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Published by: Datamonitor
Published: Sep. 12, 2002 - 270 Pages
Table of Contents
Overview
Introduction
TBC
DRIVERS AND TRENDS
Provides a comprehensive overview of the current focus and anticipated future evolution of the osteoporosis market. Explores the challenges facing companies seeking to launch new therapies for this indication and how these can be tackled.
The size of the market: just how big is the patient potential for osteoporosis?
Key barriers to higher presentation and diagnosis rates: is education or more accessible and efficacious screening the answer?
Will novel bone anabolic drugs like Forteo be welcomed in the treatment of severe osteoporosis?
How will the use of HRT in osteoporosis be affected by negative publicity from the WHI study?
Issues in clinical trial design: what does the FDA want, is this likely to change and how can companies achieve that?
Which are the most promising products in phase II/III development?
PATIENT POTENTIAL
Who suffers from low bone mineral density and how many people are affected by osteopenia, osteoporosis and osteoporotic fractures? This chapter gives an evaluation of the prevalent osteoporosis population segmented by gender and disease severity and includes: Evaluation of published epidemiological data to provide a breakdown of the osteopenia and osteporosis prevalence by gender for each of the seven markets.
Identifies osteoporosis niche populations and shifts in the composition of the patient population driven by screening and treatment patterns and discusses key clinical and environmental unmet need in the market
R&D APPROACH
What kind of products are available and in development for osteoporosis? This section provides key drug class analysis including gold standard identification and SWOT evaluation alongside an examination of clinical trial design and endpoints, it includes: Identification and detailed analysis of drug classes for the treatment of osteoporosis. Analyses the strengths, weaknesses, opportunities and threats of each therapeutic class and discusses key issues affecting the success of each class in the market.
Examines problems associated with primary and secondary clinical trial endpoints and some of the difficulties associated with osteoporosis trial design. Identifies areas in which clinical trials may need to evolve in order
to demonstrate relevant and robust efficacy data.
OSTEOPOROSIS PIPELINE ANALYSIS
Who is developing which drugs for osteoporosis and which companies are the major players in the market? This section provides an overview of all the drugs in development for osteoporosis from Phase I, II and III to registration, alongside an evaluation of key companies and strategies within the osteoporosis market, it includes: The identification of three key companies in the osteoporosis market which are discussed on the basis of their evolving existing and pipeline portfolios and similarities in approach to developing a broad range of osteoporosis therapies.
A number of significant company strategies in the osteoporosis market are examined in the areas of drug delivery, licensing strategies and the drive to attain multiple indications for individual drugs.
LATE STAGE DRUG ANALYSIS AND FORECASTS
This chapter provides detailed profiles of key bisphosphonates in late stage development for osteoporosis, providing for each a detailed examination of clinical trial data, patient potential, assessment of marketing factors and the drug’s satisfaction of unmet needs in comparison with gold standard therapies in each class. Revenue forecasts to 2010 have been generated for each drug using Datamonitor’s new interactive forecasting model. considers the trend of developing intermittent dosing schedules seen in both marketed and pipeline drugs in this class and its potential effect on uptake and patient acceptance. Pipeline drugs in this class are compared to Fosamax as the gold standard bisphosphonate therapy
SERM LATE STAGE DRUG ANALYSIS AND FORECASTS
This chapter provides detailed profiles of key SERMS in late stage development for osteoporosis, providing for each a detailed examination of clinical trial data, patient potential, assessment of marketing factors and the drug’s
satisfaction of unmet needs in comparison with gold standard therapies in each class. Revenue forecasts to 2010 have been generated for each drug using Datamonitor’s new interactive forecasting model.
SERMs: assesses pipeline drugs in this class compared with Evista as the gold standard therapy and considers the need for these drugs to also attempt to show efficacy in multiple indications in order to be competitive
PTH LATE STAGE DRUG ANALYSIS AND FORECASTS
This chapter provides detailed profiles of key PTH drugs in late stage development for osteoporosis, providing for each a detailed examination of clinical trial data, patient potential, assessment of marketing factors and the drug’s satisfaction of unmet needs in comparison with gold standard therapies in each class. Revenue forecasts to 2010 have been generated for each drug using Datamonitor’s new interactive forecasting model.
Analysis of the clinical profile of two developmental drugs in this class, both of which are compared to Fosamax as the gold standard osteoporosis therapy. Datamonitor believes that anabolic agents will drive a change in severe osteoporosis therapy and has generated a scenario forecast of the sales of Lilly’s Forteo based on low, median and high rates of uptake in the years following its launch
OTHER DRUG CLASSES LATE STAGE DRUG ANALYSIS AND FORECASTS
This chapter provides detailed profiles of key drugs with novel mechanisms of action in late stage development for osteoporosis, providing for each a detailed examination of clinical trial data, patient potential, assessment of marketing factors and the drug’s satisfaction of unmet needs in comparison with gold standard therapies in each class. Revenue forecasts to 2010 have been generated for each drug using Datamonitor’s new interactive forecasting
model.
Two drugs with novel mechanisms of action are examined in this chapter. Datamonitor believes that the significant potential of Servier’s Protos may be severely restricted by the limited marketing capacity of the developing company
HRT LATE STAGE DRUG ANALYSIS AND FORECASTS
This chapter provides detailed profiles of HRTs in late stage development for osteoporosis, providing for each an assessment of trial data where available and consideration of patient potential, marketing factors and the drug’s satisfaction of unmet needs. Revenue forecasts to 2010 have been generated for each drug using Datamonitor’s new interactive forecasting model.
HRT: the potential of developmental drugs in this class are considered in the light of the WHI trial results. atamonitor expects this to lead to a decline in the use of HRT for osteoporosis
ACTION POINTS
The launch of Forteo into the osteoporosis market in 2003 will change the treatment of osteoporotic fractures and strengthen Eli Lilly’s portfolio, making it the leading company in this market by 2010; The release of Women’s Health Initiative study data in July 2002 revealed increased risks of breast cancer and cardiovascular disease over long-term treatment with HRT and endangered sales of drugs in this class, particularly Wyeth’s Premarin family. Combined with recent changes in FDA labeling for HRT in osteoporosis, the use of HRT is likely to be restricted to the short-term treatment of climacteric symptoms in most women; Servier’s Protos is one of the most innovative drugs in the pipeline and has the potential to challenge both anabolic and antiresorptive agents in the osteoporosis market. However, to capitalize on this potential, Servier may need to consider out-licensing or co-marketing agreements. Datamonitor believes that there will be a long term shift in the epidemiology of osteoporosis, driven by changing treatment patterns and improved screening, with patients feeding through from the severe osteoporosis population into the osteoporotic and osteopenic populations
DATASETS
List of tables
Table 1: Key parameters of osteoporosis
Table 2: Forecast key pipeline products in osteoporosis in 2010
Table 3: Prevalence of osteopenia and osteoporosis across the seven major markets, 2002
Table 4: Prevalence of osteoporosis and osteopenia in men over 50 in the seven major markets, 2002
Table 5: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2002
Table 6: Prevalence of osteopenia and osteoporosis across the seven major
markets, broken down by gender, 2002
Table 7: Breakdown of the postmenopausal osteoporosis population by severity, 2002
Table 8: Forecast prevalent population of osteoporosis in postmenopausal women, 2002(10
Table 9: Forecast prevalent population of osteopenia in postmenopausal women, 2002(10
Table 10: Forecast prevalent population of osteoporosis in men over 50, 2002(2010
Table 11: Forecast prevalent population f osteopenia in men over 50, 2002(2010
Table 12: Overview of currently marketed bisphosphonates indicated for use in osteoporosis 77
Table 13: Overview of Fosamax
Table 14: Overview of Evista
Table 15: Overview of currently marketed HRT products
Table 16: Overview of Premarin
Table 17: Overview of Miacalcin
Table 18: Overview of the drugs in development for osteoporosis
Table 19: Key bisphosphonate products in late-stage R&D pipeline 2002
Table 20: Global sales forecasts for Bonviva, 2003(2010
Table 21: Impacting factors on the revenues of Bonviva, 2003-2010
Table 22: Global forecast sales revenues for Zometa, 2005(2010
Table 23: Overview of other bisphosphonates in development for osteoporosis, 2002 138
Table 24: Overview of the SERMs in late stage development for the prevention or treatment of osteoporosis
Table 25: Global sales forecast for lasofoxifene, 2003(2010
Table 26: Impacting factors on the revenues of lasfoxifene, 2003(2010
Table 27: Global sales forecast for bazedoxifene, 2005(2010
Table 29: Global sales forecasts for SERM 3339, 2007-10
Table 31: Summary of the PTH drugs in late stage development for osteoporosis
Table 32: Global sales forecasts for Forteo, 2003-10
Table 33: Impacting factors affecting Forteo sales forecast
Table 34: Forecast patient population for Forteo in the high uptake scenario
Table 35: Forecast patient population of Forteo in the low uptake scenario
Table 36: Forecast patient population of Forteo in the median uptake scenario
Table 37: Summary of the potential patient population of Forteo in the three scenario forecasts
Table 38: Global sales forecasts for Preos, 2005-10
Table 39: Summary products in alternative drug classes in late stage clinical trials for osteoporosis.
Table 40: Global sales forecasts for Protos, 2002-10
Table 41: Global sales forecasts for HCT 1026, 2002-10
Table 42: Overview of compounds in Phase I or preclinical development for osteoporosis 214
Table 43: Overview of the HRT products in development for the osteoporosis
Table 44: Global sales forecasts for Ondeva, 2002-10
Table 45: Global sales forecasts for Fem7 patch, 2002-10
Table 50: Global sales forecasts for Class X, 2002-10
AbstractIntroduction: Affecting over 25 million women across the 7 major markets, osteoporosis is a source of morbidity in the postmenopausal population. The size of the problem and its impact on healthcare budgets is expected to increase over the next decade. Osteoporosis is attracting growing R&D interest with a number of drugs in late stage development. Scope of the Report: * Evaluation of the size of the osteoporosis market based on epidemiological data and physician primary research * Assessment of the strengths and weaknesses of existing drugs classes * Analysis of drugs in late stage development *Scenario-based forecasts of penetration rates for novel parathyroid hormone therapies * Market and leading drug forecasts to 2010. Report Highlights: The release of Women's Health Initiative study data revealed increased risks of breast cancer and cardiovascular disease with long term treatment with Prempro jeopardizing sales of this brand and the class in general. Once the mainstay of osteoporosis management, HRT's use is expected to be increasingly restricted to short-term treatment of climacteric symptoms. This shift will leave a gap in the market which SERMs and bisphosphonates may be well placed to exploit. Current treatment of osteoporotic fractures involves slowing bone loss with antiresorptive agents, typically bisphosphonates. However, the launch of Forteo in 2003 will dramatically change the management of the condition. Key Reasons to Buy this Report: * Evaluates the unmet need within current osteoporosis treatment, identifying opportunities to maximize the commercial potential of pipeline therapies * Provides a breakdown of the osteoporosis population by gender and severity across the seven markets, identifying the key areas of opportunity * Provides an assessment of company portfolios and forecasts product revenues to 2010
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