Dublin, Dec. 24, 2021 (GLOBE NEWSWIRE) -- The "Multiple Myeloma- Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
This report delivers an in-depth understanding of the MM, historical and forecasted epidemiology as well as the MM market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), Japan and China.
The MM market report provides current treatment practices, emerging drugs, MM market share of the individual therapies, current and forecasted MM market size from 2017 to 2030 segmented by eight major markets. The report also covers current MM treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.
The Multiple Myeloma epidemiology division provide the insights about historical and current Multiple Myeloma patient pool and forecasted trend for each eight major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Epidemiology: Key Findings
The MM epidemiology division provides insights about historical and current patient pool and forecasted trends for each eight major countries. The Multiple Myeloma epidemiology data are studied through Multiple Myeloma possible division to give a better understanding of the Disease scenario in the 8MM.
The disease epidemiology covered in the report provides historical as well as forecasted Multiple Myeloma epidemiology [segmented as Total Incidence of Multiple Myeloma, Total Symptomatic Cases of Multiple Myeloma, Total Incident Cases of Multiple Myeloma Segmented by Gender, Total Diagnosed cases of Multiple Myeloma by Age Distribution, Total Cases of Multiple Myeloma by Line of Treatment] scenario of Multiple Myeloma in the 8MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China from 2017 to 2030
In the year 2020, the total incident case of Multiple Myeloma was 91,693 cases in the 8MM. The United States, in 2020, accounted for 32,270 cases (the highest number), which will probably rise by the year 2030. Among the EU-5 countries, the highest number of incident cases of Multiple Myeloma in the year 2020, was in Germany. In China, the total number of incident cases of Multiple Myeloma was 21,116 in 2020, and this number is expected to rise throughout the forecast period.
The overall number of symptomatic cases of Multiple Myeloma in the 8MM was 80,715, and these cases are expected to rise by 2030.
Males are more likely to develop Multiple Myeloma than females (about 55 percent of cases). When it comes to age-specific Multiple Myeloma cases, the age group 65-74 years has by far the most, followed by 75-84 years and 55-64 years.
In the 8MM, the total cases of Multiple Myeloma by treatment line were 23,581 cases for frontline transplant-eligible patients, 49,699 cases for frontline transplant-ineligible patients, 44,955 cases for second-line patients, 23,498 cases for third-line patients, and 10,236 cases for fourth-line plus patients, in the year 2020.
Drug chapter segment of the Multiple Myeloma report encloses the detailed analysis of Multiple Myeloma marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Multiple Myeloma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Blenrep (Belantamab Mafodotin /GSK2857916): GlaxoSmithKline
GlaxoSmithKline's lead candidate, Belantamab Mafodotin (GSK2857916) is a first-in-class, anti-BCMA immunoconjugate with an afucosylated, humanized IgG1 anti-BCMA monoclonal antibody conjugated by a protease-resistant maleimidocaproyl linker to a microtubule-disrupting agent, monomethyl auristatin F (MMAF). The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa. It was approved by UDFDA and the European Commission in August 2020. This drug has received orphan drug designation from the EMA and the US FDA for multiple myeloma. Apart from this, the EMA and the US FDA have also granted PRIME designation and Breakthrough Therapy designation, respectively.
Abecma (Idecabtagene vicleucel/bb2121/ ide-cel): Bristol-Myers Squibb/Bluebird bio
Abecma (ide-cel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy co-developed, and co-promoted by Bristol Myers Squibb and Bluebird bio for the treatment of adult patients with multiple myeloma who have received at least three prior therapies. In March 2021, the USFDA approved Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma.
Pepaxto (melflufen/ melphalan flufenamide): Oncopeptides AB
Pepaxto is a first-in-class anti-cancer peptide-drug conjugate that rapidly produces an alkylating payload into tumor cells. It is promptly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In February 2021, the USFDA approved Pepaxto in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Sarclisa (Isatuximab): Sanofi
Sarclisa - a product of Sanofi is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is manufactured and designed to initiate programmed tumor cell death (apoptosis) and immunomodulatory activity. In December 2017, Isatuximab received Orphan Designation for the treatment of patients with Relapsed or Refractory Multiple Myeloma by the US FDA and EMA.
Xpovio (Selinexor): Karyopharm
Karyopharm' potential candidate Selinexor is an oral, first-in-class, selective inhibitor of nuclear export also known as SINE, compound. It has been approved by the US FDA in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma 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 April 2021, EMA validated the Company's Type II Variation MAA, which seeks to expand the currently authorized indication for Nexpovio in the European Union to include, in combination with Velcade (bortezomib) and low-dose dexamethasone, the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Validation of the application confirms the submission is complete to begin the EMA's review process.
Darzalex (Daratumumab): Janssen Biotech
Darzalex (daratumumab) is a prescription medicine used to treat a type of blood cancer called multiple myeloma. Darzalex is not chemotherapy. It is a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. In November 2015, Darzalex first received the US FDA approval as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Recently, in April 2020, the US FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. Darzalex Faspro is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.
Venetoclax (ABT-199): AbbVie and Roche
Venetoclax (Venclexta, Venclyxto) is an oral B-cell lymphoma-2 (BCL-2) inhibitor developed by AbbVie and Genentech. It is used for the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) and in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2. In March 2019, the US FDA placed a partial clinical hold on Venetoclax's multiple myeloma trials after new safety concerns were raised during a review of the BELLINI Phase III trial (NCT02755597). In June 2019, the US FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol (Myeloma Positive for the t(11;14) Genetic Abnormality), including new risk mitigation measures, protocol-specified guidelines, and updated futility criteria (AbbVie News Center, 2019).
Ciltacabtagene Autoleucel (cilta-cel/ JNJ-4528/ JNJ-68284528/ LCAR-B38M): Janssen Biotech/Nanjing Legend Biotech
Ciltacabtagene Autoleucel is currently being investigated for the treatment of patients with multiple myeloma who have received at least three prior regimens, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody, and have documented disease progression within 12 months of starting the most recent therapy, or are double refractory to an immunomodulatory drug and a proteasome inhibitor. This product is being evaluated under licensing and collaboration agreements between Janssen and Legend Biotech. In the first quarter of 2021, the rolling submission of a Biologics License Application (BLA) to the USFDA was completed by Janssen, for cilta-cel, for the treatment of adults with relapsed or refractory multiple myeloma. Additionally, in April 2021, the company has also submitted the MAA to the EMA for cilta-cel (Legend Biotech, 2021b).
REGN5458: Regeneron Pharmaceuticals
REGN5458 is a BCMAxCD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma. BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. In December 2019, the company presented the results at the American Society of Hematology (ASH) Annual Meeting. Currently, REGN5458 monotherapy is being investigated in an open-label, Phase I/II (NCT03761108) dose-escalation trial in patients with relapsed or refractory multiple myeloma who are at least triple refractory to existing therapeutic options, including proteasome inhibitors, immunomodulatory drugs, and CD38 antibody treatments.
Iberdomide (CC-220): Bristol-Myers Squibb/Celgene
Iberdomide is an investigational cereblon E3 ligase modulator compound with enhanced tumoricidal and Immunostimulatory activities that induces degradation of transcription factors Aiolos and Ikaros, thereby inhibiting the growth of myeloma cells in vitro. In pre-clinical models, iberdomide has demonstrated the ability to destroy tumor cells, stimulate an immune response, overcome resistance to immunomodulatory drugs, and synergize with dexamethasone, daratumumab, and bortezomib (Celgene Corporation, 2019). In December 2018, the US FDA has granted orphan drug designation to iberdomide for the treatment of multiple myeloma.
According to the report, the Multiple Myeloma market size in the 8MM is expected to change at a CAGR of 4.3% during the study period (2017-2030). In the total market size of Multiple Myeloma in the 8MM, the United States accounted for the highest market size in 2020 followed by Japan, Germany, and France.
The United States Market Outlook
In the United States, the total market size of Multiple Myeloma is expected to increase at a CAGR of 4.0% during the study period (2017-2030).
EU-5 Countries: Market Outlook
In EU-5 countries, the total market size of Multiple Myeloma is expected to increase at a CAGR of 4.8% during the study period (2017-2030).
Japan Market Outlook
In Japan, the total market size of Multiple Myeloma is expected to increase at a CAGR of 3.9% during the study period (2017-2030).
China Market Outlook
In China, the total market size of Multiple Myeloma is expected to increase at a CAGR of 6.2% during the study period (2017-2030).
Pipeline Development Activities
The drugs which are in pipeline include:
Venetoclax (ABT-199): AbbVie and Roche
JNJ-68284528 (LCAR-B38M/JNJ-4528): Janssen Biotech/Nanjing Legend Biotech
Keytruda (Pembrolizumab): Merck Sharp & Dohme Corp.
Cetrelimab (JNJ-63723283): Janssen Research & Development
REGN5458: Regeneron Pharmaceuticals
Felzartamab (MOR202): MorphoSys AG/I-Mab Biopharma
Chidamide (Epidaza): Chipscreen Biosciences
Iberdomide (CC-220): Bristol-Myers Squibb/Celgene
Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy: RAPA Therapeutics
Encorafenib in combination with Binimetinib: Pfizer (Array Biopharma)
CLR 131 (131-CLR1404): Cellectar Biosciences
GVAX (GM-CSF) Vaccine: Celgene/Aduro Biotech
GBR 1342 (ISB 1342): Glenmark (Ichnos Sciences SA)
P-BCMA-101 CAR-T cells: Poseida Therapeutics
Opdivo (Nivolumab): Bristol-Myers Squibb
PBCAR269A: Precision BioSciences
MP0250: Molecular Partners AG
Teclistamab (JNJ-7957; JNJ-64007957): Janssen Pharmaceutical
Descartes-11: Cartesian Therapeutics
Imfinzi (Durvalumab): AstraZeneca
Imbruvica (Ibrutinib): Abbvie (Pharmacyclics) and Johnson & Johnson
Pipeline Development Activities
In June 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the USFDA has granted Breakthrough Therapy Designation for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, a bispecific antibody targeting both BCMA and CD3 receptors, follows a PRIME designation from the EMA received earlier this year.
In May 2021, Oncopeptides has announced positive results from the OCEAN study, which compared the effectiveness and safety of melflufen with pomalidomide in patients with relapsed refractory multiple myeloma. The phase III OCEAN study is a global, randomized, head-to-head, open-label study, evaluating the efficacy and safety of melflufen and dexamethasone, versus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma who have received 2-4 prior therapies.
In May 2021, the USFDA granted priority review to the Biologics License Applications (BLA) for ciltacabtagene autoleucel for the treatment of patients with relapsed/refractory multiple myeloma. The regulatory agency is expected to decide on the application by November 29, 2021, under the Prescription Drug User Fee Act.
In April 2021, Legend Biotech announced the submission of a MAA to the EMA seeking approval of ciltacabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma. The EMA's Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for this MAA.
Among the IMid's agent lenalidomide (Revlimid) dominates the Multiple Myeloma market in the 8MM, where it is included in all lines of Multiple Myeloma therapy either as monotherapy or in combination with other drugs. According to a settlement deal between Celgene and Natco Pharma, a limited generic entry will begin in March 2022 for this candidate, and from January 31, 2026, generic entry will be permitted without volume limitation in the United States. Despite the loss of patent exclusivity in important markets and the approval of other prospective pipeline candidates, lenalidomide is expected to have a significant presence in 2030. Among emerging therapies, Ciltacabtagene autoleucel (JNJ-68284528) from Janssen Biotech/Nanjing Legend Biotech is expected to give tough competition to Idecabtagene Vicleucel.
Access and Reimbursement Scenario in Multiple Myeloma Therapies
In March 2019, the Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) plus Velcade (bortezomib) and dexamethasone (DVd) for use within the Cancer Drugs Fund (CDF), as an option for treating relapsed multiple myeloma in people who have had one previous treatment. Patients at the second line will now have access to a treatment combination, which NICE accepts had a 'clinically important and statistically significant effect on progression-free survival.
With effect from August 2020, the Medicaid and NC Health Choice programs cover belantamab mafodotin-blmf for injection, for intravenous use (Blenrep) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code. Belantamab mafodotin-blmf is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent (NCDHHS, 2020).
To keep up with current market trends, the publisher takes KOLs and SME's opinion working in Multiple Myeloma domain through primary research to fill the data gaps and validate the secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Multiple Myeloma market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
The report performs Competitive and Market Intelligence analysis of the Multiple Myeloma Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.
Amgen (Onyx therapeutics)
Bristol-Myers Squibb Company (Celgene)
Glenmark (Ichnos Sciences SA)
Johnson & Johnson
Merck Sharp & Dohme Corp.
Molecular Partners AG
Nanjing Legend Biotech
Pfizer (Array Biopharma)
Takeda Pharmaceutical (Millennium Pharmaceuticals)
For more information about this report visit https://www.researchandmarkets.com/r/r5jiqe
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