IgG4 - Related diseases Market: Epidemiology, Therapies, Companies, DelveInsight | Roche, AbbVie, Gilead Sciences, Takeda Pharmaceutical Company

The market for IgG4-related diseases is anticipated to grow in the coming years, driven by emerging therapies such as Obexelimab (XmAb5871) and others.

DelveInsight has released a comprehensive report titled "IgG4-Related Diseases - Market Insights, Epidemiology, and Market Forecast 2034", providing an in-depth analysis of IgG4-related diseases, including historical and projected epidemiology, as well as market trends across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Leading companies featured in the report include Roche, AbbVie, Gilead Sciences, and Takeda Pharmaceutical Company.

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Some of the key facts of the IgG4 - Related diseases Market Report:

The IgG4-Related Disease (IgG4-RD) market was valued at around USD 170 million in 2024 and is expected to experience robust growth at a notable CAGR during the 2020-2034 forecast period. IgG4-RD is a systemic fibroinflammatory disorder that can affect nearly any organ, most commonly the pancreas, bile ducts, salivary and lacrimal glands, orbits, kidneys, lungs, and retroperitoneum. The disease is characterized by elevated serum IgG4 levels and infiltration of IgG4-positive plasma cells in affected tissues.
In April 2025, Amgen received FDA approval for UPLIZNA, marking it as the first approved treatment for adults with IgG4-RD. The therapy was granted Breakthrough Therapy Designation due to its potential to address a significant unmet need in managing this chronic, multi-organ condition.
The true prevalence of IgG4-RD remains uncertain, owing to underrecognition, nonspecific symptoms, and its recent identification. Most cases are diagnosed in men aged 30-50, although pediatric cases have also been reported. In 2024, there were approximately 148,970 diagnosed prevalent cases across the 7MM (U.S., EU4, UK, and Japan), with the United States accounting for the largest share. Japan has been particularly active in case identification, supported by multiple epidemiological studies and national data, recording roughly 38,690 diagnosed cases in 2024-a significant rise compared with 2015-2018.
Key pharmaceutical companies developing therapies for IgG4-RD include Amgen, Zenas BioPharma, Bristol Myers Squibb, Sanofi, Roche, AbbVie, Gilead Sciences, and Takeda Pharmaceutical Company. Despite advances in treatment, 20-30% of diagnosed patients do not receive systemic therapy, instead opting for surgical interventions or watchful waiting.
In 2024, the United States held the largest share of the IgG4-RD market among the 7MM, generating approximately USD 90 million. The combined EU4 and UK market reached around USD 80 million, with Germany contributing the highest share within Europe. Japan's market was valued at nearly USD 6 million in 2024 and is projected to grow at a significant CAGR from 2025 to 2034.
Emerging therapies, including Obexelimab (XmAb5871) and others, are expected to enhance the IgG4-RD treatment landscape and drive market growth in the coming years.
IgG4 - Related diseases Overview

IgG4-related disease (IgG4-RD) is a chronic, systemic fibroinflammatory disorder characterized by dense infiltration of IgG4-positive plasma cells in affected tissues, often accompanied by elevated serum IgG4 levels. This autoimmune condition can affect multiple organs, with key diagnostic features including high blood IgG4 levels and significant tissue infiltration by IgG4-expressing plasma cells.

Although the salivary glands, pancreas, and bile ducts are most commonly involved, liver involvement is less frequent. IgG4-RD has also been observed in patients with related conditions, such as Mikulicz's disease, autoimmune pancreatitis, hypophysitis, Riedel's thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysms, and inflammatory pseudotumors.

IgG4 - Related diseases Market Outlook

The precise cause of IgG4-related disease (IgG4-RD) remains unknown and continues to be an area of active research. Currently, there are no approved curative treatments. Although therapies were unavailable until recently, management guidelines have been established in the International Consensus Guidance Statement on the Management and Treatment of IgG4-RD, which defines diagnostic criteria based on IgG4 levels and provides treatment recommendations.

For patients with active or newly diagnosed IgG4-RD, glucocorticoids are generally the first-line therapy. Treatment typically starts with prednisone at 30-40 mg/day, or a weight-based dose of 0.6 mg/kg/day, depending on the severity and urgency of the disease. In some cases, conventional disease-modifying anti-rheumatic drugs (DMARDs) are also employed.

Plasmablasts, a type of B-cell precursor, serve as important biomarkers in IgG4-RD and other rheumatologic conditions. Monitoring plasmablast levels can help guide B-cell-targeted therapies and track disease activity over time.

With several new therapies currently in development, the IgG4-RD treatment landscape is expected to undergo significant changes in the coming years. The commercial success of these pipeline therapies will depend on factors such as pricing, reimbursement, and accessibility.

Leading pharmaceutical companies, including Zenas BioPharma, Amgen, and Sanofi, are actively advancing investigational candidates through various stages of clinical trials, aiming to provide innovative treatment options for this complex autoimmune disease.

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IgG4-Related Disease Marketed Drugs
UPLIZNA (inebilizumab): Amgen

IgG4 - Related diseases Emerging Drugs
Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers Squibb

Scope of the IgG4 - Related diseases Market Report
Study Period: 2020-2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key IgG4 - Related diseases Companies: Roche, AbbVie, Gilead Sciences, Takeda Pharmaceutical Company, and others
Key IgG4 - Related diseases Therapies: Obexelimab (XmAb5871), and others
IgG4 - Related diseases Therapeutic Assessment: IgG4 - Related diseases current marketed and IgG4 - Related diseases emerging therapies
IgG4 - Related diseases Market Dynamics: IgG4 - Related diseases market drivers and IgG4 - Related diseases market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
IgG4 - Related diseases Unmet Needs, KOL's views, Analyst's views, IgG4 - Related diseases Market Access and Reimbursement

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Key benefits of the IgG4 - Related diseases Market Report:
IgG4 - Related diseases market report covers a descriptive overview and comprehensive insight of the IgG4 - Related diseases Epidemiology and IgG4 - Related diseases market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
The IgG4 - Related diseases market report provides insights into the current and emerging therapies.
The IgG4 - Related diseases market report provides a global historical and forecasted market covering drug outreach in 7MM.
The IgG4 - Related diseases market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the IgG4 - Related diseases market.

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Table of Contents

1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. IgG4 - Related diseases Patient Share (%) Overview at a Glance
5. IgG4 - Related diseases Market Overview at a Glance
6. IgG4 - Related diseases Disease Background and Overview
7. IgG4 - Related diseases Epidemiology and Patient Population
8. Country-Specific Patient Population of IgG4 - Related diseases
9. IgG4 - Related diseases Current Treatment and Medical Practices
10. Unmet Needs
11. IgG4 - Related diseases Emerging Therapies
12. IgG4 - Related diseases Market Outlook
13. Country-Wise IgG4 - Related diseases Market Analysis (2020-2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. IgG4 - Related diseases Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Related Reports:

IgG4 - Related diseases Pipeline Insights, DelveInsight

"IgG4 - Related diseases Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the IgG4 - Related diseases market. A detailed picture of the IgG4 - Related diseases pipeline landscape is provided, which includes the disease overview and IgG4 - Related diseases treatment guidelines.

Contact Info:

Kritika Rehani, Assistant Manager, Marketing & Branding
krehani@delveinsight.com
info@delveinsight.com
www.delveinsight.com
+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

This release was published on openPR.