Chronic myeloid leukemia is a myeloproliferative disorder which is characterized by the abnormal granulocyte cells proliferation. Since last two decades, there have been significant advances in the management of chronic myeloid leukemia. New drug class that has transformed the treatment of CML includes tyrosine kinases (TKIs) or BCR - ABL inhibitors. The BCR - ABL targets are downstream pathways including RAS, PI3K/AKT, and JAK/STAT that address the transformation of healthy cells toward neoplastic cells responsible for pathogenesis of chronic myeloid leukemia, thus making it potential target for the drug development.
Imatinib was first BCR - ABL inhibitor, which was approved by FDA in 2001 as first-line therapy for chronic myeloid leukemia. Unfortunately, the appearance of resistance phenomena required the development of a second generation of BCR - ABL inhibitors. Currently three 2nd generation drugs including Nilotinib, Dasatinib and Bosulitinib whereas one 3rd generation drug, Ponatinib has been approved for the management of CML which have shown enhanced efficacy in comparison to already approved drugs. In addition, Olverembatinib which is third generation inhibitor developed by Ascentage Pharma has gained entry into China. The promising response of BCR - ABL inhibitors in the market has propelled the further research and development activities in this domain. Companies operating in the BCR - ABL tyrosine kinase inhibitors industry are focusing on increasing their geographic presence by means of strategic acquisitions and collaborations with leading players and increasing FDA approvals of therapeutic drugs in their respective domains and geographies. For instance, Ascentage Pharma also announced a multifaced strategic collaboration with Innovent Biologics.
This collaboration includes the joint clinical development and commercialization of Olverembatinib in China. Ascentage Pharma has recently announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted approval to Olverembatinib (HQP1351), for the treatment of patients with chronic phase CML resistant and/intolerant to first and second generation TKI. US has been dominating the global BCR - ABL inhibitor market driven by more than 100 clinical trials which are evaluating the role of novel BCR - ABL inhibitors as monotherapy or combinational therapy in wide range of therapeutic indications. Further, the governments regulatory are also increasingly granting special designations such as orphan drug, breakthrough therapy, and others which promote the research and development.
For instance in 2020, US FDA granted HQP1351 orphan drug designation for the treatment of patients with chronic myeloid leukemia. HQP1351 is a novel, orally active, potent third generation BCR - ABL inhibitor which is designed to target BCR - ABL mutants, including T3151. As per our report findings, the global BCR - ABL inhibitor market will surpass US$ 8 Billion by 2028. The major factor attributing to the growth of the market is increasing prevalence of chronic myeloid leukemia (CML). Furthermore, growing investments in research and development programs by biotechnology and pharmaceutical companies are also boosting the market growth. The development of favorable reimbursement policies and introduction of generics in the market will also drive the growth of market. The key companies in global BCR - ABL inhibitor market are Ascentage Pharma, Incyte Pharmaceuticals, Novartis, Bristol Meyer Squibb, Ariad Pharmaceuticals, and others.
Our report provides in-depth analysis on the available BCR - ABL inhibitors in the global market along with their commercial information. In addition, insights into ongoing clinical trials and key drugs in research and development are also included in the report. The report also provides profiles of leading players operating in the global tyrosine kinase inhibitors market. The report includes detailed analysis on market dynamics, market estimation and forecast for the period of 2022 to 2028. The report segments market on the basis of drug type and geographies.
Imatinib was first BCR - ABL inhibitor, which was approved by FDA in 2001 as first-line therapy for chronic myeloid leukemia. Unfortunately, the appearance of resistance phenomena required the development of a second generation of BCR - ABL inhibitors. Currently three 2nd generation drugs including Nilotinib, Dasatinib and Bosulitinib whereas one 3rd generation drug, Ponatinib has been approved for the management of CML which have shown enhanced efficacy in comparison to already approved drugs. In addition, Olverembatinib which is third generation inhibitor developed by Ascentage Pharma has gained entry into China. The promising response of BCR - ABL inhibitors in the market has propelled the further research and development activities in this domain. Companies operating in the BCR - ABL tyrosine kinase inhibitors industry are focusing on increasing their geographic presence by means of strategic acquisitions and collaborations with leading players and increasing FDA approvals of therapeutic drugs in their respective domains and geographies. For instance, Ascentage Pharma also announced a multifaced strategic collaboration with Innovent Biologics.
This collaboration includes the joint clinical development and commercialization of Olverembatinib in China. Ascentage Pharma has recently announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted approval to Olverembatinib (HQP1351), for the treatment of patients with chronic phase CML resistant and/intolerant to first and second generation TKI. US has been dominating the global BCR - ABL inhibitor market driven by more than 100 clinical trials which are evaluating the role of novel BCR - ABL inhibitors as monotherapy or combinational therapy in wide range of therapeutic indications. Further, the governments regulatory are also increasingly granting special designations such as orphan drug, breakthrough therapy, and others which promote the research and development.
For instance in 2020, US FDA granted HQP1351 orphan drug designation for the treatment of patients with chronic myeloid leukemia. HQP1351 is a novel, orally active, potent third generation BCR - ABL inhibitor which is designed to target BCR - ABL mutants, including T3151. As per our report findings, the global BCR - ABL inhibitor market will surpass US$ 8 Billion by 2028. The major factor attributing to the growth of the market is increasing prevalence of chronic myeloid leukemia (CML). Furthermore, growing investments in research and development programs by biotechnology and pharmaceutical companies are also boosting the market growth. The development of favorable reimbursement policies and introduction of generics in the market will also drive the growth of market. The key companies in global BCR - ABL inhibitor market are Ascentage Pharma, Incyte Pharmaceuticals, Novartis, Bristol Meyer Squibb, Ariad Pharmaceuticals, and others.
Our report provides in-depth analysis on the available BCR - ABL inhibitors in the global market along with their commercial information. In addition, insights into ongoing clinical trials and key drugs in research and development are also included in the report. The report also provides profiles of leading players operating in the global tyrosine kinase inhibitors market. The report includes detailed analysis on market dynamics, market estimation and forecast for the period of 2022 to 2028. The report segments market on the basis of drug type and geographies.
Table of Contents
1. Introduction to BCR - ABL Inhibitors 1.1 Overview
1.2 Evolution of BCR - ABL Inhibitors
2. BCR - ABL Inhibitor - Mechanism of Action 2.1 Overview
2.2 Role of BCR - ABL Inhibitor in Cancer
3. Global BCR - ABL Inhibitor Drug Market Insight 3.1 Current Market Scenario
3.2 Future Market Opportunity
4. BCR - ABL Inhibitor Drug Market Regional Analysis 4.1 US
4.2 Europe
4.3 Japan
4.4 Rest of World
5. BCR - ABL Inhibitor Drug Market by Product 5.1 First Generation BCR - ABL Inhibitor
5.2 Second Generation BCR - ABL Inhibitor
5.3 Third Generation BCR - ABL Inhibitor
6. Imatinib – 1st Generation BCR - ABL Inhibitor 2001 6.1 Overview
6.2 Patent & Exclusivity
6.3 Pricing & Dosage Analysis
6.3.1 Branded
6.3.2 Generic
6.4 Sales Analysis
7. Dasatinib – 2nd Generation BCR - ABL Inhibitor 2006 7.1 Overview
7.2 Patent & Exclusivity
7.3 Pricing & Dosage Analysis
7.3.1 Branded
7.3.2 Generic
7.4 Sales Analysis
8. Nilotinib – 2nd Generation BCR - ABL Inhibitor 2007 8.1 Overview
8.2 Patent & Exclusivity
8.3 Price & Dosage Analysis
8.4 Sales Analysis
9. Bosutinib – 2nd Generation BCR - ABL Inhibitor 2012 9.1 Overview
9.2 Patent & Exclusivity
9.3 Pricing & Dosage Analysis
9.4 Sales Analysis
10. Ponatinib – 3rd Generation BCR - ABL Inhibitor 2012 10.1 Overview
10.2 Patent & Exclusivity
10.3 Pricing & Dosage Analysis
10.4 Sales Analysis
11. Asciminib – 3rd Generation BCR - ABL Inhibitor 2021 11.1 Overview
11.2 Patent & Exclusivity
11.3 Pricing & Dosage Analysis
12. Olverembatinib – 3rd Generation BCR - ABL Inhibitor 2021
13. BCR - ABL Inhibitors Sales Forecast 2022 Till 2028 13.1 Gleevec/Glivec Sales Forecast
13.2 Sprycel Sales Forecast
13.3 Tasigna Sales Forecast
13.4 Bosulif Sales Forecast
13.5 Iclusig Sales Forecast
14. BCR - ABL Inhibitor Market Clinical Trial Insights
14.1 By Indication
14.2 By Organization
14.3 By Patient Segment
14.4 By Phase
14.5 By Status
14.6 By Region
15. Global BCR - ABL Tyrosine Kinase Inhibitors Clinical Trials Insight By Company, Indication & Phase 15.1 Preclinical
15.2 Clinical
15.3 Phase-I
15.4 Phase-I/II
15.5 Phase-II
15.6 Phase-II/III
15.7 Registered
16. Marketed BCR - ABL Inhibitors Clinical Trials Insight
17. BCR - ABL Inhibitors Market Dynamics 17.1 Market Favorable Parameters
17.2 Market Challenges
18. BCR - ABL Inhibitor Market Future Perspective
19. Competitive Landscape 19.1 Ascentage Pharma
19.2 AstraZeneca
19.3 Bristol Myers Squibb
19.4 Fusion Pharmaceuticals
19.5 Incyte Pharmaceutical
19.6 Merck
19.7 Novartis
19.8 Pfizer
19.9 Takeda Pharmaceuticals
19.10 Teva Pharmaceutical
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Ascentage Pharma
- AstraZeneca
- Bristol Myers Squibb
- Fusion Pharmaceuticals
- Incyte Pharmaceutical
- Merck
- Novartis
- Pfizer
- Takeda Pharmaceuticals
- Teva Pharmaceutical