生物安全测试市场- 按产品和服务（消耗品、仪器、服务、试剂和试剂盒）、应用（基因治疗、干细胞）、测试类型（内毒素测试、无菌测试、生物负载测试） - 全球预测（ 2024 - 2032）

在全球卫生当局不断加强的监管审查和严格的安全标准的推动下，生物安全检测市场规模预计在 2024 年至 2032 年期间复合年增长率为 13.6%。 FDA、EMA 和 WHO 等监管机构要求对药品、疫苗和药品进行严格的安全测试，以确保其不受污染且可供人类安全使用。由于製造商正在寻求满足这些严格的标准，对监管的重视导致了对生物安全测试服务和产品品质的强烈需求。

由于慢性病发病率不断上升以及对仿製药的高需求，生物製药行业不断扩张，因此需要先进的安全测试方法来确保新疗法的有效性。根据美国国立卫生研究院的数据，大约三分之一的人患有多种慢性病。随着单株抗体、基因疗法和细胞疗法等新型抗菌药物的发展，越来越需要开发专门的安全分析技术来检测包括细菌、病毒、支原体和内毒素在内的各种污染物。

生物安全检测产业分为产品和服务、应用、测试类型和区域。

根据应用，基因治疗领域的市场规模预计到 2032 年将产生可观的收入。由于基因疗法涉及使用基因来治疗和预防疾病，因此需要使用严格的法规和仔细的测试方案来识别任何潜在的污染物种子，包括病毒、残留的宿主细胞 DNA 和其他污染物。

在检测生物製药和生物技术产品污染日益重要的支持下，支原体测试类型领域的生物安全测试产业将在预测期内成长。支原体是一种小型、快速移动的生物体，没有细胞壁，会严重影响细胞培养，同时影响产品品质和安全。先进的检测方法，例如提供快速、灵敏检测的聚合物链反应（PCR）和酶联免疫吸附测定（ELISA）也将促进该细分市场的成长。

由于生物製药产业的快速扩张和生物技术研发活动投资的增加，亚太地区生物安全检测产业将在2032年大幅成长。在中国、印度和韩国等国家，政府透过更好的资金和监管提供强而有力的支持，以促进当地生物技术和製药业的发展。慢性病盛行率的不断上升以及随后对新疗法和疫苗的需求将推动对严格的生物安全测试的需求，以确保产品的安全性，从而促进区域市场的成长。

目录

第 1 章：方法与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业影响力
  • 成长动力
    • 政府措施和建议数量不断增加
    • 临床研究与生命科学研究的高研发投资
    • 由于疾病负担高，新生物製剂的产量增加
  • 产业陷阱与挑战
    • 审批流程耗时
• 成长潜力分析
• 技术景观
• 监管环境
• 波特的分析
• PESTEL分析

第 4 章：竞争格局

• 介绍
• 公司矩阵分析
• 公司市占率分析
• 竞争定位矩阵
• 战略展望矩阵

第 5 章：市场估计与预测：按产品和服务划分，2021 - 2032 年

• 主要趋势
• 耗材
• 仪器
• 服务
• 试剂和试剂盒

第 6 章：市场估计与预测：按应用分类，2021 - 2032

• 主要趋势
• 疫苗和治疗方法
  • 疫苗
  • 单株抗体
  • 重组蛋白
• 血液和血液製品
• 基因治疗
• 组织和组织基产品
• 干细胞

第 7 章：市场估计与预测：按测试类型，2021 - 2032 年

• 主要趋势
• 内毒素检查
• 无菌测试
• 支原体测试
• 生物负载测试
• 残留宿主细胞蛋白质和 DNA 检测测试
• 病毒安全测试
• 外源因子检测试验
• 其他测试类型

第 8 章：市场估计与预测：按地区，2021 - 2032

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 欧洲其他地区
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 澳洲
  • 韩国
  • 亚太地区其他地区
• 拉丁美洲
  • 巴西
  • 阿根廷
  • 墨西哥
  • 拉丁美洲其他地区
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋
  • 中东和非洲其他地区

第 9 章：公司简介

• bioMerieux S.A.
• Charles River Laboratories International, Inc.
• Eurofins Scientific SE
• F. Hoffmann-La Roche Ltd
• Lonza Group Ltd
• Merck KGaA
• Samsung Biologics.
• Sartorius AG
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific Inc.

Biological safety testing market size is set to register 13.6% CAGR during 2024-2032, driven by the rising regulatory scrutiny and stringent safety standards imposed by health authorities worldwide. Regulatory agencies, such as the FDA, EMA, and WHO are mandating the rigorous safety testing of pharmaceutical products, vaccines, and drug products to ensure that it is free from contamination and safe for human use. This emphasis on regulation has led to the strong demand for biosafety testing services and product quality, as manufacturers are seeking to meet these stringent standards.

The expansion of the biopharmaceutical sector due to the growing incidence of chronic diseases and the high demand for generic drugs has created the need for advanced safety testing methods to ensure the efficacy of new therapies. As per the National Institute of Health, around 1 in 3 people suffer from multiple chronic conditions. With the development of new antimicrobial agents, such as monoclonal antibodies, gene therapy and cell-based therapies, there is growing need to develop specialized safety analytical techniques to detect a wide range of contaminants including bacteria, viruses, mycoplasma, and endotoxins.

The biological safety testing industry is segmented into product and services, application, test type and region.

Based on application, the market size from the gene therapy segment is poised to generate substantial revenue by 2032. This is due to the complexity and critical nature of gene therapy, which requires rigorous safety studies to ensure efficacy and safety. As gene therapy involves the use of genes to treat and prevent diseases, strict regulations and careful testing protocols are used to identify any potential contaminants seeds, including viruses, residual host cell DNA, and other contaminants.

Biological safety testing industry from the mycoplasma test type segment is set to grow over the forecast period, backed by the increasing importance of detecting contamination in biopharmaceutical and biotechnology products. Mycoplasmas, which are small, fast-moving organisms without cell walls, can severely affect cell cultures while compromising product quality and safety. Advanced detection methods, such as polymer chain reaction (PCR) and enzyme-linked immunosorbent assays (ELISA) to provide rapid and sensitive detection will also boost the segment growth.

Asia Pacific biological safety testing industry will grow significantly through 2032, attributed to the rapid expansion of the biopharmaceutical sector and the increasing investments in biotechnology R&D activities. In countries, such as China, India and South Korea, strong government support is provided through better funding and regulation to boost the local biotechnology and pharmaceutical sectors. The increasing prevalence of chronic diseases and the subsequent demand for new treatments and vaccines will drive the demand for rigorous biosafety testing to ensure the safety of products, adding to the regional market growth.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising number of government initiatives and recommendations
    • 3.2.1.2 High R&D investments in clinical research and life sciences research
    • 3.2.1.3 Increasing production of new biologics due to high disease burden
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Time-consuming approval process
• 3.3 Growth potential analysis
• 3.4 Technological landscape
• 3.5 Regulatory landscape
• 3.6 Porter's analysis
• 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Product and Services, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Consumables
• 5.3 Instruments
• 5.4 Services
• 5.5 Reagents and kits

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Vaccine and therapeutics
  • 6.2.1 Vaccines
  • 6.2.2 Monoclonal antibodies
  • 6.2.3 Recombinant protein
• 6.3 Blood and blood-based products
• 6.4 Gene therapy
• 6.5 Tissue and tissue-based products
• 6.6 Stem cells

Chapter 7 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Endotoxin tests
• 7.3 Sterility tests
• 7.4 Mycoplasma tests
• 7.5 Bioburden tests
• 7.6 Residual host-cell proteins and DNA detection tests
• 7.7 Virus safety tests
• 7.8 Adventitious agent detection tests
• 7.9 Other test types

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Argentina
  • 8.5.3 Mexico
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 bioMerieux S.A.
• 9.2 Charles River Laboratories International, Inc.
• 9.3 Eurofins Scientific SE
• 9.4 F. Hoffmann-La Roche Ltd
• 9.5 Lonza Group Ltd
• 9.6 Merck KGaA
• 9.7 Samsung Biologics.
• 9.8 Sartorius AG
• 9.9 SGS Societe Generale de Surveillance SA
• 9.10 Thermo Fisher Scientific Inc.