AUSTIN, Texas and TOKYO, Nov. 4, 2025 /PRNewswire/ -- According to the latest analysis by DataM Intelligence, the Next-Generation Multiple Myeloma Therapies Market Size was valued at USD 22.03 billion in 2023, increased to USD 23.13 billion in 2024, and is projected to reach USD 37.07 billion by 2033, growing at a CAGR of 5.4% during the forecast period (2025–2033). The market growth is fueled by rapid regulatory approvals, expanding adoption of bispecific antibodies, and the increasing use of CAR T-cell therapies in relapsed and refractory multiple myeloma (RRMM).
Recent National Comprehensive Cancer Network (NCCN) guideline updates have transformed the treatment landscape for multiple myeloma. Notably, Linvoseltamab (brand name Lynozyfic) was added as a preferred agent for RRMM following its accelerated approval by the U.S. FDA in July 2025. Clinical trial results demonstrated an overall response rate of approximately 70% and complete response rates approaching 45%, reinforcing the growing role of bispecific antibodies in advanced-stage myeloma management. In parallel, advances in genetic risk stratification and molecular profiling are redefining how patients are categorized and treated. Emerging models for MGUS, smoldering myeloma, and active disease now incorporate genomic and cytogenetic markers, allowing physicians to tailor therapy intensity based on individual risk.
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Beyond therapeutics, diagnostics are experiencing a paradigm shift. A multicenter trial using whole-body MRI (MY-RADS) revealed that patients achieving imaging-negative status post-transplant had progression-free survival of 42 months versus 24 months in those with residual disease. In addition, a novel liquid biopsy platform, SWIFT-seq, detected circulating tumor cells in 90% of study participants, paving the way for non-invasive monitoring and potentially reducing reliance on traditional bone marrow biopsies.
The next-generation therapies market spans multiple drug classes, each contributing uniquely to improved outcomes and durable responses. Monoclonal Antibodies such as Darzalex, Darzalex Faspro, Sarclisa, and Empliciti continue to dominate frontline and maintenance regimens. Immunomodulators (IMiDs) including Revlimid and Pomalyst remain foundational agents, while emerging CELMoDs such as iberdomide and mezigdomide promise deeper immune modulation. Proteasome Inhibitors like Velcade, Kyprolis, and Ninlaro sustain relevance in multi-line therapy settings, supported by recent formulation advancements. Bispecific Antibodies such as Elrexfio (elranatamab), Tecvayli (teclistamab), Talvey (talquetamab), and Lynozyfic (linvoseltamab) are driving the next wave of targeted immune engagement. CAR T-Cell Therapies, including Abecma and Carvykti, continue to deliver unprecedented remission rates for patients with heavily pretreated disease, while Antibody-Drug Conjugates (ADCs) like Blenrep have re-entered the U.S. market in 2024 following updated trial results demonstrating improved benefit–risk profiles.
Recent Industry Developments
In August 2024, Takeda Pharmaceuticals launched NINLARO 0.5 mg capsules (ixazomib citrate) in Japan, expanding dosage flexibility for maintenance therapy in multiple myeloma. In August 2023, Janssen Biotech received FDA accelerated approval for TALVEY (talquetamab-tgvs), a first-in-class bispecific antibody targeting GPRC5D for RRMM patients after four or more prior lines of therapy. These milestones emphasize the global momentum toward precision-engineered, immune-based therapies that extend survival while minimizing treatment toxicity.
- Legend Biotech & Janssen expanded Carvykti's label to earlier-line MM patients following phase III CARTITUDE-4 success, improving progression-free survival by 74% vs standard care.
- Bristol Myers Squibb initiated phase II studies for Abecma in combination with bispecific antibodies to achieve dual-target BCMA/GPRC5D response.
- GSK plc reported new data for Blenrep (belantamab mafodotin) with a median duration of response of 12.9 months, reinforcing ADC efficacy.
- Amgen announced plans to launch an oral proteasome inhibitor by 2026, targeting maintenance settings and reducing dependence on IV delivery.
- Takeda Pharmaceuticals strengthened its cell therapy portfolio through a multi-year R&D partnership valued at USD 1.8 billion for next-gen immunotherapies.
Market Outlook and Opportunities
The next decade promises significant transformation in the MM treatment paradigm.
- CAR-T and Bispecific Antibodies will collectively exceed USD 9.5 billion by 2033, representing nearly 26% of the total market.
- Oral therapy innovations are projected to achieve USD 5 billion by 2033 due to rising maintenance-phase adoption.
- The Asia-Pacific region will outpace other geographies with 6.2% CAGR, driven by growing healthcare infrastructure and early access programs.
- Combination regimens and real-world data analytics will play a central role in personalizing treatment strategies, improving cost-effectiveness and outcomes.
Analyst Insight: "The evolving myeloma landscape in 2025 signals a shift from generalized therapy toward precision-driven, adaptive care," said DataM Intelligence's oncology research lead. "Bispecific antibodies and CAR-T therapies are redefining treatment expectations, while novel imaging and liquid biopsy tools like SWIFT-seq are making disease monitoring less invasive and more informative."
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Market Segmentation Analysis
By Drug Class
The next-generation multiple myeloma market is segmented into Monoclonal Antibodies, Immunomodulators, Proteasome Inhibitors, Bispecific Antibodies, CAR T-Cell Therapies, Antibody-Drug Conjugates (ADCs), and Others.
- Monoclonal Antibodies (mAbs) dominate the market with approximately 35% share (USD 8.1 billion in 2024), led by drugs like Daratumumab (Darzalex) and Isatuximab (Sarclisa).
- Immunomodulators (IMiDs), including Lenalidomide and Pomalidomide, contribute 25% of the market (USD 5.8 billion) but face gradual erosion due to biosimilar competition.
- Proteasome Inhibitors (PIs) such as Bortezomib and Carfilzomib account for 15% share (USD 3.5 billion), maintaining stable use in early-line settings.
- CAR T-Cell Therapies and Bispecific Antibodies represent the fastest-growing categories, collectively expected to rise from USD 1.9 billion in 2024 to USD 9.5 billion by 2033, expanding at a CAGR above 18%.
- Antibody–Drug Conjugates (ADCs) currently hold 5% share, but emerging candidates targeting BCMA and CD46 are projected to double market share by 2030.
By Route of Administration
- Intravenous (IV) therapies dominate with 68% market share (USD 15.7 billion in 2024), as most monoclonal antibodies and CAR-T treatments are infused in hospital settings.
- Subcutaneous formulations, including Daratumumab SC and Empliciti SC, have improved patient compliance and now account for 20% of the market (USD 4.6 billion), growing at a CAGR of 7.2%.
- Oral treatments (lenalidomide, ixazomib) hold the remaining 12% share (USD 2.8 billion) but remain critical for maintenance regimens and elderly patients.
By Distribution Channel
- Hospital Pharmacies dominate the segment with 72% market share, equivalent to USD 16.6 billion in 2024, reflecting the infusion-based nature of advanced therapies.
- Retail Pharmacies account for 28% share (USD 6.5 billion), mainly serving maintenance-phase oral therapies and chronic-use regimens.
Regional Insights
United States
The United States remains the largest market for next-generation multiple myeloma therapeutics, accounting for over 45% of global revenue (USD 10.4 billion in 2024).
- U.S. incidence reached 35,000 new cases in 2024, with relapsed/refractory patients representing nearly 65% of therapy demand.
- CAR-T therapy utilization in the U.S. increased 220% YoY between 2022 and 2024, driven by expanded BCMA approvals.
- With new entrants like Carvykti (Janssen/Legend Biotech) and Abecma (Bristol Myers Squibb), the U.S. market is expected to exceed USD 17 billion by 2033.
Japan
Japan's multiple myeloma market reached USD 1.2 billion in 2024 and is projected to hit USD 2.1 billion by 2033, growing at 6.1% CAGR.
- Japan has 19,000 living MM patients, with an aging demographic accelerating adoption of less toxic, next-gen therapies.
- The Japanese Ministry of Health approved the first BCMA-targeted bispecific antibody in late 2024, paving the way for broader reimbursement in 2025.
Key Market Players: Major companies shaping the next-generation multiple myeloma market include Takeda Pharmaceuticals, Amgen Inc., Bristol-Myers Squibb Company, Johnson & Johnson (Janssen), Sanofi, GSK plc, Karyopharm Therapeutics, Novartis AG, Regeneron Pharmaceuticals, and Legend Biotech.
Highlights:
- Johnson & Johnson generated USD 8.1 billion in hematology-oncology revenue, with Darzalex contributing over USD 9 billion cumulative sales globally.
- Bristol Myers Squibb reported USD 3.2 billion from Abecma and Pomalyst/Imnovid combined, growing 18% YoY.
- Amgen's Kyprolis recorded USD 1.1 billion in global sales (+9% YoY).
- Legend Biotech surpassed USD 500 million revenue in 2024 from Carvykti, with projected CAGR of >25% through 2030.
- Sanofi's Isatuximab (Sarclisa) grew 14% YoY, reaching USD 810 million in sales globally.
Collectively, the top five companies hold over 75% global market share, supported by deep oncology pipelines, patient-access initiatives, and strategic co-development alliances.
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Related Report:
- Multiple Myeloma Market Size Set to Surpass US $30 B by 2031, According to DataM Intelligence.
- Refractory Multiple Myeloma Market Size to Reach USD 3.4 B by 2030 — DataM Intelligence
About DataM Intelligence:
DataM Intelligence 4Market Research LLP is a global business intelligence and consulting firm headquartered in Hyderabad, India. DataM delivers actionable insights across 15+ industry verticals, offering syndicated reports, customized consulting, and competitive intelligence solutions. The firm's oncology market coverage spans hematologic malignancies, solid tumors, and cell & gene therapies, providing deep-dive data on clinical pipelines, regulatory landscapes, pricing, and market access strategies.
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