全球生物製品安全测试市场规模、份额、成长分析（按测试、按应用、按最终用途）- 2024-2031 年产业预测

2022年，全球生物製品安全测试市场规模为47.0亿美元，预计将从2023年的52.5亿美元成长到2031年的127.2亿美元，在预测期内（2024-2031年）复合年增长率为11.70% 。

生物安全测试涵盖一系列细緻的程序，对于确保生物来源产品的安全至关重要，特别是生物製药和医疗器材。其主要目标是透过仔细检查污染和不良生物效应等因素来评估和减轻与这些产品相关的潜在风险。遵守严格的监管标准对于确保生物材料的纯度、效力和整体安全性至关重要。无菌检测、内毒素评估和细胞检测等技术在彻底评估这些产品、确认其符合严格的安全标准并确保其适合临床应用和公共卫生保护方面发挥着至关重要的作用。

目录

执行摘要

• 市场概况
• 命运之轮

研究方法论

• 资讯采购
• 二手和主要资料来源
• 市场规模估计
• 市场假设与限制

母公司市场分析

• 市场概况
• 市场规模
• 市场动态
  • 司机
  • 机会
  • 限制
  • 挑战

主要市场洞察

• 技术分析
• 定价分析
• 供应链分析
• 价值链分析
• 市场生态系统
• 智慧财产权分析
• 贸易分析
• 启动分析
• 原料分析
• 创新矩阵
• 管道产品分析
• 总体经济指标
• 顶级投资分析
• 成功的关键因素
• 竞争程度

市场动态与展望

• 市场动态
  • 司机
  • 机会
  • 限制
  • 挑战
• 监管环境
• 波特分析
• 对未来颠覆的特别见解

按测试分類的全球生物製品安全测试市场

• 市场概况
• 内毒素检测
• 无菌测试
• 外源因子检测试验
• 其他的

全球生物製品安全测试市场（按应用）

• 市场概况
• 血液和血液製品
• 疫苗与治疗
• 干细胞
• 和别的

按最终用途分類的全球生物製品安全测试市场

• 市场概况
• 製药和生物技术公司
• 合约开发和製造公司
• 研究与学术界
• 和别的

全球生物製品安全测试市场规模（按地区）

• 市场概况
• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 拉丁美洲其他地区
• 中东和非洲 (MEA)
  • 海湾合作委员会国家
  • 南非
  • MEA 的其余部分

竞争格局

• 前 5 名玩家比较
• 2021 年关键参与者的市场定位
• 主要市场参与者所采取的策略
• 最佳制胜策略
• 近期市集活动
• 主要公司市占率（%），2021年

主要公司简介

• Cytovance Biologics
• Eurofins Scientific
• Merck KGaA
• Biomerieux SA
• Lonza
• Promega Corporation
• Thermo Fisher Scientific
• WuXi AppTec
• Nelson Laboratories, LLC
• Almac Group
• GenScript
• InvivoGen
• Toxikon
• Maravai LifeSciences

Global Biologics Safety Testing Market size was valued at USD 4.70 billion in 2022 and is poised to grow from USD 5.25 billion in 2023 to USD 12.72 billion by 2031, growing at a CAGR of 11.70% during the forecast period (2024-2031).

Biological safety testing encompasses a wide range of meticulous procedures vital for guaranteeing the safety of products sourced from biological origins, particularly biopharmaceuticals and medical devices. Its primary objective is to evaluate and mitigate potential risks associated with these products by carefully examining factors such as contamination and adverse biological effects. Adherence to strict regulatory standards is essential to ensure the purity, potency, and overall safety of biological materials. Techniques like sterility testing, endotoxin assessment, and cell-based assays play crucial roles in thoroughly assessing these products, confirming their compliance with stringent safety criteria and ensuring their suitability for clinical application and public health protection.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biologics Safety Testing Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biologics Safety Testing Market Segmental Analysis

The global Biologics Safety Testing market is segmented on the basis of test, application, end-use, and region. Based on Test, it is divided into Endotoxin Test, Bioburden Tests, Sterility Test, Adventitious Agent Detection Test, Others. Based on Application, it is divided into Blood & Blood-based Products, Gene Therapy, Vaccines & Therapeutics, Stem Cells, Others. Based on End-use, it is divided into Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia, Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.

Drivers of the Global Biologics Safety Testing Market

The significant growth observed in the pharmaceutical and biotechnology fields, driven by substantial investments in research and development, marks a crucial era in healthcare advancement. These sectors are leading the way in developing pharmaceuticals, biologics, and vaccines to tackle a wide range of healthcare challenges, particularly in combating complex diseases. This surge in innovation underscores the heightened need for rigorous safety assessments, with biological safety testing playing a pivotal role in ensuring patient safety.

Restraints in the Global Biologics Safety Testing Market

Biologics and biosimilars constitute an innovative class of drugs sourced from living organisms, providing effective therapies for a wide range of conditions such as cancer, diabetes, rheumatoid arthritis, and diverse inflammatory disorders.

Market Trends of the Global Biologics Safety Testing Market

Global regulatory authorities have intensified their oversight of biopharmaceuticals, placing significant importance on patient safety and product quality. These rigorous regulations require comprehensive safety assessments, making biological safety testing a fundamental aspect of the drug approval process. Pharmaceutical and biotech companies must rigorously comply with these evolving standards to ensure product approval and market access. The growing focus on compliance drives a surge in demand for testing services, solidifying the crucial role of biological safety testing in this regulatory landscape.

Table of Contents

Executive Summary

• Market Overview
• Wheel of Fortune

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Parent Market Analysis

• Market Overview
• Market Size
• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges

Key Market Insights

• Technology Analysis
• Pricing Analysis
• Supply Chain Analysis
• Value Chain Analysis
• Ecosystem of the Market
• IP Analysis
• Trade Analysis
• Startup Analysis
• Raw Material Analysis
• Innovation Matrix
• Pipeline Product Analysis
• Macroeconomic Indicators
• Top Investment Analysis
• Key Success Factor
• Degree of Competition

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Regulatory Landscape
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers
• Skyquest Special Insights on Future Disruptions
  • Political Impact
  • Economic Impact
  • Social Impact
  • Technical Impact
  • Environmental Impact
  • Legal Impact

Global Biologics Safety Testing Market by Test

• Market Overview
• Endotoxin Test
• Sterility Test
• Adventitious Agent Detection Test
• and Others

Global Biologics Safety Testing Market by Application

• Market Overview
• Blood & Blood-based Products
• Vaccines & Therapeutics
• Stem Cells
• and Others

Global Biologics Safety Testing Market by End-use

• Market Overview
• Pharmaceutical and Biotechnology Companies
• Contract Development and Manufacturing Companies
• Research and Academia
• and Others

Global Biologics Safety Testing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2021
• Strategies Adopted by Key Market Players
• Top Winning Strategies
  • By Development
  • By Company
  • By Year
• Recent Activities in the Market
• Key Companies Market Share (%), 2021

Key Company Profiles

• Cytovance Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Merck KGaA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biomerieux SA
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lonza
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Promega Corporation
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Almac Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• GenScript
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• InvivoGen
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Toxikon
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Maravai LifeSciences
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments