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(Albany, US) On October 28, 2026, DelveInsight’s “Waldenstrom Macroglobulinemia Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Waldenstrom Macroglobulinemia market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Waldenstrom Macroglobulinemia Pipeline @ https://www.delveinsight.com/report-store/waldenstrom-macroglobulinemia-market

Key Takeaways from the Waldenstrom Macroglobulinemia Report

• On June 2026, Cellectar Biosciences announced that, following FDA feedback from the March 2025 End-of-Phase II meeting, it plans to initiate a randomized Phase III confirmatory trial in Q4 2026 to support the accelerated and full approval pathways for iopofosine I-131 in relapsed/refractory (R/R) Waldenström macroglobulinemia.

• On December 2025, Nurix Therapeutics presented Phase I data for its BTK degrader bexobrutideg (NX-5948) in R/R Waldenström macroglobulinemia, showing an overall response rate of 75%, including very good partial responses in three patients (10.7%).

• DelveInsight’s report depicts a robust space, with the pipeline increasingly focused on next-generation targeted therapies for Waldenström macroglobulinemia treatment.

• Leading Waldenstrom Macroglobulinemia companies include Janssen, AbbVie, Takeda Pharmaceuticals, BeiGene, AstraZeneca, Millennium Pharmaceuticals, Cellectar Biosciences, TG Therapeutics, Gilead Sciences, X4 Pharmaceuticals, Regeneron Pharmaceuticals, and others.

• Promising Waldenström macroglobulinemia therapies include zanubrutinib (BRUKINSA), ibrutinib (IMBRUVICA), tirabrutinib (VELEXBRU), iopofosine I-131, nemtabrutinib, sonrotoclax, TT-01488, bexobrutideg, and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Waldenstrom Macroglobulinemia Treatment Drugs

Waldenstrom Macroglobulinemia Overview

Waldenström macroglobulinemia (WM) is a rare, indolent B-cell non-Hodgkin lymphoma and the most common subtype of lymphoplasmacytic lymphoma. It is characterized by the accumulation of lymphoplasmacytic cells in the bone marrow and the excessive production of monoclonal immunoglobulin M (IgM) protein. The disease primarily affects older adults, with a median age at diagnosis of about 70 years. Mutations in the MYD88 gene are present in the large majority of patients (95–97%) and play a central role in pathogenesis. Treatment is generally started only when symptoms or complications develop, while asymptomatic patients may be managed with active surveillance. BTK inhibitors have become the cornerstone of therapy.

Common symptoms and complications include:

• Anemia and fatigue

• Neuropathy

• Hyperviscosity syndrome

• Lymphadenopathy

• Hepatosplenomegaly

• Complications related to excess IgM

Waldenstrom Macroglobulinemia Emerging Drugs

Iopofosine I-131: Cellectar Biosciences Iopofosine I-131 is Cellectar’s lead investigational phospholipid drug conjugate (PDC) radiotherapeutic, designed to deliver iodine-131 directly to tumor cells while minimizing exposure to healthy tissue. In the Phase IIb CLOVER-WaM trial, it showed an 83.6% overall response rate and a 61.8% major response rate in a heavily pretreated R/R population, with a median duration of response of 17.8 months. It has received Orphan Drug Designation (US and EU), Breakthrough Therapy and Fast Track Designations (US), and PRIME Designation (EU). A Phase III confirmatory trial is planned for Q4 2026.

Nemtabrutinib (MK-1026-003): Merck Sharp & Dohme Nemtabrutinib (formerly ARQ 531) is an investigational, oral, non-covalent (reversible) BTK inhibitor being developed for several B-cell malignancies, including R/R Waldenström macroglobulinemia. It has shown encouraging activity in patients previously exposed to covalent BTK inhibitors. Currently, the drug is in Phase II for WM.

Bexobrutideg (NX-5948): Nurix Therapeutics Bexobrutideg is an oral BTK degrader designed to eliminate both wild-type and mutant BTK protein rather than simply inhibit it, potentially overcoming acquired resistance. In July 2025, the EMA granted it Orphan Drug Designation for lymphoplasmacytic lymphoma (Waldenström macroglobulinemia). Currently, the drug is in Phase I for R/R WM.

Sonrotoclax: BeOne Sonrotoclax is an oral BCL-2 inhibitor that promotes apoptosis by blocking the anti-apoptotic BCL-2 protein that supports malignant cell survival. Currently, the drug is in Phase II for R/R WM.

Explore groundbreaking therapies and clinical trials in the Waldenstrom Macroglobulinemia Pipeline @ New Waldenstrom Macroglobulinemia Treatment Drugs

Waldenstrom Macroglobulinemia Market Drivers

• Adoption of targeted therapies: BTK inhibitors offer durable responses and better tolerability than traditional chemoimmunotherapy, driving treatment uptake.

• Higher diagnosis rates and awareness: Better diagnostics, wider MYD88 and CXCR4 testing, and greater physician awareness support earlier, more accurate diagnosis and a growing diagnosed population.

• Robust pipeline of novel agents: Non-covalent BTK inhibitors, BTK degraders, BCL-2 inhibitors, and targeted radiotherapeutics are expanding options, especially for R/R patients.

• Longer patient survival: Longer survival with continuous therapy extends treatment duration and grows the treated population.

• Limited approved options: Only a few WM-specific approved therapies leave room for new entrants to gain share.

• Regulatory support: Orphan, Breakthrough, Fast Track, and PRIME designations are speeding development of promising candidates.

Waldenstrom Macroglobulinemia Market Barriers

• Relapse and BTK inhibitor resistance: These remain major challenges, and many patients run out of options by third line.

• Continuous therapy and toxicity: Ongoing treatment and related toxicities can hurt quality of life and adherence.

• Delayed diagnosis: Symptoms that mimic more common conditions lead to misdiagnosis and late treatment.

• No universal standard of care: Treatment variability and reliance on off-label therapies complicate practice and forecasting.

• High cost and access pressure: High-cost targeted therapies face payer scrutiny and reimbursement hurdles.

• Rare disease constraints: A very small patient pool makes trial recruitment difficult and limits commercial scale.

• Competition from entrenched BTK inhibitors: Zanubrutinib and ibrutinib are well established, so new entrants must show clear differentiation.

Download DelveInsight’s in-depth Waldenstrom Macroglobulinemia report today! @ Waldenstrom Macroglobulinemia Companies

The Waldenstrom Macroglobulinemia Report Provides Insights Into

• Companies developing and marketing WM therapies, with aggregate therapies per company

• Candidates segmented into early-, mid-, and late-stage development

• Active and inactive (dormant or discontinued) projects

• Drugs by stage, route of administration, target, monotherapy vs. combination, mechanism of action, and molecule type

• Collaborations (company–company and company–academia), licensing agreements, and financing details

• Market drivers, barriers, and unmet needs

Waldenstrom Macroglobulinemia Companies BeOne, AbbVie, Janssen (J&J), Cellectar Biosciences, Merck Sharp & Dohme, TransThera Biosciences, Nurix Therapeutics, Ascentage Pharma, Ono Pharmaceutical, and others.

Route of Administration: Oral, Intravenous

Molecule Types: Small molecule, Targeted protein degrader, Radiotherapeutic (phospholipid drug conjugate)

Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Waldenstrom Macroglobulinemia Market Drivers and Barriers

Scope of the Waldenstrom Macroglobulinemia Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Zanubrutinib (BRUKINSA), ibrutinib (IMBRUVICA), tirabrutinib (VELEXBRU), iopofosine I-131, nemtabrutinib, sonrotoclax, TT-01488, bexobrutideg, and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Table of Contents

1. Introduction

2. Executive Summary

3. Waldenstrom Macroglobulinemia: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): Iopofosine I-131 (Cellectar Biosciences, Phase III planned)

8. Mid Stage Products (Phase II): Nemtabrutinib (Merck Sharp & Dohme), Sonrotoclax (BeOne)

9. Early Stage Products (Phase I): Bexobrutideg (Nurix Therapeutics), TT-01488 (TransThera Biosciences)

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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