Stakeholder Insight: Osteoarthritis - Drug development lags behind rising osteoarthritis population

Introduction

Datamonitor expect osteoarthritis prevalence to grow by over 10 million by 2020, owing mainly to an aging population. In the near-term the approach to treatment will remain constant, with improved side-effects dominating the unmet needs. However, therapies which target the underlying causes of osteoarthritis have the potential to reshape osteoarthritis treatment.

Scope

*Snapshot of the osteoarthritis market based on a survey of 180 rheumatologists/primary care physicians, with views from key opinion leader interviews

*Analysis of osteoarthritis epidemiology, with future projections of prevalence and patient numbers to 2020

*Overview of treatment options at the class and molecule level, as well as treatment outcome analysis

*Assessment of treatment satisfaction, unmet needs and physicians' awareness of key pipeline therapies

Highlights

The estimated diagnosis rate of 55% reflects a lack of treatment-seeking by mild sufferers of the disease, who often resort to self-medication. This equates to nearly 37 million undiagnosed patients in 2009 and with a predicted rise in osteoarthritis numbers this is a market with growth potential.

Pain-relieving drugs, particularly, oral non-steroidal anti-inflammatory drugs (NSAIDs) are the foundation of pharmacological therapy in osteoarthritis. Physicians continue to be concerned over NSAID toxicity, with three-quarters of severe patients who are receiving NSAIDs currently co-prescribed a gastroprotectant.

Physicians are generally unsatisfied with current osteoarthritis pharmacological treatments. A clear need for alternative drugs exists to treat this prevalent condition. 41% of physicians ranked disease modifying osteoarthritis drugs (DMOADs) as the highest unmet need, but the majority of physicians estimate that DMOADs are 8 years from the market.

Reasons to Purchase

*Understand current therapy trends for the major drug classes used in osteoarthritis split by disease severity and assess unmet needs in the disease

*Validate new product forecasting based on diagnosis rates and treatment by patient segmentation and drug class

*Use the interactive Excel model of treatment trees and patient numbers to estimate the osteoarthritis population in each of the seven major markets


Report Highlights
The estimated diagnosis rate of 55% reflects a lack of treatment-seeking by mild sufferers of the disease, who often resort to self-medication. This equates to nearly 37 million undiagnosed patients in 2009 and with a predicted rise in osteoarthritis numbers this is a market with growth potential.

Pain-relieving drugs, particularly, oral non-steroidal anti-inflammatory drugs (NSAIDs) are the foundation of pharmacological therapy in osteoarthritis. Physicians continue to be concerned over NSAID toxicity, with three-quarters of severe patients who are receiving NSAIDs currently co-prescribed a gastroprotectant.

Physicians are generally unsatisfied with current osteoarthritis pharmacological treatments. A clear need for alternative drugs exists to treat this prevalent condition. 41% of physicians ranked disease modifying osteoarthritis drugs (DMOADs) as the highest unmet need, but the majority of physicians estimate that DMOADs are 8 years from the market.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology and Inflammation pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the osteoarthritis market 3
Contributing experts 4
Related reports 5
Upcoming related reports 5
CHAPTER 2 INTRODUCTION AND SCOPE 7
Coverage of the Stakeholder Insight Survey 7
Epidemiology and patient segmentation in osteoarthritis 7
Treatment options and guidelines 7
Improving treatment outcomes 8
Future trends 8
CHAPTER 3 COUNTRY TREATMENT TREES 9
Introduction to treatment trees 9
US 10
Japan 11
France 12
Germany 13
Italy 14
Spain 15
UK 16
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 17
Definition and classification of osteoarthritis 18
Primary (idiopathic) osteoarthritis 18
Secondary osteoarthritis 19
Epidemiology of osteoarthritis 19
Datamonitor estimates 81.4 million osteoarthritis sufferers in the seven major markets in 2009 19
Measures used to determine radiographic and clinical osteoarthritis 22
American College of Rheumatology (ACR) criteria 22
Kellgren-Lawrence scale 23
Epidemiological studies of osteoarthritis 24
Assumptions and caveats 30
US 31
Japan 35
Europe 36
France and Germany 38
Italy 38
Spain 39
UK 41
Changes in the osteoarthritis population 42
Additional international osteoarthritis epidemiology studies 45
Co-morbidities and risk factors in osteoarthritis 49
Co-morbidities in patients with osteoarthritis are common 49
Obesity, hypertension and high cholesterol, are the most common co-morbidities present in osteoarthritis patients 50
High prevalence of cardiovascular, endocrinology and pulmonary co-morbidities in osteoarthritis 52
Gastrointestinal co-morbidities in osteoarthritis 54
Previous trauma of the joint is the most common musculoskeletal co-morbidity in osteoarthritis 55
Central nervous system co-morbidities; depression is highly prevalent in osteoarthritis 56
Co-morbidities associated with lifestyle factors in osteoarthritis patients 57
Other co-morbidities present in osteoarthritis patients 58
Risk factors and patient-group segmentation are critical to osteoarthritis definition 59
Age 59
Gender 60
Mechanical stress 61
Obesity 61
Presentation and diagnosis 62
Diagnosis of osteoarthritis 62
Techniques for diagnosis 62
Diagnosis rates 66
Severity of osteoarthritis 69
Definition of each level of severity of osteoarthritis provided by Datamonitor to physicians surveyed 69
CHAPTER 5 TREATMENT OPTIONS AND GUIDELINES 72
Treatment guidelines 73
Several guidelines exist for the treatment of osteoarthritis 73
American College of Rheumatology (ACR) 74
European League Against Rheumatism (EULAR) 76
National Institute for Health and Clinical Excellence (NICE) 77
Osteoarthritis Research Society International (OARSI) 78
Treatment options 79
Pharmacological versus non-pharmacological treatment 79
Non-pharmacological treatment of osteoarthritis 83
Weight loss and weight control is an effective and common tactic 84
Nutraceuticals - divided opinion on their use in osteoarthritis treatment 86
Exercise aids in reducing pain 88
Other non-pharmacological treatment options 90
Pharmacological treatment of osteoarthritis 91
Several drug classes are used in the treatment of osteoarthritis 93
Analgesics 93
Non-steroidal anti-inflammatory drugs and COX-2 inhibitors 96
Branded versus generic drug use 124
Variations exist in the use of branded versus generic drugs in osteoarthritis treatment in the seven major markets 125
CHAPTER 6 IMPROVING TREATMENT OUTCOMES 134
Treatment outcomes and satisfaction 135
Efficacy assessment 135
Measuring disease activity in osteoarthritis patients 135
Communication between the patient and physician is the most common method of assessing treatment efficacy in osteoarthritis 136
Physicians allow an average of five months to assess treatment efficacy in their osteoarthritis patients 138
Osteoarthritis patients usually require joint surgery after 7-8 years 140
Physicians are generally unsatisfied with current pharmacological treatment for osteoarthritis 142
Unmet needs 145
Disease modifying osteoarthritis drugs is the highest unmet need in osteoarthritis 145
Other unmet needs in osteoarthritis 147
Disease modifying osteoarthritis drugs (DMOADs) 148
Most physicians believe DMOAD development is possible 149
DMOADs are up to 8 years from reaching the market 149
Challenges in clinical study design for DMOADs 150
It is important for DMOADs to show both disease modification and pain relief in clinical trials 152
Matrix-metalloproteinase (MMP) inhibitors are the most important molecular target for DMOAD 154
Pipeline products 159
Eli Lilly's Cymbalta (duloxetine) is the late-stage drug therapy which most physicians are aware of 160
Caveat of physicians' awareness to drug therapies 162
Cymbalta (duloxetine; Eli Lilly) 162
Synvisc-One (hylan G-F 20; Genzyme) 163
Naproxcinod (NicOx) 165
Tanezumab (Pfizer) 166
Vimovo (PN-400; naproxen plus esomeprazole; Pozen, AstraZeneca) 166
Fentora (fentanyl; Cephalon) 167
Diractin (ketoprofen; Idea AG/Alpharma) 168
BIBLIOGRAPHY 170
Journal papers 170
Websites 176
Datamonitor reports 179
APPENDIX A 180
Physician research methodology 180
Physician sample breakdown 180
APPENDIX B 182
The survey questionnaire 182
Diagnosis and patient segmentation 183
Treatment 186
Unmet needs 197
Treatment outcomes and Prescribing patterns 199
About Datamonitor 203
About Datamonitor Healthcare 203
About the Immunology & Inflammation analysis team 204
Disclaimer 205
List of Tables
Table 1: Estimated adult osteoarthritis populations in the seven major markets, split by sex and age group, 2009 20
Table 2: Epidemiological studies of osteoarthritis in the seven major markets, 1984-2009 25
Table 3: US osteoarthritis population by age group and gender, 2009 32
Table 4: US gender-specific prevalence of radiographic and symptomatic osteoarthritis in different anatomical sites, 2008 34
Table 5: Estimated adult osteoarthritis population in Japan by age and gender, 2009 35
Table 6: Estimated adult osteoarthritis population in five major EU markets by age and gender, 2009 37
Table 7: Spanish EPISER study showing prevalence of knee and hand osteoarthritis, 2008 40
Table 8: Combined sample of northern England studies, radiographic knee osteoarthritis by age and gender 41
Table 9: Datamonitor's future projection of the adult osteoarthritis population in the seven major markets, 2010- 2020 44
Table 10: International epidemiological studies on osteoarthritis prevalence, 2001-09 46
Table 11: Mean percentages of the co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009 49
Table 12: Association between doctor-diagnosed* arthritis and body mass index from the BFRSS study, 2009 52
Table 13: Mean percentage of osteoarthritis patients suffering from cardiovascular, endocrinology and pulmonary co-morbidities (%) , 2009 53
Table 14: Mean percentages of gastrointestinal co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009 55
Table 15: Percentage of osteoarthritis patients diagnosed by primary care physicians versus rheumatologists (%), 2009 69
Table 16: Mean percentage of osteoarthritis patients receiving each type of therapy across the seven major markets, 2009 83
Table 17: Mean percentage of osteoarthritis patients receiving oral NSAIDs in the seven major markets (%), 2009 97
Table 18: Osteoarthritis patients receiving oral NSAIDs split by molecule and disease severity in the seven major markets (%), 2009 99
Table 19: Mild osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009 101
Table 20: Moderate osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009 102
Table 21: Severe osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009 103
Table 22: Osteoarthritis patients receiving oral NSAIDs a gastroprotectant in the seven major markets (%), 2009 106
Table 23: Mean percentage of osteoarthritis patients receiving topical NSAIDs in the seven major markets (%), 2009 108
Table 24: Osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009 110
Table 25: Mild osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009 111
Table 26: Moderate osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009 112
Table 27: Severe osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009 113
Table 28: Osteoarthritis patients receiving a cyclo-oxygenase-2 (COX-2) inhibitor by molecule and disease severity in the seven major markets(%), 2009 116
Table 29: Osteoarthritis patients receiving injectable hyaluronic acids split by physician type and disease severity in the seven major markets (%), 2009 121
Table 30: Hyaluronic acid brands most commonly prescribed by physicians in the seven major markets (n; %), 2009 123
Table 31: Number of physicians who use each outcome measure in the seven major markets (n), 2009 138
Table 32: Priority ranking allocated by physicians to unmet needs in the treatment of osteoarthritis in the seven major markets, 2009 147
Table 33: Physician opinion of promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs), in the seven major markets, 2009 157
Table 34: Primary care physicians' and rheumatologists' response to promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs), 2009 157
Table 35: Physicians' awareness of drugs in development for osteoarthritis in the seven major markets, 2009 162
Table 36: Physicians surveyed regarding osteoarthritis, 2009 181
List of Figures
Figure 1: US osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 10
Figure 2: Japan osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage 11
Figure 3: France osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 12
Figure 4: Germany osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 13
Figure 5: Italy osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 14
Figure 6: Spain osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 15
Figure 7: UK osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009 16
Figure 8: Adult osteoarthritis population in the seven major markets, 2009 22
Figure 9: Estimated adult osteoarthritis population in five major EU markets, by age and gender, 2009 38
Figure 10: Datamonitor's future projection of the adult osteoarthritis population, split by age group, in the seven major markets, 2010- 2020 42
Figure 11: Datamonitor future projection of the adult osteoarthritis population, split by region, in the seven major markets, 2010- 2020 43
Figure 12: Datamonitor future projection of the 65 years and older osteoarthritis population in Japan, 2010- 2020 45
Figure 13: Mean percentages of osteoarthritis patients suffering from a co-morbidity in the seven major markets (%), 2009 50
Figure 14: Cardiovascular, endocrinology and pulmonary co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009 54
Figure 15: Gastrointestinal co-morbidities in osteoarthritis patients in the seven major markets (%), 2009 55
Figure 16: Musculoskeletal co-morbidities in osteoarthritis patients in the seven major markets (%), 2009 56
Figure 17: Central nervous system co-morbidities in osteoarthritis patients in the seven major markets (%), 2009 57
Figure 18: Lifestyle factors commonly present in osteoarthritis patients in the seven major markets (%), 2009 58
Figure 19: Other co-morbidities that 10% or more of osteoarthritis patients suffer from in the seven major markets (%), 2009 59
Figure 20: Techniques used in the diagnosis of osteoarthritis sufferers in the seven major markets, 2009 66
Figure 21: Percentage of osteoarthritis patients diagnosed versus undiagnosed in the seven major markets (%), 2009 67
Figure 22: Percentage of osteoarthritis patients diagnosed by primary care physicians versus rheumatologists (%), 2009 68
Figure 23: Percentage of diagnosed osteoarthritis patients with mild, moderate or severe osteoarthritis, 2009 71
Figure 24: NICE clinical guidelines for the care and management of osteoarthritis in adults, 2008 78
Figure 25: Mean percentage of osteoarthritis patients receiving each type of therapy across the seven major markets, 2009 82
Figure 26: Mean percentage of osteoarthritis patients receiving a non-pharmacological therapy (%), 2009 84
Figure 27: Mean percentage of osteoarthritis patients receiving weight loss therapy split by physician type (%), 2009 86
Figure 28: Mean percentage of osteoarthritis patients receiving exercise therapy split by physician type in the seven major markets (%), 2009 89
Figure 29: Mean percentage of osteoarthritis patients receiving physical therapy split by physician type in the seven major markets (%), 2009 90
Figure 30: Mean percentage of osteoarthritis patients receiving a pharmacological therapy in the seven major markets (%), 2009 92
Figure 31: Mean percentage of osteoarthritis patients receiving simple analgesics in the seven major markets (%), 2009 95
Figure 32: Mean percentage of osteoarthritis patients receiving oral NSAIDs in the seven major markets (%), 2009 97
Figure 33: Osteoarthritis patients receiving oral NSAIDs split by molecule and disease severity in the seven major markets (%), 2009 98
Figure 34: Osteoarthritis patients receiving oral NSAIDs a gastroprotectant, split by disease severity in the seven major markets (%), 2009 105
Figure 35: Mean percentage of osteoarthritis patients receiving topical NSAIDs in the seven major markets (%), 2009 107
Figure 36: Osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009 109
Figure 37: Percentage of osteoarthritis patients receiving a COX-2 (cyclooxygenase) inhibitor by molecule in the seven major markets (%), 2009 115
Figure 38: Percentage of osteoarthritis patients receiving a COX-2 (cyclooxygenase-2) inhibitor continuously versus intermittently, 2009 117
Figure 39: Percentage of osteoarthritis patients receiving injectable hyaluronic acids by molecule in the seven major markets (%), 2009 122
Figure 40: Mean percentages of osteoarthritis patients receiving treatment with each drug class in the seven major markets (%), 2009 124
Figure 41: Mean percentages of osteoarthritis patients receiving treatment with each drug class by physician type in the seven major markets (%), 2009 125
Figure 42: Percentage of osteoarthritis patients in the US receiving branded versus generic treatment for each drug class (%), 2009 127
Figure 43: Percentage of osteoarthritis patients in Japan receiving branded versus generic treatment for each drug class (%), 2009 128
Figure 44: Percentage of osteoarthritis patients in France receiving branded versus generic treatment for each drug class (%), 2009 129
Figure 45: Percentage of osteoarthritis patients in Germany receiving branded versus generic treatment for each drug class (%), 2009 130
Figure 46: Percentage of osteoarthritis patients in Italy receiving branded versus generic treatment for each drug class (%), 2009 131
Figure 47: Percentage of osteoarthritis patients in Spain receiving branded versus generic treatment for each drug class (%), 2009 132
Figure 48: Percentage of osteoarthritis patients in the UK receiving branded versus generic treatment for each drug class (%), 2009 133
Figure 49: Outcome measures used by physicians to assess treatment efficacy in osteoarthritis patients in the seven major markets, 2009 137
Figure 50: Number of months needed to assess treatment efficacy in osteoarthritis patients in the seven major markets, 2009 139
Figure 51: Number of months needed to assess treatment efficacy in osteoarthritis patients by physician type in the seven major markets, 2009 140
Figure 52: Osteoarthritis patients who will eventually require joint surgery in the seven major markets (%), 2009 141
Figure 53: Average number of months between treatment initiation and joint surgery for osteoarthritis patients in the seven major markets, 2009 142
Figure 54: Physicians level of satisfaction with current pharmacological treatments for osteoarthritis in the seven major markets, 2009 143
Figure 55: Physicians' overall satisfaction with currently available pharmacological treatments for osteoarthritis in the seven major markets, 2009 144
Figure 56: Priority ranking allocated by physicians to unmet needs in the treatment of osteoarthritis, 2009 146
Figure 57: Physicians' response to whether or not it is possible to develop a disease-modifying osteoarthritis drug (DMOAD), 2009 149
Figure 58: Physicians' estimates of the time it will take for a disease-modifying osteoarthritis drug (DMOAD) to reach market, 2009 150
Figure 59: Physicians' rating on the importance that a disease-modifying osteoarthritis drug shows both disease modification and pain relief in clinical trial data (n), 2009 153
Figure 60: Physicians' response to promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs) in the seven major markets, 2009 155
Figure 61: Physicians' awareness of drugs in development for osteoarthritis, 2009 160
Figure 62: Physicians' awareness of drugs in development for osteoarthritis in the seven major markets, 2009 161
Figure 63: Physicians' response to awareness of Synvisc-One for treatment of osteoarthritis in the seven major markets, 2009 164

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