Anti-CD38 Antibody Market Pipeline Report 2025: Key Insights on 10+ Companies and 12+ Drugs - Therapeutic Assessment by Product Type, Stage, Route of Administration, and Molecule Type - ResearchAndMarkets.com

The "Anti-CD38 antibody - Pipeline Insight, 2025" clinical trials has been added to ResearchAndMarkets.com's offering.

This "Anti-CD38 antibody - Pipeline Insight, 2025" report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Anti-CD38 antibody pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anti-CD38 antibody pipeline landscape is provided which includes the disease overview and Anti-CD38 antibody treatment guidelines. The assessment part of the report embraces in depth Anti-CD38 antibody commercial assessment and clinical assessment of the pipeline products under development.

In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anti-CD38 antibody collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Anti-CD38 antibody R&D. The therapies under development are focused on novel approaches to treat/improve Anti-CD38 antibody.

Anti-CD38 antibody Emerging Drugs Chapters

This segment of the Anti-CD38 antibody report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Anti-CD38 antibody Emerging Drugs

TAK-079: Takeda

TAK-079 is a high-affinity antibody against a specific molecule called CD38, which is found in abundance on the surface of malignant myeloma cells and at low levels on the surface of normal immune cells, including activated natural killer (NK) cells, T- and B-cells, among others. TAK-079 binds with great affinity to myeloma cells in the bone marrow and other organs. Therapy with mezagitamab is designed to deliver rapid and sustained improvement in platelet response and generally rapidly restores platelet counts to functional levels. Currently, the drug is in the Phase III stage of its development for the treatment of Immune Thrombocytopenic Purpura.

HLX15: Shanghai Henlius Biotech

HLX15 is a fully human anti-CD38 IgG1k monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM), which is an incurable clonal plasma cell dysplasia, the second most hematological malignancy which mainly develops in elderly population. In February 2025, Shanghai Henlius Biotech, Inc. announced it had entered into a license agreement with Dr. Reddy's Laboratories.

Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply. Dr. Reddy's will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States. Currently, the drug is in the Phase III stage of its development for the treatment of Multiple myeloma.

CID-103: CASI Pharmaceuticals

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy. Currently, the drug is in the Phase I stage of its development for the treatment of patients with multiple myeloma.

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Anti-CD38 antibody drugs?
• How many Anti-CD38 antibody drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Anti-CD38 antibody?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Anti-CD38 antibody therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Anti-CD38 antibody and their status?
• What are the key designations that have been granted to the emerging drugs?

Anti-CD38 antibody: Therapeutic Assessment

Major Players in Anti-CD38 antibody

• There are approx. 10+ key companies which are developing the therapies for Anti-CD38 antibody. The companies which have their Anti-CD38 antibody drug candidates in the most advanced stage, i.e. Phase III include, Takeda and Shanghai Henlius Biotech.

Phases

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Anti-CD38 antibody Report Insights

• Anti-CD38 antibody Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Anti-CD38 antibody Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Players

• I-MAB Biopharma
• Takeda
• HLX15
• Ancora Biotech
• CASI Pharmaceuticals

Key Products

• Felzartamab
• TAK-079
• Shanghai Henlius Biotech
• TNB 738
• CID-103

For more information about this clinical trials report visit https://www.researchandmarkets.com/r/4l27td

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