognosis for patients with several types of cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and Hodgkin lymphoma. These inhibitors, such as KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab), have shown remarkable efficacy in clinical trials, leading to durable responses and prolonged survival in many patients who previously had limited treatment options. Despite their success, PD-(L)1 inhibitors are not universally effective, and some patients experience immune-related adverse events due to heightened immune activation. Ongoing research aims to refine these therapies, identify biomarkers for better patient selection, and combine them with other treatments to enhance their efficacy and manage their side effects more effectively.
PD-(L)1 Inhibitors Market Overview
In recent years, cancer immunotherapy has seen significant progress, with several treatments receiving FDA approval. The PD-(L)1 pathway, which allows tumors to evade the immune system, has emerged as a promising target for therapy. The creation of anti-PD-1 and anti-PD-L1 drugs has ushered in a new era of cancer treatment. Clinical trials have demonstrated promising results across various tumor types, and the medical community eagerly anticipates further findings from ongoing and completed studies.
PD-1 inhibitors are poised to become the top-selling drug class in the future. Immuno-oncology drugs, particularly those targeting PD-(L)1, have revolutionized cancer therapy across various tumor types and stages, from advanced to early stages. The widespread adoption of PD-(L)1 therapies is driven by their proven adaptability. They can be used alone or alongside targeted treatments like tyrosine kinase inhibitors, chemotherapy, or other immunotherapies. This adaptability has resulted in long-lasting tumor responses and enhanced survival rates, all while maintaining manageable side effects. The better safety profile of PD-(L)1 therapies compared to chemotherapy allows them to serve as a foundational treatment in many combination therapies.
Merck's KEYTRUDA led the way as the first PD-1 inhibitor approved in the United States in September 2014, initially for advanced melanoma. Currently, KEYTRUDA's expansion is fueled by growing global usage in earlier-stage cancers such as triple-negative breast cancer and renal cell carcinoma, along with NSCLC in the US, and sustained high demand for advanced cancers worldwide. Both OPDIVO + YERVOY and KEYTRUDA plus axitinib are now widely recognized as primary treatments for advanced renal cell carcinoma. OPDIVO has gained approval in combination with cisplatin and gemcitabine chemotherapies as a first-line treatment for unresectable or advanced urothelial carcinoma.
Learn more about the FDA-approved PD-(L)1 inhibitors @ PD-(L)1 Inhibitors
Pipeline PD-(L)1 Inhibitors and Key Companies
- Sugemalimab: EQRx/CStone Pharmaceuticals
- Sasanlimab: Pfizer
- Spartalizumab: Novartis
- Zimberelimab: Arcus Biosciences
- Balstilimab: Agenus
- Envafolimab: Tracon Pharmaceuticals
- HLX10: Shanghai Henlius Biotech
- INCB099280: Incyte Corporation
Discover more about PD-(L)1 inhibitor drugs in development @ PD-(L)1 Inhibitors Clinical Trials
PD-(L)1 Inhibitors Market Dynamics
The dynamics of the PD-(L)1 inhibitors market are expected to change in the coming years. PD-(L)1 inhibitors have demonstrated impressive efficacy across various lines of therapy, providing valuable options for patients at different stages of their cancer journey, with some achieving durable responses and prolonged survival outcomes. The approval of the IMFINZI + IMJUDO combination after 11 and a half years in the US, alongside other options like OPDIVO + YERVOY, expands treatment choices for NSCLC, liver cancer, and BTC.
There's potential for drugs synergizing with checkpoint inhibitors, offering a large market opportunity for next-generation immunotherapies. While certain inhibitors like KEYTRUDA dominate NSCLC, OPDIVO in melanoma and renal cancer, and TECENTRIQ in SCLC, emerging PD-(L)1 inhibitors could capture significant market shares in other indications.
However, several factors may hinder the growth of the PD-(L)1 inhibitor market. Geographical disparities in biomarker testing recommendations hinder consistent patient care and treatment decision-making, despite broad agreement on the importance of biomarker testing for patients with cancer, leading to variable uptake in clinical practice. The PD-(L)1 market faces challenges due to the growing complexity and competition from the increasing number of approved therapies and combinations, making it more difficult to navigate effectively.
Next-generation immunotherapies, like the TIGIT class, aimed to replicate the success of anti-PD-1 drugs in the NSCLC market but failed to show a significant impact, leaving conservative projections for TIGIT's potential in NSCLC. The expected entry of PD-1/PD-L1 biosimilars may erode market sales, and the pursuit of combination products could impact patient access to therapies.
PD-(L)1 Inhibitors Market Report Metrics | Details |
Study Period | 2020-2034 |
Coverage | 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. |
PD-(L)1 Inhibitors Market CAGR | 5 % |
PD-(L)1 Inhibitors Market Size in 2023 | USD 36 billion |
Key PD-(L)1 Inhibitors Companies | EQRX, CStone Pharmaceuticals, Pfizer, Novartis, Arcus Biosciences, Agenus, Tracon Pharmaceuticals, Shanghai Henlius Biotech, Incyte Corporation, and others |
Key Pipeline PD-(L)1 Inhibitors | Sugemalimab, Sasanlimab, Spartalizumab, Zimberelimab, Balstilimab, Envafolimab, HLX10, INCB099280, and others |
Scope of the PD-(L)1 Inhibitors Market Report
- Therapeutic Assessment: PD-(L)1 Inhibitors current marketed and emerging therapies
- PD-(L)1 Inhibitors Market Dynamics: Key Market Forecast Assumptions of Emerging PD-(L)1 Inhibitors Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, PD-(L)1 Inhibitors Market Access and Reimbursement
To know more about PD-(L)1 inhibitors treatment guidelines, visit @ PD-(L)1 Inhibitors Management
Table of Contents
1 | KEY INSIGHTS |
2 | REPORT INTRODUCTION |
3 | EXECUTIVE SUMMARY OF PD-(L)1 INHIBITORS |
4 | KEY EVENTS |
5 | EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY |
6 | PD-(L)1 INHIBITORS MARKET OVERVIEW AT A GLANCE IN THE 7MM |
6.1 | MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2020 |
6.2 | MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2034 |
7 | PD-(L)1 INHIBITORS BACKGROUND AND OVERVIEW |
7.1 | INTRODUCTION |
7.2 | TYPES OF CHECKPOINT INHIBITORS |
7.3 | POTENTIAL OF PD1/PD-L1 INHIBITORS IN THE TREATMENT OF DIFFERENT CANCER |
7.4 | PREDICTIVE BIOMARKERS |
7.5 | CLINICAL APPLICATIONS OF PD-(L)1 INHIBITORS |
8 | EPIDEMIOLOGY AND PATIENT POPULATION |
8.1 | ASSUMPTIONS AND RATIONALE: 7MM |
8.2 | TOTAL INCIDENT CASES OF SELECTED INDICATIONS FOR PD-(L)1 INHIBITORS IN THE 7MM |
9 | MARKETED DRUGS |
9.1 | KEY CROSS COMPETITION |
9.2 | TEVIMBRA (tislelizumab-jsgr): BEIGENE |
9.2.1 | Product Description |
9.2.2 | Regulatory Milestone |
9.2.3 | Pivotal Clinical Trial |
9.2.4 | Other Developmental Activities |
9.2.5 | Clinical Development |
9.2.5.1 | Clinical Trials Information |
9.2.6 | Safety and Efficacy |
9.3 | LOQTORZI (toripalimab): COHERUS BIOSCIENCES/SHANGHAI JUNSHI BIOSCIENCES |
9.3.1 | Product Description |
9.3.2 | Regulatory Milestone |
9.3.3 | Pivotal Clinical Trial |
9.3.4 | Other Developmental Activities |
9.3.5 | Clinical Development |
9.3.5.1 | Clinical Trials Information |
9.3.6 | Safety and Efficacy |
9.4 | ZYNYZ (retifanlimab-dlwr): INCYTE |
9.4.1 | Product Description |
9.4.2 | Regulatory Milestones |
9.4.3 | Pivotal Clinical Trial |
9.4.4 | Other Developmental Activities |
9.4.5 | Clinical Development |
9.4.5.1 | Clinical Trial Information |
9.4.6 | Safety and Efficacy |
9.5 | JEMPERLI (dostarlimab): GLAXOSMITHKLINE (GSK) |
9.5.1 | Product Description |
9.5.2 | Regulatory Milestone |
9.5.3 | Pivotal Clinical Trial |
9.5.4 | Other Developmental Activities |
9.5.5 | Clinical Development |
9.5.5.1 | Clinical Trials Information |
9.5.6 | Safety and Efficacy |
9.6 | LIBTAYO (cemiplimab-rwlc): REGENERON/SANOFI |
9.6.1 | Product Description |
9.6.2 | Regulatory Milestones |
9.6.3 | Pivotal Clinical Trial |
9.6.4 | Other Developmental Activities |
9.6.5 | Clinical Development |
9.6.5.1 | Clinical Trial Information |
9.6.6 | Safety and Efficacy |
9.7 | IMFINZI (durvalumab): ASTRAZENECA |
9.7.1 | Product Description |
9.7.2 | Regulatory Milestones |
9.7.3 | Pivotal Clinical Trial |
9.7.4 | Other Developmental Activities |
9.7.5 | Clinical Development |
9.7.5.1 | Clinical Trial Information |
9.7.6 | Safety and Efficacy |
9.8 | BAVENCIO (avelumab): MERCK |
9.8.1 | Product Description |
9.8.2 | Regulatory Milestone |
9.8.3 | Pivotal Clinical Trial |
9.8.4 | Other Developmental Activities |
9.8.5 | Clinical Development |
9.8.5.1 | Clinical Trials Information |
9.8.6 | Safety and Efficacy |
9.9 | TECENTRIQ (atezolizumab): GENENTECH/HOFFMANN-LA ROCHE |
9.9.1 | Product Description |
9.9.2 | Regulatory Milestone |
9.9.3 | Pivotal Clinical Trial |
9.9.4 | Other Developmental Activities |
9.9.5 | Clinical Development |
9.9.5.1 | Clinical Trials Information |
9.9.6 | Safety and Efficacy |
9.1 | OPDIVO (nivolumab): BRISTOL-MYERS SQUIBB AND ONO PHARMACEUTICAL |
9.10.1 | Product Description |
9.10.2 | Regulatory Milestone |
9.10.3 | Pivotal Clinical Trial |
9.10.4 | Other Developmental Activities |
9.10.5 | Clinical Development |
9.10.5.1 | Clinical Trials Information |
9.10.6 | Safety and Efficacy |
9.11 | KEYTRUDA (pembrolizumab): MERCK |
9.11.1 | Product Description |
9.11.2 | Regulatory Milestone |
9.11.3 | Pivotal Clinical Trial |
9.11.4 | Other Developmental Activities |
9.11.5 | Clinical Development |
9.11.5.1 | Clinical Trial Information |
9.11.6 | Safety and Efficacy |
10 | EMERGING DRUGS |
10.1 | KEY CROSS COMPETITION |
10.2 | SUGEMALIMAB (CS1001): EQRX/CSTONE PHARMACEUTICALS |
10.2.1 | Product Description |
10.2.2 | Other Developmental Activities |
10.2.3 | Clinical Development |
10.2.3.1 | Clinical Trials Information |
10.2.4 | Safety and Efficacy |
10.3 | SASANLIMAB: PFIZER |
10.3.1 | Product Description |
10.3.2 | Other Developmental Activities |
10.3.3 | Clinical Development |
10.3.3.1 | Clinical Trials Information |
10.3.4 | Safety and Efficacy |
10.4 | SPARTALIZUMAB: NOVARTIS |
10.4.1 | Product Description |
10.4.2 | Clinical Development |
10.4.2.1 | Clinical Trials Information |
10.4.3 | Safety and Efficacy |
10.5 | ZIMBERELIMAB: ARCUS BIOSCIENCES |
10.5.1 | Product Description |
10.5.2 | Other Developmental Activities |
10.5.3 | Clinical Development |
10.5.3.1 | Clinical Trials Information |
10.5.4 | Safety and Efficacy |
10.6 | BALSTILIMAB: AGENUS |
10.6.1 | Product Description |
10.6.2 | Other Developmental Activities |
10.6.3 | Clinical Development |
10.6.3.1 | Clinical Trial Information |
10.6.4 | Safety and Efficacy |
10.7 | ENVAFOLIMAB: TRACON PHARMACEUTICALS |
10.7.1 | Product Description |
10.7.2 | Other Developmental Activities |
10.7.3 | Clinical Development |
10.7.3.1 | Clinical Trial Information |
10.7.4 | Safety and Efficacy |
10.8 | HLX10: SHANGHAI HENLIUS BIOTECH |
10.8.1 | Product Description |
10.8.2 | Other Developmental Activities |
10.8.3 | Clinical Development |
10.8.3.1 | Clinical Trial Information |
10.8.4 | Safety and Efficacy |
10.9 | INCB099280: INCYTE CORPORATION |
10.9.1 | Product Description |
10.9.2 | Other Developmental Activities |
10.9.3 | Clinical Development |
10.9.3.1 | Clinical Trials Information |
10.9.4 | Safety and Efficacy |
11 | PD-(L)1 INHIBITORS: THE 7MM ANALYSIS |
11.1 | KEY FINDINGS |
11.2 | MARKET OUTLOOK |
11.3 | KEY MARKET FORECAST ASSUMPTIONS |
11.3.1 | Cost Assumptions and Rebates |
11.3.2 | Pricing Trends |
11.3.3 | Analogue Assessment |
11.3.4 | Launch Years and Therapy Uptake |
11.4 | TOTAL MARKET SIZE OF PD-(L)1 IN THE 7MM |
11.5 | INDICATION-WISE MARKET SIZE OF PD-(L)1 INHIBITORS IN THE 7MM |
11.6 | THERAPIES-WISE MARKET SIZE OF PD-(L)1 INHIBITORS IN THE 7MM |
11.7 | THE UNITED STATES MARKET SIZE |
11.7.1 | Indication-wise Market Size of PD-(L)1 Inhibitors in the United States |
11.7.2 | Therapies-wise Market Size of PD-(L)1 Inhibitors in the United States |
11.8 | EU4 AND THE UK MARKET SIZE |
11.8.1 | Indication-wise Market Size of PD-(L)1 Inhibitors in EU4 and the UK |
11.8.2 | Therapies-wise Market Size of PD-(L)1 Inhibitors in EU4 and the UK |
11.9 | JAPAN MARKET SIZE |
11.9.1 | Indication-wise Market Size of PD-(L)1 Inhibitors in Japan |
11.9.2 | Therapies-wise Market Size of PD-(L)1 Inhibitors in Japan |
12 | UNMET NEEDS |
13 | SWOT ANALYSIS |
14 | KOL VIEWS |
15 | MARKET ACCESS AND REIMBURSEMENT |
15.1 | UNITED STATES |
15.2 | CENTRE FOR MEDICARE & MEDICAID SERVICES (CMS) |
15.2.1 | The Inflation Reduction Act (IRA)-directed Medicare Price Negotiations |
15.3 | UK |
15.4 | GERMANY |
15.5 | FRANCE |
16 | APPENDIX |
16.1 | ABBREVIATIONS |
16.2 | BIBLIOGRAPHY |
16.3 | REPORT METHODOLOGY |
17 | DELVEINSIGHT CAPABILITIES |
18 | DISCLAIMER |
19 | ABOUT DELVEINSIGHT |
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