CD-38 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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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.

Molecule name	Number of studies
Darzalex (Daratumumab)	2
Darzalex Faspro (Daratumumab hyaluronidase)	2
Sarclisa (Isatuximab-irfc)	11
Isatuximab sc (SAR650984 SC)	3
Felzatamab (MOR202)	1

Target Indication Analysis of CD-38 Inhibitors

Pharmaceuticals such as Darzalex (Daratumumab) and Sarclisa (Isatuximab-irfc) have displayed promising outcomes and are available in the market for treating conditions like Relapsed or Refractory and Refractory Multiple Myeloma. The development of the completely human CD38 monoclonal antibody Daratumumab and the chimeric CD38 monoclonal antibody Isatuximab was sparked by the target's specificity, which has sparked interest in new medications. In addition to direct apoptotic activity, direct immunological effector mechanisms, and immunomodulatory effects through eliminating CD38+ immune-suppressor cells, CD38 antibodies exhibit pleiotropic modes of action. These medications are being extensively tested in a variety of clinical trial settings for different indications, including both current and novel uses, both in combination with each other and with other treatments.

CD-38 Inhibitors Regional Analysis

CD-38 Inhibitors Market

The net trade sales of Darzalex and Darzalex Faspro in the financial year 2022 were $4,210 million in the USA and $3,767 million in the rest of the world. Sanofi enjoyed 294 million euros in global sales of Sarclisa in the financial year 2022. according to the National Institutes of Health, the global incidence of MM is about 160,000 and It is estimated that MM accounts for 2% of all cancer diagnoses. According to the American Cancer Society, there is a risk of getting a MM is 1 in 132 in the USA. Factors such as research and development advancements, favorable reimbursement policies, an aging population and an increase in the prevalence of Multiple Melanoma across the globe are the driving factors for the CD-38 inhibitor market.

Latin America

Europe

Asia Pacific

Middle East

North America

Frequently Asked Questions

Darzalex (Daratumumab) and Darzalex Faspro (Daratumumab hyaluronidase) are some of the molecules approved by the FDA.

These are being used in various indications like Relapsed or Refractory Multiple Myeloma and light chain amyloidosis

Janssen Research and Development, LLC, Sanofi, and Takeda Pharmaceutical Company Ltd. Are some of the major market players for CD-38 Inhibitors.

Rising incidence of diseases and changing lifestyles leading to cancer and bone cancers are the key opportunities for CD-38 Inhibitors in the market.

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