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DARZALEX Market Expansion Driven by Strong Demand for Multiple Myeloma Treatment | DelveInsight
DARZALEX Market
DARZALEX (daratumumab), a pioneering CD38-targeting monoclonal antibody therapy, continues to reshape the treatment landscape for multiple myeloma. As a first-in-class treatment, DARZALEX has significantly improved patient outcomes by leveraging its unique immune-mediated mechanisms of action to eliminate cancer cells.
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Janssen's DARZALEX (Daratumumab) Overview
Daratumumab is a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on multiple myeloma cells. The therapy stimulates the immune system to attack cancer cells, inducing tumor cell death through complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and apoptosis.
DARZALEX is developed by Janssen Biotech under an exclusive worldwide license from Genmab. It was the first CD38-targeted therapy approved for multiple myeloma and has since received Orphan Drug and Breakthrough Therapy designations, expediting its regulatory approval and commercial availability.
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Indications and Administration
DARZALEX is indicated for the treatment of adult patients with multiple myeloma in various settings:
• In combination with lenalidomide and dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant.
• In combination with bortezomib, melphalan, and prednisone for newly diagnosed patients ineligible for transplant.
• In combination with bortezomib, thalidomide, and dexamethasone for transplant-eligible patients.
• As monotherapy for patients who have received at least three prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent.
• Additionally, DARZALEX FASPRO, a subcutaneous formulation combining daratumumab with hyaluronidase, offers an alternative administration route for enhanced patient convenience.
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DARZALEX Market Outlook
In 2023, the multiple myeloma market across the 7MM was valued at USD 21,300 million, with projections indicating substantial growth through 2032. This expansion is fueled by rising multiple myeloma incidence, improved diagnosis rates, and the increasing adoption of novel combination therapies featuring DARZALEX.
Competitive therapies such as Sarclisa (isatuximab) and emerging BCMA-targeted treatments present additional options for patients. However, DARZALEX's well-established efficacy and expanding label indications position it as a leading therapy in the multiple myeloma market.
Key Regulatory Milestones of DARZALEX
• December 2024 - Approval in Japan for use in newly diagnosed multiple myeloma patients.
• July 2024 - EMA approval for expanded label indications, including first-line use in transplant-eligible patients.
• October 2023 - FDA approval for DARZALEX FASPRO's expanded use in combination with pomalidomide and dexamethasone.
• November 2015 - Initial FDA approval for relapsed or refractory multiple myeloma.
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Emerging Competitors and Market Dynamics
The competitive landscape for multiple myeloma therapies is evolving with the development of next-generation CD38 inhibitors and BCMA-targeted therapies. Companies such as Johnson & Johnson, Regeneron, and Bristol Myers Squibb are actively advancing novel treatments in this space. However, DARZALEX's first-mover advantage, extensive clinical trial data, and broad market penetration solidify its leadership position.
Table of Contents:
1. Report Introduction
2. DARZALEX Overview in Multiple Myeloma
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.2.3. Safety and efficacy
2.3. Regulatory Milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5. DARZALEX Market Assessment
5.1. Market Outlook of DARZALEX in Multiple Myeloma
5.2. 7MM Analysis
5.2.1. Market Size of DARZALEX in the 7MM for Multiple Myeloma
5.3. Country-wise Market Analysis
5.3.1. Market Size of DARZALEX in the United States for Multiple Myeloma
5.3.2. Market Size of DARZALEX in Germany for Multiple Myeloma
5.3.3. Market Size of DARZALEX in France for Multiple Myeloma
5.3.4. Market Size of DARZALEX in Italy for Multiple Myeloma
5.3.5. Market Size of DARZALEX in Spain for Multiple Myeloma
5.3.6. Market Size of DARZALEX in the United Kingdom for Multiple Myeloma
5.3.7. Market Size of DARZALEX in Japan for Multiple Myeloma
6. SWOT Analysis
7. Analysts' Views
8. Appendix
9. DelveInsight Capabilities
10. Disclaimer
11. About DelveInsight
12. Report Purchase Options
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Ankit Nigam
Manager Marketing
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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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