darzalex market size forecast and market insight

“DARZALEX Market Size, Forecast, and Market Insight - 2032” report provides comprehensive insights about DARZALEX for Multiple Myeloma in the seven major markets. A detailed picture of the DARZALEX for Multiple Myeloma in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 –2032 is provided in this report along with a detailed description of the DARZALEX for Multiple Myeloma. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the DARZALEX market forecast analysis for Multiple Myeloma in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in Multiple Myeloma.

Drug Summary

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. Daratumumab triggers a person’s immune system to attack cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and immunomodulatory effects and direct tumor cell death via apoptosis (programmed cell death). Daratumumab is developed by Janssen Biotech under an exclusive worldwide license to develop, manufacture, and commercialize Daratumumab from Genmab. It is the first CD38-targeted monoclonal antibody. The drug has also been granted Orphan and Breakthrough designations for multiple myeloma, accelerating its approval

It is indicated for the treatment of adult patients with multiple myeloma:

• In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. 
• In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. 
• In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients eligible for autologous stem cell transplant. 
• In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. 
• In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 
• In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. 
• As monotherapy, in patients 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

Apart from this, DARZALEX FASPRO is an SC formulation of a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, for the treatment of adult patients with: 

• Multiple myeloma in combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. 
• Multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. 
• Multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients eligible for autologous stem cell transplant. 
• Multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. 
• Multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. 
• Multiple myeloma in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 
• Multiple myeloma as monotherapy in patients 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 (FDA, 2022f).

DARZALEX is currently being investigated in multiple clinical trials for multiple myeloma. Major Phase III trials are going for smoldering multiple myeloma (SMM3001), frontline multiple myeloma transplant ineligible in combination with bortezomib, lenalidomide, and dexamethasone (MMY3019, CEPHEUS), and frontline multiple myeloma transplant eligible in combination with bortezomib, lenalidomide and dexamethasone

Mechanism of action

CD38 is a transmembrane glycoprotein (48 kDa) expressed on the surface of hematopoietic cells, including multiple myeloma and other cell types and tissues, and has multiple functions, such as receptor-mediated adhesion, signaling, and modulation of cyclase and hydrolase activity. Daratumumab is an IgG1? human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38-expressing tumor cells by inducing apoptosis directly through Fc-mediated cross-linking as well as by immune-mediated tumor cell lysis through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). A subset of myeloid-derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs), and B cells (CD38+Bregs) are decreased by daratumumab

Scope of the Report 

The report provides insights into:

• A comprehensive product overview including the DARZALEX description, mechanism of action, dosage and administration, research and development activities in Multiple Myeloma.
• Elaborated details on DARZALEX regulatory milestones and other development activities have been provided in this report.
• The report also highlights the DARZALEX research and development activities in Multiple Myeloma across the United States, Europe, and Japan.
• The report also covers the patents information with expiry timeline around DARZALEX.
• The report contains forecasted sales of DARZALEX for Multiple Myeloma till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Multiple Myeloma.
• The report also features the SWOT analysis with analyst views for DARZALEX in Multiple Myeloma.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

DARZALEX Analytical Perspective by DelveInsight

In-depth DARZALEX Market Assessment

This report provides a detailed market assessment of DARZALEX for Multiple Myeloma in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2025 to 2032.

DARZALEX Clinical Assessment

The report provides the clinical trials information of DARZALEX for Multiple Myeloma covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights  

• In the coming years, the market scenario for Multiple Myeloma is set to change due to the extensive research 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 are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence DARZALEX dominance.
• Other emerging products for Multiple Myeloma are expected to give tough market competition to DARZALEX and launch of late-stage emerging therapies in the near future will significantly impact the market. 
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of DARZALEX in Multiple Myeloma.
• Our in-depth analysis of the forecasted sales data of DARZALEX from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the DARZALEX in Multiple Myeloma. 

Key Questions

• What is the product type, route of administration and mechanism of action of DARZALEX?
• What is the clinical trial status of the study related to DARZALEX in Multiple Myeloma and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the DARZALEX development?
• What are the key designations that have been granted to DARZALEX for Multiple Myeloma?
• What is the forecasted market scenario of DARZALEX for Multiple Myeloma?
• What are the forecasted sales of DARZALEX in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?  
• What are the other emerging products available and how are these giving competition to DARZALEX for Multiple Myeloma?
• Which are the late-stage emerging therapies under development for the treatment of Multiple Myeloma?