C3 Glomerulopathy Treatment Market is expected to reach US$ 4.25 billion by 2034 | Major key players - F. Hoffmann-La Roche Ltd., Mylan N.V., Sanofi.

Market Size and Growth:

The Global C3 Glomerulopathy Treatment Market reached US$ 2.21 billion in 2024 and is expected to reach US$ 4.25 billion by 2034, growing with a CAGR of 6.7% during the forecast period 2025-2034. The Market is growing due to increasing prevalence of kidney disorders and rising adoption of targeted therapies for rare renal diseases.

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The C3 Glomerulopathy Treatment Market refers to the global industry focused on developing, manufacturing, and commercializing therapies for C3 glomerulopathy, a rare kidney disorder caused by abnormal complement system activation. It includes pharmaceutical drugs, biologics, and emerging therapies aimed at reducing proteinuria, slowing disease progression, and improving renal function in affected patients. Market growth is driven by increasing diagnosis rates and innovative treatments.

Industry Recent Developments: United States

✅ September 2025: Novartis announced FDA approval of oral iptacopan (Fabhalta) for C3G treatment to reduce proteinuria, based on successful Phase III trial results.

✅ October 2025: The US FDA approved EMPAVELI (pegcetacoplan) for complement-mediated glomerulonephritis, including C3G, marking a significant treatment advancement.

✅ November 2025: Sobi presented new one-year data on the efficacy of pegcetacoplan (Aspaveli/Empaveli) in treating C3G and primary immune complex membranoproliferative glomerulonephritis.

Industry Recent Developments: Japan

✅ September 2025: A real-world survey on diagnosis and treatment patterns in adult C3G patients in Japan was published, highlighting current clinical practices.

✅ October 2025: The market continues to grow with ongoing advances in complement pathway research and targeted therapies, with Japan being one of the key markets benefiting from novel drug developments.

✅ November 2025: Novartis showcased new data at scientific sessions demonstrating progress in their complement receptor modulation portfolio targeting C3G and related kidney diseases.

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Regulatory / FDA Approvals & Filings in 2025:

✅ Iptacopan (brand name Fabhalta) (Novartis) - U.S. FDA approval for adult C3G
In March 2025, the U.S. Food & Drug Administration (FDA) approved Iptacopan for adults with C3G to reduce proteinuria. This marked the first‐ever approved therapy for C3G.

✅ The data supporting approval: Phase III APPEAR‐C3G trial showing ~35 % reduction in proteinuria at 6 months, sustained at 12 months.
The drug is an oral Factor B inhibitor of the alternative complement pathway.
This approval was described as a "historic" milestone for patients with C3G.

✅ EU regulator positive opinion for Iptacopan
In February 2025, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation of Iptacopan for adult C3G. Regulatory review in other geographies (China, Japan) is ongoing.

✅ Pegcetacoplan (brand name Empaveli) (Apellis Pharmaceuticals) - U.S. FDA approval for C3G & primary IC‐MPGN (patients aged 12+)
In July 2025, the FDA approved Pegcetacoplan for patients aged 12 years and older with C3G and primary immune complex membranoproliferative glomerulonephritis (IC‐MPGN). The approval is based on the Phase III VALIANT trial showing a ~68 % proteinuria reduction, stabilization of kidney function, and substantial clearance of C3 deposits.

Thus, Pegcetacoplan is now the second approved therapy (after Iptacopan) and covers a broader age range (adolescents + adults) and two rare glomerular diseases.

✅ FDA acceptance + priority review of sNDA for Pegcetacoplan
Earlier in 2025 (April), Apellis announced that the FDA had accepted the supplemental New Drug Application (sNDA) for Pegcetacoplan for C3G/IC‐MPGN and granted Priority Review with a PDUFA target action date of July 28, 2025.

Mergers / Acquisitions / Deals in 2025:

✅ In July 2025, Sobi AB (Sweden) and Apellis amended their agreement: Sobi will purchase a capped royalty stream (for ex‐US royalties) on Pegcetacoplan (brand name Aspaveli outside the U.S.) for $275 million upfront + up to $25 m in milestones. This deal is linked to the regulatory approvals for C3G/IC‐MPGN.

Major Key Players:

F. Hoffmann-La Roche Ltd.
Mylan N.V.
Teva Pharmaceutical Industries Ltd.
Sanofi
Pfizer Inc.
GSK plc
Novartis AG
Alexion Pharmaceuticals
Omeros Corporation
ChemoCentryx.

Segments Covered in the C3 Glomerulopathy Treatment Market:

By Drug Class: Corticosteroids, ACE Inhibitors, Immunosuppressive Therapy, Others.

By Route of Administration: Oral, Parenteral, Others.

By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies.

Regional Analysis for C3 Glomerulopathy Treatment Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, C3 Glomerulopathy Treatment market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global C3 Glomerulopathy Treatment Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global C3 Glomerulopathy Treatment market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the C3 Glomerulopathy Treatment Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

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➠ Who are the global key manufacturers of the C3 Glomerulopathy Treatment Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the C3 Glomerulopathy Treatment market opportunities and threats faced by the vendors in the global C3 Glomerulopathy Treatment Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the C3 Glomerulopathy Treatment market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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