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市場調查報告書
臨床蛋白質體學：蛋白質生物標記發現策略重新檢討
Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery
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本報告已在2011年12月21日停止出版。
蛋白質生物標記因為能夠利用於藥物研發產品線的早期階段，提早除去功效不佳或有毒的化合物，因此對新藥研發企業而言獨具吸引力。
專門於醫療產業相關廣泛調查的美國市調公司 Decision Resources Inc. 總公司：Massachusetts State），針對蛋白質生物標記發現策略進行調查分析，並系統整理調查結果後出版報告書"Clinical Proteomics: Rethinking Approaches to Protein Biomarker Discovery"。
本報告書內容包括：蛋白質體學技術概要及從事蛋白質生物標記研究的主要企業、市場今後發展預測等。內容綱要摘記如下：
實施概要
最新技術
蛋白質體學技術
- 2D凝膠電泳誘導
- 質量分析法
- 抗體微陣列
- 微流體
- 免標籤技術
產品線藥的問題：為什麼藥品開發會落後呢？
- 蛋白質生物標記發現的課題
- 蛋白質生物標記發現的不完善過程
- 從蛋白質生物標記的發現到診斷發展
因發現刺激的研究擴展
- 根據假設的策略
- 技術上更優良的生物標記
- 系統生物學
從事蛋白質生物標記開發工作的主要企業
- Bayer Pharmaceuticals
- Eli Lilly
- Novartis
- Pfizer
- Roche
補充資料
- 針對Eli Lilly敗血症的生物標記開發策略：個案研究
今後蛋白質生物標記的相關預測
- 針對發現基礎研究的重新檢討
- 輔助性規範環境：FDA流程
- 建立穩固的合作關係
- 對地區別參考價格主導權的顧慮
- 要求改變藥品政策的產業
表
- 可購得的蛋白質生物標記診斷藥
- 蛋白質體學商業模式
- 主要技術銷售企業及服務業者
- 新興企業
- 針對蛋白質生物標記的FDA要徑機會
- 選擇診斷開發夥伴時應考量的事項
圖
- 人體血漿基因蛋白中已確定的1,175種蛋白質
- FDA診斷測試中的新蛋白質數量：1994年至2002年
- FDA已認可的蛋白質生物標記的感受度及專業性
- 替代方案：蛋白質生物標記開發技術工作流程提案
- 藥物及設備同時開發流程
Abstract
Introduction
Protein biomarkers are appealing to drug developers because they can be used
early in the drug research pipeline, which allows early elimination of
ineffective or toxic compounds. Although the promise of these biomarkers is
clear, the path to successful implementation of protein biomarkers is not.
Perhaps the discovery-based approach is not the best way to tap the potential
of protein biomarkers.
Get the Answers You Need to Shape Your Strategy
- Despite scientifi c advancements, protein biomarker discovery is slowing.
What are the challenges facing companies and researchers that are hindering
the discovery process?
- Researchers are rethinking the discovery-based approach. What other
options and innovations are available? What companies are leading the way?
- The future of protein biomarkers is extremely promising for a multitude of
businesses. What benefi ts are available for technology vendors, Big Pharma
companies, researchers, and regulatory agencies? Can collaboration between any
or all of these stakeholders ensure the success of protein biomarkers?
Scope
- Proteomics technologies: 2D PAGE, mass spectrometry, antibody
microarrays, microfl uidics, label-free technologies.
- Alternatives to discovery-based approach: hypothesis-based
approach, engineering better biomarkers, systems biology.
- Major players in protein biomarker discovery: Bayer, Eli Lilly,
Novartis, Pfi zer, Roche.
- Outlook: The path toward successful protein biomarker discovery may
include multiplexing strategies, collaborations among researchers and
developers, and support from regulatory bodies.
Companies Mentioned in This Spectrum Report
- Applied Biosystems
- Axis Shield
- Bayer Pharmaceuticals
- Beyond Genomics
- Biacore
- Bioforce Nanoscience
- Bio-Rad
- Biosite
- Bruker Daltonics
- Cantion
- Clontech
- CODA Genomics
- Eisai
- Eli Lilly
- Fujirebio
- Gene News
- Genedata
- GeneProt
- Geneva Proteomics
- Genomic Solutions
- Genoptics
- GenTel Biosciences
- Integrated Genomics
- Invitrogen
- Johnson & Johnson
- Lumera
- Matritech
- Microfl uidics
- Millennium Pharmaceuticals
- Pfi zer
- Phadia US
- Power3 Medical Products
- Predictive Diagnostics
- Proteome Systems
- Quadraspec
- RBM
- Roche
- Rosetta Inpharmatics
- Sareum
- Shimadzu
- Target Discovery
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- The State of the Art
- Key Proteomics Technologies
- Two-Dimensional Polyacrylamide Gel Electrophoresis
- Mass Spectrometry
- Antibody Microarrays
- Microfl uidics
- Label-Free Technologies
- The Pipeline Problem: Why Is Discovery Slowing?
- Challenges of Discovering Protein Biomarkers
- The Imperfect Process of Discovering Protein Biomarkers
- From Biomarker Discovery to Diagnostic Development
- Expanding Discovery-Based Research
- Hypothesis-Based Approach
- Engineering Better Biomarkers
- Systems Biology
- Major Players in Protein Biomarker Discovery
- Bayer Pharmaceuticals
- Eli Lilly
- Novartis
- Pfi zer
- Roche
- Sidebar: Eli Lilly' s Biomarker Development Strategy for Sepsis- A Case
Study
- Outlook for Protein Biomarkers
- Rethinking Discovery-Based Research
- Looking Beyond Pattern-Only Discovery
- Multiplexing Leads the Way
- Supportive Regulatory Environment: The FDA Process
- Building Strong Collaborations
Tables
- 1. Select Commercially Available Protein-Based Diagnostics
- 2. Proteomics Business Models
- 3. Key Proteomics Technology Vendors and Service Providers
- 4. Emerging Players in Protein Biomarker Discovery
- 5. FDA Critical Path Opportunities for Biomarkers
- 6. Considerations for Choosing a Diagnostic Development Partner
Figures
- 1. The 1,175 Identifi ed Proteins of the Human Plasma Proteome
- 2. Number of Novel Protein Analytes in FDA-Approved Diagnostic Tests,
1994-2002
- 3. Sensitivities and Specifi cities of Select FDA-Approved Protein
Biomarkers
- 4. Alternate Approach: Suggested Technology Workfl ow for Developing
Protein Biomarkers
- 5. Drug-Device Codevelopment Process: Key Steps During Development
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