生物安全測試市場- 按產品和服務（消耗品、儀器、服務、試劑和試劑盒）、應用（基因治療、幹細胞）、測試類型（內毒素測試、無菌測試、生物負載測試） - 全球預測（ 2024 - 2032）

在全球衛生當局不斷加強的監管審查和嚴格的安全標準的推動下，生物安全檢測市場規模預計在 2024 年至 2032 年期間複合年成長率為 13.6%。 FDA、EMA 和 WHO 等監管機構要求對藥品、疫苗和藥品進行嚴格的安全測試，以確保其不受污染且可供人類安全使用。由於製造商正在尋求滿足這些嚴格的標準，對監管的重視導致了對生物安全測試服務和產品品質的強烈需求。

由於慢性病發病率不斷上升以及對學名藥的高需求，生物製藥行業不斷擴張，因此需要先進的安全測試方法來確保新療法的有效性。根據美國國立衛生研究院的數據，大約三分之一的人患有多種慢性病。隨著單株抗體、基因療法和細胞療法等新型抗菌藥物的發展，越來越需要開發專門的安全分析技術來檢測包括細菌、病毒、支原體和內毒素在內的各種污染物。

生物安全檢測產業分為產品和服務、應用、測試類型和區域。

根據應用，基因治療領域的市場規模預計到 2032 年將產生可觀的收入。由於基因療法涉及使用基因來治療和預防疾病，因此需要使用嚴格的法規和仔細的測試方案來識別任何潛在的污染物種子，包括病毒、殘留的宿主細胞 DNA 和其他污染物。

在檢測生物製藥和生物技術產品污染日益重要的支持下，支原體測試類型領域的生物安全測試產業將在預測期內成長。支原體是一種小型、快速移動的生物體，沒有細胞壁，會嚴重影響細胞培養，同時影響產品品質和安全。先進的檢測方法，例如提供快速、靈敏檢測的聚合物鏈反應（PCR）和酶聯免疫吸附測定（ELISA）也將促進該細分市場的成長。

由於生物製藥產業的快速擴張和生物技術研發活動投資的增加，亞太地區生物安全檢測產業將在2032年大幅成長。在中國、印度和韓國等國家，政府透過更好的資金和監管提供強而有力的支持，以促進當地生物技術和製藥業的發展。慢性病盛行率的不斷上升以及隨後對新療法和疫苗的需求將推動對嚴格的生物安全測試的需求，以確保產品的安全性，從而促進區域市場的成長。

目錄

第 1 章：方法與範圍

第 2 章：執行摘要

第 3 章：產業洞察

• 產業生態系統分析
• 產業影響力
  • 成長動力
    • 政府措施和建議數量不斷增加
    • 臨床研究與生命科學研究的高研發投資
    • 由於疾病負擔高，新生物製劑的產量增加
  • 產業陷阱與挑戰
    • 核准流程耗時
• 成長潛力分析
• 技術景觀
• 監管環境
• 波特的分析
• PESTEL分析

第 4 章：競爭格局

• 介紹
• 公司矩陣分析
• 公司市佔率分析
• 競爭定位矩陣
• 戰略展望矩陣

第 5 章：市場估計與預測：按產品和服務分類，2021 - 2032 年

• 主要趨勢
• 耗材
• 儀器
• 服務
• 試劑和試劑盒

第 6 章：市場估計與預測：按應用分類，2021 - 2032

• 主要趨勢
• 疫苗和治療方法
  • 疫苗
  • 單株抗體
  • 重組蛋白
• 血液和血液製品
• 基因治療
• 組織和組織基產品
• 幹細胞

第 7 章：市場估計與預測：按測試類型，2021 - 2032 年

• 主要趨勢
• 內毒素檢查
• 無菌測試
• 支原體測試
• 生物負載測試
• 殘留宿主細胞蛋白質和 DNA 檢測測試
• 病毒安全測試
• 外源因子檢測試驗
• 其他測試類型

第 8 章：市場估計與預測：按地區，2021 - 2032

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 歐洲其他地區
• 亞太地區
  • 日本
  • 中國
  • 印度
  • 澳洲
  • 韓國
  • 亞太地區其他地區
• 拉丁美洲
  • 巴西
  • 阿根廷
  • 墨西哥
  • 拉丁美洲其他地區
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 中東和非洲其他地區

第 9 章：公司簡介

• 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.