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Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline
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284 Pages | |||||||||||
| 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. Across the seven major markets, sales for osteo.....
Introduction Osteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Across the seven major markets, sales for osteoporosis drugs grew with a compound annual growth rate (CAGR) of 2.0% from 2005 to $6.9 billion in 2009. Nonetheless, several promising pipeline drugs will help the market resume growth. Scope *Patient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China). *Review of the key clinical and environmental unmet needs supported by insight from key opinion leaders across the US, Europe and Japan. *Analysis of target product profile for an osteoporosis drug. *R&D pipeline analysis with detailed profiles and forecasts of key agents, including Amgen’s Prolia (denosumab) and Merck’s odanacatib. Highlights Osteoporosis prevalence is expected to increase due to the general aging population. By 2020, the total male and female osteoporosis population is forecast to increase by 16.0% from 168 million in 2010 to reach 188 million patients across the seven major markets. Despite some long-term safety and cost concerns, Prolia will become the osteoporosis market leader by 2019, but will not achieve blockbuster sales. Moreover, its position will be threatened should odanacatib show a superior clinical profile. Over the forecast period, three new anabolic drugs are due to launch. These will have to compete on cost, efficacy and safety with the class leader Forteo (teriparatide, Eli Lilly). While these drugs will address some unmet needs, early clinical data suggests that more potent drugs such Amgen’s antisclerostin may dominate the market in the future. Reasons to Purchase *Understand patient population dynamics *Gain insight into shortcomings of current osteoporosis treatment and to what extent pipeline drugs will address these unmet clinical needs. *Identify licensing opportunities based on company portfolio and market needs. [Studien Infos ausblenden] |
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Overview 1 Catalyst 1 Summary 1 About Datamonitor Healthcare 2 About the Genitourinary pharmaceutical analysis team 2 Executive Summary 3 Strategic scoping and focus 3 Datamonitor insight into the disease market 3 Related reports 5 Upcoming related reports 5 Table of Contents 6 1. Pipeline Overview and Dynamics 7 Key findings 7 Pipeline overview 8 Clinical pipeline 8 Comparative forecasts: Prolia to become market leader by 2019 15 Datamonitor pipeline assessment summary: anabolic treatments are the most clinically attractive products 16 Key companies involved in the osteoporosis pipeline 18 Osteoporosis drug development not limited to Big Pharma 18 Novartis remains a key market player 18 Key R&D company strategies 20 Pipeline developers focus on reformulations to address route of administration unmet needs 20 Anabolic treatments become a priority in the market 21 Indication expansions increase the market potential of osteoporosis drugs 22 2. Disease Overview - Market Potential 24 Key findings 24 Definition of osteoporosis 25 Definition of osteoporosis 25 Etiology 25 Symptoms 26 Diagnosis and treatment rates 28 Under-diagnosis is a major problem in osteoporosis 29 World Health Organization fracture risk assessment tool 30 Treatment rates have been increasing but are still low 32 Patient segmentation 33 Disease severity 33 Gender 35 Epidemiology 37 Seven major markets 37 Female osteoporosis 38 Male osteoporosis 49 BRIC countries 58 Brazil: hip fracture prevalence is higher in men than women 58 Russia: over 85% of hip fractures occur in women over 60 years of age 59 India: Indian women experience osteoporotic fractures 10-20 years earlier than Caucasian women 62 China: over 76 million Chinese women will experience a hip fracture in 2010 63 Rest of the world 64 Current treatment options 65 Bisphosphonates 66 Selective estrogen receptor modulators 68 Parathyroid hormones 68 Calcitonins 69 Dual acting bone agents 70 Vitamin D and analogs 71 Calcium 71 Current gold standard and comparator therapies 72 Fosamax (alendronate; Merck & Co) 72 Clinical trial data for Fosamax 73 Individual class comparators 74 Current market overview 75 Market definition for this report 76 Growth in the seven major markets slows down 78 Bisphosphonates remain the largest class despite generic penetration 80 Fosamax generic launch results in market decline 82 Future outlook: despite growing pressure from generics, launch of pipeline drugs will offset decline up to 2019 84 Unmet need in osteoporosis 86 Need for improved anabolic therapies 86 Efficacy at the hip 87 Increased compliance 90 Companies should focus on increasing awareness of the treatments available to increase compliance 92 Better side-effect profile and safety 93 Long-term safety of bisphosphonate use is questioned 93 Efficacy for spine fractures 95 Target product profile versus current level of attainment 95 3. R&D Approach 97 Key findings 97 Clinical trial design in osteoporosis 98 Preclinical trials 98 Two different animal species testing is required by the FDA and EMA 98 Preclinical trial design should reflect the clinical indication 98 Clinical trial design 99 The FDA and EMA have different patient inclusion requirements for osteoporosis trials 101 Clinical endpoints 102 Future developments in osteoporosis clinical trials 104 4. Pipeline Analysis & Forecasts: Bisphosphonates 106 Key findings 106 Overview for pipeline bisphosphonates 107 Pipeline summary 107 Comparative forecasts 109 EX101 (alendronate; EffRx) 109 Drug overview 109 Drug profile 110 SWOT analysis 111 Datamonitor drug assessment score card for EX101 111 Clinical attractiveness 114 Satisfaction of unmet needs 114 EX101 shows reduced gastric side effects compared to gold standard 114 Commercial attractiveness 115 EX101 can clearly differentiate itself in a competitive bisphosphonate market, but effervescent formulations can be unpopular with patients 115 Nycomed's market experience will help boost EX101's sales 115 US partner still needed 115 Forecasts to 2019 115 Almerol (MER-103, alendronate; Merrion) 116 Drug overview 116 Drug profile 117 Clinical trial data 117 SWOT analysis 118 Datamonitor drug assessment score card for Almerol 119 Clinical attractiveness 122 Satisfaction of unmet needs 122 Almerol 6mg weekly shows bioequivalence to Fosamax 122 Commercial attractiveness 123 Almerol will face strong competition upon launch 123 Merrion requires a marketing partner to launch the drug 123 Forecasts to 2019 123 5. Pipeline Analysis & Forecasts: Selective Estrogen Receptor Modulators 125 Key findings 125 Overview for pipeline selective estrogen receptor modulators 126 Pipeline summary 126 Forecast summary 127 Aprela (bazedoxifene with conjugated estrogens; Pfizer) 127 Drug overview 127 Drug profile 128 Clinical trial data 128 Ongoing clinical trials 129 SWOT analysis 130 Datamonitor drug assessment score card for Aprela 130 Clinical attractiveness 132 Satisfaction of unmet needs 132 Aprela targets menopausal women differentiating it from its competition 133 Efficacy data will boost Aprela's clinical potential 134 Aprela's safety remains an issue 134 Commercial attractiveness 135 Further delays reduces overall commercial attractiveness 135 Bazedoxifene approval in the EU paves the way for Aprela in this region 135 Aprela will be mainly prescribed by gynecologists 135 Forecasts to 2019 135 Late-stage development compounds recently discontinued 137 Eli Lilly terminates development of arzoxifene 137 6. Pipeline Analysis & Forecasts: Parathyroid Hormones and Analogs 138 Key findings 138 Overview for pipeline parathyroid hormones and analog drugs 139 Pipeline summary 139 Comparative forecasts 140 ZT-031 (hPTH1-31; Zelos Therapeutics) 141 Drug overview 141 Drug profile 142 Clinical trial data 142 SWOT analysis 143 Datamonitor drug assessment score card for ZT-031 143 Clinical attractiveness 146 Satisfaction of unmet needs 146 Faster onset of action provides differentiation from competition 146 Subcutaneous formulation is not favorable 147 Commercial attractiveness 147 Partnering is required to access the market 147 Pricing strategy will be critical to exploit full market potential 147 Forecasts to 2019 147 ZP-PTH (hPTH1-34; Zosano Pharma) 149 Drug overview 149 Drug profile 149 Clinical trial data 150 SWOT analysis 151 Datamonitor drug assessment score card for ZP-PTH 151 Clinical attractiveness 154 Satisfaction of unmet needs 154 ZP-PTH is a patient-friendly drug 154 Increased hip efficacy provides clinical differentiator 155 Commercial attractiveness 156 Big Pharma is required to reach full drug potential 156 505b2 regulatory strategy can reduce developmental costs 156 Forecasts to 2019 156 BA058 (parathyroid hormone peptide fragment; Radius) 157 Drug overview 158 Drug profile 158 Clinical trial data 159 SWOT analysis 160 Datamonitor drug assessment score card for BA058 160 Clinical attractiveness 163 Satisfaction of unmet needs 163 Phase II studies suggest good drug efficacy 163 Commercial attractiveness 164 Radius will benefit from Novartis deal should option go ahead 164 Forecasts to 2019 164 Other drugs in parathyroid hormone and analog class 165 ViaDerm-hPTH (parathyroid hormone peptide fragment; TransPharma/Eli Lilly) 165 CaPTHymone (parathyroid hormone analog; Bone Medical) 166 7. Pipeline Analysis & Forecasts: Calcitonins 167 Key finding 167 Overview for pipeline calcitonin drugs 168 Pipeline summary 168 Comparative forecasts 170 SMC021 (salmon calcitonin; Novartis) 170 Drug overview 170 Drug profile 171 Clinical trial data 171 Ongoing clinical trials 172 SWOT analysis 172 Datamonitor drug assessment score card for SMC021 173 Clinical attractiveness 175 Satisfaction of unmet needs 175 SMC021's oral formulation remains favorable 175 Commercial attractiveness 176 Sales for calcitonins have been declining 176 Novartis market experience 177 Forecasts to 2019 177 Capsitonin (BN-002; Bone Medical) 179 Drug overview 179 Drug profile 179 Clinical trial data 180 SWOT analysis 180 Datamonitor drug assessment score card for Capsitonin 181 Clinical attractiveness 183 Satisfaction of unmet needs 183 Clinical attractiveness 183 Oral formulation is an improvement over current modes of administration 183 Commercial attractiveness 184 Bone Medical will seek a marketing partner to launch the product 184 Competition from oral calcitonins will be high at the time of launch 184 Forecasts to 2019 185 8. Pipeline Analysis & Forecasts: Dual Acting Bone Modulators 186 Key finding 186 Overview for pipeline dual acting bone agents 187 Pipeline summary 187 Forecast summary 188 NBS101 (Strontium malonate; Osteologix) 188 Drug overview 188 Drug profile 189 Clinical trial data 189 SWOT analysis 190 Datamonitor drug assessment score card for NBS101 191 Clinical attractiveness 193 Satisfaction of unmet needs 193 Phase II data suggest better efficacy than Protelos 193 NBS101 oral formulation is an improvement over Protelos 194 Commercial attractiveness 194 NBS101 can target patients who stop alendronate treatment 194 US launch and partnering deals will boost the drug potential 194 Forecasts to 2019 195 9. Pipeline Analysis & Forecasts: Other Drugs 197 Key findings 197 Overview for other pipeline drugs 198 Pipeline summary 198 Comparative forecasts 199 Prolia (denosumab; Amgen) 200 Drug overview 200 Drug profile 202 Clinical trial data 202 Clinical trial 1 204 SWOT analysis 206 Datamonitor drug assessment score card for Prolia 207 Clinical attractiveness 209 Satisfaction of unmet needs 209 Prolia shows similar efficacy to alendronate 209 Serious skin disorder risk limits patient potential despite robust efficacy 211 Long-term safety remains a concern 211 Commercial attractiveness 212 Price to remain competitive without destroying the monoclonal antibody market 212 FDA panel restricts Prolia's patient potential 213 Prolia is recommended for approval in the EU 214 GlaxoSmithKline deal maximizes Prolia's potential in tough European market 214 Possible label extension for cancer indications boosts revenue potential 214 Forecasts to 2019 215 Odanacatib (MK0822; Merck & Co) 216 Drug overview 216 Drug profile 217 Clinical trial data 217 Ongoing clinical trials 219 SWOT analysis 221 Datamonitor drug assessment score card for odanacatib 221 Clinical attractiveness 224 Satisfaction of unmet needs 224 Novel target provides potential superior efficacy 224 Odanacatib shows continued efficacy after 3 years of treatment 226 Commercial attractiveness 226 Odanacatib's commercial potential will be driven by Merck & Co's market experience 226 By the time odanacatib launches the osteoporosis market will be extremely competitive 226 Forecasts to 2019 227 Eldecalcitol (ED-71; Chugai/Taisho) 228 Drug overview 228 Drug profile 229 Clinical trial data 229 Clinical trial 1 231 SWOT analysis 232 Datamonitor drug assessment score card for eldecalcitol 232 Clinical attractiveness 235 Satisfaction of unmet needs 235 Eldecalcitol met all Phase III endpoints and showed higher efficacy than Alfarol 235 Commercial attractiveness 236 Commercial potential limited by Japan launch only 236 Forecasts to 2019 236 Other drugs in other classes 238 MK5442 (Merck & Co) 238 Drug overview 238 Ongoing clinical trials 239 Sclerostin (AMG785; Amgen) 240 Drug overview 240 Ongoing clinical trials 242 2MD/DP001 (vitamin D analog; Deltanoid Pharma) 242 Drug overview 242 Clinical trial data 243 San134 (Glucagon-like peptide 2; Sanos Bioscience) 244 ACE-011 (activin inhibitor; Acceleron Pharma) 245 Late-stage development compounds recently discontinued 245 Ronacaleret fails to increase BMD and causes a mild primary hyperparathyroidism 245 10. Innovative Early-Stage Approaches 246 Key findings 246 New targets for anabolic treatments 248 Wnt signaling pathway therapeutic potential 249 Bone morphogenetic protein in osteoporosis 250 Insulin-like growth factor I 251 The future of treatment in osteoporosis 251 Combination therapies 251 Bibliography 254 Journals 254 Websites 261 Datamonitor reports 265 Conferences 265 APPENDIX 266 Data definitions, limitations and assumptions 266 Standard units 266 Country group definitions 266 Rest of European Union 266 Middle East and North Africa (MENA) 266 Rest of World 266 Derivation of sales forecasts and pricing trends 266 Indication-specific sales calculations 267 Caveats to using Prescribing insight 267 New product launches and expiries 267 Forecast methodology 271 Product forecasts 271 Contributing experts 271 Conferences attended 271 About Datamonitor 272 About Datamonitor Healthcare 272 About the Disease analysis team 272 Datamonitor consulting 273 Disclaimer 275 [Inhaltsverzeichnis ausblenden] |
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