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Programmed death-ligand 1 (PD-L1) Non-small Cell Lung Cancer (NSCLC)-Market Insights, Epidemiology and Market Forecast—2030

Programmed death-ligand 1 (PD-L1) Non-small Cell Lung Cancer (NSCLC)-Market Insights, Epidemiology and Market Forecast—2030

  • May 2020
  • 200 pages
  • ID: 5893096
  • Format: PDF
  • Delve Insight

Summary

Table of Contents

‘Programmed death-ligand 1 (PD-L1) Non-small Cell Lung Cancer (NSCLC)-Market Insights, Epidemiology and Market Forecast—2030’ report delivers an in-depth understanding of the PD-L1 NSCLC ,historical and forecasted epidemiology as well as the PD-L1 NSCLC market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
The PD-L1 NSCLC market report provides current treatment practices, emerging drugs, PD-L1 NSCLC market share of the individual therapies, current and forecasted PD-L1 NSCLC market size from 2017 to 2030 segmented by seven major markets. The Report also covers current PD-L1 NSCLC treatment practices/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain and the United Kingdom)
• Japan

Study Period: 2017–2030
PD-L1 NSCLC: Disease Understanding and Treatment Algorithm
PD-L1 NSCLC Overview
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer accounted for approximately 85% of all lung cancers. It 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. In these subtypes adenocarcinoma accounts for highest number of cases, i.e., approximately 47% followed by Squamous Cell Carcinoma and Large Cell Carcinoma.
There are several mutations associated with NSCLC but the most common are EGFR, KRAS, ROS-1, BRAF, MET, PD-L1 expression and others. Among all the mutations Programmed death ligand 1 (PD-L1), accounted for approximately 50% of the total cases of NSCLC.
PD-L1 (also known as CD274), is considered an immune checkpoint facilitating anti-tumor suppression of the immune pathway. The expression of PD-L1 is observed on the surface of macrophages, antigen-presenting cells, B and T-lymphocytes, epithelial, muscle and endothelial cells, whereas PD-1 receptor is expressed predominantly by activated cytotoxic T cells. PD-L1 ligand binds to PD-1 receptor on activated T cells and this connection results in suppression of the immune system. PD-L1 have become routinely part of the clinical approach for management of NSCLC where elevated levels of PD-L1 expression observed on the cell surface of cancer cells.

PD-L1 NSCLC Diagnosis
The diagnosis and staging of NSCLC are often done at the same time. A laboratory test is done to check for certain genes, proteins, or other molecules in a sample of tissue, blood, or other body fluid. Molecular tests check for certain gene or chromosome changes that occur in NSCLC.
PD-L1 NSCLC Treatment
PD-1/PD-L1 blocking antibodies therapy is recommended for the patients showing PD-L1 expressions. In recent years, immunotherapy has revolutionized and changed the standard of care in patients with NSCLC. Immune checkpoint inhibitors, fundamentally those that act by blocking PD-1 and its ligand, the PD-L1, have emerged as novel treatment strategies in NSCLC, demonstrating undoubted superiority over chemotherapy in terms of efficacy.
Several of these immune checkpoint modulators have recently gained regulatory approval for the treatment of advanced NSCLC, such as Opdivo (nivolumab), Tecentriq (atezolizumab), Keytruda (pembrolizumab, and recently, Imfinzi (durvalumab). Among all of the approved PD-1/PD-L1 inhibitors, the NSCLC therapy area is dominated by Keytruda (pembrolizumab), with revenues from this particular market helping the drug to achieve a hit status.
PD-L1 NSCLC Epidemiology
PD-L1 NSCLC Epidemiology division provides the insights about historical and current PD-L1 NSCLC patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings
The total NSCLC cases of patients by PD-L1 genetic biomarkers in the 7MM were observed to be 242,014 in 2017 which is expected grow during the study period, i.e., 2017–2030.
The disease epidemiology covered in the report provides historical as well as forecasted PD-L1 NSCLC Epidemiology[segmented as Total Incident Cases of NSCLC, Total Incident Cases of NSCLC Patients by Histology, Total Diagnosed Cases of NSCLC Patients by Stages, Total PD-L1-NSCLC Cases of Patients, and Treated PD-L1-NSCLC Patient Pool of NSCLC]scenario of PD-L1 NSCLC in the 7MM covering United States, EU5 countries (Germany, France, Italy , Spain, and United Kingdom), and Japan from 2017 to 2030.
Country Wise-PD-L1 NSCLC Epidemiology
Estimates show that the highest incident population of PD-L1 NSCLC is in the United States, estimated to be around 39% of the total PD-L1 in the 7MM (2017), followed by Japan, Germany, United Kingdom, France, Italy and Spain in 2017.
PD-L1 NSCLC Drug Chapters
Drug chapter segment of the PD-L1 NSCLC report encloses the detailed analysis of PD-L1 NSCLC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the PD-L1 NSCLC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
PD-L1 NSCLC Marketed Drugs
Keytruda (pembrolizumab): Merck
Keytruda is a PD-1 blocking antibody. It is mainly used for cancers that are advanced, have spread to other parts of the body or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high levels of a protein 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.
Keytruda is also approved as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ?1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda.
Imfinzi (Durvalumab): AstraZeneca
Imfinzi is a human monoclonal antibody that binds to PD-L1 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. This product is given by intravenous infusion is approved in unresectable, Stage III NSCLC after chemoradiation therapy in the US, Japan, across the EU and in many other countries, based on the Phase III PACIFIC trial.
Opdivo (Nivolumab): Bristol-Myers Squibb
Opdivo 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.
Products detail in the report…

PD-L1 NSCLC Emerging Drugs
Canakinumab (ACZ885): Novartis Pharmaceuticals
Canakinumab is a product of Novartis Pharmaceuticals. This product was approved by the US Food and Drug Administration (FDA) with brand name Ilaris for the treatment of cryopyrin-associated periodic syndromes, which is a group of rare auto-inflammatory disorders. At present this product is being investigated for the treatment of NSCLC.
Canakinumab is an injectable human monoclonal antibody intended to bind to human interleukin-1 beta (IL-1 beta). Its mode of action is based on the neutralization of 1? signaling, resulting in suppression of inflammation in patients with disorders of autoimmune origin.
Avelumab (Bavencio): Merck KGaA and Pfizer
Avelumab is a fully human monoclonal antibody developed by Merck and Pfizer as a pharmaceutical drug for use in immunotherapy, originally for the treatment of NSCLC. Avelumab targets the PD-L1.Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck (Germany), and Pfizer announced a strategic alliance to co-develop and co-commercialize Avelumab.
Libtayo (Cemiplimab): Regeneron Pharmaceuticals
Libtayo is a fully-human monoclonal antibody designed as an immune checkpoint inhibitor of the programmed cell death protein-1 (PD-1), prescribed as monotherapy and combination therapy in first-line patients with advanced NSCLC. This drug is currently in two phase III trial recruiting patients in first-line NSCLC.
M7824 (Bintrafusp alfa): GlaxoSmithKline/Merck KGaA
M7824 (Bintrafusp alfa) is an investigational bifunctional immunotherapy that is designed to combine a TGF-? trap with the anti-PD-L1 mechanism in one fusion protein, targeting both pathways aim to control tumor growth by potentially restoring and enhancing anti-tumor responses. This drug is currently in Phase I studies for solid tumors, as well as a randomized Phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC.
Products detail in the report…

PD-L1 NSCLC Market Outlook
Currently PD-1/PD-L1 blocking antibodies therapy is recommended for the patients showing PD-L1 expressions. In recent years, immunotherapy has revolutionized and changed the standard of care in patients with NSCLC. Immune checkpoint inhibitors, fundamentally those that act by blocking PD-1 and its ligand, the PD-L1, have emerged as novel treatment strategies in NSCLC, demonstrating undoubted superiority over chemotherapy in terms of efficacy.
Treatments for patients with advanced NSCLC are palliative, and thus intended to prolong survival and preserve quality of life for as long as possible, while minimizing the side effects due to treatment. Immune checkpoint inhibitors targeting either programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) have become routinely part of the clinical approach for management of NSCLC. Specifically, patients with PD-L1 expression ?50% are typically offered monotherapy with the anti-PD-1 antibody pembrolizumab, although some with rapidly progressing or very extensive disease may be treated with a platinum doublet chemotherapy plus pembrolizumab. For patients with PD-L1 expression <50%, the combination of a platinum-doublet chemotherapy and pembrolizumab is standard. Choice of chemotherapy, for those receiving it is mainly influenced by histology.
So, treatment approach of PD-L1 expressed NSCLC is mainly depend on the use of immune checkpoint inhibitors, but to increase the efficacy of the treatment several companies are developing combinational products for the treatment of PD-L NSCLC.

Key Findings
According to the analystPD-L1 NSCLC market in the 7MM is expected to change in the study period 2017–2030.The therapeutic market of PD-L1 NSCLC in seven major markets was found to be USD 6,536 million in 2017which is expected to increase during study period (2017–2030).

The United States Market Outlook
In 2017, the total market size of PD-L1 NSCLC therapies was found to be USD 3,714 million in the United States which is expected to increase in the study period (2017–2030).

EU-5 Countries: Market Outlook
In 2017, the total market size of PD-L1 NSCLC therapies was found to be USD 1,842 million in the EU-5 countries which is expected to increase in the study period (2017–2030).

Japan Market Outlook
The total market size of PD-L1 NSCLC therapies in Japan was found to be USD 980 million in 2017.

PD-L1 NSCLC Pipeline Development Activities

The drugs which are in pipeline include:
• Canakinumab (ACZ885) (Novartis Pharmaceuticals): Phase III
• Opdivo (nivolumab) ± Ipilimumab (Bristol-Myers Squibb):Phase III
• Imfinzi(durvalumab) ± Tremelimumab (AstraZeneca): Phase III
• M7824 (Bintrafusp alfa) (GlaxoSmithKline/Merck KGaA): Phase III
• Libtayo (Cemiplimab) (Regeneron Pharmaceuticals): Phase III
• Avelumab (Bavencio)(Merck KGaA and Pfizer): Phase III

Pipeline Development Activities
Key Points
• Bristol-Myers Squibb,Opdivo in combination withYervoy(ipilimumab) got Priority Review by the US FDA for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. The US FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020.
• Also, in April 2020, the US FDA granted Priority Review to the combination of Opdivo plus Yervoy with limited chemotherapy as a first-line treatment of patients with metastatic or NSCLC who have noEGFR orALKgenomic tumor aberrations. The Prescription Drug-Free User Act target action date is set as August 6, 2020, and the combination was granted Fast Track designation.
• AstraZeneca is also investigating this product ina broad development programin combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, and several other types of cancers.
• Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck (Germany), and Pfizer announced a strategic alliance to co-develop and co-commercialize Avelumab.

PD-L1 NSCLC Drugs Uptake
Keytruda is expected to major share from the overall market of PD-L1 NSCLC due to physician’s familiarities and established clinical profile. On the other hand, Opdivo is expected to take second highest share from the market due to its dominancy in second-line line setting.
Access and Reimbursement Scenario in PD-L1 NSCLC Therapies
As per the recommendation of some drugs by NICE which are approved for NSCLC, theaccess and reimbursement scenario for therapies in the UK are listed as

• In July 2018, Keytruda was recommended for, untreated PD L1-positive metastatic NSCLC in adults whose tumors express PD L1 (with at least a 50% tumor proportion score) and have no EGFR- or ALK-positive mutations.
• In January 2017, Keytruda is recommended for treating locally advanced or metastatic PD L1 positive NSCLC in adults who have had at least one chemotherapy (and targeted treatment if they have an EGFR- or ALK-positive tumor).
• In May 2019, Durvalumab is recommended for treating locally advanced unresectable NSCLC in adults whose tumors express PD L1 on at least 1% of tumor cells and whose disease has not progressed after platinum-based chemoradiation.
• It was stated by NICE that Atezolizumab +bevacizumab is recommended for metastatic NSCLC in adults who have not had treatment for their metastatic NSCLC before and whose PD-L1 tumor proportion score is between 0% and 49%.

KOL-Views
To keep up with current market trends, we take KOLs and SME’s opinion working in PD-L1 NSCLC domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PD-L1 NSCLC market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the PD-L1 NSCLC Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report
• The report covers the descriptive overview of PD-L1 NSCLC, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.
• Comprehensive insight has been provided into thePD-L1 NSCLC epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for PD-L1 NSCLC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of PD-L1 NSCLC market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global PD-L1 NSCLC market.

Report Highlights
• In the coming years, PD-L1 NSCLC market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence PD-L1 NSCLC R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for PD-L1 NSCLC. Launch of emerging therapies, will significantly impact the PD-L1 NSCLC market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for PD-L1 NSCLC.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
PD-L1 NSCLC Report Insights
• Patient Population
• Therapeutic Approaches
• PD-L1 NSCLC Pipeline Analysis
• PD-L1 NSCLC Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

PD-L1 NSCLC Report Key Strengths
• 11 Years Forecast
• 7MM Coverage

• PD-L1 NSCLC Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

• Drugs Uptake

PD-L1 NSCLC Report Assessment
• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Conjoint Analysis
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:
• What was the PD-L1 NSCLC Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the PD-L1 NSCLC total market Size as well as market size by therapies across the 7MM during the study period (2017–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest PD-L1 NSCLC market size during the study period (2017–2030)?
• At what CAGR, the PD-L1 NSCLC market is expected to grow in 7MM during the study period (2017–2030)?
• What would be thePD-L1 NSCLC market outlook across the 7MM during the study period (2017–2030)?
• What would be the PD-L1 NSCLC market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
• PD-L1 NSCLC patient types/ pool where unmet need is more and whether emerging therapieswill be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the PD-L1 NSCLC market?

Epidemiology Insights:
• What is the disease risk, burden and unmet needs of the PD-L1 NSCLC ?
• What is the historical PD-L1 NSCLC patient pool in seven major markets covering the United States, EU5 (Germany,France, Italy, Spain, and the United Kingdom), and Japan?
• What would be the forecasted patient pool of PD-L1 NSCLC in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to PD-L1 NSCLC ?
• Out of all the 7MM countries, which country would have the highest Incident population of PD-L1 NSCLC during the study period (2017–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2017–2030)?
• What are the various recent and upcoming events which are expected to improve the diagnosis of PD-L1 NSCLC ?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of PD-L1 NSCLC along with the approved therapy?
• What are the current treatment guidelines for the treatment of PD-L1 NSCLC in the US, Europe and Japan?
• What are the PD-L1 NSCLC marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of PD-L1 NSCLC ?
• How many therapies are developed by each company for the treatment of PD-L1 NSCLC ?
• How many emerging therapies are in mid stage, and late stage of development for the treatment of PD-L1 NSCLC ?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the PD-L1 NSCLC therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for PD-L1 NSCLC and their status?
• What are the key designations that have been granted for the emerging therapies for PD-L1 NSCLC ?
• What is the global historical and forecasted market of PD-L1 NSCLC ?

Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the PD-L1 NSCLC market.
To understand the future market competition in the PD-L1 NSCLC market and Insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for PD-L1 NSCLC in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for PD-L1 NSCLC market.
To understand the future market competition in the PD-L1 NSCLC market.

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