The FGFR inhibitors market is projected to witness substantial growth in the coming years, driven by the rising incidence of conditions such as urothelial carcinoma, cholangiocarcinoma, and myeloid/lymphoid neoplasms, among others. This growth is further supported by increasing awareness of FGFR inhibitors and a surge in emerging drug candidates currently in clinical trials or awaiting regulatory approval from various companies.
LAS VEGAS, Aug. 19, 2025 /PRNewswire/ — DelveInsight’s FGFR Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Cholangiocarcinoma, Urothelial Carcinoma, Myeloid/Lymphoid Neoplasms, Non-muscle Invasive Bladder Cancer, IgG4-RD, Multiple Sclerosis, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging FGFR inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM.
Key Takeaways from the FGFR Inhibitors Market Report
- As per DelveInsight’s analysis, the total market size of FGFR inhibitors in the 7MM is expected to surge significantly by 2034.
- The report provides the total potential number of patients in the indications, such as Cholangiocarcinoma, Urothelial Carcinoma, Myeloid/Lymphoid Neoplasms, Non-muscle Invasive Bladder Cancer, IgG4-RD, Multiple Sclerosis, and others.
- Leading FGFR inhibitor companies, such as Tyra Biosciences, Abbisko Therapeutics, and others, are developing novel FGFR inhibitors that can be available in the FGFR inhibitors market in the coming years.
- Some of the key FGFR inhibitors in the pipeline include TYRA-300, ABSK061, and others.
- In January 2025, Tyra Biosciences received FDA clearance to initiate the Phase II SURF302 trial of TYRA-300 in FGFR3-altered low-grade, intermediate-risk NMIBC.
Discover which indication is expected to grab the major FGFR inhibitors market share @ FGFR Inhibitors Market Report
FGFR Inhibitors Market Dynamics
The FGFR inhibitors market is evolving rapidly, driven by increased understanding of the FGFR signaling pathway’s role in oncogenesis and other diseases. FGFR alterations, such as fusions, mutations, and amplifications, are implicated in various cancers, including urothelial carcinoma, cholangiocarcinoma, and certain rare hematologic malignancies. The availability of targeted therapies has validated FGFR as a therapeutic target, fostering ongoing research and pipeline expansion. Increasing molecular diagnostic testing adoption is also enabling more precise patient selection, supporting market growth.
Regulatory approvals and label expansions are key drivers shaping the FGFR inhibitors market dynamics. For example, FDA approvals for specific FGFR-altered cancers have set strong clinical and commercial precedents, encouraging investment in novel compounds and combination strategies. The growing emphasis on personalized medicine is prompting pharmaceutical companies to integrate FGFR testing into broader oncology portfolios. Moreover, accelerated approval pathways for rare mutations and orphan indications provide opportunities for niche market entry with high-value therapeutics, further intensifying competition among established players and emerging biotech firms.
However, market growth is tempered by certain challenges. Resistance mechanisms, both primary and acquired, limit the durability of FGFR inhibitor responses, prompting research into next-generation inhibitors and combination regimens with immunotherapy or other targeted agents. Safety concerns, such as hyperphosphatemia, ocular toxicities, and other class-specific adverse effects, necessitate careful patient monitoring and may impact long-term treatment adherence. Additionally, the relatively small eligible patient population for certain FGFR-driven cancers requires strategic commercialization models to ensure profitability while maintaining accessibility.
Competitive dynamics are characterized by a blend of first-to-market advantage and differentiation strategies. While approved drugs have secured initial market share, pipeline candidates are focusing on improved selectivity, broader mutation coverage, and overcoming resistance. Collaborations between diagnostic companies and drug developers are becoming more common to streamline companion diagnostics and improve treatment uptake. Geographic expansion into emerging markets, where biomarker testing is gaining traction, presents additional growth opportunities, though regulatory and reimbursement frameworks may vary significantly.
FGFR Inhibitors Treatment Market
FDA-approved FGFR inhibitors are indicated for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR2/FGFR3 alterations, previously treated unresectable or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, and relapsed/refractory myeloid or lymphoid neoplasms with FGFR1 rearrangement. The current market includes approved therapies such as LYTGOBI (futibatinib), PEMAZYRE (pemigatinib), and BALVERSA (erdafitinib).
LYTGOBI (futibatinib), developed by Taiho Oncology, is an oral, irreversible FGFR inhibitor for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions or rearrangements. The FDA granted it accelerated approval in September 2022 based on the FOENIX-CCA2 trial, which showed a 42% objective response rate and a median response duration of 9.7 months. Unlike other FGFR inhibitors, LYTGOBI covalently binds to FGFR2, enabling prolonged inhibition of the receptor and its downstream signaling. In 2023, it also received conditional marketing authorization from the European Commission (July) and was launched in Japan (August) for biliary tract cancers with FGFR2 fusions after chemotherapy progression.
PEMAZYRE (pemigatinib), from Incyte Corporation, is another oral FGFR inhibitor approved for adults with previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements. It received FDA accelerated approval in April 2020 following the FIGHT-202 trial, which reported a 36% response rate. In 2022, the FDA also approved it for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement, supported by FIGHT-203 data. The drug is additionally approved in Japan for this rare hematologic malignancy and is under evaluation for other FGFR-driven cancers.
In May 2024, the FDA finalized the withdrawal of TRUSELTIQ (infigratinib) for previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements. The manufacturer, QED Therapeutics, requested the withdrawal due to difficulties in recruiting for a confirmatory first-line trial and the lack of commercial viability for continued second-line use. Infigratinib had gained accelerated approval in May 2021 for this population, contingent on postmarketing studies to confirm clinical benefit.
Learn more about the FGFR inhibitors @ FGFR Inhibitors Analysis
Key Emerging FGFR Inhibitors and Companies
Promising FGFR inhibitors in the pipeline include TYRA-300 (Tyra Biosciences), ABSK061 (Abbisko Therapeutics), and others.
TYRA-300 is an experimental FGFR3 inhibitor engineered for high potency and selectivity, aimed at overcoming two key limitations of currently available and investigational FGFR inhibitors: maintaining activity against treatment-emergent resistance mutations, such as the V555 gatekeeper mutation, and achieving greater selectivity for FGFR3 over FGFR1 and other isoforms to minimize off-target adverse effects.
The therapy is under evaluation in Phase I/II clinical trials for metastatic urothelial carcinoma (mUC) in the SURF301 study and has received FDA authorization to initiate a Phase II trial (SURF302) in intermediate-risk non-muscle invasive bladder cancer (NMIBC). Interim results from SURF301 demonstrated encouraging efficacy, with partial response rates reaching 54.5% and complete disease control at certain doses, alongside a favorable safety profile and rare serious adverse events. TYRA-300 has also been granted FDA Rare Pediatric Disease Designation for achondroplasia, highlighting its potential in both oncology and rare skeletal disorders. The development program includes planned pediatric trials in achondroplasia and continued global studies in bladder cancer. Through its distinct FGFR3 selectivity, TYRA-300 aims to deliver a more tolerable and effective treatment for FGFR3-driven diseases, positioning Tyra Biosciences as a strong contender in precision oncology and rare disease markets.
ABSK061 is an oral, highly selective FGFR2/3 inhibitor designed to limit FGFR1-related off-target toxicities and provide a wider therapeutic window compared to pan-FGFR inhibitors. It shows potential in oncology and non-oncology applications, including achondroplasia (ACH), a genetic disorder frequently caused by FGFR3 mutations. Notably, ABSK061 is the first FGFR2/3-specific inhibitor to advance into clinical trials worldwide, representing a next-generation approach due to its enhanced selectivity. In oncology, Abbisko is conducting Phase I studies in both China and the U.S. Preliminary results presented at the ESMO TAT conference in February 2024 reported an overall response rate (ORR) of 37.5% among patients with FGFR-altered solid tumors treated with either 75 mg BID or 150 mg QD doses.
The anticipated launch of these emerging therapies are poised to transform the FGFR inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the FGFR inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about FGFR inhibitors clinical trials, visit @ FGFR Inhibitors Treatment
FGFR Inhibitors Overview
FGFR inhibitors are a type of targeted cancer therapy that block fibroblast growth factor receptor (FGFR) signaling, which can become abnormally activated in certain cancers due to genetic changes such as mutations, fusions, or amplifications. Most FGFR inhibitors function as small-molecule tyrosine kinase inhibitors, disrupting phosphorylation and downstream pathways that fuel tumor growth. Some agents are reversible, while others irreversibly bind to the receptor; a few also act on the extracellular domain or serve as ligand traps. Clinical trials have demonstrated objective response rates of about 25–45% and disease control rates up to 60% in FGFR-altered cancers, with generally manageable side effects such as hyperphosphatemia and fatigue.
FGFR Inhibitors Epidemiology Segmentation
The FGFR inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Eligible Patient Pool by Indication for FGFR Inhibitor
- Total Treatable Cases by Indication for FGFR Inhibitor
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FGFR Inhibitors Report Metrics |
Details |
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Study Period |
2020–2034 |
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FGFR Inhibitors Report Coverage |
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
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Key Indications Covered in the Report |
Cholangiocarcinoma, Urothelial Carcinoma, Myeloid/Lymphoid Neoplasms, Non-muscle Invasive Bladder Cancer, IgG4-RD, Multiple Sclerosis, and others |
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Key FGFR Inhibitor Companies |
Tyra Biosciences, Abbisko Therapeutics, Johnson & Johnson, AstraZeneca, Taiho Oncology, Incyte Corporation, and others |
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Key FGFR Inhibitors |
TYRA-300, ABSK061, LYTGOBI, PEMAZYRE, and others |
Scope of the FGFR Inhibitors Market Report
- FGFR Inhibitors Therapeutic Assessment: FGFR Inhibitors’ current marketed and emerging therapies
- FGFR Inhibitors Market Dynamics: Conjoint Analysis of Emerging FGFR Inhibitor Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, FGFR Inhibitors Market Access and Reimbursement
Discover more about FGFR inhibitors in development @ FGFR Inhibitors Clinical Trials
Table of Contents
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1 |
Key Insights |
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2 |
Report Introduction |
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3 |
Executive Summary |
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4 |
Key Events |
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5 |
Epidemiology Market Forecast Methodology of FGFR Inhibitors |
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6 |
FGFR Inhibitors Market Overview at a Glance in the 7MM |
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6.1 |
Market Share (%) Distribution by Therapies in 2025 |
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6.2 |
Market Share (%) Distribution by Therapies in 2034 |
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6.3 |
Market Share (%) Distribution by Indications in 2025 |
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6.4 |
Market Share (%) Distribution by Indications in 2034 |
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7 |
FGFR Inhibitor: Background and Overview |
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7.1 |
Introduction |
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7.2 |
The potential of FGFR inhibitors in Different Indications |
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7.3 |
Clinical Applications of FGFR Inhibitors |
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8 |
Target Patient Pool |
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8.1 |
Key Findings |
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8.2 |
Assumptions and Rationale: 7MM |
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8.3 |
Epidemiology Scenario in the 7MM |
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8.3.1 |
Total Eligible Patient Pool by Indication for FGFR Inhibitor in the 7MM |
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8.3.2 |
Total Treatable Cases by Indication for FGFR Inhibitor in the 7MM |
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8.4 |
The US |
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8.5 |
EU4 and the UK |
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8.6 |
Japan |
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9 |
Marketed Drugs |
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9.1 |
Key Competitors |
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9.2 |
LYTGOBI (futibatinib): Taiho Oncology |
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9.2.1 |
Product Description |
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9.2.2 |
Regulatory Milestones |
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9.2.3 |
Other Developmental Activities |
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9.2.4 |
Clinical Development |
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9.2.5 |
Safety and Efficacy |
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9.2.6 |
Analyst Views |
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9.3 |
PEMAZYRE (pemigatinib): Incyte Corporation |
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10 |
Emerging Therapies |
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10.1 |
Key Cross Competition |
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10.2 |
TYRA-300: Tyra Biosciences |
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10.2.1 |
Drug Description |
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10.2.2 |
Others Developmental Activities |
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10.2.3 |
Clinical Trials Information |
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10.2.4 |
Safety and Efficacy |
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10.2.5 |
Analyst’s View |
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10.3 |
ABSK061: Abbisko Therapeutics |
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List of drugs to be continued in the final report… |
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11 |
FGFR Inhibitor: the 7MM Analysis |
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11.1 |
Key Findings |
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11.2 |
Key Market Forecast Assumptions |
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11.2.1 |
Cost Assumptions and Rebates |
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11.2.2 |
Pricing Trends |
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11.2.3 |
Analogue Assessment |
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11.2.4 |
Launch Year and Therapy Uptakes |
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11.3 |
Market Outlook |
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11.4 |
Attribute Analysis |
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11.5 |
Total Market Size of FGFR Inhibitor in the 7MM |
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11.6 |
The US Market Size |
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11.6.1 |
Total Market Size of FGFR Inhibitor in the US |
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11.6.2 |
Market Size of FGFR Inhibitors by Indication in the United States |
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11.6.3 |
Market Size of FGFR Inhibitor by Therapies in the US |
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11.7 |
EU4 and the UK Market Size |
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11.8 |
Japan Market Size |
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11 |
Unmet Needs |
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12 |
SWOT Analysis |
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13 |
KOL Views |
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14 |
Market Access and Reimbursement |
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14.1 |
The US |
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14.2 |
EU4 and the UK |
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14.3 |
Japan |
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15 |
Acronyms and Abbreviations |
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16 |
Bibliography |
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17 |
Report Methodology |
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