Market Report Source

Overview

Introduction
Osteoarthritis offers a very attractive commercial target in terms of patient potential, and the explosion in new disease modifying drugs in rheumatoid arthritis has highlighted the possibilities for OA. However, controversy in the Cox-2 class, preconceptions about alternative treatments and even debate around the definition of OA make this a more difficult market to break into than first thought.

Scope
Assessment of patient size across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK), including split by age and gender
Transcripts based on qualitative interviews with key opinion leaders including physicians, patient advocates and research scientists
Investigation of the current unmet needs from a range of professionals involved in osteoarthritis treatment and research
Current treatment controversies and novel therapies in the developmental pipeline

Highlights
High unmet need and a large patient population are key drivers towards research and innovation in osteoarthritis. Datamonitor estimates that 89 million adults have some form of symptomatic osteoarthritis in the seven major markets. However, ageist perceptions and low awareness provide a substantial negative impact on the market.

Is a paradigm shift needed in the way osteoarthritis is treated? Treatment currently centers on NSAIDs but in the light of recent controversies demand for alternatives exists. Other effective treatment options are available, not least changing lifestyle factors, but those that are currently available are battling against their own preconceptions.

Clinical trials for disease modifying and symptomatic products for osteoarthritis require careful design. However, the optimum design is not yet decided among experts. Advances in imaging offer promise, but interpretation of results must be unified and though the identification of biomarkers is progressing, they are often difficult to utilize.

Reasons to Purchase
Identify the challenges in disease modifying clinical trial design including end-point selection
Understand the key issues for alternative treatments propelled into the treatment algorithm by the Cox-2 controversies
Gain insight into opinion leaders’ thoughts on the challenges facing the osteoarthritis market
Files available on the repository”

Table of Contents

TABLE OF CONTENTS

About the CNS, Arthritis and Pain pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Datamonitor insight into the osteoarthritis market

High unmet need and a large patient population are key drivers toward research and innovation in osteoarthritis (OA), but ageist perceptions and low awareness have a substantial negative impact on the market.

The need for a paradigm shift in the way osteoarthritis is treated has been suggested in the wake of drug controversy and the failure of disease modifying approaches. Treatment currently centers on NSAID use, but following recent controversies, there is demand for an alternative. However, many alternatives are battling against their own preconceptions. This currently adds to the drive for a disease-modifying treatment, but would be more successfully directed towards a holistic approach.

Clinical trials for disease-modifying products for OA are increasingly regulated and require careful design. However, the best design for disease modification assessment has not yet been decided upon by experts. Advances in imaging offer promise for clinical trial end-points, but interpretation of results must be unified and new biomarkers are being identified but are often difficult to utilize.

CHAPTER 2 INTRODUCTION

Classifications

Primary (idiopathic) osteoarthritis

Secondary osteoarthritis

Epidemiology of osteoarthritis

Country calculations

Radiographic hugely outweighs symptomatic joint involvement

Changes in the osteoarthritis population as the “baby boomer” generation reaches retirement age

Knee osteoarthritis usually assessed in trials and epidemiology studies but hip OA may offer an easier assessment target

Additional international osteoarthritis epidemiology studies

Risk factors and patient-group segmentation are key in OA definition

Treatment

CHAPTER 3 UNMET NEEDS

Disease Modification is the key unmet need in OA

Restraints outweigh the current drivers for DMOAD development

Clinical-trial design is challenging for both DMOADs and symptom-modifying treatments as “gold-standard methods” are rapidly changing

Patient-group segmentation in clinical trials offers a way to gain approval, but risks restricted use

Quality of life and patient education should be addressed for all treatments

Osteoarthritis awareness and perception in society reduces treatment uptake

Collaboration and dedicated government-funded research organization to aid this are the key to successful future OA treatment

The role of pharmaceutical companies

Direct to consumer advertising must be responsible in order to change public perception

Emerging imaging and biomarker research will impact both diagnosis and trial endpoints

Whole-organ MRI scoring system (WORMS): not perfect but a step forward

Biomarker research offers promise

CHAPTER 4 CURRENT TREATMENT CONTROVERSIES

The Vioxx withdrawal is old news, but it still affects physician perception of osteoarthritis treatments

What is a Cox-2 inhibitor and should it still command a higher price?

Opioid use in osteoarthritis offers a good alternative to NSAIDs, but “opioid-phobia” prevents high uptake

Topical opioids appear to break down perceptual barriers

The impact of “professional patients” is increasing in industry and government

Non-pharmacological treatments are the first and the last resort in osteoarthritis

Physiotherapy

Joint replacement

Nutraceuticals, supplements and alternative therapy invade the market

The Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

The Glucosamine Unum In Die Efficacy Trial (GUIDE)

What can medical foods offer OA patients?

Is the competitive and profitable hyaluronic-acid market based on the placebo effect?

CHAPTER 5 PIPELINE DRUGS

Pain- and inflammatory-relief pipeline treatments are particularly diverse in mechanism

HCT 3012

Sativex

Licofelone

Botox

Disease modifiers in OA are yet to progress past Phase II

Matrix Metalloproteinase (MMP) inhibition

IL-1 inhibition

Enhancing cartilage repair

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

Websites

The knee injury and osteoarthritis outcome score (KOOS)

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare’s research and analysis methodologies

Datamonitor Healthcare’s therapy area capabilities

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