Key Findings
-
Market size projection: As per DelveInsight’s analysis, the total market size of IgG4-Related Disease in the 7MM is expected to reach approximately USD 182 million in 2025, projected to grow at a remarkable CAGR of 34.6% by 2034.
-
Market Drivers: Key market drivers of IgG4-Related Disease include rising awareness and diagnosis rates, unmet medical need, advancements in research, development of targeted therapies, supportive regulatory pathways, improved diagnostic tools, and increasing healthcare spending.
-
Epidemiology: The report provides the total IgG4-Related Disease potential pool of approximately 148,970 diagnosed prevalent cases in the 7MM in 2024, with the US accounting for 38%, EU4 and UK 36%, and Japan 26%.
-
Key companies: Leading IgG4-Related Disease companies, such as Amgen, Zenas BioPharma, Bristol Myers Squibb, Sanofi, and others are advancing innovative therapies to address this rare autoimmune condition.
-
Pipeline assets: Some of the key therapies in the IgG4-Related Disease pipeline include UPLIZNA (Amgen), obexelimab (Zenas BioPharma and Bristol Myers Squibb), and rilzabrutinib (Sanofi).
-
Recent developments: In April 2025, Amgen’s UPLIZNA received FDA approval as the first-ever treatment for adults with IgG4-RD, marking a historic milestone with an 87% reduction in disease flares versus placebo. Furthermore, Sanofi’s rilzabrutinib received orphan drug designation and fast track designation from the FDA, with phase 2 data showing 70% of patients remaining flare-free at 52 weeks.
Learn more recent advancements in IgG4-Related Disease market @ IgG4-Related Disease Market Recent Developments.
IgG4-Related Disease Market Insights
The IgG4-Related Disease market represents one of the most promising rare autoimmune therapeutic areas, with the 7MM market valued at USD 170 million in 2024. The United States captures the largest market share at approximately USD 90 million, followed by EU4 and UK at USD 80 million, with Japan accounting for USD 6 million. This substantial growth projection of 34.6% CAGR reflects the transformative impact of emerging targeted therapies addressing critical unmet medical needs in this previously underserved patient population.
According to DelveInsight’s comprehensive IgG4-Related Disease – Market Insight, Epidemiology and Market Forecast report, this remarkable market growth trajectory will primarily be driven by the landmark FDA approval of UPLIZNA (Amgen), which has fundamentally reshaped treatment paradigms and accelerated diagnostic recognition. This approval validates IgG4-RD as a distinct clinical entity requiring specialized therapeutic intervention, moving beyond traditional corticosteroid management toward precision B-cell targeting approaches.
The IgG4-Related Disease market drivers encompass multiple convergent factors, including enhanced disease recognition among healthcare providers, improved diagnostic capabilities, particularly through advanced biomarker identification, and the growing elderly population most susceptible to IgG4-RD manifestations.
The geographical analysis reveals significant regional variations in disease prevalence and treatment accessibility. The United States leads with approximately 56,800 diagnosed cases in 2024, while EU4 and UK combined account for 53,550 cases. Japan presents unique epidemiological characteristics with 38,690 diagnosed cases, supported by comprehensive national database studies tracking disease progression from 2015-2018.
Furthermore, the IgG4-Related Disease epidemiology demonstrates male predominance with a 69% to 31% gender distribution, affecting primarily middle-aged patients in their thirties to fifties. The disease’s multi-organ manifestations include pancreatic, biliary, salivary gland, lacrimal gland, orbital, renal, pulmonary, and retroperitoneal involvement, creating complex diagnostic challenges often requiring specialized rheumatological expertise. Approximately 20-30% of diagnosed patients currently receive no systemic therapy, opting instead for surgical interventions or watchful waiting strategies, highlighting substantial treatment gaps.
Access DelveInsight’s IgG4-Related Disease Market report featuring detailed epidemiological analysis, competitive landscape assessment, and strategic recommendations for market entry and expansion opportunities.
IgG4-Related Disease Competitive Landscape
The competitive landscape features Amgen’s UPLIZNA as the pioneering FDA-approved therapy, establishing market leadership through its CD19-targeted B-cell depletion mechanism. This humanized monoclonal antibody demonstrated unprecedented clinical efficacy with 87% flare risk reduction and 57.4% complete remission rates at 52 weeks versus 22.4% placebo response. The bi-annual infusion regimen provides convenient dosing while targeting the underlying autoimmune pathophysiology.
Zenas BioPharma and Bristol Myers Squibb’s obexelimab represents the primary competitive threat through its innovative bifunctional mechanism targeting both CD19 and FcγRIIb receptors. This dual-targeting approach enables B-cell inhibition without complete depletion, potentially offering improved safety profiles. The Phase III INDIGO trial completed enrollment in November 2024, with topline results anticipated by end-2025, positioning obexelimab as UPLIZNA’s strongest future competitor.
Sanofi’s rilzabrutinib offers differentiated oral administration through Bruton’s tyrosine kinase inhibition, addressing B-cell, mast cell, and innate immune cell signaling pathways. Phase 2 data demonstrated 70% flare-free rates at 52 weeks with significant glucocorticoid-sparing effects. The FDA granted both orphan drug designation and fast track designation, accelerating development timelines for this promising oral alternative.
Clinical development milestones include UPLIZNA’s successful MITIGATE trial demonstrating superior efficacy across multiple endpoints. Obexelimab’s Phase II Lancet Rheumatology publication established preliminary efficacy signals, supporting current Phase III development. Rilzabrutinib’s comprehensive development program spans multiple autoimmune indications, leveraging Sanofi’s acquisition of Principia Biopharma for USD 100 per share.
Commercial arrangements feature strategic partnerships between Zenas BioPharma and Bristol Myers Squibb for obexelimab co-development, combining Zenas’ innovative antibody engineering with Bristol Myers Squibb’s commercial capabilities. Amgen’s established UPLIZNA franchise, generating USD 379 million in NMOSD revenue during 2024, provides substantial commercial infrastructure supporting IgG4-RD market penetration.
Connect with our pharmaceutical market research experts for tailored IgG4-RD market intelligence, including competitive positioning, pricing strategies, and partnership opportunities aligned with your organizational objectives.
IgG4-Related Disease Market Drivers and Barriers
The unmet medical needs remain substantial despite recent therapeutic advances, with no curative treatments available due to unclear disease pathophysiology. Current glucocorticoid-based management carries significant long-term toxicity risks, while immunosuppressive alternatives lack definitive efficacy evidence. The multi-organ nature of IgG4-RD requires comprehensive disease monitoring and specialized expertise often unavailable in routine clinical settings.
Additional market drivers include supportive regulatory pathways evidenced by breakthrough therapy designations, orphan drug designations, and fast track designations across the pipeline. Enhanced diagnostic tools incorporating advanced biomarker panels, imaging modalities, and tissue-based assessments enable earlier disease recognition and intervention. Growing healthcare expenditure allocation toward rare disease management supports premium pricing acceptance for innovative biologics.
Market barriers encompass disease rarity and complexity creating physician awareness challenges, particularly in non-specialized practice settings. Lack of standardized diagnostic criteria complicates consistent disease identification and treatment monitoring across healthcare systems. High biologic therapy costs may limit patient access despite insurance coverage, while competition from off-label rituximab provides cost-effective alternatives in certain markets. Regulatory approval risks persist due to limited established endpoints and precedents for IgG4-RD clinical development programs.
Download DelveInsight’s IgG4-Related Disease – Market Insight, Epidemiology and Market Forecast report for IgG4-RD commercialization strategies, market access challenges, and emerging therapeutic opportunities with industry leaders and key opinion leaders.
Conclusion
The IgG4-Related Disease market stands at an unprecedented inflection point, driven by the first FDA-approved therapy UPLIZNA and robust pipeline development from leading pharmaceutical companies. DelveInsight’s analysis projects exceptional 34.6% CAGR growth through 2034, reflecting the convergence of unmet medical need, regulatory support, and therapeutic innovation. The competitive landscape will evolve significantly as obexelimab and rilzabrutinib advance through late-stage development, offering differentiated mechanisms and administration routes. Healthcare executives should recognize this rare autoimmune market’s substantial commercial potential while anticipating competitive dynamics that will ultimately benefit patients through expanded treatment options and improved clinical outcomes.
Scope of the Report
-
Descriptive overview of IgG4-RD, explaining causes, signs, symptoms, pathogenesis, and currently available therapies
-
Comprehensive insight into IgG4-RD epidemiology and treatment approaches
-
All-inclusive account of current and emerging therapies for IgG4-RD with assessment of market impact
-
Detailed review of historical and forecasted IgG4-RD market covering 7MM drug outreach
-
Ten-year forecast with 7MM coverage and epidemiology segmentation
-
Key cross-competition analysis and highly analyzed market dynamics
-
IgG4-RD patient population analysis and therapeutic approaches assessment
-
Current treatment practices and unmet needs evaluation
-
Pipeline product profiles and market attractiveness analysis
-
Qualitative analysis including SWOT and conjoint analysis
-
Market drivers and barriers comprehensive assessment
-
IgG4-RD drugs uptake analysis and market access scenarios
-
KOL insights and expert opinions from leading medical centers
-
Clinical trial landscape and pipeline development activities
-
Market access and reimbursement scenario analysis
Table of Contents
1. Key Insights
2. Executive Summary of IgG4-Related Disease
3. Competitive Intelligence Analysis for IgG4-Related Disease
4. IgG4-Related Disease Market Overview at a Glance
5. IgG4-Related Disease: Disease Background and Overview
6. IgG4-Related Disease Patient Journey
7. IgG4-Related Disease Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. IgG4-Related Disease Unmet Needs
10. Key Endpoints of IgG4-Related Disease Treatment
11. IgG4-Related Disease Marketed Products
12. IgG4-Related Disease Emerging Therapies
13. IgG4-Related Disease: Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Market Outlook
16. Access and Reimbursement Overview of IgG4-Related Disease
17. KOL Views
18. IgG4-Related Disease Market Drivers
19. IgG4-Related Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services