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Pipeline and Commercial Insight: Osteoporosis - Novel agents to battle for payer acceptance
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| Zahlen und Fakten zur Studie: |
Reasons to Purchase * Understand current and future osteoporosis drug market dynamics * Gain insight into the unmet needs of current osteoporosis treatment and to what extent pipeline drugs will address these issues * Evaluate the sales forecasts of marketed, generic, and key pipeline drugs to 2018 in the US, Japan, France, Germany, Italy, Spain, and the U 375 seiten | |||||||||||
| Inhalt der Studie: |
Introduction
Osteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Globally, sales for osteoporosis drugs grew 7.0.....
Introduction Osteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Globally, sales for osteoporosis drugs grew 7.0% year-on-year from 2004 to $9.6 billion in 2008 driven by strong performance of the bisphosphonate class. Scope * Patient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China). * Analysis of global osteoporosis prescriptions from 20042008, split by geographical region, drug class, molecule, and brand. * In depth profiles of key current osteoporosis brands including SWOT analyses and country-specific sales forecasts to 2018. * R&D pipeline analysis with detailed profiles and forecasts of key agents, including Amgen's denosumab and new selective estrogen receptor modulators. Highlights The osteoporosis seven major market value was $7.1 billion in 2008, 76.4% of the global market. Although between 2007 and 2008 the market declined due to generic penetration of the market leading brand Fosamax (alendronate, Merck & Co), the launch of new pipeline drugs will result in a significant market growth. The launch of four pipeline selective estrogen receptor modulators (SERMs) between 2009 and 2012 will boost class sales across the seven major markets. However, the challenge for marketing companies is to convince prescribers in the EU, where uptake has historically been low, of the effect of SERMs in the wider patient group. The largest growth driver of the osteoporosis market over the forecast period is expected to be Amgen's denosumab, potentially the first monoclonal antibody to market. However, success will rely on a good long-term safety profile and price competitiveness, which are relative unknowns at this stage. Reasons to Purchase * Understand current and future osteoporosis drug market dynamics * Gain insight into the unmet needs of current osteoporosis treatment and to what extent pipeline drugs will address these issues * Evaluate the sales forecasts of marketed, generic, and key pipeline drugs to 2018 in the US, Japan, France, Germany, Italy, Spain, and the UK Report Highlights Highlights The osteoporosis seven major market value was $7.1 billion in 2008, 76.4% of the global market. Although between 2007 and 2008 the market declined due to generic penetration of the market leading brand Fosamax (alendronate, Merck & Co), the launch of new pipeline drugs will result in a significant market growth. The launch of four pipeline selective estrogen receptor modulators (SERMs) between 2009 and 2012 will boost class sales across the seven major markets. However, the challenge for marketing companies is to convince prescribers in the EU, where uptake has historically been low, of the effect of SERMs in the wider patient group. The largest growth driver of the osteoporosis market over the forecast period is expected to be Amgen's denosumab, potentially the first monoclonal antibody to market. However, success will rely on a good long-term safety profile and price competitiveness, which are relative unknowns at this stage. [Studien Infos ausblenden] |
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DATAMONITOR HEALTHCARE 2 About the Urology and Gender specifc Health pharmaceutical analysis team 2 CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the osteoporosis market 4 Key metrics 6 Contributing experts 7 Related reports 8 CHAPTER 2 PATIENT POTENTIAL 10 Definition of osteoporosis 11 Etiology 11 Symptoms 13 Diagnosis and treatment rates 14 Underdiagnosis is a major problem in osteoporosis 16 World Health Organization fracture risk assessment tool 18 Treatment rates have been increasing but are still low 20 Patient segmentation 21 Disease severity 21 Gender 22 Epidemiology 24 Seven major markets 24 Female osteoporosis 24 Male osteoporosis 32 BRIC countries 34 Brazil - hip fracture prevalence is higher in men than women 35 Russia - over 85% of hip fractures occur in women over 60 years of age 36 India - Indian women experience osteoporotic fractures 10-20 years earlier than Caucasian women 39 China - over 61 million Chinese women will experience a hip fracture in 2009 41 Rest of the world 42 Current treatment options 44 Bisphosphonates 45 Selective estrogen receptor modulators 47 Parathyroid hormones 49 Calcitonins 50 Dual acting bone agents 51 Vitamin D and analogs 52 Calcium 52 Clinical unmet need in osteoporosis 53 Need for improved anabolic therapies 54 Efficacy at the hip 55 Increased compliance 56 Better side-effect profile and safety 58 Long-term safety of bisphosphonate use is questioned 59 Efficacy for spine fractures 61 Environmental unmet need in osteoporosis 61 Increased patient identification 62 Increased prevention of osteoporosis 64 Increase male osteoporosis awareness 65 Target product profile 66 CHAPTER 3 MARKET OVERVIEW 67 Market definition for this report 68 Seven major markets current and future market assessment 70 The osteoporosis market will continue to grow up to 2018 despite generic alendronate penetration 70 Regional dynamics - the US will remain by far the largest market region in 2018 although the fastest growing regions will be Italy and Spain 73 Drug class dynamics - bisphosphonates will remain the clear market leading class 79 Brand dynamics - Actonel (risedronic acid, Procter and Gamble Pharmaceuticals) becomes market leader in 2008 85 Rest of the world snapshot 90 The global osteoporosis market continues to display strong growth 90 The rest of the world accounted for 25.4% of the osteoporosis global market in 2008 91 The rest of the world outstrips the seven major markets in terms of volume 92 Other European countries form the largest region, but the BRIC countries are by far the fastest-growing 95 Calcium accounts for over 90% of the total volume sales in the rest of the world 98 Patient acquisition process 99 Introduction 99 Patient care path 99 Points of influence in the patient care path 102 Trigger point 1 - osteoporosis prevention 102 Trigger point 2 - disease severity influences osteoporosis treatment 102 Trigger point 3 - compliance issues and fractures 103 Drivers of drug choice 104 US formulary tier status for leading brands 105 EU osteoporosis reimbursement policies 106 Brand dynamics - bisphosphonates 107 Class overview 107 Fosamax/Fosamax Plus D (alendronate, Merck & Co.) 108 Drug profile 108 Product positioning 110 SWOT analysis 111 Brand forecast to 2018 112 Actonel/Actonel with Calcium (risedronic acid; Procter and Gamble/Sanofi-Aventis) 116 Drug profile 116 Product positioning 117 SWOT analysis 119 Brand forecast to 2018 120 Bonviva/Boniva (ibandronic acid, Roche/GlaxoSmithKline) 122 Drug profile 122 Product positioning 124 SWOT analysis 125 Brand forecast to 2018 127 Aclasta (zoledronic acid, Novartis) 129 Drug profile 129 Product positioning 130 SWOT analysis 131 Brand forecast to 2018 133 Bonoteo/Recalbon (minodronic acid, Astellas/Ono Pharmaceutical) 134 Drug profile 134 Product positioning 135 SWOT analysis 135 Brand forecast to 2018 136 Brand dynamics - selective estrogen receptor modulators 138 Evista (raloxifene, Eli Lilly) 138 Drug profile 138 Product positioning 139 SWOT analysis 140 Brand forecast to 2018 142 Brand dynamics - parathyroid hormones 144 Forteo (teriparatide, Eli Lilly) 144 Drug profile 144 Product positioning 146 SWOT analysis 147 Brand forecast to 2018 148 Preotact (full-length parathyroid hormone PTH 1-84, NPS/Nycomed) 150 Drug profile 150 Product positioning 151 SWOT analysis 152 Brand forecast to 2018 153 Brand dynamics - dual acting bone agents 155 Protelos (strontium ranelate, Servier) 155 Drug profile 155 Product positioning 157 SWOT analysis 158 Brand forecast to 2018 159 Brand dynamics - calcitonins 161 Miacalcic (calcitonin-salmon, Novartis) 161 Drug profile 161 Product positioning 162 SWOT analysis 163 Brand forecast to 2018 164 Fortical (calcitonin-salmon, Unigene) 166 Drug profile 166 Product positioning 167 SWOT analysis 167 Brand forecast to 2018 168 CHAPTER 4 PIPELINE OVERVIEW AND R&D DYNAMICS 170 Pipeline overview 171 Comparative forecasts 178 Datamonitor pipeline assessment summary 179 Key companies involved in the disease osteoporosis pipeline 183 Companies currently involved in the market are seeking novel drug developments to maintain their market share 183 Amgen - a future key market player 184 Amgen faces challenges to entry into the musculoskeletal market 185 Amgen's osteoporosis pipeline 185 Amgen geographic outlook 187 Clinical trial design in osteoporosis 188 Preclinical trials 188 Two different animal species testing is required by the FDA and EMEA 188 Preclinical trial design should reflect the clinical indication 188 Clinical trial design 190 The FDA and EMEA have different patient inclusion requirements for osteoporosis trials 192 Clinical endpoints 192 CHAPTER 5 LATE-STAGE DRUG ANALYSIS AND FORECASTS 195 Definition of current comparator therapies 196 Overall market comparator - Fosamax (alendronate, Merck & Co) 196 Clinical trial data for Fosamax 196 Individual class comparators 197 Bisphosphonates - key late-stage pipeline 198 Pipeline summary 198 Comparative forecasts 200 EX101 (alendronate; EffRx) 200 Drug overview 200 SWOT analysis 201 Clinical attractiveness 202 Commercial attractiveness 202 Datamonitor drug assessment score card for EX101 203 Satisfaction of unmet needs 204 Forecasts to 2018 205 Almerol (MER-103, alendronate; Merrion) 206 Drug overview 207 SWOT analysis 207 Clinical trial data 208 Clinical attractiveness 209 Commercial attractiveness 210 Datamonitor drug assessment score card for Almerol 210 Satisfaction of unmet needs 211 Forecasts to 2018 212 Late-stage development compounds recently discontinued 213 Selective estrogen receptor modulators - key late-stage pipeline 214 Pipeline summary 214 Comparative forecasts 215 Fablyn (lasofoxifene; Pfizer/Ligand) 216 Drug overview 216 SWOT analysis 217 Clinical trial data 218 Clinical attractiveness 222 Commercial attractiveness 223 Datamonitor drug assessment score card for Fablyn 224 Satisfaction of unmet needs 225 Forecasts to 2018 225 Conbriza/Viviant (bazedoxifene; Wyeth) 228 Drug overview 228 SWOT analysis 229 Clinical trial data 230 Clinical attractiveness 235 Commercial attractiveness 236 Datamonitor drug assessment score card for Conbriza 237 Satisfaction of unmet needs 238 Forecasts to 2018 238 Aprela (bazedoxifene with conjugated estrogens; Wyeth) 240 Drug overview 241 SWOT analysis 242 Clinical trial data 242 Clinical attractiveness 243 Commercial attractiveness 244 Datamonitor drug assessment score card for Aprela 246 Satisfaction of unmet needs 246 Forecasts to 2018 247 Arzoxifene (LY353381, Eli Lilly) 249 Drug overview 249 SWOT analysis 250 Clinical trial data 250 Clinical attractiveness 255 Commercial attractiveness 257 Datamonitor drug assessment score card for arzoxifene 257 Satisfaction of unmet needs 258 Forecasts to 2018 259 Parathyroid hormones and analogs - key late-stage pipeline 261 Pipeline summary 261 Comparative forecasts 262 ZT-031 (previously Ostabolin-C, Zelos Therapeutics) 263 Drug overview 263 SWOT analysis 264 Clinical trial data 265 Clinical attractiveness 266 Commercial attractiveness 266 Datamonitor drug assessment score card for ZT-031 267 Satisfaction of unmet needs 268 Forecasts to 2018 268 ZP-PTH (hPTH1-34, Zosano Pharma) 270 Drug overview 271 SWOT analysis 271 Clinical trial data 272 Clinical attractiveness 273 Commercial attractiveness 273 Datamonitor drug assessment score card for ZP-PTH 274 Satisfaction of unmet needs 275 Forecasts to 2018 275 Calcitonins - key late-stage pipeline 277 Pipeline summary 277 Capsitonin (BN-002, Bone medical) 278 Drug overview 279 SWOT analysis 279 Clinical trial data 280 Clinical attractiveness 281 Commercial attractiveness 281 Datamonitor drug assessment score card for capsitonin 282 Satisfaction of unmet needs 283 Forecasts to 2018 283 Other drugs - key late-stage pipeline 285 Pipeline summary 285 Comparative forecasts 286 Denosumab (AMG-162, Amgen) 287 Drug overview 287 SWOT analysis 289 Clinical trial data 290 Clinical attractiveness 296 Commercial attractiveness 299 Datamonitor drug assessment score card for denosumab 302 Satisfaction of unmet needs 302 Forecasts to 2018 303 Odanacatib (MK0822, Merck & Co) 305 Drug overview 305 SWOT analysis 306 Clinical trial data 307 Clinical attractiveness 311 Commercial attractiveness 312 Datamonitor drug assessment score card for odanacatib 312 Satisfaction of unmet needs 313 Forecasts to 2018 313 Eldecalcitol (ED-71, Chugai/Taisho) 315 Drug overview 316 SWOT analysis 316 Clinical trial data 317 Clinical attractiveness 320 Commercial attractiveness 320 Datamonitor drug assessment score card for eldecalcitol 321 Satisfaction of unmet needs 321 Forecasts to 2018 322 Key early-stage compounds in osteoporosis 324 BIBLIOGRAPHY 328 Journal papers, books, and conference abstracts 328 Websites 340 Datamonitor reports 346 APPENDIX A 347 Data definitions, limitations and assumptions 347 Standard units 347 Derivation of sales forecasts and pricing trends 347 Methodology 347 Indication-specific sales calculations 347 Forecast assumptions 348 APPENDIX B 358 Contributing experts 358 About Datamonitor 358 About Datamonitor Healthcare 358 About the Urology and Gender specifc Health analysis team 359 Disclaimer 362 [Inhaltsverzeichnis ausblenden] |
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