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生技藥品安全檢測市場規模、佔有率和成長分析（按產品/服務、檢測類型、應用、最終用戶和地區分類）—產業預測（2026-2033 年）

市場調查報告書

商品編碼

1898439

生技藥品安全檢測市場規模、佔有率和成長分析（按產品/服務、檢測類型、應用、最終用戶和地區分類）—產業預測（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個工作天內

價格

簡介目錄

預計到 2024 年，生技藥品安全測試市場規模將達到 58.6 億美元，到 2025 年將成長至 65.5 億美元，到 2033 年將成長至 158.7 億美元，在預測期（2026-2033 年）內複合年成長率為 11.7%。

生技藥品安全檢測市場分析表明，該領域在醫療保健行業至關重要，其重點在於確保生物製品（尤其是生物製藥和醫療設備）的安全性和有效性。該領域採用多種嚴謹的程序來識別和降低風險，包括污染和不良生物效應。遵守嚴格的監管標準是確保生物材料純度、有效性和整體安全性的必要條件。無菌檢測、內毒素評估和細胞檢測等關鍵技術在嚴格評估安全標準方面發揮關鍵作用。這種系統化的方法不僅保障了臨床應用，也維護了公眾健康，因此生技藥品安全檢測是產品開發和上市準備的重要組成部分。

生技藥品安全檢測市場促進因素

在研發投入的大力推動下，製藥生技產業的蓬勃發展標誌著醫學進步的關鍵時刻。這些領域主導新藥、生技藥品和疫苗的研發，積極應對各種醫學挑戰，尤其是在對抗複雜疾病方面。這波創新浪潮推動了對嚴格安全評估的需求，凸顯了生物安全測試在保障病人健康和安全方面的重要角色。維持高安全標準的緊迫性進一步強調了該市場在不斷變化的醫療保健環境中的重要性。

限制生技藥品安全檢測市場的因素

生技藥品安全檢測市場面臨許多限制因素，這些因素可能會影響其成長和發展。其中一個主要挑戰是生技藥品和生物相似藥的複雜性和變異性。這些藥物由活細胞生產，通常需要進行廣泛的測試以確保其安全性和有效性。這種固有的複雜性導致測試過程耗時且成本高昂，這可能會阻礙市場擴張。此外，監管方面的挑戰也十分突出。生技藥品的核准流程通常包括嚴格的篩選，以滿足安全標準，這可能會進一步延遲產品上市。總而言之，這些因素正在限制生技藥品安全檢測市場的發展。

生技藥品安全檢測市場趨勢

受監管審查力度加大以及對患者安全和產品品質的堅定承諾的推動，生技藥品安全檢測市場呈現顯著上升趨勢。隨著生物製藥公司面臨日益嚴格的安全評估要求，生物安全檢測已成為醫藥品認證過程中不可或缺的一部分。這一發展趨勢凸顯了生物技術製藥公司遵守不斷變化的標準的必要性，這對於確保產品核可和順利進入市場至關重要。因此，對合規性的日益重視推動了對先進檢測服務的需求，鞏固了生物安全檢測在生物製藥行業中的關鍵地位。

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2023-2025年營收年比比較
主要企業簡介
- 查爾斯河實驗室（美國）
- 龍沙集團（瑞士）
- 生物梅里埃公司（法國）
- SGS Societe Generale de Surveillance SA（瑞士）
- Eurofins Scientific（盧森堡）
- 三星生物製劑（韓國）
- 富士軟片與光純藥株式會社（日本）
- 賽默飛世爾科技公司（美國）
- 賽多利斯股份公司（德國）
- 默克集團（德國）
- 藥明康德（中國）
- IntertekGroup Limited（英國）
- 西部製藥服務公司（美國）
- 味之素生物製藥服務（美國）
- Gateway Analytical（美國）
- Reading Scientific Services Ltd. (RSSL) (英國)
- Tentamus集團（德國）
- IQVIA（美國）

結論與建議

簡介目錄

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