Multiple Myeloma Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• In 2019, the US accounted for the lion's share of the total market in the 7MM, i.e., approximately 60%, followed by EU4 and the UK capturing nearly 30% share in 2019.
• The treatment options for RRMM have expanded significantly with the recent approval of two CAR-Ts and one bispecific antibody by the FDA, creating new opportunities for companies to develop therapies for later lines of treatment, such as 4L+.
• In 2022, there were more than 70,000 incident cases of multiple myeloma in the 7MM, which is expected to rise to around 90,000 cases by 2032 and the United States had the highest among seven major markets.
• Germany had the highest number of incident cases of multiple myeloma among the EU4 and the UK followed by France, whereas Spain had the lowest number of cases.
• When it comes to age-specific cases of multiple myeloma, the age group of 65 and above years has the highest number of cases accounting for more than 70% cases in the United States, followed by 55-64 and 0-54 years.
• Among the treated patient pool, maximum patients were under frontline transplant ineligible pool, followed by second-line accouting for approximately 47,000 and 40,000 respectively and patients were observed in frontline transplant eligible group.
• In 2022, a generic version of REVLIMID was approved by the Food and Drug Administration (FDA). In terms of safety, quality, performance characteristics, and intended use, generic revlimid is the same as the marketed brand-name drug. Generic revlimid can be used as a substitute for REVLIMID.
• The market will witness further growth due to new drug approvals. By 2025, around five new therapies, including bispecific antibody and CAR-Ts, will be available for the 4L+ of multiple myeloma
• Bristol Myer Squibb is also a contender in this space with REVLIMID and POMALYST. In addition to this, it is developing novel cellMoDs for multiple myeloma such as mezigdomide and iberdomide in different lines and combinations might bring a change in the treatment paradigm.
• Despite the significant advancements in multiple myeloma (MM) 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 MM patients.
• Most key players in the emerging pipeline focus on developing bispecific antibodies and CAR-Ts. After approving the first bispecific antibody, TECVAYLI, Janssen is developing another bispecific antibody, talquetamab, for RRMM.
• The implementation of 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 “Multiple Myeloma (MM) - Market Insights, Epidemiology and Market Forecast - 2032” report delivers an in-depth understanding of MM, historical and forecasted epidemiology as well as MM market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The MM market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MM market size from 2019 to 2032. The report also covers current MM 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: 2019-2032

Multiple Myeloma Disease Understanding and Treatment Algorithm

Multiple Myeloma (MM) Overview

Multiple myeloma (MM) is the second most prevalent hematological malignancy worldwide, with a median onset of 60 years. This incurable malignancy develops from accumulating terminally differentiated monoclonal plasma cells (PC) in the bone marrow. Multiple myeloma is a malignant disorder characterized by uncontrolled proliferation of clonal plasma cells, causing various complications leading to organ dysfunction and eventually death. Recently, there has been a change in the pathogenesis of myeloma leading to major improvements in managing patients with multiple myeloma. A significant contributor to treatment failure leading to clinical relapse is the emergence of multidrug resistance (MDR), which represents a phenomenon whereby the cancer cells resist various structurally and functionally unrelated drugs following exposure to a single chemotherapeutic agent.

Multiple Myeloma (MM) Diagnosis

Multiple myeloma is often diagnosed based on tests, the patient's symptoms, and the doctor's physical exam of the patient. The tests and procedures used in the diagnosis of multiple myeloma include blood tests, urine tests, tissue tests, lab tests, imaging tests, and others.

Further details related to diagnosis are provided in the report…

Multiple Myeloma (MM) 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. Disease-directed treatment typically includes therapy using medications, such as targeted therapy and/or chemotherapy, with or without steroids. Bone marrow/stem cell transplantation may be an option. Other treatments, such as radiation therapy and surgery, are used in specific circumstances.

Further details related to treatment are provided in the report…

Multiple Myeloma (MM) Epidemiology

The MM 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 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2019 to 2032. The total incident cases of MM in the 7MM comprised more than 70,000 cases in 2022 and are projected to increase during the forecasted period.

• In the 7MM, the highest incident cases of MM were seen in the United States, followed by EU4 and the UK.
• Among the EU4 countries, Germany accounted for the highest number of incident MM cases whereas Spain accounted for the lowest cases in 2022.
• Multiple myeloma is more common in males as compared to females. In the United States, more than 50% of males are diagnosed with multiple myeloma.
• In the 7MM, there were around 47,000 frontline transplant ineligible patients and 17,000 frontline transplant eligible patients of multiple myeloma in 2022.
• When it comes to age-specific cases of Multiple myeloma, the age group of 65 and above years has the highest number of cases accounting for more than 70% cases in the United States, followed by 55-64 and 0-54 years.

Multiple Myeloma (MM) Drug Chapters

The drug chapter segment of the MM report encloses a detailed analysis of marketed and the late-stage (Phase III) pipeline drug. The marketed drugs segment encloses drugs such as DARZALEX (Janssen), CARVYKTI (Janssen), BLENREP (GlaxoSmithKline), ABECMA (BMS and Bluebird bio), and others. Furthermore, the current key players for the upcoming emerging drugs and their respective drug candidates include Pfizer (elranatamab), AbbVie and Roche (VENCLEXTA), Janssen (talquetamab), and others. The drug chapter also helps understand the MM clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

TECVAYLI: Janssen

TECVAYLI (teclistamab) is an investigational, fully humanized, T-cell redirecting, IgG4 bispecific antibody targeting BCMA and CD3 on T cells. BCMA is expressed at high levels on multiple myeloma cells. Teclistamab redirects CD3-positive T cells to BCMA-expressing myeloma cells to induce the killing of tumor cells. TECVAYLI uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

In October 2022, the US FDA approved TECVAYLI (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on the response rate.

CARVYKTI: Janssen

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. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein features two BCMA-targeting single-domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

Moreover, in May 2023, the company submitted a Type II variation application to the European Medicines Agency (EMA) based on the CARTITUDE-4 study results seeking approval of CARVYKTI for the earlier treatment of patients with relapsed and lenalidomide-refractory multiple myeloma and as per the company pipeline, the submission is also planned in 2023 itself.

Emerging Drugs

Talquetamab: Johnson & Johnson (Janssen)

Talquetamab is a first-in-class, off-the-shelf (ready to use), investigational bispecific T-cell engager antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, a primary component of the T-cell receptor. CD3 activates T cells, and GPRC5D is highly expressed in multiple myeloma cells.

Talquetamab received BTD from the US FDA in June 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38-antibody. In May 2021 and August 2021, talquetamab received an ODD for treating multiple myeloma from the US FDA and the European Commission, respectively. In January 2021, talquetamab received a PRIME designation from the European Commission.

Elranatamab: Pfizer

Elranatamab is an investigational, off-the-shelf, humanized BCMA CD3-targeted BsAb. BsAbs are a novel form of cancer immunotherapy that bind to and engage two targets simultaneously. One arm binds directly to specific antigens on cancer cells, and the other binds to T cells, bringing both cell types together. The binding affinity of elranatamab for BCMA and CD3 has been engineered to elicit potent T-cell-mediated anti-myeloma activity. Elranatamab is administered subcutaneously, offering more convenience than IV administration.

Drug Classs Insights

Immunomodulators (IMiDs)

The use of Immunomodulators (IMiDs) for multiple myeloma arose from the revival of thalidomide - sold under the name THALOMID by Celgene Corporation which was not approved by the US FDA. Followed by thalidomide, 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).

Anti CD38

It is worth mentioning that monoclonal antibodies have gained great popularity for the treatment of myeloma. Antibodies are proteins made by the body's immune system to help fight infections. The man-made versions (monoclonal antibodies) can be designed to attack a specific target, such as proteins on the surface of myeloma cells. At present, two types of monoclonal antibodies are available for the management of multiple myeloma, one of them ia antibodies against CD38 [DARZALEX (daratumumab), and SARCLISA (isatuximab)].

Note: Detailed insights will be provided in the final report.

Multiple Myeloma (MM) Market Outlook

Multiple myeloma (MM) is a clonal plasma cell proliferative disorder characterized by the abnormal increase of monoclonal immunoglobulins. Unchecked, the excess production of these plasma cells can ultimately lead to specific end-organ damage. Most commonly, this is seen when at least one of the following clinical manifestations is present: hypercalcemia, renal dysfunction, anemia, or bone pain accompanied by lytic lesions. Most patients relapse at some point due to the lack of a specific cure. Adding worries to myeloma condition, some patients do not respond to the therapy (or sometimes respond to initial treatment, but not to the treatment following a relapse), becoming refractory, hence known as R/R MM. 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.
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.

The RRMM landscape is undergoing a radical transformation with the recent FDA approvals of two CAR-Ts and one bispecific antibody, opening up new avenues for companies developing in later lines of therapy such as 4L+. Several key players are racing to bring their candidates to the market, and we estimated that about five more bispecific antibodies and CAR-Ts will join the fray by 2025. Some of the frontrunners in this space are Pfizer, Johnson & Johnson (Janssen), Regeneron Pharmaceuticals, Roche (Genentech), Abbvie (TeneoOne), CARsgen Therapeutics, and others, who are harnessing the power of CAR-Ts and bispecific antibodies for RRMM.

The total market size in the 7MM for multiple myeloma was estimated to be nearly USD 14,000 million in 2022, which is expected to show positive growth by 2032.

• By 2025, at least five new therapies are anticipated to be available in the United States, including three bispecific antibodies (Elranatamab, Talquetamab, and Linvoseltamab), one CAR-T (Zevorcabtagene autoleucel), and one BCL-2 inhibitor (Venetoclax).
• The market for multiple myeloma is rapidly evolving, and current and emerging key players face the biggest risk as a result of this high degree of innovation. ADCs, CAR-T cell treatments, and bispecific antibodies are just a few of the novel modes of action that have recently entered the market for later lines of therapy.
• In first-line treatment eligible group, Lenalidomide ± Bortezomib + dex captured the maximum market share accounting for nearly USD 1,000 million in 2019 and is expected to decline by 2032.
• The total market size for multiple myeloma in the United States was around USD 11,000 million in 2019which is expected to reach around USD 22,000 million by 2032.

Multiple Myeloma (MM) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. 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 true testament to the power of research, collaboration, and human resilience.

Multiple Myeloma (MM) Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II stage, Phase I stage. 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 MM'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 MM evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including onclogists, radiation oncologists, surgical oncologists and others.

This analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Center such as MD Anderson Cancer Center was contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MM 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

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. 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

CAR-T cell treatments are only accessible to patients in the UK as part of a clinical trial. Recently, Janssen has also made the decision not to progress its CAR-T cell treatment, CARVYKTI for UK myeloma patients at this time. The novel treatment was in the process of being assessed by the NICE, to make the treatment available on the NHS. But, for the time being, the pharmaceutical company Janssen has opted not to pursue approval from NICE. Janssen's decision not to progress with the NICE appraisal for approval of the treatment on the NHS will not affect clinical trials.

Janssen does not want to introduce its recently EU-wide conditionally approved antibody TECVAYLI (Teclistamab) in Germany under the condition that clinical data be submitted later. The company announced that it will critically examine the market entry and its possible timing. Earlier, TECVAYLI received the green light from the EU Commission in August 2022. This was preceded by an accelerated assessment procedure at the EU authority EMA based on data from a clinical Phase I/II study. According to Janssen, the evidence that appears in it is “not recognized by the AMNOG.” German citizens can use the antibody can therefore only be obtained from the already installed hardship program.

The report further 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, descriptive overview of MM, explaining its causes, signs and 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 MM 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 MM market.

Multiple Myeloma (MM) Report Insights

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

Multiple Myeloma (MM) Report Key Strengths

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

Multiple Myeloma (MM) Report Assessment

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

FAQs

• What was the MM market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2032? What are the contributing factors for this growth?
• What will be the impact of talquetamab having its expected approval in 2023?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of MM?
• What are the disease risk, burdens, and unmet needs of MM? What will be the growth opportunities across the 7MM concerning the patient population with MM?
• What is the historical and forecasted MM patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What are the current options for the treatment of MM? What are the current guidelines for treating MM in the US, Europe, and Japan?
• How many emerging therapies are in the mid-stage and late stage of development for treating MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
• What is the cost burden of current therapies on the patient?
• What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the MM 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 opportunity 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.