骨粗鬆症市場における各薬剤の商業的機会

INTRODUCTION

As negative trial results edge the HRT market into decline, osteoporosis players have an opportunity to gain market share. Drugs with multiple indications and convenient dosing regimens will drive market growth. However, best practice promotion and lifecycle management will be as important as therapeutic advances to establish and maintain competitive advantage.

SCOPE OF THE REPORT

• Breakdown of market composition by IMS and company reported data
• Performance of major drug classes: bisphosphonates, SERMs, calcitonins and HRT, and portfolio analysis of the major players
• Forecasts by class and drug, including impacting events, assumptions, treatment trends, scenario forecasts and strategic opportunities.
• Pricing analysis across four markets and brand analysis of key drugs, including promotional and physician targeting strategy

REPORT HIGHLIGHTS

More negative results in 2003 for HRT have sealed the market's fate and sales are forecast to plummet. Treatment is set to be short-term, low-dose and less widely prescribed, so it's make or break time for key players, with those in the osteoporosis market well positioned to capitalize on the losses

Additional indications and intermittent dosing of SERMs and pipeline bisphosphonates in osteoporosis will drive sales to dominate therapy and help to double market value by 2011. However, therapeutic advances must go hand-in-hand with best practice promotion, in terms of launch strategy and market penetration, to secure commercial success

KEY REASONS TO BUY THIS REPORT

• Assess market, class and drug revenue potential, identify key trends and impacts by using Datamonitor's forecasts of marketed and pipeline products
• Identify best-practice promotional strategy to end-users in the osteoporosis market
• Predict the impact of key growth drivers on the market, such as intermittent dosing and multiple indications

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 3

• Scope of the analysis 3
• Datamonitor insight into the osteoporosis market 3
• Effective detailing 7
• Phase IV/extension studies 8
• Additional indications 8
• Summary 10
• Key metrics 12

CHAPTER 2 MARKET SEGMENTATION & DEFINITION 24

• Strategic scoping & focus 25
• Market definition 26
• A11C: vitamin A and D (including combinations of the two) 26
• Advantages of vitamin D therapy 27
• Disadvantages of vitamin D therapy 27
• H4A: calcitonins 28
• Advantages of calcitonins 29
• Disadvantages of calcitonins 30
• H05AA: parathyroid hormones and analogues 30
• Advantages of PTH 31
• Disadvantages of PTH 31
• G3C and G3F: estrogens and estrogen/progestogen combinations 32
• Advantages of estrogen hormone therapy 33
• Disadvantages of estrogen hormone therapy 33
• G3H: other sex hormones and similar products: SERMs 34
• Advantages of SERMs 35
• Disadvantages of SERMs 35
• M5B: bone calcium regulators 35
• Advantages of bisphosphonates 36
• Disadvantages of bisphosphonates 36
• Definition of gold-standard drug 37
• Fosamax: the gold standard in osteoporosis 37
• Associated pharmaceutical markets 39
• Paget's disease of bone 39
• Bisphosphonates as cancer adjunct therapies: hypercalcemia of malignancy and bone metastases 40

CHAPTER 3 GLOBAL MARKET OVERVIEW 42

• Key findings 42
• Global osteoporosis market analysis 43
• Overview 43
• IMS historical perspective and implications 44
• Five-quarter performance analysis: Q1 2002 to Q1 2003 46
• The effect of the WHI on the osteoporosis market 46
• Drug contribution to market growth 48
• Global market forecast 49
• Market growth driven by pipeline drugs, today's marketed products to slow around 2007 50
• HRT market rocked again by breast cancer link: Million Women Study 51
• SERMs growth takes up HRT's decline 55
• Cautious uptake in the PTH class 56
• Forecast scenario analysis 57
• Evista shows neutral results in breast cancer prevention and CVD 57
• Fosamax patent expiry penetrates throughout the osteoporosis market 58
• Bisphosphonate class analysis 59
• Bisphosphonate market performance 59
• Bisphosphonate market forecast 62
• Long-interval, intermittent dosing 63
• Generic penetration 64
• Bisphosphonate R&D drugs 64
• Brand analysis 65
• Fosamax analysis 65
• Fosamax: 12-month event screen 67
• Fosamax strategic analysis 68
• Leading with the hip: positioning Fosamax in an increasingly competitive market 68
• Fosamax forecasts to 2011 71
• Phase IV trial results vs. Evista/Actonel 73
• Launch of novel bisphosphonates 74
• Actonel analysis 74
• Actonel 12-month event screen 75
• Actonel strategic analysis 77
• Actonel forecasts to 2011 81
• SERM class analysis 83
• SERM market performance 83
• SERM market forecast 83
• Additional indications 84
• SERM R&D drugs 85
• Brand analysis 85
• Evista analysis 85
• Evista 12-month event screen 87
• Evista strategic analysis 88
• Evista forecasts to 2011 91
• Parathyroid hormone class analysis 93
• PTH R&D drugs 93
• Brand analysis 93
• Forteo analysis 93
• Forteo 12-month event screen 95
• Forteo strategic analysis 96
• Drive diagnosis rates through disease awareness campaigns 96
• Continue trials for hip fracture risk reduction 97
• Forteo forecasts to 2011 98
• Calcitonin class analysis 100
• Calcitonin market performance 100
• Brand analysis 100
• Miacalcin analysis 100
• Miacalcin 12-month event screen 102
• Miacalcin strategic analysis 103
• Miacalcin forecasts to 2011 104
• Hormone therapy class analysis 105
• Hormone therapy market performance 105
• Brand analysis 107
• Premarin family analysis 107
• Premarin family 12-month event screen 107
• Premarin family strategic analysis 109
• Switching to low-dose Prempro/Premarin 109
• Competitive pricing of low-dose products 110
• Hormone therapy market forecasts to 2011 111
• Osteoporosis pipeline drug overview and forecasts 113
• Pipeline profiles 114
• Boniva 114
• Zometa 114
• Lasofoxifene 115
• Bazedoxifene 115
• Protos 116
• Preos 117
• Osteoporosis pipeline drug forecast to 2011 118

CHAPTER 4 PORTFOLIO AND LIFECYCLE MANAGEMENT 119

• Key findings 119
• Market attractiveness 120
• Comparative attractiveness of the osteoporosis market 120
• Class attractiveness in the osteoporosis market 123
• Bisphosphonate class attractiveness 124
• SERM class attractiveness 125
• Calcitonin class attractiveness 126
• Positioning of the major osteoporosis players 126
• Merck's potential patent woes 128
• Inclusion of the leading HRT player in osteoporosis positioning 130
• Osteoporosis and the major HRT players 131
• Performance of the major players from 2001 to 2002 133
• Pipeline activity and implications in the osteoporosis market 137
• Lifecycle management in osteoporosis 138
• The osteoporosis product lifecycle 138
• Launch strategy and market penetration 141
• Fosamax: how Merck seeded the market for optimal penetration 141
• Promotional activity: sampling and advertising 143
• Actonel: geographical licensing and co-marketing activity 145
• Accessing the Japanese market: Fosamax and Actonel 146
• Outsourcing sales capability with Evista 146
• eDetailing in osteoporosis 147
• Aventis 147
• Forteo: doing the best with what you've got 148
• Optimizing peak sales 149
• Additional indications: Fosamax leagues ahead of the pack 149
• Heavy Phase IV activity among top three drugs 149
• Combination trials with Forteo, Evista and Fosamax 151
• Alternative peak sale optimization strategies 152
• Summary 154

CHAPTER 5 STRATEGIC PRODUCT POSITIONING 155

• Physician targeting strategies 155
• Merck and Lilly promotional strategy in osteoporosis 155
• Best practice promotion in osteoporosis 157
• Patient targeting and influence 158
• Brand imaging 158
• Fosamax 158
• Actonel 162
• Evista 164
• Miacalcin 165
• Premarin family products 166
• Forteo 167
• Patient advocacy initiatives 168
• Merck sponsorship of the US NORA program 168
• Alliance for Better Bone Health 169
• International Osteoporosis Foundation patient group grants: Merck and Lilly 169
• Pricing and reimbursement 170
• Regulatory interventions 170
• NICE guidelines on osteoporosis 170
• Key Phase IV and post-marketing trial results 170
• Fosamax 170
• Actonel 172
• Evista 172
• Cost-containment initiatives 173
• Formulary status of osteoporosis medications 173
• Medicare: the elderly and discounted drug access 174
• Assessments of osteoporosis screening programs and treatment cost effectiveness 175
• Pricing data for key products in the major markets 176
• Case study: what is the rationale behind the price of Forteo? 179
• Osteoporosis product value analysis 180

APPENDIX A - MARKET DATA 182

• Global osteoporosis market data 182
• Bisphosphonate market data 182
• SERM class market data 183
• Calcitonin class market data 183
• Leading osteoporosis drugs historical data 184

Appendix B 185

• List of tables 185
• List of figures 187
• Bibliography 189
• Epidemiology 189
• Clinical trial data 190

About Datamonitor 190

• About Datamonitor Healthcare 190
• Datamonitor Healthcare's research and analysis methodologies 191
• Datamonitor Healthcare's therapy area capabilities 191
• About the Women's Health analysis team 192
• Datamonitor Healthcare's Consulting expertise 193
• Datamonitor's Therapeutic Consulting expertise 194
• Key therapy team members 194
• David Abramson, Therapeutic Lead Consultant 194
• Disclaimer 196