The Total Addressable Market (TAM) for FLT3 Inhibitors was valued at USD 444.47 million in 2022. It is estimated to reach USD 1.12 billion by 2031, growing at a CAGR of 10.87% during the forecast period (2023–2031). FMS-like tyrosine kinase 3 is a protein produced by the FLT3 gene (FLT3). Signal transduction is how FLT3 gets signals from the outside of the cell to the inside of the cell. This class of proteins is known as receptor tyrosine kinases (RTKs). This communication system primarily regulates the survival and division of many critical cellular activities, including those of hematopoietic progenitor cells, the precursors of early blood cells. Blood cancer, primarily FLT3 mutant acute myeloid leukemia, results from any mutations in the FLT3 gene (AML).
For treating blood malignancies with FLT3-positive mutations, FLT3 inhibitors supplement constitute a potential approach. The landscape of novel FLT3 inhibitors drugs for treating blood cancers with FLT3-positive mutations is rapidly expanding, with many emerging and legacy companies entering the FLT3 inhibitors industry with their respective therapeutic portfolios exclusively developed and designed for the treatment of FLT3-mutated acute myeloid leukemia (AML). Chemotherapy used to be the primary treatment option for FLT3-mutated AML patients; however, this achieved nothing to improve survival chances. The prognosis for those with the FLT3-positive mutation has improved thanks to a new class of FLT3 inhibitor supplements.
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Acute myeloid leukemia (AML) is a subtype of leukemia that is relatively rare overall, accounting for only about 1% of all cancers. FMS-like tyrosine kinase 3 (FLT3) is overexpressed on most AML blasts. Mutations in FLT3 are the most common genomic alteration found in AML. In addition, approximately one-third of newly diagnosed adult patients with AML are identified with FLT3 mutation. According to Institute for Health Metrics and Evaluation, the worldwide incidence of acute myeloid leukemia in 2019 was 1,24,332 cases. However, in 2018, acute myeloid leukemia recorded an incidence of 1,22,224 globally.
As the incidence rates of acute myeloid leukemia have increased over the past few years, drugs for acute myeloid leukemia with FLT3 mutation are improving to enhance the patient’s survival rate. The benefits provided by FLT3 in acute myeloid leukemia treatment include long-term survival rates, increased safety, improved quality, higher chances of early identification of leukemia cells, targeted therapy, and reduced chances of relapse AML, which are further expected to boost the market growth over the forecast period.
Targeting FLT3 signaling with small molecule inhibitors has been a heavily researched therapeutic approach over the past three decades due to the prevalence and poor prognosis shown by FLT3 mutations in AML, which resulted in the release of novel FLT3 inhibitors onto the market. There has been a rise in research and development for novel medications in the receptor tyrosine kinase family. Rydapt (Midostaurin), a first-generation, multitargeted FLT3 tyrosine kinase inhibitor (TKI), imparted poor drug selectivity, weak potency, and unfavorable protein-binding characteristics. This led to the development of second-generation FLT3 inhibitors, such as Xospata and Vanflyta, with improved selectivity and potency for FLT3 mutations in in-vitro biochemical and cellular assays, which resulted in much higher clinical response rates as compared with first-generation FLT3 inhibitors.
Furthermore, the global FLT3 inhibitors companies have developed several emerging therapies in different phases of development, from pre-clinical to late stage. For instance, AROG pharmaceutical's product Crenolanib, a type 1, second-generation inhibitor, is in a Phase III clinical trial for acute myeloid leukemia (AML) and gastrointestinal stromal tumor (GIST). The constant approval of such therapies for cancers with favorable FLT3 mutations will aid the market's growth over the forecast period.
In recent years, there have been updated guidelines for referral for cancers with FLT3-positive mutations and improved knowledge about the disease. However, disease relapse is still a significant challenge for FLT3 inhibitors as disease relapse continues to remain a significant cause of treatment failure. Leukemia relapse often occurs months after initial remission in the treatment of FLT3-mutated AML by FLT3 inhibitor monotherapy. This relapse is mainly related to the development of drug resistance. In addition, the treatment processes are heterogeneous and may involve the emergence of clones having resistance to FLT3 inhibitors resistance therapeutic drugs used. These mechanisms mentioned above provide bases on which the key market players can design and run clinical trials to overcome FLT3 inhibitors resistance.
Improvements in the research and development of targeted drugs for treating cancers with FLT3-positive mutations, predominantly AML, are globally prioritized. There have been significant strides in advancing targeted therapeutics and their consequent adoption; however, patients need more access in low- and middle-income economies. Despite the increase in the demand and disease burden, there are fewer approved drugs in emerging nations compared to developed countries. For instance, there are two approved products in the U.S., Canada, Japan, and Europe, and one approved in China as of July 2022.
Emerging regions such as Asia-Pacific (APAC), Middle East and Africa (MEA), and Latin America (LATAM) are likely to be highly lucrative markets in the future for developing therapeutics for FLT3-mutated cancers. Established companies in the global FLT3 inhibitors market may further enhance or modify their products to fit themselves for emerging regions in the coming years. These opportunities will create tremendous opportunities for the global FLT3 inhibitors market over the forecast period.
The global FLT3 inhibitors market is segmented by commercialized therapy and potential pipeline product.
By commercialized therapy, the global market is segmented into Type 1 FLT3 inhibitors and Type 2 FLT3 inhibitors.
The Type 1 FLT3 inhibitors segment is the highest contributor to the market and is expected to grow at a CAGR of 10.71% during the forecast period. The Type 1 FLT3 inhibitors segment is divided into two sub-segments: Xospata (Gilteritinib) and Rydapt (Midostaurin). Xospata (Gilteritinib) is a second-generation Type 1 tyrosine kinase inhibitor. The drug has an inhibitory activity against FLT3 mutation, therefore, is used to treat adults with acute myeloid leukemia having FMS-like tyrosine kinase 3 mutation when the disease has come back or has not shown any improvement after receiving previous treatments as detected by an FDA-approved test. The drug has been shown to work in two FLT3 mutations: internal tandem duplication (ITD) and tyrosine kinase domain (TKD). In addition, Xospata was developed by Astellas Pharma Inc. with exclusive rights to manufacture and commercialize the drug worldwide, although Kotobuki Pharmaceutical helped the company to identify the drug.
Rydapt is a first-generation Type 1 tyrosine kinase inhibitor with activity against FLT3 mutation by blocking several enzymes that promote cell growth. It is the first targeted therapy used to treat adult subjects with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive, as detected by an FDA-approved test. For instance, LeukoStrat CDx FLT3 Mutation Assay, a companion diagnostic test developed by Invivoscribe Technologies Inc., has also been approved for use with Ryadpt (Midostaurin) to test patients with AML for the FLT3 mutation. Rydapt was discovered and developed by Novartis International AG. The product was cleared in the U.S., Europe, Canada, and Switzerland in 2017 and Australia in 2020 to treat adult patients with newly diagnosed FLT3 mutated AML.
The only Type 2 inhibitor commercialized in Japan is Vanflyta (Quizartinib), currently. Therefore, the revenue of Vanflyta is wholly contributing to the total revenue generated by the Type 2 FLT3 inhibitors segment. Vanflyta (Quizartinib) is a second-generation Type 2 tyrosine kinase inhibitor. The medication was created as a cancer treatment for acute myeloid leukemia patients with FMS-like tyrosine kinase 3 mutations when the disease has returned or has not improved despite receiving prior treatments, as well as for patients who have undergone hematopoietic stem cell transplants. The drug showed inhibitory activity against internal tandem duplication (ITD) mutation. Vanflyta was developed by Daiichi Sankyo Company, Limited, with exclusive rights to manufacture and commercialize the drug worldwide. On June 18, 2019, the company gained approval for Vanflyta (Quizartinib) from Japan’s Ministry of Health, Labour, and Welfare (MHLW) to treat Japanese patients with relapsed/refractory FLT3-ITD AML.
By potential pipeline product, the global market is divided into Crenolanib, Dovitinib, and SKLB1028.
The Dovitinib segment owns the highest market share and is expected to grow at a CAGR of 8.92% during the forecast period. Dovitinib is a novel oral multi-kinase inhibitor that exhibits potent inhibitory activity against multiple receptor tyrosine kinases (RTKs) involved in tumor growth and angiogenesis. An early-phase clinical study demonstrated inhibitory activity associated with different cancers, including acute myeloid leukemia (AML) and multiple myeloma. The medication inhibits FMS-like tyrosine kinase 3 and other RTKs superfamily members, which decreases angiogenesis and cellular proliferation before inducing apoptosis in tumor cells. In a Phase III clinical trial, dovitinib is being investigated to see whether it is as safe and effective as sorafenib in treating patients with metastatic renal cell carcinoma. In addition, Dovitinib was in-licensed from Novartis International AG and is Allarity’s most advanced clinical therapeutic candidate. The product is expected to launch in Q2 2024 as a potential option in the third-line (3L) treatment for patients having metastatic renal cell carcinoma.
Crenolanib is a small-molecule investigational drug candidate. It is the lead product of AROG Pharmaceuticals, which is being evaluated for safety and efficacy in acute myeloid leukemia (AML) and gastrointestinal stromal tumor (GIST). It is a Type I, second-generation tyrosine kinase inhibitor that selectively and potently inhibits signaling of wild-type and mutant forms of FLT3 and platelet-derived growth factor receptor (PDGFRα/β). FLT3 and PDGFRα/β are receptor tyrosine kinases that regulate signaling cell growth and other processes. Dysregulation in their signaling pathway results in several diseases and cancers.
The drug is currently being evaluated under a Phase III clinical study for treating newly diagnosed and relapsed/refractory FLT3-mutated AML conducted by AROG Pharmaceuticals, Inc. The product is expected to launch in the fourth quarter (Q4) of 2025 for newly diagnosed (1L) acute myeloid leukemia in the U.S. the product is estimated to launch in Q4 2025 for relapsed/refractory (2L and 3L) acute myeloid leukemia in the U.S. and the second quarter (Q2) of 2026 in Europe for the same indication.
By region, the global FLT3 inhibitors market is divided into North America, Europe, Asia-Pacific, and Rest of the World (RoW)
North America Dominates the Global Market
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North America is the most significant shareholder in the global FLT3 inhibitors market and is anticipated to grow at a CAGR of 14.41% during the forecast period. North America has a far higher acceptance rate for patients and physicians than other regions. The North American FLT3 inhibitors market is expected to be driven by various research and development activities to advance and enhance the overall scope of the FLT3 inhibitors industry. These innovative research and development projects aimed explicitly toward drug discovery, development, and disease progression, have further aided in improving the lives of cancer patients. North America majorly comprises the U.S. and Canadian markets. As a result of substantial investments in the co-development of targeted therapeutics, the U.S. dominated the market in 2021.
Europe is anticipated to grow at a CAGR of 14.04% over the forecast period. The Europe FLT3 inhibitors market has been growing since its inception. Several European countries, including Germany, France, the U.K., Italy, and Spain, are working persistently to enhance the FLT3 mutated cancer treatment by conducting extensive research in the field. Moreover, the overall pharmaceutical R&D expenditure in the region has also grown significantly. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), pharmaceutical R&D expenditure in the region increased from USD 37,570 million in 2016 to USD 39,905 million in 2017.
Additionally, the increase in pharmaceutical R&D expenditure and the growing focus on FLT3 targeted therapy research are anticipated to further bolster the underlying FLT3 inhibitors market in Europe. Various European countries and companies are working toward developing novel immune therapies for different FLT3 mutated cancer, with most of them focused on acute myeloid leukemia. Novartis International AG and Astellas Pharma Inc. are the leading contributors to the Europe market.
The Asia-Pacific FLT3 inhibitors market has been segmented into countries such as China, Japan, and the Rest of Asia-Pacific, which are dedicated to researching emerging targeted therapies for various FLT3 mutated cancers. The region comprises many countries offering scientific capabilities for innovative medicines. China and Japan are the two nations that have been majorly contributing to the Asia-Pacific market. As of 2021, Japan is the leading contributor to the APAC FLT3 inhibitors market. However, different regulatory frameworks coupled with high costs for anti-FLT3 therapy-based products are some factors obstructing the Asia-Pacific market growth.
The Rest-of-the-World (RoW) region consists of several other promising areas, such as Latin America, the Middle East, and Africa. The growing number of pharmaceutical companies in the region have shown increased interest in making FLT3 mutated cancer therapies and innovative treatments available locally, which is anticipated to offer huge potential in improving the quality of life of cancer patients shortly. As a result, the RoW region holds massive potential for growth during the forecast period. The Rest-of-the-World FLT3 inhibitors market is still in nascent stages, considering the rapid developments being undertaken worldwide. Several Latin American countries, including Brazil, Mexico, and Argentina, are working rigorously to enhance the adoption of novel therapies in cancers with FLT3-positive mutations across emerging economies in Latin America.
The key players in the global FLT3 inhibitors market are