Osteoporosis - Risk management and reformulation offer best defense against generic onslaught
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Women's Health pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope and objective of the analysis - page 3
- Datamonitor insight into the osteoporosis market - page 4
- Contributing experts - page 5
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 7
- Market definition for this report - page 7
- Current market situation - page 9
- Market continues trend of steady growth - page 9
- US market share dominates but in Europe, Italy shows strongest growth - page 9
- Top five brands contribute to 73% of total market - page 11
- Merck's market dominance threatened by rival brands and generics - page 13
- Reformulation is a key brand lifecycle strategy for osteoporosis players - page 14
- Further European roll-out will boost Boniva sales - page 15
- Strategic scoping and focus - page 16
- Market continues trend of steady growth - page 9
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 18
- Summary of environmental issues affecting osteoporosis market size - page 18
- Seven major markets opportunities and threats - page 21
- Opportunities - page 21
- Ageing population expands osteoporosis patient potential - page 21
- Global organizations support initiatives for improved patient identification, increasing the number of patients available for treatment - page 22
- Increasing recognition of the male osteoporosis market - page 24
- EMEA suggests reduction in length of pivotal trials - page 26
- Threats - page 26
- Growing genericization of the market introduces strong cost competition - page 26
- EMEA to revise guidelines for evaluation of primary osteoporosis drugs creating the potential for new drugs to usurp establish products - page 28
- Parallel trade from new EU states threatens to introduce cheap alternatives - page 28
- Opportunities - page 21
- US: opportunities and threats - page 29
- Opportunities - page 29
- Manufacturers can tap into the large untreated patient population - page 29
- HEDIS criteria, supported by industry, has potential to increase diagnostic and treatment rates - page 30
- Threats - page 31
- Many elderly patients fall into the Medicare Part D 'donut hole' and are denied reimbursement - page 31
- Genericization of Fosamax exacerbated by generic reimbursement - page 32
- Direct to consumer advertising curbed limits patient visibility of new products in US - page 32
- Osteoporosis given a low priority by US government - page 32
- Opportunities - page 29
- Japan: opportunities and threats - page 33
- Opportunities - page 33
- Underdeveloped Japan market is becoming more accepting of US and 5EU products - page 33
- Japanese government supports osteoporosis awareness initiatives - page 34
- Increasing incidence of hip fractures - page 34
- Governmental funding for clinical trials - page 35
- Cash injection for elderly healthcare - page 35
- Threats - page 36
- Grades for osteoporosis drugs create more bureaucracy before launch onto Japanese market - page 36
- Lagging approval times have yet to quicken - page 36
- Opportunities - page 33
- France: opportunities and threats - page 37
- Opportunities - page 37
- French identify those at risk of fracture increasing potential treatable population - page 37
- Threats - page 38
- Generic incursion on the osteoporosis market will be most rapid in France - page 38
- Opportunities - page 37
- Germany: opportunities and threats - page 39
- Opportunities - page 39
- Large untreated patient population indicates sizeable scope for market growth - page 39
- Current consumer information needs to be updated presenting an opportunity for manufacturers to promote brand image - page 40
- Threats - page 41
- Limitations on DXA scanning reimbursement impacts diagnosis rates - page 41
- Opportunities - page 39
- Italy: opportunities and threats - page 42
- Opportunities - page 42
- Italian government makes osteoporosis a high priority - page 42
- Threats - page 43
- Extensive cost containment measures in place - page 43
- Opportunities - page 42
- Spain: opportunities and threats - page 44
- Opportunities - page 44
- Pharma tax reduction to create savings in region of $5.8m - page 44
- Threats - page 44
- Severe lack of scanning equipment limits market - page 44
- Opportunities - page 44
- UK: opportunities and threats - page 45
- Opportunities - page 45
- Creation of the 'Musculoskeletal Services Framework' improves accessibility of the health services to patients - page 45
- NOS input to NICE methodologies appraisals strives to widen potential market - page 46
- Investment in DXA scanning will increase opportunities for diagnosis - page 47
- Reduced clinical trial times will accelerate pipeline products to the market - page 47
- Threats - page 48
- Generic alendronate is a barrier to UK market entry - page 48
- Opportunities - page 45
- CHAPTER 4 FORECAST ANALYSIS - page 50
- Key events - page 50
- New product launches in the US and EU - page 50
- Preos in Europe - page 51
- Aclasta - page 52
- Bazedoxifene - page 53
- Denosumab - page 55
- BN-002 - page 56
- Ostabolin-C - page 56
- MER-103 - page 57
- New product launches in Japan - page 58
- Bisponal - page 58
- ED-71 - page 59
- hPTH - page 59
- Denosumab - page 60
- Patent expiries - page 60
- Fosamax - page 60
- Actonel - page 61
- Evista - page 61
- Miacalcin (intranasal formulation) - page 62
- Reformulations - page 63
- Boniva brand - page 63
- Miacalcin - page 64
- Fortical - page 65
- Actonel in Japan - page 65
- New product launches in the US and EU - page 50
- Data definitions, limitations and assumptions - page 66
- Standard units - page 66
- Japanese market data - page 66
- Derivation of sales forecasts and pricing trends - page 66
- Market definition - page 66
- Generic erosion and pricing assumptions - page 67
- Forecasts - page 67
- Forecast methodology - page 68
- Key events - page 50
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 69
- Introduction - page 69
- Strategies to optimize administration are well suited to the osteoporosis market - page 70
- Intermittent dosing is the key market driving strategy - page 71
- SWOT analysis of intermittent dosing - page 71
- Daily to weekly dosing switch was a key strategy for market leader - page 71
- Geographic expansion now necessary to optimize switch to weekly dosing - page 73
- From daily to yearly - opportunity still exists for more intermittently dosed products - page 73
- Innovative modes of delivery - page 75
- Intranasal delivery rejuvenates brands in the calcitonin class - page 75
- Tolerable oral solution is permissible with Servier's new mechanism of action - page 76
- Addition of vitamin D and calcium supplements - page 78
- Merck's combination product Fosamax Plus D was most successful strategy - page 78
- P&G's co-packaging strategy 'Actonel with Calcium' has drawbacks - page 80
- Intermittent dosing is the key market driving strategy - page 71
- Differing patient segmentation and product positioning of multiple brands minimizes franchise risk - page 80
- Eli Lilly: same indication, different mechanisms of action with Evista and Forteo - page 80
- Alternating brand strategies help to maintain revenue growth - page 81
- Roche: two differently administered intermittent doses of Boniva target separate patient groups - page 83
- Eli Lilly: same indication, different mechanisms of action with Evista and Forteo - page 80
- BIBLIOGRAPHY - page 84
- Journal papers - page 84
- Websites - page 86
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 89
- Summary osteoporosis market data - page 89
- Key marketed products - page 93
- Summary osteoporosis market data - page 89
- APPENDIX B - MARKET FORECAST DATA - page 99
- Global - page 99
- M5EU - page 100
- US - page 101
- Japan - page 102
- France - page 103
- Germany - page 105
- Italy - page 106
- Spain - page 107
- UK - page 108
- APPENDIX C - page 110
- Contributing experts - page 110
- Report methodology - page 110
- About Datamonitor - page 110
- About Datamonitor Healthcare - page 111
- About the Women's Health and Urology analysis team - page 112
- Disclaimer - page 113
- List of Tables
- Table 1: Summary of therapeutic classes in osteoporosis by ATC code in alphabetical order - page 7
- Table 2: Summary of the ICD-10 codes used to derive osteoporosis-specific sales from each brand - page 8
- Table 3: Key osteoporosis market players and their brands, 2006 - page 12
- Table 4: Summary of environmental issues in the global osteoporosis market, 2007 - page 18
- Table 5: Summary of environmental issues in the US and Japanese osteoporosis markets, 2007 - page 19
- Table 6: Summary of environmental issues in the French, German, Italian, Spanish and UK osteoporosis markets, 2007 - page 20
- Table 7: Key patent expiries in the osteoporosis market across the seven major markets, 2007-2016 - page 27
- Table 8: Price per year ($) of key osteoporosis treatments, 2006 - page 31
- Table 9: Datamonitor's launch dates for products in the 5EU and US, 2007-2016 - page 51
- Table 10: Datamonitor's launch dates for various formulations of the bazedoxifene brand in the US and 5EU, 2007-2016 - page 54
- Table 11: Estimated launch dates for Japanese osteoporosis products, 2007-2016 - page 58
- Table 12: Dates of Fosamax's patent expiry in the seven major markets, 2007 - page 60
- Table 13: Dates of Actonel's patent expiry in the seven major markets, 2007-2016 - page 61
- Table 14: Dates of Evista's patent expiry in the seven major markets, 2007-2016 - page 62
- Table 15: Dates of Evista's patent expiry in the US, 2007-2016 - page 62
- Table 16: Promotional spend (not including DTC) for Protelos, 2006 - page 78
- Table 17: Summary Market Data for the US - page 89
- Table 18: Summary Market Data for Japan - page 89
- Table 19: Summary Market Data for France - page 90
- Table 20: Summary Market Data for Germany - page 90
- Table 21: Summary Market Data for Italy - page 91
- Table 22: Summary Market Data for Spain - page 91
- Table 23: Summary Market Data for the UK - page 92
- Table 24: Fosamax: facts - page 93
- Table 25: Actonel: key facts - page 94
- Table 26: Boniva: key facts - page 95
- Table 27: Evista: key facts - page 96
- Table 28: Forteo: key facts - page 97
- Table 29: Miacalcin: key facts - page 98
- Table 30: Global† osteoporosis drug sales ($m) forecasts, 2007-2016 - page 99
- Table 31: 5EU osteoporosis drug sales ($m) forecasts, 2007-2016 - page 100
- Table 32: US osteoporosis drug sales ($m) forecasts, 2007-2016 - page 101
- Table 33: Japan osteoporosis drug sales ($m) forecasts, 2007-2016 - page 102
- Table 34: France osteoporosis drug sales ($m) forecasts, 2007-2016 - page 103
- Table 35: Germany osteoporosis drug sales ($m) forecasts, 2007-2016 - page 105
- Table 36: Italy osteoporosis drug sales ($m) forecasts, 2007-2016 - page 106
- Table 37: Spain osteoporosis drug sales ($m) forecasts, 2007-2016 - page 107
- Table 38: UK osteoporosis drug sales ($m) forecasts, 2007-2016 - page 108
- List of Figures
- Figure 1: Osteoporosis market value across the seven major markets, 2003-06 - page 9
- Figure 2: Performance of the individual seven major osteoporosis markets, 2005-06 - page 11
- Figure 3: Sales of the top five drugs in the global market, 2006 - page 14
- Figure 4: Breakdown of key brand sales by formulation, 2006 - page 15
- Figure 5: Breakdown of key brand sales by region, 2006 - page 16
- Figure 6: Change in the number of people aged over 50 years in the seven major markets, 2007-2017 - page 21
- Figure 7: Volume sales of Fosamax and alendronate generics in the UK, 2003-06 - page 48
- Figure 8: SWOT analysis of monthly and less frequent intermittent doses - page 71
- Figure 9: Volume sales of Fosamax tablets by dose for osteoporosis in the US and 5EU, 2003-06 - page 72
- Figure 10: Growth of oral monthly Boniva for osteoporosis in the US, Germany and the UK, 2005-07 - page 74
- Figure 11: Total brand sales of Boniva for osteoporosis in the US and 5EU, 2005-06 - page 75
- Figure 12: Sales of Protelos for osteoporosis in the 5EU, 2004-06 - page 77
- Figure 13: Contribution of Fosamax and Fosamax Plus D to total Fosamax brand osteoporosis sales in the seven major markets, 2003-06 - page 79
- Figure 14: Eli Lilly's total osteoporosis franchise ($000s), 2003-06 - page 81
- Figure 15: Key events affecting Eli Lilly brands Evista and Forteo, 1998-2012 - page 82
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