代謝疾病診斷之爭議：能否解決生物標誌及診斷工具之爭議 是由出版商Decision Resources, Inc.在2010年09月所出版的。
這份英文市場調查報告書價格從美金4600起跳。
醫師雖提倡以代謝疾病生物標誌為基礎之檢查需求，但要如何診斷、治療及監控疾病等爭議卻阻礙其發展。代謝性生物標誌及診斷工具被定期使用於治療領域中，評估藥物功效所需之臨床及實驗上，仍具臨床及商業之機會。
本報告為，提供代謝疾病之生物標誌及診斷藥物開發、採用上待解決之議題，並匯整代謝疾病概要、醫師對生物標誌重要性之看法、今後展望等，以下列摘要形式闡述。
實施概要
簡介
為何生物標誌極為重要：醫師看法
受重視之代謝疾病
- 2型糖尿病
- 舒緩疾病效能之評估
- 對邊緣性糖尿病患之非侵入性檢查
- 代謝症候群
- 胰島素抵抗
- 肥胖
- 高脂血症
- 骨質疏鬆
主要生物標誌及診斷藥物：相關爭議
- 檢測胰島素抵抗所需之HOMA指數及葡萄糖呼氣測試
- 糖尿病之葡萄糖及HbA1c測試
- 評估代謝疾病之HbA1c
交易
今後展望
圖表
Abstract
Introduction:
A vast majority of surveyed physicians point to the need for biomarker-based
testing for metabolic diseases, but controversies about how these diseases are
diagnosed, managed, and monitored hold back progress. This report focuses on
unresolved issues that complicate the development and deployment of biomarkers
and diagnostics for metabolic diseases. Metabolic biomarkers and diagnostic
tools are routinely used in practice and clinical trials to assess the
effectiveness of drugs in this therapeutic area, but clinical and commercial
opportunities remain. Attempts to address the various controversies are
providing impetus for further discovery and development, which will lead, in
turn, to innovation and standardization.
Questions Answered in This Report:
- According to surveyed physicians, biomarker-based testing is an urgent
unmet need in the area of metabolic diseases, representing a true opportunity
for drug and diagnostics developers. How do physicians rank the need for
better testing in this therapeutic area? Which specific indications do they
highlight? How can such tests best be used?
- Differing definitions and unanswered questions about risk of disease
progression characterize the difficulties in diagnosing metabolic diseases.
For instance, the concept of a metabolic syndrome, a compilation of metabolic
indications and risk factors, has long been controversial. What are these
controversies and how do they influence medical practice and physician
prescribing behavior? How do physicians handle the difficulties in diagnosing
and treating individuals? Where are the opportunities for biomarker-based
diagnostics in the metabolic disease progression process?
- Genetic research continues to reveal interesting underpinnings of
metabolic diseases. What recent findings are relevant to developers of
biomarker and diagnostics firms? How has one company turned genetic findings
related to obesity into a commercial offering?
- Given the relationships between various metabolic indications and risk
factors, best practices in diagnosis might ultimately be based on tests that
comprise a panel of biomarkers rather than on individual biomarker-based
tests. What are the leading indications for such tests? How are companies
approaching this opportunity?
- Decision Resources analysts who specialize in metabolic diseases consider
the role of biomarkers and diagnostics in the overall biopharmaceutical
marketplace. What particular unmet needs do they identify? What emerging
therapies involve specific targets that diagnostics companies could exploit to
develop novel tests?
Scope:
Indications covered: Type 2 diabetes, metabolic syndrome, insulin resistance,
osteoporosis, obesity, and dyslipidemia.
Primary research: Results from a survey of 100 U.S. physicians conducted in
July 2010, revealing useful insight into relevant biomarkers and opportunities
for diagnostics in the metabolic diseases therapeutic area.
Epidemiology estimates: Top-line estimates of prevalent cases of the
indications covered in this report for 2009 and 2019 in the United States,
France, Germany, Italy, Spain, United Kingdom, and Japan.
Dealmaking assessment: A total of 38 deals were evaluated in the biomarker and
diagnostics space for metabolic diseases over a ten-year period starting in
2000. Data are presented on deals by indication and company type.
Areas of ongoing controversy: Disease definitions, diagnostic tools, and
relevance of specific biomarkers.
Key opportunities: Insight is offered on biomarker and diagnostics companies
that are providing products and services in the metabolic diseases area. Key
proteins and genes are explored as potential targets for diagnostics
development.
Spectrum Expert Commentary: Expert commentary by a Decision Resources analyst
specializing in metabolic disorders on assessing the value of a biomarker in
osteoporosis diagnosis and management.
Table of Contents
Executive Summary
- Strategic Considerations
- Stakeholder Implications
Introduction
Why Biomarkers Matter - Physician Opinion
Metabolic Diseases of Interest
- Type 2 Diabetes
- Assessing Disease Modification Potential
- Noninvasive Screening for Prediabetes
- Metabolic Syndrome
- Insulin Resistance
- Obesity
- Dyslipidemia
- Osteoporosis
Key Biomarkers and Diagnostics: Related Controversies
- HOMA Index vs. Glucose Breath Test for Detecting Insulin Resistance
- Glucose vs. HbA1c Testing in Diabetes
- Beyond HbA1c in Metabolic Disease Assessment
Focus on Dealmaking
- Indication-Specific Deals
- Company-Specific Deals
Outlook
Expert Commentary
- What is the Value of Biomarkers in Managing Osteoporosis?
- Matthew Scutcher, Ph.D., Decision Resources
Tables
- A. Common Biomarkers in Osteoporosis for Bone Resorption and Formation
- 1. Number of Prevalent Cases of Select Metabolic Diseases in the Major
Markets, 2009 and 2019
- 2. Classifications of Diabetes
- 3. Select Genes Involved in Impaired Glucose Transport and Insulin
Signaling
- 4. Definitions of Metabolic Syndrome
- 5. Number of Total Prevalent Cases of Insulin Resistance in the Major
Markets, Segmented by Type 2 Diabetic and Nondiabetic Status, 2009 and 2019
- 6. Select HbA1c Tests Cleared by FDA
Figures
- 1. Physician Survey Results: Number of Patients Treated in a Typical
30-Day Period, by Indication
- 2. Physician Survey Results: How Can Biomarkers Help Reduce Unmet Needs?
- 3. Relationship Between Insulin Resistance, Prediabetes, and Type 2
Diabetes
- 4. Number of Metabolic Biomarker and Diagnostic Deals, 2000-First Half 2010
- 5. Metabolic Deals: Biomarkers vs. Diagnostics, 2000-First Half 2010
- 6. Number of Metabolic Biomarker and Diagnostic Deals, by Deal Focus,
2000-First Half 2010
- 7. Number of Metabolic Biomarker and Diagnostic Deals, by Indication,
2000-First Half 2010
- 8. Leading Companies with Metabolic Biomarker and Diagnostic Deals,
2000-First Half 2010
- 9. Number of Metabolic Biomarker and Diagnostic Deals, by Company Type,
2000-First Half 2010
