プログラム死リガンド1(PD-L1)非小細胞肺癌(NSCLC)治療薬の世界市場:インサイト・疫学・市場予測

◆英語タイトル:Programmed death-ligand 1 (PD-L1) Non-small Cell Lung Cancer (NSCLC)-Market Insights, Epidemiology and Market Forecast - 2030
◆商品コード:DELV20JU162
◆発行会社(リサーチ会社):DelveInsight
◆発行日:2020年5月
◆ページ数:200
◆レポート言語:英語
◆レポート形式:PDF
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【レポートの概要】

DelveInsight’s ‘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 DelveInsight 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.

Products detail in the report…

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.

Products detail in the report…

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 1β signaling, resulting in suppression of inflammation in patients with disorders of autoimmune origin.

Products detail in the report…

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.

Products detail in the report…

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.

Products detail in the report…

M7824 (Bintrafusp alfa): GlaxoSmithKline/Merck KGaA

M7824 (Bintrafusp alfa) is an investigational bifunctional immunotherapy that is designed to combine a TGF-β 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 DelveInsight, PD-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 2017 which 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.

【レポートの目次】

1. Key Insights

2. Executive Summary of PD-L1 NSCLC

3. SWOT Analysis of PD-L1 NSCLC

4. PD-L1 NSCLC: Market Overview at a Glance

4.1. Total Market Share (%) Distribution of PD-L1 NSCLC in 2017: By Country

4.2. Total Market Share (%) Distribution of PD-L1 NSCLC in 2030: By Country

5. PD-L1 Non-small Cell Lung Cancer (NSCLC): Disease Background and Overview

5.1. Introduction

5.1.1. Cellular Classification of NSCLC

5.1.2. Signs and Symptoms of NSCLC

5.1.3. Risk Factors of Lung Cancer

5.1.4. Causes of NSCLC

5.1.5. Disease Biology: NSCLC

6. Diagnosis of PD-L1 NSCLC

6.1. Diagnostic Algorithm for NSCLC

6.2. Stages of NSCLC

6.3. Staging System

7. Epidemiology and Patient Population

7.1. Epidemiology Key Findings

7.2. Assumptions and Rationale: 7MM

7.3. Epidemiology Scenario: 7MM

7.3.1. Total Incident cases of NSCLC patients in the 7MM

7.3.2. Total Incident cases of NSCLC patients by Histology in the 7MM

7.3.3. Total Diagnosed cases of NSCLC patients by Stages in the 7MM

7.4. The United States Epidemiology

7.4.1. Total Incident cases of NSCLC patients in the United States

7.4.2. Total Incident cases of NSCLC patients by Histology in the United States

7.4.3. Total Diagnosed cases of NSCLC patients by Stages in the United States

7.4.4. Total PD-L1 NSCLC cases in the United States

7.4.5. Total PD-L1 NSCLC Treated patient Pool in the United States

8. EU-5 Epidemiology

8.1. Germany

8.1.1. Total Incident cases of NSCLC patients in Germany

8.1.2. Total Incident cases of NSCLC patients by Histology in Germany

8.1.3. Total Diagnosed cases of NSCLC patients by Stages in Germany

8.1.4. Total PD-L1 NSCLC cases in Germany

8.1.5. Total PD-L1 NSCLC Treated patient Pool in Germany

8.2. France

8.2.1. Total Incident cases of NSCLC patients in France

8.2.2. Total Incident cases of NSCLC patients by Histology in France

8.2.3. Total Diagnosed cases of NSCLC patients by Stages in France

8.2.4. Total PD-L1 NSCLC cases in France

8.2.5. Total PD-L1 NSCLC Treated patient Pool in France

8.3. Italy

8.3.1. Total Incident cases of NSCLC patients in Italy

8.3.2. Total Incident cases of NSCLC patients by Histology in Italy

8.3.3. Total Diagnosed cases of NSCLC patients by Stages in Italy

8.3.4. Total PD-L1 NSCLC cases in Italy

8.3.5. Total PD-L1 NSCLC Treated patient Pool in Italy

8.4. Spain

8.4.1. Total Incident cases of NSCLC patients in Spain

8.4.2. Total Incident cases of NSCLC patients by Histology in Spain

8.4.3. Total Diagnosed cases of NSCLC patients by Stages in Spain

8.4.4. Total PD-L1 NSCLC cases in Spain

8.4.5. Total PD-L1 NSCLC Treated patient Pool in Spain

8.5. The United Kingdom

8.5.1. Total Incident cases of NSCLC patients in the United Kingdom

8.5.2. Total Incident cases of NSCLC patients by Histology in the United Kingdom

8.5.3. Total Diagnosed cases of NSCLC patients by Stages in the United Kingdom

8.5.4. Total PD-L1 NSCLC cases in the United Kingdom

8.5.5. Total PD-L1 NSCLC Treated patient Pool in the United Kingdom

9. Japan Epidemiology

9.1. Japan

9.1.1. Total Incident cases of NSCLC patients in Japan

9.1.2. Total Incident cases of NSCLC patients by Histology in Japan

9.1.3. Total Diagnosed cases of NSCLC patients by Stages in Japan

9.1.4. Total PD-L1 NSCLC cases in Japan

9.1.5. Total PD-L1 NSCLC Treated patient Pool in Japan

10. Current Treatment Practices: PD-L1 NSCLC

10.1. Advanced/Metastatic NSCLC Treatment Algorithm

10.2. Chemotherapy

10.3. Targeted Therapy

10.4. Immunotherapy

10.5. Surgery

10.6. Radiation Therapy

10.7. Stage-wise Treatment Options of NSCLC

11. Guideline of NSCLC

11.1. The National Comprehensive Cancer Network (NCCN) Clinical Guidelines: 2020

11.2. The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up

11.3. The Spanish Society of Medical Oncology (SEOM) Clinical Guidelines: 2018

11.4. The Japanese Lung Cancer Society Guideline for NSCLC, Stage IV: 2018

12. Unmet Needs of PD-L1 NSCLC

13. Key Endpoints in NSCLC Clinical Trials

14. Marketed Therapies

14.1. Key Cross

14.2. Imfinzi (Durvalumab): AstraZeneca

14.2.1. Product Description

14.2.2. Regulatory Milestones

14.2.3. Other Developmental Activities

14.2.4. Pivotal Clinical Trials

14.2.5. Ongoing Current Pipeline Activity

14.2.6. Safety and Efficacy of Ongoing Clinical Trials

14.3. Opdivo (Nivolumab): Bristol-Myers Squibb

14.3.1. Product Description

14.3.2. Regulatory Milestones

14.3.3. Other Developmental Activities

14.3.4. Pivotal Clinical Trials

14.3.5. Ongoing Current Pipeline Activity

14.4. Tecentriq (Atezolizumab): Genentech/Hoffmann-La Roche

14.4.1. Product Description

14.4.2. Regulatory Milestones

14.4.3. Other Developmental Activities

14.4.4. Pivotal Clinical Trials

14.4.5. Ongoing Current Pipeline Activity

14.5. Keytruda (Pembrolizumab): Merck

14.5.1. Product Description

14.5.2. Regulatory Milestones

14.5.3. Other Developmental Activities

14.5.4. Pivotal Clinical Trials

14.5.5. Ongoing Current Pipeline Activity

15. Emerging Therapies

15.1. Canakinumab (ACZ885): Novartis Pharmaceuticals

15.1.1. Product Description

15.1.2. Clinical Development

15.2. Avelumab (Bavencio): Merck KGaA and Pfizer

15.2.1. Product Description

15.2.2. Clinical Development

15.2.3. Safety and Efficacy

15.3. Libtayo (Cemiplimab): Regeneron Pharmaceuticals

15.3.1. Product Description

15.3.2. Clinical Development

15.3.3. Safety and Efficacy

15.4. M7824 (Bintrafusp alfa): GlaxoSmithKline/Merck KGaA

15.4.1. Product Description

15.4.2. Clinical Development

15.4.3. Safety and Efficacy

16. PD-L1Non-Small Cell Lung Cancer (NSCLC): Seven Major Market Analysis

16.1. Key Findings

16.2. Market Outlook: 7MM

17. PD-L1—Market Size

17.1. Total Market Size of PD-L1 NSCLC in the 7MM

17.2. Market Size of PD-L1 NSCLC by Therapeutic Class in the 7MM

17.3. United States Market Size

17.3.1. Total Market size of PD-L1 NSCLC in the United States

17.4. EU-5 Market Size

17.4.1. Germany Market Size

17.4.2. France Market Size

17.4.3. Italy Market Size

17.4.4. Spain Market Size

17.4.5. United Kingdom Market Size

17.5. Japan Market Size

17.5.1. Total Market size of PD-L1 NSCLC in Japan

18. Market Access and Reimbursement of PD-L1 NSCLC Therapies

19. Market Drivers of PD-L1 NSCLC

20. Market Barriers of PD-L1 NSCLC

21. Appendix

21.1. Bibliography

21.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

Table 1 Summary of Non-small-cell Lung Cancer (NSCLC) Market, Epidemiology, and Key Events (2017–2030)

Table 2 TNM Staging of NSCLC

Table 3 Total Incident cases of NSCLC patients in the 7MM (2017–2030)

Table 4 Total Incident cases of NSCLC patients by Histology in the 7MM (2017–2030)

Table 5 Total Diagnosed cases of NSCLC patients by Stages in the 7MM (2017–2030)

Table 6 Total Incident cases of NSCLC patients in the United States (2017–2030)

Table 7 Total Incident cases of NSCLC patients by Histology in the United States (2017–2030)

Table 8 Total Diagnosed cases of NSCLC patients by Stages in the United States (2017–2030)

Table 9 Total NSCLC cases of patients by Genetic mutation/Biomarkers in the United States (2017–2030)

Table 10 Total Incident cases of NSCLC patients in Germany (2017–2030)

Table 11 Total Incident cases of NSCLC patients by Histology in Germany (2017–2030)

Table 12 Total Diagnosed cases of NSCLC patients by Stages in Germany (2017–2030)

Table 13 Total NSCLC cases of patients by Genetic mutation/Biomarkers in Germany (2017–2030)

Table 14 Total Incident cases of NSCLC patients in France (2017–2030)

Table 15 Total Incident cases of NSCLC patients by Histology in France (2017–2030)

Table 16 Total Diagnosed cases of NSCLC patients by Stages in France (2017–2030)

Table 17 Total NSCLC cases of patients by Genetic mutation/Biomarkers in France (2017–2030)

Table 18 Total Incident cases of NSCLC patients in Italy (2017–2030)

Table 19 Total Incident cases of NSCLC patients by Histology in Italy (2017–2030)

Table 20 Total Diagnosed cases of NSCLC patients by Stages in Italy (2017–2030)

Table 21 Total NSCLC cases of patients by Genetic mutation/Biomarkers in Italy (2017–2030)

Table 22 Total Incident cases of NSCLC patients in Spain (2017–2030)

Table 23 Total Incident cases of NSCLC patients by Histology in Spain (2017–2030)

Table 24 Total Diagnosed cases of NSCLC patients by Stages in Spain (2017–2030)

Table 25 Total NSCLC cases of patients by Genetic mutation/Biomarkers in Spain (2017–2030)

Table 26 Total Incident cases of NSCLC patients in the United Kingdom (2017–2030)

Table 27 Total Incident cases of NSCLC patients by Histology in the United Kingdom (2017–2030)

Table 28 Total Diagnosed cases of NSCLC patients by Stages in the United Kingdom (2017–2030)

Table 29 Total NSCLC cases of patients by Genetic mutation/Biomarkers in the United Kingdom (2017–2030)

Table 30 Total Incident cases of NSCLC patients in Japan (2017–2030)

Table 31 Total Incident cases of NSCLC patients by Histology in Japan (2017–2030)

Table 32 Total Diagnosed cases of NSCLC patients by Stages in Japan (2017–2030)

Table 33 Total NSCLC cases of patients by Genetic mutation/Biomarkers in Japan (2017–2030)

Table 34 Standard Treatment Options of NSCLC (Stage-wise)

Table 35 Summary of Recommendations (SEOM Clinical Guideline)

Table 36 Strength of Evidence

Table 37 Strength of Evidence

Table 38 Marketed Drugs Key Cross

Table 39 Imfinzi (Durvalumab), Clinical Trial Description, 2020

Table 40 Opdivo (Nivolumab), Clinical Trial Description, 2020

Table 41 Tecentriq (Atezolizumab), Clinical Trial Description, 2020

Table 42 Keytruda (Pembrolizumab), Clinical Trial Description, 2020

Table 43 Canakinumab (ACZ885), Clinical Trial Description, 2020

Table 44 Avelumab, Clinical Trial Description, 2020

Table 45 Libtayo (cemiplimab) Clinical Trial Description, 2020

Table 46 M7824 (Bintrafusp alfa), Clinical Trial Description, 2020

Table 47 7MM Market Size of PD-L1 NSCLC, in USD Million (2017–2030)

Table 48 7MM Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 49 7MM Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 50 United States Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 51 United States Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 52 Germany Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 53 Germany Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 54 France Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 55 France Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 56 Italy Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 57 Italy Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 58 Spain Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 59 Spain Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 60 United Kingdom Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 61 United Kingdom Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 62 Japan Market Size of PD-L1 NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 63 Japan Market Size of PD-L1 NSCLC by therapies, in USD Million (2017–2030)

Table 64 National Institute for Health and Care Excellence (NICE) Decisions for NSCLC Therapies

Table 65 IQWiG Decisions for NSCLC Therapies

Table 66 Haute Autorité de santé (HAS) Decisions for NSCLC Therapies



List of Figures:

Figure 1 PD-L1 NSCLC SWOT Analysis

Figure 2 Major Types of NSCLC

Figure 3 Sign and Symptoms of NSCLC

Figure 4 Risks Factors of NSCLC

Figure 5 Alterations in Targetable Oncogenic Pathways in LUAD and LUSC

Figure 6 Schematic Illustration of the NSCLC Staging

Figure 7 Stage IA Lung Cancer

Figure 8 Stage IB Lung Cancer

Figure 9 Stage IIA Lung Cancer

Figure 10 Stage IIB Lung Cancer

Figure 11 Stage IIIA Lung Cancer

Figure 12 Stage IIIB Lung Cancer

Figure 13 Stage IVA Lung Cancer

Figure 14 Global Heat Map of Lung Cancer

Figure 15 Total Incident cases of NSCLC patients in the 7MM (2017–2030)

Figure 16 Total Incident cases of NSCLC patients by Histology in the 7MM (2017–2030)

Figure 17 Total Diagnosed cases of NSCLC patients by Stages in the 7MM (2017–2030)

Figure 18 Total Incident cases of NSCLC patients in the United States (2017–2030)

Figure 19 Total Incident cases of NSCLC patients by Histology in the United States (2017–2030)

Figure 20 Total Diagnosed cases of NSCLC patients by Stages in the United States (2017–2030)

Figure 21 Total Incident cases of PD-L1 NSCLC in the United States (2017–2030)

Figure 22 Total Incident cases of NSCLC patients in Germany (2017–2030)

Figure 23 Total Incident cases of NSCLC patients by Histology in Germany (2017–2030)

Figure 24 Total Diagnosed cases of NSCLC patients by Stages in Germany (2017–2030)

Figure 25 Total Incident cases of PD-L1 NSCLC in Germany (2017–2030)

Figure 26 Total Incident cases of NSCLC patients in France (2017–2030)

Figure 27 Total Incident cases of NSCLC patients by Histology in France (2017–2030)

Figure 28 Total Diagnosed cases of NSCLC patients by Stages in France (2017–2030)

Figure 29 Total Incident cases of PD-L1 NSCLC in France (2017–2030)

Figure 30 Total Incident cases of NSCLC patients in Italy (2017–2030)

Figure 31 Total Incident cases of NSCLC patients by Histology in Italy (2017–2030)

Figure 32 Total Diagnosed cases of NSCLC patients by Stages in Italy (2017–2030)

Figure 33 Total Incident cases of PD-L1 NSCLC in Italy (2017–2030)

Figure 34 Total Incident cases of NSCLC patients in Spain (2017–2030)

Figure 35 Total Incident cases of NSCLC patients by Histology in Spain (2017–2030)

Figure 36 Total Diagnosed cases of NSCLC patients by Stages in Spain (2017–2030)

Figure 37 Total Incident cases of PD-L1 NSCLC in Spain (2017–2030)

Figure 38 Total Incident cases of NSCLC patients in the United Kingdom (2017–2030)

Figure 39 Total Incident cases of NSCLC patients by Histology in the United Kingdom (2017–2030)

Figure 40 Total Diagnosed cases of NSCLC patients by Stages in the United Kingdom (2017–2030)

Figure 41 Total Incident cases of PD-L1 NSCLC in the United Kingdom (2017–2030)

Figure 42 Total Incident cases of NSCLC patients in Japan (2017–2030)

Figure 43 Total Incident cases of NSCLC patients by Histology in Japan (2017–2030)

Figure 44 Total Diagnosed cases of NSCLC patients by Stages in Japan (2017–2030)

Figure 45 Total Incident cases of PD-L1 NSCLC in Japan (2017–2030)

Figure 46 Advanced/Metastatic NSCLC Treatment Algorithm

Figure 47 Timeline Illustrating the Development of Targeted Therapies and Immunotherapy’s for the Treatment of NSCLC Over two decades

Figure 48 Immune Checkpoint Inhibitor

Figure 49 Unmet Needs

Figure 50 Market Size ofPD-L1 NSCLC in the 7MM Countries, in USD Million (2017–2030)

Figure 51 Market Size of PD-L1 NSCLC by Line of therapies in the 7MM, in USD Million (2017–2030)

Figure 52 Market Size ofPD-L1 NSCLC by Line of therapies in the 7MM, in USD Million (2017–2030)

Figure 53 Market Size ofPD-L1 NSCLC in the United States by Therapies, in USD Million (2017–2030)

Figure 54 Market Size ofPD-L1 NSCLC in Germany by Therapies, in USD Millions (2017–2030)

Figure 55 Market Size ofPD-L1 NSCLC in France by Therapies, in USD Millions (2017–2030)

Figure 56 Market Size ofPD-L1 NSCLC in Italy by Therapies, in USD Millions (2017–2030)

Figure 57 Market Size ofPD-L1 NSCLC in Spain by Therapies, in USD Millions (2017–2030)

Figure 58 Market Size of PD-L1 NSCLC in the United Kingdom by Therapies, in USD Millions (2017–2030)

Figure 59 Market Size of PD-L1 NSCLC in Japan, in USD Millions (2017–2030)

Figure 60 Market Drivers

Figure 61 Market Barriers

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