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市場調查報告書
商品編碼
1832025

2025 年至 2033 年生物安全檢測市場規模、佔有率、趨勢及預測（按產品和服務、檢測類型、應用和地區分類）

Biological Safety Testing Market Size, Share, Trends, and Forecast by Product and Services, Test Type, Application, and Region, 2025-2033
出版日期: | 出版商: IMARC | 英文 148 Pages | 商品交期: 2-3個工作天內

價格

2024年，全球生物安全檢測市場規模為49.5億美元。展望未來， IMARC Group估計，到2033年，市場規模將達到132.9億美元，2025-2033年期間的複合年成長率為10.38%。目前，北美佔據市場主導地位，2024年其市佔率將超過38.8%。製藥和生物技術領域的擴張、新冠疫情的影響以及對法規遵循和安全標準的日益重視，是生物安全檢測市場佔有率成長的主要因素。

由於醫療保健需求的不斷成長和慢性病的流行，對生物製藥、疫苗和生物學名藥的需求不斷成長，推動了生物安全檢測市場的發展。嚴格的產品安全性和有效性監管準則，以及對生物技術研發不斷成長的投資，進一步推動了市場的成長。細胞和基因療法的進步以及合約研究組織 (CRO) 的擴張也推動了對可靠安全測試的需求。傳染病和大流行病防範的增加加速了疫苗的生產，因此需要進行嚴格的安全測試。自動化系統和高通量篩選等測試技術的創新提高了測試效率，促進了市場的擴張。人們對產品品質的認知不斷提高，進一步推動了全球生物安全檢測市場的成長。

美國生物安全檢測市場受慢性病和傳染病發病率上升導致對生物製藥、疫苗和先進療法的需求不斷成長的推動。 FDA 和其他機構制定的嚴格監管標準要求進行全面的安全檢測，以確保產品品質和合規性。美國在採用創新檢測技術方面也處於領先地位，包括自動化和高通量系統，從而提高了檢測的準確性和效率。此外，知名製藥公司的出現、對疫情防控的高度重視以及合約研究組織 (CRO) 的蓬勃發展，也代表了生物安全檢測市場的一些關鍵趨勢。例如，2024 年 10 月，在美國馬裡蘭州羅克維爾，德國達姆施塔特默克集團旗下生命科學部門 MilliporeSigma 推出了價值 2.9 億歐元的全新生物安全檢測設施。對於傳統和創新模式而言，生物安全檢測和分析開發是藥物開發和商業化的重要組成部分。全球對這些服務的需求正以兩位數的速度成長。此次擴建是該公司歷史上在合約測試方面最大的投資，它將能夠在單一綜合中心推動自動化和技術發展。

生物安全測試市場趨勢：

不斷擴大的製藥和生物技術領域

由於研發投入的增加，製藥和生物技術產業正在蓬勃發展。一份產業報告顯示，2023年全球製藥業的研發支出超過約3,000億美元。這些產業主導著針對各種疾病（包括複雜疾病）的藥物、生物製劑和疫苗的開發。因此，對全面安全評估的需求日益增加，而生物安全測試對於保障病人安全至關重要。它需要對細菌、病毒和內毒素等污染物進行全面評估，確保符合安全和法律要求。同時，疾病的演變和產品的持續創新使得對安全測試的需求持續旺盛，包括對基因和細胞療法等新興療法的專門評估，這極大地促進了生物安全測試市場的需求。

COVID-19 疫情的影響

新冠疫情加速了疫苗和治療方法的研發和部署，對疫苗產業產生了重大影響。例如，根據世界衛生組織 (WHO) 的數據，截至 2021 年，全球已接種超過 130 億劑新冠疫苗。這凸顯了嚴格的安全測試至關重要。此外，全球各國政府和監管機構加強了對這些產品的審查，導致對各種測試服務的需求激增，包括疫苗安全性評估、病毒檢測以及新冠診斷和治療的品質控制措施。此外，疫情改變了產業的重點，並強調了為即將到來的衛生緊急情況做好準備的必要性，從而保持了市場的成長。

日益重視監理合規性

全球監管機構正在加強對生物製藥產品的監管，強調病人安全和產品品質。這些法規要求進行全面的安全評估，使生物安全性測試成為藥品核准不可或缺的一部分。過去幾年，基因和細胞療法等先進療法藥物獲得了越來越多的批准。例如，歐洲藥品管理局先進療法委員會在2024年5月的全體會議上通過了一份關於Durveqtix（fidanacogene elaparvovec）的積極意見草案，該藥物用於治療重度和中度血友病B。這反映了獲批先進療法藥物（ATMP）數量持續成長的總體趨勢。製藥和生技企業必須嚴格遵守不斷變化的標準才能獲得產品核准和市場准入，這凸顯了對檢測服務的需求日益成長，生物安全性合規測試的重要性也因此凸顯。此外，監管法規日益複雜，尤其對於基因和細胞療法等複雜療法而言，也凸顯了專業檢測的必要性。隨著專家評估適應這些治療方法的獨特特點，確保其有效性和安全性，同時滿足不斷變化的監管要求，這保持了市場成長。

目錄

第1章：前言

第2章：範圍與方法

  • 研究目標
  • 利害關係人
  • 資料來源
    • 主要來源
    • 二手資料
  • 市場評估
    • 自下而上的方法
    • 自上而下的方法
  • 預測方法

第3章：執行摘要

第4章：簡介

第5章：全球生物安全檢測市場

  • 市場概況
  • 市場表現
  • COVID-19的影響
  • 市場預測

第6章：市場區隔：依產品與服務

  • 試劑盒和試劑
  • 儀器
  • 服務

第7章：市場區隔：依測試類型

  • 內毒素檢測
  • 無菌測試
  • 細胞株鑑定和特性測試
  • 生物負載測試
  • 殘留宿主污染物檢測測試
  • 外來因子檢測試驗
  • 其他

第 8 章：市場區隔：按應用

  • 疫苗研發
  • 血液製品檢測
  • 細胞和基因治療
  • 組織及組織相關產品檢測
  • 幹細胞研究

第9章：市場細分：依地區

  • 北美洲
    • 美國
    • 加拿大
  • 亞太
    • 中國
    • 日本
    • 印度
    • 韓國
    • 澳洲
    • 印尼
    • 其他
  • 歐洲
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙
    • 俄羅斯
    • 其他
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他
  • 中東和非洲

第 10 章：SWOT 分析

第 11 章：價值鏈分析

第 12 章：波特五力分析

第13章：價格分析

第 14 章：競爭格局

  • 市場結構
  • 關鍵參與者
  • 關鍵參與者簡介
    • Avance Biosciences
    • Charles River Laboratories
    • Creative Biogene
    • Eurofins Scientific
    • Lonza Group AG
    • Maravai LifeSciences
    • Pace Analytical Services Inc.
    • Pacific BioLabs
    • Sartorius AG
    • SGS SA
    • ViruSure GmbH (Asahi Kasei Corporation)
    • WuXi Biologics
Product Code: SR112025A4634

The global biological safety testing market size was valued at USD 4.95 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 13.29 Billion by 2033, exhibiting a CAGR of 10.38% during 2025-2033. North America currently dominates the market, holding a significant market share of over 38.8% in 2024. The expansion of the pharmaceutical and biotechnology sectors, the impact of the COVID-19 pandemic, and the rising emphasis on regulatory compliance and safety standards are some of the major factors increasing the biological safety testing market share.

The increasing demand for biopharmaceuticals, vaccines, and biosimilars drives the biological safety testing market due to rising healthcare needs and chronic disease prevalence. Stringent regulatory guidelines for product safety and efficacy, and the growing investment in biotechnology research and development, further fuel market growth. Advancements in cell and gene therapies and the expansion of contract research organizations (CROs) have also boosted the demand for reliable safety testing. The rise in infectious diseases and pandemic preparedness has accelerated vaccine production, necessitating rigorous safety testing. Innovations in testing technologies, such as automated systems and high-throughput screening, enhance testing efficiency, contributing to the market's expansion. The increasing awareness about product quality further drives the biological safety testing market growth across the globe.

The biological safety testing market in the United States is driven by the growing demand for biopharmaceuticals, vaccines, and advanced therapies due to the rising prevalence of chronic and infectious diseases. Stringent regulatory standards from the FDA and other authorities necessitate comprehensive safety testing to ensure product quality and compliance. The U.S. is also a leader in adopting innovative testing technologies, including automation and high-throughput systems, enhancing testing accuracy and efficiency. Additionally, the presence of well-established pharmaceutical companies, a strong focus on pandemic preparedness, and the growth of contract research organizations (CROs) represent some of the key biological safety testing market trends. For instance, in October 2024, in Rockville, Maryland, USA, MilliporeSigma, the Life Science division of Merck KGaA, Darmstadt, Germany, unveiled a new biosafety testing facility worth €290 million. For conventional and innovative modalities, biosafety testing and analytical development are essential elements of medication development and commercialization. The demand for these services is increasing at a double-digit rate on a global scale. The company will be able to drive automation and technological development in a single integrated hub due to this expansion, which represents the largest investment in contract testing in its history.

Biological Safety Testing Market Trends:

Expanding Pharmaceutical and Biotechnology Sectors

The pharmaceutical and biotechnology industries are expanding due to increased investments in research and development. According to an industrial report, in 2023, global R&D spending in the pharmaceutical sector exceeded approximately USD 300 billion. The development of medications, biologics, and vaccines for a range of medical conditions, including complicated illnesses, is dominated by these sectors. As a result, there is a greater need for thorough safety evaluations, and biological safety testing is essential to guaranteeing patient safety. It entails comprehensive assessments for pollutants including bacteria, viruses, and endotoxins, ensuring adherence to safety and legal requirements. Concurrently, the evolving nature of diseases and the continuous innovation in products maintain a high demand for safety testing, including specialized assessments for emerging therapies including gene and cell therapies, contributing significantly to the biological safety testing market demand.

Impact of the COVID-19 Pandemic

The COVID-19 pandemic has significantly impacted the industry by accelerating the development and deployment of vaccines and treatments. For instance, according to the World Health Organization (WHO), more than 13 billion COVID-19 vaccine doses were administered globally by 2021. This has emphasized the crucial role of rigorous safety testing. In addition to this, governments and regulatory authorities globally have intensified their scrutiny of these products, leading to a surge in demand for various testing services, including vaccine safety assessments, virus detection assays, and quality control measures for COVID-19 diagnostics and treatments. In addition, the pandemic has changed the industry's emphasis by emphasizing the necessity of readiness for upcoming health emergencies, which has maintained market expansion.

Rising Emphasis on Regulatory Compliance

Global regulatory bodies are tightening oversight of biopharmaceutical products, emphasizing patient safety and product quality. These regulations mandate comprehensive safety evaluations, making biological safety testing integral to drug approvals. Advanced therapy medicinal products, such as gene and cell therapies, have been receiving more approvals over the past few years. For example, the Committee for Advanced Therapies of the European Medicines Agency adopted a positive draft opinion for Durveqtix (fidanacogene elaparvovec) during its plenary meeting in May 2024 for the treatment of severe and moderately severe haemophilia B. This is part of a general trend where the number of approved ATMPs is constantly on the rise. The need for testing services is increased and the significance of biological safety testing in compliance is emphasized by the strict adherence to changing standards that pharmaceutical and biotech businesses must follow to obtain product approval and market access. Additionally, the necessity for specialist testing is highlighted by the growing complexity of regulatory regulations, particularly for sophisticated therapeutics like gene and cell therapies. As specialist evaluations adjust to the distinct features of these treatments, guaranteeing their efficacy and safety while satisfying changing regulatory requirements, this maintains market growth.

Biological Safety Testing Industry Segmentation:

Analysis by Product and Services:

  • Kits and Reagents
  • Instruments
  • Services

Kits and reagents leads the market with around 41.3% of market share in 2024. The increasing trend towards decentralized testing and point-of-care (POC) diagnostics driving the need for user-friendly and portable testing kits represents one of the prime factors fueling the demand for biological safety testing. These kits enable healthcare professionals to perform safety assessments quickly and efficiently, especially in resource-limited settings. In confluence with this, the expansion of research and development activities in the life sciences, including genomics, proteomics, and cell culture, necessitates a continuous supply of high-quality testing reagents and kits for various applications, spurring market growth. Furthermore, the growing focus on ensuring product quality and safety in the food and beverage (F&B) industry, where biological contaminants can pose significant risks, is boosting demand for testing kits and reagents for microbiological analysis, aiding market expansion.

Analysis by Test Type:

  • Endotoxin Tests
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Residual Host Contaminant Detection Tests
  • Adventitious Agent Detection Tests
  • Others

Endotoxin tests leads the market with around 24.9% of market share in 2024. The rising demand for endotoxin tests primarily propelled by the critical need to ensure the safety and efficacy of medical devices and pharmaceutical products is strengthening the global biological safety testing market. Endotoxins, toxic substances present in the cell walls of Gram-negative bacteria, can lead to severe health complications when introduced into the human body. The increasing complexity and diversity of medical devices, including implants and drug delivery systems, necessitate stringent testing for endotoxins to mitigate potential patient risk. Furthermore, the rising focus on personalized medicine and biopharmaceuticals, such as gene therapies and monoclonal antibodies, requires meticulous endotoxin testing to guarantee the purity and safety of these advanced therapies, strengthening the market. Besides this, regulatory agencies worldwide mandate compliance with strict endotoxin limits, reinforcing the demand for accurate and reliable endotoxin tests in pharmaceutical manufacturing and healthcare settings, thereby bolstering the market growth.

Analysis by Application:

  • Vaccine Development
  • Blood Products Testing
  • Cellular and Gene Therapy
  • Tissue and Tissue-related Products Testing
  • Stem Cell Research

Vaccine development leads the market with around 28.7% of market share in 2024. The demand for biological safety testing in vaccine development is primarily propelled by the urgent global need for safe and effective vaccines. As the world faces various infectious diseases and viral outbreaks, including the COVID-19 pandemic, there is an unprecedented focus on vaccine development. Regulatory authorities require comprehensive safety assessments to ensure that vaccines are not only effective but also free from harmful contaminants. Biological safety testing plays a critical role in this process, involving the evaluation of vaccine candidates for potential viral and microbial contaminants, ensuring the absence of endotoxins, and assessing their overall safety for human use. Moreover, the emergence of novel vaccine technologies, such as mRNA-based vaccines, necessitates specialized safety evaluations, contributing to the growing demand for biological safety testing services. This heightened emphasis on vaccine safety underscores the crucial role played by such testing in safeguarding public health on a global scale.

Regional Analysis

  • North America
    • United States
    • Canada
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

In 2024, North America accounted for the largest market share of over 38.8%. North America boasts a robust pharmaceutical and biotechnology industry, with a strong emphasis on research and development. The constant innovation and introduction of new drugs, biologics, and medical devices necessitate rigorous safety evaluations, driving the demand for biological safety testing services. In addition to this, the region's proactive regulatory environment, governed by stringent standards set by the FDA and other regulatory bodies, mandates comprehensive safety assessments, further propelling market growth. Moreover, the ongoing efforts to combat public health threats, such as the COVID-19 pandemic, have heightened the demand for vaccine development and testing, particularly in North America, where numerous pharmaceutical companies and research institutions are actively involved in vaccine research and production. These factors, combined with the region's advanced healthcare infrastructure and the increasing awareness of product quality and safety, continue to fuel the expansion of the North America biological safety testing market.

Key Regional Takeaways:

United States Biological Safety Testing Market Analysis

In 2024, the United States accounted for the largest market share of over 88.60% in North America. There are increased growth aspects related to U.S. biological safety testing with an increase in the development of pharmaceuticals, the rise of treatments based on biologics. In 2023 alone, the FDA approved 25 biologics under 55 newly approved drugs; 12 monoclonal antibodies (mAbs) and 5 of those were either an enzyme or protein. According to an industrial report, as of January 2024, there were 20,465 clinical trials accepting patients in the United States that clinically signified the growing need for biologics safety testing. There are major vendors of companies such as Charles River Laboratories and WuXi AppTec, which are interested in bringing testing technologies forward. The high urge for advanced safety testing of gene therapies and vaccines further amplified the market growth. The increasing focus on in-vitro testing and automation is also augmenting enhanced market efficiency. Improvements in technology are enhancing testing accuracy and reducing the turnaround time, while higher standards of safety regulatory requirements continue to drive innovation that positions the United States as the key player globally in the field of biological safety testing.

Europe Biological Safety Testing Market Analysis

The biological safety testing market is also growing in Europe due to strong regulatory framework and increased demands for safe pharmaceutical and biologic products. A recent industrial report suggests that revenue in the European pharmaceutical industry already surpassed EUR 300 billion (USD 309 billion) in 2022, which creates high demand for solutions in terms of safety testing. Germany and Switzerland happen to be strong market contributors while the pharmaceutical leaders Roche and Bayer are always concerned about their biologic safety. In more detail, especially, regulatory institutions such as EMA have upgraded testing standards due to which more quality biologic testing services flourished. Growth in the demand for clinical research, gene therapy, and also the increasing significance of biosimilars fuels the market demand. Additionally, the emerging concept of personalized medicine, coupled with precision testing, is further changing the playing field for regional safety testing service providers. Efficiency in testing has been improved with the increasing utilization of automation and AI technology.

Asia Pacific Biological Safety Testing Market Analysis

Asia Pacific's market for biological safety testing is fast growing due to increased investments in biotechnology as well as increasing pharmaceutical manufacturing. According to industrial reports, China's pharmaceutical market reached a value of USD 160 billion in 2023, which also led to greater demand for biologics. Rising population with above the age bracket population makes investment by the nation, in region attractive to multinationals for example Labcorp and Bio-merieux extending the presence based on rising spending in R and D. Advanced technologies like high-throughput testing and next-generation sequencing have been adopted by the biotech sector in the region, leading to a more sophisticated safety testing environment. In addition, strong manufacturing capabilities in the region along with cost-effective testing solutions have made it an important player in the global biological safety testing arena.

Latin America Biological Safety Testing Market Analysis

The biological safety testing market in Latin America is also on the rise, that is driven by growing pharmaceutical production and a deepening focus on compliance with international standards for safety. Brazil leads this boom, and the growing demand for biologic safety testing services can be tracked in response to the country's further increasing biologics production capability. Argentina and Mexico are also contributing to the growth through investments in upgrading their pharmaceutical manufacturing capabilities. According to an industry report, as of April 2024, Brazil boasts the highest number of clinical trials in the region with approximately 10,000 studies. Mexico ranks next with about 5,000 studies. Thus, this signifies a heavy reliance on clinical research and biologic safety. Testing requirements have become even more rigorous on the part of Brazil's regulatory body, ANVISA. This is leading to increased demands for high-tech safety testing to meet the new international standards set. Moreover, the investment by local manufacturers in testing services and infrastructure enhancement to meet the increasing demands is directly contributing to the expanding market and makes the region increasingly significant in the global biological safety testing market.

Middle East and Africa Biological Safety Testing Market Analysis

In the Middle East and Africa, the biological safety testing market is burgeoning, driven by increased healthcare investment and pharmaceutical production in many countries. Saudi Arabia's defense spending, which includes allocations for medical and pharmaceutical safety, fuels the growth of the market. The pharmaceutical market in the UAE remains in growth mode, and biological safety testing is fast becoming a key area of focus. South Africa is emerging as one of the key biomanufacturing hubs. There is a huge growth in domestic biologic production. There are 4,593 clinical trials in the Middle East and 861 in Africa as of 2022 according to the WHO International Clinical Trial Registry Platform, where there is increased demand for clinical research and biologic safety. Demand for biological safety testing services will be raised due to increases in healthcare facilities and clinical trials in the region. Testing service will grow annually at 10% over the next five years. This trend is further supported by the efforts of local governments to improve healthcare standards and infrastructure.

Competitive Landscape:

The fierce competition among major companies in the global biological safety testing market is a result of the sector's vital role in guaranteeing the quality and safety of pharmaceuticals, biologics, and medical devices. Prominent companies in this landscape engage in various strategies to maintain their market positions, such as mergers, acquisitions, and collaborations to expand their service portfolios and geographic reach. Furthermore, companies can also remain ahead of industry trends by investing in research and development to adopt cutting-edge testing technologies and procedures. The increasing focus on personalized medicine and advanced therapies, such as gene and cell therapies, presents growth opportunities for firms specializing in specialized safety testing services. Overall, the competitive landscape of the global biological safety testing market is marked by a dynamic interplay of established players.

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

  • Avance Biosciences
  • Charles River Laboratories
  • Creative Biogene
  • Eurofins Scientific
  • Lonza Group AG
  • Maravai LifeSciences
  • Pace Analytical Services Inc.
  • Pacific BioLabs
  • Sartorius AG
  • SGS SA
  • ViruSure GmbH (Asahi Kasei Corporation)
  • WuXi Biologics

Key Questions Answered in This Report

  • 1.How big is the biological safety testing market?
  • 2.What is the future outlook of biological safety testing market?
  • 3.What are the key factors driving the biological safety testing market?
  • 4.Which region accounts for the largest biological safety testing market share?
  • 5.Which are the leading companies in the global biological safety testing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Biological Safety Testing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product and Services

  • 6.1 Kits and Reagents
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Instruments
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Services
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Test Type

  • 7.1 Endotoxin Tests
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Sterility Tests
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Cell Line Authentication and Characterization Tests
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Bioburden Tests
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Residual Host Contaminant Detection Tests
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast
  • 7.6 Adventitious Agent Detection Tests
    • 7.6.1 Market Trends
    • 7.6.2 Market Forecast
  • 7.7 Others
    • 7.7.1 Market Trends
    • 7.7.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Vaccine Development
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Blood Products Testing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Cellular and Gene Therapy
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Tissue and Tissue-related Products Testing
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Stem Cell Research
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by Region

  • 9.1 North America
    • 9.1.1 United States
      • 9.1.1.1 Market Trends
      • 9.1.1.2 Market Forecast
    • 9.1.2 Canada
      • 9.1.2.1 Market Trends
      • 9.1.2.2 Market Forecast
  • 9.2 Asia-Pacific
    • 9.2.1 China
      • 9.2.1.1 Market Trends
      • 9.2.1.2 Market Forecast
    • 9.2.2 Japan
      • 9.2.2.1 Market Trends
      • 9.2.2.2 Market Forecast
    • 9.2.3 India
      • 9.2.3.1 Market Trends
      • 9.2.3.2 Market Forecast
    • 9.2.4 South Korea
      • 9.2.4.1 Market Trends
      • 9.2.4.2 Market Forecast
    • 9.2.5 Australia
      • 9.2.5.1 Market Trends
      • 9.2.5.2 Market Forecast
    • 9.2.6 Indonesia
      • 9.2.6.1 Market Trends
      • 9.2.6.2 Market Forecast
    • 9.2.7 Others
      • 9.2.7.1 Market Trends
      • 9.2.7.2 Market Forecast
  • 9.3 Europe
    • 9.3.1 Germany
      • 9.3.1.1 Market Trends
      • 9.3.1.2 Market Forecast
    • 9.3.2 France
      • 9.3.2.1 Market Trends
      • 9.3.2.2 Market Forecast
    • 9.3.3 United Kingdom
      • 9.3.3.1 Market Trends
      • 9.3.3.2 Market Forecast
    • 9.3.4 Italy
      • 9.3.4.1 Market Trends
      • 9.3.4.2 Market Forecast
    • 9.3.5 Spain
      • 9.3.5.1 Market Trends
      • 9.3.5.2 Market Forecast
    • 9.3.6 Russia
      • 9.3.6.1 Market Trends
      • 9.3.6.2 Market Forecast
    • 9.3.7 Others
      • 9.3.7.1 Market Trends
      • 9.3.7.2 Market Forecast
  • 9.4 Latin America
    • 9.4.1 Brazil
      • 9.4.1.1 Market Trends
      • 9.4.1.2 Market Forecast
    • 9.4.2 Mexico
      • 9.4.2.1 Market Trends
      • 9.4.2.2 Market Forecast
    • 9.4.3 Others
      • 9.4.3.1 Market Trends
      • 9.4.3.2 Market Forecast
  • 9.5 Middle East and Africa
    • 9.5.1 Market Trends
    • 9.5.2 Market Breakup by Country
    • 9.5.3 Market Forecast

10 SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Avance Biosciences
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
      • 14.3.1.3 SWOT Analysis
    • 14.3.2 Charles River Laboratories
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
      • 14.3.2.3 SWOT Analysis
    • 14.3.3 Creative Biogene
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
      • 14.3.3.3 SWOT Analysis
    • 14.3.4 Eurofins Scientific
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 SWOT Analysis
    • 14.3.5 Lonza Group AG
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
      • 14.3.5.3 SWOT Analysis
    • 14.3.6 Maravai LifeSciences
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
      • 14.3.6.3 SWOT Analysis
    • 14.3.7 Pace Analytical Services Inc.
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
      • 14.3.7.3 SWOT Analysis
    • 14.3.8 Pacific BioLabs
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
      • 14.3.8.3 SWOT Analysis
    • 14.3.9 Sartorius AG
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
      • 14.3.9.3 SWOT Analysis
    • 14.3.10 SGS SA
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
      • 14.3.10.3 SWOT Analysis
    • 14.3.11 ViruSure GmbH (Asahi Kasei Corporation)
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 SWOT Analysis
    • 14.3.12 WuXi Biologics
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
      • 14.3.12.3 SWOT Analysis

List of Figures

  • Figure 1: Global: Biological Safety Testing Market: Major Drivers and Challenges
  • Figure 2: Global: Biological Safety Testing Market: Sales Value (in Billion USD), 2019-2024
  • Figure 3: Global: Biological Safety Testing Market Forecast: Sales Value (in Billion USD), 2025-2033
  • Figure 4: Global: Biological Safety Testing Market: Breakup by Product and Services (in %), 2024
  • Figure 5: Global: Biological Safety Testing Market: Breakup by Test Type (in %), 2024
  • Figure 6: Global: Biological Safety Testing Market: Breakup by Application (in %), 2024
  • Figure 7: Global: Biological Safety Testing Market: Breakup by Region (in %), 2024
  • Figure 8: Global: Biological Safety Testing (Kits and Reagents) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 9: Global: Biological Safety Testing (Kits and Reagents) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 10: Global: Biological Safety Testing (Instruments) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 11: Global: Biological Safety Testing (Instruments) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 12: Global: Biological Safety Testing (Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 13: Global: Biological Safety Testing (Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 14: Global: Biological Safety Testing (Endotoxin Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 15: Global: Biological Safety Testing (Endotoxin Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 16: Global: Biological Safety Testing (Sterility Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 17: Global: Biological Safety Testing (Sterility Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 18: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 19: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 20: Global: Biological Safety Testing (Bioburden Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 21: Global: Biological Safety Testing (Bioburden Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 22: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 23: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 24: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 25: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 26: Global: Biological Safety Testing (Other Test Types) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 27: Global: Biological Safety Testing (Other Test Types) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 28: Global: Biological Safety Testing (Vaccine Development) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 29: Global: Biological Safety Testing (Vaccine Development) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 30: Global: Biological Safety Testing (Blood Products Testing) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 31: Global: Biological Safety Testing (Blood Products Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 32: Global: Biological Safety Testing (Cellular and Gene Therapy) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 33: Global: Biological Safety Testing (Cellular and Gene Therapy) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 34: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 35: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 36: Global: Biological Safety Testing (Stem Cell Research) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 37: Global: Biological Safety Testing (Stem Cell Research) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 38: North America: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 39: North America: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 40: United States: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 41: United States: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 42: Canada: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 43: Canada: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 44: Asia-Pacific: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 45: Asia-Pacific: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 46: China: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 47: China: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 48: Japan: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 49: Japan: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 50: India: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 51: India: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 52: South Korea: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 53: South Korea: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 54: Australia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 55: Australia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 56: Indonesia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 57: Indonesia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 58: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 59: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 60: Europe: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 61: Europe: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 62: Germany: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 63: Germany: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 64: France: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 65: France: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 66: United Kingdom: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 67: United Kingdom: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 68: Italy: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 69: Italy: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 70: Spain: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 71: Spain: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 72: Russia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 73: Russia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 74: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 75: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 76: Latin America: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 77: Latin America: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 78: Brazil: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 79: Brazil: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 80: Mexico: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 81: Mexico: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 82: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 83: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 84: Middle East and Africa: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 85: Middle East and Africa: Biological Safety Testing Market: Breakup by Country (in %), 2024
  • Figure 86: Middle East and Africa: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 87: Global: Biological Safety Testing Industry: SWOT Analysis
  • Figure 88: Global: Biological Safety Testing Industry: Value Chain Analysis
  • Figure 89: Global: Biological Safety Testing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Biological Safety Testing Market: Key Industry Highlights, 2024 and 2033
  • Table 2: Global: Biological Safety Testing Market Forecast: Breakup by Product and Services (in Million USD), 2025-2033
  • Table 3: Global: Biological Safety Testing Market Forecast: Breakup by Test Type (in Million USD), 2025-2033
  • Table 4: Global: Biological Safety Testing Market Forecast: Breakup by Application (in Million USD), 2025-2033
  • Table 5: Global: Biological Safety Testing Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 6: Global: Biological Safety Testing Market: Competitive Structure
  • Table 7: Global: Biological Safety Testing Market: Key Players