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).
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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