Table of Contents
About the CNS, Arthritis and Pain pharmaceuticalanalysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Datamonitor insight into the osteoarthritis market
- High unmet need and a large patient population are keydrivers towards
research and innovation in osteoarthritis (OA), butageist perceptions and
low awareness have a substantial negative impacton the market.
- The need for a paradigm shift in the way osteoarthritisis treated has
been suggested in the wake of drug controversy and thefailure of disease
modifying approaches. Treatment currently centers onNSAID use, but
following recent controversies, there is demand for analternative.
However, many alternatives are battling against their ownpreconceptions.
This currently adds to the drive for a disease-modifyingtreatment, but
would be more successfully directed towards a holisticapproach.
- Clinical trials for disease-modifying products for Oaare increasingly
regulated and require careful design. However, the bestdesign for disease
modification assessment has not yet been decided uponby experts. Advances
in imaging offer promise for clinical trialend-points, but interpretation
of results must be unified and newbiomarkers are being identified but are
often difficult to utilize.
CHAPTER 2 INTRODUCTION AND EPIDEMIOLOGY
- Classifications
- Primary (idiopathic) osteoarthritis
- Secondary osteoarthritis
- Epidemiology of osteoarthritis
- Country calculations
- US population
- European population
- Japanese population
- Radiographic hugely outweighs symptomatic jointinvolvement
- Changes in the osteoarthritis population as the"baby boomer"
generation reaches retirement age
- Knee osteoarthritis usually assessed in trials andepidemiology studies
but hip OA may offer an easier assessment target
- Additional international osteoarthritis epidemiologystudies
- Beijing OA study, China
- Joint-replacement study, 2004, and the AustralianNational Health
Survey, 1995
- Prevalence of Rheumatic diseases in Greece: Across-sectional,
population-based epidemiological study: The ESORDIGStudy, Andrianakos et
al., 2003, 2005
- Risk factors and patient-group segmentation are key inOA definition
- Age
- Gender
- Mechanical stress
- Obesity
- Treatment
CHAPTER 3 UNMET NEEDS
- Disease Modification is the key unmet need in OA
- Restraints outweigh the current drivers for DMOADdevelopment
- Clinical-trial design is challenging for both DMOADs
andsymptom-modifying treatments as "gold-standard methods"
arerapidly changing
- Patient-group segmentation in clinical trials offers away to gain
approval, but risks restricted use
- Quality of life and patient education should beaddressed for all
treatments
- Osteoarthritis awareness and perception in societyreduces treatment
uptake
- Collaboration and dedicated government-funded researchorganization to
aid this are the key to successful future OA treatment
- The role of pharmaceutical companies
- Direct to consumer advertising must be responsible inorder to change
public perception
- Emerging imaging and biomarker research will impact bothdiagnosis and
trial endpoints
- Whole-organ MRI scoring system (WORMS): not perfect buta step forward
- Biomarker research offers promise
CHAPTER 4 CURRENT TREATMENT CONTROVERSIES
- The Vioxx withdrawal is old news, but it still affectsphysician
perception of osteoarthritis treatments
- What is a Cox-2 inhibitor and should it still command ahigher price?
- Opioid use in osteoarthritis offers a good alternativeto NSAIDs, but
"opioid-phobia" prevents high uptake
- Topical opioids appear to break down perceptual barriers
- The impact of "professional patients" isincreasing in industry
and government
- Non-pharmacological treatments are the first and thelast resort in
osteoarthritis
- Physiotherapy
- Joint replacement
- Nutraceuticals, supplements and alternative therapyinvade the market
- The Glucosamine/Chondroitin Arthritis Intervention Trial(GAIT)
- The Glucosamine Unum In Die Efficacy Trial (GUIDE)
- So does glucosamine work?
- What can medical foods offer OA patients?
- Is the competitive and profitable hyaluronic-acid marketbased on the
placebo effect?
CHAPTER 5 PIPELINE DRUGS
- Pain- and inflammatory-relief pipeline treatments areparticularly
diverse in mechanism
- HCT 3012
- Sativex
- Licofelone
- Botox
- Disease modifiers in OA are yet to progress past PhaseII
- Matrix Metalloproteinase (MMP) inhibition
- IL-1 inhibition
- Enhancing cartilage repair
- Autologous chondrocytes transplantation
CHAPTER 6 OPINION LEADER TRANSCRIPTS
- Contributing experts
- Professor Howard Bird
- Dr. Felix Eckstein
- Dr. Robin Poole
- Jane Tadman, Arthritis Research Campaign (ARC)
- Professor Paul Dieppe
- Cheryl Koehn, Arthritis Consumer Expert
CHAPTER 7 APPENDIX
- Bibliography
- The knee injury and osteoarthritis outcome score (KOOS)
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcares research and analysismethodologies
- Datamonitor Healthcares therapy area capabilities
- Disclaimer
List of Tables
- Table 1: Estimated adult OA populations in the sevenmajor markets, by
age group, 2006 (000s)
- Table 2: OA sufferers who present with the disease inspecific parts of
the body (%): US, Japan and 5 EU markets, 2003
- Table 3: US OA patient population by age group andgender, 2006 (000s)
- Table 4: Breakdown of arthritis population from NHISsurvey and estimated
OA percentages, 2003
- Table 5: Adult OA population in five major Eucountries, by age and
gender, 2006 (000s)
- Table 6: Combined sample of northern England studies,radiographic knee
OA by age and gender
- Table 7: Estimated symptomatic knee OA prevalence: Ukadults
- Table 8: Spanish EPISER study showing breakdown ofhand and knee OA by
age group, 2001
- Table 9: Adult OA population in Japan, by age andgender, 2006 (000s)
- Table 10: Results of Framingham Heart Study/knee Oacohort, 1983-85
- Table 11: Results of Framingham Heart Study/knee Oacohort Follow-Up,
1992-93
- Table 12: Estimated US adult population and projectedprevalence of
doctor-diagnosed arthritis and arthritis-attributableactivity limitations,
among adults aged 18 years and older, US,2005-2030
- Table 13: Hip and knee OA patients in seven majormarkets (millions), 2006
- Table 14: WHO statistics for obesity and averagesystolic blood pressure
in the seven major markets
- Table 15: Duragesic (fentanyl) trial results in OA,2005
- Table 16: GAIT study response rates by treatment groupand pain level,
2005
- Table 17: Pain and anti-inflammatory products inclinical trials for OA,
2006
- Table 18: Disease-modifying treatments for OA, 2006
List of Figures
- Figure 1: Adult (15+) OA population in the seven majormarkets, 2006
- Figure 2: Adult OA population, five major Eucountries, by age group, 2006
- Figure 3: Relationship between radiographic andsymptomatic OA
- Figure 4: Drivers of and impediments to DMOADdevelopment and their
comparative importance and difficulty
- Figure 5: Opportunities and threats to companieswishing to enter the
Cox-2 market
- Figure 6: Guidelines for selecting the appropriateNSAID in various
clinical situations, 2006
- Figure 7: Effects of various NSAIDs on theconcentration of Cox-1 and
Cox-2 in vitro
- Figure 8: US and UK knee and hip replacements,2000-2002
- Figure 9: Knee and hip replacement procedures per100,000 population, by
country, 2000
- Figure 10: The knee injury and osteoarthritis outcomescore
- Figure 11: The knee injury and osteoarthritis outcomescore (cont.)
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