Stakeholder Opinions: Biomarkers in Rheumatology - Awaiting the next step towards personalized medicine

Introduction

The growing recognition from companies of the applied benefits from biomarkers in rheumatology has spurred commercial interest in this field. Despite the lack of major advancements, the hope remains that soon rheumatologists will be able to predict response to expensive biologic therapies and match specific treatments to patients based upon biomarker profiles.

Scope

*Classification and overview of biomarkers used in routine clinical practice across five rheumatology indications.

*Identification of potentially promising future biomarkers and assays with insight from key opinion leaders from the seven major markets.

*Overview of key companies actively involved in biomarker R&D, with review of latest data presented at international rheumatology conferences.

*Assessment of the market impact of biomarkers across different facets including: diagnosis, drug development and clinical trial design, and treatment.

Highlights

Future biomarkers will help stratify patient subgroups, aid treatment positioning and healthcare costs, but a personalized approach will ultimately lead to market fragmentation. As competition among marketed products increases, biomarkers and a shift towards market stratification is one way of ensuring new products get to market and find a niche.

Oncology leads the way with a personalized medicine approach, but unless there is a significant breakthrough, rheumatologists estimate this tailored treatment approach will be a minimum of 5 years away for chronic diseases, such as rheumatoid arthritis.

Ensuring that biomarker assays have adequate and extensive reimbursement is vital for uptake, and will involve demonstrating cost-effectiveness through clinical trials and healthcare economics. While necessary, this will be expensive, and there is also the risk that if not cost-effective, novel biomarker assays could be excluded from clinical use.

Reasons to Purchase

*Understand the drivers and resistors behind biomarker identification and validation, and learn which biomarkers have the greatest future potential.

*Learn which companies are active in the biomarker field, what approaches they are adopting and the commercialization issues they face.

*Appreciate the potential market impact form a personalized treatment approach in rheumatology, with case studies from other fields of medicine.


Report Highlights

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TABLE OF CONTENTS
Catalyst 1
Summary 1
ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology & Inflammation pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 4
Chapter 1 Overview of Biomarkers in Rheumatology 9
Key findings 9
Overview 10
What is a biomarker? 10
Classification of rheumatology biomarkers 11
Ideal biomarker characteristics 13
Summary of biomarkers currently used in clinical practice 16
Rheumatoid arthritis biomarkers 16
Rheumatologists use few biomarkers in current practice 16
Rationale for identifying biomarkers – towards objectivity, earlier diagnosis and treatment 17
Serum biomarkers 19
Synovial, cartilage and bone biomarkers 22
Genetic markers 28
Imaging as a biomarker for rheumatoid arthritis 31
Ankylosing spondylitis biomarkers 33
MMP-3 in the limelight again 34
Anti-TNFs show beneficial impact on biomarkers in ankylosing spondylitis 34
Psoriatic arthritis biomarkers 35
Candidate biomarkers are incorrectly borrowed from rheumatoid arthritis 35
Certain biomarkers correlate with disease activity 35
MMP-3 may predict response to anti-TNF therapy in psoriatic arthritis 36
Osteoarthritis biomarkers 37
Physicians ranked biomarkers as the lowest priority unmet need in osteoarthritis 37
Summary of osteoarthritis biomarkers 38
Systemic lupus erythematosus biomarkers 39
Biomarkers are a major unmet need in this disease 39
Renewed enthusiasm for identifying SLE biomarkers 41
Potential biomarkers exist, but further validation is required 41
Companies are looking specifically at SLE biomarkers 43
Chapter 2 Key Companies Involved in Biomarker R&D 45
Key findings 45
Huge commercial interest in the biomarker field 46
There is a clear demand for new biomarkers 47
Commercialization issues 48
Collaboration is vital for commercializing novel rheumatology biomarkers 48
Biomarker patents – an area of uncertainty 48
Differences between US and EU regulatory pathway add to complexity of the biomarker area 50
Companies 52
Overview of companies 52
Axis-Shield 53
Abbott 54
Centocor Ortho Biotech and Schering-Plough 55
Crescendo Bioscience 60
Cypress Bioscience 61
Euro-Diagnostica 65
GeneNews 66
GlaxoSmithKline 66
HuBit Genomix 67
Nordic Bioscience 67
Novartis 68
Pfizer 68
Roche/Genentech 69
Sense Proteomic (now part of Oxford Gene Technology) 71
SQI Therapeutics 72
23andMe 72
Chapter 3 Market Impact and Case Studies 73
Key findings 73
Drivers and resistors of biomarkers development and personalized medicine 74
Impact of biomarkers on diagnosis 75
Earlier identification and treatment of patients at risk of severe disease 75
Impact of biomarkers on drug development 76
Reducing the time and cost of drug development 76
Biomarkers and clinical trial design in rheumatology 78
Impact of biomarkers on treatment 79
Predicting response to therapy 79
Towards a personalized treatment approach in rheumatology 82
Issues with market segmentation fragmentation 84
Case studies 88
Oncology – what rheumatology can learn from this disease area 88
Pharmacogenomic biomarkers of susceptibility to adverse drug reactions 90
Warfarin – optimizing the dosing regimen using genomic biomarkers 91
Bibliography 94
Journal papers and conference abstracts 94
Websites 99
Datamonitor Reports 102
APPENDIX 104
Contributing experts 104
About Datamonitor 105
About Datamonitor Healthcare 105
About the Disease analysis team 105
Datamonitor consulting 106
Disclaimer 106



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