Osteogenesis Imperfecta Market Size in the 7MM was ~USD 30 million in 2023 and is projected to grow with a significant CAGR by 2034, estimates DelveInsight

DelveInsight's "Osteogenesis Imperfecta Market Insights, Epidemiology, and Market Forecast 2034" report delivers an in-depth understanding of Osteogenesis Imperfecta, historical and forecasted epidemiology as well as Osteogenesis Imperfecta therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from Osteogenesis Imperfecta Market Report
• On December 15, 2025- Ultragenyx Pharmaceutical Inc. initiated a study will be conducted in Japan only and consists 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 All participants will receive setrusumab until it becomes commercially available in Japan, consent is withdrawn, or the study is otherwise discontinued.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 study is to evaluate the effect of romosozumab treatment 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 ~40.000 cases which, as per DelveInsight's estimates, is expected to increase in the forecasted period.
• In the US, there were ~20,000 prevalent cases of COL1A1 gene mutation, ~7,000 cases of COL1A2 gene mutation, and cases of other mutations were ~800 in 2023.
• Germany had the highest prevalence of Osteogenesis Imperfecta among the EU4 and the UK, accounting for ~25% of cases, followed by the France with ~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 ~10%.
• The leading Osteogenesis Imperfecta Companies such as Amgen, UCB, Ultragenyx Pharmaceuticals, Angitia, Sanofi, Mereo BioPharma, and others
• Promising Osteogenesis Imperfecta Therapies such as UX143 (setrusumab), EVENITY (romosozumab), PROLIA (Denosumab), and others.

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Osteogenesis Imperfecta Overview
Osteogenesis imperfecta (OI) is 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

Osteogenesis Imperfecta Epidemiology 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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Osteogenesis Imperfecta Treatment Market
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.

Osteogenesis Imperfecta Emerging Drugs
• EVENITY (romosozumab): Amgen/UCB
Romosozumab-aqqg is 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 the treatment of osteoporosis in postmenopausal women at high-risk for fracture. Currently, it is being investigated in Phase III for the treatment of osteogenesis imperfecta in pediatric patients.

• Setrusumab (UX143): Ultragenyx Pharmaceuticals/Mereo BioPharma
UX143 is 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 the production of collagen, 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 the treatment of osteogenesis imperfecta in pediatric patients.

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

Scope of the Osteogenesis Imperfecta Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Osteogenesis Imperfecta Companies- Amgen, UCB, Ultragenyx Pharmaceuticals, Angitia, Sanofi, Mereo BioPharma, and others.
• Osteogenesis Imperfecta Therapies- UX143 (setrusumab), EVENITY (romosozumab), PROLIA (Denosumab), and others.
• Osteogenesis Imperfecta Therapeutic Assessment: Osteogenesis Imperfecta current marketed and Osteogenesis Imperfecta emerging therapies
• Osteogenesis Imperfecta Market Dynamics: Osteogenesis Imperfecta market drivers and Osteogenesis Imperfecta market barriers
• Osteogenesis Imperfecta Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• 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 Us

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