BRAF Mutated Non-small Cell Lung Cancer (NSCLC) -Market Insights, Epidemiology and Market Forecast—2030

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) -Market Insights, Epidemiology and Market Forecast—2030

  • May 2020 •
  • 200 pages •
  • Report ID: 5893093 •
  • Format: PDF
‘BRAF Mutated Non-small Cell Lung Cancer (NSCLC) -Market Insights, Epidemiology and Market Forecast—2030’ report delivers an in-depth understanding of the BRAF Mutated NSCLC, historical and forecasted epidemiology as well as the BRAF Mutated NSCLC market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.
The BRAF Mutated NSCLC market report provides current treatment practices, emerging drugs, BRAF Mutated NSCLC market share of the individual therapies, current and forecasted BRAF Mutated NSCLC market size from 2017 to 2030 segmented by seven major fmarkets. The Report also covers current BRAF Mutated 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
BRAF Mutated NSCLC: Disease Understanding and Treatment Algorithm
BRAF Mutated 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 mutation associated with NSCLC but the most common are EGFR, KRAS, ROS-1 , BRAF , BRAF , PD-L1 expression and others. Among all the mutations BRAF accounted for approximately 5% of the total cases of NSCLC.
BRAF mutated NSCLC is now recognized as a rare form of lung cancer. The biologic behavior of BRAF mutated lung tumors tends to be more aggressive. The one unique aspects of BRAF mutated NSCLC, which differentiates it from other molecularly driven tumors such as EGFR, ALK, and ROS1, is that patients with BRAF V600E-mutant NSCLC tend to be patients with a smoking history. The BRAF gene encodes for a serine/threonine kinase that belongs to the RAS-RAF-MEK-ERK axis that regulates cellular growth.
BRAF Mutated NSCLC Diagnosis
For diagnosis of mutation associated with NSCLC 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.
BRAF Mutated NSCLC Treatment
There is only single US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved product is present for the treatment of BRAF mutated NSCLC, i.e., dabrafenib and trametinib combination. Current treatment choices for BRAF mutated NSCLC includes targeted therapies, platinum based chemotherapy and off-label therapies.
BRAF Mutated NSCLC Epidemiology
The BRAF mutated NSCLC epidemiology division provides the insights about historical and current BRAF Mutated NSCLC patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings
The total incident cases of BRAF mutated NSCLC in the 7MM were found to be 19,275 in 2017 which is expected to grow during the study period, i.e., 2017–2030.
The disease epidemiology covered in the report provides historical as well as forecasted BRAF mutated 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 NSCLC Cases of Patients by Genetic mutation/Biomarkers, and Treated Patient Pool of NSCLC] scenario of BRAF mutated NSCLC in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.
Country Wise- BRAF Mutated NSCLC Epidemiology
Estimates shows that the highest incident population of BRAF mutated NSCLC were in the United States, followed by Germany, United Kingdom, and France in 2017.
BRAF Mutated NSCLC Drug Chapters
Drug chapter segment of the BRAF Mutated NSCLC report encloses the detailed analysis of BRAF Mutated NSCLC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the BRAF Mutated 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.
BRAF Mutated NSCLC Marketed Drugs
Tafinlar (dabrafenib) in combination with Mekinist (trametinib): Novartis Pharmaceuticals
Tafinlar (Dabrafenib) in combination with Mekinist (Trametinib)is indicated for the treatment BRAFV600E mutationin various types of cancers. This combination is approved for the treatment of patients with metastatic NSCLC with BRAF V600E mutation as detected by an FDA-approved test.In addition to this, this combination is also use in patients with stage III resectable, unresectable or metastatic melanoma who have a BRAF V600 mutation.
Tafinlar is an inhibitor of some mutated forms of BRAF kinases with in vitro IC50 values of 0.65, 0.5, and 1.84 nM for BRAF V600E, BRAF V600K, and BRAF V600D enzymes, respectively. Dabrafenib also inhibits wild-type BRAF and CRAF kinases with IC50 values of 3.2 and 5.0 nM, respectively, and other kinases such as SIK1, NEK11, and LIMK1 at higher concentrations. Some mutations in the BRAF gene, including those that result in BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth.
In June 2017, the US FDA approved Tafinlar and Mekinist for the treatment of patients with metastatic NSCLC with BRAF V600E mutation as detected by a USFDA approved test. These approvals are the first specifically for the treatment of patients with BRAF V600E–mutant metastatic NSCLC. Also in In April 2017, the EC has approved Tafinlar in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic NSCLC.

In 2015, the US FDA has granted Breakthrough Therapy designation for the combination of dabrafenib and trametinib for the treatment of patients with advanced and metastatic BRAF V600E mutation-positive NSCLC who received at least one prior line of platinum-containing therapy

Products detail in the report…

BRAF Mutated NSCLC Emerging Drugs
Braftovi (encorafenib) plus Mektovi (binimetinib): Pfizer
Braftovi (encorafenib) plus Mektovi (binimetinib) combination is currently under investigation in phase II clinical trial by the Pfizer. This combination is already approved for unresectable or metastatic melanoma with a BRAFV-600E or BRAFV-600K mutation in the United States. Braftovi is an oral small molecule BRAF kinase inhibitor and Mektovi (binimetinib) is an oral small molecule MEK inhibitor which target key enzymes in the MAPK signaling pathway.
Enfortumab Vedotin: Astellas Pharma/ Seattle Genetics
Enfortumab Vedotin is under development by Astellas Pharma in collaboration with Seattle Genetics. It is first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4. Currently it is being investigated in phase II clinical trial for NSCLC.
Products detail in the report…

BRAF Mutated NSCLC Market Outlook
Current treatment choices for BRAF mutated NSCLC includes targeted therapies, platinum based chemotherapy and off-label therapies. However there is only one approved therapy present for the treatment of BRAF mutated i.e., Tafinlar (dabrafenib) plus Mekinist (trametinib).
On the other hand due to lack of approved therapies among all the predicted treatment choices, chemotherapies would remain an important aspect of NSCLC treatment, with platinum-based regimens being crucial. However, in future the use of platinum based chemotherapy is expected to decline because of development of therapies specifically targeting BRAF mutation.
As in the market, only one approved therapy is available, so off-label therapies such as vemurafenib and combinations and others are also used in the treatment of BRAF mutated NSCLC. Also Vemurafenib and Cobimetinib in combination are being investigated in phase II clinical trial for BRAF and other types of mutated NSCLC. So, the treatment paradigm of BRAF mutated NSCLC is developing and several efforts are ongoing for the development of treatment.
According to the expert insights, there is very limited data available about the specific efficacy of immunotherapy and chemoimmunotherapy for BRAF mutated patients. Based on that experts tend to favor targeted therapy for these patients. Several problems associated with this type of mutation for NSCLC one of them is resistance towards targeted therapy.
In BRAF mutated NSCLC after failure of dabrafenib-trametinib, there’s really not a second-line targeted-therapy approach that can be used for the treatment. Also the knowledge about mechanisms of resistance is very little. So, there is a desperate need of next-line targeted therapy. However, several researchers are working towards improvement of knowledge for this mutation to overcome the problem of resistance.

Key Findings
According to the analyst BRAF Mutated NSCLC market in the 7MM is expected to change during the study period 2017–2030.The therapeutic market of BRAF Mutated NSCLC in seven major markets was found to be USD 273 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 BRAF Mutated NSCLC therapies was found to be USD 164 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 BRAF Mutated NSCLC therapies was found to be USD 103 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 BRAF Mutated NSCLC therapies in Japan was found to be USD 7.0 million in 2017.

BRAF Mutated NSCLC Pipeline Development Activities

The drugs which are in pipeline include:
1. Braftovi (encorafenib) plus Mektovi (binimetinib) (Pfizer): Phase II
2. Enfortumab Vedotin (Astellas Pharma/ Seattle Genetics): Phase II
Whole list of emerging products will be provided in the report...

BRAF Mutated NSCLC Drugs Uptake
Due to the monopoly of Tafinlar/Mekinist combo in the market and better clinical profile, this combo is expected to take major share among all the therapies for BRAF mutated NSCLC. However, due to expected launch of emerging therapies the Tafinlar/Mekinist combo sales is expected to be affected during the study period (2017–2030).
Access and Reimbursement Scenario in BRAF Mutated NSCLC Therapies
• The current scenario of therapeutics for NSCLC is mainly based on the use of targeted therapies and immunotherapy’s. Especially the current paradigm is mainly associated with treatment specific to mutations that occur in NSCLC.
• Due to the high costs, some of the therapies are not able to show their cost-effectiveness and are unable to get a recommendation by assessment agencies. So, the access and reimbursement scenario of drugs for NSCLC is not easy as cost-effectiveness is a major barrier for therapies in NSCLC.
• In February 2019, NICE unable to make a recommendation about the use in the NHS of dabrafenib with trametinib for treating advanced metastatic BRAF V600E mutation-positive NSCLC because no evidence submission was received from Novartis.

KOL-Views
To keep up with current market trends, we take KOLs and SME’s opinion working in BRAF Mutated 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 BRAF Mutated 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 BRAF Mutated 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 BRAF Mutated NSCLC, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.
• Comprehensive insight has been provided into the BRAF Mutated NSCLC epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for BRAF Mutated NSCLC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of BRAF Mutated 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 BRAF Mutated NSCLC market.

Report Highlights
• In the coming years, BRAF Mutated 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 BRAF Mutated 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 BRAF Mutated NSCLC. Launch of emerging therapies, will significantly impact the BRAF Mutated NSCLC market.
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for BRAF Mutated 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.
BRAF Mutated NSCLC Report Insights
• Patient Population
• Therapeutic Approaches
• BRAF Mutated NSCLC Pipeline Analysis
• BRAF Mutated NSCLC Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

BRAF Mutated NSCLC Report Key Strengths
• 11 Years Forecast
• 7MMCoverage

• BRAF Mutated NSCLC Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

• Drugs Uptake

BRAF Mutated 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 BRAF Mutated NSCLC Market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the BRAF Mutated 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 BRAF Mutated NSCLC market size during the study period (2017–2030)?
• At what CAGR, the BRAF Mutated NSCLC market is expected to grow in 7MM during the study period (2017–2030)?
• What would be the BRAF Mutated NSCLC market outlook across the 7MM during the study period (2017–2030)?
• What would be the BRAF Mutated 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?
• BRAF Mutated NSCLC 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 on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the BRAF Mutated NSCLC market?

Epidemiology Insights:
• What is the disease risk, burden and unmet needs of the BRAF Mutated NSCLC?
• What is the historical BRAF Mutated 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 BRAF Mutated NSCLC 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 BRAF Mutated NSCLC?
• Out of all the 7MM countries, which country would have the highest incident population of BRAF Mutated 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 BRAF Mutated NSCLC?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
• What are the current options for the treatment of BRAF Mutated NSCLC along with the approved therapy?
• What are the current treatment guidelines for the treatment of BRAF Mutated NSCLC in the US, Europe and Japan?
• What are the BRAF Mutated 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 BRAF Mutated NSCLC?
• How many therapies are developed by each company for the treatment of BRAF Mutated NSCLC?
• How many emerging therapies are in mid stage, and late stage of development for the treatment of BRAF Mutated NSCLC?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the BRAF Mutated 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 BRAF Mutated NSCLC and their status?
• What are the key designations that have been granted for the emerging therapies for BRAF Mutated NSCLC?
• What is the global historical and forecasted market of BRAF Mutated NSCLC?

Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the BRAF Mutated NSCLC market.
To understand the future market competition in the BRAF Mutated NSCLC market and Insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for BRAF Mutated 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 BRAF Mutated NSCLC market.
To understand the future market competition in the BRAF Mutated NSCLC market.