風濕性疾病之生物標的：朝個別化醫療的下一步邁進 是由出版商Datamonitor在2009年12月所出版的。
這份英文市場調查報告書包含106 pages 價格從美金3800起跳。
生物標的在風濕性疾病研究應用上的優勢逐漸備受肯定，許多企業對此領域表示高度興趣。
本研究報告收集五種風濕性疾病之生物標的物之種類與概況、具有前瞻性的生物標的、參與生物標的研究開發之企業概況與最新資料，將其分析整理如下。
序論
研究摘要
風濕性疾病之生物標的物概況
- 關鍵研究成果
- 簡介
- 類風濕性關節炎之生物標的
- 僵直性脊椎炎之生物標的
- 乾癬性關節炎之生物標的
- 骨關節炎之生物標的
- 系統性紅斑性狼瘡之生物標的
參與生物標的研究開發之企業
- 關鍵研究成果
- 對生物標的領域之高度矚目
- 商品化之挑戰
- 企業資料
- 簡介
- Axis-Shield
- Abbott
- Centocor Ortho Biotech and Schering-Plough
- Crescendo Bioscience
- Cypress Bioscience
- Euro-Diagnostica
- GeneNews
- GlaxoSmithKline
- HuBit Genomix
- Nordic Bioscience
- Novartis
- Pfizer
- Roche/Genentech
- Sense Proteomic (now part of Oxford Gene Technology)
- SQI Therapeutics
- 23andMe
市場影響與案例研究
- 關鍵研究成果
- 生物標的物研發之助力與阻力以及個別化醫療
- 生物標的物對診斷之影響
- 生物標的物對藥物開發之影響
- 縮減藥物開發的時間與成本
- 風濕病之治療方法設計與生物標的
- 生物標的物對治療之影響
- 預測治療反映
- 風濕病之個別化治療
- 市場細分化之分割問題
- 案例研究
參考資料
附錄
圖表
Abstract
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 of this research
- 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.
Research and analysis 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.
Key reasons to purchase this research
- 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.
Table of Contents
OVERVIEW
EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
OVERVIEW OF BIOMARKERS IN RHEUMATOLOGY
- Key findings
- Overview
- What is a biomarker?
- Classification of rheumatology biomarkers
- Ideal biomarker characteristics
- Summary of biomarkers currently used in clinical practice
- Rheumatoid arthritis biomarkers
- Rheumatologists use few biomarkers in current practice
- Rationale for identifying biomarkers - towards objectivity, earlier
diagnosis and treatment
- Serum biomarkers
- Synovial, cartilage and bone biomarkers
- Genetic markers
- Imaging as a biomarker for rheumatoid arthritis
- Ankylosing spondylitis biomarkers
- MMP-3 in the limelight again
- Anti-TNFs show beneficial impact on biomarkers in ankylosing spondylitis
- Psoriatic arthritis biomarkers
- Candidate biomarkers are incorrectly borrowed from rheumatoid arthritis
- Certain biomarkers correlate with disease activity
- MMP-3 may predict response to anti-TNF therapy in psoriatic arthritis
- Osteoarthritis biomarkers
- Physicians ranked biomarkers as the lowest priority unmet need in
osteoarthritis
- Summary of osteoarthritis biomarkers
- Systemic lupus erythematosus biomarkers
- Biomarkers are a major unmet need in this disease
- Renewed enthusiasm for identifying SLE biomarkers
- Potential biomarkers exist, but further validation is required
- Companies are looking specifically at SLE biomarkers
KEY COMPANIES INVOLVED IN BIOMARKER R&D
- Key findings
- Huge commercial interest in the biomarker field
- There is a clear demand for new biomarkers
- Commercialization issues
- Collaboration is vital for commercializing novel rheumatology biomarkers
- Biomarker patents - an area of uncertainty
- Differences between US and EU regulatory pathway add to complexity of
the biomarker area
- Companies
- Overview of companies
- Axis-Shield
- Abbott
- Centocor Ortho Biotech and Schering-Plough
- Crescendo Bioscience
- Cypress Bioscience
- Euro-Diagnostica
- GeneNews
- GlaxoSmithKline
- HuBit Genomix
- Nordic Bioscience
- Novartis
- Pfizer
- Roche/Genentech
- Sense Proteomic (now part of Oxford Gene Technology)
- SQI Therapeutics
- 23andMe
MARKET IMPACT AND CASE STUDIES
- Key findings
- Drivers and resistors of biomarkers development and personalized medicine
- Impact of biomarkers on diagnosis
- Earlier identification and treatment of patients at risk of severe
disease
- Impact of biomarkers on drug development
- Reducing the time and cost of drug development
- Biomarkers and clinical trial design in rheumatology
- Impact of biomarkers on treatment
- Predicting response to therapy
- Towards a personalized treatment approach in rheumatology
- Issues with market segmentation fragmentation
- Case studies
- Oncology - what rheumatology can learn from this disease area
- Pharmacogenomic biomarkers of susceptibility to adverse drug reactions
- Warfarin - optimizing the dosing regimen using genomic biomarkers
BIBLIOGRAPHY
- Journal papers and conference abstracts
- Websites
- Datamonitor Reports
APPENDIX
TABLES
- Table: Markers of degradation of cartilage and bone in rheumatoid arthritis
- Table: Genetic markers in rheumatoid arthritis, 2009
- Table: Serum biomarkers for disease activity in psoriatic arthritis, 2008
- Table: Osteoarthritis biomarkers of bone, cartilage and synovial turnover
and how they relate to the BIPED classification, 2007
- Table: Potential biomarkers for systemic lupus erythematosus, shown by
category, 2009
- Table: Potential urinary biomarkers in lupus nephritis, 2009
- Table: Patent information for well known rheumatoid diagnostic tests, 2009
- Table: Overview of companies involved in rheumatology biomarkers, 2009
- Table: Centocor Ortho Biotech publications for rheumatology biomarkers,
2007 - 09
- Table: Efficacy difference between rituximab and placebo treated patients
at week 24 in the SERENE trial, 2009
- Table: Diagnosis rates, time from symptom onset to physician presentation
and time to receipt of first DMARD for rheumatoid arthritis across the seven
major markets, 2006
- Table: Advances in genomic predictors of response, 2009
FIGURES
- Figure: Classification of biomarkers in rheumatology, 2009
- Figure: Generalized overview of currently validated markers in each of the
major rheumatology indications, 2009
- Figure: Relation of disease activity, joint damage, disability and
biomarkers reflecting the three elements of the natural history of rheumatoid
arthritis
- Figure: Impact of disease-modifying antirheumatic drugs on rheumatoid
arthritis progression
- Figure: A 2-year blinded study comparing methotrexate and infliximab with
methotrexate alone in aggressive early rheumatoid arthritis on joint damage
progression using ultrasonography, radiography and serum biomarkers, 2009
- Figure: Design of study identifying biomarkers associated with response to
anti-TNF therapy in patients with psoriatic arthritis, 2009
- Figure: Priority ranking allocated by physicians to unmet needs in the
treatment of osteoarthritis, 2009
- Figure: Priority rating allocated by rheumatologists to challenges in
systemic lupus erythematosus management, 2008
- Figure: Division of companies in the rheumatology biomarker field
- Figure: The US and EU regulatory pathways for market authorization of
biomarker-based assays/in vitro diagnostics, 2009
- Figure: Anti-CCP product timeline for Axis-Shield, 2001 - 09
- Figure: Sales of Axis-Shield' s non-AxSYM xtra anti-CCP laboratory
diagnostic tests in the EU, 2005 - 08
- Figure: Pilot matrix risk model quantifying the probability of patients
who will experience rapid radiographic progression, 2009
- Figure: BeSt trial matrix models in recent-onset rheumatoid arthritis
patients, 2009
- Figure: Nordic Bioscience R&D operates a number of programs, including
biomarker research, across a number of therapeutic areas
- Figure: Drivers and resistors of biomarker development and personalized
medicine in rheumatology, 2009
- Figure: Investment required for the successful launch of a single drug and
areas where use of biomarkers could reduce costs
- Figure: Integration of biomarkers into the various stages of drug
development
- Figure: Personalized medicine versus translational medicine
drug-development strategies
- Figure: Impact on market share from the adoption of personalized medicine
in rheumatology
- Figure: Patient care path for rheumatoid arthritis showing points of
impact from biomarkers, 2009
- Figure: Impact of biomarkers on current rheumatoid arthritis treatment
recommendations
- Figure: FDA' s biomarker testing requirements, 2009
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