Disease Analysis: Osteoporosis
Author: Michael Haydock
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 Europe 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 value of this class is expected to decrease, due primarily to Forteo’s loss of exclusivity coupled with the arrival of two cheaper anabolic therapies in the US. Tymlos is expected to take significant market share from Forteo due to its competitive efficacy profile. Evenity’s growth will also contribute to the reduction in volume of Forteo, primarily due to a favorable efficacy profile and convenient monthly dosing over 12 months. However, while physicians may have found a way to mitigate the black box warning for increased CV risk (particularly by excluding patients with prior myocardial infarction, stroke, or CV risk factors), this will remain a growth barrier for Evenity.
- 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 4.7%, 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 9.7 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
9 TREATMENT
9 Lifestyle and dietary measures
9 Pharmacological treatment
9 Treatment classes
10 Summary of US treatment guidelines
11 Summary of EU treatment guidelines
13 EPIDEMIOLOGY
13 Prevalence methodology
16 MARKETED DRUGS
22 PIPELINE DRUGS
26 KEY REGULATORY EVENTS
26 Alkem Looks To Biosimilars With Enzene’s Teriparatide In India
26 SVA Says No To Fluoride
26 Germany First As Pfenex And Alvogen Biosimilar Forsteo Is Launched
26 Reverse-Switch Of Stada’s Lemocin On The Agenda Of Germany’s Switch Committee
27 Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India
27 Pfenex And Alvogen Forsteo Biosimilars Primed For EU Market
27 New China Approvals Include Amgen, Sanofi, Hengrui Drugs, Innovent Biosimilar
27 Pfenex And Alvogen Launch US Teriparatide
29 PROBABILITY OF SUCCESS
30 LICENSING AND ASSET ACQUISITION DEALS
30 BioGaia Creates Investment Arm
30 Alvotech And Cipla Expand Biosimilars Deal For Australia And New Zealand
31 CLINICAL TRIAL LANDSCAPE
32 Sponsors by status
33 Sponsors by phase
34 Recent events
36 DRUG ASSESSMENT MODEL
38 MARKET DYNAMICS
39 FUTURE TRENDS
39 Growth of Prolia in the US will be a major driver of market growth
39 Lower price of injectable Tymlos will lead to reduction in anabolic sales
39 Tymlos transdermal patch will change the dynamic of the US osteoporosis market
40 Biosimilars will become strong resistors to market growth
41 CONSENSUS FORECASTS
45 KEY UPCOMING EVENTS
46 UNMET NEEDS
47 BIBLIOGRAPHY
49 APPENDIX
LIST OF FIGURES
15 Figure 1: Trends in prevalent cases of osteoporosis, 2018–27
22 Figure 2: Overview of pipeline drugs for osteoporosis in the US
22 Figure 3: Pipeline drugs for osteoporosis, by company
22 Figure 4: Pipeline drugs for osteoporosis, by drug type
23 Figure 5: Pipeline drugs for osteoporosis, by classification
29 Figure 6: Probability of success in the osteoporosis pipeline
31 Figure 7: Clinical trials in osteoporosis
31 Figure 8: Top 10 drugs for clinical trials in osteoporosis
32 Figure 9: Top 10 companies for clinical trials in osteoporosis
32 Figure 10: Trial locations in osteoporosis
33 Figure 11: Osteoporosis trials status
34 Figure 12: Osteoporosis trials sponsors, by phase
36 Figure 13: Datamonitor Healthcare’s drug assessment summary for osteoporosis
38 Figure 14: Market dynamics in osteoporosis
39 Figure 15: Future trends in osteoporosis
45 Figure 16: Key upcoming events in osteoporosis
46 Figure 17: Unmet needs in osteoporosis
LIST OF TABLES
8 Table 1: World Health Organization definitions of bone mass based on BMD
11 Table 2: Summary of US treatment guidelines
12 Table 3: Summary of EU treatment guidelines
14 Table 4: Prevalent cases of osteoporosis, 2018–27
17 Table 5: Marketed drugs for osteoporosis
24 Table 6: Pipeline drugs for osteoporosis in the US
42 Table 7: Historical global sales, by drug ($m), 2016–20
44 Table 8: Forecasted global sales, by drug ($m), 2021–25
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