United States Multiple Myeloma Market Assessment, By Drug Class, By Disease Type, By Distribution Channel, By Region, Opportunities and Forecast, 2018-2032F

United States multiple myeloma market is projected to witness a CAGR of 5.50% during the forecast period 2025-2032, growing from USD 8.01 billion in 2024 to USD 12.29 billion in 2032. Rising incidence of multiple myeloma and early diagnosis are expanding the treatment-seeking patient base. Regulatory incentives like accelerated approvals are encouraging R&D and speeding market entry of novel therapies. Surging adoption of immunotherapies, especially Anti-CD38 monoclonal antibodies, is reshaping treatment preferences.

For instance, the American Cancer Society projects that in 2025, there will be approximately 36,110 new diagnoses of multiple myeloma in the United States, comprising 20,030 men and 16,080 women. It is anticipated that around 12,030 fatalities will occur, with 6,540 in men and 5,490 in women. The lifetime risk of developing multiple myeloma in the United States is estimated to be less than 1%, translating to about 1 in 108 for men and 1 in 133 for women; however, individual risk may vary based on specific risk factors. This type of cancer predominantly affects older adults, with less than 1% of cases occurring in individuals under 35 years of age. The majority of those diagnosed are at least 65 years old, with the average age at diagnosis being 69.

Rising Incidences of Multiple Myeloma and Expanding Diagnostic Capabilities

The growing incidence of multiple myeloma in the United States is significantly fueling demand for effective therapeutic options. As one of the most common forms of blood cancer, multiple myeloma accounts for roughly 1.8% of all cancer diagnoses in the country. Early diagnosis and disease monitoring have improved owing to advancements in imaging techniques and laboratory diagnostics such as serum protein electrophoresis and free light chain assays. Moreover, awareness campaigns by organizations like the Multiple Myeloma Research Foundation have boosted early detection rates, allowing for the timely initiation of treatment. This has increased the need for targeted and combination therapies to improve patient survival. To meet rising demand, pharmaceutical companies are investing in robust drug pipelines. For instance, in April 2024, Bristol Myers Squibb announced US FDA approval for a subcutaneous version of Abecma, a CAR-T cell therapy, offering faster administration for relapsed or refractory multiple myeloma.

Robust Pipeline and Accelerated Regulatory Approvals Propel Market Growth

The United States multiple myeloma therapeutics landscape is evolving rapidly with continuous pipeline expansion and an increase in expedited drug approvals by the U.S. Food and Drug Administration (FDA). Due to the high unmet clinical need and the progressive nature of the disease, the FDA offers designations like Fast Track, Breakthrough Therapy, and Orphan Drug to promote quicker access to innovative treatments. This favorable regulatory environment has encouraged major players to develop and commercialize novel agents targeting disease-specific pathways, such as BCMA (B-cell maturation antigen). Pharmaceutical giants are also leveraging biologics, cell therapies, and bispecific antibodies to address treatment-resistant cases. In August 2023, the FDA granted accelerated approval to Johnson & Johnson's bispecific antibody Talvey (talquetamab-tgvs), a first-in-class GPRC5D-targeting therapy for relapsed or refractory multiple myeloma. This milestone illustrates how regulatory incentives are reducing development timelines, bolstering investment in R&D, and increasing the number of approved therapies on the U.S. market.

Growing Preference for Targeted Immunotherapies and Monoclonal Antibodies

Segment-specific growth in the U.S. multiple myeloma market is being significantly driven by rising adoption of targeted immunotherapies, particularly Anti-CD38 monoclonal antibodies such as daratumumab and isatuximab. These therapies have demonstrated superior efficacy over conventional treatment regimens by targeting specific antigens on myeloma cells while sparing healthy tissues. Anti-CD38 agents are increasingly used in frontline therapy settings and in combination with other classes like proteasome inhibitors and immunomodulatory drugs. The growing clinician and patient preference for these biologics is fueled by their proven survival benefits, fewer adverse events, and extended duration of response. Additionally, pharma companies are actively investing in next-generation monoclonal antibodies with enhanced tumor cell-killing properties. For example, in September 2024, the US Food and Drug Administration (FDA) granted approval for Sarclisa (isatuximab) to be used in conjunction with bortezomib, lenalidomide, and dexamethasone (VRd) as a primary treatment option for adult patients diagnosed with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplants (ASCT). Sarclisa represents the first anti-CD38 therapy that, when combined with the standard VRd regimen, has been shown to significantly decrease the risk of disease progression or mortality (by 40%) compared to VRd alone in patients with NDMM who are not eligible for transplants.

Future Market Scenario (2025-2032F)

The United States multiple myeloma market is poised for strong growth in the coming years due to rising disease incidence, increased awareness, and advances in diagnostic and therapeutic technologies. With a rapidly aging population and improved early detection, the patient pool is expected to expand, driving demand for targeted therapies, immunomodulators, and monoclonal antibodies. Innovations such as CAR-T cell therapies and bispecific antibodies are revolutionizing treatment approaches, offering better survival outcomes and improved quality of life. Additionally, the favorable regulatory environment, coupled with strong investments in research and development, is accelerating drug approvals. As pharmaceutical companies focus on the combination of regimens and personalized medicine, the market is expected to witness robust expansion and continuous clinical innovation.

Key Players Landscape and Outlook

The key players in the market are significantly investing in developing multiple myeloma and are utilizing strategies such as mergers, acquisitions, partnerships, and new product launches to improve their services and competitiveness. Such efforts will propel significant growth in the market, allowing large-cap industry players to increase their presence and, therefore, find new opportunities in this market.

For instance, on November 6, 2024, Nanjing Leads Biolabs Co., Ltd. announced that LBL-034, a humanized bispecific T-cell engaging antibody aimed at GPRC5D and CD3 for the treatment of multiple myeloma, has been granted Orphan Drug Designation (ODD) by the U.S. FDA.