BRAF-Mutant Metastatic Melanoma Market

• BRAF-mutant metastatic melanoma is characterized by the spread of cancer and a mutation in the BRAF gene, with mutant BRAF found in 40–50% of cases driving uncontrolled cell growth and serving as a key target for therapy.
• Metastatic melanoma with BRAF mutations frequently exhibits aggressive behavior and confers an unfavorable prognosis. 
• Although dual checkpoint inhibition remains the preferred frontline approach for patients with BRAF-mutated, advanced-stage melanoma, there is a significant need for effective treatment alternatives for those who are refractory to, ineligible for, or did not respond to standard checkpoint blockade or BRAF/MEK inhibitors.
• The 2024 FDA approval of the tumor-infiltrating lymphocyte (TIL) therapy AMTAGVI as a third-line treatment for patients with BRAF mutations and a second-line option for broader melanoma populations represents a feasible treatment option for those who are sufficiently healthy and fit to tolerate next-line therapy. 
• The emergence of immune checkpoint inhibitors (ICIs) significantly improved patient outcomes and survival. However, targeted therapies (TT), including BRAF inhibitors and MEK inhibitors, have also become standard treatments after demonstrating efficacy in the treatment of patients with BRAF V600 mutation-positive metastatic melanoma and in earlier disease stages, including the adjuvant setting, particularly when used in combination.

DelveInsight’s "BRAF-mutant Metastatic Melanoma – Market Insight, Epidemiology, and Market Forecast – 2034" report delivers an in-depth understanding of BRAF-mutant metastatic melanoma, historical and forecasted epidemiology as well as the BRAF-mutant metastatic melanoma market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The BRAF-mutant metastatic melanoma market report provides current treatment practices, emerging drugs, BRAF-mutant metastatic melanoma share of individual therapies, and current and forecasted BRAF-mutant metastatic melanoma market size from 2020 to 2034, segmented by seven major markets. The report also covers current BRAF-mutant metastatic melanoma treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

BRAF-mutant Metastatic Melanoma Disease Understanding and Treatment Algorithm

BRAF-mutant Metastatic Melanoma Overview

BRAF-mutant metastatic melanoma is a subtype of melanoma driven by activating mutations in the BRAF gene, most commonly the V600E mutation, which leads to uncontrolled cell growth through the MAPK signaling pathway. It affects approximately 40–60% of patients with cutaneous melanoma and is often associated with aggressive disease and a higher likelihood of metastasis. Diagnosis includes molecular testing to detect the BRAF mutation and imaging to assess the extent of disease spread. Treatment has improved significantly with the use of targeted therapies, such as BRAF inhibitors combined with MEK inhibitors, which offer rapid tumor shrinkage. Immunotherapy, including PD-1 and CTLA-4 checkpoint inhibitors, is also widely used for its potential to induce long-term remission. Treatment selection is based on factors such as disease burden, mutation profile, and overall patient health. Ongoing research focuses on overcoming resistance and optimizing sequencing and combination strategies for better outcomes.

BRAF-mutant Metastatic Melanoma Diagnosis

Diagnosis of BRAF-mutant metastatic melanoma involves a combination of clinical evaluation, imaging, and molecular testing to confirm the presence of the mutation and determine the extent of disease spread. Initially, patients undergo a clinical examination to assess suspicious skin lesions and any signs of metastasis, such as lymph node enlargement or organ involvement. A biopsy of the primary or metastatic lesion is then performed to confirm the melanoma diagnosis histologically. Once confirmed, molecular testing (typically PCR or next-generation sequencing) is conducted on the tumor tissue to detect BRAF mutations, particularly the common V600E or V600K variants, which are critical for guiding targeted therapy. To evaluate the stage and extent of metastasis, imaging studies such as CT scans, PET scans, or MRI (especially for brain metastases) are employed. Blood tests, including lactate dehydrogenase (LDH) levels, may also provide prognostic information. Together, these diagnostic steps enable accurate staging, mutation profiling, and selection of appropriate treatment strategies.

Further details related to diagnosis will be provided in the report…

BRAF-mutant Metastatic Melanoma Treatment

Treatment of BRAF-mutant metastatic melanoma typically involves a combination of targeted therapy and immunotherapy, selected based on BRAF mutation status, disease burden, and patient condition. Targeted combinations like TAFINLAR with MEKINIST or ZELBORAF with COTELLIC inhibit abnormal BRAF/MEK signaling, providing rapid tumor shrinkage—especially beneficial in aggressive or symptomatic cases. Immunotherapies such as OPDIVO and YERVOY enhance immune-mediated tumor control and are often used together for durable responses. The OPDIVO + YERVOY combination is approved for frontline treatment and has shown significant survival benefits. Treatment sequencing may start with targeted therapy for quick control, followed by immunotherapy for long-term response. Research continues to refine these strategies, focusing on combination efficacy, resistance mechanisms, and personalized approaches.

Further details related to treatment will be provided in the report…

BRAF-mutant Metastatic Melanoma Epidemiology

The BRAF-mutant metastatic melanoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of BRAF mutant metastatic melanoma,  type-specific incident cases of BRAF mutant metastatic melanoma, stage-specific incident cases of BRAF mutant metastatic melanoma, age-specific incident cases of BRAF mutant metastatic melanoma, and total treated cases of BRAF mutant metastatic melanoma in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In Europe, overall incidence of metastatic melanoma is 13 per 100,000 population.
• In the US, approximately 40–50% of cutaneous melanomas harbor BRAF mutations, predominantly in the V600 codon.
• In Spain, approximately 40–60% of melanomas harbor mutations in the BRAF oncogene, mainly occurring in exon 15 and involving the amino acid substitution at position 600 (BRAF V600E).
• The annual incidence of melanoma in Japan has been reported to be 1–2 /100,000.

BRAF-mutant Metastatic Melanoma Drug Chapters

Marketed Drugs

YERVOY (ipilimumab): Bristol Myers Squibb

Ipilimumab (YERVOY), is a cytotoxic T-lymphocyte-antigen 4 (CTLA-4) inhibitor monoclonal antibody approved by the EMA and the US FDA in 2011 for the treatment of unresectable or metastatic melanoma. In 2016, both YERVOY and OPDIVO were approved in combination to treat people with metastatic melanoma, regardless of whether their tumors had BRAF mutations.

OPDIVO (nivolumab): Bristol Myers Squibb

OPDIVO is a type of cancer treatment drug called an immunotherapy. It is a treatment for a number of different types of cancer. In September 2015, FDA granted accelerated approval to nivolumab in combination with the antibody ipilimumab to treat patients with unresectable or metastatic melanoma that does not have a BRAF V600 mutation. FDA also expands use of OPDIVO as single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients, based on accelerated approval. The use of OPDIVO as a single-agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is approved under accelerated approval based on progression-free survival.

Emerging Drugs

Intismeran autogene (V940): Merck Sharp & Dohme/Moderna 

V940 is an investigational mRNA-based individualized neoantigen therapy targeting tumor associated antigens expressed by a patient’s cancer cells. V940 is being developed in collaboration with Moderna. V940 is being developed in combination with KEYTRUDA. It is currently being developed in Phase II for first-line advanced melanoma.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insight

In melanoma, approved immunotherapies like YERVOY and OPDIVO have become key treatments, enhancing immune response through CTLA-4 and PD-1 inhibition. Emerging therapies such as intismeran autogene, a personalized neoantigen vaccine, aim to further improve outcomes through tailored immune activation.

PD-1 receptor antagonists

PD-1 receptor antagonists play a central role in the treatment of melanoma, particularly in advanced or metastatic stages. These agents are a form of immune checkpoint inhibitors that block the PD-1 receptor on T cells, preventing it from binding to its ligands (PD-L1/PD-L2) expressed on tumor cells. This blockade restores T-cell activity and enables the immune system to recognize and attack melanoma cells more effectively. In the context of melanoma, PD-1 inhibitors have shown significant clinical benefits, including improved overall survival, durable responses, and a better safety profile compared to traditional chemotherapy. They are widely used as first-line therapy in both BRAF-mutant and wild-type melanoma, either as monotherapy or in combination with other checkpoint inhibitors (such as CTLA-4 inhibitor). Their effectiveness extends across various stages of disease, including metastatic, unresectable, and adjuvant settings. PD-1 receptor antagonists have transformed the treatment paradigm for melanoma, making immunotherapy a cornerstone in its management. Ongoing studies continue to evaluate their use in earlier disease stages, combination strategies, and as part of personalized treatment approaches based on biomarkers and tumor characteristics.

BRAF-mutant Metastatic Melanoma Market Outlook

The therapeutic landscape for metastatic melanoma has undergone a profound transformation over the past decade, moving beyond traditional chemotherapy and into the era of immunotherapy and targeted therapy. Historically, treatment options were limited and outcomes poor, as cytotoxic agents provided minimal survival benefit. The discovery of key molecular drivers, such as BRAF mutations, led to the development of targeted therapies that inhibit components of the MAPK signaling pathway, providing rapid tumor responses and meaningful improvements in survival. However, resistance often develops, and these treatments may not offer long-term disease control for all patients.

The introduction of immune checkpoint inhibitors, particularly agents targeting CTLA-4 and PD-1, has significantly improved survival and durability of response, becoming central to the management of advanced melanoma. These therapies restore and enhance T-cell activity, enabling the immune system to mount an effective antitumor response. In recent years, personalized immunotherapies such as neoantigen vaccines and cell-based therapies have entered clinical development, aiming to further refine treatment by tailoring immune responses to individual tumor profiles.

As research continues to advance, the focus is shifting toward precision medicine, integrating molecular diagnostics, biomarker-driven treatment selection, and novel therapeutic combinations. These innovations are redefining long-term disease management, with the goal of achieving sustained remission, improved quality of life, and reduced toxicity in patients with metastatic melanoma.

Further details will be provided in the report….

BRAF-mutant Metastatic Melanoma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034. The landscape of BRAF-mutant metastatic melanoma treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience. 

BRAF-mutant Metastatic Melanoma Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, and Phase II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for BRAF-mutant metastatic melanoma emerging therapies. 

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, Professor and Vice Chair of the Department of Cancer and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or BRAF-mutant metastatic melanoma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the Washington University School of Medicine, University Medical Center Hamburg-Eppendorf, and University Graduate School of Medicine etc. were contacted. Their opinion helps understand and validate BRAF-mutant metastatic melanoma epidemiology and market trends.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Further detailed analysis will be provided in the report….

Scope of the Report

• The report covers a descriptive overview of BRAF-mutant metastatic melanoma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into BRAF-mutant metastatic melanoma epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for BRAF-mutant metastatic melanoma 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-mutant metastatic melanoma market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM BRAF-mutant metastatic melanoma market. 

BRAF-mutant Metastatic Melanoma Report Insights

• Patient Population
• Therapeutic Approaches
• BRAF-mutant Metastatic Melanoma Pipeline Analysis
• BRAF-mutant Metastatic Melanoma Market Size and Trends
• Market Opportunities
• Impact of Upcoming Therapies

BRAF-mutant Metastatic Melanoma Report Key Strengths

• Ten Years Forecast
• 7MM Coverage 
• BRAF-mutant Metastatic Melanoma Epidemiology Segmentation
• Key Cross Competition 
• Highly Analyzed Market
• Drugs Uptake

BRAF-mutant Metastatic Melanoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the BRAF-mutant metastatic melanoma market share (%) distribution in 2020 and what it would look like in 2034?
• What would be the BRAF-mutant metastatic melanoma total market size as well as market size by therapies across the 7MM during the study period (2020–2034)?
• What are the key findings about the market across the 7MM and which country will have the largest BRAF-mutant metastatic melanoma market size during the study period (2020–2034)?
• At what CAGR, the BRAF-mutant metastatic melanoma market is expected to grow at the 7MM level during the study period (2020–2034)?
• What would be the BRAF-mutant metastatic melanoma market growth till 2034?
• What are the disease risks, burdens, and unmet needs of BRAF-mutant metastatic melanoma?
• What is the historical BRAF-mutant metastatic melanoma patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
• What will be the growth opportunities across the 7MM concerning the patient population of BRAF-mutant metastatic melanoma?
• Amon the 7MM which country would have the most incident cases of BRAF-mutant metastatic melanoma?
• At what CAGR the population is expected to grow across the 7MM during the study period (2020–2034)?
• How many companies are developing therapies for the treatment of BRAF-mutant metastatic melanoma?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of BRAF-mutant metastatic melanoma?
• What are the key collaborations (industry–industry, industry-academia), Mergers and acquisitions, and licensing activities related to BRAF-mutant metastatic melanoma therapies? 
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies? 
• What are the clinical studies going on for BRAF-mutant metastatic melanoma and their status?
• What are the key designations that have been granted for the emerging therapies for BRAF-mutant metastatic melanoma?
• What are the 7MM historical and forecasted market of BRAF-mutant metastatic melanoma?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the BRAF-mutant metastatic melanoma market.
• To understand the future market competition in the BRAF-mutant metastatic melanoma market and insightful review of the SWOT analysis of BRAF-mutant metastatic melanoma.
• Organize sales and marketing efforts by identifying the best opportunities for BRAF-mutant metastatic melanoma in the US, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• To understand the future market competition in the BRAF-mutant metastatic melanoma.