BRAF Mutated Non-small Cell Lung Cancer (NSCLC) - Market Insight, Epidemiology, and Market Forecast - 2036

Key Highlights

• The total number of NSCLC Incidence Cases of in the 7MM was nearly 526,800 in 2022 and is projected to increase during the forecasted period.
• Only one product is available for the BRAF-mutated NSCLC patient pool: TAFINLAR (dabrafenib) in combination with MEKINIST (trametinib).
• In June 2017, the US FDA approved TAFINLAR and MEKINIST to treat patients with metastatic NSCLC whose tumors express the BRAF V600E mutation.
• Key companies active in the BRAF NSCLC market include Pierre Fabre Medicament, Xynomic Pharmaceuticals, Kinnate Biopharma, Revolution Medicines, Black Diamond Therapeutics, Inc., and others.

The "BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Insights, Epidemiology, and Market Forecast-2036" report delivers an in-depth understanding of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC), historical and forecasted epidemiology as well as the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market report provides current treatment practices, emerging drugs, BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market share of the individual therapies, current and forecasted BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market Size from 2022 to 2036 segmented by seven major markets. The report also covers current BRAF Mutated Non-small Cell Lung Cancer (NSCLC) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Disease Understanding and Treatment Algorithm

The DelveInsight’s BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market report gives a thorough understanding of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment.

Lung cancer typically originates in the lungs and can spread to nearby lymph nodes or distant organs such as the brain. It can also occur when cancers from other parts of the body migrate to the lungs, a process known as metastasis.

There are two primary categories of lung cancer: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC represents about 85% of all lung cancer cases. While it spreads to other organs more slowly than SCLC, SCLC consists of much smaller cells under the microscope and can be life-threatening within weeks if not treated - unlike most NSCLC cases.

NSCLC includes any epithelial lung cancer that is not classified as SCLC. Its main subtypes include adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, along with less common forms such as adenosquamous and sarcomatoid carcinomas.

Both NSCLC and SCLC share similar symptoms, such as a long-lasting cough, chest discomfort, breathing difficulties, wheezing, reduced appetite, weight loss, and fatigue.

Diagnosis and staging of NSCLC often occur simultaneously. Common diagnostic tools include physical examinations, medical history reviews, laboratory assessments, and molecular testing.

After a lung cancer diagnosis, further evaluations determine whether the disease has spread within the lungs or to other organs. This process, known as staging, is essential for developing an appropriate treatment plan. NSCLC is classified into four stages (I-IV).

Although several new BRAF-targeted therapies are expected to enter the NSCLC market, they are unlikely to substantially shift current treatment patterns due to physicians’ established familiarity with existing options.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Diagnosis

This segment of the report covers the detailed diagnostic methods or tests for BRAF Mutated Non-small Cell Lung Cancer (NSCLC).

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Treatment

It covers the details of conventional and current medical therapies available in the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market for the treatment of the condition. It also provides BRAF Mutated Non-small Cell Lung Cancer (NSCLC) treatment algorithms and guidelines in the United States, Europe, and Japan.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Epidemiology

The BRAF Mutated Non-small Cell Lung Cancer (NSCLC) epidemiology section provides insights about the historical and current BRAF Mutated Non-small Cell Lung Cancer (NSCLC) patient pool and forecasted trends for individual 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 BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted BRAF Mutated Non-small Cell Lung Cancer (NSCLC) epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2022 to 2036.

• The total number of NSCLC Incidence Cases of in the 7MM was nearly 526,800 in 2022 and is projected to increase during the forecasted period.
• The total number of incident cases of NSCLC in the United States was nearly 201,200 in 2022.
• The total number of cases in the United States for BRAF NSCLC was estimated to be nearly 10,000 in 2022, which is expected to show positive growth by 2034.
• The total number of cases in Japan for BRAF NSCLC was estimated to be nearly 2,500 in 2022, which is expected to show positive growth by 2034.
• Among EU4 and the UK, the highest number of cases for BRAF NSCLC was found in Germany, estimated to be nearly 2,000 cases in 2022, which is expected to show positive growth by 2034.

Country Wise- BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Epidemiology

The epidemiology segment also provides the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Drug Chapters

The drug chapter segment of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) report encloses the detailed analysis of BRAF Mutated Non-small Cell Lung Cancer (NSCLC) marketed drugs and late-stage (Phase-III and Phase-II) BRAF NSCLC Pipeline Drugs. It also helps to understand the BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC) Marketed Drugs

TAFINLAR: Novartis

TAFINLAR (dabrafenib), developed by Novartis, is a BRAF-targeted therapy designed to inhibit specific mutated BRAF kinases, notably the BRAFV600E and BRAFV600K variants. It has been authorized for several clinical uses, frequently alongside MEKINIST. Initially approved in 2013 as a standalone treatment for melanoma, it later received approval in 2014 for use in combination with MEKINIST. The paired regimen was cleared in 2017 for treating NSCLC harboring BRAFV600E mutations, followed by a 2018 approval for BRAF-positive anaplastic thyroid cancer. In 2022, its use was broadened to include BRAFV600E-mutant solid tumors, and in 2023, it was additionally approved for pediatric patients with BRAFV600E-mutant low-grade glioma.

ZELBORAF: Genentech

Zelboraf (vemurafenib), created by Genentech, a subsidiary of Roche, is a BRAF kinase inhibitor used to treat melanoma and Erdheim-Chester disease (ECD). It received its initial approval in 2011 for patients with unresectable or metastatic melanoma carrying a BRAFV600E mutation, identified using a companion diagnostic cleared by the FDA. In 2017, its indication was broadened to include individuals with ECD who also have a BRAFV600E mutation.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Emerging Drugs

Plixorafenib: Fore Biotherapeutics

Plixorafenib (previously called FORE8394 or PLX-8394) is an investigational next-generation small-molecule therapy designed to selectively target mutated BRAF. By shutting down ERK pathway activity, it shows potential for treating tumors driven by class I or II BRAF mutations and BRAF fusions.

In September 2022, it received Fast Track Designation from the U.S. Food and Drug Administration for cancers harboring BRAF class 1 (V600) or class 2 mutations - including fusions - in patients who have no remaining treatment options. In March 2023, the agency also granted it Orphan Drug Designation for primary brain and other central nervous system cancers. The therapy is presently undergoing Phase II clinical evaluation in the United States.

CFT1946: C4 Therapeutics

CFT1946 is an experimental, orally available small-molecule degrader that targets BRAFV600 mutations in solid tumors. It is currently being tested in a global Phase I/II clinical study involving patients who no longer respond to BRAF inhibitors. The compound was engineered to be both potent and highly selective for the BRAFV600 mutant variant. Notably, CFT1946 is the only BRAFV600-mutant tumor degrader being evaluated in clinical trials.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Outlook

The report’s outlook on the BRAF-mutated Non-Small Cell Lung Cancer (NSCLC) market provides an in-depth understanding of historical, current, and projected trends. It examines how existing treatments influence the market, alongside unmet needs, key drivers and barriers, and the demand for improved therapeutic technologies.

This section delivers detailed insights into market trends for each approved therapy and late-stage pipeline candidate. It evaluates their expected impact using factors such as annual treatment cost, eligibility criteria, mechanism of action, patient adherence, market demand, growing patient population, target patient segments, anticipated launch dates, competitive landscape, brand strength, and expert perspectives. The resulting market projections are supported by clear tables and graphs for quick interpretation.

BRAF is part of the RAF kinase family involved in regulating the MAP kinase pathway, with V600E being the most common mutation. Treatment strategies for advanced NSCLC have progressed significantly, with most patients receiving first-line systemic chemotherapy, followed by immunotherapies, targeted agents, or combination regimens.

Currently, only one approved therapy specifically targets the BRAF-mutated NSCLC population: Tafinlar (dabrafenib) combined with Mekinist (trametinib). The combination received FDA approval in June 2017 for metastatic NSCLC with the BRAF V600E mutation. It was also approved by the European Commission in April 2017 for BRAF V600-positive advanced or metastatic NSCLC, and by Japan in March 2018 for unresectable advanced or recurrent NSCLC with BRAF mutations.

In 2022, therapies for BRAF-mutated NSCLC generated approximately USD 250 million in the EU4 and the UK, with the market projected to expand significantly by 2034.

Zelboraf (vemurafenib) serves as an alternative for patients with BRAF V600-mutated NSCLC when dabrafenib/trametinib is unsuitable or not reimbursed.

In Japan, Tafinlar (dabrafenib) plus Mekinist (trametinib) accounted for the largest share of the BRAF-mutated NSCLC therapy market in 2022.

DelveInsight forecasts substantial market evolution for BRAF-mutated NSCLC across the 7MM between 2022 and 2036.

Key Findings

This section includes a glimpse of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market in 7MM.

The United States BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Outlook

This section provides the total BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market size and market size by therapies in the United States.

EU-5 Countries: BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Outlook

The total BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.

Japan BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Outlook

The total BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market size and market size by therapies in Japan is also mentioned.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Drugs Uptake

This section focuses on the rate of uptake of the potential BRAF Mutated Non-small Cell Lung Cancer (NSCLC) drugs recently launched in the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market or expected to get launched in the market during the study period 2020-2034. The analysis covers BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market uptake by drugs; patient uptake by therapies; and sales of each drug.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Drugs Uptake helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Pipeline Development Activities

The BRAF Mutated Non-small Cell Lung Cancer (NSCLC) report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses BRAF Mutated Non-small Cell Lung Cancer (NSCLC) key players involved in developing targeted therapeutics.

Pipeline Development Activities

The BRAF Mutated Non-small Cell Lung Cancer (NSCLC) report covers the detailed information of collaborations, acquisition, and merger, licensing, patent details, and other information for BRAF Mutated Non-small Cell Lung Cancer (NSCLC) emerging therapies.

Reimbursement Scenario in BRAF Mutated Non-small Cell Lung Cancer (NSCLC)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market trends, we take KOLs and SMEs ' opinion working in the BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC) market trends. 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 Non-small Cell Lung Cancer (NSCLC) Market by using various Competitive Intelligence tools that include - 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 BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Report

• The report covers the descriptive overview of BRAF Mutated Non-small Cell Lung Cancer (NSCLC), explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
• Comprehensive insight has been provided into the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for BRAF Mutated Non-small Cell Lung Cancer (NSCLC) is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC) market

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Report Highlights

• In the coming years, the BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC). The launch of emerging therapies will significantly impact the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market

• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC) Report Insights

• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Patient Population
• Therapeutic Approaches
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Pipeline Analysis
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Size and Trends
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Opportunities
• Impact of upcoming BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Therapies

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed BRAF Mutated Non-small Cell Lung Cancer Market
• BRAF Mutated Non-small Cell Lung Cancer Drugs Uptake

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Report Assessment

• Current Treatment Practices
• Unmet Needs
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Pipeline Product Profiles
• BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Attractiveness
• BRAF Mutated Non-small Cell Lung Cancer Market Drivers
• BRAF Mutated Non-small Cell Lung Cancer Market Barriers

Key Questions

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Market Insights:

• What was the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) drug class share (%) distribution in 2025 and how it would look like in 2036?
• What would be the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) total market size as well as market size by therapies across the 7MM during the forecast period (2026-2036)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market size during the forecast period (2026-2036)?
• At what CAGR, the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market is expected to grow by 7MM during the forecast period (2026-2036)?
• What would be the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market outlook across the 7MM during the forecast period (2026-2036)?
• What would be the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market growth till 2034, and what will be the resultant market Size in the year 2036?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

BRAF Mutated Non-small Cell Lung Cancer (NSCLC) Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of the BRAF Mutated Non-small Cell Lung Cancer (NSCLC)?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What is the historical BRAF Mutated Non-small Cell Lung Cancer (NSCLC) patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of BRAF Mutated Non-small Cell Lung Cancer (NSCLC) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to BRAF Mutated Non-small Cell Lung Cancer (NSCLC)?
• Out of all 7MM countries, which country would have the highest prevalent population of BRAF Mutated Non-small Cell Lung Cancer (NSCLC) during the forecast period (2026-2036)?
• At what CAGR the patient population is expected to grow in 7MM during the forecast period (2026-2036)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of BRAF Mutated Non-small Cell Lung Cancer (NSCLC) in the USA, Europe, and Japan?
• What are the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of BRAF Mutated Non-small Cell Lung Cancer (NSCLC)?
• How many therapies are in-development by each company for BRAF Mutated Non-small Cell Lung Cancer (NSCLC) treatment?
• How many are emerging therapies in mid-stage, and late stage of development for BRAF Mutated Non-small Cell Lung Cancer (NSCLC) treatment?
• What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for BRAF Mutated Non-small Cell Lung Cancer (NSCLC) and their status?
• What are the current challenges faced in drug development?
• What are the key designations that have been granted for the emerging therapies for BRAF Mutated Non-small Cell Lung Cancer (NSCLC)?
• What are the global historical and forecasted market of BRAF Mutated Non-small Cell Lung Cancer (NSCLC)?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market
• To understand the future market competition in the BRAF Mutated Non-small Cell Lung Cancer (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 Non-small Cell Lung Cancer (NSCLC) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
• Identification of strong upcoming players in the 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 Non-small Cell Lung Cancer (NSCLC) market
• To understand the future market competition in the BRAF Mutated Non-small Cell Lung Cancer (NSCLC) market

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