IgG4-related disease Drugs Market 2034: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, IgG4-related disease Prevalence, Medication, Revenue, Statistics and Companies by DelveInsight

(Albany, USA) 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 as well as the IgG4-related disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The IgG4-related disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted IgG4-related disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current IgG4-related disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the IgG4-related disease market.

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Some facts of the IgG4-related disease Market Report are:
• The IgG4-Related Disease market size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• DelveInsight estimates that the market size for IgG4-RD is expected to grow from USD 170 million in 2024, with a significant CAGR by 2034.
• IgG4 related disease is a systemic disease that causes fibrosis, tumor-like nodules, and lymphoid hyperplasia with infiltration of IgG4-positive plasma cells. It can manifest in many organ systems.
• There are no approved therapies for IgG4-related disease (IgG4-RD) specifically and hence, the current treatment landscape is driven by off-label therapies such as glucocorticoids, immunomodulators, and rituximab.
• The market size of IgG4-related disease in the seven major markets (7MM) was around USD 150 million in 2023.
• Glucocorticoids (GCs) have been considered the first-line therapy in IgG4-related disease (IgG4-RD), whereas rituximab accounted for the majority of the market share as annual treatment cost is significantly higher for patients taking rituximab.
• The United States accounted for the largest market size (around USD 115 million) of IgG4-related disease treatment market, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Amgen recorded USD 379 million in UPLIZNA sales in 2024 from its original indication alone. However, the recent approval for IgG4-related disease presents a significant growth opportunity, as this new market includes a treatable patient population that is roughly twice as large as that for NMOSD.
• Limited number of therapies are being investigated for the treatment of IgG4 related disease. Some of the key players involved in the development are Zenas Biopharma (obexelimab), Amgen/Horizon Therapeutics (inebilizumab), and Sanofi (rilzabrutinib).
• Approval of ZB012 (obexelimab) and UPLIZNA (inebilizumab) will change the treatment pattern drastically over the forecast period as these will be the first few drugs to be launched for the treatment of IgG4-related disease.
• IgG4-related disease is a rare disease, with an estimated prevalence of 6 cases per 100,000 individuals. This condition primarily affects middle-aged to elderly men.
• The 7MM accounted for approximately 300,000 prevalent cases of IgG4-related disease in 2023. These cases are expected to increase due to increased awareness and improved diagnostic methods that contribute to the rise in identified cases of IgG4-related disease, especially among aging populations with higher incidences of autoimmune disorders.
• Key IgG4-Related Disease Companies: Zenas BioPharma, Horizon Therapeutics, Sanofi, Roche, AbbVie, Gilead Sciences, Takeda Pharmaceutical Company, and others
• Key IgG4-Related Disease Therapies: ZB012 (obexelimab), UPLIZNA (inebilizumab), Rilzabrutinib, and others
• The IgG4-Related Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage IgG4-Related Disease pipeline products will significantly revolutionize the IgG4-Related Disease market dynamics.
• In April 2025, the FDA approved Amgen's anti-CD19 therapy, UPLIZNA, for the treatment of IgG4-related disease, making it the first and only approved treatment specifically for this condition, according to the company's announcement. This label expansion is supported by data from the Phase III MITIGATE trial, initially presented by Amgen in November 2024.
• In February 2025, Amgen announced that the FDA had accepted the regulatory submission for the Phase III MITIGATE study under priority review, with a PDUFA action date of April 3, 2025.
• Amgen's MITIGATE Trial: Amgen reported positive topline outcomes from the Phase III MITIGATE trial assessing UPLIZNA (inebilizumab-cdon). The trial met its primary endpoint, demonstrating an 87% decline in flare risk versus placebo. The trial enrolled 135 adults across 80 sites in 22 countries. The results were published on June 6, 2024.
• Zenas BioPharma's INDIGO Trial: Zenas BioPharma is conducting the Phase III INDIGO trial to evaluate the safety and efficacy of obexelimab in patients with active IgG4-RD. The trial has completed targeted enrollment with approximately 190 patients across 100 sites in 20 countries. The trial includes a randomized controlled period (RCP) followed by an optional open-label extension (OLE) period.

IgG4-related disease Overview
IgG4-related disease (IgG4-RD) is a rare, chronic, and often systemic inflammatory condition characterized by tissue infiltration with IgG4-positive plasma cells, fibrosis, and swelling in affected organs. It can involve multiple systems, including the pancreas, bile ducts, salivary glands, kidneys, lungs, lymph nodes, and blood vessels, presenting as painless swelling or masses.
The disease's exact cause is unknown but is thought to involve a combination of autoimmune and allergic mechanisms. Elevated serum IgG4 levels are commonly observed, though not always present. Common manifestations include autoimmune pancreatitis, sclerosing cholangitis, retroperitoneal fibrosis, or orbital pseudotumors, depending on the organs involved.
Diagnosis is challenging and relies on a combination of clinical features, imaging, biopsy findings (showing lymphoplasmacytic infiltration, storiform fibrosis, and IgG4-positive cells), and elevated IgG4 levels. Ruling out malignancies and other autoimmune diseases is crucial due to overlapping symptoms.
Treatment typically involves corticosteroids to reduce inflammation and swelling, often leading to significant improvement. In refractory cases, immunosuppressive agents like rituximab may be used. Early diagnosis and intervention are essential to prevent permanent organ damage. Long-term monitoring is necessary, as the disease may relapse or involve additional organs over time.

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IgG4-related disease Market
The IgG4-related disease market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted IgG4-related disease market trends by analyzing the impact of current IgG4-related disease therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the IgG4-related disease market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated IgG4-related disease market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

The IgG4-related disease market is primarily driven by increasing awareness and recognition of the condition among healthcare professionals, advancements in diagnostic tools such as imaging and biopsy techniques, and growing research interest in understanding the underlying autoimmune mechanisms. The development of targeted therapies, especially monoclonal antibodies like rituximab, has significantly improved treatment options and outcomes, further fueling market growth.

Additionally, rising prevalence rates and improved access to specialist care in developed regions support the expansion of the IgG4-related disease market. However, several barriers hinder progress. These include a lack of standardized diagnostic criteria globally, underdiagnosis due to symptom overlap with other autoimmune and inflammatory diseases, and limited treatment options beyond corticosteroids and off-label use of immunosuppressants. High treatment costs and the chronic, relapsing nature of the disease also pose challenges in long-term disease management.

Moreover, clinical trials are limited due to the rarity of the disease, slowing the pace of new drug development and regulatory approvals.

According to DelveInsight, the IgG4-related disease market in 7MM is expected to witness a major change in the study period 2020-2034.

IgG4-related disease Epidemiology

The IgG4-related disease epidemiology section provides insights into the historical and current IgG4-related disease patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the IgG4-related disease market report also provides the diagnosed patient pool, trends, and assumptions.

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IgG4-related disease Drugs Uptake

This section focuses on the uptake rate of the potential IgG4-related disease drugs recently launched in the IgG4-related disease market or expected to be launched in 2020-2034. The analysis covers the IgG4-related disease market uptake by drugs, patient uptake by therapies, and sales of each drug.

IgG4-related disease Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on IgG4-related disease market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

IgG4-related disease Pipeline Development Activities

The IgG4-related disease report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses IgG4-related disease key players involved in developing targeted therapeutics.

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IgG4-related disease Therapeutics Assessment

Major key companies are working proactively in the IgG4-related disease Therapeutics market to develop novel therapies which will drive the IgG4-related disease treatment markets in the upcoming years are Zenas BioPharma, Amgen Inc (NASDAQ: AMGN), Horizon Therapeutics (NASDAQ: HZNP), Sanofi (EPA: SAN), Roche (SWX: ROG), AbbVie (NYSE: ABBV), Gilead Sciences (NASDAQ: GILD), Takeda Pharmaceutical Company (TYO: 4502), and others.

Do you know how new drugs market launch will be impacting the IgG4-related disease market CAGR? Download sample report @ IgG4-related disease Drugs Market - https://www.delveinsight.com/sample-request/igg4-related-disease-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

IgG4-related disease Report Key Insights

1. IgG4-related disease Patient Population
2. IgG4-related disease Market Size and Trends
3. Key Cross Competition in the IgG4-related disease Market
4. IgG4-related disease Market Dynamics (Key Drivers and Barriers)
5. IgG4-related disease Market Opportunities
6. IgG4-related disease Therapeutic Approaches
7. IgG4-related disease Pipeline Analysis
8. IgG4-related disease Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the IgG4-related disease Market

Table of Contents

1. Key Insights
2. Executive Summary
3. IgG4-related disease Competitive Intelligence Analysis
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. IgG4-related disease 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. IgG4-related disease Market Outlook (7 major markets)
16. IgG4-related disease Access and Reimbursement Overview
17. KOL Views on the IgG4-related disease Market
18. IgG4-related disease Market Drivers
19. IgG4-related disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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