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

Date: December 1, 2009
Pages: 205
Price:
US$ 15,200.00
Publisher: Datamonitor
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: SF55D4281A0EN
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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
ABOUT DATAMONITOR HEALTHCARE

About the Immunology and Inflammation pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis
Datamonitor insight into the osteoarthritis market
Contributing experts
Related reports
Upcoming related reports

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey
Epidemiology and patient segmentation in osteoarthritis
Treatment options and guidelines
Improving treatment outcomes
Future trends

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction to treatment trees
US
Japan
France
Germany
Italy
Spain
UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

Definition and classification of osteoarthritis
Primary (idiopathic) osteoarthritis
Secondary osteoarthritis
Epidemiology of osteoarthritis
Datamonitor estimates 81.4 million osteoarthritis sufferers in the seven major markets in 2009
Measures used to determine radiographic and clinical osteoarthritis
American College of Rheumatology (ACR) criteria
Kellgren-Lawrence scale
Epidemiological studies of osteoarthritis
Assumptions and caveats
US
Japan
Europe
France and Germany
Italy
Spain
UK
Changes in the osteoarthritis population
Additional international osteoarthritis epidemiology studies
Co-morbidities and risk factors in osteoarthritis
Co-morbidities in patients with osteoarthritis are common
Obesity, hypertension and high cholesterol, are the most common co-morbidities present in osteoarthritis patients
High prevalence of cardiovascular, endocrinology and pulmonary co-morbidities in osteoarthritis
Gastrointestinal co-morbidities in osteoarthritis
Previous trauma of the joint is the most common musculoskeletal co-morbidity in osteoarthritis
Central nervous system co-morbidities; depression is highly prevalent in osteoarthritis
Co-morbidities associated with lifestyle factors in osteoarthritis patients
Other co-morbidities present in osteoarthritis patients
Risk factors and patient-group segmentation are critical to osteoarthritis definition
Age
Gender
Mechanical stress
Obesity
Presentation and diagnosis
Diagnosis of osteoarthritis
Techniques for diagnosis
Diagnosis rates
Severity of osteoarthritis
Definition of each level of severity of osteoarthritis provided by Datamonitor to physicians surveyed

CHAPTER 5 TREATMENT OPTIONS AND GUIDELINES

Treatment guidelines
Several guidelines exist for the treatment of osteoarthritis
American College of Rheumatology (ACR)
European League Against Rheumatism (EULAR)
National Institute for Health and Clinical Excellence (NICE)
Osteoarthritis Research Society International (OARSI)
Treatment options
Pharmacological versus non-pharmacological treatment
Non-pharmacological treatment of osteoarthritis
Weight loss and weight control is an effective and common tactic
Nutraceuticals - divided opinion on their use in osteoarthritis treatment
Exercise aids in reducing pain
Other non-pharmacological treatment options
Pharmacological treatment of osteoarthritis
Several drug classes are used in the treatment of osteoarthritis
Analgesics
Non-steroidal anti-inflammatory drugs and COX-2 inhibitors
Branded versus generic drug use
Variations exist in the use of branded versus generic drugs in osteoarthritis treatment in the seven major markets

CHAPTER 6 IMPROVING TREATMENT OUTCOMES

Treatment outcomes and satisfaction
Efficacy assessment
Measuring disease activity in osteoarthritis patients
Communication between the patient and physician is the most common method of assessing treatment efficacy in osteoarthritis
Physicians allow an average of five months to assess treatment efficacy in their osteoarthritis patients
Osteoarthritis patients usually require joint surgery after 7-8 years
Physicians are generally unsatisfied with current pharmacological treatment for osteoarthritis
Unmet needs
Disease modifying osteoarthritis drugs is the highest unmet need in osteoarthritis
Other unmet needs in osteoarthritis
Disease modifying osteoarthritis drugs (DMOADs)
Most physicians believe DMOAD development is possible
DMOADs are up to 8 years from reaching the market
Challenges in clinical study design for DMOADs
It is important for DMOADs to show both disease modification and pain relief in clinical trials
Matrix-metalloproteinase (MMP) inhibitors are the most important molecular target for DMOAD
Pipeline products
Eli Lilly's Cymbalta (duloxetine) is the late-stage drug therapy which most physicians are aware of
Caveat of physicians' awareness to drug therapies
Cymbalta (duloxetine; Eli Lilly)
Synvisc-One (hylan G-F 20; Genzyme)
Naproxcinod (NicOx)
Tanezumab (Pfizer)
Vimovo (PN-400; naproxen plus esomeprazole; Pozen, AstraZeneca)
Fentora (fentanyl; Cephalon)
Diractin (ketoprofen; Idea AG/Alpharma)

BIBLIOGRAPHY

Journal papers
Websites
Datamonitor reports

APPENDIX A

Physician research methodology
Physician sample breakdown

APPENDIX B

The survey questionnaire
Diagnosis and patient segmentation
Treatment
Unmet needs
Treatment outcomes and Prescribing patterns
About Datamonitor
About Datamonitor Healthcare
About the Immunology & Inflammation analysis team
Disclaimer

LIST OF TABLES

Table 1: Estimated adult osteoarthritis populations in the seven major markets, split by sex and age group, 2009
Table 2: Epidemiological studies of osteoarthritis in the seven major markets, 1984-2009
Table 3: US osteoarthritis population by age group and gender, 2009
Table 4: US gender-specific prevalence of radiographic and symptomatic osteoarthritis in different anatomical sites, 2008
Table 5: Estimated adult osteoarthritis population in Japan by age and gender, 2009
Table 6: Estimated adult osteoarthritis population in five major EU markets by age and gender, 2009
Table 7: Spanish EPISER study showing prevalence of knee and hand osteoarthritis, 2008
Table 8: Combined sample of northern England studies, radiographic knee osteoarthritis by age and gender
Table 9: Datamonitor's future projection of the adult osteoarthritis population in the seven major markets, 2010- 2020
Table 10: International epidemiological studies on osteoarthritis prevalence, 2001-09
Table 11: Mean percentages of the co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009
Table 12: Association between doctor-diagnosed* arthritis and body mass index from the BFRSS study, 2009
Table 13: Mean percentage of osteoarthritis patients suffering from cardiovascular, endocrinology and pulmonary co-morbidities (%) , 2009
Table 14: Mean percentages of gastrointestinal co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009
Table 15: Percentage of osteoarthritis patients diagnosed by primary care physicians versus rheumatologists (%), 2009
Table 16: Mean percentage of osteoarthritis patients receiving each type of therapy across the seven major markets, 2009
Table 17: Mean percentage of osteoarthritis patients receiving oral NSAIDs in the seven major markets (%), 2009
Table 18: Osteoarthritis patients receiving oral NSAIDs split by molecule and disease severity in the seven major markets (%), 2009
Table 19: Mild osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009
Table 20: Moderate osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009
Table 21: Severe osteoarthritis patients receiving oral NSAIDs split by molecule in the seven major markets (%), 2009
Table 22: Osteoarthritis patients receiving oral NSAIDs a gastroprotectant in the seven major markets (%), 2009
Table 23: Mean percentage of osteoarthritis patients receiving topical NSAIDs in the seven major markets (%), 2009
Table 24: Osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009
Table 25: Mild osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009
Table 26: Moderate osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009
Table 27: Severe osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009
Table 28: Osteoarthritis patients receiving a cyclo-oxygenase-2 (COX-2) inhibitor by molecule and disease severity in the seven major markets(%), 2009
Table 29: Osteoarthritis patients receiving injectable hyaluronic acids split by physician type and disease severity in the seven major markets (%), 2009
Table 30: Hyaluronic acid brands most commonly prescribed by physicians in the seven major markets (n; %), 2009
Table 31: Number of physicians who use each outcome measure in the seven major markets (n), 2009
Table 32: Priority ranking allocated by physicians to unmet needs in the treatment of osteoarthritis in the seven major markets, 2009
Table 33: Physician opinion of promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs), in the seven major markets, 2009
Table 34: Primary care physicians' and rheumatologists' response to promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs), 2009
Table 35: Physicians' awareness of drugs in development for osteoarthritis in the seven major markets, 2009
Table 36: Physicians surveyed regarding osteoarthritis, 2009

LIST OF FIGURES

Figure 1: US osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 2: Japan osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage
Figure 3: France osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 4: Germany osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 5: Italy osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 6: Spain osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 7: UK osteoarthritis patient population, split by physician-estimated diagnosis, disease severity, drug-treated population and drug-class usage, 2009
Figure 8: Adult osteoarthritis population in the seven major markets, 2009
Figure 9: Estimated adult osteoarthritis population in five major EU markets, by age and gender, 2009
Figure 10: Datamonitor's future projection of the adult osteoarthritis population, split by age group, in the seven major markets, 2010- 2020
Figure 11: Datamonitor future projection of the adult osteoarthritis population, split by region, in the seven major markets, 2010- 2020
Figure 12: Datamonitor future projection of the 65 years and older osteoarthritis population in Japan, 2010- 2020
Figure 13: Mean percentages of osteoarthritis patients suffering from a co-morbidity in the seven major markets (%), 2009
Figure 14: Cardiovascular, endocrinology and pulmonary co-morbidities suffered by osteoarthritis patients in the seven major markets (%), 2009
Figure 15: Gastrointestinal co-morbidities in osteoarthritis patients in the seven major markets (%), 2009
Figure 16: Musculoskeletal co-morbidities in osteoarthritis patients in the seven major markets (%), 2009
Figure 17: Central nervous system co-morbidities in osteoarthritis patients in the seven major markets (%), 2009
Figure 18: Lifestyle factors commonly present in osteoarthritis patients in the seven major markets (%), 2009
Figure 19: Other co-morbidities that 10% or more of osteoarthritis patients suffer from in the seven major markets (%), 2009
Figure 20: Techniques used in the diagnosis of osteoarthritis sufferers in the seven major markets, 2009
Figure 21: Percentage of osteoarthritis patients diagnosed versus undiagnosed in the seven major markets (%), 2009
Figure 22: Percentage of osteoarthritis patients diagnosed by primary care physicians versus rheumatologists (%), 2009
Figure 23: Percentage of diagnosed osteoarthritis patients with mild, moderate or severe osteoarthritis, 2009
Figure 24: NICE clinical guidelines for the care and management of osteoarthritis in adults, 2008
Figure 25: Mean percentage of osteoarthritis patients receiving each type of therapy across the seven major markets, 2009
Figure 26: Mean percentage of osteoarthritis patients receiving a non-pharmacological therapy (%), 2009
Figure 27: Mean percentage of osteoarthritis patients receiving weight loss therapy split by physician type (%), 2009
Figure 28: Mean percentage of osteoarthritis patients receiving exercise therapy split by physician type in the seven major markets (%), 2009
Figure 29: Mean percentage of osteoarthritis patients receiving physical therapy split by physician type in the seven major markets (%), 2009
Figure 30: Mean percentage of osteoarthritis patients receiving a pharmacological therapy in the seven major markets (%), 2009
Figure 31: Mean percentage of osteoarthritis patients receiving simple analgesics in the seven major markets (%), 2009
Figure 32: Mean percentage of osteoarthritis patients receiving oral NSAIDs in the seven major markets (%), 2009
Figure 33: Osteoarthritis patients receiving oral NSAIDs split by molecule and disease severity in the seven major markets (%), 2009
Figure 34: Osteoarthritis patients receiving oral NSAIDs a gastroprotectant, split by disease severity in the seven major markets (%), 2009
Figure 35: Mean percentage of osteoarthritis patients receiving topical NSAIDs in the seven major markets (%), 2009
Figure 36: Osteoarthritis patients receiving a topical NSAID by molecule in the seven major markets (%), 2009
Figure 37: Percentage of osteoarthritis patients receiving a COX-2 (cyclooxygenase) inhibitor by molecule in the seven major markets (%), 2009
Figure 38: Percentage of osteoarthritis patients receiving a COX-2 (cyclooxygenase-2) inhibitor continuously versus intermittently, 2009
Figure 39: Percentage of osteoarthritis patients receiving injectable hyaluronic acids by molecule in the seven major markets (%), 2009
Figure 40: Mean percentages of osteoarthritis patients receiving treatment with each drug class in the seven major markets (%), 2009
Figure 41: Mean percentages of osteoarthritis patients receiving treatment with each drug class by physician type in the seven major markets (%), 2009
Figure 42: Percentage of osteoarthritis patients in the US receiving branded versus generic treatment for each drug class (%), 2009
Figure 43: Percentage of osteoarthritis patients in Japan receiving branded versus generic treatment for each drug class (%), 2009
Figure 44: Percentage of osteoarthritis patients in France receiving branded versus generic treatment for each drug class (%), 2009
Figure 45: Percentage of osteoarthritis patients in Germany receiving branded versus generic treatment for each drug class (%), 2009
Figure 46: Percentage of osteoarthritis patients in Italy receiving branded versus generic treatment for each drug class (%), 2009
Figure 47: Percentage of osteoarthritis patients in Spain receiving branded versus generic treatment for each drug class (%), 2009
Figure 48: Percentage of osteoarthritis patients in the UK receiving branded versus generic treatment for each drug class (%), 2009
Figure 49: Outcome measures used by physicians to assess treatment efficacy in osteoarthritis patients in the seven major markets, 2009
Figure 50: Number of months needed to assess treatment efficacy in osteoarthritis patients in the seven major markets, 2009
Figure 51: Number of months needed to assess treatment efficacy in osteoarthritis patients by physician type in the seven major markets, 2009
Figure 52: Osteoarthritis patients who will eventually require joint surgery in the seven major markets (%), 2009
Figure 53: Average number of months between treatment initiation and joint surgery for osteoarthritis patients in the seven major markets, 2009
Figure 54: Physicians level of satisfaction with current pharmacological treatments for osteoarthritis in the seven major markets, 2009
Figure 55: Physicians' overall satisfaction with currently available pharmacological treatments for osteoarthritis in the seven major markets, 2009
Figure 56: Priority ranking allocated by physicians to unmet needs in the treatment of osteoarthritis, 2009
Figure 57: Physicians' response to whether or not it is possible to develop a disease-modifying osteoarthritis drug (DMOAD), 2009
Figure 58: Physicians' estimates of the time it will take for a disease-modifying osteoarthritis drug (DMOAD) to reach market, 2009
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
Figure 60: Physicians' response to promising molecular targets for disease-modifying osteoarthritis drugs (DMOADs) in the seven major markets, 2009
Figure 61: Physicians' awareness of drugs in development for osteoarthritis, 2009
Figure 62: Physicians' awareness of drugs in development for osteoarthritis in the seven major markets, 2009
Figure 63: Physicians' response to awareness of Synvisc-One for treatment of osteoarthritis in the seven major markets, 2009

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