항CD38 모노클로널 항체 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• In 2025, the United States held the largest share of the market among the 7MM.
• Anti-CD38 mAb is a targeted therapy primarily used to treat multiple myeloma, a cancer of plasma cells. These drugs bind specifically to CD38, a protein highly expressed on the surface of myeloma cells, and help the immune system recognize and destroy these cancer cells.
• Anti-CD38 monoclonal antibodies play an important role in treating newly diagnosed and refractory multiple myeloma. There are currently two approved antiCD38 medications, DARZALEX (daratumumab) and SARCLISA (isatuximab).
• DARZALEX (daratumumab) is the first mAb approved by the FDA that targets the CD38 protein on the surface of myeloma cells, causing myeloma cell death and the DARZALEX FASPRO (daratumumab + hyaluronidase-fish) is a newer formulation of this targeted therapy.
• Recently, data from IMROZ demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with VRd for newly diagnosed transplant-ineligible multiple myeloma in Phase III.
• The pipeline for anti-CD38 therapies is robust, with several promising candidates in development such as Mezagitamab (TAK-079), CID-103, and others.
• Companies, including Takeda Pharmaceuticals, HI-Bio, Genmab, and others are engaged in the development of anti-CD38 mAb, with approved and emerging drugs.

DelveInsight's "Anti-CD38 mAb - Target Population, Competitive Landscape, and Market Forecast - 2036" report delivers an in-depth understanding of the Anti-CD38 mAb, historical and Competitive Landscape as well as the Anti-CD38 mAb inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Anti-CD38 mAb market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Anti-CD38 mAb market size from 2022 to 2036. The report also covers current Anti-CD38 mAb treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2022-2036

Anti-CD38 mAb Understanding

Anti-CD38 mAb Overview

CD38 is a transmembrane glycoprotein with ectoenzymatic activity, highly expressed on multiple myeloma cells, and minimally expressed on normal cells, making it an ideal therapeutic target. This specificity has led to the development of CD38 monoclonal antibodies, such as the fully human DARZALEX and the chimeric SARCLISA. These antibodies exhibit pleiotropic mechanisms, including Fc-dependent immune effector functions, direct apoptotic activity, and immunomodulatory effects by eliminating CD38+ immune-suppressor cells. The introduction of anti-CD38 mAbs has revolutionized multiple myeloma treatment, significantly enhancing response depth.

Anti-CD38 mAb treatment

Anti-CD38 mAb plays an important role in treating newly diagnosed and refractory multiple myeloma. There are currently two approved anti-CD38 medications, DARZALEX and SARCLISA. The roles of these medications in multiple myeloma and plasma cell dyscrasias have been established through multiple Phase III clinical trials. CD38-targeted therapies are also in development for a range of other diseases, including primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematological malignancies.

Anti-CD38 mAb Epidemiology

The Anti-CD38 mAb epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indication for anti-CD38 mAb, total eligible patient pool for anti-CD38 mAb in selected indication, total treated cases in selected indication for anti-CD38 mAb in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2022 to 2036.

• Epidemiology assessed for multiple myeloma showed that the US, in 2024, accounted for approximately 33,700 incident cases of multiple myeloma.
• Among the gender-specific contributions, males are affected more by multiple myeloma than females.
• Among EU4 and the UK, Germany reported the highest number of multiple myeloma cases in 2024, with approximately 6,600 cases, while Spain had the lowest, with around 3,100 cases.
• In the United States, the total cases of multiple myeloma by age distribution were highest for ages above 65 years.

Anti-CD38 mAb Drug Chapters

The drug chapter segment of the Anti-CD38 mAb reports encloses a detailed analysis of Anti-CD38 mAb marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Anti-CD38 mAb's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

SARCLISA (isatuximAb-irfc): Sanofi

SARCLISA is an IgG1 monoclonal antibody used for multiple myeloma that targets the CD38 protein highly expressed on myeloma cells. It works by directly causing cancer cell death (apoptosis), activating immune responses like antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC), and by blocking the CD38 enzyme activity that helps cancer cells evade the immune system.

In September 2024, the US FDA approved SARCLISA combined with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adults with newly diagnosed multiple myeloma who cannot receive an autologous stem cell transplant (ASCT).

DARZALEX (daratumumAb): Johnson & Johnson/GenmAb

DARZALEX is a novel monoclonal antibody that received FDA approval for the treatment of multiple myeloma in patients who have received at least 1 prior line of therapy. DARZALEX induces tumor cell death through multiple mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis.

DARZALEX first received accelerated FDA approval in November 2015 as a single-agent therapy for multiple myeloma patients who had tried at least three prior treatments, and over the following years-including approvals in November 2016 for use with lenalidomide/dexamethasone or bortezomib/dexamethasone after at least one prior therapy it was approved in various other combinations, steadily expanding its role in multiple myeloma treatment from 2015 to 2021.

Emerging Drugs

MezagitamAb (TAK-079): Takeda Pharmaceuticals

MezagitamAb (also known as TAK-079) is a fully human IgG1 monoclonal antibody targeting CD38, being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, mezagitamAb received Fast Track designation and Orphan Drug status from the FDA for idiopathic thrombocytopenic purpura (ITP). Additionally, Takeda announced plans to initiate a global Phase III trial for mezagitamAb in ITP later in 2024. Currently, it is in Phase II.

FelzartamAb: HI-Bio

HI-Bio's lead asset, felzartamAb, is a fully human anti-CD38 monoclonal antibody that has been shown in clinical studies to selectively deplete CD38+ cells including plasma cells and natural killer, or NK, cells which may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases. FelzartamAb has received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the US FDA for development in the treatment of primary membranous nephropathy and has received an Orphan Drug Designation in the treatment of antibody-mediated kidney transplant recipients. Phase II studies have been completed in primary membranous nephropathy and antibody-mediated transplant rejection and remain ongoing in IgA nephropathy, and HI-Bio has plans to advance each indication to Phase III.

Recent Developments in the Anti-CD38 mAB Market

• In August 2026, the FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab/hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy containing a proteasome inhibitor and an immunomodulatory agent.
• In August 2026, the European Commission approved teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma, strengthening the role of anti-CD38 therapy in combination with next-generation T-cell-engaging therapies.
• In July 2026, the FDA approved Sarclisa Escena (isatuximab-irfc) for subcutaneous administration across its existing multiple myeloma indications. The approval expands administration options for this anti-CD38 mAb beyond intravenous infusion.
• In June 2026, the European Commission approved subcutaneous isatuximab administered through the CirCLIQ on-body injector. Sanofi described it as the first anticancer treatment in the EU delivered through an on-body injector and the first multiple myeloma treatment available through both an OBI and manual subcutaneous injection.
• In March 2026, the FDA approved daratumumab and hyaluronidase-fihj for adults with high-risk smoldering multiple myeloma, making it the first FDA-approved treatment for this precursor condition. The decision was based on the Phase III AQUILA study.

Anti-CD38 mAb Market Outlook

The market for Anti-CD38 mAb is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, and autoimmune disorders, the growing awareness of Anti-CD38 mAb, and the increasing number of Anti-CD38 mAb that are under clinical trials and filed for approval by various companies.

The market outlook for anti-CD38 monoclonal antibodies is promising, with two established products, SARCLISA and DARZALEX already approved for treating multiple myeloma. SARCLISA, approved by the FDA in 2020 and 2021 for use with different drug combinations, and daratumumAb, first approved in 2015, have revolutionized multiple myeloma treatment. The pipeline for anti-CD38 therapies is robust, with several promising candidates in development. MezagitamAb (TAK-079) by Takeda has received Fast Track and Orphan Drug status and is advancing to Phase III trials for idiopathic thrombocytopenic purpura. HI-Bio's felzartamAb, with breakthrough therapy and orphan drug designations, is progressing toward Phase III for various immune-mediated diseases. Additionally, CID-103 is in early-phase trials for multiple myeloma, thrombocytopenic purpura, and antibody-mediated rejection, respectively. This expanding pipeline underscores the significant potential of anti-CD38 antibodies in addressing unmet medical needs across a range of diseases.

Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of Anti-CD38 mAb and define their role in the therapy of cancer.

Anti-CD38 mAb Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging Anti-CD38 mAb expected to be launched in the market during 2026-2036.

Anti-CD38 mAb Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for Anti-CD38 mAb market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Anti-CD38 mAb therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on Anti-CD38 mAb's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins Sidney Kimmel Cancer Center, UCSF Health, Memorial Sloan Kettering Cancer Center, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or Anti-CD38 mAb market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the Anti-CD38 mAb, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the Anti-CD38 mAb market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM Anti-CD38 mAb market.

Anti-CD38 mAb Report Insights

• Anti-CD38 mAb Targeted Patient Pool
• Therapeutic Approaches
• Anti-CD38 mAb Pipeline Analysis
• Anti-CD38 mAb Market Size and Trends
• Existing and future Market Opportunity

Anti-CD38 mAb Report Key Strengths

• Eleven years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions
• Anti-CD38 mAb Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

• What was the Anti-CD38 mAb total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2036? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2036?
• Which is the most lucrative market for Anti-CD38 mAb?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for Anti-CD38 mAb evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with Anti-CD38 mAb? What will be the growth opportunities across the 7MM for the patient population of Anti-CD38 mAb?
• What are the key factors hampering the growth of the Anti-CD38 mAb market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for Anti-CD38 mAb?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the Anti-CD38 mAb Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Anti-CD38 mAb

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Anti-CD38 mAb Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Indication in 2022
• 6.2. Market Share (%) Distribution by Indication in 2036

7. Anti-CD38 mAb: Background and Overview

8. Treatment

9. Target Patient Pool

• 9.1 Key Findings
• 9.2 Assumptions and Rationale: 7MM
• 9.3 Epidemiology Scenario in the 7MM
  • 9.3.1 Total Incident Cases of Selected Indication for Anti-CD38 mAb in the 7MM
  • 9.3.2 Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication in the 7MM
  • 9.3.3 Total Treatable Cases in Selected Indication for Anti-CD38 mAb in the 7MM

10. Marketed Therapies

• 10.1. Key Competitors
• 10.2. SARCLISA (isatuximAb-irfc): Sanofi
  • 10.2.1. Product Description
  • 10.2.2. Regulatory milestones
  • 10.2.3. Other developmental activities
  • 10.2.4. Clinical development
  • 10.2.5. Safety and efficacy
• 10.3. DARZALEX (daratumumAb): Johnson & Johnson innovative medicine/GenmAb
  • 10.3.1. Product Description
  • 10.3.2. Regulatory milestones
  • 10.3.3. Other developmental activities
  • 10.3.4. Clinical development
  • 10.3.5. Safety and efficacy

11. Emerging Therapies

• 11.1. Key Competitors
• 11.2. MezagitamAb (TAK-079): Takeda Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Other developmental activities
  • 11.2.3. Clinical development
  • 11.2.4. Safety and efficacy
• 11.3. FelzartamAb: HI-Bio
  • 11.3.1. Product Description
  • 11.3.2. Other developmental activities
  • 11.3.3. Clinical development
  • 11.3.4. Safety and efficacy

12. Anti-CD38 mAb: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebates
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptakes
• 12.5. Total Market Size by Indication in the 7MM
• 12.6. Total Market Size by Therapies in the 7MM
• 12.7. The United States
  • 12.7.1. Market Size of Anti-CD38 mAb by Indication in the United States
  • 12.7.2. Market Size of Anti-CD38 mAb by Therapies in the United States
• 12.8. EU4 and the UK
  • 12.8.1. Market Size of Anti-CD38 mAb by Indication in EU4 and the UK
  • 12.8.2. Market Size of Anti-CD38 mAb by Therapies in EU4 and the UK
• 12.9. Japan
  • 12.9.1. Market Size of Anti-CD38 mAb by Indication in Japan
  • 12.9.2. Market Size of Anti-CD38 mAb by Therapies in Japan

13. SWOT Analysis

14. KOL Views

15. Unmet Needs

16. Market Access and Reimbursement

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight