Billion-Dollar Battle in Multiple Myeloma: Janssen and Sanofi Vie for Dominance as Daratumumab Surpasses $10 Billion Milestone
Johnson & Johnson
Medical Device R&D and Manufacturer
In recent years, significant progress has been made in the development of drugs for the treatment of multiple myeloma. From traditional chemotherapy drugs to targeted therapies, and the rise of immunotherapy and cell therapy, the range of treatment options has expanded considerably, leading to a notable improvement in patients' quality of life and prognosis. In particular, the emergence of novel drugs such as CD38 monoclonal antibodies, immunomodulatory agents, proteasome inhibitors, and BCMA CAR-T therapy has not only provided new treatment options for patients with multiple myeloma but has also greatly advanced the entire field of treatment.
Against this backdrop, MaxEntropy Consulting released the "Market Research Special Report — Multiple Myeloma Drugs," which provides a comprehensive analysis of the epidemiological data, diagnosis and treatment guidelines, and the competitive landscape of the drug market for multiple myeloma, offering valuable references and insights for the industry. Based on certain content from this report and supported by data from the MaxEntropy Pharma database, this article reveals the current market competition dynamics through an in-depth analysis of the multiple myeloma drug market, providing decision-making support for relevant enterprises and researchers.
Daratumumab Global Sales Nearly 10 Billion USD, Strong Demand
DaratumumabIt is a monoclonal antibody targeting CD38, which directly acts on myeloma cells and exerts immune-mediated activity, mainly including complement-dependent cytotoxicity.（CDC）Antibody-dependent cell-mediated cytotoxicity（ADCC）And antibody-dependent cellular phagocytosis（ADCP）, as well as direct cytotoxicity induced by Fcγ receptor-mediated cross-linking apoptosis; simultaneouslyDaratumumabBy modulating the immune microenvironment, activating killer T cells (CD8+) and helper T cells (CD4+), rapidly and durably eliminating CD38+ immunosuppressive cells, and continuously promoting myeloma cell death, deep and sustained remission can be achieved.
As the world's first monoclonal antibody targeting CD38 to be approved for marketing, since receiving FDA approval in 2015, the drug developed by Johnson & Johnson...DaratumumabRapidly expanding indications globally, successively approved for marketing in the EU, Canada, Japan, Australia, and China, and has now secured all indications from last-line monotherapy to first-line treatment.
After its launch, global sales have been soaring, reaching $9.7 billion in 2023, and are expected to surpass the $10 billion mark in 2024. This demonstratesDaratumumabThe important role in treating plasma cell disorders and the significant clinical demand.
Data Source: Mosun Pharmaceutical Sales Database
Daratumumab Multiple Indications Approved in China, Sales Exceed 1.4 Billion Yuan
According to the MoEntropy pharmaceutical database,DaratumumabApproved for marketing in China in July 2019. May 2023,Daratumumab Injection(Subcutaneous Injection)Approved for marketing under the brand name "Megatron," indicated for six conditions related to multiple myeloma, in addition to previously approved primary light chain amyloidosis.（AL），Megakaryocyte has been approved for a total of 7 indications in two major treatment areas. The 3-5 minute subcutaneous administration will significantly reduce the treatment time for MM and AL patients, allowing the treatment of plasma cell diseases in China to be in line with international standards.
In 2021,Daratumumab InjectionSuccessfully negotiated for the first-time inclusion in medical insurance, and successfully renewed in 2024 with further price reductions. As the number of approved indications continues to increase, sales in China have also grown rapidly, reaching 1.4 billion yuan in 2023.
Data Source: Mosun Pharmaceutical Sales Database, Mox Consulting
SanofiDeveloped byIsatuximab——Isatuximab, is the second globally approved monoclonal antibody targeting CD38, and was approved for marketing by the FDA in 2020. In the United States and the European Union,IsatuximabAwarded for the Treatment of Relapsed or Refractory Multiple Myeloma（R/RMM）Orphan Drug Designation.
December 2023,SanofiSubmitted to China CDE for the First TimeIsatuximabThe listing application has been accepted. With the further expansion of indications,IsatuximabCorrectDaratumumabThe market impact will be further exacerbated.
At the same time,DaratumumabThe patent expiration date is March 2026. Currently, multiple companies worldwide are in the process of development.DaratumumabBiological similar drugs, such as Zhengda Tianqing, Hangzhou Jiuyuan Gene, and Shijiazhuang Pharmaceutical Group, etc.
Market Analysis of Daratumumab in Hospitals at All Levels (Taking Beijing as an Example)
According to the drug flow data from Mose Pharm, taking Beijing as an example,DaratumumabSales volume and sales revenue for each quarter of 2023 are shown in the figure below.
Data Source: Mosun Pharmaceutical Sales Database, Mox Consulting
DaratumumabTop 3 Hospitals in Sales for 2023(Taking Beijing as an example)Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; People's Hospital of Peking University; Third Hospital of Peking University.
Data Source: Mosun Pharmaceutical Sales Database, Mox Consulting
Taking Beijing as an example,DaratumumabSales in Q2 2023 showed a significant increase, reaching 54.5089 million yuan, and then began to decline, with sales in Q4 2023 dropping to the lowest point of the year. Tertiary hospitals were the main sales market, with sales from tertiary hospitals accounting for over 97% each quarter.
Source of image: Maxentropy Consulting's "Market Research Special Report - Multiple Myeloma Drugs"
MaxEntropy Pharma's pharmaceutical flow data is the drug distribution data across China, compiled in collaboration with multiple pharmaceutical distribution partners in various provinces and cities nationwide. The data is desensitized, compliant, detailed, and comprehensive, reaching specific hospitals. It covers over 3,000 tertiary hospitals, more than 10,000 secondary hospitals, and over 75,000 primary and unrated hospitals in China, providing enterprises with comprehensive market insights to optimize their market strategies, supply chain management, and policy responses.
In the late 1990s, the first generation of immunomodulatory drugsThalidomideThe introduction has brought about a significant shift in the treatment paradigm for multiple myeloma.ThalidomideBy a German pharmaceutical companyChemieGrunenthalManufactured as an anti-nausea drug for pregnancy, it was later withdrawn from the market after being found to cause birth defects. It was approved by the FDA in 2006 for use in multiple myeloma.
Data Source:ModiMed Global R&D Database, MoMed Sales Database, MoConsulting
Lenalidomide isThalidomideA derivative, belonging to the second-generation immunomodulatory imide drugs (IMiDs), is the first oral medication for the treatment of multiple myeloma. Developed by Celgene Corporation, it offers the convenience of oral administration and significantly reduced neurotoxicity compared to first-generation immunomodulatory drugs. With overwhelming sales in China, its sales reached 1.6 billion yuan in 2023, capturing three-quarters of the market share.
Data Source: Mosearch Medicine Global R&D Database, Mosearch Medicine Sales Database
The Third Generation ProductPomalidomideIn 2013, it was approved by the FDA for the treatment of relapsed or refractory multiple myeloma. In the Chinese market,Pomalidomide CapsulesThis is a typical case where a generic drug was approved for marketing before the original drug. The first company to launch the product was Zhengda Tianqing, which received approval for the first generic version in November 2020. Its sales in 2023 have exceeded 300 million yuan.
Proteasome inhibitors induce apoptosis in MM cells by inhibiting the proteasomal degradation of related proteins, leading to the accumulation of ubiquitinated and/or misfolded proteins within the cell. In China, three proteasome inhibitors have been approved for marketing: bortezomib, carfilzomib, and ixazomib.
Among themBortezomibDue to its widespread application in the entire treatment process of myeloma induction, consolidation, and maintenance, it has become the preferred first-line treatment regimen for myeloma. In 2020, the sales revenue of bortezomib once exceeded 2 billion yuan, but its sales have been declining year by year due to the impact of the centralized procurement policy.
Image Source:MaxEntropy Consulting "Market Research Special Report —— Multiple Myeloma Drugs"
CarfilzomibDue to irreversible risks of cardiotoxicity and nephrotoxicity, sales performance has been consistently poor.IxazomibAs the first oral dosage form, but with a single approved treatment regimen, only the Ixazomib + Lenalidomide + Dexamethasone regimen has been approved in China and globally. Sales in 2023 reached 600 million yuan.
CarfilzomibDue to irreversible risks of cardiotoxicity and nephrotoxicity, its sales performance has been consistently poor. Ixazomib, as the first oral formulation, offers certain conveniences; however, the approved treatment options are relatively limited, both domestically and internationally.Ixazomib+Lenalidomide+DexamethasoneThe plan has limited its market expansion, with sales reaching 600 million yuan in 2023.
Image Source:Maxent Consulting《Market Research Special Report —— Multiple Myeloma Drugs》
Nevertheless, these three protease inhibitors still maintain a certain market influence overall, with combined sales exceeding 1 billion yuan in 2023, securing their position in the multiple myeloma treatment drug market.
BCMA is a protein highly expressed in multiple myeloma cells. CAR-T therapy targeting BCMA has significantly improved the remission rate in patients with relapsed/refractory multiple myeloma (RRMM) and has now advanced to become a second-line treatment for multiple myeloma.
As of October 2024, four products have been approved for marketing globally: BMS's Abecma and Johnson & Johnson/Legend Biotech's Carvykti, with Carvykti's global sales exceeding $500 million in 2023; as well as China's Innovent Biologics/IASO Biotherapeutics' Equecabtagene Autoleucel and CARsgen Therapeutics/Huadong Medicine's Zevorcabtagene Autoleucel, which are still in the market introduction phase due to their recent launch and not yet being included in medical insurance, with future growth anticipated.
Image Source:MaxEntropy Consulting《Market Research Special Report——Multiple Myeloma Drugs》
SelinexorIt is the world's first oral XPO-1 inhibitor and is currently still in the growth phase.
SelinexorBy specifically binding to and inhibiting XPO-1, it prevents the transport of key proteins, thereby suppressing the growth and metastasis of tumor cells. The drug was developed by Karyopharm Therapeutics and received FDA approval in 2019 for the treatment of fifth-line relapsed/refractory multiple myeloma, in 2020 for second-line relapsed/refractory multiple myeloma, and in 2024 for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).
Image Source:MaxEntropy Consulting "Market Research Special Report - Multiple Myeloma Drugs"
Antengene Corporation Introduces SaiLenisChina rights, and in 2023, the domestic commercialization rights were licensed to Hansoh Pharma. In 2023,SelinexorSales in the United States reached $112 million. In the Chinese market, due to its recent launch and not yet being included in medical insurance, as well as having received approval for relatively later-line indications, it is still in the growth phase, with sales reaching 39 million yuan in 2023.
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