DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: Osteoporosis” report has been added to ResearchAndMarkets.com’s offering.
Osteoporosis is the most common metabolic bone disease, and is characterized by compromised bone strength which predisposes individuals to an increased risk of fracture. Bone strength itself is not directly measurable, but can be inferred from bone mass and quality, with bone mass being most commonly approximated by assessing bone mineral density (BMD). A person with a BMD measurement that falls within one standard deviation (SD) of the healthy reference (30-year-old male or female) is considered to have healthy bone mass and structure (T-score >-1).
Latest Key Takeaways
- The publisher estimates that in 2018, there were 345.8 million prevalent cases of osteoporosis among adults aged 50 years and older worldwide, and forecasts that number to increase to 427.8 million prevalent cases by 2027.
- The osteoporosis market is set for moderate growth during the forecast period of 2018-27, primarily driven by growth of Amgen’s Prolia in the US, Japan, and EU until its loss of patent exclusivity allows biosimilars to enter the market.
- Although the uptake of anabolic therapies will increase in terms of volumes, the market value is expected to decrease, due primarily to Forteo’s loss of exclusivity coupled with the arrival of two cheaper anabolic therapies in the US. While Tymlos is expected to take significant market share from Forteo due to its competitive efficacy profile, Evenity’s restricted patient population as a result of the black box warning of increased risk of myocardial infarction, stroke, and cardiovascular death will severely limit its market uptake.
- Use of anabolic therapies remains limited due to their nature as injectable therapies (daily in the case of Forteo and Tymlos), which is associated with poor compliance and adherence. Radius Health is aiming to overcome this with a transdermal formulation of Tymlos. Once approved, the favorable delivery route of the transdermal patch will enable it to capture the majority of the anabolic market in the US.
- The overall likelihood of approval of a Phase I osteoporosis asset is 6.3%, and the average probability a drug advances from Phase III is 72.2%. Osteoporosis drugs, on average, take 10.4 years from Phase I to approval, compared to 9.4 years in the overall endocrine space.
- The US, Canada, and the UK have seen the greatest number of osteoporosis trials, globally. Within Asia, Japan has the top spot.
- Clinical trial activity in the osteoporosis space is dominated by completed trials. Novartis has the highest number of completed clinical trials for osteoporosis, with 120 trials.
Key Topics Covered:
Overview
- Latest key takeaways
Disease Background
- Disease definition
- Patient segmentation
Treatment
- Lifestyle and dietary measures
- Pharmacological treatment
- Treatment classes
- Summary of US treatment guidelines
- Summary of EU treatment guidelines
Epidemiology
- Prevalence methodology
Marketed Drugs
Pipeline Drugs
Key Regulatory Events
- Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India
- Pfenex And Alvogen Forsteo Biosimilars Primed For EU Market
- New China Approvals Include Amgen, Sanofi, Hengrui Drugs, Innovent Biosimilar
- Pfenex And Alvogen Launch US Teriparatide
- Henlius Has Denosumab Application Accepted In China
- EU Approvals: Evenity Cleared For Severe Osteoporosis
- Mochida Debuts Japanese Teriparatide Biosimilar
- Pfenex Expects To Be Alone With Teriparatide
- Evenity Gets CHMP Nod On Second Pass
- Pfenex Gets US Teriparatide Nod
- Japan Approves Biosimilar Teriparatide And Darbepoetin
Probability of Success
Clinical Trial Landscape
- Sponsors by status
- Sponsors by phase
Drug Assessment Model
Market Dynamics
Future Trends
- Growth of Prolia in the US will be a major driver of market growth
- Lower price of injectable Tymlos will lead to reduction in anabolic sales
- Tymlos transdermal patch will change the dynamic of the US osteoporosis market
- Biosimilars will become strong resistors to US market growth
- EU anabolic market decline will be steeper due to EMA rejection of Tymlos
Consensus Forecasts
Recent Events and Analyst Opinion
- Multiple Drugs for Osteoporosis (June 25, 2019)
Key Upcoming Events
Unmet Needs
Bibliography
- Prescription information
Appendix
Companies Mentioned
- Alvogen
- Amgen
- Mochida
- Pfenex
- UCB
For more information about this report visit https://www.researchandmarkets.com/r/pd5ueq
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