Home > Market Research > Indication Areas > Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline

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Market Study
Published: June 2010
Pages: 284
Tables: For full details, please email keithw@cmsinfo.com
From: GBP 7600.00   Buy Now!
Research from: Datamonitor
Sector: Indication Areas

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.

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.

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Table of Contents

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

For full details, please email keithw@cmsinfo.com

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