DelveInsight’s “IgG4-Related Disease Market Insights, Epidemiology, and Market Forecast- 2034” report delivers an in-depth understanding of IgG4-Related Disease, historical and forecasted epidemiology, and the IgG4-Related Disease market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the IgG4-Related Disease Market Report

• In May 2026, Hansa Biopharma, a pioneer in immunomodulatory enzyme technology for rare IgG-mediated diseases, announced that a late-breaking abstract detailing data from its CONFIDES Phase 3 trial has been selected for an oral presentation at the 2026 American Transplant Congress (ATC). The CONFIDES trial evaluates imlifidase as a desensitization treatment to enable kidney transplantation in highly sensitized patients who otherwise face exceptionally long wait times. The presentation will spotlight crucial topline efficacy and safety findings from the study, demonstrating how the treatment effectively reduces donor-specific antibodies to facilitate successful, life-altering transplants. Selection for a late-breaking oral session underscores the transplant community’s strong interest in imlifidase’s clinical potential. Hansa intends to leverage these significant findings to advance its ongoing regulatory strategies and clinical programs, ultimately aiming to improve access and long-term outcomes for highly sensitized transplant candidates globally.
• In 2024, the total diagnosed prevalent cases of IgG4-RD in the United States were approximately 56,800 cases, projected to increase during the forecast period (2025–2034).
• In 2024, gender-specific diagnosed prevalent cases accounted for approximately 39,100 and 17,700 cases for males and females, respectively, in the US.
• The total diagnosed prevalent cases of IgG4-RD in EU4 and the UK were approximately 53,550 in 2024. Males accounted for approximately 38,850 cases, and 14,750 cases in females.
• We have considered six age groups for the categorization of age groups, i.e., 0–17 years, 18–29 years, 30–44 years, 45–64 years, 65–74 years, and =75 years. As per our analysis, a higher percentage of diagnosed prevalent cases was observed in the age group =75 years in Japan. In 2024, the age-specific diagnosed prevalent cases of IgG4-RD in Japan were approximately 12,800 cases in the age group =75 years. The cases will increase during the forecast period (2025–2034).
• The leading IgG4-Related Disease Companies include Zenas BioPharma, Bristol Myers Squibb, Amgen, Sanofi, and others.
• Promising IgG4-Related Disease Therapies include Obexelimab (XmAb5871), and others.

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IgG4-RD Overview

IgG4-RD is a systemic fibro inflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. It is a chronic fibroinflammatory disorder affecting a wide range of organs. Elevation of serum IgG4 concentrations and abundant infiltration of IgG4-expressing plasma cells are key diagnostic features of this autoimmune disease. Although common organ involvement of IgG4-RD includes the salivary glands, pancreas, and bile duct, hepatic involvement is less well established. IgG4-RD may be present in a certain proportion of patients with a wide variety of diseases, including Mikulicz’s disease, autoimmune pancreatitis, hypophysitis, Riedel thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysm, and inflammatory pseudotumor.

IgG4-Related Disease Epidemiology Segmentation in the 7MM

• Total IgG4 related Disease diagnosed prevalent cases
• IgG4 related Disease Gender-specific diagnosed prevalent cases
• IgG4 related Disease Age-specific diagnosed prevalent cases

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IgG4-Related Disease Marketed Drugs

• UPLIZNA (inebilizumab): Amgen

UPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). After two initial infusions, patients need one dose of UPLIZNA every 6 months. UPLIZNA is also approved for the treatment of Neuromyelitis Optica.

IgG4-Related Disease Emerging Drugs

• Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers Squibb

Obexelimab (XmAb5871) is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B-cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered SC injection regimen may broadly and effectively address the pathogenic role of B-cell lineage in chronic autoimmune disease. Currently, Zenas is conducting multiple Phase II and Phase III trials of obexelimab in several autoimmune diseases, including IgG4-RD, multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. In August 2023, The Lancet Rheumatology published findings from a Phase II study evaluating obexelimab for the treatment of patients with IgG4-RD. Based on these results, a Phase III study in patients with IgG4-RD is ongoing to investigate further the efficacy and safety of obexelimab administered as an SC injection.

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IgG4-Related Disease Drugs Market

The current IgG4-RD emerging landscape has only three drugs. Among them, obexelimab (bifunctionally) and UPLIZNA target CD-19. Targeting CD19, a protein found in B cells, shows promise as a treatment for IgG4-RD by depleting B cells, which are thought to play a role in the disease’s pathogenesis. Specifically, UPLIZNA, a CD19-targeted antibody, has demonstrated efficacy in reducing flares and achieving remission in IgG4-RD patients.

IgG4-Related Disease Market Outlook

As the etiology of IgG4-RD is unclear and still being studied, no particular medications can cure the disease. For people with IgG4-RD, there are no approved treatments on the market at this time. The criteria for identifying the disease caused by IgG4 levels and patient treatment recommendations were recently detailed in the guidelines released by the “International Consensus Guidance Statement on the Management and Treatment of IgG4-RD.”

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Scope of the IgG4-Related Disease Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• IgG4-Related Disease Companies- Zenas BioPharma, Bristol Myers Squibb, Amgen, Sanofi, and others.
• IgG4-Related Disease Therapies- Obexelimab (XmAb5871), and others.
• IgG4-Related Disease Therapeutic Assessment: IgG4-Related Disease Current marketed and IgG4-Related Disease Emerging Therapies
• IgG4-Related Disease Market Dynamics: IgG4-Related Disease market drivers and IgG4-Related Disease market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• IgG4-Related Disease Unmet Needs, KOL’s views, Analyst’s views, IgG4-Related Disease Market Access and Reimbursement

Table of Contents

1. Key Insights
2. IgG4-Related Disease Market Report Introduction
3. IgG4-Related Disease Market Overview at a Glance
4. IgG4-Related Disease Epidemiology and Market Forecast Methodology
5. Executive Summary
6. Key Events
7. Disease Background and Overview
8. IgG4-Related Disease Treatment and Management
9. IgG4-Related Disease Epidemiology and Patient Population
10. IgG4-Related Disease Patient Journey
11. IgG4-Related Disease Marketed Therapies
12. IgG4-Related Disease Emerging Therapies
13. IgG4-Related Disease: 7 Major Market Analysis
14. IgG4-Related Disease KOL Views
15. IgG4-Related Disease SWOT Analysis
16. IgG4-Related Disease Unmet Needs
17. IgG4-Related Disease Reimbursement Scenario
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer

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