CD-38 Inhibitors Market Size, Share, Growth, Trends, and Global Industry Analysis: Competitive Landscape, Pipeline, and Market Size, Share, Growth, Trends, and Global Industry Analysis: Analysis 2023

CD38 is an ectoenzyme (glycoprotein) found on the surface of many immune cells and plays a catalytic role in the synthesis of Nicotinamide (NAM) ADPR using NAD⁺. It mediates NAD⁺ and extracellular and intracellular homeostasis and CA⁺, respectively. CD-38 Inhibitors or Anti-CD38 monoclonal Antibodies are used in combination therapy to treat Multiple Myeloma (MM) for newly diagnosed and/or recurrent cases. These bind with the CD38 protein that is overexpressed in Multiple Myeloma cells. As CD38 is highly expressed in MM cells while limited expression of these receptors in other cells, inhibiting CD38 receptors is an effective way the treatment of Multiple Myeloma. An increase in the incidence of melanoma and other solid tumors will significantly enhance the revenue of the market. The development and launch of newer products by the market players significantly enhance the revenue of the CD-38 Inhibitors market over the forecast years. In 2020, according to The Global Cancer Observatory, the prevalence of Multiple Myeloma in North America was 22.3%, while it was 30.6% in Europe. Therefore, the companies are focusing on the development and launch of novel molecules for these indications to enhance their revenue in the market

A number of these inhibitors are in the market, while many are in ongoing clinical trials. 29 companies have various products in their pipelines, with 29 products in various stages of clinical trials. 2 products are in Phase 4, 3 products are in Phase 3, 5 products are in Phase 2, and 19 products are in Phase 1 of the clinical trials.

Key Developments:

• In November 2021, Darzalex Faspro received FDA approval for the treatment of Multiple Myeloma after 1^st or subsequent relapse in combination with Carfilzomib and Dexamethasone in adult patients with Relapsed or Refractory Multiple Myeloma who have received 1 to 3 prior lines of therapy.
• In July 2021, Darzalex Faspro received FDA approval for treating Multiple Myeloma after 1^st or subsequent relapse in combination with Pomalidomide and Dexamethasone.
• In March 2021, Sarclisa (Isatuximab-irfc) received FDA approval for the treatment of adults patients with Relapsed or Refractory Multiple Myeloma in combination with Carfilzomib and dexamethasone, who have received 1 to 3 prior lines of therapy.
• In January 2021, Darzalex Faspro received accelerated approval from FDA for combination with Bortezomib, Cyclophosphamide, and Dexamethasone in newly diagnosed light chain amyloidosis.
• In March 2020, Sarclisa (Isatuximab-irfc) received FDA approval for the treatment of adults patients with Multiple Myeloma in combination with pomalidomide and dexamethasone, who have received at least two prior therapies, including lenalidomide and a protease inhibitor.

Approved drugs

• Darzalex (Daratumumab) – Janssen Research and Development, LLC
• Darzalex Faspro (Daratumumab hyaluronidase) – Janssen Research and Development, LLC

Drugs in Pipeline

• Sarclisa (isatuximab-irfc)
• felzartamab (MOR202)
• Mezagitamab (TAK-079)
• isatuximab subcutaneous (SAR650984 SC)
• FT538
• modakafusp alfa (TAK-573)
• CM313
• 211At-OKT10-B10
• XmAb968
• 225Ac-DOTA-daratumumab
• BHV-1100
• CID-103
• FT576
• GEN3014
• HLX15 (daratumumab biosimilar)
• GM-2644
• ISB 1342
• ISB 1442
• ISB 2001
• SAR442085
• SAR442257
• SG2501
• SG301
• STI-1492
• TNB-738
• VP301
• Y150

Clinical Activity and Developments of CD-38 Inhibitors

Companies have their products in the pipeline in various phases of clinical trials with approximately 29 products for the 31 diseases.

• Poitiers University Hospital is conducting a Phase 3 trial to study the efficacy of Isotuximab plus Lenalidomide and Dexamethasone with or without Bortezomib in the treatment of newly diagnosed Non-Frail Transplant ineligible Multiple Myeloma elderly patients that is expected to conclude in August 2027.
• Sanofi is conducting a Phase 3 trial to assess the clinical benefits of Isatuximab (SAR650984) in combination with Bortezomib, Lenalidomide and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in patients with newly diagnosed Multiple Myeloma who are not eligible for transplant and is expected to complete by June, 2027.
• Sanofi is conducting a Phase 3 trial to compare the clinical benefits of Isatuximab, Pomalidomide and Dexamethasone to Pomalidomide and Dexamethasone in patients with Relapsed or Refractory and Refractory Multiple Myeloma is expected to complete by September 2023.