藥物發明的生物標記:有效降低藥物損耗率的生物仿製藥的使用最佳階段 是由出版商GBI Research在2011年10月所出版的。
這份英文市場調查報告書包含Pages: 103 價格從美金3500起跳。
癌症的生物標記市場在全球生物標記市場中發揮重要的作用。在腫瘤標記（癌症篩檢）市場中乳癌的高得病率提高最大的收益，目前已開發許多標記。藉由FDA及生物標記，縮短8∼12年藥物發明所需時間，能降低1億美元的開發費用。全球生物標記市場趨於成熟，2010年增加大約101億美元。2002年以後，該市場在分子診斷和臨床服務中生物標記的應用有很大的成長。預計到2017年為止該市場將達到273億美元。
本報告提供全球藥物發明的生物標記市場相關調查，市場趨勢與技術引進，再加上主要企業的競爭趨勢，法律規範趨勢等，以及各企業簡介和開發平台彙整，為您概述為以下內容。
第1章 目錄
第2章 藥物發明的生物標記:簡介
第3章 概要
- 生物標記的歷史
- 生物標記的分類
- 生物標誌物藥物發明和驗證流程
- 生物標記的一般應用
- 藥物發明的生物標記的應用
- 生物標記使用的優點
- 生物標記使用的相關課題
第4章 相關案例研究
- Cell Signaling Technology與Astellas製藥公司簽訂聯合行銷合約
- 定義
- 肺癌相關
- 企業簡介
- 使用的技術
- 市場資訊
- 優點
- 未來的預測
第5章 市場特性
- 市場概要
- 市場規模與預測
- 未滿足需求:生物標記滿足藥物發明的未滿足需求
第6章 趨勢分析
- 法律制度
- 已認證的生物標記
- 有效生物標記的法律認證
- FDA，新興歐非中東(EMEA)，衛生署的相關法規指導
第7章 技術引進
- 未滿足需求:藥物發明
- 認識度提高與醫藥品，研究部門
- 廣泛應用的增加
- 生物標記的未來:藥物發明的未滿足需求
第8章 競爭環境
- 主要企業
- Quest Diagnostics
- Life Technologies Corporation
- Vermillion
- BG Medicine
- Menarini
- Abbott
- Roche
- Genentech
- Affymetrix
- Amgen
- 各地區環境
第9章 開發平台分析
- 開發平台分析
- 藥物發明階段
- 第一階段
- 第二階段
- 第三階段
- 第四階段
- 各方面分析
- 治療層級
- 各地區
第10章 策略性整合
- 交易各類型策略性整合
- 合併·收購
- 授權契約
- 合作契約
第11章 附錄
圖表
Abstract
Summary
GBI Research, the leading business intelligence provider, has released its latest report, "Biomarkers in Drug Discovery - Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly", which provides key data, information and analysis of the major trends and issues affecting biomarkers in the drug discovery process. The report provides a comprehensive insight into the history of biomarkers, their uses and efficiency, as well as their limitations. The report also provides a detailed analysis of the biomarkers market's characterization in terms of its market size, segmentation by use of biomarkers in drug discovery, diagnostics and others and the major market drivers and barriers. The report also looks into the biomarkers pipeline as well as an analysis on the pipeline by indication, phase of development and geography of development. The report also provides a competitive landscape of the market that profiles key market players along with their brief business description, major products and major Mergers & Acquisitions (M&A) and partnership deals. The report also provides detailed analysis of major partnership and M&A deals that have taken place in the biomarkers market in the year 2010 and till May 2011 along with segmentation by deal type, geography and companies. Finally, the report provides the major conclusions about the biomarkers market
Scope
The report analyses the biomarkers in the drug discovery market along with the major forces driving the current market and the potential challenges that can restrain the growth. The scope of the report includes:
- An overview of biomarkers in the drug discovery process along with their use, efficiency and limitations.
- Annualized market data from 2002 and forecast forward to 2017, along with segmentation of the market into drug discovery, diagnostic and others.
- Key market drivers and restraints shaping the biomarkers market.
- Pipeline analysis of the biomarkers, along with segmentation by indication, phase and geography.
- Competitive landscape analysis with profiling of leading companies such as Quest Diagnostics, Vermillion, Amgen, Abbott and Roche.
- Analysis of partnership and M&A deals from 2010 till May 2011, along with segmentation by indication, deal type, geography and companies.
Reasons to buy
The report will enhance your decision making capability. It will allow you to:
- Develop better strategies for biomarkers research by understanding the market dynamics of the biomarker drug discovery industry.
- Develop market-entry and market expansion strategies by identifying the key areas for high growth and high opportunities.
- Understand the factors shaping the biomarkers drug discovery market.
- Reinforce the R&D pipeline by identifying the key biomarker tests which can provide more accurate and early diagnosis of diseases.
- Identify the key players best positioned to take the advantage of the opportunities in the global biomarkers drug discovery market.
- Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.
Companies Mentioned
- Quest Diagnostics
- Life Technologies Corporation
- Vermillion
- BG Medicine
- Menarini
- Abbott
- Roche
- Genentech
- Affymetrix
- Amgen
Table of Contents
1. Table of Contents
- 1.1. List of Tables
- 1.2. List of Figures
2. Biomarkers in Drug Discovery - Introduction
- 2.1. Introduction
- 2.2. GBI Research Report Guidance
3. Biomarkers in Drug Discovery - Overview
- 3.1. History of Biomarkers
- 3.2. Biomarker Classification
- 3.2.1. Biomarker Categories
- 3.2.2. Types of Biomarkers
- 3.2.3. Example of Type 0, I and II Biomarker
- 3.2.4. Reasons Surrogate Endpoints ‘Fail’
- 3.3. Biomarker Discovery and the Validation Process
- 3.3.1. Product Development Process from Discovery to Launch
- 3.4. General Application of Biomarkers
- 3.4.1. Biomarkers in Drug Discovery and Drug Development
- 3.4.2. Role of Biomarkers in the Drug Discovery Process
- 3.4.3. Application of Biomarkers in Disease Diagnosis and Prognosis
- 3.4.4. Potential Impact of Biomarkers on Disease States
- 3.4.5. Population Genetics Study
- 3.4.6. Environmental Health and Risk Assessment
- 3.4.7. Role of Biomarkers in Environmental Health and Risk Assessment
- 3.4.8. Toxicology Studies in Dietary Items or Nutraceuticals
- 3.5. Application of Biomarkers in Drug Discovery
- 3.5.1. Lead Identification and Optimization
- 3.5.2. Potential Role of Biomarkers in Lead Identification and Optimization
- 3.5.3. Target Validation
- 3.5.4. Toxicological Assay (Preclinical and Clinical)
- 3.5.5. Mechanism of Action
- 3.5.6. Monitor Therapy and Dose Response
- 3.5.7. Stratify Patient Population
- 3.5.8. Filing and Post Marketing Surveillance
- 3.6. Benefits of Biomarker Utilization
- 3.6.1. Disease Understanding
- 3.6.2. Project Prioritization through Early Attrition
- 3.6.3. Streamlining Clinical Trials
- 3.6.4. Reducing Cost of Drug Development
- 3.6.5. Speeding Drug Development
- 3.6.6. Avoiding Adverse Drug Reactions (ADR) and Rationalizing Dosing Regimen
- 3.6.7. Drug Repositioning
- 3.7. Challenges in Biomarker Utilization
- 3.7.1. Variability
- 3.7.2. Validity
- 3.7.3. Measurement Errors
4. Biomarkers in Drug Discovery - Case Study
- 4.1. Cell Signaling Technology Enters Into Co-Marketing Agreement with
Astellas Pharma
- 4.1.1. Definition
- 4.1.2. About Lung Cancer
- 4.1.3. Company Profile
- 4.1.4. Technology Used
- 4.1.5. Market Information
- 4.1.6. Advantages
- 4.1.7. Future Prospect
5. Biomarkers in Drug Discovery - Market Characterization
- 5.1. Market Overview
- 5.2. Market Size and Forecasts
- 5.2.1. Global Biomarkers Market Size
- 5.2.2. Global Biomarkers Drug Discovery Market
- 5.2.3. Global Biomarker's Molecular Diagnostics Market
- 5.2.4. Global Biomarkers Others Market
- 5.2.5. Global Biomarkers Market Segmentation
- 5.2.6. Drivers and Restraints
- 5.2.7. Drivers for the Global Biomarkers Market
- 5.2.8. Barriers for the Global Biomarkers Market
- 5.3. Unmet Needs - Biomarkers Fulfilling the Unmet Needs of Drug Discovery
- 5.3.1. High Attrition Rates
- 5.3.2. High Drug Discovery Cost
- 5.3.3. Time Consuming
- 5.3.4. Safety and Efficacy
- 5.3.5. Invasiveness, Selectivity and Sensitivity
6. Biomarkers in Drug Discovery - Trends Analysis
- 6.1. Regulatory Landscape (Current and Future)
- 6.1.1. Investigative/Exploratory Biomarker
- 6.1.2. Probable Valid Biomarker
- 6.1.3. Known Valid Biomarker
- 6.1.4. Regulatory Biomarker
- 6.1.5. Letter Of Intent to Propose Biomarker Qualification
- 6.1.6. Structure of Biomarker Qualification Briefing Document
- 6.2. Validated Biomarker
- 6.3. Regulatory Acceptance of Valid Biomarkers
- 6.4. Regulatory Guidance from the FDA, EMEA, and MHLW (Japan)
7. Biomarkers in Drug Discovery - Technology Adoptions
- 7.1. Unmet Need - Drug Discovery
- 7.1.1. Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs
- 7.2. Increased Awareness among Pharmaceutical and Research Sector
- 7.3. Increasing Adoption Due to Wide Application
- 7.4. Biomarkers' Future - Drug Discovery Unmet Needs Fulfilled
8. Biomarkers in Drug Discovery - Competitive Landscape
- 8.1. Key Biomarkers Players
- 8.1.1. Quest Diagnostics
- 8.1.2. Life Technologies Corporation
- 8.1.3. Vermillion
- 8.1.4. BG Medicine
- 8.1.5. Menarini
- 8.1.6. Abbott
- 8.1.7. Roche
- 8.1.8. Genentech
- 8.1.9. Affymetrix
- 8.1.10. Amgen
- 8.2. Global Biomarkers Market - Geographic Landscape
9. Biomarkers in Drug Discovery - Pipeline Analysis
- 9.1. Pipeline Analysis
- 9.1.1. Biomarkers in Discovery Phase
- 9.1.2. Biomarkers in Phase I
- 9.1.3. Biomarkers in Phase II
- 9.1.4. Biomarkers in Phase III
- 9.1.5. Biomarkers in Phase IV
- 9.1.6. Pipeline Analysis by Phase
- 9.1.7. Pipeline Analysis - Therapeutic Class
- 9.1.8. Pipeline Analysis by Geography
10. Biomarkers in Drug Discovery - Strategic Consolidations
- 10.1. Strategic Consolidations by Deal Type
- 10.2. Mergers and Acquisitions
- 10.2.1. Mergers and Acquisitions by Geography
- 10.2.2. Major M&A Deals
- 10.3. Licensing Agreement Deals
- 10.3.1. Licensing Agreement Deals by Geography
- 10.3.2. Major Licensing Agreements
- 10.4. Partnership Deals
- 10.4.1. Major Partnership Deals
11. Biomarkers in Drug Discovery - Appendix
- 11.1. Market Definitions
- 11.2. Abbreviations
- 11.3. Research Methodology
- 11.3.1. Biomarkers in Drug Discovery- Overview
- 11.3.2. Biomarkers in Drug Discovery- Case Study
- 11.3.3. Biomarkers in Drug Discovery- Market Characterisation
- 11.3.4. Biomarkers in Drug Discovery- Trends Analysis
- 11.3.5. Biomarkers in Drug Discovery- Technology Adoptions
- 11.3.6. Biomarkers in Drug Discovery- Competitive Landscape
- 11.3.7. Biomarkers in Drug Discovery- Pipeline Analysis
- 11.3.8. Biomarkers in Drug Discovery- Strategic Consolidations
- 11.3.9. Coverage
- 11.3.10. Secondary Research
- 11.3.11. Primary Research
- 11.3.12. Expert Panel Validation
- 11.4. Contact Us
- 11.5. Disclaimer
- 11.6. Sources
List of Tables
- Table 1: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue
($bn), 2010-2017
- Table 2: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue
Forecasts ($bn), 2010-2017
- Table 3: Biomarkers in Drug Discovery, Global Biomarkers Market, Market
Segmentation by Therapy Area, 2009-2017
- Table 4: Biomarkers in Drug Discovery, Global Biomarker's Drug Discovery
Market, Revenue ($bn), 2002-2010
- Table 5: Biomarkers in Drug Discovery, Global Biomarker's Drug Discovery
Market, Revenue Forecast ($bn), 2010-2017
- Table 6: Biomarkers in Drug Discovery, Global Biomarker's Molecular
Diagnostics Market, Historical Revenue, ($bn), 2002-2010
- Table 7: Biomarkers in Drug Discovery, Global Biomarker's Molecular
Diagnostics Market, Revenue Forecast, ($bn), 2010-2017
- Table 8: Biomarkers in Drug Discovery, Global Others Market, Historical
Revenue ($bn), 2002-2010
- Table 9: Biomarkers in Drug Discovery, Global Others Market, Revenue
Forecast ($bn), 2010-2017
- Table 10: Biomarkers in Drug Discovery, Global, Validated Biomarkers
Applied in FDA Approved Drugs, 2011
- Table 11: Biomarkers in Drug Discovery, Global, Biomarkers in Discovery
Phase, 2011
- Table 12: Biomarkers in Drug Discovery, Global, Biomarkers in Phase I, 2011
- Table 13: Biomarkers in Drug Discovery, Global, Biomarkers in Phase II,
2011
- Table 14: Biomarkers in Drug Discovery, Global, Biomarkers in Phase III,
2011
- Table 15: Biomarkers in Drug Discovery, Global, Biomarkers in Phase IV,
2011
- Table 16: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Mergers and Acquisitions, 2010-2011
- Table 17: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Mergers and Acquisitions, Top Three Deals, 2010-2011
- Table 18: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Licensing Agreement Deals, 2010-2011
- Table 19: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Partnerships Deals, 2010-2011
List of Figures
- Figure 1: Biomarkers in Drug Discovery, Global, Commonly Identified
Biomarkers, 2011
- Figure 2: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2011
- Figure 3: Biomarkers in Drug Discovery, Global, Biomarkers Classification,
Disease and Drugrelated Biomarkers, 2011
- Figure 4: Biomarkers in Drug Discovery, Global, Biomarker Categories, 2011
- Figure 5: Biomarkers in Drug Discovery, Global, Types of Biomarkers, 2011
- Figure 6: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint
Fail (False Positive), 2011
- Figure 7: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint
Fail (False Positive), 2011
- Figure 8: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint
Fail (False Negative), 2011
- Figure 9: Biomarkers in Drug Discovery, Global, Reasons Surrogate Endpoint
Fail (False Negative or Positive), 2011
- Figure 10: Biomarkers in Drug Discovery, Global, Reasons Surrogate
Endpoint Fail , 2011
- Figure 11: Biomarkers in Drug Discovery, Global, Biomarker Discovery and
Validation Process, 2009
- Figure 12: Biomarkers in Drug Discovery, Global, General Application of
Biomarkers, 2010
- Figure 13: Biomarkers in Drug Discovery, Global, Role of Biomarkers in
Drug Discovery and Development, 2011
- Figure 14: Biomarkers in Drug Discovery, Global, Drug Discovery Process,
2011
- Figure 15: Biomarkers in Drug Discovery, Global, Application of Biomarkers
in Diagnosis, 2011
- Figure 16: Biomarkers in Drug Discovery, Global, Potential Impact of
Biomarkers on Disease States, 2011
- Figure 17:Biomarkers in Drug Discovery, Global, Application of Biomarkers
in Population Genetic Studies, 2011
- Figure 18:Biomarkers in Drug Discovery, Global, Role of Biomarkers in Risk
Assessment, 2011
- Figure 19:Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the
Drug Discovery Process, 2011
- Figure 20: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by
Top Companies in Drug Discovery, 2011
- Figure 21: Biomarkers in Drug Discovery, Global, Case Study, 2011
- Figure 22 Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue
Forecast ($bn), 2002-2017
- Figure 23: Biomarkers in Drug Discovery, Global Biomarkers Market, Market
Segmentation by Therapy Area, 2011
- Figure 24: Biomarkers in Drug Discovery, Global Biomarkers Drug Discovery
Market, Revenue Forecast ($bn), 2002-2017
- Figure 25: Biomarkers in Drug Discovery, Biomarkers Molecular Diagnostics
Market, Revenue Forecast ($bn), 2002-2010
- Figure 26: Biomarkers in Drug Discovery, Global Others Market, Revenue
Forecast ($bn), 2002-2017
- Figure 27: Biomarkers in Drug Discovery, Global Biomarkers Market
Segmentation, 2011
- Figure 28: Biomarkers in Drug Discovery, Global, Market Drivers and
Restrains, 2011
- Figure 29:Biomarkers in Drug Discovery, Global, Integration of
‘Omics’ Drive Global Biomarker Market, 2011
- Figure 30:Biomarkers in Drug Discovery, Global, Biomarkers Fulfill Unmet
Needs of Conventional Drug Discovery Methods, 2011
- Figure 31: Biomarkers in Drug Discovery, Global, Reasons for Attrition,
2011
- Figure 32: Biomarkers in Drug Discovery, Global, Biomarkers Technology
Adoption Framework, 2011
- Figure 33: Biomarkers in Drug Discovery, Global, Company Profile - Quest
Diagnostics, 2011
- Figure 34: Biomarkers in Drug Discovery, Quest Diagnostics, SWOT Analysis,
2011
- Figure 35: Biomarkers in Drug Discovery, Global, Company Profile - Life
Technologies, 2011
- Figure 36: Biomarkers in Drug Discovery, Life Technologies, SWOT Analysis,
2011
- Figure 37: Biomarkers in Drug Discovery, Global, Company Profile -
Vermillion, 2011
- Figure 38: Biomarkers in Drug Discovery, Vermillion, SWOT Analysis, 2011
- Figure 39: Biomarkers in Drug Discovery, Global, Company Profile -
BGMedicine, 2011
- Figure 40: Biomarkers in Drug Discovery, BGMedicine, SWOT Analysis, 2011
- Figure 41: Biomarkers in Drug Discovery, Global, Company Profile -
Menarini, 2011
- Figure 42: Biomarkers in Drug Discovery, Menarini, SWOT Analysis, 2011
- Figure 43: Biomarkers in Drug Discovery, Global, Company Profile - Abbott,
2011
- Figure 44: Biomarkers in Drug Discovery, Abbott, SWOT Analysis, 2011
- Figure 45: Biomarkers in Drug Discovery, Global, Company Profile - Roche,
2011
- Figure 46: Biomarkers in Drug Discovery, Roche, SWOT Analysis, 2011
- Figure 47: Biomarkers in Drug Discovery, Global, Company
Profile-Genentech, 2011
- Figure 48: Biomarkers in Drug Discovery, Genentech, SWOT Analysis, 2011
- Figure 49: Biomarkers in Drug Discovery, Global, Company Profile -
Affymetrix, 2011
- Figure 50: Biomarkers in Drug Discovery, Affymetrix, SWOT Analysis, 2011
- Figure 51: Biomarkers in Drug Discovery, Global, Company Profile Amgen,
2011
- Figure 52: Biomarkers in Drug Discovery, Amgen, SWOT Analysis, 2011
- Figure 53: Biomarkers in Drug Discovery, Global, Geographic Landscape -
Global Biomarkers Market, 2011
- Figure 54: Biomarkers in Drug Discovery, Global, Pipeline Analysis by
Phase, 2010
- Figure 55: Biomarkers in Drug Discovery, Global, Pipeline Analysis by
Therapeutic Class, 2011
- Figure 56: Biomarkers in Drug Discovery, Global, Pipeline Analysis by
Geography, 2011
- Figure 57: Biomarkers in Drug Discovery, Global, Strategic Consolidations
by Deal Type, 2010-2011
- Figure 58: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Mergers and Acquisitions by Geography (%), 2010-2011
- Figure 59: Biomarkers in Drug Discovery, Global, Strategic Consolidations,
Licensing Agreement Deals by Geography (%), 2010-2011
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