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

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

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