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生物学的安全性試験:各種技術と世界の市場

Biologics Development and Manufacturing Testing: Technologies and Global Markets

発行 BCC Research 商品コード 605092
出版日 ページ情報 英文 92 Pages
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生物学的安全性試験:各種技術と世界の市場 Biologics Development and Manufacturing Testing: Technologies and Global Markets
出版日: 2018年02月15日 ページ情報: 英文 92 Pages
概要

世界の生物学的安全性試験の市場は予測期間中20.9%のCAGR (年間複合成長率) で推移し、2017年の51億ドルから、2022年には131億ドルの規模に成長すると予測されています。

当レポートでは、世界の生物学的安全性試験の市場を調査し、市場の定義と概要、生物学的製剤の開発・製造動向、試験目的・試験用途・試験技術・地域別の動向と市場規模の推移と予測、市場機会の分析、主要企業のプロファイルなどをまとめています。

第1章 イントロダクション

第2章 サマリー・ハイライト

第3章 生物学的安全性試験の概要

  • 創薬
  • プロセス開発
  • 配合開発
  • 製造
  • プロセスバリデーション
  • 安全性・出荷
  • 生物製剤製造の成長

第4章 生物学的安全性試験市場の分析・予測:試験目的別

  • 安全性
  • 有効性 (ポテンシー)
  • 有効性 (エフィカシー)
  • 安定性
  • 製品ロット出荷試験
  • 純度
  • 製品安定性試験、など

第5章 生物学的安全性試験市場の分析・予測:試験用途別

  • エンドトキシン試験
  • 無菌試験
  • 外来性因子検出
  • バイオバーデン試験
  • 宿主由来残留汚染物質 (宿主細胞由来タンパク質) 検出試験

第6章 生物学的安全性試験市場の分析・予測:試験技術別

  • In Vivo安全性試験
    • 毒性:LD50試験
    • 変異原性・発癌性
    • トキシコキネティクス・ADME
    • 代謝毒性
    • 発熱性物質試験
    • 胎児毒性
    • 内分泌攪乱物質
    • トキシコゲノミクス
  • In Vitro安全性試験
    • 核酸増幅試験
    • 組織・細胞試験
    • 細胞分析
    • 細胞株開発・試験
  • 安全性試験解析サービス

第7章 地域分析

  • 北米 (米国・カナダ)
  • EU・東欧
  • アジア太平洋・その他 (日本・中国・オーストラリア・南米)

第8章 特許レビュー・新たな発展

第9章 市場機会の分析

  • バイオシミラー
  • バイオベター
  • 安全性試験の意義
  • In Vivo試験の主要動向
  • In Vitro試験の主要動向
  • 解析試験サービスの主要動向

第10章 企業プロファイル

BCC Researchについて

図表

List of Tables

  • Table 1 Definition of Biologics
  • Summary Table: Global Market for Biological Safety Testing, by Market Segmentation, Through 2022 ($ Millions)
  • Table 2 Market Segments for Biological Safety Testing
  • Table 3 Definition of Protein-based Drugs and Vaccines
  • Table 4 Global Biological Safety Testing Market, by Protein-based Drugs, Through 2022 ($ Millions) . 17
  • Table 5 Global Market for Biological Safety Testing, by Objective
  • Table 6 Analytical Methods used for Determination of Protein Structure
  • Table 7 Global Market for Biological Safety Testing, by Objective, Through 2022 ($ Millions)
  • Table 8 Segmentation of Biological Safety Testing Market, by Application
  • Table 9 Global Market for Biological Safety Testing, by Application, Through 2022 ($ Millions)
  • Table 10 Segmentation of Biological Safety Testing Market, by Test Technology
  • Table 11 Drivers of Cell Analysis Market Growth
  • Table 12 Segmentation of Analytical Testing Services Market, by Technology
  • Table 13 Global Market for Biological Safety Testing, by Test Technology, Through 2022 ($ Millions) 50
  • Table 14 Segmentation of the Biological Safety Testing Market, by Region
  • Table 15 Global Market for Biological Safety Testing, by Region, Through 2022 ($ Millions)
  • Table 16 Biologics: Patent Expiration, by Year, 2003-2019
  • Table 17 Key Trends in In Vivo Based Testing
  • Table 18 Key Trends in Cell-Based In Vitro Safety Testing
  • Table 19 Key Trends in Analytical Testing Services

List of Figures

  • Summary Figure: Global Market for Biological Safety Testing, by Market Segmentation, 2016-2022 ($ Millions)
  • Figure 1 Value Chain Model for Biological Safety Testing and Product Lifecycle
  • Figure 2 Global Market for Biological Safety Testing, by Objective, 2016-2022 ($ Millions)
  • Figure 3 Global Market for Biological Safety Testing, by Application, 2016-2022 ($ Millions)
  • Figure 4 Value Chain Model for Biological Analytical Testing and Good Practice
  • Figure 5 Global Market for Biological Safety Testing, by Test Technology, 2016-2022 ($ Millions)
  • Figure 6 Global Market for Biological Safety Testing, by Region, 2016-2022 ($ Millions)
目次
Product Code: BIO155A

The global biological safety testing market should reach $13.1 billion by 2022 from $5.1 billion in 2017 at a compound annual growth rate (CAGR) of 20.9%, from 2017 to 2022.

Report Includes

  • An overview of the global market for biological safety testing and related technologies.
  • Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022.
  • Discussion of the latest market trends, regulatory environments, market projections, and market share.
  • A look at future of biological patents and biosimilars along with biologics patents by year.
  • Company profiles of major players in the industry, including Charles River Laboratories, WuXi AppTec, SGS SA, Thermo Fisher Scientific and Lonza Group.

Report Scope

The scope of this study encompasses all aspects of biological safety testing used for characterization and release of biopharmaceutical, veterinary and medical diagnostics products. BCC Research analyzes each market and its applications, regulatory environments, technology, market projections, and market share. Technological issues discussed in the report include the latest trends and developments.

Analyst Credentials

David Peters is a process development manager with 30 years of applied biological research and development experience, as well as over 18 years of process development and commercial manufacturing experience in the biopharmaceutical industry. He has worked for biopharmaceutical industry leaders on preclinical development programs, as well as on commercial production of a recombinant protein-based vaccine. He holds a B.S. in biology, an M.S. in health sciences, and an MBA in business management.

Table of Contents

Chapter 1: Introduction

  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Geographic Breakdown
  • Analyst's Credentials
  • Related BCC Research Reports

Chapter 2: Summary and Highlights

  • Summary of Key Insights
  • Market Segment Breakdown

Chapter 3: Overview

  • Drug Discovery
  • Process Development
  • Formulation Development
  • Manufacturing
  • Process Validation
  • Stability and Release
  • Growth in Biological Manufacturing

Chapter 4: Market Breakdown by Test Objective

  • Market Breakdown by Objective
    • Safety
    • Efficacy
    • Potency
    • Stability
    • Product Lot Release Testing
    • Potency
    • Purity
    • Excipients
    • Product Stability Testing

Chapter 5: Market Breakdown by Test Application

  • Market Breakdown by Test Application
    • Endotoxin Testing
    • Sterility Testing
    • Adventitious Agent Detection
    • Bioburden Testing
    • Residual Host Contaminant (Host Cell Protein) Detection Testing

Chapter 6: Market Breakdown by Test Technology

  • In Vivo Safety Testing
    • Toxicity-LD50 Test
    • Mutagenicity and Carcinogenicity
    • Toxicokinetics and ADME
    • Metabolic Toxicity
    • Pyrogen Testing
    • Embryotoxicity
    • Endocrine Disruptors
    • Toxicogenomics
  • In Vitro Safety Testing
    • Nucleic Acids-based Testing
    • Tissue and Cell-based Testing
    • Cell Analysis
    • Cell Line Development and Testing
  • Safety Testing Analytical Services

Chapter 7: Market Breakdown by Region

  • Global Biological Safety Testing Market, by Region
    • North America (U.S., Canada)
    • E.U and Eastern Europe
    • Asia-Pacific and Other (Japan, China, Australia, South America)

Chapter 8: Patent Review/ New Developments

  • Future of Biological Patents and Biosimilars
  • Biologics: Patent Expiration by Year

Chapter 9: Analysis of Market Opportunities

  • Biosimilars
  • Biobetters
  • Implications for Safety Testing
  • Key Trends in In Vivo Testing
  • Key Trends in In Vitro Testing
  • Key Trends in Analytical Testing Services

Chapter 10: Company Profiles

  • Types of Biological Products Tested
  • Types of Biological Safety Testing Performed

About BCC Research

  • About BCC Research
  • BCC Membership
  • BCC Custom Research
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