Multiple Myeloma Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The total market size in the 7MM for multiple myeloma was estimated to be nearly USD 21.30 billion in 2023, which is expected to show positive growth by 2034, owing to rise in incident cases, label expansion and penetration of current therapies in earlier lines, high adoption of newer therapies mainly CAR-T cell therapies and anti-BCMA, rich emerging pipeline, and expected increase in investment in the R&D activities
• In 2023, the US accounted for the maximum share of the total market in the 7MM, i.e., approximately USD 14.30 billion followed by EU4 and the UK.
• Despite the significant advancements in multiple myeloma treatment, including various biological drugs and their combinations like IMiDs (lenalidomide, pomalidomide), anti-CD38 monoclonal antibodies (daratumumab, isatuximab), anti-SLAM7 monoclonal antibody (elotuzumab), and new proteasome inhibitors (carfilzomib, ixazomib), relapse after first-line therapy remains a common challenge for most multiple myeloma patients.
• In frontline multiple myeloma clinical studies, DARZALEX was successful and is now considered the standard of therapy. DARZALEX has outperformed rivals' expectations regarding effectiveness and safety and is expected to rule the multiple myeloma market.
• A second CD38 antibody called SARCLISA has been approved for the treatment of multiple myeloma. SARCLISA continues its rapid acceptance in key markets. But DARZALEX has an advantage over SARCLISA of more than four years. Both monoclonal antibodies are competing against one another in a quadruplet regimen in both transplant-eligible and ineligible settings. The two CD38 antibodies are also close to a final showdown in patients who are not eligible for transplant. This wave of evidences for the CD38-RVd combinations comes from studies in the transplant-eligible group.
• In March 2024, Johnson & Johnson announced that the United States Food and Drug Administration (US FDA) Oncologic Drugs Advisory Committee (ODAC) recommended CARVYKTI for the treatment of adult patients with Relapsed/Refractory Multiple Myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an IMiD and who are refractory to lenalidomide
• Implementing CAR T-cell therapy in standard practice can be challenging due to the stricter GMP manufacturing requirements mandated by the FDA and the real-world application of the treatment across diverse patient populations.

This report delivers an in-depth understanding of multiple myeloma, historical and forecasted epidemiology as well as multiple myeloma market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The multiple myeloma market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM multiple myeloma market size from 2020 to 2034. The report also covers current multiple myeloma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Multiple Myeloma Disease Understanding and Treatment Algorithm

Multiple Myeloma Overview

Multiple myeloma is a malignant disorder characterized by uncontrolled proliferation of clonal plasma cells, causing various complications leading to organ dysfunction and eventually death. This incurable malignancy develops from accumulating terminally differentiated monoclonal plasma cells (PC) in the bone marrow. The mechanism of action of MM is that it is a clonal plasma cell proliferative disorder characterized by the unusual increase of monoclonal paraprotein leading to evidence of specific end-organ damage. MM is part of the spectrum of monoclonal gammopathy. Recently, there has been a change in the pathogenesis of myeloma leading to major improvements in managing patients with multiple myeloma.

Multiple Myeloma Diagnosis

Multiple myeloma is often diagnosed based on tests, the patient’s symptoms, including bone pain, weakness, hypercalcemia, etc., and the doctor’s physical exam. Following these symptoms, lab tests are conducted, mainly blood and urine tests. After these tests, a biopsy (bone marrow aspiration, fine needle aspiration) is conducted. Apart from these tests, a few other tests are also used to confirm the diagnosis of multiple myeloma, namely plasma cell proliferation, which shows what percentage of plasma cells are dividing; serum viscosity which measures the thickness of the blood; echocardiogram, an ultrasound that checks how well the heart is beating and pumping blood. After the diagnosis, it is also important to check whether it is smoldering or active myeloma; depending on this, treatment is initiated.

Multiple Myeloma Treatment

The treatment of multiple myeloma depends on whether the patient is experiencing symptoms and the patient’s overall health. Often, doctors work with the patient to determine the best treatment plan. The treatment goals are to eliminate myeloma cells, control tumor growth, control pain, and allow patients to live actively. While there is no cure for multiple myeloma, the cancer can be managed successfully in many patients for years. Treatment for people with symptomatic myeloma includes treatment to control the disease and supportive care to improve quality of life, such as by relieving symptoms and maintaining good nutrition. The standard treatment for multiple myeloma often involves a combination of three medications- sometimes called triplet therapy. This often includes a targeted therapy, an immunomodulator, and a corticosteroid.

Multiple Myeloma Epidemiology

The multiple myeloma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of multiple myeloma, total symptomatic cases of multiple myeloma, gender-specific cases of multiple myeloma, age-specific cases of multiple myeloma, transplant-eligible cases of multiple myeloma, and treated patient pool across all lines of therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. The total incident cases of multiple myeloma in the 7MM comprised nearly 75,000 in 2023 and are projected to increase during the forecast period.

• In the 7MM, the highest incident cases of multiple myeloma were seen in the United States, followed by EU4 and the UK.
• Among EU4 and the UK, Germany accounted for the highest number of incident cases of multiple myeloma, whereas Spain accounted for the lowest in 2023.
• Multiple myeloma is more common in males as compared to females. More than 50% of males in the United States are diagnosed with multiple myeloma.
• Data suggests that roughly half of newly diagnosed multiple myeloma patients are ineligible for transplant, and around a third of eligible patients do not receive the transplant. In the US, there were around 23,600 frontline transplant-ineligible patients and 9,200 transplant-eligible patients of multiple myeloma patients in 2023.
• Regarding age-specific cases of Multiple myeloma, the age group of 65 and above has the highest number of cases accounting for more than 70% of cases in the United States, followed by 55-64 and 0-54 years.

Multiple Myeloma Drug Chapters

The drug chapter segment of the multiple myeloma report encloses a detailed analysis of the marketed and late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as DARZALEX (Johnson & Johnson Innovative Medicine), CARVYKTI (Johnson & Johnson Innovative Medicine), BLENREP (GSK), ABECMA (Bristol-Myers Squibb/Bluebird bio), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include Bristol Myers Squibb (mezigdomide), AbbVie and Roche (VENCLEXTA), Regeneron (linvoseltamab), and others. The drug chapter also helps understand the multiple myeloma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

CARVYKTI (ciltacabtagene autoleucel): Johnson & Johnson Innovative Medicine

CARVYKTI is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s T cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In February 2022, Johnson & Johnson Innovative Medicine announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Currently, the company is investigating the drug in the Phase III CARTITUDE-4 trial for RRMM with 1-3 prior lines of therapy, in the CARTITUDE-6 trial for frontline multiple myeloma transplant eligibility, and CARTITUDE-5 trial for NDMM for whom hematopoietic stem cell transplant is not planned as initial therapy.

TALVEY (talquetamab): Johnson & Johnson Innovative Medicine

TALVEY is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue. TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Emerging Drugs

Mezigdomide (CC-92480): Bristol Myers Squibb

Mezigdomide is a highly potent modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities. Mezigdomide binds to cereblon (CRBN) upon administration, affecting the ubiquitin E3 ligase activity and targeting certain substrate proteins for ubiquitination. This induces proteasome-mediated degradation of certain transcription factors, some of which are transcriptional repressors in T cells. The company is evaluating the drug in different clinical trials in different lines of therapies for treating NDMM and RRMM. In January 2023, the company initiated the Phase III trial of CC-92480 in combination with carfilzomib and dexamethasone (480kd) vs. carfilzomib and dexamethasone in 2L+ participants with RRMM (SUCCESSOR-2). The company is expecting the first approval of mezigdomide by 2026-2027.

Linvoseltamab (REGN5458): Regeneron

Linvoseltamab is a BCMAxCD3 bispecific antibody in patients with RRMM. It is designed to bind to BCMA on multiple myeloma cells and the CD3 receptor on T cells, bridging them together and activating T-cell killing of the cancer cell. The drug is designed to closely resemble natural human antibodies, using Regeneron’s proprietary ‘human antibody mouse’ technology (VelocImmune) and ‘full-length bispecific antibody’ platform (VelociBi). The linvoseltamab clinical development program includes a Phase III confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a Phase I/II trial in the first-line setting, a Phase II trial in high-risk smoldering MM, and a Phase II trial in monoclonal gammopathy of undetermined significance. Apart from that, a Phase I trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned. In February 2024, the company announced that the US FDA had accepted for priority review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with RRMM that has progressed after at least three prior therapies. Moreover, the target action date for the FDA decision is August 22, 2024.

Drug Class Insights

The existing multiple myeloma treatment is mainly dominated by classes such as Proteasome Inhibitors, Immunomodulating Agents, Monoclonal Antibodies, Nuclear export inhibitors, CAR-T cell therapy, and Bi-specific antibodies. Apart from these classes, Histone Deacetylase (HDAC) inhibitors were also included in the treatment regimen, but now it has been withdrawn from the US market.

Immunomodulators (IMiDs)

Immunomodulators (IMiDs) for multiple myeloma arose from the revival of thalidomide - sold under the name THALOMID by Celgene Corporation. Initially, the US FDA did not approve it for multiple myeloma. Followed by thalidomide, REVLIMID (lenalidomide) came into existence. It is similar to thalidomide and works well in treating multiple myeloma. In June 2006, the US FDA approved REVLIMID plus dexamethasone for use in multiple myeloma patients who have received at least one prior therapy. To this date, the regulatory authorities for the treatment of multiple myeloma have approved IMiDs, including thalidomide (THALOMID), lenalidomide (REVLIMID), and pomalidomide (POMALYST).

Proteasome Inhibitors (PI)

Proteasome Inhibitors are also a widely used class of therapy for the treatment of multiple myeloma, which includes VELCADE (bortezomib), KYPROLIS (carfilzomib), and NINLARO (ixazomib). The US FDA approved Millennium Pharmaceuticals’ (Now a part of Takeda Pharmaceuticals) VELCADE (bortezomib) injection for patients with multiple myeloma that has relapsed after two prior treatments and has shown resistance to the last treatment. In addition, carfilzomib and ixazomib are other approved second-generation proteasome inhibitors for managing multiple myeloma.

Anti CD38

At present, two types of monoclonal antibodies are available for the management of multiple myeloma; one of them is antibodies against CD38 [DARZALEX (daratumumab) and SARCLISA (isatuximab)]. DARZALEX is used by healthcare experts in combination with existing therapies for good treatment strategies and better outcomes. For example, in 2021, the US FDA approved the expansion of the KYPROLIS US prescribing information to include its use in combination with DARZALEX FASPRO and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy and in 2020, the US FDA approved the expansion of the KYPROLIS US prescribing information to include its use in combination with DARZALEX plus dexamethasone (DKd) in two dosing regimens - once weekly and twice weekly - for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy. A second CD38 antibody called SARCLISA has been approved for treating multiple myeloma. Comparing SARCLISA and DARZALEX, the latter has an advantage over the former.

Moreover, the upcoming treatment landscape is poised to expand further classes such as cellMoDs, BCL-2 inhibitors, ADCs, CAR-Ts, etc.

Multiple Myeloma (MM) Market Outlook

At present, the market holds a diverse range of therapeutic alternatives for treatment, which includes Proteasome Inhibitors, Immunomodulating Agents, Histone Deacetylase (HDAC) inhibitors, Monoclonal Antibodies, Chemotherapy, Corticosteroids, Nuclear export inhibitors, CAR-T cell therapy, and Bispecific antibody in different lines of treatment. For several decades, the standard therapy for multiple myeloma included a combination of alkylating agents, primarily melphalan and cyclophosphamide, together with corticosteroids, such as dexamethasone and prednisone, all of which were augmented in the mid-1980s by the introduction of autologous stem cell transplantation.

XPOVIO (selinexor), which is a nuclear export inhibitor has emerged as a novel class for treatment. The nucleus of a cell holds most of the cell’s genetic material (DNA), which is required for the protein production used for proper cell functioning. In July 2019, Selinexor received accelerated approval from the US FDA in combination with dexamethasone for adult patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. In December 2023, EMA’s human medicines committee (CHMP) confirmed its initial recommendation not to renew the conditional marketing authorization for BLENREP because recent data did not confirm its effectiveness; the benefits of BLENREP are therefore considered to no longer outweigh its risks.

The relapsed/refractory multiple myeloma landscape is undergoing a radical transformation with the FDA approvals of two CAR-Ts and one bispecific antibody, opening up new avenues for companies developing later lines of therapy. Several key players are racing to bring their candidates to the market, and we estimate that few bispecific antibodies and CAR-Ts will join the fray by 2025. Some of the frontrunners in this space are Pfizer, Johnson & Johnson, Regeneron Pharmaceuticals, Roche, Abbvie, CARsgen Therapeutics, and others, who are harnessing the power of CAR-Ts and bispecific antibodies for relapsed/refractory multiple myeloma.

• The total market size in the 7MM for multiple myeloma was estimated to be nearly USD 21.30 billion in 2023, which is expected to show positive growth by 2034.
• The total market size for multiple myeloma in the US was around USD 14.30 billion in 2023, expected to rise by 2034.
• Among the EU4 and the UK, Germany captured the maximum market share in 2023, whereas Spain was at the bottom of the ladder in the same year.
• In the 4L+ setting, approved CAR-Ts (ABECMA and CARVYKTI) were expected to garner nearly USD 828 million in 2023 in the US and will rise with the approval of other emerging CAR-Ts during the forecast period.

Multiple Myeloma (MM) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of multiple myeloma treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Although CAR-T treatments have demonstrated significant effectiveness, they also come with safety issues such as CRS. Initially, cost, convenience, and manufacturing turnaround time could prevent CAR-T from being widely adopted, but companies may reduce side effects and speed up manufacturing time over time. CAR-Ts might not pose a significant threat to DARZALEX due to its better efficacy and safety profile and evolving use in earlier lines of setting.

Multiple Myeloma Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for multiple myeloma’s emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on multiple myeloma evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Dana-Farber Cancer Institute, Colorado Blood Cancer Institute, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or multiple myeloma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

MyCARVYKTI patient support program: The MyCARVYKTI Patient Support Program, sponsored by Janssen and Legend Biotech, is designed to help eligible patients prescribed CARVYKTI and their caregivers with support during treatment.

Patients who meet financial and other eligibility requirements and their caregivers may receive:

• Assistance with transportation, lodging, and out-of-pocket costs related to meals and other travel expenses associated with treatment at the CARVYKTI Certified Treatment Center.
• Support from MyCARVYKTI patient support specialists, who are available to help guide eligible patients through the enrollment process and assist with program benefits.

Janssen CarePath helps verify insurance coverage for the patients taking TECVAYLI and provides reimbursement information. Affordability support to help the patients start and stay on the treatment prescribed: Janssen CarePath can help the patient find out what affordability assistance may be available for the patients taking TECVAYLI. Janssen CarePath Savings Program for TECVAYLI can help eligible patients save on their out-of-pocket medication costs for TECVAYLI. Depending on the patient’s health insurance plan, savings may apply toward copay, co-insurance, or deductible. Eligible patients will pay USD 5 per dose for medication costs, with a USD 26,000 maximum program benefit each calendar year. It is not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of multiple myeloma, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the multiple myeloma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM multiple myeloma market.

Multiple Myeloma Report Insights

• Patient Population
• Therapeutic Approaches
• Multiple Myeloma Pipeline Analysis
• Multiple Myeloma Market Size and Trends
• Existing and Future Market Opportunity

Multiple Myeloma Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Multiple Myeloma Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Multiple Myeloma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

FAQs

• What was the multiple myeloma market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of multiple myeloma?
• What will be the impact on the sales of REVLIMID after its patent expiry?
• What are the disease risks, burdens, and unmet needs of multiple myeloma? What will be the growth opportunities across the 7MM concerning the patient population with multiple myeloma?
• What is the impact of generics on the sales of REVLIMID?
• Who is the major competitor of daratumumab in the market?
• How much market share will be captured by bispecific antibodies and CAR-Ts by 2034?
• What are the current options for the treatment of multiple myeloma? What are the current guidelines for treating multiple myeloma in the US, Europe, and Japan?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the patient share in frontline transplant-eligible and transplant-ineligible?
• Which countries within EU4 and the UK do not have access to CAR-T therapies?
• What is the right place to use CAR-T cell therapies and Bispecific antibodies?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the multiple myeloma market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.