With an increasing prevalence due to aging populations, the major-market osteoporosis patient pool is large and growing. The combined influence of increased patient numbers and drug launches will contribute to market growth through 2029. However, this growth will be tempered by generic erosion of key brands. The relatively low diagnosis and drug-treatment rates for osteoporosis owing to the asymptomatic nature of the disease will also continue to constrain the market. Driven largely by their widespread generic availability and high physician familiarity, bisphosphonates continue to dominate first-line treatment, creating a significant barrier to uptake for novel therapies. Emerging therapies will need to demonstrate a significant risk-benefit balance at a competitive price to challenge the bisphosphonates in the first line. Therefore, most emerging therapies will compete for use as second- or third-line treatments.

Questions Answered:

  • Novel agents—Radius Health’s abaloparatide TD (Phase III) and Amgen / UCB / Astellas's romosozumab (first market launch in 2019) for the treatment of osteoporosis. What do interviewed thought leaders say about the advantages and disadvantages of each therapy? How do they anticipate using these agents in the osteoporosis treatment algorithm? Which agents in the current market are most likely to be replaced by these novel therapies, and which will constrain the uptake of new drugs?
  • The bisphosphonate drug class (e.g., alendronate, risedronate, ibandronate, zoledronate) is the dominant class for the treatment of osteoporosis but is associated with adverse effects, including osteonecrosis of the jaw and an elevated risk of atypical femoral fractures. How much impact will this association have on osteoporosis drug-treatment rates? To what extent will this association adversely affect bisphosphonate sales?
  • Teriparatide and denosumab hold a sizable share of the market. How will the loss of patent protection affect their market share? What effect will the launch of novel agents have on their patient share?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 19 country-specific interviews with experts.

Epidemiology: Prevalence of osteoporosis by country, with diagnosis and drug-treatment rates.

Population segments in market forecast: Osteoporosis.

Emerging therapies: Phase III: 1 drug; Phase II: 1 drug. Coverage of select preclinical and Phase I products.

Key drugs: Denosumab, teriparatide, abaloparatide SC, abaloparatide TD, alendronate, romosozumab, raloxifene.

Table of contents

  • Osteoporosis - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q3 2021
        • July 2021
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • 2020 Updates
        • October 2020
        • July 2020
        • May 2020
    • Key Findings
      • Osteoporosis - Key Findings - November 2020
        • October 2020
        • July 2020
        • May 2020
    • Market Outlook
      • Key Findings
        • Market Overview
        • Market Share of Osteoporosis Drug Classes: 2019
        • Market Share of Osteoporosis Drug Classes: 2029
        • Osteoporosis SWOT Analysis
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Osteoporosis?
        • What Factors Are Constraining the Market for Osteoporosis?
        • Market Sales of Osteoporosis Drugs in the Major Markets: 2019-2029
        • Patient Share of Osteoporosis Drugs in the Major Markets: 2019-2029
      • Drug-Class-Specific Trends
        • Patient Share of Bisphosphonates in Osteoporosis in the United States: 2019-2029
        • Patient Share of Bisphosphonates in Osteoporosis in Europe: 2019-2029
        • Patient Share of Bisphosphonates in Osteoporosis in Japan: 2019-2029
        • Patient Share of SERMs in Osteoporosis in the Major Markets: 2019-2029
        • Patient Share of Parathyroid Hormone Analogues in Osteoporosis in the United States: 2019-2029
        • Patient Share of Parathyroid Hormone Analogues in Osteoporosis in Europe: 2019-2029
        • Patient Share of Parathyroid Hormone Analogues in Osteoporosis in Japan: 2019-2029
        • Patient Share of the RANKL Inhibitors in Osteoporosis in the United States: 2019-2029
        • Patient Share of the RANKL Inhibitors in Osteoporosis in Europe: 2019-2029
        • Patient Share of the RANKL Inhibitors in Osteoporosis in Japan: 2019-2029
        • Patient Share of Sclerostin Inhibitors in Osteoporosis in the Major Markets: 2019-2029
        • Patient Share of Calcitonins, Hormonal Agents, and Other Therapies to Treat Osteoporosis in the Major Markets: 2019-2029
    • Forecast
      • Market-Forecast-Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Disease Overview
        • Etiology
          • Primary Osteoporosis
          • Secondary Osteoporosis
          • Causes of Secondary Osteoporosis
          • Risk Factors
          • Risk Factors for Developing Osteoporosis
          • Osteoporosis: A Risk Factor for Fractures
          • Risk Factors for Fracture
        • Key Pathways and Drug Targets
          • Anatomy
          • Bone Remodeling and Turnover
          • Immunologic Effects
          • Drug Targets
          • Summary of Osteoporosis Drug Targets and Their Mechanisms of Action
          • Drug Targets in the Bone Remodeling Process
      • Epidemiology
        • Introduction
          • Epidemiology Populations
            • Disease Definition of Osteoporosis and Osteopenia
            • Methods: Osteoporosis and Osteopenia
            • Sources Used for Prevalence of Osteoporosis and Osteopenia
            • Total Prevalent Cases of Osteoporosis (NBHA Definition) in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteoporosis (NBHA Definition) Among Females in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteoporosis (WHO Definition) in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteoporosis (WHO Definition) Among Males in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteoporosis (WHO Definition) Among Females in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteopenia (WHO Definition) in the Mature Markets (millions): 2019-2029
            • Total Prevalent Cases of Osteopenia (WHO Definition) Among Males in the Mature Markets (thousands): 2019-2029
            • Total Prevalent Cases of Osteopenia (WHO Definition) Among Females in the Mature Markets (thousands): 2019-2029
            • Disease Definition: FRAX High-Risk
            • Methods: FRAX High-Risk
            • Sources Used for FRAX High-Risk Prevalence
            • Total Prevalence of Persons at High Risk of a Hip Fracture or Major Osteoporotic Fracture in the Next Ten Years (thousands): 2019-2029
            • Total Prevalent Cases of Men at High Risk of a Hip Fracture or Major Osteoporotic Fracture in the Next Ten Years (thousands): 2019-2029
            • Total Prevalent Cases of Women at High Risk of a Hip Fracture or Major Osteoporotic Fracture in the Next Ten Years (thousands): 2019-2029
            • Sources Used for Diagnosed Prevalence of Osteoporosis
            • Diagnosed Prevalent Cases of Osteoporosis in the Mature Markets (Thousands): 2019-2029
            • Sources Used for Drug-Treated Prevalence of Osteoporosis
            • Drug-Treated Prevalent Cases of Osteoporosis in the Mature Markets (Thousands): 2019-2029
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Osteoporosis
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Osteoporosis
              • Current Treatments Used for Osteoporosis
              • Market Events Impacting the Use of Key Current Therapies in Osteoporosis
              • Advantages and Disadvantages of Bisphosphonates
              • Expert Insight: Bisphosphonates
              • Advantages and Disadvantages of Selective Estrogen Receptor Modulators
              • Expert Insight: Selective Estrogen Receptor Modulators
              • Advantages and Disadvantages of Teriparatide
              • Key Results from Select Clinical Trials Investigating Teriparatide for the Treatment of Osteoporosis
              • Expert Insight: Teriparatide
              • Key Ongoing Clinical Trials Investigating Teriparatide for the Treatment of Osteoporosis
              • Advantages and Disadvantages of Abaloparatide SC
              • Key Ongoing Clinical Trials of Abaloparatide SC in the Treatment of Osteoporosis
              • Expert Insight: Abaloparatide SC
              • Advantages and Disadvantages of RANKL Inhibitors
              • Key Results from Select Clinical Trials Investigating Denosumab for the Treatment of Osteoporosis
              • Key Ongoing Clinical Trials of Denosumab in the Treatment of Osteoporosis
              • Expert Insight: RANKL Inhibitors
              • Advantages and Disadvantages of Romosozumab
              • Expert Insight: Romosozumab
              • Advantages and Disadvantages of Strontium Salts
              • Expert Insight: Strontium Salts
              • Advantages and Disadvantages of Calcitonins
              • Expert Insight: Calcitonins
              • Advantages and Disadvantages of Hormone Replacement Therapy
              • Expert Insight: Hormone Replacement Therapy
              • Advantages and Disadvantages of Synthetic Steroids
            • Medical Practice
              • Overview
              • Treatment Guidelines
              • Country-Specific Osteoporosis Treatment Guidelines
              • Factors Influencing Drug Selection in Osteoporosis
              • Treatment Decision Tree for Osteoporosis: United States
              • Treatment Decision Tree for Osteoporosis: Europe
              • Treatment Decision Tree for Osteoporosis: Japan
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Osteoporosis
            • Top Unmet Needs in Osteoporosis: Current and Future Attainment
            • Expert Insight: Unmet Need in Osteoporosis
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends in Osteoporosis
            • Key Emerging Therapies
              • Notable Developments Among Key Emerging Therapies for Osteoporosis
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Osteoporosis
              • Key Results from Select Clinical Trials Investigating Abaloparatide TD for the Treatment of Osteoporosis
              • Key Ongoing Clinical Trials of Abaloparatide TD in the Treatment of Osteoporosis
              • Analysis of the Clinical Development Program for Abaloparatide TD
              • Expert Insight: Abaloparatide TD
              • Expectations for Launch and Sales Opportunity of Abaloparatide TD in Osteoporosis
              • EB-613
              • Key Results from Select Clinical Trials Investigating EB-613 for the Treatment of Osteoporosis
              • Expectations for Launch and Sales Opportunity of EB-613 in Osteoporosis
            • Early-Phase Pipeline Analysis
              • Select Compounds in Early-Phase Development for Osteoporosis
            • Key Discontinuations and Failures in Osteoporosis
              • Expert Insight: Osteoporosis Therapy Development
          • Access & Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • Key Market Access Considerations in Osteoporosis: United States
              • General Reimbursement Environment: United States
              • Key Market Access Considerations in Osteoporosis: EU5
              • General Reimbursement Environment: EU5
              • Key Market Access Considerations in Osteoporosis: Japan
              • General Reimbursement Environment: Japan
          • Appendix
            • Key Abbreviations Related to Osteoporosis
            • Brands, Marketers, and Generic Availability of Key Therapies for Osteoporosis by Market
            • Osteoporosis Bibliography
            • Supplemental Epidemiology Bibliography

        Author(s): Shambhavi Shukla

        Shambhavi Shukla, MTech., is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at Clarivate. Before joining Clarivate, Shambhavi was with Evalueserve for four years, where she worked closely with top pharmaceutical companies, helping them with commercial and technical ad-hoc requests. She has delivered competitive landscape and market insight projects for various indications, including Schizophrenia, Multiple Sclerosis, Myopia, Osteoporosis, and FSGS. She holds a master’s degree in biotechnology from Amity University, India.


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