Epidermal Growth Factor Receptor Non Small Cell Lung Cancer Market

DelveInsight’s ‘Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)-Market Insights, Epidemiology and Market Forecast—2030’ report delivers an in-depth understanding of the EGFR NSCLC, historical and forecasted epidemiology as well as the EGFR NSCLC market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.


The EGFR-NSCLC market report provides current treatment practices, emerging drugs, EGFR-NSCLC market share of the individual therapies, current and forecasted EGFR-NSCLC market size from 2017 to 2030 segmented by seven major markets. The Report also covers current EGFR-NSCLC treatment practice/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


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC): Disease Understanding and Treatment Algorithm


Epidermal Growth Factor Receptor-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 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. Among these, Adenocarcinoma accounts for highest number of cases, i.e., approximately 47% followed by Squamous Cell Carcinoma and Large Cell Carcinoma.


There are several genetic mutations identified to play a major role in the progression of this indication. Mutations in EGFR, KRAS, and ALK are mutually exclusive in patients with NSCLC, and the presence of one mutation instead of another can influence response to targeted therapy.


Epidermal Growth Factor Receptor (EGFR)—the most well-established driver mutation in NSCLC—is a cell signaling, trans-membrane protein intimately involved in proliferation. Mutations occur in the kinase region and lead to unregulated phosphorylation and activation of cell survival/proliferation pathways. There are multiple therapies approved by the regulatory authorities that work against this mutation. A large proportion of NSCLC patients have sensitizing mutations in exon 19 or 21 which activate the tyrosine kinase domain in EGFR. As per the secondary domain, it has been observed that mutations in EGFR are found more frequently in patients with adenocarcinomas, nonsmokers, patients of Asian ethnicity. It has been observed that EGFR mutation occurs in 35% cases of NSCLC in Japan, whereas in the United States it is around 20% of NSCLC cases.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Diagnosis


Since the finding of EGFR mutations, several diagnostic tests have been developed to assay for these genomic alterations. As advancement in this field had culminated in the expansion of multiple highly sophisticated genomic sequencing technologies, it is imperative to have a firm understanding of the various options and the institutional guidelines available in selecting the appropriate tests.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Treatment


There are several treatment options available to treat this condition in the seven major markets. Typically, chemotherapy, targeted treatments, and immunotherapy—alone or in combination—are used to treat lung cancer. Besides, pharmacological treatment choices, surgery, and radiation are also frequently opted. When the patient is in the initial stages, the tumor is usually resectable. Most stage I and stage II NSCLC are treated with surgery to remove the tumor. Giotrif/Gilotrif (afatinib), Tagrisso (Osimertinib), and several other approved therapies are recommended for the treatment of EGFR-NSCLC.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Epidemiology


The EGFR-NSCLC epidemiology division provide the insights about historical and current EGFR-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 Incident cases of EGFR-NSCLC in the 7MM were found to be 1,11,060 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 EGFR-NSCLC epidemiology [segmented as Total Incidence of NSCLC Total Incident cases of NSCLC patients by Histology, Total Diagnosed cases of NSCLC patients by Stages, Total EGFR-NSCLC cases, and Treated Patient Pool of EGFR-NSCLC] scenario of EGFR-NSCLC in the 7MM covering United States, EU5 countries (Germany, France, Italy , Spain, and United Kingdom), and Japan from 2017 to 2030.


Country Wise- Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Epidemiology


Estimates show the highest Incident population of EGFR-NSCLC is in the United States. Furthermore, among the European 5 countries, the Germany had highest incident population of NSCLC.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Drug Chapters


Drug chapter segment of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer report encloses the detailed analysis of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Marketed Drugs


Iressa (gefitinib): AstraZeneca

In July 2015, the US FDA approved Iressa (gefitinib) for the first-line treatment of patients with NSCLC whose tumor harbor specific types of EGFR gene mutations, as detected by an FDA-approved test. However, before a nod from the US FDA, in July 2009, European Medicines Agency (EMA) granted marketing authorization for gefitinib for the treatment of locally advanced or metastatic NSCLC with sensitizing mutations of the EGFR gene, across all lines of therapy.


Tagrisso (Osimertinib): AstraZeneca

Tagrisso (Osimertinib) has been approved for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. For the previously untreated EGFR mutation-positive metastatic NSCLC, it was demonstrated in a randomized, multicenter, double-blind, active-controlled trial (FLAURA [NCT02296125]). The use of osimertinib in the frontline setting had increased quite rapidly in the few months after the FLAURA data were released, and was expected to continue for a while.

Products detail in the report…


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Emerging Drugs


TAK-788 (AP32788): Takeda

Takeda is investigating their drug candidate, TAK-788 (AP32788), which is a potent and selective next-generation, small-molecule tyrosine kinase inhibitor (TKI) intelligently designed and under clinical investigation to inhibit EGFR and human EGFR 2 (HER2) exon 20 mutations with selectivity over wild type (WT) EGFR. It is currently being explored in EGFR exon 20 insertion mutations in several clinical trials. Previously conducted non-clinical studies demonstrated antitumor activity against de novo mutations in EGFR including EGFR exon 20 insertions and the acquired resistance mutation T790M. Last year, Takeda presented the result of phase I/II trial, and results from this trial showed that TAK-788 effectively treated NSCLC patients whose tumor harbor EGFR exon 20 insertion mutations and who had been previously treated with multiple prior therapies.


Lazertinib: Yuhan Corporation/ Janssen Research & Development


It is a third-generation EGFR- tyrosine kinase (EGFR-TK) inhibitor that could penetrate the brain barrier. Yuhan believes that it has the potential to be first-line therapy for treatment of NSCLC. Lazertinib is currently undergoing Phase III trials in Korea. Interim data has shown that Lazertinib exhibited robust disease activity in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis and was well-tolerated with low rates of Grade 3 or higher adverse events. The South Korean firm entered into licensing deal with Janssen for Lazertinib. Under this agreement, Janssen will be responsible for the development of Lazertinib. In addition to this, Janssen will also be responsible for the manufacturing and commercialization of this drug except for Korea. Both companies under this collaboration initiated Phase I/II clinical trial outside Korea.


JNJ-61186372 (JNJ-6372): Janssen


Janssen, a Johnson and Johnson Company is currently investigating their lead product JNJ-61186372 (JNJ-6372) in Advance NSCLC patients. It is a novel Human Bispecific EGFR and c-Met Antibody that company believes has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies. These two receptors (EGFR and c-Met), in their mutant form, play major roles in the proliferation of cancer cells. By targeting EGFR and c-Met, JNJ-61186372 triggers a chain of events leading to the degradation of these receptors and prevents their activation in the future. The mechanism of JNJ-61186372 is believed to prevent the proliferation of tumor cells and thus aids in the treatment of cancer.

Products detail in the report…


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market Outlook

Key Findings

According to DelveInsight, Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market in the 7MM is expected to change in the study period 2017–2030. The therapeutic market of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in seven major markets was found to be USD 1,893 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 EGFR-NSCLC therapies was found to be USD 1,150 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 EGFR-NSCLC therapies was found to be USD 536 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 EGFR-NSCLC therapies in Japan was found to be USD 208 million in 2017.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Pipeline Development Activities


The drugs which are in pipeline includes:

1. JNJ-61186372 (JNJ-6372): Janssen Research & Development

2. Lazertinib: Yuhan Corporation/ Janssen Research & Development

3. TAK-788: Takeda

and others….

Products detail in the report…


Pipeline Development Activities

Key Points

1. In March 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson announced stated that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 for the treatment of patients with metastatic NSCLC with EGFR Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Drugs Uptake

The EGFR NSCLC market is expected to be dominated by Tagrisso (osimertinib). The market domination is mainly because of it selectively inhibits EGFR-TKI-sensitizing and EGFR T790M resistance mutations, also its use as first-line therapy in NSCLC does not lead to T790M mutations. Other therapies like JNJ-6372 and TAK-788 which are mainly targeting EGFR exon 20 insertion mutations are expected to generate revenue mainly attributed due to lack of treatment options for EGFR exon 20 insertion mutations.


Access and Reimbursement Scenario in Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Therapies

• In January 2020, the National Institute for Health and Care Excellence (NICE) has published final guidance. And as per that guidance, NICE does not recommend AstraZeneca’s Tagrisso for untreated locally advanced or metastatic EGFR-positive NSCLC. This decision was entirely based on a clinical trial, which despite showing that the drug stalled cancer-growth for around 18.9 months compared with 10.2 months in patients treated with erlotinib or gefitinib, did not show direct evidence that the drug would be more effective than afatinib, which may be more effective than erlotinib or gefitinib. As it stands, the first line of treatment for locally advanced stages of NSCLC is a daily oral dose of afatinib, erlotinib, gefitinib or dacomitinib, which have all previously been recommended by NICE. Unfortunately, the drug is not considered eligible for inclusion in the Cancer Drugs Fund (CDF) as it does not have the potential to be cost-effective at the price offered


KOL- Views

To keep up with current market trends, we take KOLs and SME’s opinion working in Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.

• Comprehensive insight has been provided into the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer epidemiology and treatment in the 7MM.

• Additionally, an all-inclusive account of both the current and emerging therapies for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.

• A detailed review of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.


Report Highlights

• In the coming years, Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer. Launch of emerging therapies, will significantly impact the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.

• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer.

• 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.


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Insights

• Patient Population

• Therapeutic Approaches

• Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Pipeline Analysis

• Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market Size and Trends

• Market Opportunities

• Impact of upcoming Therapies


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Key Strengths

• 11 Years Forecast

• 7MM Coverage

• Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Epidemiology Segmentation

• Key Cross Competition

• Highly Analyzed Market

• Drugs Uptake


Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Report Assessment

• SWOT Assessment

• Current Treatment Practices

• Unmet Needs

• Pipeline Product Profiles

• Conjoint Analysis

• Market Attractiveness

• Market Drivers and Barriers


Key Questions

Market Insights:

• What was the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer Market share (%) distribution in 2017 and how it would look like in 2030?

• What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market size during the study period (2017–2030)?

• At what CAGR, the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market is expected to grow in 7MM during the study period (2017–2030)?

• What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market outlook across the 7MM during the study period (2017–2030)?

• What would be the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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?

• Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer patient types/ pool where unmet need is more and whether emerging therapies will 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 based on their clinical trial results?

• Among the emerging therapies, what are the potential therapies which are expected to disrupt the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market?


Epidemiology Insights:

• What is the disease risk, burden and unmet needs of the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• What is the historical Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• Out of all the 7MM countries, which country would have the highest Incident population of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?


Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer along with the approved therapy?

• What are the current treatment guidelines for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer in the US, Europe and Japan?

• What are the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• How many therapies are developed by each company for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• How many emerging therapies are in mid stage, and late stage of development for the treatment of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer and their status?

• What are the key designations that have been granted for the emerging therapies for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?

• What are the global historical and forecasted market of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer?


Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.

• To understand the future market competition in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market and Insightful review of the key market drivers and barriers.

• Organize sales and marketing efforts by identifying the best opportunities for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer 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 Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.

• To understand the future market competition in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer market.


What is Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)?

EGFR is a transmembrane receptor tyrosine kinase protein expressed in some normal epithelial, mesenchymal, and neurogenic tissue. Overexpression of EGFR has been reported and implicated in the pathogenesis of many human malignancies, including NSCLC.  

 

What is Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market size in the 7 major markets (MM) in 2017? 

The market size of EGFR- NSCLC in 7MM was USD 1,893 million in 2017.

 

What was the incident cases of Epidermal Growth Factor Receptor mutation in the United States in 2017

The incident cases of Epidermal Growth Factor Receptor mutation in the United States were 37,370 cases in 2017.


What are the market drivers of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)?

Increasing use of biomarker testing, increase in the mutation-specific trials activity and approval, increasing incidence of NSCLC, and rich pipeline and label expansion of approved therapies are the market drivers of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer.

 

What are the market barriers of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)?

Cost-effectiveness of therapies, small patient populations for specific subsets of NSCLC, and generic or biosimilar erosion are the market barriers of Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer. 

 

Which are the emerging therapies in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market?

Nazartinib (EGF816), Capmatinib (INC280), JNJ-61186372 (JNJ-6372), Lazertinib, TAK-788 are the emerging therapies in EGFR-NSCLC market.

 

Which are the leading companies in the Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) market? 

Novartis Pharmaceuticals, Janssen Research & Development, Yuhan Corporation, Takeda are the leading companies in the EGFR-NSCLC market.

 

How is epidemiology segmented for Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC)?

Epidermal Growth Factor Receptor-Non Small Cell Lung Cancer (EGFR-NSCLC) Epidemiology is segmented as Total Incidence of NSCLC, Total Incident cases of NSCLC patients by Histology, Total Diagnosed cases of NSCLC patients by Stages, Total EGFR-NSCLC cases, and EGFR-NSCLC Treated cases in 7MM from 2017 to 2030

1. Key Insights

2. Executive Summary of EGFR-NSCLC

3. SWOT Analysis of EGFR-NSCLC

4. EGFR-NSCLC: Market Overview at a Glance

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

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

5. EGFR-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 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 EGFR NSCLC cases in the United States

7.4.5. Total EGFR 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 EGFR NSCLC cases in Germany

8.1.5. Total EGFR 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 EGFR NSCLC cases in France

8.2.5. Total EGFR 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 EGFR NSCLC cases in Italy

8.3.5. Total EGFR 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 EGFR NSCLC cases in Spain

8.4.5. Total EGFR 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 EGFR NSCLC cases in the United Kingdom

8.5.5. Total EGFR 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 EGFR NSCLC cases in Japan

9.1.5. Total EGFR NSCLC Treated patient Pool in Japan

10. Current Treatment Practices: 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 EGFR NSCLC

13. Key Endpoints in EGFR NSCLC Clinical Trials

14. Marketed Therapies

14.1. Key Cross

14.2. Tagrisso(Osimertinib): 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

14.3. Vizimpro (Dacomitinib): Pfizer

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

15. Emerging Therapies

15.1. Nazartinib (EGF816): Novartis Pharmaceuticals

15.1.1. Product Description

15.1.2. Clinical Development

15.1.3. Safety and Efficacy

15.2. Capmatinib (INC280): Novartis Pharmaceuticals

15.2.1. Product Description

15.2.2. Other Development Activities

15.2.3. Clinical Development

15.2.4. Safety and Efficacy

15.3. JNJ-61186372 (JNJ-6372): Janssen Research & Development

15.3.1. Product Description

15.3.2. Other Development Activity

15.3.3. Clinical Development

15.3.4. Safety and Efficacy

15.4. Lazertinib: Yuhan Corporation/ Janssen Research & Development

15.4.1. Product Description

15.4.2. Clinical Development

15.4.3. Safety and Efficacy

15.5. TAK-788: Takeda

15.5.1. Product Description

15.5.2. Clinical Development

15.5.3. Safety and Efficacy

16. EGFR-Non-Small Cell Lung Cancer (NSCLC): Seven Major Market Analysis

16.1. Key Findings

16.2. Market Outlook: 7MM

17. EGFR Mutation—Market Size

17.1. Total Market Size of EGFR-positive NSCLC in the 7MM

17.2. Market Size of EGFR-positive NSCLC by Therapeutic Class in the 7MM

17.3. United States Market Size

17.3.1. Total Market size of EGFR 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 NSCLC in Japan

18. Market Access and Reimbursement of NSCLC Therapies

19. Market Drivers of NSCLC

20. Market Barriers of NSCLC

21. Appendix

21.1. Bibliography

21.2. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

Table 1 Summary of EGFR 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 EGFR NSCLC cases in the United States

Table 10 Total EGFR NSCLC Treated patient Pool in the United States

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

Table 12 Total Incident cases of NSCLC patients by Histology in Germany (2017–2030)

Table 13 Total Diagnosed cases of NSCLC patients by Stages in Germany (2017–2030)

Table 14 Total EGFR NSCLC cases in Germany

Table 15 Total EGFR NSCLC Treated patient Pool in Germany

Table 16 Total Incident cases of NSCLC patients in France (2017–2030)

Table 17 Total Incident cases of NSCLC patients by Histology in France (2017–2030)

Table 18 Total Diagnosed cases of NSCLC patients by Stages in France (2017–2030)

Table 19 Total EGFR NSCLC cases in France

Table 20 Total EGFR NSCLC Treated patient Pool in France

Table 21 Total Incident cases of NSCLC patients in Italy (2017–2030)

Table 22 Total Incident cases of NSCLC patients by Histology in Italy (2017–2030)

Table 23 Total Diagnosed cases of NSCLC patients by Stages in Italy (2017–2030)

Table 24 Total EGFR NSCLC cases in Italy

Table 25 Total EGFR NSCLC Treated patient Pool in Italy

Table 26 Total Incident cases of NSCLC patients in Spain (2017–2030)

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

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

Table 29 Total EGFR NSCLC cases in Spain

Table 30 Total EGFR NSCLC Treated patient Pool in Spain

Table 31 Total Incident cases of NSCLC patients in the United Kingdom (2017–2030)

Table 32 Total Incident cases of NSCLC patients by Histology in the United Kingdom (2017–2030)

Table 33 Total Diagnosed cases of NSCLC patients by Stages in the United Kingdom (2017–2030)

Table 34 Total EGFR NSCLC cases in the United Kingdom

Table 35 Total EGFR NSCLC Treated patient Pool in the United Kingdom

Table 36 Total Incident cases of NSCLC patients in Japan (2017–2030)

Table 37 Total Incident cases of NSCLC patients by Histology in Japan (2017–2030)

Table 38 Total Diagnosed cases of NSCLC patients by Stages in Japan (2017–2030)

Table 39 Total EGFR NSCLC cases in Japan

Table 40 Total EGFR NSCLC Treated patient Pool in Japan

Table 41 Standard Treatment Options of NSCLC (Stage-wise)

Table 42 Summary of Recommendations (SEOM Clinical Guideline)

Table 43 Strength of Evidence

Table 44 Strength of Evidence

Table 45 Marketed Drugs Key Cross

Table 46 Standard Treatment Options of NSCLC (Stage-wise)

Table 47 Summary of Recommendations (SEOM Clinical Guideline)

Table 48 Strength of Evidence

Table 49 Strength of Evidence

Table 50 Marketed Drugs Key Cross

Table 51 Tagrisso (Osimertinib), Clinical Trial Description, 2020

Table 52 Vizimpro (Dacomitinib), Clinical Trial Description, 2020

Table 53 Nazartinib (EGF816), Clinical Trial Description, 2020

Table 54 Capmatinib (INC280), Clinical Trial Description, 2020

Table 55 JNJ-61186372 (JNJ-6372), Clinical Trial Description, 2020

Table 56 Lazertinib (YH25448), Clinical Trial Description, 2020

Table 57 TAK-788, Clinical Trial Description, 2020

Table 58 7MM Market Size of EGFR-positive NSCLC, in USD Million (2017–2030)

Table 59 7MM Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 60 7MM Market Size of EGFR-positive NSCLC by therapies in USD Million (2017–2030)

Table 61 United States Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 62 United States Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 63 Germany Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 64 Germany Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 65 France Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 66 France Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 67 Italy Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 68 Italy Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 69 Spain Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 70 Spain Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 71 United Kingdom Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 72 United Kingdom Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 73 Japan Market Size of EGFR-positive NSCLC By Line of Therapy in USD Million (2017–2030)

Table 74 Japan Market Size of EGFR-positive NSCLC by Therapies in USD Million (2017–2030)

Table 75 National Institute for Health and Care Excellence (NICE) Decisions for NSCLC Therapies

Table 76 IQWiG Decisions for NSCLC Therapies

Table 77 Haute Autorité de santé (HAS) Decisions for NSCLC Therapies

Figure 1 EGFR 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 EGFR NSCLC cases in the United States

Figure 22 Total EGFR NSCLC Treated patient Pool in the United States

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

Figure 24 Total Incident cases of NSCLC patients by Histology in Germany (2017–2030)

Figure 25 Total Diagnosed cases of NSCLC patients by Stages in Germany (2017–2030)

Figure 26 Total EGFR NSCLC cases in Germany

Figure 27 Total EGFR NSCLC Treated patient Pool in Germany

Figure 28 Total Incident cases of NSCLC patients in France (2017–2030)

Figure 29 Total Incident cases of NSCLC patients by Histology in France (2017–2030)

Figure 30 Total Diagnosed cases of NSCLC patients by Stages in France (2017–2030)

Figure 31 Total EGFR NSCLC cases in France

Figure 32 Total EGFR NSCLC Treated patient Pool in France

Figure 33 Total Incident cases of NSCLC patients in Italy (2017–2030)

Figure 34 Total Incident cases of NSCLC patients by Histology in Italy (2017–2030)

Figure 35 Total Diagnosed cases of NSCLC patients by Stages in Italy (2017–2030)

Figure 36 Total EGFR NSCLC cases in Italy

Figure 37 Total EGFR NSCLC Treated patient Pool in Italy

Figure 38 Total Incident cases of NSCLC patients in Spain (2017–2030)

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

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

Figure 41 Total EGFR NSCLC cases in Spain

Figure 42 Total EGFR NSCLC Treated patient Pool in Spain

Figure 43 Total Incident cases of NSCLC patients in the United Kingdom (2017–2030)

Figure 44 Total Incident cases of NSCLC patients by Histology in the United Kingdom (2017–2030)

Figure 45 Total Diagnosed cases of NSCLC patients by Stages in the United Kingdom (2017–2030)

Figure 46 Total EGFR NSCLC cases in the United Kingdom

Figure 47 Total EGFR NSCLC Treated patient Pool in the United Kingdom

Figure 48 Total Incident cases of NSCLC patients in Japan (2017–2030)

Figure 49 Total Incident cases of NSCLC patients by Histology in Japan (2017–2030)

Figure 50 Total Diagnosed cases of NSCLC patients by Stages in Japan (2017–2030)

Figure 51 Total EGFR NSCLC cases in Japan

Figure 52 Total EGFR NSCLC Treated patient Pool in Japan

Figure 53 Advanced/Metastatic NSCLC Treatment Algorithm

Figure 54 Timeline Illustrating the Development of Targeted Therapies and Immunotherapies for the Treatment of NSCLC Over two decades

Figure 55 Immune Checkpoint Inhibitor

Figure 56 Unmet Needs

Figure 57 Market Size of EGFR-positive NSCLC in the 7MM, in USD Million (2017–2030)

Figure 58 Market Size of EGFR-positive NSCLC by Line of therapies in the 7MM, in USD Million (2017–2030)

Figure 59 Market Size of EGFR-positive NSCLC by therapies in the 7MM, in USD Million (2017–2030)

Figure 60 Market Size of EGFR-positive NSCLC in the US, USD Millions (2017–2030)

Figure 61 Market Size of EGFR-positive NSCLC in Germany, USD Millions (2017–2030)

Figure 62 Market Size of NSCLC in France, USD Millions (2017–2030)

Figure 63 Market Size of EGFR-positive NSCLC in Italy, USD Millions (2017–2030)

Figure 64 Market Size of EGFR-positive NSCLC in Spain, USD Millions (2017–2030)

Figure 65 Market Size of EGFR-positive NSCLC in the United Kingdom, IN USD Millions (2017–2030)

Figure 66 Market Size of NSCLC in Japan, USD Millions (2017–2030)

Figure 67 Market Drivers

Figure 68 Market Barriers

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