Cover Image
市場調查報告書

藥物研發研究外部委託:臨床研究委外機構(CRO)的全球市場

Outsourcing in Drug Discovery, 7th Edition

出版商 Kalorama Information 商品編碼 302663
出版日期 內容資訊 英文 230 Pages
訂單完成後即時交付
價格
Back to Top
藥物研發研究外部委託:臨床研究委外機構(CRO)的全球市場 Outsourcing in Drug Discovery, 7th Edition
出版日期: 2016年04月26日 內容資訊: 英文 230 Pages
簡介

藥物研發研究,首先是發現先導化合物,也就是分子藉由結合靶蛋白質或核酸以對疾病治療上有益的方式來影響生物學功能,接著確認先導化合物確中目標、生成、最佳化,再加上數個中間工程構成,是花費時間和勞力、成本的工作。也因如此,代行這個流程的受託開發經營者才有存在的意義。

本報告將開發藥劑中臨床研究委外機構(CRO)的全球市場,分為化學、生物學、篩檢、先導物質最佳化的4個研究服務領域,提供轉變分析、預測、市場趨勢和課題、技術開發、競爭環境、有力參與企業等相關最新調查資訊。

第1章 摘要整理

  • 概要
    • 調查的範圍與方法
  • 簡介
    • 醫藥品產業課題
    • 1993-2013年期間已批准新藥及生技藥品的申請數
    • 開發費的削減
  • 藥物研發的工程
    • 藥物研發工程的迅速化
    • 藥物研發工程的障礙
    • 使效率提高的外部委託
  • 藥物研發研究外部委託(外包)
    • 外部委託的決策
    • 委託計劃的籌劃
  • 臨床研究委外機構
    • 比較外部委託的「策略性」模式和「戰術性」模式
    • 實效的互相理解必需條件
    • 知識產權保護問題的減輕
  • 藥物研發研究遷移海外
    • 以海外遷移應該考慮的係數
    • 全球發展的優點
    • 全球發展的問題點
  • 移轉至中國
    • 中國的臨床研究委外機構
    • 美國食品藥物管理局(FDA)的中國支部
  • 移轉至印度
    • 印度的藥物研發研究經營者
  • 移轉至東歐
  • 藥物研發研究受託產業的全球市場
    • 全球不景氣對藥物研發產業只有最小限度的影響
    • 市場現狀及預測
    • 各分類市場分析

第2章 簡介:藥物研發研究外部委託

  • 背景
    • 1993-2013年期間已批准新藥及生技藥品申請數
    • 開發費的削減
    • 開發平台的強化
  • 藥物研發外部委託
    • 外部委託的決策
    • 委託計劃的籌劃
    • 判斷標準
  • 海外訂貨上應考慮的係數
  • 委託全球發展的優點
    • 成本的優勢
    • 人力資源及技術的存取
    • 期間縮短
  • 委託全球發展的問題點
    • 知識產權(IP)的保護
    • 秘密資訊及商業機密
    • 詐欺、貪污
    • 法規遵守
    • 遠隔性
  • 臨床研究委外機構的選擇
    • 簡介
    • 適當的臨床研究委外機構的選擇
    • 契約醫藥品企業的委託調查
  • 委託的全球發展

第3章 藥物研發工程

  • 簡介
    • 藥物研發的工作階段
  • 藥物研發工程的迅速化
    • 用作藥物研發研究的技術
    • 藥物研發工程的障礙
    • 使效率提高的外部委託
    • 存取新技術的外部委託
  • 生物資訊學
  • 實驗室晶片:藥物研發研究的微流體工程

第4章 藥物研發研究外部委託

  • 概要
    • 傳統藥物研發模式改變?
    • 藥物研發研究外部委託 - 有益的基礎經營策略
  • 臨床研究委外機構
    • 簡介
    • 臨床研究委外機構所扮演的角色
    • 契約模式
    • 實效性互相理解為良好聯盟關係的必需條件
    • 知識產權保護問題的減輕
  • 藥物研發研究遷移海外
    • 簡介
    • 在亞洲堅實的藥物研發研究受託產業
  • 轉移至中國
    • 簡介
    • 在中國設立研究開發設備的多國籍醫藥品廠商
    • 中國的臨床研究委外機構
    • 中國第一個臨床研究委外機構聯合組織
    • 美國食品藥物管理局(FDA)的中國支部
    • 針對偽造醫藥品、智慧財產權、法規的中國管理體制
  • 轉移至印度
    • 簡介
    • 印度的藥物研發研究經營者
    • 印度的智慧財產權、法規的處理
    • 美國食品藥物管理局(FDA)的印度支部
  • 轉移至東歐
    • 簡介
    • 俄羅斯及烏克蘭的臨床研究委外機構

第5章 藥物研發研究受託產業市場

  • 概要
  • 藥物研發研究受託產業市場
    • 全球不景氣對藥物研發產業只有最小限度的影響
    • 市場現狀及預測
  • 各分類市場分析
    • 化學研究服務市場
      • 估計市場規模
      • 預測
    • 生物學研究服務市場
      • 估計市場規模
      • 預測
    • 高通量篩檢研究服務市場
      • 估計市場規模
      • 預測
    • 領導化合物最佳化研究服務市場
      • 估計市場規模
      • 預測
  • 藥物研發研究受託競爭企業
    • 在藥物研發領域氣勢漸增的先進開放式革新模式
  • 學術機構和臨床研究委外機構的聯合組織
    • 開發業務受託的學術機構
    • 臨床研究委外機構之間的聯合組織
  • 以全球規模擴大的藥物研發研究服務市場

第6章 競爭企業簡介(歷史、產業線,藥物研發研究服務等)

  • Albany Molecular Research, Inc.
  • Aptuit, LLC
  • Argenta Discovery, Ltd
  • Asclepia MedChem Solutions
  • Asinex Ltd.
  • AsisChem, Inc.
  • Axxam SpA
  • BioDuro
  • BioFocus DPI
  • Caliper Life Sciences
  • Charles River Laboratories, Inc.
  • ChemBridge Corp.
  • Chemical Diversity Inc.
  • Covance, Inc.
  • CreaGen Biosciences, Inc.
  • Crown Bioscience
  • Cyprotex PLC
  • Domainex
  • Emerald Biostructures
  • Enamine Ltd.
  • Evotec AG
  • Exelgen Discovery
  • GVK Biosciences Private Limited
  • GenScript USA Inc.
  • Graffinity Pharmaceuticals GmbH
  • Hutchison MediPharma Ltd.
  • Jubilant Biosys Ltd
  • Nanosyn, Inc.
  • Pharmaron Inc.
  • Ricerca Biosciences, LLC
  • Scynexis, Inc.
  • Selcia Limited
  • Selvita S.A.
  • Shanghai ChemPartner Co., Ltd.
  • Shanghai Medicilon Inc.
  • Sundia Meditech Company, Ltd.
  • Sygnature Discovery Limited
  • TCG Lifesciences Limited
  • Viva Biotech, Ltd
  • WuXI AppTec Co. Ltd.

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: KLI5979268

The drug discovery process is long, arduous and costly, which has driven outsourcing in this field. Only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the Food & Drug Administration (FDA). The first phase is discovery of a lead compound, a molecule that affects biological function by binding to a target protein or nucleic acid in a way that is useful for treatment of disease. There are several steps in the drug discovery process including hit confirmation, lead generation, lead optimization, and other studies.

This Kalorama Information Report, Outsourcing in Drug Discovery, 7th Edition, provides an in depth look into the industry for the outsourcing of this services. The report examines trends that have shaped the drug discovery outsourcing market today, and details the current and future global market. For seven editions, this authoritative resource has defined the market opportunity for companies assisting in the beginning phase of the drug development process. As part of its coverage, the report provides markets and forecasts for the following segments:

  • Chemistry Services Market: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services,
  • Biology Market: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service Screening Services Market: Assay Development, Primary Screening, Secondary Screening
  • Lead Optimization Services Market: Early ADMET/Tox, Create Analogues, Computational Support, and Other Services
  • High Throughput Screening

The report also provides the following data:

  • An Overview of the Drug Discovery Process
  • Eastern European, Indian and Chinese CMOs
  • Research Spending for Pharmaceutical Companies
  • Trend Assessment for CRO Market
  • Appendix of CRO Firms
  • Detailed Company Profiles of Top Competitors
  • Current State of Pharmaceutical Company R&D Operations
  • Alliances between CROs

The process by which molecules are identified for their therapeutic value involves synthesis and analysis of many derivatives of the original leads.

The drug discovery process consists of iterative cycles between chemistry and biology that begin with the target finding phase, or selecting a protein (a drug target) leading to the identification of a chemical compound with biological activity (a hit). After confirmation of biological activity and chemical feasibility, the hit becomes a lead structure, which is improved through chemical modifications until it fulfills the criteria for a clinical candidate. A drug candidate then moves into the next stage of drug development, the preclinical phase.

The following companies are profiled in the report:

  • Albany Molecular Research, Inc.
  • Aptuit, LLC
  • Asclepia MedChem Solutions
  • Asinex Ltd.
  • AsisChem, Inc.
  • Aurelia Bioscience
  • BioDuro
  • BioFocus DPI
  • Caliper Life Sciences
  • Charles River Laboratories, Inc.
  • ChemBridge Corp.
  • Chemical Diversity Inc.
  • Covance, Inc.
  • CreaGen Biosciences, Inc.
  • Crown Bioscience
  • Cyprotex PLC
  • Domainex
  • Emerald Biostructures
  • Enamine Ltd.
  • Evotec AG
  • Exelgen Discovery
  • GVK Biosciences Private Limited
  • GenScript USA Inc.
  • Graffinity Pharmaceuticals GmbH
  • HitGen, Ltd.
  • Hutchison MediPharma Ltd.
  • Jubilant Biosys Ltd
  • Nanosyn, Inc.
  • Pharmaron Inc.
  • Ricerca Biosciences, LLC
  • Scynexis, Inc.
  • Selcia Limited
  • Selvita S.A.
  • Shanghai ChemPartner Co., Ltd.
  • Shanghai Medicilon Inc.
  • Sundia Meditech Company, Ltd.
  • Sygnature Discovery Limited
  • TCG Lifesciences Limited
  • Viva Biotech, Ltd
  • WuXI AppTec Co. Ltd.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • Pharmaceutical Industry Challenges
  • Reducing R&D Spending
  • Number of Nmes and Blas Approved Between 1993-2013
  • Source: Biolog, Inc. and Kalorama Information
  • Scope and Methodology
  • The Drug Discovery Process
  • Accelerating The Drug Discovery Process
  • Bottlenecks Within The Drug Discovery Process
  • Outsourcing to Increase Efficiency
  • Outsourcing Drug Discovery
  • The Outsourcing Decision
  • Developing An Outsourcing Plan
  • Contract Research Organizations
  • Strategic Versus Tactical Outsourcing Model
  • Effective Communication Is Essential
  • Mitigating The Challenges of Protecting IP Rights
  • offshoring Contract Drug Discovery
  • Factors to Consider In offshore Outsourcing
  • Benefits of Global Outsourcing
  • Cost Advantage
  • Concerns About Global Outsourcing
  • Outsourcing to China
  • Chinese Contract Research Organizations
  • FDA offices In China
  • Outsourcing to India
  • Drug Discovery Services In India
  • Outsourcing to Eastern Europe
  • Drug Discovery Outsourcing Market
  • Global Economic Downturn Has Minimal Affect On Drug Discovery

CHAPTER TWO: INTRODUCTION

  • Introduction to Outsourcing Drug Discovery
  • OUTSOURCING DRUG DISCOVERY
  • THE OUTSOURCING DECISION
  • Developing An Outsourcing Plan
  • Factors to Consider In offshore Outsourcing
  • Benefits of Global Outsourcing
  • Cost Advantage
  • Access to Talent and Technologies
  • Compress Timeline
  • Increase Production
  • Concerns About Global Outsourcing
  • Intellectual Property Protection (IP)
  • Confidential Information and Trade Secrets
  • Fraud and Corruption
  • Meeting Regulatory Compliance Demands
  • Long Distance
  • Introduction
  • Choosing The Right CRO
  • Experience Is Paramount
  • Facility Standards
  • Excellent Track Record
  • Global Outsourcing

CHAPTER THREE: THE DRUG DISCOVERY PROCESS

  • The Drug Discovery Process
  • Introduction
  • Drug Discovery Stages
  • Target Identification
  • Target Validation
  • High Throughput Screening
  • Lead Optimization
  • Accelerating The Drug Discovery Process
  • Technologies Utilized In Drug Discovery
  • Combinatorial Chemistry
  • Bioinformatics/Pharmacogenomics
  • ADME/tox Screening
  • High Throughput Screening
  • Computational Modeling and Bioinformatics
  • Bottlenecks Within The Drug Discovery Process
  • Outsourcing to Increase Efficiency
  • Outsourcing to Access Novel Technologies
  • Bioinformatics
  • Lab-On-A-Chip: Microfluidics In Drug Discovery

CHAPTER FOUR: TRENDS

  • Trends In Outsourcing Drug Discovery
  • Overview
  • Is The Traditional Drug Discovery Model Changing?
  • Outsourcing Drug Discovery: A Useful Core Management tool
  • Contract Research Organizations
  • Introduction
  • Role of A CRO
  • Outsourcing Models
  • The Tactical Model
  • The Strategic Model
  • The Insourcing Model
  • Effective Communication Is Essential
  • for A Successful Partnership
  • Mitigating The Challenges of Protecting IP Rights
  • offshoring Contract Drug Discovery
  • Introduction
  • Robust Growth of Outsourcing Drug Discovery In Asia
  • Outsourcing to China
  • Introduction
  • Multi-National Pharmaceutical Companies Establish Research and Development
  • Facilities In China
  • Chinese Contract Research Organizations
  • Wuxi Apptec China's Largest CRO
  • First Chinese CRO Alliance
  • FDA offices In China
  • IP Rights Enforcement System
  • Outsourcing to India
  • Introduction
  • Drug Discovery Services In India
  • India's Handling of IP Rights and Laws
  • Patent Filing Considerations
  • Limitations On Patentability
  • Compulsory Licenses
  • FDA offices In India
  • Outsourcing to Eastern Europe
  • Introduction
  • Eastern European Cros

CHAPTER FIVE: MARKET ANALYSIS

  • Overview
  • Drug Discovery Outsourcing Market
  • Current Market and forecast
  • Market Analysis By Segment
  • Chemistry Services Market
  • Current Market and forecast
  • Biology Services Market
  • Current Market and forecast
  • High Throughput Screening Services Market
  • Current Market and forecast
  • Lead Optimization Services Market
  • Current Market and forecast
  • Contract Drug Discovery Competitors
  • Recent Acquisitions In Drug Discovery Outsourcing, 2014-2016
  • Alliances Between Academic Organizations and Cros
  • Alliances Between The Pharmaceutical/Biotechnology Industries and Academia
  • Alliances Between Cros
  • Market Growth Expanding Global Reach and Scale of Drug Discovery Services

CHAPTER SIX: COMPETITOR PROFILES

  • Albany Molecular Research, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Assay Design and Development Services
  • Key Features of Screening Capabilities
  • Screening Libraries
  • Lead Optimization
  • Natural Product Services
  • Medicinal Chemistry
  • Computer-Aided Drug Discovery (CADD)
  • In Vitro ADMET
  • Aptuit, LLC
  • History and Lines of Business
  • Drug Discovery Services
  • Medicinal Chemistry
  • Computational Chemistry
  • Discovery Pharmacology
  • Drug Metabolism and Pharmacokinetics
  • Analytical Discovery Support
  • Asclepia Medchem Solutions
  • History and Lines of Business
  • Drug Discovery Services
  • Target Development
  • Assay Development
  • Hit Identification
  • Hit to Lead
  • Lead Optimization
  • Preclinical Development
  • Asinex Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Computational Services
  • Medicinal Chemistry
  • Bioscreening
  • Library Design
  • Integrated Drug Discovery
  • Asischem, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Aurelia Bioscience Ltd
  • History and Lines of Business
  • Drug Discovery Services
  • High-Throughput Screening
  • Cell Culture Services
  • Phenotypic Screening
  • Biochemical Screening
  • Cell-Based Screening
  • Label-Free Screening
  • FLIPR Screening
  • FMAT Screening
  • High Content Screening
  • Axxam Spa
  • History and Lines of Business
  • Drug Discovery Services
  • Assay Development
  • High-Throughput Screening
  • Hit Follow Up
  • Bioduro
  • History and Lines of Business
  • Drug Discovery Services
  • Chemistry Services
  • Biology Services
  • Caliper Life Sciences
  • History and Lines of Business
  • Drug Discovery Services
  • Charles River Laboratories, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Charnwood Molecular
  • History and Background
  • Drug Discovery Services
  • Lead Discovery
  • Lead Optimization and Development:
  • Chembridge Corp.
  • History and Background
  • Drug Discovery Services
  • Discovery Chemistry Services
  • Screening Libraries and EXPRESS-Pick Compound Collection
  • Chemical Building Blocks
  • Hit2Lead.Com Online Chemical Store
  • Chemical Diversity Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Lead Optimization Services
  • High Throughput Services
  • Biologically Annotated Libraries
  • Focused Diversity
  • Chempartner Co.,Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Chemistry
  • CMC Development
  • Biology
  • Cell Biology and Pharmacology
  • DMPK & toxicology
  • Biologics R&D
  • Integrated Drug Discovery Services
  • Covance, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Creagen Biosciences, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Medicinal Chemistry
  • Synthetic Chemistry
  • Analytical Chemistry
  • Crown Bioscience
  • History and Lines of Business
  • Drug Discovery Services
  • Cyprotex PLC
  • History and Line of Business
  • Sygnature Discovery
  • Drug Discovery Services
  • Integrated Drug Discovery Services
  • High Throughput ADME Screening
  • Customised ADME Assays
  • Genomic ADME
  • In Silico Pharmacokinetics Modeling
  • In Vitro toxicology
  • Domainex
  • History and Lines of Business
  • Drug Discovery Services
  • Protein Expression
  • Structural Biology
  • Computational Chemistry
  • Design and Synthesis From Hits to Candidate Drugs
  • Biochemical Assays
  • Emerald Biostructures
  • History and Lines of Business
  • Drug Discovery Services
  • Gene to Structure
  • Fragment Screening
  • Rapid Co-Crystal Structures
  • Antibodies and Epitope Mapping
  • Membrane Proteins
  • Structural Genomics Services
  • Biophysical Characterization
  • Enamine Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Evotec AG
  • History and Lines of Business
  • Drug Discovery Services
  • Assay Development Services
  • High Throughput Screening
  • Structural Biology Services
  • Medicinal Chemistry Services
  • Compound Library Services
  • Exelgen Discovery
  • History and Lines of Business
  • Drug Discovery Services
  • Collaborative Services
  • Additional Discovery Services
  • GVK Biosciences Private Limited
  • History and Lines of Business
  • Drug Discovery Services
  • Bioinformatics
  • Chemoinformatics
  • Structural Biology
  • Biology Services
  • Genscript USA Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Bio-Reagent Center
  • Bio-Assay Center
  • Lead Optimization Center
  • Antibody Drug Development
  • Herg Testing for Drug Candidates
  • Bioprocess Services
  • Griffinity Pharmaceuticals Gmbh
  • Drug Discovery Services
  • Design and Synthesis
  • Array Production
  • Fingerprinting/Fragment Screening
  • Imaging Data Analysis
  • Hit Evolution
  • Hitgen, Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Lead Generation By DNA Encoded Libraries
  • Hit to Lead Expansion and Lead Optimization
  • Custom Compound/Compound Library Synthesis
  • Protein Expression and Crystallization
  • High-Throughput Sequencing
  • Hutchison Medipharma Ltd.
  • History and Lines of Business
  • Drug Discovery Services
  • Discovery Chemistry
  • Discovery Biology
  • Discovery Pharmacology
  • Drug Metabolism and Pharmacokinetics (DMPK)
  • Jubilant Biosys Ltd
  • History and Lines of Business
  • Drug Discovery Services
  • Discovery Informatics
  • Discovery Research
  • Validating and Optimizing Active Compounds for A Discovery Program
  • Lead Optimization Through SAR
  • Library Design - Focused
  • IT Services
  • Nanosyn, Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Medicinal Chemistry
  • Screening and Profiling Service
  • Proprietary Library Development
  • Analytical Services
  • Pharmaron Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Chemistry
  • Biology
  • DMPK
  • In Vivo Pharmacology
  • Ricerca Biosciences, LLC
  • History and Lines of Business
  • Drug Discovery Services
  • Discovery Pharmacology
  • Chemical Development
  • Drug Safety and Metabolism
  • Selcia Limited
  • History and Lines of Business
  • Drug Discovery Services
  • Hit Identification
  • Lead Optimization
  • Medicinal Chemistry
  • ADME/PK
  • Profiling Assays
  • Selvita S.A.
  • History and Lines of Business
  • Drug Discovery Services
  • Contract Chemistry Services
  • Biology Services
  • Integrated Drug Discovery Projects
  • Shanghai Medicilon Inc.
  • History and Lines of Business
  • Drug Discovery Services
  • Biology
  • Discovery Biology Services
  • Gene-to-Structure
  • Assay Development
  • CADD
  • M9 Selenomethionine
  • Chemistry
  • Preclinical
  • Pharmacokinetics Services
  • Pharmacology Services
  • toxicology Services
  • Integrated Services
  • Sundia Meditech Company, LTD.
  • History and Lines of Business
  • Drug Discovery Services
  • Integrated Drug Discovery Service
  • Medicinal Chemistry
  • Discovery Biology
  • Organic Synthesis and Parallel Synthesis
  • Drug Metabolism and Pharmacokinetics (DMPK)
  • Sygnature Discovery Limited
  • History and Lines of Business
  • Drug Discovery Services
  • Medicinal Chemistry
  • Computational Chemistry
  • Arrays and Libraries
  • Fragment-Based Drug Discovery:Fragment Library and NMR Screening
  • Process and Scale-Up Chemistry
  • Bioscience (In Vitro Biology and Screening)
  • ADME/tox (Cyprotex Discovery)
  • TCG Lifesciences Limited
  • History and Lines of Business
  • Drug Discovery Services
  • Medicinal Chemistry Services
  • Molecular Modeling Services
  • Chemistry Services
  • Molecular Biology Services
  • VIVA BIOTECH, LTD
  • History and Lines of Business
  • Drug Discovery Services
  • History and Lines of Buisness
  • Drug Discovery Services
  • Synthetic Chemistry and Library
  • Medicinal Chemistry Services
  • Analytical Chemistry
  • Discovery Biological
  • Pharmacology
  • Safety Pharmacology
  • Drug Metabolism and Pharmacokinetics
  • Bioanalytical
  • Appendix

COMPANY NAMES AND ADDRESSES

Back to Top