Europe Bruton Tyrosine Kinase (BTK) Inhibitors Market: By Molecule (Ibrutinib, Zanubrutinib, Acalabrutinib, Pirtobrutinib), Disease (Chronic lymphocytic leukemia (CLL), Diffuse large B cell lymphoma (DLBCL), Follicular lymphoma (FL), Graft-versus-host disease (GvHD), Marginal Zone Lymphoma (MZL), Waldenström Macroglobulinemia (WM), Central nervous system lymphoma (CNSL), and Mantle cell lymphoma (MCL)), Country Wise Location (Germany, United Kingdom,  France, Spain, and Italy), and Forecast To 2030

Europe Bruton Tyrosine Kinase (BTK) Inhibitors Market size was valued at USD USD 1,911.3 Million in 2021, growing at a CAGR of 21.3% within the forecast period of 2022-2028. BTK is a prospective therapeutic target for different B cell malignancies and inflammatory illnesses since it is a crucial part of numerous signaling pathways that control B cell and myeloid cell proliferation, survival, and activities. Ibrutinib, Acalabrutinib, Zanubrutinib, Tirabrutinib, and Orelabrutinib are five small-molecule inhibitors that have been authorized to treat various forms of hematological malignancies and have demonstrated impressive effectiveness. Ibrutinib, a first-in-class medication, has ushered in a new era of chemotherapy-free B cell cancer treatment. Ibrutinib is so well-liked that it rose to fourth place among all cancer medications sold globally in 2021 (USD 1835.98 million in Sales). BTK inhibitors have recently been put to use in the management of inflammatory disorders. Preclinical and early-phase clinical investigations have produced promising results. The therapy of hematological malignancies and inflammatory illnesses has greatly benefited in recent years with the discovery of BTKi.

BTKi is classified into covalent or non-covalent inhibitors. Covalent bonding is the mechanism through which covalent inhibitors attach to the wild-type (WT) or mutant cysteine 481 (Cys481) residue. Using non-covalent forces like hydrogen bonds or hydrophobic interactions, non-covalent inhibitors can occupy the ATP binding pocket or a particular H3 pocket of BTK. All currently authorized medications fall within the category of irreversible covalent inhibitors, which are capable of effectively and permanently inhibiting BTK's enzyme activity. Patients taking BTKi may have undesirable side effects and acquired resistance due to off-target effects and the formation of mutations in the BTK binding sites. Pharmaceutical businesses and research institutes are creating new BTKi with greater selectivity and larger binding site coverage to overcome these challenges.

Key Updates:

• We anticipate that the BTKi market will have severe competition between the acalabrutinib and zanubrutinib. It was very evident from the ibrutinib Q1 2023 sales and it has lost ground for second generation BTK inhibitors. The company respondents have accepted the same in the investor call that their product sales decreased due to competitive pressures, but it still maintains its market leadership position worldwide.
• In Q1 2023, Imbruvica (Ibrutinib) sales decreased by 22.9% when compared with the Q1 2022 sales. The sales of Imbruvica shown a decreasing trend over the last two years and withdrawal from the MCL indication in United States has a negative impact on the product. Calquence was taking 64% of new patient market share in the U.S. among BTK inhibitors.
• To compete in this environment, Imbruvica is conducting clinical trials in combination with the other molecules such as venetoclax, and newer indications to sustain in these competitive markets.
• Calquence (Acalabrutinib) is registering double digit growth (25.6%) when compared with Q4 2022. Surprisingly the USA sales decreased by 17.4%. Q4 2022 and Q1 2023 USA acalabrutinib sales were 588 Million and 532 Million. In Jan 23, approval of Zanubrutinib for CLL contributed to the dip in the acalabrutinib sales in the United States.
• In 2023, Brukinsa (Zanubrutinib) registered strong sales in Q1 2023 and the majority of the sales coming from the Europe region. Zanubrutinib sales USD 211.4 Million Q1 2023 Vs USD 104 Million (Q1 2022). In 2022, Zanubrutinib received the EU approval for the treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL) condition.
• On July 12th, 2023, the US FDA accepted Beigene's sNDA application for the use of BRUKINSA® (zanubrutinib) in combination with obinutuzumab to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone at least two prior lines of therapy. This application was filed based on the positive results of the ROSEWOOD study (NCT03332017). Patients suffering from R/R FL will benefit significantly from this new treatment option.