Osteoporosis: Global Drug Forecast and Market Analysis to 2027

Osteoporosis is a disease in which the density and quality of bone are reduced over time. In a natural process known as remodeling, some of the bone cells dissolve (resorption) and new bone cells grow back (formation). For people with osteoporosis, bone loss outpaces the growth of new bone. Consequently, bones become more porous and fragile, leading to weakness of the skeleton and an increased risk of hip, spine, and wrist fractures. Osteoporosis is often referred to as a “silent” disease, because the loss of bone occurs progressively and often there are no symptoms until the first fracture occurs.

Despite being a market currently monopolized by generics, osteoporosis is expected to undergo substantial change between 2017 and 2027. Clear changes are already being seen with the recent launch of Radius Health’s Tymlos (abaloparatide) in the US in 2017. Anabolic agents are likely to further revolutionize the market with the arrival of a novel sclerostin inhibitor, Evenity (romosozumab), and teriparatide biosimilars. This diversification of the anabolic offering will increase competition in this space, driving down high price tags and potentially bolstering the use of these therapies up the treatment paradigm. The launch of Evenity will keep Amgen a key player in the osteoporosis market as they lose patent protection of current market leading therapy, Prolia (denosumab). The arrival of new anabolic agents and the loss of patent protection for key branded therapies will shape the osteoporosis market over the forecast period. However, poor diagnosis rates, badly perceived drug side effects, and low compliance rates will continue to prove major barriers to growth over the next 10 years.

Key Questions Answered

What are the key osteoporosis treatments in 2017?

When will the late stage pipeline products launch, and how will it affect drug sales and the overall osteoporosis market in the 7MM?

Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

Overview of osteoporosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized osteoporosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (postmenopausal, male, glucocorticoid-induced and osteopenia) forecast from 2017 to 2027.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the osteoporosis therapeutics market

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for osteoporosis therapy. The most promising candidates in Phase III development are profiled.

Analysis of the current and future market competition in the global osteoporosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

Anabolics will be the product of choice for future players in the market. Historic markets leaders have focused on the manufacturing of anti-resorptive agents. However, focus has turned to the benefits of anabolic agents.

The silent nature of osteoporosis, a low public perception surrounding the adverse events of many medications and the high burden of many osteoporosis therapies leave low diagnosis rates and compliance as key unmet needs in the market.

The high cost of current branded therapies continue to force generic bisphosphate into the first-line of therapy. However as the market diversifies and competition drives down the price of agents, anabolic therapies both current and pipeline may move up the treatment paradigm.

Two new anabolic agents, Tymlos and Evenity, will shape the osteoporosis market along with the arrival of Prolia and Forteo biosimilars.

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Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global osteoporosis therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global osteoporosis therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Companies mentioned

Allergan

Amgen

Astellas Pharma

AstraZeneca

Azelon Pharmaceuticals

Daiichi Sankyo

Eli Lilly

Entera Bio

F. Hoffman-La Roche

Gedeon Richter

Merck & Co

Mereo Biopharma

Mochida Pharmaceutical ...

Allergan

Amgen

Astellas Pharma

AstraZeneca

Azelon Pharmaceuticals

Daiichi Sankyo

Eli Lilly

Entera Bio

F. Hoffman-La Roche

Gedeon Richter

Merck & Co

Mereo Biopharma

Mochida Pharmaceutical

Novartis

Ono Pharmaceutical

Pfizer

Radius Health

Stada Arzneimittel

Stelis Biopharma

Teijin Pharma

UCB

Unigene

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Osteoporosis: Executive Summary

2.1 Sales for Osteoporosis by Region ...

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Osteoporosis: Executive Summary

2.1 Sales for Osteoporosis by Region, 2017–2027

2.2 Anabolic Therapy Will Be the Product of Choice for Future Players

2.3 Low Diagnosis Rates and Compliance Leave Key Unmet Needs in the Osteoporosis Market

2.4 Current Market Leader Prolia Will Make Way for New Anabolic Therapies

2.5 Biosimilars Will Dominate the Market in 2027

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Classification

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions

5.5 Epidemiological Forecast for Osteoporosis (2017–2027)

5.5.1 Total Prevalent Cases of Osteoporosis

5.5.2 Age-Specific Total Prevalent Cases of Osteoporosis

5.5.3 Sex-Specific Total Prevalent Cases of Osteoporosis

5.5.4 Total Prevalent Cases of Osteoporosis by Primary and Secondary Osteoporosis

5.5.5 Total Prevalent Cases of Primary Osteoporosis by Type

5.5.6 Total Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use

5.5.7 Diagnosed Prevalent Cases of Osteoporosis

5.5.8 Age-Specific Diagnosed Prevalent Cases of Osteoporosis

5.5.9 Sex-Specific Diagnosed Prevalent Cases of Osteoporosis

5.5.10 Diagnosed Prevalent Cases of Osteoporosis by Primary and Secondary Osteoporosis

5.5.11 Diagnosed Prevalent Cases of Primary Osteoporosis by Type

5.5.12 Diagnosed Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use

5.5.13 Total Prevalent Cases and Diagnosed Prevalent Cases of Osteopenia

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis Overview

6.2 Treatment Overview

6.2.1 Treatment Guidelines

6.2.2 Disease Management

6.3 US

6.4 5EU

6.5 Japan

7 Competitive Assessment

7.1 Overview

7.2 Bisphosphates

7.2.1 Overview

7.2.2 Efficacy

7.2.3 Safety

7.2.4 SWOT Analysis

7.2.5 Forecast

7.3 Prolia (Denosumab)

7.3.1 Overview

7.3.2 Efficacy

7.3.3 Safety

7.3.4 SWOT Analysis

7.3.5 Forecast

7.4 Parathyroid Hormones

7.4.1 Forteo (Teriparatide)

7.4.2 Tymlos (Abaloparatide)

7.5 SERMs

7.5.1 Evista (Raloxifene Hydrochloride) and Generics

7.5.2 Viviant (Bazedoxifene)

7.5.3 Duavee (Bazedoxifene Acetate + Conjugated Estrogens)

7.6 Other Therapies for the Treatment of Osteoporosis

7.6.1 Miacalcin/Fortical (Salmon Calcitonin)

7.6.2 Protelos and Generics (Strontium Ranelate)

7.6.3 Estrogen/Hormone Replacement Therapies

8 Opportunity Analysis and Unmet Needs

8.1 Overview

8.2 Earlier Disease Detection and Treatment

8.2.1 Unmet Need

8.3 Improved Compliance

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Improved Safety Profile of Long-Term Treatments

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Therapies that Stimulate Bone Formation

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 Evenity (Romosozumab)

9.3 Other Drugs in Development

9.4 Biosimilars

9.4.1 Teriparatide Biosimilars

9.4.2 Denosumab Biosimilars

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Amgen

10.3.2 Eli Lilly

10.3.3 Radius Health

10.3.4 UCB

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research

12.4.1 KOLs

12.4.2 Primary Research – Prescriber Survey

12.5 About the Authors

12.5.1 Analyst

12.5.2 Therapy Area Director

12.5.3 Epidemiologist

12.5.4 Managing Epidemiologist

12.5.5 Global Director of Therapy Analysis and Epidemiology

12.5.6 Global Head and EVP of Healthcare Operations and Strategy

12.6 About GlobalData

12.7 Contact Us

12.8 Disclaimer

List of Tables

Table 1: Osteoporosis: Key Metrics in the 7MM

Table 2: Etiology of Primary Osteoporosis

Table 3: Etiology of Secondary Osteoporosis

Table 4: Diagnosis Classification of ...

Table 1: Osteoporosis: Key Metrics in the 7MM

Table 2: Etiology of Primary Osteoporosis

Table 3: Etiology of Secondary Osteoporosis

Table 4: Diagnosis Classification of Osteoporosis

Table 5: Symptoms of Osteoporosis

Table 6: Risk Factors and Comorbidities for Osteoporosis

Table 7: 7MM Total Prevalent Cases of Osteoporosis by Primary Osteoporosis and Secondary Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Table 8: 7MM, Total Prevalent Cases of Primary Osteoporosis by Type, Ages ≥30 Years, N, 2017

Table 9: 7MM Diagnosed Prevalent Cases of Osteoporosis by Primary Osteoporosis and Secondary Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Table 10: 7MM, Diagnosed Prevalent Cases of Primary Osteoporosis by Type, Ages ≥30 Years, N, 2017

Table 11: 7MM Total Prevalent Cases and Diagnosed Prevalent Cases of Osteopenia, Both Sexes, Ages ≥30 Years, N, 2017

Table 12: Diagnostic Tests for Osteoporosis

Table 13: Diagnosis Classification of Osteoporosis

Table 14: Treatment Guidelines for Osteoporosis

Table 15: Country Profile – US

Table 16: Country Profile – 5EU

Table 17: Country Profile – Japan

Table 18: Marketed Products for Osteoporosis

Table 19: Product Profile – Bisphosphates

Table 20: Summary of the Bisphosphates Currently Used for the Treatment of Osteoporosis

Table 21: SWOT Analysis – Bisphosphates, 2017

Table 22: Product Profile – Prolia

Table 23: Efficacy Results from Phase III Study of Prolia for the Treatment of Postmenopausal Osteoporosis

Table 24: Efficacy Results from Phase III Study of Prolia as a Treatment to Increase Bone Mass in Men with Osteoporosis

Table 25: Adverse Events Reported in ≥2% of Patient Population in Phase III Trial for Prolia in Postmenopausal Osteoporosis

Table 26: SWOT Analysis – Prolia, 2017

Table 27: Product Profile – Forteo

Table 28: Efficacy Results from the Phase III Study of Forteo for the treatment of Postmenopausal Osteoporosis

Table 29: Efficacy Results from Phase III Study of Forteo for the Treatment of Osteoporosis in Men

Table 30: Efficacy Results from Phase III Study of Forteo for the Treatment of Glucocorticoid-Induced Osteoporosis

Table 31: Adverse Events Reported in ≥2% of Patients Treated with Forteo from Two Pivotal Phase III Trials

Table 32: Adverse Events Reported in ≥2% of Patients Treated with Forteo from Two Pivotal Phase III Trials

Table 33: SWOT Analysis – Forteo, 2017

Table 34: Product Profile – Tymlos

Table 35: Efficacy Results after 18 months of Tymlos Therapy in Phase III Clinical trial, ACTIVE

Table 36: Adverse Events Reported in ≥5% of Patients in ACTIVE Clinical Trial

Table 37: SWOT Analysis – Tymlos, 2017

Table 38: Product Profile – Evista and Generics

Table 39: Raloxifene Hydrochloride Generics Marketed in the 7MM

Table 40: Adverse Reactions Reported in Clinical Trials Assessing Evista for the Prevention of Osteoporosis

Table 41: Adverse Reactions Reported in Clinical Trials Assessing Evista for the Prevention of Osteoporosis

Table 42: SWOT Analysis – Evista, 2017

Table 43: Product Profile – Viviant

Table 44: SWOT Analysis – Vivant, 2017

Table 45: Product Profile – Duavee

Table 46: Summary of the SMART Program Investigating Duavee for the Prevention of Postmenopausal Osteoporosis

Table 47: Adverse Reactions Reported in ≥5% of Patients in SMART Clinical Trials

Table 48: SWOT Analysis – Duavee, 2017

Table 49: Product Profile – Evenity

Table 50: Efficacy Results from Phase III FRAME Study of Evenity vs. Placebo for the Treatment of Osteoporosis

Table 51: Efficacy Results from Phase III ARCH Study of Evenity vs. Alendronate for the Treatment of Osteoporosis

Table 52: Safety Results from Phase III FRAME Study of Evenity vs. Placebo for the Treatment of Osteoporosis

Table 53: Safety Results from Phase III ARCH Study of Evenity vs. Alendronate for the Treatment of Osteoporosis

Table 54: SWOT Analysis – Evenity, 2017

Table 55: Early-Stage Drugs in Clinical Development for Osteoporosis in the 7MM, 2018

Table 56: Teriparatide Biosimilars in Development, 2018

Table 57: Key Companies in the Osteoporosis Market in the 7MM, 2018

Table 58: Amgen’s Osteoporosis Portfolio Assessment, 2018

Table 59: Eli Lilly’s Osteoporosis Assessment, 2018

Table 60: Radius Health’s Osteoporosis Assessment, 2018

Table 61: UCB’s Osteoporosis Assessment, 2018

Table 62: Osteoporosis Market – Global Drivers and Barriers, 2017–2027

Table 63: Key Events Impacting Sales for Osteoporosis in the US, 2017–2027

Table 64: Osteoporosis Market – Drivers and Barriers in the US, 2017–2027

Table 65: Key Events Impacting Sales for Osteoporosis in the 5EU, 2017–2027

Table 66: Osteoporosis Market – Drivers and Barriers in the 5EU, 2017–2027

Table 67: Key Events Impacting Sales for Osteoporosis in Japan, 2017–2027

Table 68: Osteoporosis Market – Drivers and Barriers in Japan, 2017–2027

Table 69: Key Historical and Projected Launch Dates for Osteoporosis

Table 70: Key Historical and Projected Patent Expiry Dates for Osteoporosis

Table 71: Annual Cost of Oral Bisphosphates

Table 72: Annual Cost of IV Bisphosphates

Table 73: Annual Cost of Prolia (Denosumab)

Table 74: Annual Cost of Evista (Raloxifene)

Table 75: Annual Cost of Viviant (Bazedoxifene)

Table 76: Annual Cost of Duavee (Bazedoxifene + Conjugated Estrogen)

Table 77: Annual Cost of Oral Bisphosphates

Table 78: Annual Cost of Forteo (Teriparatide)

Table 79: Annual Cost of Tymlos (Abaloparatide)

Table 80: Predicted Annual Cost of Evenity (Romosozumab)

Table 81: High-Prescribing Physicians (Non-KOLs), Surveyed by Country, 2018

List of Figures

Figure 1: 7MM Sales Forecast for Osteoporosis, by Country, 2017 and 2027

Figure 2: Global Sales of Branded Osteoporosis Products, by Company, 2017–2027

Figure ...

Figure 1: 7MM Sales Forecast for Osteoporosis, by Country, 2017 and 2027

Figure 2: Global Sales of Branded Osteoporosis Products, by Company, 2017–2027

Figure 3: Unmet Needs for the Treatment of Osteoporosis, 2017

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Osteoporosis, 2017–2027

Figure 5: Global (7MM) Sales Forecast by Drug Class for Osteoporosis, 2017–2027

Figure 6: Etiology of Osteoporosis

Figure 7: 7MM, Age-Standardized Total Prevalence of Osteoporosis, Men and Women, Ages ≥30 Years, 2017

Figure 8: 7MM, Age-Standardized Diagnosed Prevalence of Osteoporosis, Men and Women, Ages ≥30 Years, 2017

Figure 9: 7MM, Sources Used and Not Used to Forecast Total Prevalent Cases of Osteoporosis

Figure 10: 7MM, Sources Used to Forecast Total Prevalent Cases and Diagnosed Prevalent Cases of Primary and Secondary Osteoprosis

Figure 11: 7MM, Sources Used to Forecast Total Prevalent Cases of Osteopenia

Figure 12: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of Osteoporosis

Figure 13: 7MM, Sources Used to Forecast Diagnosed Prevalent Cases of Osteopenia

Figure 14: 7MM, Total Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 15: 7MM, Age-Specific Total Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 16: 7MM, Sex-Specific Total Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 17: 7MM, Total Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use, Both Sexes, Ages ≥30 Years, N, 2017

Figure 18: 7MM, Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 19: 7MM, Age-Specific Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of Osteoporosis, Both Sexes, Ages ≥30 Years, N, 2017

Figure 21: 7MM, Diagnosed Prevalent Cases of Osteoporosis Secondary to Glucocorticoid Use, Both Sexes, Ages ≥30 Years, N, 2017

Figure 22: Osteoporosis Treatment Algorithm

Figure 23: Level of Use versus Line of Therapy for Currently Marketed Therapies for Osteoporosis

Figure 24: Unmet Needs for the Treatment of Osteoporosis, 2017

Figure 25: Overview of the Development Pipeline in Osteoporosis, March 2019

Figure 26: Osteoporosis – Key Phase IIB–III Clinical Trials, 2017

Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in Osteoporosis, 2017–2027

Figure 28: Clinical and Commercial Positioning – Evenity, 2017

Figure 29: Global Sales of Branded Osteoporosis Products by Company, 2017–2027

Figure 30: Company Portfolio Gap Analysis in Osteoporosis, 2017–2027

Figure 31: Global (7MM) Sales Forecast by Country for Osteoporosis in 2017 and 2027

Figure 32: Global (7MM) Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027

Figure 33: Global (7MM) Sales Forecast by Drug Class for Osteoporosis, 2017–2027

Figure 34: Global (7MM) Sales Forecast by Osteoporosis Patient Segment, 2017–2027

Figure 35: US Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027

Figure 36: 5EU Sales Forecast by Country for Osteoporosis in 2017 and 2027

Figure 37: 5EU Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027

Figure 38: Japan Sales Forecast by Drug Class for Osteoporosis in 2017 and 2027

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