Disease Analysis: Osteoporosis

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Report
48 Pages
March 2021
Region: Global
Citeline
ID: 5009190

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, 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 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.

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 DRUGSPIPELINE DRUGS

KEY REGULATORY EVENTS

Alkem Looks To Biosimilars With Enzene’s Teriparatide In India
SVA Says No To Fluoride
Germany First As Pfenex And Alvogen Biosimilar Forsteo Is Launched
Reverse-Switch Of Stada’s Lemocin On The Agenda Of Germany’s Switch Committee
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

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

DRUG ASSESSMENT MODELMARKET 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 FORECASTSKEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY
Prescription information

APPENDIX

LIST OF FIGURES

Figure 1: Trends in prevalent cases of osteoporosis, 2018–27
Figure 2: Overview of pipeline drugs for osteoporosis in the US
Figure 3: Pipeline drugs for osteoporosis, by company
Figure 4: Pipeline drugs for osteoporosis, by drug type
Figure 5: Pipeline drugs for osteoporosis, by classification
Figure 6: Probability of success in the osteoporosis pipeline
Figure 7: Clinical trials in osteoporosis
Figure 8: Top 10 drugs for clinical trials in osteoporosis
Figure 9: Top 10 companies for clinical trials in osteoporosis
Figure 10: Trial locations in osteoporosis
Figure 11: Osteoporosis trials status
Figure 12: Osteoporosis trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for osteoporosis
Figure 14: Market dynamics in osteoporosis
Figure 15: Future trends in osteoporosis
Figure 16: Key upcoming events in osteoporosis
Figure 17: Unmet needs in osteoporosis

LIST OF TABLES

Table 1: World Health Organization definitions of bone mass based on BMD
Table 2: Summary of US treatment guidelines
Table 3: Summary of EU treatment guidelines
Table 4: Prevalent cases of osteoporosis, 2018–27
Table 5: Marketed drugs for osteoporosis
Table 6: Pipeline drugs for osteoporosis in the US
Table 7: Historical global sales, by drug ($m), 2015–19
Table 8: Forecasted global sales, by drug ($m), 2021–25

Table of Contents

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