Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Women' s Health pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope and objective of the analysis
- Datamonitor insight into the osteoporosis market
- Contributing experts
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Current market situation
- Market continues trend of steady growth
- US market share dominates but in Europe, Italy shows strongest growth
- Top five brands contribute to 73% of total market
- Merck' s market dominance threatened by rival brands and generics
- Reformulation is a key brand lifecycle strategy for osteoporosis
players
- Further European roll-out will boost Boniva sales
- Strategic scoping and focus
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Summary of environmental issues affecting osteoporosis market size
- Seven major markets opportunities and threats
- Opportunities
- Ageing population expands osteoporosis patient potential
- Global organizations support initiatives for improved patient
identification, increasing the number of patients available for treatment
- Increasing recognition of the male osteoporosis market
- EMEA suggests reduction in length of pivotal trials
- Threats
- Growing genericization of the market introduces strong cost
competition
- EMEA to revise guidelines for evaluation of primary osteoporosis
drugs creating the potential for new drugs to usurp establish products
- Parallel trade from new EU states threatens to introduce cheap
alternatives
- US: opportunities and threats
- Opportunities
- Manufacturers can tap into the large untreated patient population
- HEDIS criteria, supported by industry, has potential to increase
diagnostic and treatment rates
- Threats
- Many elderly patients fall into the Medicare Part D ' donut hole' and
are denied reimbursement
- Genericization of Fosamax exacerbated by generic reimbursement
- Direct to consumer advertising curbed limits patient visibility of
new products in US
- Osteoporosis given a low priority by US government
- Japan: opportunities and threats
- Opportunities
- Underdeveloped Japan market is becoming more accepting of US and 5EU
products
- Japanese government supports osteoporosis awareness initiatives
- Increasing incidence of hip fractures
- Governmental funding for clinical trials
- Cash injection for elderly healthcare
- Threats
- Grades for osteoporosis drugs create more bureaucracy before launch
onto Japanese market
- Lagging approval times have yet to quicken
- France: opportunities and threats
- Opportunities
- French identify those at risk of fracture increasing potential
treatable population
- Threats
- Generic incursion on the osteoporosis market will be most rapid in
France
- Germany: opportunities and threats
- Opportunities
- Large untreated patient population indicates sizeable scope for
market growth
- Current consumer information needs to be updated presenting an
opportunity for manufacturers to promote brand image
- Threats
- Limitations on DXA scanning reimbursement impacts diagnosis rates
- Italy: opportunities and threats
- Opportunities
- Italian government makes osteoporosis a high priority
- Threats
- Extensive cost containment measures in place
- Spain: opportunities and threats
- Opportunities
- Pharma tax reduction to create savings in region of $5.8m
- Threats
- Severe lack of scanning equipment limits market
- UK: opportunities and threats
- Opportunities
- Creation of the ' Musculoskeletal Services Framework' improves
accessibility of the health services to patients
- NOS input to NICE methodologies appraisals strives to widen
potential market
- Investment in DXA scanning will increase opportunities for diagnosis
- Reduced clinical trial times will accelerate pipeline products to
the market
- Threats
- Generic alendronate is a barrier to UK market entry
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- New product launches in the US and EU
- Preos in Europe
- Aclasta
- Bazedoxifene
- Denosumab
- BN-002
- Ostabolin-C
- MER-103
- New product launches in Japan
- Bisponal
- ED-71
- hPTH
- Denosumab
- Patent expiries
- Fosamax
- Actonel
- Evista
- Miacalcin (intranasal formulation)
- Reformulations
- Boniva brand
- Miacalcin
- Fortical
- Actonel in Japan
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Market definition
- Generic erosion and pricing assumptions
- Forecasts
- Forecast methodology
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Strategies to optimize administration are well suited to the
osteoporosis market
- Intermittent dosing is the key market driving strategy
- SWOT analysis of intermittent dosing
- Daily to weekly dosing switch was a key strategy for market leader
- Geographic expansion now necessary to optimize switch to weekly
dosing
- From daily to yearly - opportunity still exists for more
intermittently dosed products
- Innovative modes of delivery
- Intranasal delivery rejuvenates brands in the calcitonin class
- Tolerable oral solution is permissible with Servier' s new mechanism
of action
- Addition of vitamin D and calcium supplements
- Merck' s combination product Fosamax Plus D was most successful
strategy
- P&G' s co-packaging strategy ' Actonel with Calcium' has drawbacks
- Differing patient segmentation and product positioning of multiple
brands minimizes franchise risk
- Eli Lilly: same indication, different mechanisms of action with Evista
and Forteo
- Alternating brand strategies help to maintain revenue growth
- Roche: two differently administered intermittent doses of Boniva
target separate patient groups
- BIBLIOGRAPHY
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary osteoporosis market data
- APPENDIX B - MARKET FORECAST DATA
- Global
- M5EU
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- APPENDIX C
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Women' s Health and Urology analysis team
- Disclaimer
- List of Tables
- Table 1: Summary of therapeutic classes in osteoporosis by ATC code in
alphabetical order
- Table 2: Summary of the ICD-10 codes used to derive
osteoporosis-specific sales from each brand
- Table 3: Key osteoporosis market players and their brands, 2006
- Table 4: Summary of environmental issues in the global osteoporosis
market, 2007
- Table 5: Summary of environmental issues in the US and Japanese
osteoporosis markets, 2007
- Table 6: Summary of environmental issues in the French, German,
Italian, Spanish and UK osteoporosis markets, 2007
- Table 7: Key patent expiries in the osteoporosis market across the
seven major markets, 2007-2016
- Table 8: Price per year ($) of key osteoporosis treatments, 2006
- Table 9: Datamonitor' s launch dates for products in the 5EU and US,
2007-2016
- Table 10: Datamonitor' s launch dates for various formulations of the
bazedoxifene brand in the US and 5EU, 2007-2016
- Table 11: Estimated launch dates for Japanese osteoporosis products,
2007-2016
- Table 12: Dates of Fosamax' s patent expiry in the seven major markets,
2007
- Table 13: Dates of Actonel' s patent expiry in the seven major markets,
2007-2016
- Table 14: Dates of Evista' s patent expiry in the seven major markets,
2007-2016
- Table 15: Dates of Evista' s patent expiry in the US, 2007-2016
- Table 16: Promotional spend (not including DTC) for Protelos, 2006
- Table 17: Summary Market Data for the US
- Table 18: Summary Market Data for Japan
- Table 19: Summary Market Data for France
- Table 20: Summary Market Data for Germany
- Table 21: Summary Market Data for Italy
- Table 22: Summary Market Data for Spain
- Table 23: Summary Market Data for the UK
- Table 24: Fosamax: facts
- Table 25: Actonel: key facts
- Table 26: Boniva: key facts
- Table 27: Evista: key facts
- Table 28: Forteo: key facts
- Table 29: Miacalcin: key facts
- Table 30: Global† osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 31: 5EU osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 32: US osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 33: Japan osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 34: France osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 35: Germany osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 36: Italy osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 37: Spain osteoporosis drug sales ($m) forecasts, 2007-2016
- Table 38: UK osteoporosis drug sales ($m) forecasts, 2007-2016
- List of Figures
- Figure 1: Osteoporosis market value across the seven major markets,
2003-06
- Figure 2: Performance of the individual seven major osteoporosis
markets, 2005-06
- Figure 3: Sales of the top five drugs in the global market, 2006
- Figure 4: Breakdown of key brand sales by formulation, 2006
- Figure 5: Breakdown of key brand sales by region, 2006
- Figure 6: Change in the number of people aged over 50 years in the
seven major markets, 2007-2017
- Figure 7: Volume sales of Fosamax and alendronate generics in the UK,
2003-06
- Figure 8: SWOT analysis of monthly and less frequent intermittent doses
- Figure 9: Volume sales of Fosamax tablets by dose for osteoporosis in
the US and 5EU, 2003-06
- Figure 10: Growth of oral monthly Boniva for osteoporosis in the US,
Germany and the UK, 2005-07
- Figure 11: Total brand sales of Boniva for osteoporosis in the US and
5EU, 2005-06
- Figure 12: Sales of Protelos for osteoporosis in the 5EU, 2004-06
- Figure 13: Contribution of Fosamax and Fosamax Plus D to total Fosamax
brand osteoporosis sales in the seven major markets, 2003-06
- Figure 14: Eli Lilly' s total osteoporosis franchise ($000s), 2003-06
- Figure 15: Key events affecting Eli Lilly brands Evista and Forteo,
1998-2012
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