Global NTRK Fusion Gene Positive Advanced Solid Tumor market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Treatment Type;
Targeted Therapy, Chemotherapy, Immunotherapy, Surgery, and Radiation TherapyBy Tumor Type;
Lung Cancer, Colorectal Cancer, Breast Cancer, Pancreatic Cancer, and SarcomaBy Indication;
NTRK 1 Fusion Tumors, NTRK 2 Fusion Tumors, and NTRK 3 Fusion TumorsBy End-User;
Hospitals & Clinics, Cancer Centers, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)NTRK Fusion Gene Positive Advanced Solid Tumor Market Overview
NTRK Fusion Gene Positive Advanced Solid Tumor Market (USD Million)
NTRK Fusion Gene Positive Advanced Solid Tumor Market was valued at USD 145.36 million in the year 2024. The size of this market is expected to increase to USD 221.40 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 6.2%.
Global NTRK Fusion Gene Positive Advanced Solid Tumor market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 6.2 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 6.2 % |
Market Size (2024) | USD 145.36 Million |
Market Size (2031) | USD 221.40 Million |
Market Concentration | Medium |
Report Pages | 315 |
Major Players
- Bayer AG
- Cephalon, Inc.
- Empire Genomics, LLC.
- Exelixis, Inc
- F. Hoffmann-La Roche Ltd
- NeoGenomics Laboratories, Inc.
- OncoDNA
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global NTRK Fusion Gene Positive Advanced Solid Tumor market
Fragmented - Highly competitive market without dominant players
The NTRK fusion gene positive advanced solid tumor market is witnessing notable expansion, primarily fueled by advancements in molecular diagnostics and the growing availability of precision-targeted therapies. While NTRK gene fusions are relatively rare, their detection across various tumor types is gaining clinical significance. The increasing emphasis on personalized oncology and the integration of advanced genetic profiling tools are supporting consistent market growth.
Rising Prevalence and Diagnostic Adoption
Despite their occurrence in less than 1% of solid tumors, NTRK gene fusions have become crucial markers due to their strong correlation with positive treatment outcomes. The use of next-generation sequencing (NGS) has surged by over 35%, facilitating earlier and more accurate identification of these rare mutations. This widespread adoption of advanced diagnostics is reshaping clinical decision-making and driving the adoption of precision therapies.
Therapeutic Breakthroughs Driving Demand
The introduction of TRK inhibitors has revolutionized the treatment landscape, demonstrating response rates surpassing 75% among patients with NTRK fusion-positive malignancies. These promising results have led to swift regulatory approvals and their incorporation into mainstream oncology protocols. Continuous drug development and expanding clinical trials are further enhancing the therapeutic pipeline and strengthening market potential.
Future Outlook
Several factors are accelerating market evolution, including increased genomic screening, substantial investment in cancer research, and proven efficacy of targeted treatments. With more than 40% of cancer care facilities now conducting routine testing for actionable mutations like NTRK fusions, the diagnostic and therapeutic framework is undergoing rapid transformation. The continued advancement of precision medicine is set to propel the NTRK fusion gene positive solid tumor market forward, making it a key focus area in oncology.
NTRK Fusion Gene Positive Advanced Solid Tumor Market Recent Developments
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In January 2024, the launch of combination therapies integrating TRK inhibitors (such as Larotrectinib and Entrectinib) with immunotherapy marked a significant advancement in oncology. This innovative approach aims to enhance treatment outcomes for patients with advanced NTRK fusion-positive tumors, a rare but aggressive form of cancer.
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In June 2024, the FDA granted accelerated approval to repotrectinib (AUGTYRO), developed by Bristol-Myers Squibb, for the treatment of adult and pediatric patients aged 12 and above with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. This approval applies specifically to cases where patients have experienced disease progression following prior therapy. The decision underscores the growing importance of targeted therapies in managing genetically defined cancers and reflects the agency's commitment to expanding treatment options for rare, mutation-driven malignancies.
NTRK Fusion Gene Positive Advanced Solid Tumor Market Segment Analysis
In this report, the NTRK Fusion Gene Positive Advanced Solid Tumor Market has been segmented by Treatment Type, Tumor Type, Indication, End-User, and Geography.
NTRK Fusion Gene Positive Advanced Solid Tumor Market, Segmentation by Treatment Type
The NTRK Fusion Gene Positive Advanced Solid Tumor market has been segmented by Treatment Type into Targeted Therapy, Chemotherapy, Immunotherapy, Surgery, and Radiation Therapy.
Targeted Therapy
Targeted therapy leads the NTRK fusion gene positive advanced solid tumor treatment market, comprising approximately 46% of total share. Innovative TRK inhibitors such as larotrectinib and entrectinib offer high tumor-agnostic efficacy across various cancer types. Their ability to produce durable responses with fewer side effects makes them the preferred option in patients with confirmed NTRK gene fusions, especially in advanced-stage settings.
Chemotherapy
Chemotherapy holds about 22% of the global market and continues to play a role in treating NTRK fusion-positive cancers, particularly where genetic testing is unavailable or when targeted treatments fail. It is also used as a complementary therapy in combination with surgery or radiation, especially in low-resource or late-diagnosis cases.
Immunotherapy
Immunotherapy makes up roughly 14% of the market. While still under investigation for this patient group, immune checkpoint inhibitors such as PD-1/PD-L1 blockers show promise, especially in tumors with high tumor mutational burden (TMB). As evidence grows, this segment is expected to expand through clinical trial adoption and biomarker-based selection.
Surgery and Radiation Therapy
Surgery and radiation therapy together contribute around 18% of the market and remain integral in managing localized tumors or for palliative care in advanced-stage patients. These conventional approaches are especially important when rapid tumor debulking or symptom relief is needed, often in combination with systemic treatments.
NTRK Fusion Gene Positive Advanced Solid Tumor Market, Segmentation by Tumor Type
The NTRK Fusion Gene Positive Advanced Solid Tumor market has been segmented by Tumor Type into Lung Cancer, Colorectal Cancer, Breast Cancer, Pancreatic Cancer, and Sarcoma.
Lung Cancer
Lung cancer holds the largest share in the NTRK fusion gene positive advanced solid tumor market, accounting for approximately 31%. Due to the high incidence of non-small cell lung cancer (NSCLC) and advancements in molecular diagnostics, the identification of NTRK gene fusions is increasing. As a result, TRK inhibitors are gaining momentum as a preferred treatment pathway, significantly improving outcomes in fusion-positive lung cancer patients.
Colorectal Cancer
Colorectal cancer makes up nearly 24% of the market. Though NTRK fusions occur in a small subset of colorectal tumors, the integration of comprehensive genomic profiling has expanded detection. Patients with these rare fusions benefit significantly from targeted therapies, contributing to rising demand for TRK inhibitors in this segment.
Breast Cancer
Breast cancer accounts for about 18% of the global market. Fusion events are most commonly found in secretory breast carcinoma, a rare and often indolent subtype. With the increasing use of next-generation sequencing (NGS) and heightened awareness of tumor-agnostic therapies, targeted treatment options are becoming more available for these patients.
Pancreatic Cancer and Sarcoma
Pancreatic cancer and sarcoma together constitute approximately 27% of the market. Sarcomas, especially infantile fibrosarcoma and certain soft tissue sarcomas, have higher rates of NTRK fusions, making them prime candidates for TRK-targeted therapy. Although pancreatic tumors with NTRK alterations are rare, the availability of tumor-agnostic approvals enhances treatment accessibility for these hard-to-treat malignancies.
NTRK Fusion Gene Positive Advanced Solid Tumor Market, Segmentation by Indication
The NTRK Fusion Gene Positive Advanced Solid Tumor market has been segmented by Indication into NTRK 1 Fusion Tumors, NTRK 2 Fusion Tumors, and NTRK 3 Fusion Tumors.
NTRK 1 Fusion Tumors
NTRK 1 fusion tumors lead the NTRK fusion gene positive advanced solid tumor market, contributing around 48% of the total share. These genetic alterations are most frequently found in cancers such as thyroid cancer, colorectal cancer, and salivary gland tumors. Owing to their relatively higher prevalence and strong clinical response rates to TRK inhibitors, particularly larotrectinib, this segment remains a major focus for therapeutic development and clinical adoption.
NTRK 2 Fusion Tumors
NTRK 2 fusion tumors represent approximately 29% of the global market and are primarily observed in central nervous system (CNS) malignancies, including gliomas. Although less common than NTRK 1, advancements in genomic sequencing and tumor profiling are enhancing detection. With ongoing research and expanding clinical trial inclusion, this segment is poised for gradual growth as precision oncology evolves.
NTRK 3 Fusion Tumors
NTRK 3 fusion tumors make up roughly 23% of the market, predominantly seen in secretory breast carcinoma and infantile fibrosarcoma. These tumors exhibit strong responsiveness to TRK-targeted therapy, offering high efficacy in both pediatric and adult populations. As awareness of rare tumor diagnostics improves, NTRK 3 fusion testing and treatment utilization are expected to increase steadily.
NTRK Fusion Gene Positive Advanced Solid Tumor Market, Segmentation by End-User
The NTRK Fusion Gene Positive Advanced Solid Tumor market has been segmented by End-User into Hospitals & Clinics, Cancer Centers, and Others.
Hospitals & Clinics
Hospitals and clinics dominate the NTRK fusion gene positive advanced solid tumor market, accounting for nearly 59% of global end-user adoption. These institutions are critical for delivering integrated oncology care, where patients undergo genetic testing, receive targeted therapies, and benefit from multidisciplinary consultations. Their robust clinical infrastructure supports the growing demand for personalized cancer treatment involving TRK inhibitors.
Cancer Centers
Cancer centers represent approximately 31% of the market and play a pivotal role in the management of rare gene fusion cancers. With access to cutting-edge diagnostics, clinical research, and specialized oncology teams, these centers are leading hubs for implementing precision medicine. Their ability to rapidly adopt and integrate tumor-agnostic therapies makes them key drivers in the uptake of NTRK-targeted treatment.
Others
The Others category, comprising around 10% of the market, includes ambulatory surgical centers, private clinics, and diagnostic laboratories. These settings are becoming more involved in early genetic screening and outpatient therapy as access to molecular diagnostics improves. With further decentralization of care, this segment is likely to witness steady growth.
NTRK Fusion Gene Positive Advanced Solid Tumor Market, Segmentation by Geography
In this report, the NTRK Fusion Gene Positive Advanced Solid Tumor market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Regions and Countries Analyzed in this Report
NTRK Fusion Gene Positive Advanced Solid Tumor Market Share (%), by Geographical Region, 2024
North America
North America dominates the NTRK fusion gene positive advanced solid tumor market, with a share of approximately 41%. This growth is driven by strong adoption of genomic profiling, widespread availability of TRK inhibitors, and early integration of tumor-agnostic treatments. The United States, in particular, benefits from advanced oncology infrastructure, a high concentration of clinical trials, and supportive insurance frameworks.
Europe
Europe contributes around 27% of the global market. Nations such as Germany, France, and the UK have adopted next-generation sequencing (NGS) and biomarker testing into routine oncology workflows. With increased emphasis on personalized medicine and early detection, the region is well-positioned to expand its adoption of NTRK-targeted therapies.
Asia Pacific
Asia Pacific represents roughly 21% of the market and is projected to grow at the fastest pace. Rising incidence of cancer, rapid improvements in diagnostic technology, and strategic initiatives by governments to promote precision oncology are fueling regional growth. Countries like China, Japan, and South Korea are actively participating in clinical research and are accelerating market penetration.
Middle East & Africa and Latin America
Together, Middle East & Africa and Latin America make up the remaining 11% of the market. Despite infrastructural challenges, the introduction of international partnerships, expanding cancer care programs, and enhanced access to molecular diagnostics are contributing to steady progress. Latin America, in particular, is increasing participation in targeted therapy protocols, while African regions are beginning to adopt tumor-specific screening practices.
NTRK Fusion Gene Positive Advanced Solid Tumor Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of NTRK Fusion Gene Positive Advanced Solid Tumor market Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
---|---|---|---|---|---|
Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers:
- Growth in Precision Oncology Solutions
- Breakthroughs in Targeted Cancer Therapies
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Surge in Global Oncology Trials - The increasing number of oncology clinical trials worldwide is significantly boosting the growth of the NTRK fusion gene positive advanced solid tumor market. As precision oncology continues to evolve, there is a rising focus on investigating treatments specifically targeting tumors with NTRK gene fusions. Pharmaceutical companies and research institutions are actively investing in clinical studies to evaluate the safety and effectiveness of TRK inhibitors, particularly in patients with advanced or treatment-resistant tumors. These trials not only generate crucial clinical data but also accelerate drug approvals and expand access to innovative therapies.
One of the main drivers behind this growth is the tumor-agnostic nature of NTRK fusion positive cancers, which allows therapies to be tested across different tumor types within a single study. This pan-cancer approach helps reduce development timelines and improves the efficiency of regulatory processes. Regulatory bodies such as the FDA and EMA have increasingly supported these strategies through fast-track designations and conditional approvals, especially when trials demonstrate strong response rates despite limited patient populations.
The globalization of oncology trials has also played a pivotal role, as more countries across regions like Asia-Pacific, Europe, and Latin America participate in patient recruitment and data collection. Broader geographic involvement ensures diverse genetic representation and improves access to breakthrough therapies. This expansion supports a more inclusive approach to cancer care and strengthens the reliability of trial outcomes, encouraging wider clinical adoption of NTRK-targeted treatments.
Technological advancements are further transforming the clinical trial landscape. The use of real-time digital platforms, AI-enhanced recruitment strategies, and advanced biomarker monitoring tools is streamlining trial operations and reducing associated costs. These innovations make it easier for emerging biotech firms to conduct research and bring novel therapies to market. Ultimately, the rise in global clinical trials is not only enhancing the therapeutic landscape for NTRK fusion-positive cancers but also fostering broader awareness and adoption of molecular diagnostics in oncology.
Restraints:
- Emergence of Drug Resistance Mutations
- Insufficient Validation of Predictive Biomarkers
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Unequal Access to Oncology Care - One of the major challenges restraining the growth of the NTRK fusion gene positive advanced solid tumor market is the widespread disparity in access to oncology care. Despite the advancements in targeted cancer therapies and precision diagnostics, a significant portion of the global population still lacks access to specialized cancer treatment. This inequality is especially pronounced in low-income regions, rural areas, and underserved communities where healthcare infrastructure remains limited and specialized services are scarce.
Access to essential diagnostic tools, such as next-generation sequencing (NGS), plays a pivotal role in identifying NTRK gene fusions. However, these advanced molecular tests are not readily available or affordable in many parts of the world. Even in healthcare systems where such technologies exist, utilization may be hampered by a lack of clinical awareness, inadequate reimbursement policies, or logistical hurdles. This results in delayed or missed diagnoses, depriving patients of potentially life-saving targeted therapies.
Another significant barrier lies in the high cost of TRK inhibitors. While these treatments have demonstrated high efficacy, their premium pricing makes them inaccessible to many patients who lack sufficient insurance coverage or live in countries without subsidized healthcare systems. For individuals diagnosed with NTRK-positive tumors, the financial burden of initiating or maintaining treatment can be overwhelming, often leading to incomplete care and poorer outcomes.
To address this critical issue, there is a growing need for collaborative efforts among healthcare providers, policymakers, and pharmaceutical companies. Expanding global access programs, investing in infrastructure, and implementing equitable reimbursement policies will be essential steps toward reducing the treatment gap. Until such measures are in place, the lack of equal access will remain a significant restraint, limiting the full potential of NTRK fusion-targeted therapies across the global cancer care spectrum.
Opportunities:
- Expansion in Next-Gen Targeted Therapies
- Advancements in Novel Biomarker Research
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Shift Toward Personalized Cancer Care - The growing emphasis on personalized cancer care presents a significant opportunity for the NTRK fusion gene positive advanced solid tumor market. This evolving approach in oncology focuses on customizing treatment based on the unique genetic makeup of an individual’s tumor, enabling highly targeted therapeutic strategies. As NTRK gene fusions are recognized as key drivers in a subset of cancers, therapies that directly inhibit these genetic alterations are becoming central to precision treatment models, offering a more focused and effective intervention.
A major contributor to this shift is the increasing adoption of comprehensive genomic profiling within routine clinical workflows. Technologies such as next-generation sequencing (NGS) are enabling earlier and more accurate detection of rare mutations, including NTRK fusions. As testing becomes more accessible and affordable, more patients are being identified as candidates for TRK inhibitor therapies. This expanding diagnostic coverage is helping to unlock the commercial potential of targeted treatments by broadening the eligible patient base.
Patients and clinicians are also increasingly favoring therapies that are not only effective but better tolerated than traditional options like chemotherapy. Targeted treatments for NTRK fusion-positive tumors offer improved clinical outcomes and reduced side effects, aligning with the broader shift toward patient-centric care. This focus on quality of life, combined with higher response rates, is reinforcing the value proposition of personalized medicine in the oncology space.
Furthermore, advancements in real-world data collection, companion diagnostics, and biomarker-driven research are accelerating the pace of innovation. These developments are supporting quicker regulatory approvals, encouraging payer acceptance, and paving the way for broader access to precision therapies. As the personalized treatment model continues to gain momentum, it is set to play a pivotal role in shaping the future of NTRK-targeted cancer care.
NTRK Fusion Gene Positive Advanced Solid Tumor Market Competitive Landscape Analysis
Key players in NTRK Fusion Gene Positive Advanced Solid Tumor Market include:
- Bayer
- Teva Pharmaceuticals
- Empire Genomics
- SeraCare Life Sciences
- F. Hoffmann-La Roche
- NeoGenomics Laboratories
- GlaxoSmithKline
- OncoDNA
- Merck & Co.
- Daiichi Sankyo
- Deciphera Pharmaceuticals
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Treatment Type
- Market Snapshot, By Tumor Type
- Market Snapshot, By Indication
- Market Snapshot, By End-User
- Market Snapshot, By Region
- NTRK Fusion Gene Positive Advanced Solid Tumor Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Growth in Precision Oncology Solutions
- Breakthroughs in Targeted Cancer Therapies
- Surge in Global Oncology Trials
- Restraints
- Emergence of Drug Resistance Mutations
- Insufficient Validation of Predictive Biomarkers
- Unequal Access to Oncology Care
- Opportunities
- Expansion in Next-Gen Targeted Therapies
- Advancements in Novel Biomarker Research
- Shift Toward Personalized Cancer Care
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By Treatmrent Type, 2021 - 2031 (USD Million)
- Targeted Therapy
- Chemotherapy
- Immunotherapy
- Surgery
- Radiation Therapy
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By Tumor Type, 2021 - 2031 (USD Million)
- Lung Cancer
- Colorectal Cancer
- Breast Cancer
- Pancreatic Cancer
- Sarcoma
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By Indication, 2021 - 2031 (USD Million)
- NTRK 1 Fusion Tumors
- NTRK 2 Fusion Tumors
- NTRK 3 Fusion Tumors
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By End-User 2021 - 2031 (USD Million)
- Hospitals & Clinics
- Cancer Centers
- Others
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- NTRK Fusion Gene Positive Advanced Solid Tumor Market, By Treatmrent Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Bayer
- Teva Pharmaceuticals
- Empire Genomics
- SeraCare Life Sciences
- F. Hoffmann-La Roche
- NeoGenomics Laboratories
- GlaxoSmithKline
- OncoDNA
- Merck & Co.
- Daiichi Sankyo
- Deciphera Pharmaceuticals
- Company Profiles
- Analyst Views
- Future Outlook of the Market