NTRK 융합 유전자 양성 진행 고형 종양 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the NTRK fusion gene positive advanced solid tumor market size is expected to grow from USD 437.45 million in 2025 to USD 460.82 million in 2026 and is forecast to reach USD 597.73 million by 2031 at 5.34% CAGR over 2026-2031.

This report is Segmented by Product Type (Therapeutics [First-Generation TRK Inhibitors and More], and Diagnostics [NGS Panels, and More]), Tumor Origin (Thyroid Cancer, Salivary Gland Cancer, and More), End-User (Hospitals and Clinics, Cancer Centers, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global NTRK Fusion Gene Positive Advanced Solid Tumor Market Trends and Insights

Surging Global Cancer Incidence & Earlier-Stage Molecular Testing

Cancer prevalence is rising, and oncologists are moving molecular profiling to earlier treatment lines, which lifts the identification rate of NTRK fusions across tumor groups. Guidelines now recommend up-front NGS rather than sequential single-gene tests, lengthening the therapeutic window for tissue-agnostic agents. Platforms such as TruSight Oncology Comprehensive allow the simultaneous detection of multiple biomarkers from limited tissue, which cuts diagnostic turnaround and speeds therapy selection. Earlier detection aligns with physician comfort in prescribing TRK inhibitors outside traditional tumor labels, so prescription volumes rise even though fusion rates remain low. Countries with mature reimbursement for broad NGS, notably the US and Germany, show the fastest conversion from positive test to drug initiation. Over the medium term, the driver lifts the NTRK fusion gene positive advanced solid tumor market by an estimated 1.2 percentage points of CAGR.

Accelerated FDA/EMA Tissue-Agnostic Approvals for TRK Inhibitors

Regulators have endorsed the principle that a genomic alteration, not tumor site, can define a drug label. The initial approvals of larotrectinib and entrectinib set the precedent, and more approvals under this pathway shorten clinical development timelines. Pharmaceutical firms now pursue a single basket study across multiple histologies, which lowers trial cost and speeds global launch. The EMA's synchronised reviews remove regional sequencing barriers, enabling nearly simultaneous access across major markets. Repotrectinib's 2024 clearance for ROS1-positive NSCLC shows the expanding regulatory appetite for biomarker-centric drugs. The approach raises investor confidence, resulting in more pipelines targeting rare fusions and reinforcing market growth in the near term.

High Cost & Patchy Reimbursement for TRK Testing / Therapies

NGS panels may cost USD 3,000-5,000, an outlay that strains payer budgets when fusion prevalence is low. Private insurers often approve narrower panels, compelling clinicians to order second tests if initial screens miss an NTRK fusion. Patient assistance programs offer temporary relief but do not fix systemic reimbursement gaps. The Large Urology Group Practice Association continues to lobby for universal coverage on the grounds that precise therapy reduces later-line spending. Until reimbursement stabilises, uneven access is likely to subtract 0.9 percentage points from the global CAGR.

Other drivers and restraints analyzed in the detailed report include:

1. Investment Spike in CNS-Penetrant Next-Gen TRK Inhibitors
2. Rapid Adoption of NGS-Based Comprehensive Genomic Profiling
3. Limited Molecular Pathology Capacity in Emerging Markets

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Therapeutics captured 83.96% of revenue in 2025, reflecting the willingness of payors to reimburse drugs that improve progression-free survival in biomarker-selected patients. First-generation agents created the initial revenue base, and the pipeline of CNS-penetrant molecules positions the segment for steady share retention. The NTRK fusion gene positive advanced solid tumor market benefited from surge pricing linked to orphan drug status in major markets. Combination strategies that include radioligand or immune-checkpoint blockers promise additional life-cycle options, so the therapeutic segment's 15.55% CAGR remains credible. Diagnostics, while representing 16.04% of revenue, contribute indirect value because broader testing widens the funnel of treatable patients and thus bolsters drug demand. Integrated companies that sell both a therapy and its companion test are gaining scale efficiencies and can bundle offerings under value-based contracts, reinforcing the premium attached to their therapeutic portfolios.

Diagnostic innovation continues to lower sequencing costs and raise sensitivity, creating a positive feedback loop for therapeutic prescribing. NGS panels dominate current diagnostic revenue because they assess multiple alterations within a single workflow. IHC and FISH remain for confirmation and for sites that cannot finance high-throughput sequencers. Liquid biopsy tests, still early in their adoption curve, show strong potential in monitoring for resistance mutations and may gradually cannibalise repeat tissue biopsies. As evidence of clinical utility accumulates, payors will likely align reimbursement with these less-invasive assays, further supporting diagnostic growth and indirectly raising therapy volumes.

Complete Report Scope:

• By Product Type
  • Therapeutics
    • First-Generation TRK Inhibitors
    • Next-Generation TRK Inhibitors
  • Diagnostics
    • NGS Panels
    • Immunohistochemistry (IHC)
    • FISH
    • RT-PCR
    • Others
• By Tumor Origin
  • Thyroid Cancer
  • Salivary Gland Cancer
  • Lung Cancer (NSCLC)
  • Colorectal Cancer
  • Others
• By End-User
  • Hospitals & Clinics
  • Cancer Centers
  • Diagnostic Laboratories
  • Others
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America led with a 41.90% share in 2025 on the back of strong reimbursement for NGS, mature clinical trial networks, and the earliest adoption of tissue-agnostic labels. Public payors have clarified coverage for comprehensive panels, but commercial insurers continue to apply variable utilisation management criteria that can delay testing in community settings. Large pharmaceutical investments, including Roche's USD 50 billion allocation for new manufacturing and diagnostics capacity, expand supply chain resilience in the region.

Asia-Pacific posts the highest 15.05% CAGR because of parallel momentum in China's precision medicine blueprint and Japan's national genomic screening initiatives. Seoul and Taipei have demonstrated viable reimbursement models that bundle testing with therapy, while India's private oncology chains incorporate broad molecular profiling for self-pay patients. Pathology capacity gaps persist outside tier-one cities, yet regional governments are funding training to close the skills deficit. The rapid rise in lung and colorectal cancer incidence underpins test volume, and payors are now experimenting with risk-sharing deals that lower the budget impact of premium drugs.

Europe maintains balanced growth as coordinated EMA reviews keep launch timelines close to those in the United States. Germany and the United Kingdom anchor adoption with robust molecular tumour boards, while France links reimbursement to outcome-based evidence. Central and Eastern European states still lag due to budget constraints, yet EU-wide initiatives aim to harmonise test quality and data-sharing frameworks. Digital pathology networks allow cross-border consultation that compensates for local workforce shortages, supporting gradual convergence in testing standards. Overall, the region's focus on cost-effectiveness exerts down-ward pressure on price but increases volume predictability.

1. Bayer
2. Eli Lilly and Company
3. Roche
4. Bristol-Myers Squibb
5. Blueprint Medicines Corp.
6. Novartis
7. Takeda Pharmaceutical Co.
8. Regeneron Pharmaceuticals
9. Pfizer
10. Guardant Health
11. NeoGenomics Laboratories
12. Foundation Medicine Inc.
13. Thermo Fisher Scientific
14. QIAGEN
15. Illumina
16. Natera
17. Caris Life Sciences
18. Tempus Labs Inc.
19. OncoDNA S.A.
20. Empire Genomics LLC
21. LGC Clinical Diagnostics (SeraCare)
22. Fulgent Genetics Inc.
23. Exact Sciences Corp.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Surging Global Cancer Incidence & Earlier-Stage Molecular Testing
  • 4.2.2 Accelerated FDA/EMA Tissue-Agnostic Approvals For TRK Inhibitors
  • 4.2.3 Investment Spike In CNS-Penetrant Next-Gen TRK Inhibitors
  • 4.2.4 Rapid Adoption Of NGS-Based Comprehensive Genomic Profiling
  • 4.2.5 Breakthroughs In Liquid-Biopsy TRK Fusion Assays
  • 4.2.6 Pharma-Diagnostics Codevelopment Rebates In Select Payor Contracts
• 4.3 Market Restraints
  • 4.3.1 High Cost & Patchy Reimbursement For TRK Testing/Therapies
  • 4.3.2 Limited Molecular Pathology Capacity In Emerging Markets
  • 4.3.3 Low Oncologist Awareness Causing Sub-Optimal Clinical Uptake
  • 4.3.4 On-Target Resistance Mutations Shortening Therapy Duration
• 4.4 Supply-Chain Analysis
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Therapeutics
    • 5.1.1.1 First-Generation TRK Inhibitors
    • 5.1.1.2 Next-Generation TRK Inhibitors
  • 5.1.2 Diagnostics
    • 5.1.2.1 NGS Panels
    • 5.1.2.2 Immunohistochemistry (IHC)
    • 5.1.2.3 FISH
    • 5.1.2.4 RT-PCR
    • 5.1.2.5 Others
• 5.2 By Tumor Origin
  • 5.2.1 Thyroid Cancer
  • 5.2.2 Salivary Gland Cancer
  • 5.2.3 Lung Cancer (NSCLC)
  • 5.2.4 Colorectal Cancer
  • 5.2.5 Others
• 5.3 By End-User
  • 5.3.1 Hospitals & Clinics
  • 5.3.2 Cancer Centers
  • 5.3.3 Diagnostic Laboratories
  • 5.3.4 Others
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Bayer AG
  • 6.3.2 Eli Lilly & Company
  • 6.3.3 F. Hoffmann-La Roche Ltd
  • 6.3.4 Bristol Myers Squibb
  • 6.3.5 Blueprint Medicines Corp.
  • 6.3.6 Novartis AG
  • 6.3.7 Takeda Pharmaceutical Co.
  • 6.3.8 Regeneron Pharmaceuticals
  • 6.3.9 Pfizer Inc.
  • 6.3.10 Guardant Health Inc.
  • 6.3.11 NeoGenomics Laboratories Inc.
  • 6.3.12 Foundation Medicine Inc.
  • 6.3.13 Thermo Fisher Scientific Inc.
  • 6.3.14 Qiagen N.V.
  • 6.3.15 Illumina Inc.
  • 6.3.16 Natera Inc.
  • 6.3.17 Caris Life Sciences
  • 6.3.18 Tempus Labs Inc.
  • 6.3.19 OncoDNA S.A.
  • 6.3.20 Empire Genomics LLC
  • 6.3.21 LGC Clinical Diagnostics (SeraCare)
  • 6.3.22 Fulgent Genetics Inc.
  • 6.3.23 Exact Sciences Corp.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment