BCR-ABL Tyrosine Kinase Inhibitor Market Assessment and Forecast – Competition Landscape, Commercial, and Pipeline Analysis, 2023-2029

BCR-ABL, a constitutively activated tyrosine kinase, is the product of the Philadelphia chromosome. This enzyme is present in virtually all cases of chronic myeloid leukemia (CML) throughout the course of the disease. BCR-ABL tyrosine kinase inhibitors inhibit the enzyme BCR-ABL tyrosine kinase, which is important in the pathogenesis of chronic myelogenous leukemia(CML). During the translocation when the Philadelphia chromosome is created, a fusion gene called BCR-ABL gene is formed. The BCR-ABL gene encodes for the BCR-ABL tyrosine kinase. The BCR-ABL positive cells in chronic myelogenous leukemia have increased proliferation and resistance to cell death. BCR-ABL tyrosine kinase inhibitors are used to treat chronic myelogenous leukemia. BCR-ABL tyrosine kinase inhibitors have the predominant role in treatment of chronic myeloid leukemia, hematologic diseases, lymphatic diseases, sarcoma, digestive system diseases, respiratory tract diseases, bone marrow diseases, colorectal neoplasm, endocrine system diseseses, etc. According to the American Cancer society 2023, About 15% of all new cases of leukemia are chronic myeloid leukemia. About 1 person in 526 will get CML in t heir lifetime in the United States. The average age at diagnosis of CML is around 64 years. Almost half of cases are diagnosed in people 65 and older. This type of leukemia mainly affects adults and is rarely seen in children. According to centers for disease control and prevention 2019, 5.9% adults diagnosed with the ulcers and 8 million people visited to emergency departments with digestive system diseases. launch of newer products by the market players significantly enhances the revenue of BCR-ABL tyrosine kinase inhibitors market over the forecast years. For instance, Novartis Glivec (imatinib mesylate) for the treatment of malignant gastrointestinal stromal tumors and philadelphia positive CML in pediatric patient. Scemblix (asciminib) of novartis for treatment of Philadelphia chromosome positive CML in chronic phase.  Development of other molecules by market players are coming up with more treatment options. For instances, Aldeyra’s ganetespib(ADX-1612) for the indication of carcinoma, bronchial neoplasm and lung neoplasm, Deciphera’s rebastinib(DCC-2036) for the indication of bone marrow diseases, CML, hematologic diseases are  under the various stages of clinical studies.

Key Market Developments:

• In February 2016, Sun pharma launched Imatinib mesylate in USA leukemia patients and its first-to-file product, granted 180 days of marketing exclusivity by FDA from time of its launch.
• In January 2018, FDA approved a supplemental New Drug Application to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
• In October 2021, FDA approved Novartis’s Scemblix(asciminib) for treatment of  adult patients with Philadelphia chromosome positive CML in chronic phase.
• In June 2021, Bayer announced the availability of new packaging for the Stivarga(regorafenib) to help to dispense. Stivarga is now available in four 21-count bottles, replacing the previous packaging of three 28-count bottles.

Approved Drug Molecules and Brand Names for BCR-ABL Tyrosine Kinase Inhibitors:

• Glivec (Imatinib mesylate) - Novartis
• Stivarga (Regorafenib) – Bayer
• Tasigna (Nilotinib) – Novartis
• Bosulif (Bosutinib) – Pfizer
• Iclusig (Ponatinib) – Takeda
• Scemblix (Asciminib) – Novartis
• Nailike (Olverembatinib) – Ascentage pharma
• Hansoh Xinfu (Flumatinib) – Hansoh Pharma
• Supect (Radotinib) – IL-Yang Pharma
• Dasynoc (Dasatinib Amorphous) – Xspray Pharma

Drugs under the Pipeline for BCR-ABL Tyrosine Kinase Inhibitors:

• Ganetespib (ADX-1612)
• Ruserontinib (SKLB-1028)
• Danusertib (PHA-739358)
• Bafetinib (INNO-406)
• Rebastinib (DCC-2036)
• Vodobatinib (SCC – 138)
• Imatinib Dry Powder (AV-101)
• FB-101 
• KW-2449 
• XL228 
• AZD 0424 
• ELVN-001 
• PF-114 
• TERN-701 
• TGRX-678 
• Imatinib (AER-901)
• Imatinib Prodrug (Ikt-001Pro)
• Vodobatinib (SCO - 088)

Clinical Activity and Developments of BCR-ABL Tyrosine Kinase Inhibitors:

As of June 2023, more than 30 companies have approximately 29 molecules for above 549 diseases. For these molecules, more than 493 clinical trials are being conducted by the players across the globe. For instance,

• In May 2023, Novartis Nilotinib has found 60% phase transition success rate in Phase 2 clinical development for Tenosynovial Giant Cell Tumor.
• In July 2019, Bayer, Bristol-M yers Squibb and Ono Pharmaceutical enter into a Clinical Collaboration Agreement to Investigate Stivarga (regorafenib) and Opdivo (nivolumab) as combination therapy in patients with Metastatic Colorectal Cancer.
• In April 2020, Pfizer conducted Multicenter Phase 3 trial, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients for indication of Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.