PD-L1 Metastatic Non-small Cell Lung Cancer Market

Key Highlights

• The total PD-L1 Metastatic Non-small Cell Lung Cancer market size in the 7MM for PD-L1 mNSCLC was estimated to be nearly USD 10,500 million in 2022, which is expected to show positive growth by 2032.
• In 2022, the US accounted for the maximum share of the total market in the 7MM, i.e., approximately 60%.
• PD-L1 therapies are mainly utilized in patients without genetic drivers. Merck’s KEYTRUDA is generally considered as the ‘gold standard’ of care in 1L NSCLC when combined with platinum chemotherapy, regardless of PD-1 status.
• Acquired resistance to these anti-PD-1/L1 therapies is a key issue. Given the high unmet need in this area, many companies are exploring novel molecules and combinations in second-line NSCLC post-IO.
• Novel antibody Drug Conjugates (ADCs) are also being explored for with and without biomarker selected subset of patients. ADCs are made to deliver anti-cancer therapies specifically to tumors that express a particular cell surface target. Despite the outstanding patient responses that conventional ADCs have produced, they have only been tested on patients who have the highest levels of target expression and a narrow number of targets. Although there is only one ADC approved for NSCLC, and it is only for a limited subgroup (HER2m NSCLC), companies are attempting to target a larger NSCLC population, particularly in areas where KEYTRUDA is the market leader.
• Targeting the non-actionable genomic aberration NSCLC market are DATO-Dxd and TRODELVY. DATO-DxD targets TROP2, not HER2-expressing malignancies, and uses half as many chemo agents and the same linker and payload as ENHERTU. Given Dato-DXd's advantage in treating NSCLC and its higher efficacy in early-stage studies, we anticipate that it could eventually surpass alternative therapy approaches presently being researched as the market's top TROP2 ADC for NSCLC.

DelveInsight’s “PD-L1 Metastatic Non-small Cell Lung Cancer– Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of PD-L1 mNSCLC, historical and forecasted epidemiology as well as PD-L1 mNSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PD-L1 mNSCLC market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM PD-L1 mNSCLC market size from 2019 to 2032. The report also covers current PD-L1 mNSCLC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

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

Study Period: 2019–2032

PD-L1 Metastatic Non-small Cell Lung Cancer Disease Understanding and Treatment Algorithm

PD-L1 Metastatic Non-small Cell Lung Cancer Overview

Lung cancer mainly begins in the lungs, and it may spread to lymph nodes or other organs in the body, such as the brain. However, cancer from other organs may also spread to the lungs. When cancer cells spread from one organ to another, they are called metastases.

There are mainly two types of lung cancer small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

NSCLC is the most common type of lung cancer accounted for approximately 85% of all lung. However, NSCLC metastasizes to other organs slower in comparison to SCLC, and microscopically, SCLC is composed of much smaller cells. If untreated, SCLC can be fatal in a few weeks, in contrast to most cases of NSCLC.

NSCLC can be defined as any type of epithelial lung cancer other than SCLC. It is mainly subcategorized into adenocarcinomas, squamous cell carcinomas, large cell carcinomas and several other types that occur less frequently include adenosquamous carcinomas, and sarcomatoid carcinomas.

The symptoms of NSCLC and SCLC can be similar, which may include a persistent cough, chest pain, shortness of breath, wheezing, loss of appetite, weight loss, and unusual tiredness.

The diagnosis and staging of NSCLC are often done at the same time. The tests and procedures used in the diagnosis of NSCLC are Physical Exam and History, Laboratory Tests, Molecular Test and others.

After the diagnosis of lung cancer, tests are done to find out if cancer cells have spread within the lungs or to other parts of the body. The process to find out the metastasis of cancer from the lungs to other parts of the body is known as staging, which is vital to plan the treatment method. There are IV stages of NSCLC.

The results of the standard treatment of NSCLC are poor except for the most localized cancers. The newly diagnosed patients with NSCLC are potential candidates for studies evaluating new forms of treatment. Immune checkpoint inhibitor therapy is a type of immunotherapy that is used in the treatment of NSCLC. PD-1 is a protein on the surface of T cells that helps keep the body’s immune responses in check. When PD-1 attaches to another protein called PD-L1 on a cancer cell, it stops the T cell from killing the cancer cell. PD-1 inhibitors attach to PD-L1 and allow the T cells to kill cancer cells. Nivolumab, pembrolizumab, atezolizumab, and durvalumab are types of immune checkpoint inhibitors.

Several PD-L1 are expected to enter the NSCLC market; however, given the physicians’ familiarity with the existing products on the market, we do not expect new entrants to disrupt the market significantly.

In the US, KEYTRUDA, OPDIVO, JEMPERLI, and LIBTAYO are the four main PD-1 players. Both KEYTRUDA and OPDIVO were introduced in 2014 and had a sizable time advantage over rival drugs. The year 2018 marked a 4-year delay in approving the third PD-1 LIBTAYO. KEYTRUDA and OPDIVO dominate the PD-1 market and, to some extent, compete with PD-L1.

PD-L1 Metastatic Non-small Cell Lung Cancer Diagnosis

The diagnosis and staging of PD-L1 NSCLC are often done at the same time. The tests and procedures used in the diagnosis of NSCLC are Physical Exam and History, Laboratory Tests, Chest X-ray, CT scan (CAT scan), Sputum Cytology, Thoracentesis, Fine-needle aspiration (FNA) biopsy of the Lung, Bronchoscopy and other techniques.

Further details related to diagnosis are provided in the report…

PD-L1 Metastatic Non-small Cell Lung Cancer Treatment

The results of the standard treatment of NSCLC are poor except for the most localized cancers. The newly diagnosed patients with NSCLC are potential candidates for studies evaluating new forms of treatment. There are different types of treatment available for NSCLC; however, mainly 10 types of standard treatment are used, which include: Surgery, Radiation therapy, Chemotherapy, Targeted therapy, Immunotherapy, Laser therapy, Photodynamic therapy (PDT), Cryosurgery, Electrocautery and Watchful waiting.

PD-1 is a protein on the surface of T cells that helps keep the body’s immune responses in check. When PD-1 attaches to another protein called PD-L1 on a cancer cell, it stops the T cell from killing the cancer cell. PD-1 inhibitors attach to PD-L1 and allow the T cells to kill cancer cells.

Nivolumab, pembrolizumab, atezolizumab, and durvalumab are types of immune checkpoint inhibitors.

Further details related to treatment are provided in the report…

PD-L1 Metastatic Non-small Cell Lung Cancer Epidemiology

The PD-L1 mNSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of NSCLC, Gender-specific Cases of NSCLC, Age-specific Cases of NSCLC, Total Incident Cases of NSCLC, Total Incident Cases of NSCLC by Stage, and Total Cases of NSCLC by Genetic Mutations/Biomarkers in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032.

• The total number of incident cases of NSCLC in the 7MM was nearly 526,800 cases in 2022 and are projected to increase during the forecasted period.
• The total number of incident cases of NSCLC in the United States was nearly 201,200 in 2022.
• The total number of cases in United states for PD-L1 NSCLC was estimated to be nearly 100,600 cases in 2022, which is expected to show positive growth by 2032.
• The total number of cases in EU4 and the UK for PD-L1 NSCLC was estimated to be nearly 102,200 cases in 2022.
• Among EU4 and the UK, the highest number of cases for PD-L1 NSCLC was found in Germany which was estimated to nearly 27,800 cases in 2022.
• The total number of cases in Japan for PD-L1 NSCLC was estimated to be nearly 59,900 cases in 2022

PD-L1 Metastatic Non-small Cell Lung Cancer Drug Chapters

The drug chapter segment of the PD-L1 mNSCLC report encloses a detailed analysis of the marketed and the late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as KEYTRUDA (MSD), OPDIVO (Bristol-Myers Squibb/Ono Pharmaceutical), TECENTRIQ (Genentech/Hoffmann-La Roche), LIBTAYO (Regeneron/Sanofi) and IMFINZI + IMJUDO (AstraZeneca). The drug chapter also helps understand the PD-L1 NSCLC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

KEYTRUDA (Pembrolizumab): MSD

Keytruda, also known as Pembrolizumab, is a PD-1 blocking antibody. It is mainly used for advanced cancers that have spread to other body parts or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-L1. This drug is also used to help prevent cancer from coming back after patients had surgery. It is approved for multiple types of cancer. In NSCLC, it is in combination with pemetrexed and platinum chemotherapy as first-line treatment of patients with metastatic non squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. Combining with carboplatin and either paclitaxel or paclitaxel protein-bound as first-line treatment of patients with metastatic squamous NSCLC.

In January 2023, Merck announced that the US FDA had approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with Stage IB (T2a =4 cm), II, or IIIA NSCLC.

OPDIVO (nivolumab): Bristol-Myers Squibb/Ono Pharmaceutical

Opdivo (Nivolumab) by Bristol-Myers Squibb is a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1, with immune checkpoint inhibitory and antineoplastic activities. It is a prescription medicine used to treat people with unresectable or metastatic melanoma, metastatic NSCLC, SCLC, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer and hepatocellular carcinoma

In March 2022, Bristol Myers Squibb announced that the US FDA approved Opdivo (nivolumab) 360 mg (injection for IV use) in combination with platinum-doublet chemotherapy every 3 weeks for three cycles for adult patients with resectable (tumors =4 cm or node-positive) NSCLC in the neoadjuvant setting.

Emerging Drugs

Sugemalimab (CS1001): EQRx/CStone

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.

In May 2023, CStone announced that they would regain rights for developing and commercializing sugemalimab outside Greater China upon terminating the license agreement for sugemalimab between CStone and EQRx. Upon transition completion, CStone will lead the regulatory process for sugemalimab MAA reviews by the EMA and the UK MHRA.

In December 2022, EQRx announced the acceptance of the Marketing Authorization Application by the UK’s Medicines and Healthcare Products Regulatory Agency for sugemalimab in metastatic NSCLC. The application was based on data from the pivotal Phase III GEMSTONE-302 trial assessing sugemalimab in combination with chemotherapy as first-line treatment of metastatic NSCLC.

In 2021, sugemalimab was granted the Innovation Passport designation in the UK through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations, including the MHRA. The ILAP was established in early 2021 to accelerate the development of and access to medicines in the UK.

Datopotamab Deruxtecan: Daiichi Sankyo/AstraZeneca

Datopotamab Deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Datopotamab Deruxtecan is one of five lead ADCs in the oncology pipeline of Daiichi Sankyo and one of the most advanced programs in AstraZeneca’s ADC scientific platform. In NSCLC, the TROPION-Lung07, TROPION-Lung08, and AVANZAR Phase III trials are evaluating Datopotamab Deruxtecan and immune checkpoint inhibitor combinations as potential first-line treatment options for patients with advanced or metastatic disease, a strategy informed by the results of two early trials. AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with Datopotamab Deruxtecan.

Datopotamab Deruxtecan is currently in Phase III clinical trials for NSCLC. Together with Daiichi Sankyo, AstraZeneca is accelerating Phase III trials in lung and breast cancers for TROP2-directed ADC, Datopotamab Deruxtecan, as monotherapy and in combinations following promising clinical data and strong tolerability profile

In January 2021, AstraZeneca and Daiichi Sankyo Company, Datopotamab Deruxtecan, and Enhertu (Trastuzumab Deruxtecan) showed encouraging results from both antibody–drug conjugates (ADCs) in patients with advanced or metastatic NSCLC. The data were presented in two oral presentations during the World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC)

In July 2020, AstraZeneca and Daiichi Sankyo entered a global collaboration to develop and commercialize Datopotamab Deruxtecan jointly, except in Japan, where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Datopotamab Deruxtecan.

Drug Class Insights

Since the last decade, there has been tremendous development for patients expressing PD-L1 tumors without mutation. The PD-L1 NSCLC current market is mainly dominated by classes such as Immune Checkpoint Inhibitors (ICI). KEYTRUDA and OPDIVO dominate the PD-1 market and, to some extent, compete with PD-L1. As per the latest findings, TROP-2-directed ADCs and LAG-3 inhibitors are doing quite well in this developmental space, while TIGIT seems to be struggling. Numerous high-profile TIGIT clinical studies have shown disappointing outcomes in NSCLC, which has hampered the advancement of TIGIT in this disease.

Note: Detailed insights will be provided in the final report.

PD-L1 Metastatic Non-small Cell Lung Cancer Market Outlook

Till the last decade, chemotherapy was used as the standard of care in the advanced and metastatic stages until the first ICI ‘KEYTRUDA (Pembrolizumab)’ got approved in 2015 as a second-line treatment option for such advanced patients; a similar path was followed by TECENTRIQ (Atezolizumab) who entered the market in 2016. These therapies entered the first-line domain after 2016 and expanded their labels by expanding the targetable pool. Recently, in 2020, OPDIVO (nivolumab) + ipilimumab was approved as a 1L treatment for patients with metastatic NSCLC. Chinese companies are trying to enter the US and EU market, especially the EU Market, where Tislelizumab and Sugemalimab currently under review. Tislelizumab's and Sugemalimab's developers have abandoned their filing plans in the United States. In the EU, these companies are trying for approval based on Chinese trials. The new area of development in NSCLC includes TROP-2-directed ADC’s, T cell immunoreceptors with Ig and ITIM domains (TIGIT), and LAG-3 inhibitors majorly being targeted by the researchers, and the big companies such as AstraZeneca, Daiichi Sankyo, Beigene, Hoffmann-La Roche, Gilead Sciences, and others have their potential candidates in late stages of development.

• The total market size in the US for PD-L1 mNSCLC was estimated to be nearly USD 5,900 million in 2022, which is expected to increase due to the launch of emerging therapies and label expansion of current therapies.
• The development of TIGIT class in NSCLC has been hampered by the fact that several high-profile TIGIT clinical studies have revealed underwhelming results. Effective combinations to augment current ICIs have historically been challenging as seen with Merck's and Roche's recent anti-TIGIT/PD-1 disappointment.
• In 2022, KEYTRUDA captured the highest market size of approximately USD 800 million in Japan.
• With the top-selling drugs KEYTRUDA and OPDIVO each earning USD 20.9 billion and USD 8.2 billion in global sales in 2022, the anti-PD-1 drug class has grown to become one of the best-selling drug classes in the history.
• Front-line NSCLC represents a large market, currently only being dominated by anti-PD1 drugs and anti-PD-1 + CTx combination, leaving a significant opportunity for therapy beyond anti-PD1 to deliver higher clinical benefit.

PD-L1 Metastatic Non-small Cell Lung Cancer Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019–2032. The landscape of PD-L1 NSCLC treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

In the emerging therapies, given Dato-DXd's advantage in treating NSCLC and its higher efficacy in early-stage studies, it is expected that this drug could eventually surpass alternative therapy approaches presently being researched as the market's top TROP2 ADC for NSCLC. Dato-DXd is expected to capture a market size of approximately USD 1,360 million by 2032 in the United States.

Further detailed analysis of emerging therapies drug uptake in the report…

PD-L1 Metastatic Non-small Cell Lung Cancer Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I. 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-L1 NSCLC emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on PD-L1 NSCLC evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

Delveinsight’s analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD, The University of Texas MD Anderson Cancer Center, MD, Duke Cancer Institute at Duke University, PhD, MD, MPH, Dana-Farber Brigham Cancer Center, Michigan State University, Director, Massachusetts General Hospital etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PD-L1 NSCLC market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

The current scenario of therapeutics for NSCLC is mainly based on the use of targeted therapies and immunotherapy. The current paradigm is mainly associated with treatment specific to mutations that occur in NSCLC.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of PD-L1 NSCLC, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the PD-L1 NSCLC 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 shape and drive the 7MM PD-L1 NSCLC market.

PD-L1 Metastatic Non-small Cell Lung Cancer Report Insights

• Patient Population
• Therapeutic Approaches
• PD-L1 NSCLC Pipeline Analysis
• PD-L1 NSCLC Market Size and Trends
• Existing and Future Market Opportunity

PD-L1 Metastatic Non-small Cell Lung Cancer Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• PD-L1 NSCLC Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

PD-L1 Metastatic Non-small Cell Lung Cancer Report Assessment

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

FAQs

• What was the PD-L1 mNSCLC market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2032? What are the contributing factors for this growth?
• What will be the impact of Sugemalimab having its expected approval in 2023?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of PD-L1 mNSCLC?
• What will be the impact on the sales of KEYTRUDA after its patent expiry?
• What are the disease risk, burdens, and unmet needs of PD-L1 NSCLC? What will be the growth opportunities across the 7MM concerning the patient population with PD-L1 NSCLC?
• Who is the major competitor of OPDIVO in the market?
• What are the current options for the treatment of PD-L1 NSCLC? What are the current guidelines for treating PD-L1 NSCLC in the US, Europe, and Japan?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the PD-L1 mNSCLC market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunity 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.
• 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 Analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.