[Report] Osteoporosis Commercial Insight Market Research, Trends, Analysis TOC

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
- Journal papers
- Websites
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary osteoporosis market data
  - Key marketed products
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

Commercial Insight: Osteoporosis - Risk management and reformulation offer best defense against generic onslaught

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