CD38: a Blockbuster sales target under fire by biosuperior and biosmilar antibody competitors – a pipeline review

STUTTGART, Germany I August 26, 2025 I La Merie Publishing announced the release of its newest product offering reviewing the pipeline of active anti-CD38 immunotherapeutics in R&D: Pipeline of CD38-Targeted Immunotherapies.

This competitive intelligence report about CD38-Targeted Immunotherapies provides a competitor evaluation in the field of product candidates in research and development targeting CD38. This report will be prepared on demand within one working day upon order placement. The report lists CD38-targeted R&D programs by R&D phase in a tabular format and describes in brief the profile of CD38-targeted immunotherapies by drug modality. The report will be provided in pdf format and sent by e-mail to the customer.

As an example of this category of on demand reports, please see our free sample report of “Pipeline of 5T4-Targeted Immunotherapies”.

CD38 is a transmembrane glycoprotein found on the surface of immune cells, including a range of bone marrow cells. In peripheral blood, CD38 is expressed on approximately 90% of plasma cells and approximately 60% of natural killer cells and monocytes. In normal cells, CD38 has many roles, in some instances stimulating lymphocytes, and in other circumstances inhibiting cell growth in B cell precursors. CD38 is an attractive target for antibody therapy because it is highly expressed on malignant plasma cells. In multiple myeloma, more than 90% of malignant plasma cells show surface expression of CD38. Expression is also seen in B cell and T cell neoplasms.

Multiple Myeloma (MM) is a hematological cancer characterized by proliferation of malignant plasma cells in the bone marrow. MM represents the second most frequent hematological malignancy, accounting 1% of all cancer and 13% of hematological tumors, with ~9,000 new cases per year. Multiple myeloma (MM) cells express high levels of the transmembrane glycoprotein CD38, while CD38 is expressed at relatively low levels on normal lymphoid and myeloid cells, and in some non-hematopoietic tissues. This expression profile, together with the role of CD38 in adhesion and as ectoenzyme, resulted in the development of CD38 antibodies for the treatment of multiple myeloma (MM). At this moment several CD38 antibodies are at different phases of clinical testing, with daratumumab and isatuximab already approved for various indications both as monotherapy and in combination with standards of care in MM.

Thus, CD38 is a clinically validated and commercially very successful target with a current market size of more than US$ 12.16 bln (in 2024) attracting interest for development of biosimilar and of biosuperior therapeutics. Darzalex became the number 4 blockbuster biologic in 2024, just behind Keytruda, Dupixent and Skyrizi. However, the patent holder of Darzalex expects that royalties from sales of DARZALEX will begin to decline materially in 2029 following expiration of U.S. patent rights on daratumumab, assuming constant underlying sales of DARZALEX (see Annual Report 2024).

The report “Pipeline of CD38-Targeted Immunotherapies” can be acquired at La Merie Publishing’s online store: https://lamerie.com/report/pipeline-of-cd38-targeted-immunotherapies/

About La Merie Publishing

La Merie Publishing is an independent business information provider for the biotechnology and pharmaceutical industry. La Merie Publishing prepares brief and full reports. La Merie Publishing products can be purchased in the online store www.lamerie.com and from selected Resellers.

La Merie Publishing offers the service of custom report preparation for corporate clients, including, but not limited to, customized reports about target evaluation, pipeline analysis, technology assessments, drug and competitor profiles, partnering and business deal terms and any other competitive intelligence elaboration of interest.

SOURCE: La Merie Publishing