Despite the current Bruton tyrosine kinase (BTK) inhibitor market being valued at approximately $6 billion, sales specifically for chronic lymphocytic leukemia (CLL) are predicted to be nearly $5 billion by 2032 in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan).  Eli Lilly’s Jaypirca (pirtobrutinib) is forecast to become the market leader in BTK inhibitors for CLL, garnering nearly 60% share with about $3 billion in sales by 2032, according to GlobalData, a leading data and analytics company.

Additionally, the generic erosion of AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib), a first-generation BTK inhibitor and the market leader since 2013, is expected to affect sales, with its market exclusivity ending in the US by 2028 and the 5EU (France, Germany, Italy, Spain, and the UK) by 2029. In the price negotiations program between manufacturers and Medicare under the Biden administration, Imbruvica is the only cancer drug on the list that needs to slash its sale price in the US in 2026.

It is expected that second-generation BTK inhibitor AstraZeneca‘s Calquence (acalabrutinib) will occupy second place in the market, with sales exceeding $1 billion and a share of 21.7%. BeiGene’s Brukinsa (zanubrutinib) is predicted to attain third place with $774 million in sales, representing 15.8% of the overall BTK inhibitor therapy market share by 2032.

Biswajit Podder, PhD, Oncology and Hematology Analyst at GlobalData, comments: “In the future, Jaypirca’s role is set to expand. Presently, 16 Phase I-III clinical trials are in progress, investigating the potential of this drug as a first-line and subsequent-line therapy for hematological malignancies. Its potential uses include maintenance therapy after CAR-T-cell therapy, in cases of CAR-T failure, as a bridging therapy before CAR-T, and in combination with other targeted immunotherapies, such as bispecific or trispecific antibodies.”

Remarkably, the current landscape boasts a total of six marketed BTK drugs in the oncology sector globally. Further bolstering this optimistic outlook, there are nearly 400 ongoing Phase I-III trials worldwide, utilizing 37 distinct BTK inhibitors.

Podder concludes: “In addition to the success of Imbruvica, second-generation BTK inhibitors are taking a significant share of the BTK inhibitor market because of their superiority to first-generation BTK inhibitor drugs. Second-generation inhibitors Jaypirca, Brukinsa, Calquence, and Gilead/Ono’s Velexbru (tirabrutinib) offer fewer off-target effects, leading to less cardiotoxicity and allowing patients to maintain treatment longer, thereby increasing efficacy.

“In addition, if Jaypirca gets approval for other indications like diffuse large B-cell lymphoma, follicular lymphoma, and marginal zone B-cell lymphoma, it will strengthen its market position.”