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市場調查報告書

生物學的安全性實驗:各種技術和全球市場

Biologics Development and Manufacturing Testing: Technologies and Global Markets

出版商 BCC Research 商品編碼 605092
出版日期 內容資訊 英文 92 Pages
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生物學的安全性實驗:各種技術和全球市場 Biologics Development and Manufacturing Testing: Technologies and Global Markets
出版日期: 2018年02月15日內容資訊: 英文 92 Pages
簡介

全球生物學的安全性實驗的市場在預測期間內預計以20.9%的年複合成長率發展,從2017年的51億美元,成長到2022年的131億美元的規模。

本報告提供全球生物學的安全性實驗的市場調查,市場定義和概要,生物製藥的開發、製造趨勢,實驗目的、實驗用途、實驗技術、各地區的趨勢與市場規模的變化與預測,市場機會分析,主要企業簡介等彙整。

第1章 簡介

第2章 摘要、亮點

第3章 生物學的安全性實驗概要

  • 藥物研發
  • 製程發展
  • 配合開發
  • 製造
  • 流程驗證
  • 安全性、出貨
  • 生技藥品製造的成長

第4章 生物學的安全性測試市場分析、預測:各實驗目的

  • 安全性
  • 效力(Potency)
  • 有效性(Efficacy)
  • 穩定性
  • 產品組出貨實驗
  • 純度
  • 產品穩定性實驗等

第5章 生物學的安全性測試市場分析、預測:各實驗用途

  • 終局毒素實驗
  • 無菌實驗
  • 外來性因素檢測
  • 微生物附著量實驗
  • 宿主來源殘留污染物質 (宿主細胞來源蛋白質) 檢測實驗

第6章 生物學的安全性測試市場分析、預測:各實驗技術

  • In Vivo安全性實驗
    • 毒性:LD50實驗
    • 致突變性、致癌性
    • 毒物動力學、ADME
    • 代謝毒性
    • 發熱性物質實驗
    • 胎兒毒性
    • 內分泌干擾物
    • 毒理基因體學
  • In Vitro安全性實驗
    • 核酸擴增實驗
    • 組織、細胞實驗
    • 細胞分析
    • 細胞株開發、實驗
  • 安全性實驗分析服務

第7章 地區分析

  • 北美 (美國、加拿大)
  • EU、東歐
  • 亞太地區、其他 (日本、中國、澳洲、南美)

第8章 專利檢討、新的發展

第9章 市場機會分析

  • 生物相似藥
  • 生技改良藥
  • 安全性實驗的意義
  • In Vivo實驗的主要趨勢
  • In Vitro實驗的主要趨勢
  • 分析實驗服務的主要趨勢

第10章 企業簡介

關於BCC Research

目錄
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

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)
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