BCR-ABL Tyrosine Kinase Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2024

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 disease. BC -ABL tyrosine kinase inhibitors inhibit the enzyme BCR-ABL tyrosine kinase, which is important in the pathogenesis of chronic myelogenous leukemia(CML). Ch onic myelogenous leukemia occurs due to a single genetic abnormality, known as the Philadelphia chromosome. When the Philadelphia chromosome is created, a fusion gene called the BCR-ABL gene is formed during the translocation.The BCR-ABL-positive cells in chronic myelogenous leukemia have increased proliferation and resistance to cell death. BC -ABL tyrosine kinase inhibitors are used to treat chronic myelogenous leukemia. BC -ABL tyrosine kinase inhibitors have the predominant role in the treatment of chronic myeloid leukemia, hematologic diseases, lymphatic diseases, sarcoma, digestive system diseases, respiratory tract diseases, bone marrow diseases, colorectal neoplasm, and endocrine system diseases. 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 their 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 the Centers for Disease Control and Prevention 2019,  5.9% of adults were diagnosed with ulcers, and 8 million people visited emergency departments with digestive system diseases. The launch of newer products by the market players significantly enhances the revenue of the BCR-ABL tyrosine kinase inhibitors market over the forecast years. For instance, in pediatric patients, Novartis Glivec (imatinib mesylate) treats malignant gastrointestinal stromal tumors and Philadelphia-positive CML. Scemblix (asciminib) of Novartis for treatment of Philadelphia chromosome-positive CML in chronic phase. For instance, Aldeyra’s, ganetespib(ADX-1612) for the indication of carcinoma, bronchial neoplasm, and lung neoplasm, Deciphers'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 launches 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 Philadelphiachromosome-positive chronic myelogenous leukemia.
• In October 2021, US Food and Drug Administration (FDA) has approved Novartis 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 dispensing. Stivarga now available in four 21-count bottles, replacing the previous packaging of three 28-count bottles.

Approved Drug Molecules for BCR-ABL Tyrosine Kinase Inhibitor along with the Brand Names:

• 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 Inhibitor:

• 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  molecules:

• In February 2017, In collaboratiom with ArrayBiopharma, Phase I/II Study of Nilotinib  (Tasigna) and MEK-162 (ARRY-162)  in Combination were conducted for Patients   With Refractory or Advanced Chronic Myeloid Leukemia with E objective the the the objective to find the   highest tolerated dose of the combination of  nilotinib and MEK-162 that can be given  to patients with CML or acute leukemia.
• 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.