FLT3 Inhibitors Market

Market Overview

The global FLT3 inhibitors market size was valued at USD 487.53 million in 2023. It is expected to reach USD 1,234.03 million in 2032, growing at a CAGR of 10.87% over the forecast period (2024-32). FLT3 (Fms-like tyrosine kinase 3) inhibitors are primarily used in the treatment of AML, particularly in patients with FLT3 mutations. The increasing prevalence of AML worldwide drives demand for effective targeted therapies, including FLT3 inhibitors, to improve patient outcomes.

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.

Market Dynamics

Global FLT3 Inhibitors Market Drivers

Increasing Incidence of Acute Myeloid Leukemia

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.

Introduction of Novel Products

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.

Global FLT3 Inhibitors Market Restraints

Disease Relapse in FLT3 Mutated AML

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.

Global FLT3 Inhibitors Market Opportunities

Massive Scope in Emerging Markets

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.

Regional Analysis

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

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.

Segmental Analysis

The global FLT3 inhibitors market is segmented by commercialized therapy and 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.

Based on product the market is segmented into Crenolanib, Dovitinib, SKLB1028, Gilteritinib, and Others.

The FLT3 inhibitor market is poised for expansion with a dynamic pipeline of promising drugs. Crenolanib is a targeted therapy undergoing trials for efficacy in FLT3-ITD positive AML. Dovitinib, a multi-targeted inhibitor, presents potential for AML patients with FLT3 mutations. SKLB1028 is a next-generation FLT3 inhibitor aiming to overcome resistance to existing treatments. However, it's important to acknowledge the absence of a dominant product in the pipeline currently. Each candidate is at a distinct development stage, and their market impact depends on successful clinical trial outcomes and regulatory approvals. The future leader will likely be the one demonstrating the most efficacious and well-tolerated profile for treating FLT3 mutation-positive AML, thereby capturing significant market share.

Recent Developments

• June 2024 - The FDA approved the IND for Lomonitinib (ZE46-0134), enabling Eilean Therapeutics LLC to move forward with a Phase 1 clinical trial in FLT3 mutant relapsed/refractory (R/R) AML. The business is happy to share this development. Although the Phase I study has already started in Australia, the trial can now begin in the US with FDA approval.