Waldenström Macroglobulinemia Market Poised for Steady Growth Through 2036 on Novel BTK Degraders, Non-Covalent BTKis, and Targeted Radiotherapeutics
核心洞察
The Waldenström macroglobulinemia (搜索) treatment market across the 7MM is expected to grow steadily through 2036, driven by rising diagnosis rates, aging populations, and adoption of targeted therapies.
Emerging agents including nemtabrutinib, bexobrutideg (搜索) (NX-5948), and iopofosine I-131 aim to address relapsed/refractory disease and overcome resistance to covalent BTK (搜索) inhibitors.
Cellectar's iopofosine I-131 achieved an 83.6% overall response rate and 61.8% major response rate in the Phase IIb CLOVER-WaM trial, with a median duration of response of 17.8 months.
The Waldenström macroglobulinemia (搜索) (WM) treatment market is expected to witness steady growth through 2036, propelled by increasing disease awareness, improvements in diagnostic capabilities, and the continued development of targeted therapies, according to a recently published market insights report from DelveInsight (搜索) Business Research. The report forecasts market size from 2022 to 2036 across the leading markets—the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan—and highlights an expanding pipeline of BTK (搜索) degraders, non-covalent BTK inhibitors, BCL-2 inhibitors, and targeted radiotherapeutic agents.
Waldenström macroglobulinemia (搜索) has an incidence rate of approximately 3 cases per million annually in the US, with 1,000 to 1,500 new diagnoses each year. The disease predominantly affects older adults, with an average age at diagnosis of 70. The United States accounted for the largest WM treatment market size in the 7MM in 2025 compared with the EU4 countries, the United Kingdom, and Japan.
Evolution of the Treatment Landscape
The treatment landscape for Waldenström macroglobulinemia (搜索) has evolved considerably over the past decade, largely driven by the emergence of Bruton's tyrosine kinase (BTK (搜索)) inhibitors. Before the advent of targeted therapies, treatment primarily centered on rituximab-based immunochemotherapy regimens, which were often associated with substantial treatment-related toxicities.
The approval of ibrutinib (IMBRUVICA) in 2015 represented a major milestone, as it became the first therapy specifically approved for the disease and established BTK (搜索) inhibition as a key component of treatment. Subsequently, zanubrutinib has emerged as a strong competitor, supported by favorable efficacy and tolerability outcomes demonstrated in the ASPEN trial. Although IMBRUVICA continues to generate significant global revenue, its sales have declined from previous levels amid increasing competition from next-generation BTK inhibitors, particularly zanubrutinib.
Emerging Pipeline and Mechanisms of Action
The emerging pipeline is expected to further diversify treatment options for relapsed/refractory (R/R) disease. Nemtabrutinib (MK-1026-003), an investigational oral, non-covalent and reversible BTK (搜索) inhibitor from Merck Sharp & Dohme, has demonstrated encouraging clinical activity in patients previously treated with covalent BTK inhibitors, potentially positioning it as an important therapeutic option in the R/R setting.
Bexobrutideg (搜索) (NX-5948), a next-generation BTK (搜索) degrader from NURIX (搜索), employs a differentiated mechanism by targeting both wild-type and mutant BTK proteins, potentially addressing acquired resistance to conventional BTK inhibitors. NX-5948 is an orally administered, CNS-penetrating small-molecule degrader targeting BTK, currently under investigation for chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), and WM.
Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight (搜索), said that nemtabrutinib is expected to achieve meaningful uptake following potential approval, particularly in R/R patients who have progressed on covalent BTK (搜索) inhibitors. Bexobrutideg (搜索) may establish a differentiated position through its BTK degradation mechanism, which could help overcome resistance-associated mutations and support adoption in heavily pretreated patients.
Iopofosine I-131 Clinical Data
Iopofosine I-131 is Cellectar Biosciences' lead investigational phospholipid drug conjugate (PDC) radiotherapeutic, developed to selectively deliver iodine-131 to tumor cells while limiting radiation exposure to healthy tissues. The therapy has been evaluated in the completed CLOVER-WaM Phase II pivotal study in patients with R/R Waldenström macroglobulinemia (搜索).
In May 2026, Cellectar Biosciences announced updated and mature 12-month follow-up data from its Phase IIb CLOVER-WaM clinical trial. An 83.6% overall response rate (ORR) and 61.8% major response rate (MRR) were achieved in a heavily pretreated population, with a median duration of response of 17.8 months. In June 2026, the company announced efficacy results from a subset of patients who received iopofosine I-131 immediately following BTK (搜索) inhibitor therapy, featured in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting held May 29–June 2, 2026, in Chicago, Illinois.
Pending potential FDA approval, iopofosine could offer a meaningful treatment option for patients with R/R disease, particularly given the estimated ~11,500 R/R patients and ~1,000 patients who exhaust available treatment options by the third-line setting in the US. Iopofosine I-131 has received multiple regulatory designations in the US and EU, including Orphan Drug Designation in both regions, as well as Breakthrough Therapy Designation and Fast Track Designation in the US and PRIME Designation in the EU.
Competitive Landscape and Market Outlook
Additional WM drugs under development include Sonrotoclax (BeOne), an orally active small-molecule BCL2 (搜索) inhibitor in the BH3 mimetic class that demonstrates greater selectivity and enhanced pharmacological potency against BCL2 compared with venetoclax; TT-01488 (TransThera Biosciences); SGR-1505 (Schrödinger, Inc.); Lisaftoclax (APG-2575; Ascentage Pharma); and Loncastuximab tesirine (Lonca; ADC Therapeutics).
Overall, the Waldenström macroglobulinemia (搜索) market across the 7MM is anticipated to experience steady growth through 2036. Market expansion is expected to be supported by rising diagnosis rates, improved patient survival, increasing adoption of targeted therapies, and continued innovation in the treatment of B-cell malignancies. Greater understanding of molecular alterations, including MYD88 (搜索) and CXCR4 (搜索) mutations, is facilitating more precise disease characterization and supporting biomarker-driven treatment strategies and the development of novel targeted therapies.