Table of Contents

TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope and objective of the analysis 3
Datamonitor insight into the osteoporosis market 4
Contributing experts 5
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 14
Market definition for this report 14
Current market situation 16
Market continues trend of steady growth 16
US market share dominates but in Europe, Italy shows strongest growth 16
Top five brands contribute to 73% of total market 18
Merck’s market dominance threatened by rival brands and generics 20
Reformulation is a key brand lifecycle strategy for osteoporosis players 21
Further European roll-out will boost Boniva sales 22
Strategic scoping and focus 23
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 25
Summary of environmental issues affecting osteoporosis market size 25
Seven major markets opportunities and threats 28
Opportunities 28
Ageing population expands osteoporosis patient potential 28
Global organizations support initiatives for improved patient identification, increasing the number of patients available for treatment 29
Increasing recognition of the male osteoporosis market 31
EMEA suggests reduction in length of pivotal trials 33
Threats 33
Growing genericization of the market introduces strong cost competition 33
EMEA to revise guidelines for evaluation of primary osteoporosis drugs creating the potential for new drugs to usurp establish products 35
Parallel trade from new EU states threatens to introduce cheap alternatives 35
US: opportunities and threats 36
Opportunities 36
Manufacturers can tap into the large untreated patient population 36
HEDIS criteria, supported by industry, has potential to increase diagnostic and treatment rates 37
Threats 38
Many elderly patients fall into the Medicare Part D ‘donut hole’ and are denied reimbursement 38
Genericization of Fosamax exacerbated by generic reimbursement 39
Direct to consumer advertising curbed limits patient visibility of new products in US 39
Osteoporosis given a low priority by US government 39
Japan: opportunities and threats 40
Opportunities 40
Underdeveloped Japan market is becoming more accepting of US and 5EU products 40
Japanese government supports osteoporosis awareness initiatives 41
Increasing incidence of hip fractures 41
Governmental funding for clinical trials 42
Cash injection for elderly healthcare 42
Threats 43
Grades for osteoporosis drugs create more bureaucracy before launch onto Japanese market 43
Lagging approval times have yet to quicken 43
France: opportunities and threats 44
Opportunities 44
French identify those at risk of fracture increasing potential treatable population 44
Threats 45
Generic incursion on the osteoporosis market will be most rapid in France 45
Germany: opportunities and threats 46
Opportunities 46
Large untreated patient population indicates sizeable scope for market growth 46
Current consumer information needs to be updated presenting an opportunity for manufacturers to promote brand image 47
Threats 48
Limitations on DXA scanning reimbursement impacts diagnosis rates 48
Italy: opportunities and threats 49
Opportunities 49
Italian government makes osteoporosis a high priority 49
Threats 50
Extensive cost containment measures in place 50
Spain: opportunities and threats 51
Opportunities 51
Pharma tax reduction to create savings in region of $5.8m 51
Threats 51
Severe lack of scanning equipment limits market 51
UK: opportunities and threats 52
Opportunities 52
Creation of the ‘Musculoskeletal Services Framework’ improves accessibility of the health services to patients 52
NOS input to NICE methodologies appraisals strives to widen potential market 53
Investment in DXA scanning will increase opportunities for diagnosis 54
Reduced clinical trial times will accelerate pipeline products to the market 54
Threats 55
Generic alendronate is a barrier to UK market entry 55
CHAPTER 4 FORECAST ANALYSIS 57
Key events 57
New product launches in the US and EU 57
Preos in Europe 58
Aclasta 59
Bazedoxifene 60
Denosumab 62
BN-002 63
Ostabolin-C 63
MER-103 64
New product launches in Japan 65
Bisponal 65
ED-71 66
hPTH 66
Denosumab 67
Patent expiries 67
Fosamax 67
Actonel 68
Evista 68
Miacalcin (intranasal formulation) 69
Reformulations 70
Boniva brand 70
Miacalcin 71
Fortical 72
Actonel in Japan 72
Data definitions, limitations and assumptions 73
Standard units 73
Japanese market data 73
Derivation of sales forecasts and pricing trends 73
Market definition 73
Generic erosion and pricing assumptions 74
Forecasts 74
Forecast methodology 75
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 76
Introduction 76
Strategies to optimize administration are well suited to the osteoporosis market 77
Intermittent dosing is the key market driving strategy 78
SWOT analysis of intermittent dosing 78
Daily to weekly dosing switch was a key strategy for market leader 78
Geographic expansion now necessary to optimize switch to weekly dosing 80
From daily to yearly – opportunity still exists for more intermittently dosed products 80
Innovative modes of delivery 82
Intranasal delivery rejuvenates brands in the calcitonin class 82
Tolerable oral solution is permissible with Servier’s new mechanism of action 83
Addition of vitamin D and calcium supplements 85
Merck’s combination product Fosamax Plus D was most successful strategy 85
P&G’s co-packaging strategy ‘Actonel with Calcium’ has drawbacks 87
Differing patient segmentation and product positioning of multiple brands minimizes franchise risk 87
Eli Lilly: same indication, different mechanisms of action with Evista and Forteo 87
Alternating brand strategies help to maintain revenue growth 88
Roche: two differently administered intermittent doses of Boniva target separate patient groups 90
BIBLIOGRAPHY 91
Journal papers 91
Websites 93
APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 96
Summary osteoporosis market data 96
Key marketed products 100
APPENDIX B – MARKET FORECAST DATA 106
Global 106
M5EU 107
US 108
Japan 109
France 110
Germany 112
Italy 113
Spain 114
UK 115
APPENDIX C 117
Contributing experts 117
Report methodology 117
About Datamonitor 117
About Datamonitor Healthcare 118
About the Women’s Health and Urology analysis team 119
Disclaimer 120