FAK Inhibitors Market Summary

• The Focal Adhesion Kinase market in the 7MM is projected to grow at a significant CAGR by 2034 in leading countries (US, EU4, UK and Japan). 

Focal Adhesion Kinase Market and Epidemiology Analysis

• Focal adhesion kinase (FAK), also known as PTK2, is a non-receptor tyrosine kinase encoded by the PTK2 gene. It plays a critical role in signal transduction mediated by both growth factor receptors and integrins.
• Overexpression of FAK is associated with poor cancer prognosis, as it contributes to therapy resistance and supports cancer cell survival, growth, and proliferation.
• The efficacy of bevacizumab (FAK inhibitor) has been tested in various tumor types, including pancreatic cancer and hepatocellular carcinoma, renal cell carcinoma, neuroendocrine tumors, non-small cell lung cancer, and breast cancer, brain cancer, and ovarian cancer. As with colorectal cancer, results have been promising but mixed. 
• Verastem's FAKZYNJA (defactinib), is currently the only US Food and Drug Administration (FDA) approved FAK inhibitor in 2025, used as part of a combination therapy.
• In May 2025, Verastem announced that the FDA has approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy.
• In June 2024, announced results from the Phase Ib/II clinical trial of ifebemtinib, the company's focal adhesion kinase (FAK) inhibitor, in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation, for the first-line treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation. 
• Ascentage Pharma, InxMed (Shanghai), and several other companies are currently engaged in the development and production of selective FAK inhibitors, which have the potential to significantly impact and enhance the FAK inhibitor market.

DelveInsight’s “Focal Adhesion Kinase (FAK) Inhibitor– Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the FAK, historical and Competitive Landscape as well as the FAK inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The FAK market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM FAK market size from 2020 to 2034. The report also covers current FAK treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

FAK Inhibitor Understanding 

FAK Inhibitor Overview

FAK is a non-receptor tyrosine kinase that increasingly has been implicated in cancer progression, and as such, appears to be a valuable target for anti-cancer agents. FAK is a 125kDa protein that was identified at adhesion sites between cells and the extracellular environment. It is encoded by a gene located on chromosome 8 and houses three domains, the amino-N-terminal domain, the central catalytic domain, and the carboxy-C-terminal domain. FAK activation relies upon autophosphorylation of the unique Y-397 site that is found in the N-terminal domain. Y-397 has some interesting properties. This region binds some signaling proteins such as src, PI-3 kinase, and Grb-7. It also binds EGFR, VEGFR, p53, and other molecules that are critical for carcinogenesis. FAK is upregulated in several types of cancer including ovarian, thyroid, head and neck, lung, kidney, brain, hepatocellular, pancreatic, colorectal, breast, cervical, and prostate cancers, as well as melanoma, neuroblastoma, osteosarcoma, and sarcoma.

Further details related to country-based variations are provided in the report…

FAK Inhibitor Epidemiology

The FAK inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indication for FAK inhibitor, total eligible patient pool for FAK inhibitor in selected indication, total treated cases in selected indication for FAK inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. 

Key Findings from the FAK Inhibitor Patient Pool Analysis

• Among the 7MM, the US accounted for the highest diagnosed prevalent cases of prostate cancer in 2024. 
• Among EU4 and the UK, Germany accounted for the highest number of prostate cancer prevalent cases, while Spain accounted for the least Incident cases.
• Cases of NSCLC are higher among those aged≥65 years than those aged <65 years.

FAK Drug Chapters

The drug chapter segment of the FAK reports encloses a detailed analysis of late-stage (Phase II and Phase I) pipeline drugs. It also helps understand the FAK’s 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.

FAK Inhibitor Marketed Drugs

FAKZYNJA (Defactinib): Verastem

An orally bioavailable, small-molecule Defactinib is an inhibitor of FAK and proline-rich tyrosine kinase-2 (Pyk2), the two members of the FAK family of nonreceptor tyrosine kinases. Defactinib inhibited FAK autophosphorylation in cancer cells in vitro and mouse xenograft models. Avutometinib in combination with defactinib enhanced inhibition of cell proliferation in vitro and antitumor activity in mouse tumor models including LGSOC.

Defactinib has been approved as AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated LGSOC.

In March 2024, the FDA granted Orphan Drug Designation (ODD) to avutometinib, an RAF/MEK clamp, alone or in combination with defactinib, a selective FAK inhibitor, for the treatment of all patients with recurrent LGSOC.

FAK Inhibitor Emerging Drugs

IN10018: InxMed (Shanghai)

Protein Tyrosine Kinase 2 Inhibitor IN10018 is an orally bioavailable inhibitor of the non-receptor, cytoplasmic tyrosine kinase protein tyrosine kinase 2 (focal adhesion kinase 1; FAK1; FAK: PTK2) with potential antineoplastic activity. Upon oral administration, IN10018 targets and inhibits, in an adenosine triphosphate (ATP)-competitive manner, PTK2. This prevents PTK2-mediated downstream signaling and inhibits migration, proliferation, invasion, and survival in PTK2-overexpressing tumor cells. The cytoplasmic tyrosine kinase PTK2, a signal transducer for integrins overexpressed in various tumor cell types, is involved in tumor cell invasion, migration, and proliferation.

In October 2022, announced that the clinical data from an open-label, phase Ib trial evaluating the efficacy and safety of IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), alone or in combination with cobimetinib (Cobi, an approved mitogen-activated protein kinase [MEK] inhibitor from Roche) showed positive results.

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

FAK Inhibitor Market Outlook 

As of May 2025, Verastem’s FAKZYNJA (defactinib) remains the only approved focal adhesion kinase (FAK) inhibitor on the market. Given its regulatory success and head start in clinical development, FAKZYNJA is expected to retain the largest market share for the foreseeable future.

This market dominance is largely because most other FAK inhibitors are still in early-stage development, with none having reached comparable levels of clinical or regulatory progress. Although several investigational agents are moving through mid- to late-phase trials, they have yet to match FAKZYNJA’s momentum.

Current research is expanding beyond low-grade serous ovarian cancer (LGSOC) to include a broad range of malignancies. Ongoing clinical trials are evaluating both monotherapy and combination regimens involving FAK inhibitors in cancers such as non-small cell lung cancer (NSCLC), pancreatic cancer, hematologic malignancies, and other advanced solid tumors.

Among the emerging candidates, ifebemtinib (IN10018) has shown promising efficacy across multiple cancer types. FAK continues to be a compelling therapeutic target due to its central role in tumor cell survival, migration, and metastasis. It interacts with several key signaling pathways—such as Src, AKT, MAPK, PI3K, and EGFR/HER2—making it a strategic node for therapeutic intervention.

To enhance efficacy and overcome resistance often seen with monotherapies, dual-targeted strategies are being explored, including agents that inhibit FAK in combination with other signaling molecules. Recent findings suggest that monotherapy approaches may contribute to chemotherapy resistance, further supporting the rationale for combination regimens.

Industry players such as InxMed (Shanghai), Ascentage, and others are actively developing FAK inhibitors for various indications, including prostate, pancreatic, and lung cancers. However, until these candidates achieve advanced clinical success or regulatory approval, FAKZYNJA is expected to maintain its leadership position in the FAK inhibitor market.

FAK Drugs Uptake

This section focuses on the uptake rate of potential emerging FAK expected to be launched in the market during –2034.

FAK Pipeline Development Activities

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

The presence of numerous drugs under different stages is expected to generate immense opportunity for FAK market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for FAK therapies. 

Latest KOL Views on FAK Inhibitor 

To keep up with current and future market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on FAK's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center, UCSF Health, Memorial Sloan Kettering Cancer Center, Edinburgh Cancer Research UK Centre at the University of Edinburgh, Division of Hematology & Oncology, University of Illinois Health, Oncology Department at San Luigi Hospital Center for Thoracic Cancers at the Massachusetts General Hospital, Dana-Farber Brigham Cancer Center, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or FAK market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and 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, the Children's 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 approved 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.

Key Updates on FAK Inhibitor

• In May 2025, Verastem announces positive updated results from RAMP 205 evaluating avutometinib plus defactinib in combination with standard-of-care chemotherapy in frontline metastatic pancreatic ductal adenocarcinoma.
• In May 2024, GSK presented efficacy and adverse event data from a Phase II trial in Meningioma at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)
• In October 2023, InxMed presented preclinical data at the 14th Annual World ADC Conference in San Diego regarding IN10018, a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), to boost the efficacy of ADCs, and IN30718， a First-in-Class cancer-associated fibroblast (CAF) targeting ADC for high stroma tumors.
• In October 2023, InxMed announced that clinical data of Ifebemtinib (IN10018), a highly potent and selective oral inhibitor of focal adhesion kinase (FAK), in platinum-resistant recurrent ovarian cancer (PROC) and triple-negative breast cancer (TNBC) was presented at the 2023 European Society for Medical Oncology (ESMO) Congress that took place in Spain.
• In August 2021, the FDA granted a fast-track designation to IN10018, a selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor, for the treatment of platinum-resistant ovarian cancer.

The abstract list is not exhaustive, will be provided in the final report

Scope of the FAK Inhibitor Market Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of the FAK, explaining its mechanism, and therapies (emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the FAK market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM FAK market.

FAK Inhibitor Report Insights

• FAK Targeted Patient Pool
• Therapeutic Approaches
• FAK Pipeline Analysis
• FAK Market Size and Trends
• Existing and Future Market Opportunity

FAK Inhibitor Report Key Strengths

• 10 years Forecast
• The 7MM Coverage 
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

FAK Inhibitor Report Assessment

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

Key Questions Answered in the FAK Inhibitor Market Report

• What was the FAK total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for FAK Inhibitor?
• What are the risks, burdens, and unmet needs of treatment with FAK-based therapies? What will be the growth opportunities across the 7MM for the patient population of FAK-based therapies?
• What are the key factors hampering the growth of the FAK Inhibitor market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for FAK inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? 

Reasons to buy FAK Inhibitor Market Report

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the FAK Inhibitor Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.