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市場調査レポート

創薬研究の外部委託:開発業務受託機関(CRO)の世界市場

Outsourcing in Drug Discovery, 7th Edition

発行 Kalorama Information 商品コード 302663
出版日 ページ情報 英文 230 Pages
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創薬研究の外部委託:開発業務受託機関(CRO)の世界市場 Outsourcing in Drug Discovery, 7th Edition
出版日: 2016年04月26日 ページ情報: 英文 230 Pages
概要

創薬研究は、リード化合物質すなわち標的タンパク質や核酸に結合させることで生物機能に疾患治療上有益な効果を上げる分子を発見する初期作業をはじめ、リード物質の的中確認、生成、最適化ほか、いくつかの中間工程から構成される時間と労力、そしてコストのかかる作業です。であるがゆえに、このプロセスを代行する受託開発事業者に存立意義が生まれます。

当レポートでは、創薬における開発業務受託機関(CRO)の世界市場を化学、生物学、スクリーニング、リード物質最適化の4研究サービス分野に区分して、推移を分析・予測するほか、市場の動向や課題、技術開発、競合環境、有力参入企業などに関する最新調査情報を提供しています。

第1章 エグゼクティブサマリー

  • 概要
    • 調査の範囲と方法
  • イントロダクション
    • 医薬品産業の課題
    • 1993-2013年の期間に承認された新薬および生物製剤の申請数
    • 開発費の削減
  • 創薬の工程
    • 創薬工程の迅速化
    • 創薬工程における障害
    • 効率を高める外部委託
  • 創薬研究の外部委託(アウトソーシング)
    • 外部委託の意思決定
    • 委託計画の立案
  • 開発業務受託機関
    • 外部委託の「戦略的」モデルと「戦術的」モデルを比較する
    • 実効的相互理解が必須条件
    • 知財保護問題の軽減
  • 創薬研究の海外移転
    • 海外移転で考慮すべきファクター
    • 世界展開の利点
    • 世界展開の問題点
  • 中国への移転
    • 中国の開発業務受託機関
    • 米国食品医薬品局(FDA)の中国支部
  • インドへの移転
    • インドにおける創薬研究事業者
  • 東欧への移転
  • 創薬研究受託事業の世界市場
    • 世界不況も創薬事業には最小限の影響
    • 市場の現況と予測
    • セグメント別市場分析

第2章 イントロダクション:創薬研究の外部委託

  • 背景
    • 1993-2013年の期間に承認された新薬および生物製剤申請数
    • 開発費の削減
    • パイプラインの強化
  • 創薬の外部委託
    • 外部委託の意思決定
    • 委託計画の立案
    • 判定基準
  • 海外発注で考慮すべきファクター
  • 委託世界展開の利点
    • コストの優位性
    • 人材および技術へのアクセス
    • 期間短縮
  • 委託世界展開の問題点
    • 知的所有権(IP)の保護
    • 秘密情報および商業機密
    • 不正・腐敗
    • 法令順守
    • 遠隔性
  • 開発業務受託機関の選定
    • イントロダクション
    • 適正な開発業務受託機関の選定
    • 契約医薬品企業の委託調査
  • 委託の世界展開

第3章 創薬工程

  • イントロダクション)
    • 創薬の作業段階
  • 創薬工程の迅速化
    • 創薬研究に用いる技術
    • 創薬工程における障害
    • 効率を高める外部委託
    • 新技術にアクセスする外部委託
  • バイオインフォマティクス
  • ラボ・オン・チップ:創薬研究におけるマイクロ流体工学

第4章 創薬研究の外部委託

  • 概要
    • 従来の創薬モデルは変化する?
    • 創薬研究の外部委託 - 有益な基軸経営策
  • 開発業務受託機関
    • イントロダクション
    • 開発業務受託機関の役割
    • 契約モデル
    • 実効的相互理解が良好な提携関係の必須条件
    • 知財保護問題の軽減
  • 創薬研究の海外移転
    • イントロダクション
    • アジアで堅調な創薬研究受託事業
  • 中国への移転
    • イントロダクション
    • 中国に研究開発施設を設立する多国籍医薬品メーカー
    • 中国の開発業務受託機関
    • 中国初の開発業務受託機関連合組織
    • 米国食品医薬品局(FDA)の中国支部
    • 偽造医薬品、知的財産権・法令に対する中国の管理体制
  • インドへの移転
    • イントロダクション
    • インドにおける創薬研究事業者
    • インドにおける知的財産権・法令の取扱い
    • 米国食品医薬品局(FDA)のインド支部
  • 東欧への移転
    • イントロダクション
    • ロシアおよびウクライナの開発業務受託機関

第5章 創薬研究受託事業市場

  • 概要
  • 創薬研究受託事業市場
    • 世界不況も創薬事業には最小限の影響
    • 市場の現況と予測
  • セグメント別市場分析
    • 化学研究サービス市場
      • 推定市場規模
      • 予測
    • 生物学研究サービス市場
      • 推定市場規模
      • 予測
    • ハイスループットスクリーニング研究サービス市場
      • 推定市場規模
      • 予測
    • リード化合物最適化研究サービス市場
      • 推定市場規模
      • 予測
  • 創薬研究受託競合企業
    • 創薬分野で勢いを増す先進オープンイノベーションモデル
  • 学術機関と開発業務受託機関の連合組織
    • 開発業務を受託する学術機関
    • 開発業務受託機関の間による連合組織
  • 世界規模で拡大する創薬研究サービス市場

第6章 競合企業プロフィール(歴史・事業ライン、創薬研究サービスなど)

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目次
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

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