United States Primary Hyperoxaluria Treatment Market is expected to reach US$ 365.49 million by 2031 | Top key players - Pfizer Inc., Novo Nordisk A/S, Merck KGaA.

Market Size and Forecast:

The Global Primary Hyperoxaluria Treatment Market size reached US$ 168.96 million in 2023 and is expected to reach US$ 365.49 million by 2031, growing at a CAGR of 9.8% during the forecast period 2024-2031. The Market is growing due to rising prevalence of the disorder and increasing adoption of advanced therapies.

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The Primary Hyperoxaluria Treatment Market encompasses therapies and interventions designed to manage and treat primary hyperoxaluria, a rare genetic disorder causing excessive oxalate production. The market includes pharmaceuticals, enzyme replacement therapies, RNAi-based treatments, and supportive care options aimed at preventing kidney stones, renal damage, and systemic complications, driven by rising disease awareness, early diagnosis, and advancements in targeted therapeutics.

Industry Recent Developments:

United States:

✅ Advancements in genetic diagnostics and increased FDA approvals for RNA interference-based therapies have been driving the gradual growth of the market in the U.S. (September 2025).

✅ There is growing awareness and diagnosis of primary hyperoxaluria type 1, supporting earlier and more effective treatments in the U.S. healthcare system (September 2025).

✅ Continued investment in orphan drug development and introduction of novel therapeutic approaches targeting primary hyperoxaluria are expanding treatment options and patient access in the United States (September 2025).

Japan:

✅ The pharmaceutical company Alnylam Pharmaceuticals received regulatory approval for its drug Lumasiran, the first targeted therapy for primary hyperoxaluria type 1, in Japan (2024-2025 development carried into 2025).

✅ Increased clinical research activity and development of localized therapies are boosting market prospects in Japan (October 2025).

✅ Awareness of primary hyperoxaluria is increasing in Japan, supported by healthcare initiatives and regulatory incentives to promote patient access and diagnosis (September - October 2025).

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FDA Approvals & Regulatory Designations:

1. Nedosiran (Rivfloza) - Expanded Indication
In March 2025, the FDA approved a supplemental New Drug Application (sNDA) for nedosiran (brand name Rivfloza), expanding its indication to include children aged 2 to Less than 9 years with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function.

2. ABO-101 - Gene Editing Therapy
Arbor Biotechnologies received FDA clearance in December 2024 to initiate a Phase 1/2 clinical trial (redePHine) for ABO-101, a gene editing therapeutic targeting the HAO1 gene to reduce oxalate production in PH1 patients. The trial is expected to begin in the first half of 2025.

3. YOLT-203 - CRISPR Therapy
YolTech Therapeutics' investigational CRISPR therapy, YOLT-203, received Orphan Drug Designation from the European Medicines Agency (EMA) in July 2025. The FDA had previously granted Orphan Drug and Rare Pediatric Disease Designations in February 2025.

Mergers & Acquisitions:

The primary hyperoxaluria treatment market has experienced moderate merger and acquisition (M&A) activity, with larger pharmaceutical companies seeking to expand their portfolios in rare disease treatments. Estimates place the total value of M&A activity in this space at approximately $250 million annually.

Major Key Players:

Pfizer Inc.
Novo Nordisk A/S
Eli Lilly and Company
Merck KGaA
Ferring B.V.
F. Hoffmann-La Roche Ltd
Sandoz Inc.
Ascendis Pharma
AnkeBio Co., Ltd
Changchun GeneScience Pharmaceutical Co., Ltd.

Segments Covered in the Primary Hyperoxaluria Treatment Market:

By Type: Primary Hyperoxaluria Type I, Primary Hyperoxaluria Type II, Primary Hyperoxaluria Type III.

By Treatment Type: Medication, Dialysis, Transplantation.

Regional Analysis:

⇥ 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, Primary Hyperoxaluria Treatment market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Primary Hyperoxaluria 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 Primary Hyperoxaluria 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 Primary Hyperoxaluria 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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