FLT3 Inhibitors Market - A Global and Country Analysis

Focus on Commercialized Therapy, Potential Pipeline Product, and Region - Analysis and Forecast, 2022-2032

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Market Report Coverage

FLT3 Inhibitors Market
Forecast Period: 2022-2032
CAGR During Forecast Period: 14.88%

FLT3 Inhibitors Market

Base Year

2021

Market Size in 2021

$400.9 Million

Forecast Period

2022-2032

Value Projection and Estimation by 2032

$2,061.3 Million

CAGR During Forecast Period

14.88%

Number of Tables

17

Number of Pages

152

Number of Figures

105

 

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

•    Cullinan Oncology, LLC
•    Astellas Pharma Inc.
•    Allarity Therapeutics, Inc.
•    AROG Pharmaceuticals, Inc.
•    Aptose Biosciences Inc.
•    Novartis International AG
•    Daiichi Sankyo Company, Limited
•    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
•    FUJIFILM Pharmaceuticals U.S.A., Inc.
•    Jiangsu HengRui Medicine Co., Ltd.

How Can This Report Add Value to an Organization?

The study provides the reader with a detailed understanding of regional analysis based on the presence of FLT3 inhibitors.

Product/Innovation Strategy: The product segment helps the reader understand the commercialized therapies present in the market, along with potential pipeline products that are in different stages of clinical trials. Moreover, the study provides the reader with a detailed understanding of regional analysis based on the presence of FLT3 inhibitors.

Growth/Marketing Strategy: The global FLT3 inhibitors market has seen major development by key players operating in the market, such as regulatory and legal activities, product approvals and launches, partnerships and alliances, and other development activities. The favored strategy for the companies has been regulatory and legal activities along with product approvals to strengthen their position in the market.

Competitive Strategy: Key players in the global FLT3 inhibitors market analyzed and profiled in the study involve drug manufacturers for the treatment of cancer with FLT3 positive mutations. Moreover, a detailed competitive benchmarking of players operating in the global FLT3 inhibitors market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Industry and Technology Overview

The market is expected to reach $2,061.3 million in 2032 from $400.9 million in 2021.

Global FLT3 Inhibitors Market: Industry Overview

The global FLT3 inhibitors market is expected to reach $2,061.3 million in 2032 from $400.9 million in 2021 at a CAGR of 14.88% during the forecast period 2022-2032. The global FLT3 inhibitors market growth is expected to be driven by the introduction of novel products, the increasing incidence of acute myeloid leukemia, and the rising research and development investments, among others.

Market Lifecycle Stage

The global FLT3 inhibitors market is in the nascent stage. The landscape of treatment of blood cancers with FLT3 positive mutations by novel inhibitory therapeutics is massively growing, with many emerging and legacy companies venturing into the industry with their respective therapeutic portfolio exclusively developed and designed for the treatment of FLT3 mutated acute myeloid leukemia (AML). Through imaging, genetic, and biomarker studies, researchers are gaining a deeper understanding of the biology of AML, which will likely resolve many current problems in FLT3 mutated AML diagnosis and classification.

The current study aims to assess the global FLT3 inhibitors market by focusing on the marketed and potential pipeline therapies. The current market for FLT3 inhibitors is majorly dominated by pharmaceutical companies such as Novartis International AG, Astellas Pharma Inc., and Daiichi Sankyo Company, Limited. Increasing investments in the research and development of drug manufacturing are one of the major opportunities in the global FLT3 inhibitors market.

Figure: Global FLT3 Inhibitors Market, $Million, 2021-2032

Global FLT3 Inhibitors Market

Source: BIS Research Analysis

Impact

The growing interest of the pharmaceutical industry in the therapeutic potential for treating blood cancers with FLT3 positive mutations has been a catalyst for the progress of the global FLT3 inhibitors market. Recently approved products such as Xospata and Rydapt for treating FLT3 mutated acute myeloid leukemia (AML)  The recent increase in the number of drug approvals received for treating acute myeloid leukemia with FLT3 positive mutations is considered to have added value to the emerging potential drug development. There are three FLT3 inhibitors approved by the U.S. Food and Drug Administration during 2015-2021. Also, many FLT3 inhibitors are in preclinical or clinical trials, indicating progress toward making an impact in the pharmaceutical industry.

Drug development is more prominent in countries such as the U.S., Germany, the U.K., and Japan. Moreover, the presence of major market players such as Astellas Pharma Inc., Daiichi Sankyo Company, Limited., Novartis AG, Allarity Therapeutics, Inc., and AROG Pharmaceuticals, Inc. has a positive impact on the market growth.

Market Segmentation

Global FLT3 Inhibitors Market

Segmentation 1: by Commercialized Therapies
•    Type 1 FLT3 Inhibitors
•    Type 2 FLT3 Inhibitors

The Type 1 FLT3 inhibitors segment represented the largest market share at 96.63% of total commercialized therapies in 2021. However, the Type 2 FLT3 inhibitors segment is anticipated to register a high growing CAGR of 14.63% during the forecast period 2022-2032.

Segmentation 2: by Potential Pipeline Products
•    Crenolanib
•    Dovitinib
•    SKLB1028

The Dovitinib is expected to hold 59.56% of total potential pipeline products in 2032, while Crenolanib and SKLB1028 segment is expected to hold 33.71% and 6.73% in 2032, respectively.

Segmentation 3: by Region
•    North America - U.S., Canada
•    Europe - Germany, Italy, France, U.K., Spain, Rest-of-Europe
•    Asia-Pacific - China, Japan, Rest-of-APAC (RoAPAC)
•    Rest-of-the-World (RoW)

The North America FLT3 inhibitors market was valued at $252.7 million in 2021, and the region is currently the leading contributor to the market. The growth can be attributed to the increased research and development activities in the region.

Recent Developments in the Global FLT3 Inhibitors Market

•    In March 2021, Astellas Pharma's Xospata (Gilteritinib) met the overall survival endpoint in the COMMODORE trial of subjects having FLT3 mutated relapsed or refractory acute myeloid leukemia.
•    In December 2021, Allarity Therapeutics submitted a New Drug Application (NDA) to the U.S. FDA for Dovitinib as a third-line treatment for renal cell carcinoma (RCC).
•    In June 2021, Cullinan Oncology received Investigational New Drug (IND) Clearance from the FDA for CLN-049 to treat relapsed/refractory AML.
•    In June 2019, Daiichi Sankyo Company, Limited received a Complete Response Letter (CRL) from the U.S. FDA for the New Drug Application (NDA) of Vanflyta (Quizartinib) to treat adult patients with relapsed/ refractory FLT3-ITD acute myeloid leukemia.

Demand – Drivers and Limitations

Following are the demand drivers for the global FLT3 inhibitors market:

•    Introduction of Novel Products
•    Increasing Incidence of Acute Myeloid Leukemia
•    Rising Research and Development Investments

The market is expected to face some limitations too due to the following challenges:

•    High Treatment Cost Impacting the Adoption Rate
•    Disease Relapse in FLT3 Mutated AML

Analyst's Thoughts

According to Vaishali Chauhan, Research Analyst, BIS Research, "The global FLT3 inhibitors market is a small segment of the entire tyrosine kinase inhibitors market and is growing. Moreover, along with it, the rising interest of the pharmaceutical industry in developing and marketing novel drugs for treating blood cancers with FLT3 positive mutations is making headway in the growth of the global FLT3 inhibitors market. Until recently, patients suffering from FLT3 mutated AML were mainly treated with chemotherapy, which was not very efficient at improving survival rates. A new group of drugs known as FLT3 inhibitors is enhancing the outlook for people with the FLT3 positive mutation."

Table of Contents

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1.1    Product Definition
         1.1.1    Inclusion and Exclusion
1.2    Market Scope
         1.2.1    Key Questions Answered in This Report
1.3    Research Methodology
         1.3.1    Global FLT3 inhibitors Market: Research Methodology
         1.3.2    Data Sources
                     1.3.2.1    Primary Data Sources
                     1.3.2.2    Secondary Data Sources
         1.3.3    Market Estimation Model
         1.3.4    Criteria for Company Profiling
1.4    Market Overview
         1.4.1    Introduction
         1.4.2    Current Market Size and Growth Potential, $Million, 2021-2032
         1.4.3    Types of FLT3 Gene Mutations Involved in AML
                     1.4.3.1    FLT3-ITD Mutation
                     1.4.3.2    FLT3-TKD Mutation
         1.4.4    Mechanism of FLT3 Inhibitors
         1.4.5    Classification of FLT3 Inhibitors
         1.4.6    Resistance to AML Therapy Targeted at FLT3
         1.4.7    Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
                     1.4.7.1    Global Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
                     1.4.7.2    North America Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
                     1.4.7.3    Europe Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
                     1.4.7.4    China Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
                     1.4.7.5    Japan Epidemiology of FLT3 Mutated Acute Myeloid Leukemia
         1.4.8    Role of Companion Diagnostics in FLT3 Inhibitors Market
                     1.4.8.1    Drug-Diagnostic Co-Development
                     1.4.8.2    Companion Diagnostic Tests for FLT3 Mutated Acute Myeloid Leukemia
                                    1.4.8.2.1    LeukoStrat CDx FLT3 Mutation Assay
                                    1.4.8.2.2    Dovitinib DRP Companion Diagnostic
         1.4.9    Pipeline Analysis
                     1.4.9.1    By Clinical Phase

2.1    Overview
2.2    Legal Requirements and Frameworks in the U.S.
         2.2.1    Clinical Trial Authorization
         2.2.2    Marketing Authorization
         2.2.3    Post-Authorization Regulations
2.3    Legal Requirements and Frameworks in Europe
2.4    Legal Requirements and Frameworks in Japan
2.5    Reimbursement and Cost Analysis
         2.5.1    U.S.
         2.5.2    Europe

3.1    Overview
3.2    Impact Analysis
3.3    Market Drivers
         3.3.1    Increasing Incidence of Acute Myeloid Leukemia
         3.3.2    Introduction of Novel Products
         3.3.3    Rising Research and Development Investments
3.4    Market Restraints
         3.4.1    High Treatment Cost Impacting the Adoption Rate
         3.4.2    Disease Relapse in FLT3 Mutated AML
3.5    Market Opportunities
         3.5.1    Massive Scope in Emerging Markets

4.1    Overview
4.2    Key Developments and Strategies
         4.2.1    Regulatory and Legal Activities
         4.2.2    Product Approvals and Launches
         4.2.3    Partnerships and Alliances
         4.2.4    Other Developments
4.3    Market Share Analysis (by Company), 2021
4.4    Growth-Share Analysis

5.1    Overview
5.2    Type 1 FLT3 Inhibitors
         5.2.1    Xospata (Gilteritinib)
         5.2.2    Rydapt (Midostaurin)
5.3    Type 2 FLT3 Inhibitors
         5.3.1    Vanflyta (Quizartinib)

6.1    Overview
6.2    Crenolanib
         6.2.1     Crenolanib for Indication 1 (Newly Diagnosed FLT3 Mutated AML)
                      6.2.1.1    Safety and Efficacy Results of Crenolanib for Newly Diagnosed FLT3 Mutated AML
         6.2.2    Crenolanib for Indication 2 (Relapsed/Refractory FLT3 Mutated AML)
                     6.2.2.1    Safety and Efficacy Results of Crenolanib for Relapsed/Refractory FLT3 Mutated AML
6.3    Dovitinib
         6.3.1    Safety and Efficacy Results of Dovitinib for Metastatic Renal Cell Carcinoma
6.4    SKLB1028

7.1    Overview
7.2    North America
         7.2.1    U.S.
                     7.2.1.1    Commercialized Products
                     7.2.1.2    Market Size and Forecast
         7.2.2    Canada
                     7.2.2.1    Commercialized Products
                     7.2.2.2    Market Size and Forecast
7.3    Europe
         7.3.1    Germany
                     7.3.1.1    Market Size and Forecast
         7.3.2    Italy
                     7.3.2.1    Market Size and Forecast
         7.3.3    France
                     7.3.3.1    Market Size and Forecast
         7.3.4    U.K.
                     7.3.4.1    Market Size and Forecast
         7.3.5    Spain
                     7.3.5.1    Market Size and Forecast
         7.3.6    Rest-of-Europe
                     7.3.6.1    Market Size and Forecast
7.4    Asia-Pacific
         7.4.1    Japan
                     7.4.1.1    Commercialized Products
                     7.4.1.2    Market Size and Forecast
         7.4.2    China
                     7.4.2.1    Commercialized Products
                     7.4.2.2    Market Size and Forecast
         7.4.3    Rest-of-Asia-Pacific
                     7.4.3.1    Market Size and Forecast
7.5    Rest-of-the-World

8.1    Overview
8.2    Cullinan Oncology, LLC
         8.2.1    Company Overview
         8.2.2    Role of Cullinan Oncology, LLC in the Global FLT3 inhibitors Market    
         8.2.3    Key Competitors of the Company
         8.2.4    Key Insights about Financial Health of the Company
         8.2.5    Recent Developments
         8.2.6    Analyst’s Perspective
8.3    Astellas Pharma Inc.
         8.3.1    Company Overview
         8.3.2    Role of Astellas Pharma Inc. in the Global FLT3 inhibitors Market
         8.3.3    Key Competitors of the Company
         8.3.4    Financials
         8.3.5    Key Insights about Financial Health of the Company
         8.3.6    Recent Developments
         8.3.7    Analyst’s Perspective
8.4    Allarity Therapeutics, Inc.
         8.4.1    Company Overview
         8.4.2    Role of Allarity Therapeutics, Inc. in the Global FLT3 inhibitors Market
         8.4.3    Key Competitors of the Company
         8.4.4    Recent Developments
         8.4.5    Analyst’s Perspective
8.5    AROG Pharmaceuticals, Inc.
         8.5.1    Company Overview
         8.5.2    Role of AROG Pharmaceuticals, Inc. in the Global FLT3 inhibitors Market
         8.5.3    Key Competitors of the Company
         8.5.4    Analyst’s Perspective
8.6    Aptose Biosciences Inc.
         8.6.1    Company Overview
         8.6.2    Role of Aptose Biosciences Inc. in the Global FLT3 inhibitors Market
         8.6.3    Key Competitors of the Company
         8.6.4    Key Insights about Financial Health of the Company
         8.6.5    Recent Developments
         8.6.6    Analyst’s Perspective    
8.7    Novartis International AG
         8.7.1    Company Overview
         8.7.2    Role of Novartis International AG in the Global FLT3 inhibitors Market
         8.7.3    Key Competitors of the Company
         8.7.4    Financials
         8.7.5    Key Insights about Financial Health of the Company
         8.7.6    Analyst’s Perspective
8.8    Daiichi Sankyo Company, Limited
         8.8.1    Company Overview
         8.8.2    Role of Daiichi Sankyo Company, Limited. in Global FLT3 inhibitors Market
         8.8.3    Key Competitors of the Company
         8.8.4    Financials
         8.8.5    Key Insights about Financial Health of the Company    
         8.8.6    Recent Developments
         8.8.7    Analyst’s Perspective
8.9    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
         8.9.1    Company Overview
         8.9.2    Role of CSPC ZhongQi Pharmaceutical Technology Co., Ltd. in the Global FLT3 Inhibitors Market
         8.9.3    Key Competitors of the Company
         8.9.4    Financials
         8.9.5    Key Insights about Financial Health of the Company
         8.9.6    Analyst’s Perspective
8.10    FUJIFILM Pharmaceuticals U.S.A., Inc.
           8.10.1    Company Overview
           8.10.2    Role of FUJIFILM Pharmaceuticals U.S.A., Inc. in the Global FLT3 Inhibitors Market
           8.10.3    Key Competitors of the Company
           8.10.4    Analyst’s Perspective
8.11    Jiangsu HengRui Medicine Co., Ltd.
           8.11.1    Company Overview
           8.11.2    Role of Jiangsu HengRui Medicine Co., Ltd. in the Global FLT3 Inhibitors Market
           8.11.3    Key Competitors of the Company
           8.11.4    Financials
           8.11.5    Key Insights about Financial Health of the Company
           8.11.6    Analyst’s Perspective

Table 1:    Mechanisms of Resistance of FLT3-Mutated AML Cells to FLT3 Inhibitors
Table 2:    Prominent CDx Tests for FLT3 Mutated AML
Table 3:    Emerging Phase III FLT3 Therapeutics Pipeline
Table 4:    Annual Cost of Approved FLT3 Inhibitors in the U.S.
Table 5:    Reimbursement Scenario of Approved FLT3 Inhibitors in the U.S.
Table 6:    Likert Scale
Table 7:    Impact Analysis of Market Drivers
Table 8:    Impact Analysis of Market Restraints
Table 9:    Approved FLT3 Inhibitors for FLT3 Mutated AML
Table 10:    Approved FLT3 Inhibitors Products in Developed Nations
Table 11:    Commercialized Products in the Global FLT3 Inhibitors Market
Table 12:    Potential Pipeline Products to Global FLT3 Inhibitors Market
Table 13:    List of Selective Commercialized FLT3 Inhibitors in the U.S.
Table 14:    List of Selective Commercialized FLT3 Inhibitors in Canada
Table 15:    List of Selective Commercialized FLT3 Inhibitors in Europe
Table 16:    List of Selective Commercialized FLT3 Inhibitors in Japan
Table 17:    List of Selective Commercialized FLT3 Inhibitors in China

Figure 1:    FLT3 Inhibitors Approved by U.S. Food and Drug Administration (FDA), 2015-2021
Figure 2:    FLT3 Inhibitors Global Clinical Trials (by Phase)
Figure 3:    Global FLT3 Inhibitors Market (by Commercialized Therapies), $Million, 2021-2032
Figure 4:    Global FLT3 Inhibitors Market: Impact Analysis of Market Drivers and Restraints
Figure 5:    Global FLT3 Inhibitors Market (by Potential Pipeline Products), $Million, 2021-2032
Figure 6:    Global FLT3 Inhibitors Market (by Region), $Million, 2021-2032
Figure 7:    Global FLT3 inhibitors Market Segmentation
Figure 8:    Global FLT3 inhibitors Market: Research Methodology
Figure 9:    Primary Research Methodology
Figure 10:    Bottom-Up Approach (Segment-Wise Analysis)
Figure 11:    Step by Step Approach
Figure 12:    Global FLT3 Inhibitors Market, $Million, 2021-2032
Figure 13:    FLT3 Gene Mutations in AML Patients
Figure 14:    Classification of FLT3 Inhibitors
Figure 15:    Common and Notable Toxicities Associated with FLT3 Inhibitors
Figure 16:    Estimated Global Prevalence and Incidence of FLT3 Mutated Acute Myeloid Leukemia, 2021-2032
Figure 17:    Estimated Prevalence and Incidence of FLT3 Mutated Acute Myeloid Leukemia in North America, 2021-2032
Figure 18:    Estimated Prevalence and Incidence of FLT3 Mutated Acute Myeloid Leukemia in Europe, 2021-2032
Figure 19:    Percentage of FLT3 Mutated Acute Myeloid Leukemia Prevalence (by Country), 2021
Figure 20:    Estimated Prevalence and Incidence of FLT3 Mutated Acute Myeloid Leukemia in China, 2021-2032
Figure 21:    Estimated Prevalence and Incidence of FLT3 Mutated Acute Myeloid Leukemia in Japan, 2021-2032
Figure 22:    Drug Diagnostic Co-Development Model
Figure 23:    FLT3 Inhibitors Emerging Therapies: Developmental Phases
Figure 24:    Clinical Trial Authorization for FLT3 Inhibitors
Figure 25:    Process for Obtaining Marketing Authorization
Figure 26:    Procedures Offered by the Food and Drug Administration (FDA) for Drugs Intended to Treat Serious Health Conditions
Figure 27:    U.S. Food and Drug Administration Review Timeline
Figure 28:    EMA Review Timeline
Figure 29:    Current Reimbursement Scenario in Europe
Figure 30:    Global Incidence of Acute Myeloid Leukemia, 2015-2019
Figure 31:    Global Incidence of FLT3 Mutated Acute Myeloid Leukemia, 2016-2020
Figure 32:    Number of Clinical Trials for FLT3 Inhibitors (by Major Player)
Figure 33:    Mechanisms Responsible for Resistance to FLT3 Inhibitors
Figure 34:    Clinical Strategies to Overcome Drug Resistance in FLT3-ITD AML
Figure 35:    Share of Key Developments and Strategies, January 2019-June 2022
Figure 36:    Regulatory and Legal Activities (by Company), January 2019-June 2022
Figure 37:    Product Approvals and Launches (by Company), January 2019-June 2022
Figure 38:    Partnerships and Alliances (by Company), January 2019-June 2022
Figure 39:    Market Share Analysis of the Global FLT3 Inhibitors market (by Company), 2021
Figure 40:    Growth-Share Matrix for the Global FLT3 inhibitors Market (by Company), 2021
Figure 41:    Global FLT3 Inhibitors Market (by Commercialized Therapies), $Million, 2021-2032
Figure 42:    Global FLT3 Inhibitors Market (by Type 1 FLT3 Inhibitors), $Million, 2021-2032
Figure 43:    Global FLT3 Inhibitors Market (Xospata, by Type 1 FLT3 Inhibitors), $Million, 2021-2032
Figure 44:    Global FLT3 Inhibitors Market (Rydapt, by Type 1 FLT3 Inhibitors), $Million, 2021-2032
Figure 45:    Global FLT3 Inhibitors Market (Vanflyta, by Type 2 FLT3 Inhibitors), $Million, 2021-2032
Figure 46:    Global FLT3 Inhibitors Market (by Potential Pipeline Products), $Million, 2021-2032
Figure 47:    Global FLT3 Inhibitors Market (Crenolanib), $Million, 2021-2032
Figure 48:    Crenolanib Phase III Clinical Trial Design for Newly Diagnosed FLT3 Mutated AML
Figure 49:    Crenolanib Phase III Clinical Trial Design for Relapsed/Refractory FLT3 Mutated AML
Figure 50:    Global FLT3 Inhibitors Market (Dovitinib), $Million, 2021-2032
Figure 51:    Dovitinib Phase III Clinical Trial Design for Metastatic Renal Cell Carcinoma
Figure 52:    Global FLT3 Inhibitors Market (SKLB1028), $Million, 2021-2032
Figure 53:    SKLB1028 Phase III Clinical Trial Design for Relapsed/Refractory FLT3 Mutated AML
Figure 54:    Global FLT3 Inhibitors Market (by Region), $Million, 2021-2032
Figure 55:    North America FLT3 Inhibitors Market, $Million, 2021-2032
Figure 56:    North America: Market Dynamics
Figure 57:    North America FLT3 Inhibitors Market (by Country), $Million, 2021 and 2032
Figure 58:    U.S. FLT3 Inhibitors Market, $Million, 2021-2032
Figure 59:    Canada FLT3 Inhibitors Market, $Million, 2021-2032
Figure 60:    Europe FLT3 Inhibitors Market, $Million, 2021-2032
Figure 61:    Europe: Market Dynamics
Figure 62:    Europe FLT3 Inhibitors Market (by Country), $Million, 2021 and 2032
Figure 63:    Germany FLT3 Inhibitors Market, $Million, 2021-2032
Figure 64:    Italy FLT3 Inhibitors Market, $Million, 2021-2032
Figure 65:    France FLT3 Inhibitors Market, $Million, 2021-2032
Figure 66:    U.K. FLT3 Inhibitors Market, $Million, 2021-2032
Figure 67:    Spain FLT3 Inhibitors Market, $Million, 2021-2032
Figure 68:    Rest-of-Europe FLT3 Inhibitors Market, $Million, 2021-2032
Figure 69:    Asia-Pacific FLT3 Inhibitors Market, $Million, 2021-2032
Figure 70:    Asia-Pacific: Market Dynamics
Figure 71:    Asia-Pacific FLT3 Inhibitors Market (by Country), $Million, 2021 and 2032
Figure 72:    Japan FLT3 Inhibitors Market, $Million, 2021-2032
Figure 73:    China FLT3 Inhibitors Market, $Million, 2021-2032
Figure 74:    Rest-of-Asia-Pacific FLT3 Inhibitors Market, $Million, 2021-2032
Figure 75:    Rest-of-the-World FLT3 Inhibitors Market, $Million, 2021-2032
Figure 76:    Total Number of Companies Profiled
Figure 77:    Cullinan Oncology, LLC: Pre-Clinical and Clinical Assets
Figure 78:    Cullinan Oncology, LLC: R&D Expenditure, $Million, 2019-2021
Figure 79:    Astellas Pharma Inc.: Commercialized Product
Figure 80:    Astellas Pharma Inc.: Overall Financials, $Million, 2019-2021
Figure 81:    Astellas Pharma Inc.: Revenue (by Region), $Million, 2019-2021
Figure 82:    Astellas Pharma Inc.: R&D Expenditure, $Million, 2019-2021
Figure 83:    Allarity Therapeutics, Inc.: Pre-Clinical and Clinical Assets
Figure 84:    AROG Pharmaceuticals, Inc.: Pre-Clinical and Clinical Assets
Figure 85:    Aptose Biosciences Inc.: Pre-Clinical and Clinical Assets
Figure 86:    Aptose Biosciences Inc.: R&D Expenditure, $Million, 2019-2021
Figure 87:    Novartis International AG: Commercialized Product
Figure 88:    Novartis International AG: Overall Financials, $Million, 2019-2021
Figure 89:    Novartis International AG: Revenue (by Segment), $Million, 2019-2021
Figure 90:    Novartis International AG: Revenue (by Region), $Million, 2019-2021
Figure 91:    Novartis International AG: R&D Expenditure, $Million, 2019-2021
Figure 92:    Daiichi Sankyo Company, Limited: Commercialized Product
Figure 93:    Daiichi Sankyo Company, Limited.: Overall Financials, $Million, 2019-2021
Figure 94:    Daiichi Sankyo Company, Limited.: Revenue (by Segment), $Million, 2019-2021
Figure 95:    Daiichi Sankyo Company, Limited.: Revenue (by Region), $Million, 2019-2021
Figure 96:    Daiichi Sankyo Company, Limited.: R&D Expenditure, $Million, 2019-2021
Figure 97:    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: Pre-Clinical and Clinical Assets
Figure 98:    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: Overall Financials, $Million, 2019-2021
Figure 99:    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: Revenue (by Segment), $Million, 2019-2021
Figure 100:    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: Revenue (by Region), $Million, 2019-2021
Figure 101:    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: R&D Expenditure, $Million, 2019-2021
Figure 102:    FUJIFILM Pharmaceuticals U.S.A., Inc.: Pre-Clinical and Clinical Assets
Figure 103:    Jiangsu HengRui Medicine Co., Ltd.: Pre-Clinical and Clinical Assets
Figure 104:    Jiangsu HengRui Medicine Co., Ltd.: Overall Financials, $Million, 2019-2021
Figure 105:    Jiangsu HengRui Medicine Co., Ltd.: R&D Expenditure, $Million, 2019-2021

Market Report Coverage

FLT3 Inhibitors Market

Base Year

2021

Market Size in 2021

$400.9 Million

Forecast Period

2022-2032

Value Projection and Estimation by 2032

$2,061.3 Million

CAGR During Forecast Period

14.88%

Number of Tables

17

Number of Pages

152

Number of Figures

105

 

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

•    Cullinan Oncology, LLC
•    Astellas Pharma Inc.
•    Allarity Therapeutics, Inc.
•    AROG Pharmaceuticals, Inc.
•    Aptose Biosciences Inc.
•    Novartis International AG
•    Daiichi Sankyo Company, Limited
•    CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
•    FUJIFILM Pharmaceuticals U.S.A., Inc.
•    Jiangsu HengRui Medicine Co., Ltd.

How Can This Report Add Value to an Organization?

Product/Innovation Strategy: The product segment helps the reader understand the commercialized therapies present in the market, along with potential pipeline products that are in different stages of clinical trials. Moreover, the study provides the reader with a detailed understanding of regional analysis based on the presence of FLT3 inhibitors.

Growth/Marketing Strategy: The global FLT3 inhibitors market has seen major development by key players operating in the market, such as regulatory and legal activities, product approvals and launches, partnerships and alliances, and other development activities. The favored strategy for the companies has been regulatory and legal activities along with product approvals to strengthen their position in the market.

Competitive Strategy: Key players in the global FLT3 inhibitors market analyzed and profiled in the study involve drug manufacturers for the treatment of cancer with FLT3 positive mutations. Moreover, a detailed competitive benchmarking of players operating in the global FLT3 inhibitors market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.

Industry and Technology Overview

Global FLT3 Inhibitors Market: Industry Overview

The global FLT3 inhibitors market is expected to reach $2,061.3 million in 2032 from $400.9 million in 2021 at a CAGR of 14.88% during the forecast period 2022-2032. The global FLT3 inhibitors market growth is expected to be driven by the introduction of novel products, the increasing incidence of acute myeloid leukemia, and the rising research and development investments, among others.

Market Lifecycle Stage

The global FLT3 inhibitors market is in the nascent stage. The landscape of treatment of blood cancers with FLT3 positive mutations by novel inhibitory therapeutics is massively growing, with many emerging and legacy companies venturing into the industry with their respective therapeutic portfolio exclusively developed and designed for the treatment of FLT3 mutated acute myeloid leukemia (AML). Through imaging, genetic, and biomarker studies, researchers are gaining a deeper understanding of the biology of AML, which will likely resolve many current problems in FLT3 mutated AML diagnosis and classification.

The current study aims to assess the global FLT3 inhibitors market by focusing on the marketed and potential pipeline therapies. The current market for FLT3 inhibitors is majorly dominated by pharmaceutical companies such as Novartis International AG, Astellas Pharma Inc., and Daiichi Sankyo Company, Limited. Increasing investments in the research and development of drug manufacturing are one of the major opportunities in the global FLT3 inhibitors market.

Figure: Global FLT3 Inhibitors Market, $Million, 2021-2032

Global FLT3 Inhibitors Market

Source: BIS Research Analysis

Impact

The growing interest of the pharmaceutical industry in the therapeutic potential for treating blood cancers with FLT3 positive mutations has been a catalyst for the progress of the global FLT3 inhibitors market. Recently approved products such as Xospata and Rydapt for treating FLT3 mutated acute myeloid leukemia (AML)  The recent increase in the number of drug approvals received for treating acute myeloid leukemia with FLT3 positive mutations is considered to have added value to the emerging potential drug development. There are three FLT3 inhibitors approved by the U.S. Food and Drug Administration during 2015-2021. Also, many FLT3 inhibitors are in preclinical or clinical trials, indicating progress toward making an impact in the pharmaceutical industry.

Drug development is more prominent in countries such as the U.S., Germany, the U.K., and Japan. Moreover, the presence of major market players such as Astellas Pharma Inc., Daiichi Sankyo Company, Limited., Novartis AG, Allarity Therapeutics, Inc., and AROG Pharmaceuticals, Inc. has a positive impact on the market growth.

Market Segmentation

Global FLT3 Inhibitors Market

Segmentation 1: by Commercialized Therapies
•    Type 1 FLT3 Inhibitors
•    Type 2 FLT3 Inhibitors

The Type 1 FLT3 inhibitors segment represented the largest market share at 96.63% of total commercialized therapies in 2021. However, the Type 2 FLT3 inhibitors segment is anticipated to register a high growing CAGR of 14.63% during the forecast period 2022-2032.

Segmentation 2: by Potential Pipeline Products
•    Crenolanib
•    Dovitinib
•    SKLB1028

The Dovitinib is expected to hold 59.56% of total potential pipeline products in 2032, while Crenolanib and SKLB1028 segment is expected to hold 33.71% and 6.73% in 2032, respectively.

Segmentation 3: by Region
•    North America - U.S., Canada
•    Europe - Germany, Italy, France, U.K., Spain, Rest-of-Europe
•    Asia-Pacific - China, Japan, Rest-of-APAC (RoAPAC)
•    Rest-of-the-World (RoW)

The North America FLT3 inhibitors market was valued at $252.7 million in 2021, and the region is currently the leading contributor to the market. The growth can be attributed to the increased research and development activities in the region.

Recent Developments in the Global FLT3 Inhibitors Market

•    In March 2021, Astellas Pharma's Xospata (Gilteritinib) met the overall survival endpoint in the COMMODORE trial of subjects having FLT3 mutated relapsed or refractory acute myeloid leukemia.
•    In December 2021, Allarity Therapeutics submitted a New Drug Application (NDA) to the U.S. FDA for Dovitinib as a third-line treatment for renal cell carcinoma (RCC).
•    In June 2021, Cullinan Oncology received Investigational New Drug (IND) Clearance from the FDA for CLN-049 to treat relapsed/refractory AML.
•    In June 2019, Daiichi Sankyo Company, Limited received a Complete Response Letter (CRL) from the U.S. FDA for the New Drug Application (NDA) of Vanflyta (Quizartinib) to treat adult patients with relapsed/ refractory FLT3-ITD acute myeloid leukemia.

Demand – Drivers and Limitations

Following are the demand drivers for the global FLT3 inhibitors market:

•    Introduction of Novel Products
•    Increasing Incidence of Acute Myeloid Leukemia
•    Rising Research and Development Investments

The market is expected to face some limitations too due to the following challenges:

•    High Treatment Cost Impacting the Adoption Rate
•    Disease Relapse in FLT3 Mutated AML

Analyst's Thoughts

According to Vaishali Chauhan, Research Analyst, BIS Research, "The global FLT3 inhibitors market is a small segment of the entire tyrosine kinase inhibitors market and is growing. Moreover, along with it, the rising interest of the pharmaceutical industry in developing and marketing novel drugs for treating blood cancers with FLT3 positive mutations is making headway in the growth of the global FLT3 inhibitors market. Until recently, patients suffering from FLT3 mutated AML were mainly treated with chemotherapy, which was not very efficient at improving survival rates. A new group of drugs known as FLT3 inhibitors is enhancing the outlook for people with the FLT3 positive mutation."

FAQ's

What are fms-like tyrosine kinase 3 (FLT3) inhibitors?

The FLT3 gene gives instructions for making a protein known as fms-like tyrosine kinase 3 (FLT3). FLT3 is recognized as a part of a family of proteins called receptor tyrosine kinases (RTKs) which transmit signals from the cell surface into the cell through a process known as signal transduction. This signaling mechanism tends to control many crucial cellular processes, including cell proliferation and survival, specifically of early blood cells called hematopoietic progenitor cells. Any changes in the FLT3 gene result in the form of blood cancer, predominantly FLT3 mutated acute myeloid leukemia (AML).

What new strategies are existing market players adopting to strengthen their market position in the industry?

The global FLT3 inhibitors market has seen major development by key players operating in the market, such as partnerships and alliances, product approvals and launches, regulatory and legal activities, and other developments. According to BIS Research analysis, among the different key developments, regulatory and legal activities constitute the dominant contributor's strategies with a 65.22% share of the total strategies witnessed by the market between January 2019 and June 2022.

For a new company looking to enter the FLT3 inhibitors market, which areas could it focus upon to stay ahead of the competition?

A new entrant can focus on the development of second-generation FLT3 inhibitors being offered by a few established market players of FLT3 inhibitors. This might create an excellent opportunity for a new company to enter the FLT3 inhibitors market.

What is the USP of this report?

The following can be seen as some of the USPs of the report:

• Extensive competitive benchmarking of the top 12 players to offer a holistic view of the global FLT3 inhibitors market landscape

• Market ranking analysis based on product portfolio, recent developments, and regional analysis

Who should buy this report?

Pharmaceutical or biopharmaceutical companies involved in developing novel therapeutic drugs to treat blood cancers with FLT3 positive mutations.

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