CD-19 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Currently, the marketed of CD-19 targeting therapies is dominated with therapies like MONJUVI (Incyte Corporation), UPLIZNA (Horizon Therapeutics), BLINCYTO (Amgen), ZYNLONTA (ADC Therapeutics), BREYANZI (Juno Therapeutics), AUCATZYL (Autolus Therapeutics), and others.
• The emerging key players targeting CD-19 include Zenas BioPharma (obexelimab), Galapagos NV (GLPG5101), Iksuda Therapeutics (IKS03), Caribou Biosciences (vispacabtagene regedleucel) and others.
• While CD19 inhibitors, like CAR T-cell therapies, have shown efficacy in treating B-cell cancers and some autoimmune diseases, they often lead to depletion of B cells, which can increase the risk of infections and negatively affecting the immune system. Developing CD19 inhibitors that can selectively modulate B cell function without depleting them could offer a safer and more effective treatment option, especially for chronic autoimmune conditions.

DelveInsight's "CD-19 Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of CD-19, addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The CD-19 market report provides insights around existing treatment practices in patients with CD-19, approved (if any) and emerging CD-19, market share of individual therapies, patient pool eligible for treatment with CD-19, along with current and forecasted 7MM CD-19 market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new CD-19 in different geographies, along with insights on CD-19 pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

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

Study Period: 2022-2036

CD-19 Overview

CD19 is a key target in B-cell cancers like Non-Hodgkin Lymphomas (NHL) and Acute Lymphoblastic Leukemia (ALL) due to its high expression on malignant B cells. It's also being investigated in autoimmune conditions such as Neuromyelitis Optica Spectrum Disorder (NMOSD), Immunoglobulin G4-related disease (IgG4-RD), Systemic Lupus Erythematosus (SLE), multiple sclerosis and others, underscoring its broad therapeutic potential.

CD19 inhibitors encompass a variety of immunotherapeutic approaches including monoclonal antibodies, bispecific antibodies, Antibody-Drug Conjugates (ADCs), and CAR T-cell therapies, all targeting the CD19 antigen on B cells. They represent important advances in the treatment of B-cell malignancies, particularly for patients with relapsed or refractory disease.

Target Patient Pool Analysis

• According to DelveInsight, the total incident cases of MCL, Diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma, Primary Mediastinal Large B-cell lymphoma (PMBCL), Marginal Zone Lymphoma (MZL), and Chronic Lymphocytic Leukemia/Small-cell Lymphocytic Lymphoma (CLL/SLL) in the US are 9,800, 77,900, 38,400, 5,800, 14,100, and 13,100 cases in 2025.
• According to DelveInsight, the total incident cases of ALL in EU4 and the UK were nearly 4,200 in 2025.
• As per DelveInsight, there were nearly 9,700 diagnosed prevalent males with IgG4-RD and 4,300 females in Germany in 2025.
• As per DelveInsight, the UK had nearly 200 cases of diagnosed prevalent cases of SLE (pediatric).
• As per DelveInsight, in Japan, the severity-specific cases of SLE were 21% for mil and moderate each and 13% for severe in 2025.
• In a study conducted by Briggs and Shaia (2024), there were 1,772 NMOSD patients amongst 25,743,039 patients for a prevalence of 6.88/100,000. It was observed that a 3/5:1 female-to-male ratio was there in NMOSD. The age and sex-adjusted 2022 estimate of persons with NMOSD in the US was 15,413 females and 6,233 males.

CD-19 Drug Chapters

The drug chapter segment of the CD-19 report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the CD-19 clinical trial details, pharmacological action, agreements and collaborations related to CD-19, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

CD-19 Marketed Drugs

AUCATZYL: Autolus Therapeutics

AUCATZYL (obecabtagene autoleucel), by Autolus Therapeutics, is a CD19-directed, genetically modified autologous T cell immunotherapy approved for adults with relapsed or refractory B-cell precursor ALL. AUCATZYL is administered as a cell suspension for intravenous infusion and is supplied in patient-specific infusion bags. The most common risks include cytokine release syndrome and neurotoxicity, which require specialized monitoring and management.

MONJUVI: Incyte

MONJUVI (tafasitamab-cxix), by Incyte Corporation, is a humanized, Fc-engineered monoclonal antibody targeting the CD19 antigen expressed on B cells, including malignant B cells in diseases like diffuse large DLBCL. Tafasitamab is approved in combination with lenalidomide for patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplantation. Clinical studies have demonstrated significant reductions in peripheral B-cell counts and durable responses in this patient population.

CD-19 Emerging Drugs

Obexelimab (XmAb5871): Zenas BioPharma

Obexelimab is a monoclonal antibody that targets CD19 with its variable domain and uses Xencor's XmAb immune inhibitor Fc domain to target FcYRIIb, a receptor that inhibits B-cell function.

Currently, the drug is in Phase III stage of its clinical trial for the treatment of Warm Autoimmune Hemolytic Anemia (wAIHA) and IgG4-RD. The drug is also being developed for the treatment of Multiple Sclerosis and SLE.

Zenas BioPharma announced that results from the Phase II (MoonStone trial) of obexelimab in relapsing multiple sclerosis were presented in a late-breaking oral presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026.

According to the corporate presentation of Zenas BioPharma, February 2026, in January 2026, the INDIGO Phase III IgG4-RD trial achieved primary endpoint and all key secondary endpoints. The company anticipates the BLA submission in Q2 2026 and SunStone Phase II for SLE topline results and biomarker data in Q4 2026. Its IgG4-RD approval and launch in the US and Japan is planned in 1H 2027. First launch in Europe is anticipated in H2 2027. The potential Phase III SLE trial is anticipated to begin in 1H 2027.

GLPG5101: Galapagos NV

GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The therapy is being evaluated for MCL, primary central nervous system lymphoma, DLBCL, CLL, high risk diffuse large B-cell lymphoma, Burkitt lymphoma, and follicular lymphoma/MZL.

According to the Full Year 2025 Financial Results and Fourth Quarter Business Update of February 2026, the company announced the early termination of Phase I/II (ATALANTA-1) of GLPG5101, after data was presented in ASH 2025.

In August 2025, Galapagos NV announced that the US FDA had granted Regenerative Medicine Advanced Therapy (RMAT) Designation to GLPG5101 for the treatment of relapsed/refractory MCL.

GLPG5101 is being advanced toward pivotal development in Mantle Cell Lymphoma (MCL), with enrollment expected to start in 2026. Following updates to the clinical study design, the Biologics License Application (BLA) filing is anticipated in 2028 with approval now expected in 2029.

IKS03: Iksuda Therapeutics

IKS03 has been designed to deliver high anti-cancer activity with good patient tolerability. The ADC benefits from tumor-selective release and activation of ultra-potent PBD payloads for an enhanced TI. Preclinical studies have demonstrated class leading efficacy across a wide range of B-cell cancer models and improved safety over in-clinic comparators.

IKS03 is currently being evaluated in the Phase I for the treatment of B-cell malignancies. In May 2025, Iksuda Therapeutics announced the completion of dosing of its first patient with IKS03.

Recent Developments in the CD-19 Market

• In January 2026, Zenas BioPharma announced positive results from the Phase III (INDIGO) trial of obexelimab in IgG4-RD.
• In December 2025, Galapagos NV announced new and updated Phase II data from the ongoing ATALANTA-1 study for patients with relapsed or refractory MCL.

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on CD-19 as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of CD-19, their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

CD-19 Market Outlook

This section will include details on changing CD-19 market dynamics post initiation of clinical development activities of the inhibitor. It will also provide a detailed summary and comparison of all the therapies being developed by leading players in this space. This section will highlight the advantages of one therapy over the other after assessment based on parameters such as data availability in the form of safety and efficacy, number of patients enrolled in each trial, and trial's inclusion criteria. There will be a Key focus on the importance of development and need for the commercial success of these targeted therapies to achieve treatment goals that physicians and patients are looking for. It will also sum up all the early stage players active in this space.

CD-19 Drugs Uptake

This section focuses on the uptake rate of potential CD-19 already launched and expected to be launched in the market during 2022-2036, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

CD-19 Pipeline Development Activities

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

CD-19 Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for CD-19.

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on CD-19' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the cost analysis and existing and evolving treatment landscape.

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on CD-19 addressable patient pool
• A detailed review of the CD-19 market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM CD-19 market.
• Market Size of Inhibitors by therapies and indication will be provided

CD-19 Report Key Strengths

• 11 Years CD-19 Market Forecast
• The 7MM Coverage
• CD-19 Competitive Landscape of current and emerging therapies
• CD-19 Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• CD-19 Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the CD-19 total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for CD-19 market growth?
• Which CD-19 Inhibitor is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of CD-19?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the CD-19 Market.
• Understand the existing CD-19 market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• 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 and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of CD-19

4. Key Events

5. CD-19 Market Overview At A Glance

• 5.1. Market Share (%) Distribution of CD-19 By Therapy in 2025
• 5.2. Market Share (%) Distribution of CD-19 By Therapy in 2036

6. Background And Overview

7. Target Population

8. CD-19 Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. CD-19 Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. CD-19: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of CD-19 in the 7MM
  • 10.4.1. Market Size of CD-19 By Therapies In the 7MM
  • 10.4.2. Market Size of CD-19 By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of CD-19 in the United States
  • 10.6.2. Market Size of CD-19 By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of CD-19 in EU4 and the UK
  • 10.7.2. Market Size of CD-19 By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of CD-19 in Japan
  • 10.8.2. Market Size of CD-19 By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight