Disease Analysis: Osteoporosis
Author: Hannah Cohen
Publisher: Informa Pharma Intelligence
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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 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.
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 Henlius Has Denosumab Application Accepted In China
25 EU Approvals: Evenity Cleared For Severe Osteoporosis
25 Mochida Debuts Japanese Teriparatide Biosimilar
25 Pfenex Expects To Be Alone With Teriparatide
26 Evenity Gets CHMP Nod On Second Pass
26 Pfenex Gets US Teriparatide Nod
26 Japan Approves Biosimilar Teriparatide And Darbepoetin
26 Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating
27 Amgen/UCB To Appeal EMA’s ‘Over Cautious’ Evenity Rejection
27 Alvogen And Pfenex Have Teriparatide Filing Accepted By EMA
27 Evenity’s Postmarketing Requirement Includes Feasibility Component Familiar To Other Osteoporosis Drugs
27 Amgen’s Evenity Clears US FDA With Preferred Indication, Black Box Warning
28 PROBABILITY OF SUCCESS
29 CLINICAL TRIAL LANDSCAPE
30 Sponsors by status
31 Sponsors by phase
33 DRUG ASSESSMENT MODEL
35 MARKET DYNAMICS
36 FUTURE TRENDS
36 Growth of Prolia in the US will be a major driver of market growth
36 Lower price of injectable Tymlos will lead to reduction in anabolic sales
36 Tymlos transdermal patch will change the dynamic of the US osteoporosis market
36 Biosimilars will become strong resistors to US market growth
37 EU anabolic market decline will be steeper due to EMA rejection of Tymlos
38 CONSENSUS FORECASTS
40 RECENT EVENTS AND ANALYST OPINION
40 Evenity for Osteoporosis (January 16, 2019)
42 Evenity for Osteoporosis (January 14, 2019)
44 KEY UPCOMING EVENTS
45 UNMET NEEDS
46 BIBLIOGRAPHY
47 Prescription information
48 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
33 Figure 13: Datamonitor Healthcare’s drug assessment summary for osteoporosis
35 Figure 14: Market dynamics in osteoporosis
36 Figure 15: Future trends in osteoporosis
44 Figure 16: Key upcoming events in osteoporosis
45 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
38 Table 7: Historical global sales, by drug ($m), 2014–18
39 Table 8: Forecasted global sales, by drug ($m), 2020–24
40 Table 9: Evenity for Osteoporosis (January 16, 2019)
42 Table 10: Evenity for Osteoporosis (January 14, 2019)
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