Osteogenesis Imperfecta Market Intelligence: Epidemiology Trends 

DelveInsight's comprehensive report on "Osteogenesis Imperfecta Market Insights, Epidemiology, and Market Forecast 2034" delivers extensive understanding of Osteogenesis Imperfecta, encompassing historical and projected epidemiology alongside therapeutic market dynamics in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Highlights from the Market Report

• On December 15, 2025- Ultragenyx Pharmaceutical Inc. commenced an investigation to be conducted exclusively in Japan, consisting of a screening period, an open-label treatment period, and an open-label extension period. Participants will receive setrusumab for up to 24 months during the open-label Treatment Period followed by continued setrusumab treatment during the open-label Extension Period. All participants will receive setrusumab until it becomes commercially available in Japan, consent is withdrawn, or the study is otherwise discontinued.

• On December 12, 2025- Amgen announced a Phase 3 investigation to evaluate romosozumab treatment effect for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

• In 2023, the prevalent population of Osteogenesis Imperfecta in the United States was found to be approximately 40,000 cases which, as per DelveInsight's estimates, is expected to increase during the forecasted period.

• In the US, there were approximately 20,000 prevalent cases of COL1A1 gene mutation, approximately 7,000 cases of COL1A2 gene mutation, and cases of other mutations were approximately 800 in 2023.

• Germany demonstrated the highest Osteogenesis Imperfecta prevalence among the EU4 and the UK, accounting for approximately 25% of cases, followed by France with approximately 20%, in 2023.

• Osteogenesis imperfecta prevalence is estimated at 6 to 7 per 100,000 individuals worldwide, with varying severity across different genetic mutations.

• In 7MM, according to the analysis, in 2023, Japan's contribution to the total treated cases of Osteogenesis Imperfecta stood at a modest approximately 10%.

• Key pharmaceutical developers include Amgen, UCB, Ultragenyx Pharmaceuticals, Angitia, Sanofi, Mereo BioPharma, and others.

• Notable therapies comprise UX143 (setrusumab), EVENITY (romosozumab), PROLIA (Denosumab), and others.

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Understanding Osteogenesis Imperfecta

Osteogenesis imperfecta (OI) represents a rare inherited connective tissue disorder characterized primarily by fragile bones that break easily, often with minimal or no trauma, due to defects in the quantity or quality of type I collagen. The condition presents with a wide spectrum of clinical severity, ranging from mild forms with occasional fractures to severe, life-threatening types associated with multiple fractures, skeletal deformities, short stature, blue sclerae, hearing loss, dentinogenesis imperfecta, joint laxity, and, in some cases, cardiopulmonary complications.

Epidemiological Segmentation in the 7MM

• Prevalent Cases of Osteogenesis Imperfecta

• Diagnosed Cases of Osteogenesis Imperfecta

• Gene-specific Cases of Osteogenesis Imperfecta

• Type-specific Cases of Osteogenesis Imperfecta

• Total Treated Cases of Osteogenesis Imperfecta

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Treatment Market Landscape

The Osteogenesis Imperfecta Treatment Market is evolving steadily, driven by growing awareness of this rare genetic bone disorder, improved diagnostic capabilities, and increasing focus on early and long-term disease management. Treatment primarily aims to reduce fracture risk, improve bone strength, and enhance quality of life through a combination of pharmacological therapies, surgical interventions, and supportive care. Bisphosphonates remain the cornerstone of treatment, especially in pediatric patients, while emerging anabolic agents, gene-based approaches, and novel bone-modifying therapies are gaining attention as research advances.

Emerging Osteogenesis Imperfecta Therapeutics

EVENITY (romosozumab): Amgen/UCB Romosozumab-aqqg represents a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese hamster ovary) by recombinant DNA technology that binds to and inhibits sclerostin. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity, resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength. It is approved by the FDA for treating osteoporosis in postmenopausal women at high-risk for fracture. Currently, it is being investigated in Phase III for treating osteogenesis imperfecta in pediatric patients.

Setrusumab (UX143): Ultragenyx Pharmaceuticals/Mereo BioPharma UX143 represents an investigational, fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway and inhibits the activity of bone-forming cells. By selectively binding to and inhibiting sclerostin, UX143 is designed to increase bone formation and density, increase collagen production, and increase bone mineral density and strength. Sclerostin inhibition also reduces excessive bone resorption, further improving bone density. Currently, it is being investigated in Phase III for treating osteogenesis imperfecta in pediatric patients.

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Featured Companies

Amgen, UCB, Ultragenyx Pharmaceuticals, Angitia, Sanofi, Mereo BioPharma, and others.

Report Scope

• Geographic Coverage: 7MM

• Study Period: 2020-2034

• Featured Companies: Amgen, UCB, Ultragenyx Pharmaceuticals, Angitia, Sanofi, Mereo BioPharma, and others

• Pipeline Therapies: UX143 (setrusumab), EVENITY (romosozumab), PROLIA (Denosumab), and others

• Therapeutic Assessment: Osteogenesis Imperfecta current marketed and Osteogenesis Imperfecta emerging therapies

• Market Dynamics: Osteogenesis Imperfecta market drivers and Osteogenesis Imperfecta market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

• Additional Coverage: Osteogenesis Imperfecta Unmet Needs, KOL's views, Analyst's views, Osteogenesis Imperfecta Market Access and Reimbursement

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Table of Contents

1. Key Insights

2. Osteogenesis Imperfecta Market Report Introduction

3. Executive Summary

4. Osteogenesis Imperfecta Market Overview at A Glance

5. Key Osteogenesis Imperfecta Events

6. Osteogenesis Imperfecta Epidemiology and Market Methodology

7. Osteogenesis Imperfecta Background and Overview

8. Osteogenesis Imperfecta Treatment and Management

9. Osteogenesis Imperfecta Epidemiology and Patient Population

10. Osteogenesis Imperfecta Patient Journey

11. Osteogenesis Imperfecta Marketed Drugs

12. Osteogenesis Imperfecta Discontinued Product

13. Osteogenesis Imperfecta Emerging Drugs

14. Osteogenesis Imperfecta: Seven Major Market Analysis

15. Osteogenesis Imperfecta Unmet Needs

16. Osteogenesis Imperfecta SWOT Analysis

17. Osteogenesis Imperfecta KOL Views

18. Osteogenesis Imperfecta Market Access and Reimbursement

19. Appendix

20. Delveinsight Capabilities

21. Disclaimer

22. About Delveinsight

About DelveInsight

DelveInsight operates as a premier healthcare-focused market research and consulting organization, delivering high-caliber market intelligence and analytical insights that empower informed business decision-making. Supported by seasoned industry specialists and comprehensive expertise in life sciences and healthcare domains, the firm provides tailored research solutions and strategic insights to a global client base. Engage with our team to access premium-quality, precise, and current intelligence that positions you ahead of market developments.

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