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SUMMARY
Introduction - The osteoporosis and HRT market was valued at $8.3 billion in 2003 and isforecast to grow to $17.9 billion by 2014, driven by a number of novelosteoporosis drug launches before 2009. Since the Womens Health Initiative,the HRT market has been in decline and non-hormonal osteoporosis drugs havepartially realized the opportunity to increase market share and value,further boosting sector growth.
Scope of this report - Epidemiology of female and male osteoporosis in the seven major markets
- Country specific forecasts based on IMS MIDAS data of key ATC classesA11C2; G3C; G3E; G3F; H4A; H4V; M5B1; M5B2; M5B9
- Analysis of WHI impact on the osteoporosis and HRT market and portfoliomanagement strategy in hormone therapy
- Extensive secondary research and utilization of licensed and in-housedatabases augmented by primary research interviews with key opinion leaders
Research and analysis highlights - The osteoporosis market is forecast to be worth $14.7 billion by 2014.Growth is driven by uplift after the WHI and new product launches to 2009.The market will face its first major genericization when Fosamax losespatent protection. Generics are expected in the UK in 2005, followed bypatent expiries in Europe in 2007 and the US in 2008.
- The WHI wiped $850 million off HRT market value in 2003, sending thesector into decline. Wyeth and other players in the market have respondedwith investment in R&D to expand their portfolios to meet the demand fortailored treatment in the menopausal population.
- Additional indications are critical in maximizing osteoporosis drugscommercial potential. Lillys Evista and Pfizers lasofoxifene are in trialsfor breast cancer and cardiovascular disease prevention, and Novartissbisphosphonate Zometa is moving into the osteoporosis market. Suchindications could add over $1 billion to brand revenues.
Key reasons to read this report - Predict the impact of key growth drivers on the market, such asintermittent dosing and multiple indications
- Review leading drug class and identify key success factors within thissector
- Quantify the impact of key patent expiries using the forecasting model
TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE- About the Womens Health pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY - Objective of the analysis
- Datamonitor insight into the osteoporosis and HRT market
CHAPTER 2 MARKET DEFINITION AND OVERVIEW - Market definition for this report
- Current market situation
- Strategic scope and focus
- Epidemiology of osteoporosis
- Methodological difficulties in assessing prevalence
- Prevalence of osteoporosis and osteopenia in postmenopausal women
- Overview of the prevalence of osteoporosis and osteopenia inpostmenopausal women
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Segmentation of osteoporosis
- Prevalence of osteoporosis and osteopenia in men
- Introduction
- Overview of the prevalence of osteoporosis/osteopenia in men
- US
- Japan
- France
- Germany
- Spain
- UK
CHAPTER 3 COUNTRY MARKET ASSESSMENTS - Current and future opportunities and threats in the osteoporosis and HRTmarket
- Global opportunities and threats
- US: opportunities and threats
- Japan: opportunities and threats
- France: opportunities and threats
- Italy: opportunities and threats
- UK: opportunities and threats
CHAPTER 4 FORECAST ANALYSIS - Assumptions and events
- Bisphosphonates
- Fosamax
- Actonel
- Pipeline bisphosphonates
- SERMs
- Calcitonins
- Miacalcin
- Pipeline calcitonins
- Parathyroid hormone derivatives
- Forteo
- Pipeline PTH therapy
- Hormone therapy
- Limitations of data
- Forecasts
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - Introduction
- Case studies
- Wyeth HRT portfolio strategy - preserving the Premarin brand andgambling on new molecules
- Premarin/Prempro
- Bazedoxifene and trimegestone
- NPS pre-launch strategy for Preos - piggybacking Kineret detailingactivity
- Chugai cornering the Japanese market
- Mercks Fosamax launch activity
- Heavy Phase IV activity among top three drugs
- Combination trials with Forteo, Evista and Fosamax
- Impact of the WHI on non-hormonal osteoporosis drugs
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - Bisphosphonates market data
- SERMs market data
- Calcitonins market data
- PTH market data
APPENDIX B - Bibliography
- Epidemiology
- Clinical trial data
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Disease analysis team
- Key therapy team members
- Name, Director Disease
- Disclaimer
- List of Tables
- Table 1: Key players in the osteoporosis and HRT market
- Table 2: WHO classification of osteoporotic bone loss
- Table 3: Epidemiology overview of osteoporosis
- Table 4: Prevalence of osteopenia and osteoporosis in postmenopausalwomen across the seven major markets, 2003
- Table 5: Prevalence of osteopenia and osteoporosis in men over 50 inthe seven major markets, 2003
- Table 6: Fosamax: key facts
- Table 7: Actonel: key brand facts
- Table 8: Evista: key facts
- Table 9: Miacalcin: key facts
- Table 10: Forteo: key facts
- List of Figures
- Figure 1: Prevalence of osteopenia and osteoporosis in postmenopausalwomen across the seven major markets, 2003
- Figure 2: Prevalence of osteopenia and osteoporosis in men over 50 inthe seven major markets, 2003
- Figure 3: Impact of Fosamax genericization by volume
- Figure 4: Critical success factors for treating physicians toprescribe novel bisphosphonates over currently marketed products
- Figure 5: US five-year sales trend of Premarin and Prempro
- Figure 6: US DTC advertising spend for Premarin and Prempro ($000s),1998(2003
- Figure 7: Premarin/Prempro online homepage
- Figure 8: Forecast of Evista US sales with approval in breast cancerand CVD indications, $000s, 2003(14
- Figure 9: Summary of Phase IV trial strategies for key marketedosteoporosis brands
- Figure 10: Impact of WHI on sales of key osteoporosis brands from 2001to 2003, $bn
- Figure 11: Change in share and value of key non-hormonal osteoporosisbrands before and after the 2002 release of WHI study data
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