未分化リンパ腫キナーゼ非小細胞肺癌(ALK-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:Anaplastic lymphoma kinase Non-Small Cell Lung Cancer (ALK-NSCLC)-Market Insights, Epidemiology and Market Forecast—2030
◆商品コード:DELV20JU149
◆発行会社(リサーチ会社):DelveInsight
◆発行日:2020年5月
◆ページ数:200
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【レポートの概要】

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

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

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer (ALK-NSCLC): Disease Understanding and Treatment Algorithm
Anaplastic lymphoma kinase 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. 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 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. Among those most common are EGFR, KRAS, ROS-1, BRAF, C-Met, PD-L1 expression and others. Amongst all the mutations ALK mutation accounted for approximately 4% of the total cases of NSCLC.

ALK-positive mutation was discovered in 2007. ALK-positive lung cancers harbor a gene rearrangement referred to as the EML4-ALK fusion gene, compose a subset of tumors for which medical treatment has expanded rapidly (along with survival) in the past few years.

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Diagnosis

An ALK mutation is diagnosed by molecular profiling of a sample of the tumor. It’s important in doing this testing that an adequate supply of tissue from either a lung biopsy or lung cancer surgery is obtained. Researchers are also looking at ways to determine if an ALK mutation is present before genetic testing is done, or could substitute for genetic testing.

Anaplastic lymphoma kinase 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. To recommend a treatment option to a patient of NSCLC, several key factors are taken into consideration, such age of the patient, previous medical history, health status, and smoking history. Along with those, another essential factor to consider is the stage of cancer at the time of diagnosis. Staging is usually carried out twice: after clinical and radiological examinations; and after surgery, in the case of the surgically resected tumor. There are several therapies approved under this category, such as Alunbrig (Brigatinib), Zykadia (Ceritinib), Xalkori (Crizotinib), and Alectinib. Apart from this, Lorbrena (Lorlatinib) is another therapy available for the ALK-positive NSCLC patient pool.

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer (ALK-NSCLC) Epidemiology
The ALK NSCLC epidemiology division provide the insights about historical and current ALK 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 ALK NSCLC in the 7MM were found to be 22,197 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 ALK 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 ALK-NSCLC cases, and Treated Patient Pool of ALK-NSCLC] scenario of ALK NSCLC in the 7MM covering United States, EU5 countries (Germany, France, Italy , Spain, and United Kingdom), and Japan from 2017 to 2030.

Country Wise- Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Epidemiology

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

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

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Marketed Drugs

Xalkori (Crizotinib): Pfizer

Xalkori (Crizotinib), an ALK inhibitor, was first-ever approved treatment for metastatic NSCLC by the US FDA. This product received accelerated approval in 2011. The US FDA approval of Xalkori is based on data from 255 patients with locally advanced or metastatic ALK-positive NSCLC across two multicenter, single-arm studies, including a Phase II study (PROFILE 1005) and a Part 2 expansion cohort of a Phase I study (Study 1001).

Products detail in the report…

Alunbrig (Brigatinib): Takeda

Alunbrig (Brigatinib) was approved by the US FDA in April 2017 for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to Crizotinib. In the year 2018, the European Commission (EC) also granted marketing authorization for Alunbrig as a monotherapy for the treatment of adult patients with ALK+ NSCLC previously treated with Crizotinib. In April 2020, the European Commission (EC) extended the current marketing authorization of Alunbrig to include use as a monotherapy for the treatment of adult patients with ALK+ advanced NSCLC previously not treated with an ALK inhibitor. This decision came after a positive opinion from the CHMP on February 27, 2020.

Products detail in the report…

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Emerging Drugs
Ensartinib: Xcovery Holding Company

Xcovery is investigating their drug candidate, Ensartinib which is a potential best-in-class oral compound for the first-line treatment of ALK–positive NSCLC. This product has additional activity against MET, ABL, Axl, EPHA2, LTK, ROS1, and SLK. In phase I/II clinical trial, this product has shown promising activity in both ALK TKI naïve and crizotinib-resistant ALK+ NSCLC patients. Ensartinib is generally well tolerated with the most common toxicities being rash and nausea/vomiting, the latter often resolved with food.

At present, a global Phase III clinical trial (eXalt3) is ongoing comparing Ensartinib to Crizotinib in TKI naïve ALK-positive NSCLC patient. The primary purpose of this study is to evaluate the efficacy and safety of ensartinib vs. crizotinib in patients with ALK-positive NSCLC that have received up to one prior chemotherapy regimen and no prior ALK inhibitor.

Products detail in the report…

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Market Outlook
Key Findings

According to DelveInsight, Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market in the 7MM is expected to change in the study period 2017–2030. The therapeutic market of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer in seven major markets was found to be USD 841 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 ALK NSCLC therapies was found to be USD 422 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 ALK NSCLC therapies was found to be USD 267 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 ALK NSCLC therapies in Japan was found to be USD 152 million in 2017.

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Pipeline Development Activities
The drugs which are in pipeline includes:

1. Ensartinib: Xcovery Holding Company: Phase III

Products detail in the report…

Pipeline Development Activities

Key Points

1. At present, a global Phase III clinical trial (eXalt3) is ongoing comparing Ensartinib to Crizotinib in TKI naïve ALK-positive NSCLC patient. The primary purpose of this study is to evaluate the efficacy and safety of ensartinib vs. crizotinib in patients with ALK-positive NSCLC that have received up to one prior chemotherapy regimen and no prior ALK inhibitor.

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Drugs Uptake
The current market is dominated by Alecensa (alectinib) which is expected to generate its peak revenue in coming years, and after that its revenue is expected to decline. This decline is a majorly attributed due to the presence of Lorbrena (because it is targeting the patient pool which is refractory to Crizotinib, Alectinib, and Ceritinib.

Access and Reimbursement Scenario in Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Therapies
• In 2018, Alecensa was recommended, within its marketing authorization, for untreated patients with NSCLC, whose tumors are identified as ALK-positive. Alecensa demonstrated considerable improvements in delaying cancer growth in enrolled patients. It has also shown significant improvements in preventing and delaying cancer spread into the brain.

• This decision was entirely based on data from the Phase III ALEX study, which showed a reduction in the risk of disease worsening, or death by 57% compared with standard of care Xalkori.

KOL- Views
To keep up with current market trends, we take KOLs and SME’s opinion working in Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.

• Comprehensive insight has been provided into the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer epidemiology and treatment in the 7MM.

• Additionally, an all-inclusive account of both the current and emerging therapies for Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market.

Report Highlights
• In the coming years, Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer. Launch of emerging therapies, will significantly impact the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market.

• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Anaplastic lymphoma kinase 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.

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Report Insights
• Patient Population

• Therapeutic Approaches

• Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Pipeline Analysis

• Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Market Size and Trends

• Market Opportunities

• Impact of upcoming Therapies

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Report Key Strengths
• 11 Years Forecast

• 7MM Coverage

• Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Epidemiology Segmentation

• Key Cross Competition

• Highly Analyzed Market

• Drugs Uptake

Anaplastic lymphoma kinase Non-Small Cell Lung Cancer 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer Market share (%) distribution in 2017 and how it would look like in 2030?

• What would be the Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market size during the study period (2017–2030)?

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

• What would be the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market outlook across the 7MM during the study period (2017–2030)?

• What would be the Anaplastic lymphoma kinase 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?

• Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

• What is the historical Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

• Out of all the 7MM countries, which country would have the highest Incident population of Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer along with the approved therapy?

• What are the current treatment guidelines for the treatment of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer in the US, Europe and Japan?

• What are the Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

• How many therapies are developed by each company for the treatment of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

• How many emerging therapies are in mid stage, and late stage of development for the treatment of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

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

• What are the key designations that have been granted for the emerging therapies for Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

• What are the global historical and forecasted market of Anaplastic lymphoma kinase Non-Small Cell Lung Cancer?

Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market.
To understand the future market competition in the Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase 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 Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market.
To understand the future market competition in the Anaplastic lymphoma kinase Non-Small Cell Lung Cancer market.

【レポートの目次】

1. Key Insights

2. Executive Summary of ALK-NSCLC

3. SWOT Analysis of ALK-NSCLC

4. ALK-NSCLC: Market Overview at a Glance

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

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

5. ALK-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 ALK NSCLC cases in the United States

7.4.5. Total ALK 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 ALK NSCLC cases in Germany

8.1.5. Total ALK 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 ALK NSCLC cases in France

8.2.5. Total ALK 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 ALK NSCLC cases in Italy

8.3.5. Total ALK 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 ALK NSCLC cases in Spain

8.4.5. Total ALK 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 ALK NSCLC cases in the United Kingdom

8.5.5. Total ALK 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 ALK NSCLC cases in Japan

9.1.5. Total ALK 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 ALK NSCLC

13. Key Endpoints in ALK NSCLC Clinical Trials

14. Marketed Therapies

14.1. Key Cross

14.2. Alunbrig (Brigatinib): Takeda Pharmaceuticals

14.2.1. Product Description

14.2.2. Regulatory Milestones

14.2.3. Pivotal Clinical Trials

14.2.4. Ongoing Current Pipeline Activity

14.2.5. Safety and Efficacy of Ongoing Clinical Trials

14.3. Alecensa (Alectinib): Hoffmann-La Roche

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. X-396 (Ensartinib): Xcovery

15.1.1. Product Description

15.1.2. Clinical Development

15.1.3. Safety and Efficacy

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

16.1. Key Findings

16.2. Market Outlook: 7MM

17. ALK-Mutation—Market Size

17.1. Total Market Size of ALK NSCLC in the 7MM

17.2. Market Size of ALK NSCLC by Therapeutic Class in the 7MM

17.3. United States Market Size

17.3.1. Total Market size of ALK 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 ALK NSCLC

20. Market Barriers of ALK 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 ALK NSCLC cases in the United States

Table 10 Total ALK 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 ALK NSCLC cases in Germany

Table 15 Total ALK 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 ALK NSCLC cases in France

Table 20 Total ALK 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 ALK NSCLC cases in Italy

Table 25 Total ALK 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 ALK NSCLC cases in Spain

Table 30 Total ALK 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 ALK NSCLC cases in the United Kingdom

Table 35 Total ALK 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 ALK NSCLC cases in Japan

Table 40 Total ALK 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 Lorbrena (Lorlatinib), Clinical Trial Description, 2020

Table 47 Alunbrig (Brigatinib), Clinical Trial Description, 2020

Table 48 Alecensa (Alectinib), Clinical Trial Description, 2020

Table 49 X-396 (Ensartinib), Clinical Trial Description, 2020

Table 50 7MM Market Size of ALK NSCLC, in USD Million (2017–2030)

Table 51 7MM Market Size of ALK NSCLC By Line of Therapy, in USD Million (2017–2030)

Table 52 7MM Market Size of ALK NSCLC by therapies, in USD Million (2017–2030)

Table 53 United States Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 54 United States Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 55 Germany Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 56 Germany Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 57 France Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 58 France Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 59 Italy Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 60 Italy Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 61 Spain Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 62 Spain Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 63 United Kingdom Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 64 United Kingdom Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 65 Japan Market Size of ALK NSCLC by Line of Therapy, in USD Million (2017–2030)

Table 66 Japan Market Size of ALK NSCLC by Therapies, in USD Million (2017–2030)

Table 67 National Institute for Health and Care Excellence (NICE) Decisions for NSCLC Therapies

Table 68 IQWiG Decisions for NSCLC Therapies

Table 69 Haute Autorité de santé (HAS) Decisions for NSCLC Therapies



List of Figures:

Figure 1 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 ALK NSCLC cases in the United States

Figure 22 Total ALK 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 ALK NSCLC cases in Germany

Figure 27 Total ALK 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 ALK NSCLC cases in France

Figure 32 Total ALK 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 ALK NSCLC cases in Italy

Figure 37 Total ALK 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 ALK NSCLC cases in Spain

Figure 42 Total ALK 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 ALK NSCLC cases in the United Kingdom

Figure 47 Total ALK 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 ALK NSCLC cases in Japan

Figure 52 Total ALK 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 ALK NSCLC in the 7MM, in USD Million (2017–2030)

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

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

Figure 60 Market Size of ALK NSCLC in the United States by Therapies, in USD Millions (2017–2030)

Figure 61 Market Size of ALK NSCLC in Germany by Therapies, in USD Millions (2017–2030)

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

Figure 63 Market Size of ALK NSCLC in Italy by Therapies, in USD Millions (2017–2030)

Figure 64 Market Size of ALK NSCLC in Spain by Therapies, in USD Millions (2017–2030)

Figure 65 Market Size of ALK NSCLC in the United Kingdom by Therapies, in USD Millions (2017–2030)

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

Figure 67 Market Drivers

Figure 68 Market Barriers

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