The “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 human CD38 antigen is a 46 kilodalton (kDa) type II transmembrane glycoprotein with a short N-terminal cytoplasmic tail and a long extracellular domain.CD38 can be internalized and shed and it also exists in a 39 kDa soluble form in biological fluids. The gene encoding CD38 is on Chromosome. It is present in hematopoietic cells (its distribution seems to depend on the activation and differentiation of the cell) and can be expressed also in various tissues. It is also expressed on regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells with a high surface expression associated with compromised immune surveillance for malignancies. CD38 is present in most of the circulating T- and B-cells are CD38-, and activated B- and T-cells, it is also present on monocytes, natural killer cells, dendritic cells, and plasma cells.
CD38 is highly and uniformly expressed on multiple myeloma (MM) cells, and at relatively low levels on normal lymphoid and myeloid cells, and in some tissues of nonhematopoietic origin. CD38 is a transmembrane glycoprotein with ectoenzymatic activity, and also functions as a receptor and adhesion molecule. CD38 was inferred to be a receptor after observations of signals induced by agonistic antibodies. These signals were accessory cell- and IL-2-dependent and additive with both CD3 and CD2. The CD38 molecule was later reported to be involved in triggering activation and proliferation signals that are lineage-unrestricted. Since the identification of CD31 as a specific ligand, CD38 has been generally recognized as a receptor, despite its intrinsic inability to act in this function, because of a very short cytoplasmic domain. Indeed, to act as a receptor, CD38 needs to be redirected to specialized micro domains of the cell membrane, in close proximity to professional receptors. This point has been confirmed by visually monitoring the formation of the immunological synapse in T lymphocytes. CD38 is a multifunctional ectoenzyme involved in the catabolism of nicotinamide adenine dinucleotide (NAD+) and nicotinamide adenine dinucleotide phosphate (NADP), the 2 main substrates of the molecule identified so far. This reaction leads to the generation of potent intracellular Ca2+-mobilizing compounds (cyclic adenosine diphosphate [ADP] ribose, ADP ribose, and nicotinic acid adenine dinucleotide phosphate).
CD38 antibodies also have activity against lymphoma cell lines and in a lymphoma mouse model. Furthermore, daratumumab exerts significant cytotoxicity against chronic lymphocytic leukemia cells via ADCC and ADCP, but without significant CDC, probably as a result of high complement inhibitor expression. In addition, daratumumab interferes with CD38 signaling and reduces CLL adhesion, migration, and homing. CD38 antibodies may also have therapeutic potential beyond the treatment of hematologic malignancies. Because daratumumab has immunomodulatory effects via elimination of CD38+ immune-suppressor cells, CD38 antibodies may even be effective in CD38- tumors. Interestingly, preclinical lung cancer studies suggest that CD38 confers resistance to PD-L1 blockade by inhibiting CD8+ T-cell function, which explains the marked efficacy of combination therapy of PD-L1 blocker and CD38 antibody. This forms the preclinical rationale of various ongoing studies with daratumumab plus PD-1/PD-L1-neutralizing antibodies.
"Anti-CD38 antibody- Pipeline Insight, 2025" 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.
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Geography Covered
- Global coverage
Anti-CD38 antibody: Understanding
Anti-CD38 antibody: Overview
CD38 is a membrane-bound protein first identified by monoclonal antibody typing of lymphocytes and thus thought of as a lymphocyte-specific antigen. CD38 was discovered in 1980 by E.L Reinherz and S. Schlossman, and is a type II transmembrane glycoprotein. CD38 plays a role in regulation of migration, receptor-mediated adhesion by interaction with CD31 or hyaluronic acid, and signaling events. Consistently, its expression in lymphocytes shows stage-related variations and ligation by agonistic antibodies against CD38 can trigger a wide range of responses in various types of blood cells. It is present not only on cell surfaces but also in various intracellular organelles, including the nucleus. The unexpected discovery that CD38 is homologous to ADP-ribosyl cyclase has brought in a new perspective on the cellular function of CD38 and ushered in a new field of investigation. Indeed, it has now been established that CD38 is a multi-functional enzyme catalyzing the metabolism of two distinct Ca2+ messengers, cyclic ADP-ribose (cADPR) and nicotinic acid adenine dinucleotide phosphate (NAADP). The former is a novel cyclic nucleotide that modulates the ryanodine receptor and mobilizes the endoplasmic Ca2+ stores. NAADP is structurally distinct from cADPR and targets separate Ca2+ stores, acidic organelles like lysosomes.The human CD38 antigen is a 46 kilodalton (kDa) type II transmembrane glycoprotein with a short N-terminal cytoplasmic tail and a long extracellular domain.CD38 can be internalized and shed and it also exists in a 39 kDa soluble form in biological fluids. The gene encoding CD38 is on Chromosome. It is present in hematopoietic cells (its distribution seems to depend on the activation and differentiation of the cell) and can be expressed also in various tissues. It is also expressed on regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells with a high surface expression associated with compromised immune surveillance for malignancies. CD38 is present in most of the circulating T- and B-cells are CD38-, and activated B- and T-cells, it is also present on monocytes, natural killer cells, dendritic cells, and plasma cells.
CD38 is highly and uniformly expressed on multiple myeloma (MM) cells, and at relatively low levels on normal lymphoid and myeloid cells, and in some tissues of nonhematopoietic origin. CD38 is a transmembrane glycoprotein with ectoenzymatic activity, and also functions as a receptor and adhesion molecule. CD38 was inferred to be a receptor after observations of signals induced by agonistic antibodies. These signals were accessory cell- and IL-2-dependent and additive with both CD3 and CD2. The CD38 molecule was later reported to be involved in triggering activation and proliferation signals that are lineage-unrestricted. Since the identification of CD31 as a specific ligand, CD38 has been generally recognized as a receptor, despite its intrinsic inability to act in this function, because of a very short cytoplasmic domain. Indeed, to act as a receptor, CD38 needs to be redirected to specialized micro domains of the cell membrane, in close proximity to professional receptors. This point has been confirmed by visually monitoring the formation of the immunological synapse in T lymphocytes. CD38 is a multifunctional ectoenzyme involved in the catabolism of nicotinamide adenine dinucleotide (NAD+) and nicotinamide adenine dinucleotide phosphate (NADP), the 2 main substrates of the molecule identified so far. This reaction leads to the generation of potent intracellular Ca2+-mobilizing compounds (cyclic adenosine diphosphate [ADP] ribose, ADP ribose, and nicotinic acid adenine dinucleotide phosphate).
CD38 antibodies also have activity against lymphoma cell lines and in a lymphoma mouse model. Furthermore, daratumumab exerts significant cytotoxicity against chronic lymphocytic leukemia cells via ADCC and ADCP, but without significant CDC, probably as a result of high complement inhibitor expression. In addition, daratumumab interferes with CD38 signaling and reduces CLL adhesion, migration, and homing. CD38 antibodies may also have therapeutic potential beyond the treatment of hematologic malignancies. Because daratumumab has immunomodulatory effects via elimination of CD38+ immune-suppressor cells, CD38 antibodies may even be effective in CD38- tumors. Interestingly, preclinical lung cancer studies suggest that CD38 confers resistance to PD-L1 blockade by inhibiting CD8+ T-cell function, which explains the marked efficacy of combination therapy of PD-L1 blocker and CD38 antibody. This forms the preclinical rationale of various ongoing studies with daratumumab plus PD-1/PD-L1-neutralizing antibodies.
"Anti-CD38 antibody- Pipeline Insight, 2025" 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
- Felzartamab: I-MAB Biopharma
- TAK-079: Takeda
- ISB 1342: Ichnos Sciences
Anti-CD38 antibody: Therapeutic Assessment
This segment of the report provides insights about the different Anti-CD38 antibody drugs segregated based on following parameters that define the scope of the report, such as: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, I-MAB Biopharma.
Phases
The report covers around 12+ products under different phases of clinical development like
- 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
Anti-CD38 antibody pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Molecule Type
Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.Anti-CD38 antibody: Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Anti-CD38 antibody therapeutic drugs key players involved in developing key drugs.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anti-CD38 antibody drugs.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 Questions
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?
Key Players
- I-MAB Biopharma
- Takeda
- Ichnos Sciences
- Ancora Biotech
- CASI Pharmaceuticals
- Arcellx
Key Products
- Felzartamab
- TAK-079
- ISB 1342
- TNB 738
- CID-103
- Anitocabtagene autoleucel
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Table of Contents
IntroductionExecutive SummaryAnti-CD38 antibody - Analytical PerspectiveAnti-CD38 antibody Key CompaniesAnti-CD38 antibody Key ProductsAnti-CD38 antibody - Unmet NeedsAnti-CD38 antibody - Market Drivers and BarriersAnti-CD38 antibody - Future Perspectives and ConclusionAnti-CD38 antibody Analyst ViewsAnti-CD38 antibody Key CompaniesAppendix
Anti-CD38 antibody: Overview
Pipeline Therapeutics
Therapeutic Assessment
Late Stage Products (Phase III)
Felzartamab: I-MAB Biopharma
Mid Stage Products (Phase II)
Drug Name: Company Name
Early Stage Products (Phase I)
ISB 1342: Ichnos Sciences
Preclinical and Discovery Stage Products
Drug Name: Company Name
Inactive Products
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- I-MAB Biopharma
- Takeda
- Ichnos Sciences
- Ancora Biotech
- CASI Pharmaceuticals
- Arcellx
