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生技药品安全检测市场规模、份额和成长分析（按产品/服务、检测类型、应用、最终用户和地区划分）—产业预测（2026-2033 年）

市场调查报告书

商品编码

1898439

生技药品安全检测市场规模、份额和成长分析（按产品/服务、检测类型、应用、最终用户和地区划分）—产业预测（2026-2033 年）

Biologics Safety Testing Market Size, Share, and Growth Analysis, By Product and Services (Consumables, Instruments), By Test Type (Endotoxin tests, Sterility tests), By Application, By End User, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月16日 | 出版商:

SkyQuest | 英文 219 Pages | 商品交期: 3-5个工作天内

价格

简介目录

预计到 2024 年，生技药品安全测试市场规模将达到 58.6 亿美元，到 2025 年将成长至 65.5 亿美元，到 2033 年将成长至 158.7 亿美元，在预测期（2026-2033 年）内复合年增长率为 11.7%。

生技药品安全检测市场分析表明，该领域在医疗保健行业至关重要，其重点在于确保生物製品（尤其是生物製药和医疗设备）的安全性和有效性。该领域采用多种严谨的程序来识别和降低风险，包括污染和不良生物效应。遵守严格的监管标准是确保生物材料纯度、有效性和整体安全性的必要条件。无菌检测、内毒素评估和细胞检测等关键技术在严格评估安全标准方面发挥关键作用。这种系统化的方法不仅保障了临床应用，也维护了公众健康，因此生技药品安全检测是产品开发和上市准备的重要组成部分。

生技药品安全检测市场驱动因素

在研发投入的大力推动下，製药生技产业的蓬勃发展标誌着医学进步的关键时刻。这些领域主导新药、生技药品和疫苗的研发，积极应对各种医学挑战，尤其是在对抗复杂疾病方面。这波创新浪潮推动了对严格安全评估的需求，凸显了生物安全测试在保障病人健康和安全方面的重要角色。维持高安全标准的紧迫性进一步强调了该市场在不断变化的医疗保健环境中的重要性。

限制生技药品安全检测市场的因素

生技药品安全检测市场面临许多限制因素，这些因素可能会影响其成长和发展。其中一个主要挑战是生技药品和生物相似药的复杂性和变异性。这些药物由活细胞生产，通常需要进行广泛的测试以确保其安全性和有效性。这种固有的复杂性导致测试过程耗时且成本高昂，这可能会阻碍市场扩张。此外，监管方面的挑战也十分突出。生技药品的核准流程通常包括严格的筛选，以满足安全标准，这可能会进一步延迟产品上市。总而言之，这些因素正在限制生技药品安全检测市场的发展。

生技药品安全检测市场趋势

受监管审查力度加大以及对患者安全和产品品质的坚定承诺的推动，生技药品安全检测市场呈现显着上升趋势。随着生物製药公司面临日益严格的安全评估要求，生物安全检测已成为医药品认证过程中不可或缺的一部分。这一发展趋势凸显了生物技术製药公司遵守不断变化的标准的必要性，这对于确保产品核可和顺利进入市场至关重要。因此，对合规性的日益重视推动了对先进检测服务的需求，巩固了生物安全检测在生物製药行业中的关键地位。

前五大公司对比
主要企业的市场定位（2025 年）
主要市场参与者所采取的策略
近期市场趋势
公司市占率分析（2025 年）
主要企业公司简介
- 公司详情
- 产品系列分析
- 依业务板块进行公司股票分析
- 2023-2025年营收年比比较
主要企业简介
- 查尔斯河实验室（美国）
- 龙沙集团（瑞士）
- 生物梅里埃公司（法国）
- SGS Societe Generale de Surveillance SA（瑞士）
- Eurofins Scientific（卢森堡）
- 三星生物製剂（韩国）
- 富士软片与光纯药株式会社（日本）
- 赛默飞世尔科技公司（美国）
- 赛多利斯股份公司（德国）
- 默克集团（德国）
- 药明康德（中国）
- Intertek集团有限公司（英国）
- 西部製药服务公司（美国）
- 味之素生物製药服务（美国）
- Gateway Analytical（美国）
- Reading Scientific Services Ltd. (RSSL) (英国)
- Tentamus集团（德国）
- IQVIA（美国）

结论与建议

简介目录

Product Code: SQMIG35A2786

Biologics Safety Testing Market size was valued at USD 5.86 Billion in 2024 and is poised to grow from USD 6.55 Billion in 2025 to USD 15.87 Billion by 2033, growing at a CAGR of 11.7% during the forecast period (2026-2033).

Market insights into biologics safety testing reveal a vital segment within the healthcare sector focused on ensuring the safety and efficacy of biological products, particularly biopharmaceuticals and medical devices. This field employs a variety of meticulous procedures designed to identify and mitigate risks, including contamination and adverse biological effects. Compliance with stringent regulatory standards is crucial, as it guarantees the purity, potency, and overall safety of biological materials. Key techniques such as sterility testing, endotoxin assessment, and cell-based assays play significant roles in rigorous evaluations, confirming adherence to safety benchmarks. This systematic approach not only safeguards clinical applications but also upholds public health, making biologics safety testing an essential component of product development and market readiness.

Top-down and bottom-up approaches were used to estimate and validate the size of the 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.

Biologics Safety Testing Market Segments Analysis

Global Biologics Safety Testing Market is segmented by Product and Services, Test Type, Application, End User and region. Based on Product and Services, the market is segmented into Consumables, Instruments, Services, Reagents and kits and Other Biologics Safety Testing Services. Based on Test Type, the market is segmented into Endotoxin tests, Sterility tests, Mycoplasma tests, Bioburden tests, Residual host-cell proteins and DNA detection tests, Virus safety tests, Adventitious agent detection tests and Other test types. Based on Application, the market is segmented into Monoclonal Antibodies Development And Manufacturing, Vaccines Development And Manufacturing, Cellular & Gene Therapy Products Development And Manufacturing, Blood & Blood Products Development And Manufacturing and Other Applications. Based on End User, the market is segmented into Pharmaceutical & Biotechnology Companies, Cros & Cdmos and Academic & Research Institutes. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Biologics Safety Testing Market

The growth of the pharmaceutical and biotechnology industries, driven by significant investments in research and development, represents a crucial period in the advancement of healthcare. As these sectors lead the way in developing new pharmaceuticals, biologics, and vaccines, they are actively tackling various healthcare challenges, particularly in the fight against complex diseases. This wave of innovation creates a heightened demand for rigorous safety assessments, highlighting the essential role of biological safety testing in ensuring the health and safety of patients. The urgency to maintain high standards of safety further emphasizes the importance of this market in the evolving landscape of healthcare.

Restraints in the Biologics Safety Testing Market

The Biologics Safety Testing market faces several constraints that can impact its growth and development. One significant challenge is the complexity and variability associated with biologics and biosimilars, which are produced from living cells and often require extensive testing to ensure safety and efficacy. This inherent complexity can lead to longer and more costly testing processes, potentially hindering market expansion. Additionally, regulatory challenges are prevalent, as the approval process for biologics typically involves rigorous scrutiny to meet safety standards, which can further delay product availability. Overall, these factors contribute to a constrained environment for the Biologics Safety Testing market.

Market Trends of the Biologics Safety Testing Market

The Biologics Safety Testing market is experiencing a significant upward trend driven by escalating regulatory scrutiny and an unwavering commitment to patient safety and product quality. As biopharmaceutical companies face stringent safety evaluation requirements, biological safety testing has become integral to the drug approval process. This evolution underscores the necessity for pharmaceutical and biotech firms to comply with evolving standards, which is crucial for securing product approvals and facilitating market entry. Consequently, the growing focus on compliance is propelling demand for advanced testing services, solidifying the critical position of biological safety testing in the biopharmaceutical landscape.

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, 2025
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis

Global Biologics Safety Testing Market Size by Product and Services & CAGR (2026-2033)

Market Overview
Consumables
- Mycoplasma Testing Services
- Sterility Testing Services
- Endotoxin Testing Services
- Virus Safety Testing Services
- Bioburden Testing Services
Instruments
Services
Reagents and kits
Other Biologics Safety Testing Services

Global Biologics Safety Testing Market Size by Test Type & CAGR (2026-2033)

Market Overview
Endotoxin tests
Sterility tests
Mycoplasma tests
Bioburden tests
Residual host-cell proteins and DNA detection tests
Virus safety tests
Adventitious agent detection tests
Other test types

Global Biologics Safety Testing Market Size by Application & CAGR (2026-2033)

Market Overview
Monoclonal Antibodies Development And Manufacturing
Vaccines Development And Manufacturing
Cellular & Gene Therapy Products Development And Manufacturing
Blood & Blood Products Development And Manufacturing
Other Applications

Global Biologics Safety Testing Market Size by End User & CAGR (2026-2033)

Market Overview
Pharmaceutical & Biotechnology Companies
Cros & Cdmos
Academic & Research Institutes

Global Biologics Safety Testing Market Size & CAGR (2026-2033)

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

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

Charles River Laboratories (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza Group (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
bioMerieux SA (France)
- 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
Eurofins Scientific (Luxembourg)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Biologics (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
FUJIFILM Wako Pure Chemical Corporation (Japan)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Intertek Group plc (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
West Pharmaceutical Services, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Ajinomoto Bio-Pharma Services (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Gateway Analytical (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Reading Scientific Services Ltd. (RSSL) (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Tentamus Group (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
IQVIA (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments