Waldenstrom's Macroglobulinaemia | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

A chronic, slowly progressing lymphoproliferative disease, Waldenstrom's macroglobulinemia is a malignant monoclonal disease. Immunoglobulin M [IgM] levels are elevated, serum viscosity is elevated, and lymphoid infiltrates can be found in the bone marrow. Only 1-2% of all hematomas are caused by the uncommon malignancy Waldenstrom's macroglobulinemia (WM), which has an incidence of 3-4 ppm. Since WM is so uncommon, it can be challenging to find epidemiological data on the condition. The diagnosis of indolent or smoldering disease and Waldenstrom's macroglobulinemia is given to patients who meet the diagnostic criteria for WM based on serum protein monoclonal IgM, lymphoblastic infiltration, or both absence of end-organ damage. Asymptomatic illness has no particular treatment.

Description

Malignant monoclonal Waldenstrom's macroglobulinemia is a chronic, slowly progressing lymphoproliferative disease. Immunoglobulin M [IgM] levels are elevated, serum viscosity is elevated, and lymphoid infiltrates can be found in the bone marrow. The World Health Organization (WHO) and the Revised European American Classification of Lymphomas (REAL) classify Waldenstrom's macroglobulinemia, a clonal disease of B lymphocytes, as a lymphoblastic lymphoma. IgM protein and malignant lymphocytic infiltration in the bone marrow and other tissue sites are related to the clinical characteristics of Waldenstrom's macroglobulinemia. The clinical presentation is similar to that of multiple myeloma, with the exception that organomegaly is more frequent in Waldenstrom's macroglobulinemia than in multiple myeloma, and degenerative bone disease and renal disease are less frequent in Waldenstrom's macroglobulinemia than in multiple myeloma. Although there is no known treatment for Waldenstrom's macroglobulinemia, many have shown promise. Randomized trial results, however, remain ambiguous. Treatment for asymptomatic patients without end-organ injury entails close observation. For symptomatic patients, particularly those with non-chronic diseases, rituximab monotherapy is typically the treatment of choice. Symptomatic diseases might benefit from a combination of therapies, like chemotherapy. In rituximab-resistant cases, particularly those with mutations in the MYD88 gene, ibrutinib has been shown to be effective as monotherapy. Plasmapheresis may be necessary in cases of hyperviscosity syndrome. An autologous stem cell transplant is taken into consideration in some circumstances.

Waldenstrom's Macroglobulinaemia (Epidemiology)

Only 1-2% of all hematomas are caused by Waldenstrom's macroglobulinemia (WM), a malignancy with an incidence of 3-4 ppm. WM is uncommon, making it challenging to gather epidemiological data on the condition. With 1,500 cases per year, Waldenstrom's macroglobulinemia is a relatively uncommon condition that accounts for 2% of all hematologic malignancies identified in the US. Only 5% of patients in the United States of African descent have Waldenstrom's macroglobulinemia, which is more common in white people. Waldenstrom's macroglobulinemia is a disease of the elderly, with an annual incidence of 10.3 in Great Britain. Most patients are between the ages of seven and eight. The average diagnosis age in the US is 65, and the majority of diagnoses are male.

Waldenstrom's Macroglobulinaemia -Current Market Size & Forecast Trends

The market for Waldenstrom's macroglobulinemia (WM) treatment is expected to grow steadily, with a projected value of approximately USD 1.3 billion by 2030, reflecting a compound annual growth rate (CAGR) of 5.2% from 2025 to 2030. The increasing incidence of WM, particularly among the aging population, and the development of new targeted therapies are key drivers of this growth. In the U.S., around 1,000 to 1,500 new cases are diagnosed annually, predominantly affecting individuals aged 60-79. North America is anticipated to dominate the market due to high prevalence rates and significant investment in research and development. Additionally, advancements in treatment options, including targeted therapies and combination therapies, are expected to enhance patient outcomes and further propel market expansion through 2035.

The diagnosis of indolent or smoldering disease and Waldenstrom's macroglobulinemia is given to patients who meet the diagnostic criteria for WM based on serum protein monoclonal IgM, lymphoblastic infiltration, or both absence of end-organ damage. Asymptomatic illness has no particular treatment. With routine assessments of the M component, immunoglobulins, and serum viscosity, patients can be closely watched. Chemotherapy and various forms of biological therapy (immunotherapy) are the two main WM treatments. Both treatments and either one could be applied. In the past few years, significant advancements have been made in the treatment of WM patients. There have been many new WM drugs discovered, but there haven't been many comparison studies to see which is best. The lack of a universally applicable standard of care results in. The mSMART guidelines recommend 4 to 6 bendamus cycles of Tinga rituximab with patients on plasma exchange in patients with extensive disease, severe leukopenia (hemoglobin 10 g/dl, platelets 100 x 109/l), structural symptoms, or symptoms of hyperviscosity. earlier than plasma exchange. Sticky at times. Dexamethasone plus rituximab and cyclophosphamide are another choice, particularly for patients without WM acromegaly. Patients who are 70 years of age or older and at risk for an autologous stem cell transplant may be considered to receive stem cells for future use after remission. Except for those who need immediate treatment for hyperviscosity, the majority of patients can be treated in an outpatient setting. To track development and help with treatment choices, routine chemistry assessments, coagulation tests for organomegaly, serum protein levels, and assessments of serum viscosity should be carried out on a regular basis. Patients in need of an emergency plasma exchange should be directed to a facility that offers this therapy. Patients who are well tolerated and achieve a durable response (3 years or more) may receive initial treatment for recurrent disease. Ibrutinib's use in WM has been given a broader indication by the US Food and Drug Administration (FDA), which now allows for use in combination with rituximab rather than as a monotherapy. The US Food and Drug Administration authorized the use of another BTK inhibitor, zanubrutinib (Brookins), in 2021 for the treatment of adult patients with WM. For certain patients with chemosensitive disease who experience their first or second relapse, particularly if the length of their initial remission was only a few months or weeks (2 years), autologous stem cell transplantation should be taken into consideration. Patients with WM resistance shouldn't be offered transplants.

Report Highlights

Waldenstrom's Macroglobulinaemia - Current Market Trends

Waldenstrom's Macroglobulinaemia - Current & Forecasted Cases across the G8 Countries

Waldenstrom's Macroglobulinaemia - Market Opportunities and Sales Potential for Agents

Waldenstrom's Macroglobulinaemia - Patient-based Market Forecast to 2035

Waldenstrom's Macroglobulinaemia - Untapped Business Opportunities

Waldenstrom's Macroglobulinaemia - Product Positioning Vis-a-vis Competitors' Products

Waldenstrom's Macroglobulinaemia - KOLs Insight