首頁 > 市場調查報告書 > 醫療設備

生技設備

市場調查報告書

商品編碼

1630764

生物安全檢測市場規模、佔有率和成長分析（按產品、檢測類型、應用和地區）- 產業預測 2025-2032

Biological Safety Testing Market Size, Share, Growth Analysis, By Product (Reagents & Kits, Services), By Test Type (Endotoxin Tests, Sterility Tests), By Application, By Region - Industry Forecast 2025-2032

出版日期: 2025年01月09日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

2023 年全球生物安全測試市場規模價值 52 億美元，預計將從 2024 年的 58.1 億美元成長到 2032 年的 140.8 億美元，預測期內（2025-2032 年）的複合年成長率為 11.7%。

由於製藥和生物技術領域研發的快速成長、感染疾病的增加以及醫療保健品管意識的增強，全球生物安全測試市場預計將大幅成長。該市場專注於評估疫苗、血液製品和細胞治療等生物製藥的安全性和有效性，並遵守嚴格的監管標準，要求徹底的測試以降低不良事件的風險。核酸擴增和序列測定等先進檢測技術的出現將提高污染物檢測的靈敏度並提高患者的安全性。此外，基於細胞化驗分析和免疫測量等體外檢測方法的使用越來越多，透過提供更快、更具成本效益的結果並減少對動物測試的依賴，正在加速市場擴大。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲國家地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 其他亞太地區
拉丁美洲
- 巴西
- 其他拉丁美洲國家
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前 5 家公司對比
主要企業市場定位（2024年）
主要市場參與者所採用的策略
近期市場趨勢
公司市場佔有率分析（2024 年）
主要企業簡介
- 公司簡介
- 產品系列分析
- 按細分市場分析市場佔有率
- 收益與前一年同期比較（2022-2024 年）

主要企業簡介

bioMerieux SA（France）
Charles River Laboratories International, Inc.（United States）
Eurofins Scientific SE（Luxembourg）
Lonza Group Ltd.（Switzerland）
Merck KGaA（Germany）
Samsung Biologics（South Korea）
Sartorius AG（Germany）
SGS Societe Generale de Surveillance SA（Switzerland）
Thermo Fisher Scientific Inc.（United States）
Avance Biosciences（United States）
Promega Corporation（United States）
Toxikon Corporation（United States）
WuXi AppTec（China）
Pace Analytical Services LLC（United States）
Nelson Laboratories, LLC（United States）
BioReliance Corporation（United States）
Microbac Laboratories, Inc.（United States）
Intertek Group plc（United Kingdom）
Covance Inc.（United States）

結論和建議

簡介目錄

Product Code: SQMIG35J2092

Global Biological Safety Testing Market size was valued at USD 5.2 billion in 2023 and is poised to grow from USD 5.81 billion in 2024 to USD 14.08 billion by 2032, growing at a CAGR of 11.7% during the forecast period (2025-2032).

The global biological safety testing market is poised for substantial growth, fueled by a surge in research and development across pharmaceutical and biotechnology sectors, an increase in infectious diseases, and heightened awareness of healthcare quality control. This market focuses on the safety and efficacy evaluation of biological products like vaccines, blood products, and cell-based therapies, adhering to stringent regulatory standards that mandate thorough testing to mitigate adverse risks. The advent of advanced testing technologies, including nucleic acid amplification and sequencing, enhances sensitivity in contaminant detection, thus improving patient safety. Furthermore, the rising utilization of in vitro testing methods, such as cell-based assays and immunoassays, is expediting market expansion by providing quicker, cost-effective results and reducing animal testing reliance.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biological 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 Biological Safety Testing Market Segmental Analysis

Global Biological Safety Testing Market is segmented by Product, Test Type, Application and region. Based on Product, the market is segmented into Reagents & Kits, Services and Instruments. Based on Test Type, the market is segmented into Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests and Others. Based on Application, the market is segmented into Vaccines & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products, Stem Cell and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is being significantly influenced by the rising adoption of in vitro testing methods, including cell-based assays and immunoassays. These innovative approaches are favored due to their numerous benefits over conventional animal testing, such as faster results, decreased reliance on animal subjects, and enhanced cost-effectiveness. The urgency to combat the growing prevalence of infectious diseases, highlighted by the COVID-19 pandemic, has intensified the focus on biological safety testing. This has increased the demand for advanced testing techniques that can reliably detect and mitigate the risks posed by pathogens and contaminants, further propelling market expansion.

Restraints in the Global Biological Safety Testing Market

One of the significant challenges facing the Global Biological Safety Testing market is the shortage of skilled professionals with expertise in this specialized field. The intricate methodologies involved in biological safety testing demand a high level of training and experience, particularly in areas such as sample handling, result interpretation, and adherence to regulatory compliance. This scarcity of qualified personnel can significantly hinder market growth, as organizations may struggle to find individuals capable of executing these complex tests efficiently. Consequently, the lack of available talent may restrict market expansion and innovation within the biological safety testing sector.

Market Trends of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is experiencing a notable upward trend, driven by an increasing emphasis on patient safety within the healthcare sector. The demand for rigorous testing protocols is propelled by heightened awareness of the repercussions associated with contaminated or low-quality biological products. As healthcare providers, regulatory authorities, and manufacturers prioritize stringent quality control measures to safeguard patient wellbeing, the market is witnessing growth in comprehensive testing services. This trend reflects a broader commitment to enhance safety standards, positioning biological safety testing as an essential component in the lifecycle of biological products, thus driving innovation and investment across the industry.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Case Studies
Technological Advancement

Global Biological Safety Testing Market Size by Product & CAGR (2025-2032)

Market Overview
Reagents & Kits
Services
Instruments

Global Biological Safety Testing Market Size by Test Type & CAGR (2025-2032)

Market Overview
Endotoxin Tests
Sterility Tests
Cell Line Authentication & Characterization Tests
Bioburden Tests
Adventitious Agent Detection Tests
Residual Host Contamination Detection Tests
Others

Global Biological Safety Testing Market Size by Application & CAGR (2025-2032)

Market Overview
Vaccines & Therapeutics
- Vaccines
- Monoclonal Antibodies
- Recombinant Protein
Blood & Blood-based Products
Gene Therapy
Tissue & Tissue-based Products
Stem Cell
Others

Global Biological Safety Testing Market Size & CAGR (2025-2032)

North America (Product, Test Type, Application)
- US
- Canada
Europe (Product, Test Type, Application)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Product, Test Type, Application)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Product, Test Type, Application)
- Brazil
- Rest of Latin America
Middle East & Africa (Product, Test Type, Application)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2024
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2024
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

bioMerieux S.A. (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories International, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Eurofins Scientific SE (Luxembourg)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza Group Ltd. (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Biologics (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SGS Societe Generale de Surveillance SA (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Avance Biosciences (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Promega Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Toxikon Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pace Analytical Services LLC (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nelson Laboratories, LLC (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BioReliance Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Microbac Laboratories, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Intertek Group plc (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Covance Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments