Sep 4, 2020   SOURCE: PR NewsWire

Multiple Myeloma Analysis in 8MM, Forecast to 2030

DUBLIN, Sept. 4, 2020 /PRNewswire/ -- The "Multiple Myeloma - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

http://mma.prnewswire.com/media/539438/Research_and_Markets_Logo.jpg

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 seven 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.

Epidemiology

The MM epidemiology division provides insights about historical and current MM patient pool and forecasted trend for each seven 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.

Key Findings

The MM epidemiology division provides insights about historical and current patient pool and forecasted trends for each seven major countries. The MM epidemiology data are studied through MM 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 MM epidemiology [segmented as Total Incidence of Multiple Myeloma, Total Symptomatic Cases of MM, Total Incident Cases of MM Segmented by Gender, Total Incident Cases of MM Segmented by Age, Total Cases of MM by Line of Treatment] scenario of MM in the 8MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China from 2017 to 2030.

Country-wise Epidemiology

    --  In the year 2017, the total incident case of Multiple Myeloma was 85,971
        cases in the 8MM. The United States, in 2017, accounted for 30,271 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 was in Germany 7,337, in the year 2017. In the year
        2017, the total incident cases of Multiple Myeloma were 7,504 in Japan.
    --  In the year 2017, the total incident cases of Multiple Myeloma was
        19,536 in China, which might increase cases by 2030.

Drug Chapters

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.

Marketed Drugs

Sarclisa (Isatuximab): Sanofi

Sarclisa - a product of Sanofi is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. It is basically manufactured and designed to initiate programmed tumor cell death (apoptosis) and immunomodulatory activity.

Xpovio (Selinexor): Karyopharm

Karyopharm' potential candidate Selinexor is an oral, first-in-class, selective inhibitor of nuclear export also known as SINE, compound., till date it has only been approved by the USFDA, in fact has been given accelerated approval on the response rate for one specific indication. It has only 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.

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.

Emerging Drugs

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. This candidate 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.

Idecabtagene vicleucel (bb2121/ ide-cel): Bristol-Myers Squibb/bluebird bio

Idecabtagene vicleucel (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. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem.

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. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing proapoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization, and the activation of caspases. 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 July 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).

JNJ-68284528 (LCAR-B38M/JNJ-4528): Janssen Biotech/Nanjing Legend Biotech

JNJ-68284528 (LCAR-B38M/JNJ-4528) 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 proteasome inhibitor. This product is being evaluated under licensing and collaboration agreement between Janssen and Legend Biotech.

Melflufen (melphalan flufenamide): Oncopeptides AB

Melflufen is a first-in-class anti-cancer peptide-drug conjugate that rapidly produces an alkylating payload into tumor cells. The phase III clinical study (OCEAN, OP-103) is currently enrolling and has been approved under the US FDA's Special Protocol Assessment. In the OCEAN study, melflufen is compared directly against the current standard of care in patients with relapsed or refractory multiple myeloma.

REGN5458: Regeneron Pharmaceuticals

REGN5458 is a BCMAxCD3 bispecific antibody, in patients with relapsed or refractory (R/R) 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.

JCARH125 (Orvacabtagene autoleucel; Orva-cel): Juno Therapeutics (a Bristol-Myers Squibb company)

JCARH125 is a BCMA-targeting CAR T cell product candidate that is being developed by Juno Therapeutics. It incorporates several important elements that are believed to be important for maximizing patient benefit, including a next-generation manufacturing process, a fully-human binding domain, and a 4-1BB costimulatory domain. JCARH125 has received orphan drug designation from the FDA for multiple myeloma.

Market Outlook

Key Findings

According to the report, Multiple Myeloma market in the 8MM is expected to change in the study period 2017-2030. The therapeutic market of Multiple Myeloma in seven major markets was found to be USD 14,111 million in 2017 which is expected to increase during the study period (2017-2030).

The United States Market Outlook

In 2017, the total market size of MM therapies was found to be USD 9,467 million in the United States which is expected to increase in the study period (2017-2030).

EU-5 Countries: Market Outlook

In 2017, the total market size of MM therapies was found to be USD 3,139 million in the EU-5 countries which is expected to increase in the study period (2017-2030).

Japan Market Outlook

The total market size of MM therapies in Japan was found to be USD 1,019 million in 2017.

Pipeline Development Activities

The drugs which are in pipeline includes:

    1. Belantamab Mafodotin (GSK2857916): GlaxoSmithKline
    2. Idecabtagene vicleucel (bb2121/ ide-cel): Bristol-Myers Squibb/Bluebird
       bio
    3. Venetoclax (ABT-199): AbbVie and Roche
    4. JNJ-68284528 (LCAR-B38M/JNJ-4528): Janssen Biotech/Nanjing Legend Biotech
    5. Melflufen (melphalan flufenamide): Oncopeptides AB
    6. Keytruda (Pembrolizumab): Merck Sharp & Dohme Corp.
    7. Cetrelimab (JNJ-63723283): Janssen Research & Development
    8. REGN5458: Regeneron Pharmaceuticals
    9. Felzartamab (MOR202): MorphoSys AG/I-Mab Biopharma
    10. Chidamide (Epidaza): Chipscreen Biosciences
    11. Iberdomide (CC-220): Bristol-Myers Squibb/Celgene
    12. Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy: RAPA Therapeutics
    13. Encorafenib in combination with Binimetinib: Pfizer (Array Biopharma)
    14. CLR 131 (131-CLR1404): Cellectar Biosciences
    15. NY-ESO-1C259T Cells: Adaptimmune Therapeutics /GlaxoSmithKline /Merck
        Sharp & Dohme Corp
    16. BL-8040: BioLineRx
    17. GVAX (GM-CSF) Vaccine: Celgene/Aduro Biotech
    18. ECT-001: ExCellThera
    19. TAK-079: Takeda
    20. GBR 1342 (ISB 1342): Glenmark (Ichnos Sciences SA)
    21. P-BCMA-101 CAR-T cells: Poseida Therapeutics
    22. Opdivo (Nivolumab): Bristol-Myers Squibb
    23. AMG 420 (BI 836909): Amgen
    24. PBCAR269A: Precision BioSciences
    25. JCARH125 (Orvacabtagene autoleucel; Orva-cel): Juno Therapeutics (a
        Bristol-Myers Squibb company)
    26. MP0250: Molecular Partners AG
    27. Teclistamab (JNJ-7957; JNJ-64007957): Janssen Pharmaceutical
    28. Descartes-11: Cartesian Therapeutics
    29. Imfinzi (Durvalumab): AstraZeneca
    30. Imbruvica (Ibrutinib): Abbvie (Pharmacyclics) and Johnson & Johnson

Key Points

1. In June 2020, the Company submits NDA application to the US Food and Drug Administration (FDA) for accelerated approval of melflufen (INN melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody (i.e., triple-class refractory multiple myeloma patients).

2. In May 2020, Bristol-Myers Squibb announced that European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for idecabtagene vicleucel (ide-cel, bb2121). Validation of each application confirms the respective submission is complete and begins the EMA's centralized review process.

3. In May 2020, Bristol Myers Squibb and bluebird bio announced that the companies received a Refusal to File letter from the US FDA regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.

4. In February 2020, GlaxoSmithKline announced that the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for Belantamab Mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab Mafodotin was accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP)

5. In December 2019, Janssen announced receipt of a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for JNJ-4528, which is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.

Drugs Uptake

Among the IMid's agent lenalidomide (Revlimid, Celgene) 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, after that generic entry will be permitted. In the European Union, the patent is set to expire in 2024, which will lead to the penetration of generics in the European Market. In 2017, Lenalidomide generated a revenue of USD 7,140 million in the 8MM. Despite the loss of patent exclusivity among the major markets and approval of other potential pipeline candidates, lenalidomide as a molecule will likely maintain a strong presence during the forecast period.

Among emerging therapies, Bristol Myers Squibb and Bluebird Bio's anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) expected to generate the maximum revenue owing to promising results, one-time dosing.

Access and Reimbursement Scenario in MM 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 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.

KOL Views

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 study 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.

Scope of the Report

    --  The report covers the descriptive overview of Multiple Myeloma,
        explaining its causes, signs and symptoms, pathophysiology and currently
        available therapies.
    --  Comprehensive insight has been provided into the Multiple Myeloma
        epidemiology and treatment in the 8MM.
    --  Additionally, an all-inclusive account of both the current and emerging
        therapies for Multiple Myeloma are provided, along with the assessment
        of new therapies, which will have an impact on the current treatment
        landscape.
    --  A detailed review of Multiple Myeloma market; historical and forecasted
        is included in the report, covering drug outreach in the 8MM.
    --  The report provides an edge while developing business strategies, by
        understanding trends shaping and driving the global Multiple Myeloma
        market.

Report Highlights

    --  In the coming years, Multiple Myeloma market is set to change due to the
        rising awareness of the disease, and incremental healthcare spending
        across the world; which would expand the size of the market to enable
        the drug manufacturers to penetrate more into the market.
    --  The companies and academics are working to assess challenges and seek
        opportunities that could influence Multiple Myeloma R&D. The therapies
        under development are focused on novel approaches to treat/improve the
        disease condition.
    --  Major players are involved in developing therapies for Multiple Myeloma.
        Launch of emerging therapies will significantly impact the Multiple
        Myeloma market.
    --  A better understanding of disease pathogenesis will also contribute to
        the development of novel therapeutics for Multiple Myeloma.
    --  the in-depth analysis of the pipeline assets across different stages of
        development (Phase III and Phase II), different emerging trends and
        comparative analysis of pipeline products with detailed clinical
        profiles, key cross-competition, launch date along with product
        development activities will support the clients in the decision-making
        process regarding their therapeutic portfolio by identifying the overall
        scenario of the research and development activities.

Companies Mentioned 

    --  Abbvie (Pharmacyclics)
    --  Adaptimmune Therapeutics /GlaxoSmithKline /Merck Sharp & Dohme Corp.
    --  Amgen
    --  AstraZeneca
    --  BioLineRx
    --  bluebird bio
    --  Bristol-Myers Squibb
    --  Cartesian Therapeutics
    --  Celgene/Aduro Biotech
    --  Cellectar Biosciences
    --  Chipscreen Biosciences
    --  ExCellThera
    --  GlaxoSmithKline
    --  Glenmark (Ichnos Sciences SA)
    --  Janssen Biotech/Nanjing Legend Biotech
    --  Janssen Pharmaceutical
    --  Johnson & Johnson
    --  Juno Therapeutics (a Bristol-Myers Squibb company)
    --  Merck Sharp & Dohme Corp.
    --  Molecular Partners AG
    --  MorphoSys AG/I-Mab Biopharma
    --  Oncopeptides AB
    --  Pfizer (Array Biopharma)
    --  Poseida Therapeutics
    --  Precision BioSciences
    --  RAPA Therapeutics
    --  Regeneron Pharmaceuticals
    --  Roche
    --  Takeda

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/oq6j1p

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

View original content:http://www.prnewswire.com/news-releases/multiple-myeloma-analysis-in-8mm-forecast-to-2030-301124426.html

SOURCE Research and Markets