(Albany, New York) – October 07, 2026 – DelveInsight’s “Osteoporosis Market Insights, Epidemiology, and Market Forecast – 2036” report offers an in-depth understanding of Osteoporosis, historical and forecasted epidemiology, as well as Osteoporosis market trends in the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.
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Key Takeaways from the Osteoporosis Market Report
• In March 2026, Entera Bio submitted a streamlined Phase III protocol to initiate a registrational program for EB613 in postmenopausal women with osteoporosis, committing to a 12-month extension study running parallel to a potential NDA review.
• In January 2026, Angita Biopharmaceuticals completed enrollment in its Phase II (ARTEMIS) trial of AGA2118 for osteoporosis treatment, with topline data expected in 2027.
• In September 2026, Shanghai Henlius Biotech and Organon announced US FDA approval of BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), biosimilars to PROLIA and XGEVA, respectively, across all indications of the reference products.
• In September 2026, Naitive Technologies received 510(k) clearance from the US FDA for OsteoSight, an AI-driven software enabling bone mineral density assessment using standard X-rays to support earlier osteoporosis detection.
• In September 2026, Biocon Biologics received FDA approval for its biosimilars Bosaya and Aukelso (denosumab-kyqq), referencing Prolia and Xgeva respectively, with both products also granted provisional interchangeability status.
• The Osteoporosis Market is anticipated to grow during the forecast period (2026-2036), driven by rising prevalent cases, increased R&D for novel therapies, potential approvals/launches of pipeline treatments, and growing demand for effective disease management solutions.
• Major challenges limiting market growth include a thin late-stage pipeline, leading to greater reliance on already-marketed biosimilars and generics.
• As per the National Institute of Health Osteoporosis and Related Bone Diseases National Resource Center, more than 53 million people in the US either already have osteoporosis or are at high risk due to low bone mass.
• The National Health Service reports that osteoporosis affects over 3 million people in the UK, with more than 500,000 people receiving hospital treatment for fragility fractures every year.
• As per the International Osteoporosis Foundation (2024), an estimated 75 million people across Europe, the US, and Japan are affected by osteoporosis, while the condition remains greatly underdiagnosed and undertreated in Asia.
• In osteoporosis-related comorbidities, diabetes, respiratory disease, and cardiovascular disease contributed the most cases in 2024.
• Key Osteoporosis Companies driving the market include Entera Bio, Rani Therapeutics, Celltrion, Shanghai JMT-Bio Inc., Transcenta Holding, Sandoz, Enzene Biosciences, Fresenius Kabi, Gedeon Richter, Samsung Bioepis, Alvotech, MAbxience, Shanghai Henlius Biotech, and others.
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Osteoporosis Overview
Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to increased bone fragility and susceptibility to fracture. Causes include hyperparathyroidism, hyperglycemia, certain medications, smoking, alcohol use, oxidative stress, inflammation, calcium deficiency, and menopause. The most common symptoms are vertebral compression fractures and hip fractures, and key risk factors include genetics, lack of exercise, and insufficient calcium and vitamin D intake.
Osteoporosis Epidemiology Segmentation in the 7MM
• Total Prevalent Cases of Osteoporosis
• Total Diagnosed Prevalent Cases of Osteoporosis
• Gender-specific Prevalent Cases of Osteoporosis
• Age-specific Prevalent Cases of Osteoporosis
• Treatable Cases of Osteoporosis
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Osteoporosis Marketed Drugs
• EVENITY (Romosozumab): Amgen and UCB
Romosozumab is a humanized monoclonal antibody (IgG2) and the first and only bone builder with a dual effect, increasing bone formation while also reducing bone resorption to rapidly lower fracture risk. It was approved by the US FDA in April 2019 for the treatment of osteoporosis in postmenopausal women at high risk for fracture, and by the European Commission in December 2019 for severe osteoporosis in postmenopausal women at high risk of fracture.
• PROLIA (Denosumab): Amgen
Approved by the US FDA in June 2010 for the treatment of osteoporosis in postmenopausal women at high risk of fracture, with a further approval in September 2012 to increase bone mass in men.
• DUAVEE (Conjugated estrogens/bazedoxifene): Pfizer
The first FDA-approved medication combining conjugated estrogens with an estrogen agonist/antagonist, bazedoxifene.
• TYMLOS (Abaloparatide): Radius Health
Approved by the US FDA in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Emerging Osteoporosis Drugs
• EB613 (PTH 1-34): Entera Bio
EB613 is being developed as the first oral, osteoanabolic once-daily tablet treatment for postmenopausal women with low bone mineral density (BMD) and high-risk osteoporosis with no prior fracture. A placebo-controlled, dose-ranging Phase II study met its primary and secondary endpoints, and the company is anticipated to initiate a Phase III trial in late 2026, with topline data expected in H2 2028.
• RT-102: Rani Therapeutics
RT-102 is the original RaniPill capsule containing the parathyroid hormone analog PTH(1-34) for the treatment of osteoporosis. Rani Therapeutics has completed a pre-IND meeting with the US FDA for RT-102 (RaniPill GO) and plans to initiate a Phase II clinical trial.
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Osteoporosis Companies
Merck & Co. Inc., Amgen Inc., Radius Health Inc., Teva Pharmaceutical Industries Ltd, GlaxoSmithKline PLC, Pfizer Inc., Eli Lilly and Company, F. Hoffmann-La Roche, Novartis International AG, Actavis PLC, Shanghai JMT-Bio Inc., Transcenta Holding, Celltrion, Sandoz, Enzene Biosciences, Fresenius Kabi, Gedeon Richter, Samsung Bioepis, Alvotech, MAbxience, Shanghai Henlius Biotech, and others.
Osteoporosis Market Outlook
Treatment recommendations are largely based on estimating a patient’s 10-year fracture risk using tools such as bone density testing. For patients not at high risk, management may focus on modifying risk factors for bone loss and falls rather than medication. For both men and women at increased fracture risk, the most widely prescribed osteoporosis medications remain bisphosphonates such as Alendronate (Binosto, Fosamax) and Risedronate (Actonel, Atelvia). The US FDA has approved multiple drugs for osteoporosis, including RECLAST (zoledronic acid), EVENITY (romosozumab), and PROLIA (denosumab); in October 2019, the FDA also approved Bonsity, a biosimilar of Forteo. When medication, exercise, and diet fail to control the effects of osteoporosis after three months, surgical options such as kyphoplasty and vertebroplasty may be used to address spinal fractures.
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Scope of the Osteoporosis Market Report
• Coverage: 7MM
• Study Period: 2022-2036
• Forecast Period: 2026-2036
• Osteoporosis Companies: Entera Bio, Rani Therapeutics, Celltrion, Shanghai JMT-Bio Inc., Transcenta Holding, Sandoz, Enzene Biosciences, Fresenius Kabi, Gedeon Richter, Samsung Bioepis, Alvotech, MAbxience, Shanghai Henlius Biotech, and others
• Treatment Classes: Anti-resorptive agents, Bisphosphonates, Anabolic agents, Estrogen replacement and selective estrogen receptor modulators
• Osteoporosis Therapeutic Assessment: Current marketed and emerging therapies
• Osteoporosis Market Dynamics: Market drivers and market barriers
• Competitive Intelligence Analysis: SWOT analysis, KOL views, market entry strategies
• Osteoporosis Unmet Needs, Market Access and Reimbursement
Table of Contents
1. Key Insights
2. Report Introduction
3. Osteoporosis Market Overview at a Glance
4. Executive Summary of Osteoporosis
5. Key Events
6. Disease Background and Overview: Osteoporosis
7. Epidemiology and Patient Population
8. Osteoporosis Patient Journey
9. Osteoporosis Marketed Drugs
10. Osteoporosis Emerging Therapies
11. Osteoporosis: Seven Major Market Analysis
12. Key Opinion Leaders’ Views
13. Osteoporosis Unmet Needs
14. Osteoporosis Market Drivers
15. Osteoporosis Market Barriers
16. SWOT Analysis
17. Market Access and Reimbursement
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About Us
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