Disease Analysis: Osteoporosis
Author: Hannah Cohen
Publisher: Informa Pharma Intelligence
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Disease Overview
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
- Datamonitor Healthcare 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, 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 4.9%, 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.
CONTENTS
6 OVERVIEW
6 Latest key takeaways
7 DISEASE BACKGROUND
7 Disease definition
7 Patient segmentation
8 TREATMENT
8 Lifestyle and dietary measures
8 Pharmacological treatment
8 Treatment classes
9 Summary of US treatment guidelines
10 Summary of EU treatment guidelines
12 EPIDEMIOLOGY
12 Prevalence methodology
15 MARKETED DRUGS
21 PIPELINE DRUGS
25 KEY REGULATORY EVENTS
25 Reverse-Switch Of Stada’s Lemocin On The Agenda Of Germany’s Switch Committee
25 Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India
25 Pfenex And Alvogen Forsteo Biosimilars Primed For EU Market
25 New China Approvals Include Amgen, Sanofi, Hengrui Drugs, Innovent Biosimilar
26 Pfenex And Alvogen Launch US Teriparatide
26 Henlius Has Denosumab Application Accepted In China
26 EU Approvals: Evenity Cleared For Severe Osteoporosis
27 Mochida Debuts Japanese Teriparatide Biosimilar
28 PROBABILITY OF SUCCESS
29 CLINICAL TRIAL LANDSCAPE
30 Sponsors by status
31 Sponsors by phase
32 Recent events
34 DRUG ASSESSMENT MODEL
36 MARKET DYNAMICS
37 FUTURE TRENDS
37 Growth of Prolia in the US will be a major driver of market growth
37 Lower price of injectable Tymlos will lead to reduction in anabolic sales
37 Tymlos transdermal patch will change the dynamic of the US osteoporosis market
37 Biosimilars will become strong resistors to US market growth
38 EU anabolic market decline will be steeper due to EMA rejection of Tymlos
39 CONSENSUS FORECASTS
41 RECENT EVENTS AND ANALYST OPINION
41 Multiple Drugs for Osteoporosis (June 25, 2019)
42 KEY UPCOMING EVENTS
43 UNMET NEEDS
44 BIBLIOGRAPHY
45 Prescription information
46 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in prevalent cases of osteoporosis, 2018–27
21 Figure 2: Overview of pipeline drugs for osteoporosis in the US
21 Figure 3: Pipeline drugs for osteoporosis, by company
22 Figure 4: Pipeline drugs for osteoporosis, by drug type
22 Figure 5: Pipeline drugs for osteoporosis, by classification
28 Figure 6: Probability of success in the osteoporosis pipeline
29 Figure 7: Clinical trials in osteoporosis
29 Figure 8: Top 10 drugs for clinical trials in osteoporosis
30 Figure 9: Top 10 companies for clinical trials in osteoporosis
30 Figure 10: Trial locations in osteoporosis
31 Figure 11: Osteoporosis trials status
32 Figure 12: Osteoporosis trials sponsors, by phase
34 Figure 13: Datamonitor Healthcare’s drug assessment summary for osteoporosis
36 Figure 14: Market dynamics in osteoporosis
37 Figure 15: Future trends in osteoporosis
42 Figure 16: Key upcoming events in osteoporosis
43 Figure 17: Unmet needs in osteoporosis
LIST OF TABLES
7 Table 1: World Health Organization definitions of bone mass based on BMD
10 Table 2: Summary of US treatment guidelines
11 Table 3: Summary of EU treatment guidelines
13 Table 4: Prevalent cases of osteoporosis, 2018–27
16 Table 5: Marketed drugs for osteoporosis
23 Table 6: Pipeline drugs for osteoporosis in the US
39 Table 7: Historical global sales, by drug ($m), 2015–19
40 Table 8: Forecasted global sales, by drug ($m), 2020–24
41 Table 9: Multiple Drugs for Osteoporosis (June 25, 2019)
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