PD-(L)1 Inhibitors - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• 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.
• Clinical trials testing of PD-(L)1 inhibitors have tripled in the recent few years, with more than 4,400 clinical trials (more than 3,600 are ongoing). This growth has been led by combination trials; ~90% of the new trials started in 2020 are combination strategies.
• In the competitive landscape of PD-1 inhibitors, KEYTRUDA dominates the US market, while OPDIVO leads in Japan. Initially, OPDIVO was the first PD-1 inhibitor approved in Japan, securing its market leadership. Although KEYTRUDA briefly overtook OPDIVO. OPDIVO regained its top position 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.
• KEYTRUDA’s and OPDIVO (IV) patent is set to expire in the US in 2028. This expiration is expected to significantly affect the PD-(L)1 market, as KEYTRUDA and OPDIVO currently hold substantial market shares. With loss of patent exclusivity, PD-(L)1 market set witness decline, and emerging players, who are targeting limited indications, will struggle to fully replace the dominance of KEYTRUDA and OPDIVO in the near future, even if they achieve approvals across multiple indications.
• To tackle the biosimilar impact, Bristol Myers Squibb has already developed the subcutaneous formulation of OPDIVO and patent expire for SC formulation is in 2030.
• In April 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.
• Following the approvals of BAVENCIO and KEYTRUDA for Merkel cell carcinoma, ZYNYZ also received approval for this indication. With Merkel cell carcinoma patient population of approximately 3,000 cases in the US, ZYNYZ is expected to encounter strong competition from these established drugs, and is projected that ZYNYZ could achieve near to USD 50 million in sales by 2034.

This report delivers an in-depth analysis of PD-(L)1 inhibitors epidemiology, market, and clinical development understanding of PD-(L)1 inhibitors. In addition, this report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the PD-(L)1 inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

PD-(L)1 inhibitors market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted PD-(L)1 inhibitors market size from 2020 to 2034 in the 7MM. The report also covers current PD-(L)1 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

PD-(L)1 Inhibitors Understanding and Treatment Algorithm

PD-(L)1 Inhibitors Overview

Over the last decade, immune checkpoint inhibitors have revolutionized cancer care, offering patients an alternative to chemotherapy or targeted therapies and a chance at long-term remission across many tumor types. The first two immune checkpoint receptors for which clinically efficient inhibitors were successfully developed were the cytotoxic lymphocyte antigen-4 (CTLA-4) and the PD-1 receptor. Most solid tumors and a subset of hematologic malignancies benefit from using one or both drug classes. While immune checkpoint inhibitors were initially evaluated and approved for the treatment of metastatic cancers, their use has now expanded to include early-stage cancer in certain tumor types, such as triple-negative breast cancer or non-small-cell lung cancer. PD-1 is a checkpoint protein in T cells that acts as a type of “off switch” that helps keep the T cells from attacking other cells in the body, especially when it attaches to PD-(L)1 - a protein on some normal (and cancer) cells. Some cancer cells have large amounts of PD-(L)1, which helps them hide from an immune attack. Monoclonal antibodies that target either PD-1 or PD-(L)1 can block this binding and boost the immune response against cancer cells. Examples of drugs that target PD-1 include KEYTRUDA, OPDIVO, and LIBTAYO. Examples of drugs that target PD-(L)1 include TECENTRIQ, BAVENCIO, and IMFINZI. Both PD-1 and PD-(L)1 inhibitors help treat different types of cancer.

There are many emerging PD-(L)1 inhibitors entering clinical trials. The developing pipeline of immune checkpoint inhibitors may lead to improvements in efficacy and tolerability rates for PD-1 inhibition. Spartalizumab, sugemalimab, HLX10, INCB99280, balstilimab, envafolimab, and others are currently being investigated for various cancers, including advanced hepatocellular carcinoma, melanoma, urothelial carcinoma bladder, metastatic esophageal cancer, metastatic gastric cancer, NSCLC, and others.

PD-(L)1 Inhibitors Epidemiology

PD-(L)1 Inhibitors Drug Chapters

The drug chapter segment of the PD-(L)1 inhibitors report encloses a detailed analysis of PD-(L)1 inhibitors marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the PD-(L)1 inhibitors pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

KEYTRUDA (pembrolizumab): Merck

KEYTRUDA is a PD-1-blocking antibody. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-(L)1 and PD-(L)2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-(L)1. It is approved for multiple types of cancer. It was first approved by the FDA in September 2014 for advanced melanoma. Since then, it has received multiple approvals, and the latest FDA approval was in January 2024 as a treatment for patients with FIGO 2014 Stage III-IVA cervical cancer. In February 2024, Merck announced that the US FDA has accepted for priority review a new sBLA seeking approval for KEYTRUDA in combination with standard-of-care chemotherapy (carboplatin and paclitaxel), followed by KEYTRUDA as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.

IMFINZI (durvalumab): AstraZeneca

IMFINZI is a human monoclonal antibody that binds to PD-(L)1 and blocks the interaction of PD-L1 with PD 1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. It is approved in four indications, NSCLC, ES-SCLC, BTC, and HCC. The first FDA approval of IMFINZI was in February 2018 for patients with Stage III NSCLC. The company is expecting an FDA decision for IMFINZI as neoadjuvant therapy in the AEGEAN trial in the first half of 2024 for small-cell lung cancer, and the company is anticipating Phase III data readout of the NILE trial in first-line bladder cancer in the second half of 2024.

Emerging Drugs

Sugemalimab (CS1001): EQRx/CStone Pharmaceuticals

Sugemalimab (CS1001) is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the US-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs. The drug is currently in Phase III clinical trial for the treatment of patients with metastatic NSCLC, and extranodal NK/T-cell lymphoma. The company is anticipating an opinion from the CHMP to the MAA for the first-line treatment of Stage IV NSCLC in the EU in the first half of 2024, MAA approval in the second half of 2024, and the MAA approval for the first-line treatment of Stage IV NSCLC in the UK in the second half of 2024. In December 2023, CStone and the US FDA reached an agreement in a Type B consultation regarding the registration pathway for R/R ENKTL indication. The company will also discuss with the US FDA regarding registration pathways for gastric/gastroesophageal junction adenocarcinoma and ESCC indications in the future.

Sasanlimab: Pfizer

Sasanlimab is a humanized immunoglobulin G4 monoclonal antibody that binds to the programmed cell death (PD-1) receptor and blocks its interaction with PD-1 ligands. Sasanlimab blocks the interaction between PD-1 and PD-L1/-L2, thus releasing the PD-1 pathway-mediated inhibition of the immune response and leading to an antitumor immune response. Sasanlimab has been shown to induce T-cell proliferation and secretion of interferon-? and other pro-inflammatory cytokines in human-activated CD8+ T cells. Currently, the company is conducting a pivotal Phase III CREST study of sasanlimab in people with non-muscle invasive bladder cancer. The company anticipates data readout from the Phase III trial of sasanlimab for BCG-naïve, high-risk non-muscle invasive bladder cancer by the first half of 2025.

Drug Class Insights

Checkpoint inhibitors targeting PD-(L)1 have emerged as dominant forces in the immunotherapy landscape for cancer treatment, with ten PD-(L)1 inhibitors approved, comprising seven PD-1 and three PD-L1 inhibitors in the United States. Their efficacy has been notable across various solid tumors, with KEYTRUDA being a standout among these agents, approved for a remarkable twenty indications and holding a significant market presence for several years. However, recent concerns over adverse events have prompted a shift towards combination approaches aimed at enhancing both efficacy and safety. This strategy involves combining PD-(L)1 inhibitors with other checkpoint inhibitors such as CTLA-4, TIGIT, and LAG-3, as well as exploring novel targets like TROP-2. Despite their potential, immune checkpoint inhibitors face challenges including immune-related side effects and high costs, highlighting the critical need for reliable biomarkers to identify patients who would benefit most from these treatments.

PD-(L)1 Inhibitors Market Outlook

PD-1 inhibitors are expected to be the leading drug class in terms of sales in the future. Immuno-oncology agents, especially the PD-(L)1 class, have transformed cancer treatment across various tumor types and stages, from metastatic to early stage. The adoption of PD-(L)1 therapies has been driven by their proven versatility. They can be used as monotherapy or in combination with targeted agents like tyrosine kinase inhibitors, chemotherapy, or other immunotherapy agents. This versatility has led to durable tumor responses and improved survival benefits, all while maintaining acceptable toxicity profiles. The improved safety profile of PD-(L)1 therapies compared to chemotherapy allows them to be used as a backbone therapy in a wide range of combination regimens.

Immune checkpoint inhibitors, particularly PD-(L)1 inhibitors, have been a breakthrough in cancer treatment. However, the development of new targets beyond PD-(L)1 has faced challenges. TIGIT and TIM-3 were once promising new targets but have seen limited progress after experiencing high-profile failures. Despite this, both TIM-3 and TIGIT products are still in development. LAG-3 is another potential target. Apart from this Efti’s unique and differentiated approach as an MHC Class II agonist makes it an attractive target for combination therapies.

In the crowded PD-(L)1 landscape, differentiation is key to success. Companies must strive to be innovative and address areas where current therapies are sub-optimal. Being the first-in-class in new indications or addressing white space can also help companies stand out in this competitive environment. The emerging PD-(L)1 inhibitors include, spartalizumab (Novartis), sasanlimab (Pfizer), zimberelimab (Arcus Biosciences), sugemalimab (EQRx/CStone Pharmaceuticals), HLX10 (Shanghai Henlius Biotech), balstilimab (Agenus), and others.

• Among the 7MM, the United States captured the largest market size of PD-(L)1 inhibitors, with nearly USD 26 billion in 2023, which is projected to increase during the forecast period (2024-2034).
• Among EU4 and the UK, Germany captured the largest market size of PD-(L)1 inhibitors, followed by the UK in 2023.
• KEYTRUDA and OPDIVO currently hold the largest market size of PD-(L)1 inhibitors in the United States.
• Gastric cancer is more prevalent among the Asian population, resulting in OPDIVO capturing over 50% market share in Japan for this indication, surpassing other indications. Conversely, in the US and EU4 and the UK, OPDIVO's leading indications are NSCLC and melanoma.

PD-(L)1 Inhibitors Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

PD-(L)1 Inhibitors Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PD-(L)1 Inhibitors emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, Chief of Thoracic Service at the Memorial Sloan Kettering Cancer Center, Dermatologists at the Johns Hopkins Hospital, and Others.

The analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PD-L(1) inhibitors market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Market Access and Reimbursement

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present. The Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for certain high expenditures, qualifying single-source Medicare drugs without generic or biosimilar competition. Negotiations with participating manufacturers for the first group of 10 drugs selected for the first cycle of Medicare drug price negotiations began in 2023, with any negotiated maximum fair prices going into effect in 2026. In 2026-2028, it is estimated that Medicare will negotiate prices for 38 Medicare Part D drugs and 2 Part B drugs. KEYTRUDA and OPDIVO come under Part B drugs.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of PD-(L)1 inhibitors, explaining their causes, signs and symptoms, pathogenesis, and currently available therapies.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the PD-(L)1 inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM PD-(L)1 inhibitors market.

PD-(L)1 Inhibitors Report Insights

• Patient Population
• Therapeutic Approaches
• PD-(L)1 Inhibitors Pipeline Analysis
• PD-(L)1 Inhibitors Market Size and Trends
• Existing and future Market Opportunity

PD-(L)1 Inhibitors Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• PD-(L)1 Inhibitors Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

PD-(L)1 Inhibitors Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the PD-(L)1 inhibitors total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Which combination treatment approaches will have a significant impact on PD-(L)1 inhibitors drug treatment market size?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What will be the impact of KEYTRUDA’s and OPDIVO expected patent expiry?
• Which drug is going to be the largest contributor in market size in 2034?
• Which drug will dominate the NSCLC market in 2034 and how many companies are developing PD-(L)1 for the treatment of NSCLC?
• What are the pricing variations among different geographies for approved therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action are explored in combination with PD-(L)1?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• Which therapy is market leader in non-melanoma skin cancers?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the PD-(L)1 inhibitors Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Patient-based forecast model which uses bottom-up forecasting techniques is accepted as a gold standard in pharma forecasting.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.