Stakeholder Insight: Osteoporosis - Poor Disease Awareness and Patient Identification Hinder Market Growth

SUMMARY

Osteoporosis, with an estimated prevalent population of over 127 million in the seven major markets and valued at around $7 billion in 2002,presents a commercially attractive target for development.

SCOPE OF THE REPORT

• Survey of 160 treating physicians in the seven major markets, with in-depth interviews with osteoporosis opinion leaders
• Detailed treatment trees show the proportion of patients screened, presented, diagnosed and receiving treatment, by disease severity and country
• Review of the use of combination therapy in key patient and physician populations, and of physician perception of R&D trends & potentialof novel drugs
• Investigation of therapeutic and diagnostic unmet needs, highlighting areas where pharma investment is vital to drive patient identification

REPORT HIGHLIGHTS

Datamonitor's research has identified strong variances in class and brand prescribing preferences among physicians, according to both diseaseseverity and geography. Combination therapy is prescribed in the US, Japan, the UK, France and Spain, though not in Italy and Germany.

Just 10% ofthe prevalent population in the seven major markets are diagnosed; just over half of those are drug treated. Market growth depends on driving patientidentification and diagnosis: potential barriers to growth include low disease awareness and limited access to and utilization of diagnostic tools.

Threedevelopments have the potential to radically change treatment and expand the market: SERMs in additional indications; PTH/anabolic drugs in fracturepatients and novel bisphosphonates in flexible dosing and delivery formulations.

KEY REASONS TO BUY THIS REPORT

• Understand physician prescribing behavior by specialty
• Identify differential treatment and unmet needs in key patient populations identified by sex and disease severity
• Validate new product forecasting based on diagnosis and treatment rates, and potential uptake for a new product based on physicians' perceptions

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoporosis market

• Osteoporosis is severely underdiagnosed and undertreated. Datamonitor primary research suggests that just 10% of the prevalent population acrossthe seven major markets is diagnosed with osteoporotic bone loss and only just over half of those receive drug treatment. Growth in this marketdepends on driving patient identification and diagnosis, yet this is an area fraught with unmet needs including disease awareness and access toand utilization diagnostic tools.
• Datamonitor primary research has identified strong variances in class and brand prescribing preferences among physicians, according to bothdisease severity and geography. Combination therapy is prescribed in the US, Japan, the UK, France and Spain, though not in Italy and Germany. Thepractice varies significantly in the extent of physician participation and use in the patient population
• Three trends in osteoporosis R&D have the potential to radically change treatment and expand the market: SERMs in additional indications;PTH/anabolic drugs in fracture patients and novel bisphosphonates in flexible dosing and delivery formulations. However, Datamonitor primaryresearch suggests that prescribers will vary widely in how receptive they are to these innovations.

Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight survey

Supporting data sets

CHAPTER 3 COUNTRY TREATMENT TREES

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Osteoporosis definition and classification

Introduction

Classification of osteoporosis

Etiology of osteoporosis

Epidemiology of osteoporosis

Methodological difficulties in assessing prevalence

Prevalence of osteoporosis and osteopenia in postmenopausal women

Prevalence of osteoporosis and osteopenia in men

Comparative physician-based patient population data

Osteoporosis population forecast

Fractures, their implications and minor risk groups

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

Presentation and diagnosis

The problem of patient identification in osteoporosis

Diagnosis – techniques and patient population

Treatment rates

Treatment options

Treatment guidelines

CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS

Prescribing trends

Drug therapy – an overview

Geographical trends in osteoporosis drug prescriptions

HRT in osteoporosis – not fade away?

Changes in therapy

Case study: SERMs vs. HRT in osteoporosis

CHAPTER 7 IMPROVING TREATMENT OUTCOMES

Treatment outcomes

New product development

Bisphosphonates in development

Parathyroid hormone – teriparatide (Forteo)

Unmet needs

Physician/patient education

Diagnostic unmet needs

Therapeutic unmet needs

CHAPTER 8 OTHER STAKEHOLDER INFLUENCES

Regulatory perspectives

Clinical trial endpoints in osteoporosis

Fracture risk reduction

Bone turnover markers

Bone microarchitecture and bone quality

Clinical trial design in osteoporosis

Payer/provider perspectives

Cost-effectiveness in preventive therapy

CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS

Key Opinion Leader 1 – Belgium

Key Opinion Leader 2 - UK

Key opinion Leader 3 – UK

Key Opinion Leader 4 - Germany

APPENDIX A BIBLIOGRAPHY

Epidemiology

Clinical trial data

APPENDIX B

Physician research methodology

Physician Sample breakdown

US

Japan

France

Germany

Italy

Spain

UK

Contributing experts

Stakeholder Insight: Osteoporosis QUESTIONNAIRE

1. Epidemiology

2. Screening and Diagnosis

List of Tables

Table 1: Prevalence of osteoporosis and osteopenia in the seven major markets, 000s, 2003-2011

Table 2: WHO classification of osteoporotic bone loss

Table 3: Causes of secondary (Type III) osteoporosis

Table 4: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003

Table 5: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003

Table 6: Percentage of interviewed physician' s patients with low bone mass by sex

Table 7: Estimated forecast of the osteoporosis and osteopenia populations over 50 years in the seven major markets, 000s, 2003(11

Table 8: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003

Table 9: Breakdown of osteoporotic populations by disease severity, country and sex, %, 2003

Table 10: Patients receiving drug treatment by disease severity and country, %, 2003

Table 11: Patients receiving drug treatment by physicians specialty and disease severity across the seven major markets, %, 2003

Table 12: Patients receiving either calcium and/or vitamin D by disease severity and by country, %, 2003

Table 13: Patients receiving either calcium and/or vitamin D by specialty across the seven major markets, %, 2003

Table 14: Patients receiving different drug classes in monotherapy and by disease severity and by country, %, 2003

Table 15: Patients receiving bisphosphonates in monotherapy by disease severity and by country, %, 2003

Table 16: Physician' s responses to the question ' Will positive trial results for SERMs in breast cancer and CVD lead to an increase in the useof SERMs for osteoporosis?'  by country, %, 2003

Table 17: Physician' s responses to the question ' Will positive trial results for SERMs in breast cancer and CVD lead to an increase in the useof SERMs for osteoporosis?'  by physician specialty, %, 2003

Table 18: Patient non-compliance at 6, 12 and 12+ month periods by country and disease severity, %, 2003

Table 19: Importance of treatment outcomes to physicians in response to the question "What are the main treatment outcomes for these (osteoporotic)patients?" across the seven major markets, %, 2003

Table 20: Physician' s awareness of novel bisphosphonates in development by country, %, 2003

Table 21: Physicians awareness of novel bisphosphonates in development by specialty, %, 2003

Table 22: Physicians who that think longer interval dosing will improve compliance by country, %, 2003

Table 23: Physicians who think that longer interval dosing will improve compliance by specialty, %, 2003

Table 24: Physicians awareness of Forteo by country, %, 2003

Table 25: US physician sample breakdown, 2003

Table 26: Japan physician sample breakdown, 2003

Table 27: France physician sample breakdown, 2003

Table 28: Germany physician sample breakdown, 2003

Table 29: Italy physician sample breakdown, 2003

Table 30: Spain physician sample breakdown, 2002

Table 31: UK physician sample breakdown, 2003

List of Figures

Figure 1: Osteoporosis drug treated population in the seven major markets, according to diagnosis and treatment rates, 2003

Figure 2: Osteoporosis patient flow schematic, 2003

Figure 3: Diagrammatic overview of the coverage of the Osteoporosis Stakeholder Insight survey, 2003

Figure 4: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, US, 2003

Figure 5: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, Japan, 2003

Figure 6: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, France, 2003

Figure 7: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, Germany, 2003

Figure 8: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, Italy, 2003

Figure 9: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, Spain, 2003

Figure 10: Breakdown of monotherapy treatment for the osteoporotic population over 50 years by disease severity, UK, 2003

Figure 11: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2003

Figure 12: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2003

Figure 13: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2003

Figure 14: Estimated rates of patient identification, diagnosis and treatment by country

Figure 15: Osteoporosis drug treated population in the seven major markets, according to diagnosis and treatment rates, 2003

Figure 16: Use of diagnostic techniques for osteoporosis by specialty, %, 2003

Figure 17: Patients receiving drug treatment by physicians specialty and disease severity across the seven major markets, %, 2003

Figure 18: Percentage of patients receiving drug treatment and calcium and/or vitamin D by severity across the seven major markets, %, 2003

Figure 19: Physician' s use osteoporosis treatment guidelines by country, %, 2003

Figure 20: Physician' s use of osteoporosis treatment guidelines by specialty across the seve major market, %, 2003

Figure 21: Physicians responses to the question ' Are SERMs a viable alternative to HRT in osteoporosis?' , by country, %, 2003

Figure 22: Physicians responses to the question ' Are SERMs a viable alternative to HRT in osteoporosis?' , by physician specialty, %, 2003

Figure 23: Physician' s responses to the question ' have you switched any of your patients using HRT for osteopenia or osteoporosis onto a SERM(Evista)?'  by country, %, 2003

Figure 24: Physician' s responses to the question ' have you switched any of your patients using HRT for osteopenia or osteoporosis onto a SERM(Evista)?'  by physician specialty, %, 2003

Figure 25: Physician' s responses to the question ' Will positive trial results for SERMs in breast cancer and CVD lead to an increase in theuse of SERMs for osteoporosis?'  across the seven major markets, %, 2003

Figure 26: Physicians prescribing drug/drug combinations by country and disease severity, %, 2003

Figure 27: Patients receiving any drug/drug combination by country and disease severity, %, 2003

Figure 28: Strategies to address poor compliance with osteoporosis treatment

Figure 29: Mean rankings of factors influencing drug choice across the seven major pharmaceutical markets, 2003

Figure 30: Mean ranking of factors affecting physician' s decision to switch treatment across the seven major markets, 2003

Figure 31: Physician awareness of novel bisphosphonates in development by candidate, %, 2003

Figure 32: Critical success factors for treating physicians to prescribe novel bisphosphonates over currently marketed products, 2003

Figure 33: Osteoporosis patient flow schematic

Figure 34: Osteoporosis stakeholders: interactions and relationships