Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Women' s Health pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the osteoporosis market
- Contributing experts
- Related reports
- CHAPTER 2 COUNTRY TREATMENT TREES
- Introduction to treatment trees
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- CHAPTER 3 DISEASE BACKGROUND AND EPIDEMIOLOGY
- Disease background
- Osteoporosis classification: primary and secondary
- Patient segmentation
- Severity: osteopenia, osteoporosis and severe/established
osteoporosis
- Gender
- Ethnicity
- Osteoporosis in children
- Niche populations with osteoporosis
- Epidemiology
- Methodological difficulties in assessing prevalence
- Differences in the definition of osteopenia, osteoporosis,
severe/established osteoporosis and vertebral fractures
- Disparities in the reference points (T-score) used for bone mineral
density measurement
- Differences in the skeletal sites scanned to measure bone mineral
density and diagnose osteoporosis
- Patient populations include different age groups
- Prevalence of osteopenia, osteoporosis and severe/established
osteoporosis in postmenopausal women
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Ageing population expands osteoporosis patient potential
- CHAPTER 4 PRESENTATION, DIAGNOSIS AND TREATMENT RATES
- Presentation
- Similar number of patients are diagnosed after screening as those
presenting with a fracture
- Initial presentation is most often with a specialist in an out-patient
hospital setting
- There is not one particular reason most common for presentation
- Diagnosis
- Under-diagnosis is a major problem in osteoporosis
- Patients are most often diagnosed by a specialist in the out-patient
setting
- The combination of primary assessment and additional diagnostic
techniques to achieve an osteoporosis diagnosis is underused
- Patient history and physical exam are the most important parts of
primary assessment
- Dual-energy X-ray absorptiometry (DXA) of the spine/hip is most widely
used additional diagnostic technique
- Treatment rates
- Treatment rates have been increasing but are still low
- Guidelines base initiation of pharmacological treatment on
cost-effectiveness
- The US National Osteoporosis Foundation guidelines on the prevention
and treatment of osteoporosis
- The European Guidance for the diagnosis and management of
osteoporosis in postmenopausal women
- The UK National Institute of Clinical Excellence guidelines on
primary and secondary prevention of fractures
- The German Dachverband Osteologie guideline osteoporosis in women
after menopause and in men after age 60
- The use of pharmacological treatment increases with disease severity
- Type of physician responsible for initial and long-term treatment
varies per country
- Most patients treated by specialists are treated in the out-patient
setting
- CHAPTER 5 TREATMENT OPTIONS AND TRENDS
- Non-pharmacological treatment of osteoporosis
- Overview of the available drug classes
- Bisphosphonates
- Bisphosphonate combinations
- Selective estrogen receptor modulators (SERMs)
- Parathyroid hormone (PTH) and analogs
- Calcitonins
- Dual action bone agents (DABAs)
- Hormone replacement therapy (HRT)
- Vitamin D
- Guidelines often favor bisphosphonates as first-line therapy but do not
give detailed recommendations
- The European Guidance for the Diagnosis and Management of Osteoporosis
in Postmenopausal Women
- The National Institute for Health and Clinical Excellence (NICE)
guidelines for the primary prevention of fractures
- The National Institute for Health and Clinical Excellence (NICE)
guidelines for the secondary prevention of fractures
- The German Dachverband Osteologie (DVO) guidelines
- The guidelines published by the National Osteoporosis Foundation (NOF)
- Trends in pharmacological treatment
- Compliance is an important issue in the treatment of osteoporosis
- Trends in first-line treatment
- Oral bisphosphonates dominate all severities across the seven major
markets
- Injectable bisphosphonates are mainly reserved for most severe
disease
- Selective estrogen receptor modulators (SERMs) are most often
prescribed in osteopenia
- Parathyroid hormones (PTHs) are most often prescribed in severe
osteoporosis
- Calcitonins are still prominent in Japanese treatment regimens
- Strontium ranelate particularly popular in France, Italy and Spain
- Reasons to switch to second-line treatment
- Trends in second-line treatment
- Entry of generic alendronate in the US and Japan
- CHAPTER 6 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT
- Factors influencing physician decision making
- Physician perception of key brands
- Total scores per drug per country
- Interpreting a brand map
- The bisphosphonate class
- Bisphosphonates brand map
- Bisphosphonates individual scores
- Bisphosphonates treatment trends
- Overview of key brands
- The selective estrogen receptor modulator (SERM) class
- Selective estrogen receptor modulator (SERM) brand map
- Selective estrogen receptor modulator (SERM) individual scores
- Selective estrogen receptor modulator (SERM) treatment trends
- Overview of key brands
- Products from other drug classes
- Products from other drug classes brand map
- Products from other drug classes individual scores
- Products from other drug classes prescribing trends
- Overview of key brands
- BIBLIOGRAPHY
- Articles
- Websites
- Press releases
- APPENDIX A
- Physician research methodology
- Physician sample breakdown
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- Contributing experts
- APPENDIX B
- The survey questionnaire
- Section 1 - Patient Segmentation
- Section 2 - Presentation and diagnosis
- Section 3 - Treatment options
- Section 4 - Treatments
- Section 5 - Product Profiles
- Section 6 -Generic Erosion
- About Datamonitor
- About Datamonitor Healthcare
- About the Women' s Health and Urology analysis team
- Disclaimer
- List of Tables
- Table 1: Niche populations with osteoporosis
- Table 2: Overview of studies estimating the prevalence of osteopenia in
the seven major markets, 2008
- Table 3: Overview of studies estimating the prevalence of osteoporosis
in the seven major markets
- Table 4: Overview of studies estimating the prevalence of
severe/established osteoporosis in the seven major markets
- Table 5: Prevalence of osteopenia in postmenopausal women across the
seven major markets, 2008
- Table 6: Prevalence of osteoporosis in postmenopausal women across the
seven major markets, 2008
- Table 7: Prevalence of severe/established osteoporosis in postmenopausal
women across the seven major markets, 2008
- Table 8: Overview of the postmenopausal patient populations across the
seven major markets with each severity of osteoporosis, 2008
- Table 9: Osteoporosis management of hip fracture patients by study site
in the US
- Table 10: Guideline recommendations on when to initiate pharmacological
treatment of osteoporosis, 2008
- Table 11: Overview of level of evidence for three bisphosphonates in the
primary and secondary prevention of fractures in postmenopausal osteoporosis
- Table 12: Overview of the key bisphosphonates available for osteoporosis
(sales are osteoporosis-specific), 2008
- Table 13: Overview of the key bisphosphonate combinations available for
osteoporosis (sales are osteoporosis-specific), 2008
- Table 14: Overview of the only selective estrogen receptor modulators
(SERM) available for osteoporosis (sales are osteoporosis-specific), 2008
- Table 15: Overview of the key parathyroid hormone (PTH) and analogs
available for osteoporosis (sales are osteoporosis-specific), 2008
- Table 16: Overview of the key calcitonins available for osteoporosis
(sales are osteoporosis-specific), 2008
- Table 17: Overview of the only dual action bone agent available for
osteoporosis in the seven major markets, 2008
- Table 18: First-line recommendations of a selection of osteoporosis
guidelines, 2008
- Table 19: Anti-fracture efficacy of the most frequently used treatments
for postmenopausal osteoporosis when given with calcium and vitamin D, as
derived from randomized controlled trials
- Table 20: Number and percentage of physicians able to rate each
osteoporosis drug, 2008
- Table 21: Total scores (out of 100) of each osteoporosis drug for each
of the individual seven major markets
- Table 22: US physician sample breakdown, 2008
- Table 24: France physician sample breakdown, 2008
- Table 25: Germany physician sample breakdown, 2008
- Table 26: Italy physician sample breakdown, 2008
- Table 27: Spain physician sample breakdown, 2008
- Table 28: UK physician sample breakdown, 2008
- List of Figures
- Figure 1: US treatment tree, 2008
- Figure 2: Japan treatment tree, 2008
- Figure 3: France treatment tree, 2008
- Figure 4: Germany treatment tree, 2008
- Figure 5: Italy treatment tree, 2008
- Figure 6: Spain treatment tree, 2008
- Figure 7: UK treatment tree, 2008
- Figure 8: Osteoporotic fractures occur most commonly at the spine, hip
and wrist
- Figure 9: World Health Organization classification of osteoporotic bone
loss
- Figure 10: Average prevalence according to osteoporosis severity across
the seven major markets, 2008
- Figure 11: Average age at diagnosis for each severity of osteoporosis
across the seven major markets, 2008
- Figure 12: Rising percentage of women over 50 years of age in the seven
major markets, 2008 and 2020
- Figure 13: Different routes of diagnosis: screening and presenting with
a fracture - average across the seven major markets, 2008
- Figure 14: Percentage of patients who present initially to each type of
physician, 2008
- Figure 15: Percentage of patients who present initially to a specialist
in each location, 2008
- Figure 16: Percentage of osteopenic and osteoporotic patients who
present for each reason, 2008
- Figure 17: Percentage of patients who are diagnosed by each type of
physician, 2008
- Figure 18: Percentage of patients who are diagnosed by a specialist in
each location, 2008
- Figure 19: Use of each method of patient assessment by PCPs/GPs and
specialists in order to reach osteoporosis diagnosis, 2008
- Figure 20: Potentially osteoporotic patients who receive each method of
primary assessment, 2008
- Figure 21: Potentially osteoporotic patients who receive each method of
additional diagnostic technique, 2008
- Figure 22: Advantages of central dual-energy X-ray absorptiometry (DXA)
- Figure 23: Treatment of Caucasian women aged 60 years or older with
osteoporosis or vertebral fractures by primary care physicians, by drug
type, 1993-97
- Figure 24: Management algorithm in postmenopausal women based on an
health economic analysis for the UK, 2008
- Figure 25: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each type of treatment, 2008
- Figure 26: Percentage of patients who are treated (initially and
long-term) by each type of physician, 2008
- Figure 27: Percentage of patients who are treated by a specialist in
each location, 2008
- Figure 28: Percentage of patients discontinuing pharmacological
treatment due to non-compliance at different times across the seven major
markets, 2008
- Figure 29: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each drug class in the 7MM, 2008
- Figure 30: Overview of the prescription of oral bisphosphonates across
osteoporosis severities, per country, 2008
- Figure 31: Overview of the prescription of injectable bisphosphonates
across osteoporosis severities, per country, 2008
- Figure 32: Overview of the prescription of selective estrogen receptor
modulators (SERMs) across osteoporosis severities, per country, 2008
- Figure 33: Overview of the prescription of parathyroid hormones across
osteoporosis severities, per country, 2008
- Figure 34: Overview of the prescription of calcitonins across
osteoporosis severities, per country, 2008
- Figure 35: Overview of the prescription of drugs from other drug classes
across osteoporosis severities, per country, Figure 36: Percentage of
patients switching from first-line therapy to second-line therapy due to a
new or recurrent fracture, 2008
- Figure 37: Percentage of patients switching from first-line therapy to
second-line therapy for other reasons, 2008
- Figure 38: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each drug class in first-line, second-line due to
fracture and second-line for another reason, 2008
- Figure 39: Sales of Fosamax and generic Fosamax in the five major
European countries, 2003-07
- Figure 40: Percentage of patients in the US and Japan who will be
switched to generic alendronate from Fosamax, a different bisphosphonate or
a drug from a different class, 2008
- Figure 41: Number of points allocated to each factor to indicate its
relative importance in each country or region, 2008
- Figure 42: Brand map of the scoring attributes of osteoporosis drugs in
relation to each other
- Figure 43: Brand map of the scores of the individual products in
relation to each other
- Figure 44: Brand map highlighting the position of bisphosphonate
products, 2008
- Figure 45: Number of points allocated to each bisphosphonate on all
factors, seven major markets, 2008
- Figure 46: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each bisphosphonate brand, 2008
- Figure 47: Brand map highlighting the position of selective estrogen
receptor modulators (SERMs), 2008
- Figure 48: Number of points allocated to each selective estrogen
receptor modulator (SERM) on all factors, seven major markets, 2008
- Figure 49: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each selective estrogen receptor modulator (SERM) brand,
2008
- Figure 50: Brand map highlighting the position of products from other
drug classes, 2008
- Figure 51: Number of points allocated to products in other drug classes
on all factors, seven major markets, 2008
- Figure 52: Osteopenic, osteoporotic and severe/established osteoporotic
patients receiving each drug from other drug classes, 2008
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