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市場調查報告書
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1555687

生物製劑安全測試市場,按產品類型、測試方法、測試類型、最終用戶、國家和地區 - 2024-2032 年行業分析、市場規模、市場佔有率和預測

Biologics Safety Testing Market, By Product Type, By Test Method, By Test Type, By End-User, By Country, and By Region - Industry Analysis, Market Size, Market Share & Forecast from 2024-2032

出版日期: | 出版商: AnalystView Market Insights | 英文 345 Pages | 商品交期: 2-3個工作天內

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簡介目錄

報告要點

2023年生物製品安全測試市場規模為38.7643億美元,2024年至2032年複合年成長率為11.2%。

生物製品安全測試市場-市場動態

疾病治療中擴大採用生物製劑刺激了對綜合安全測試解決方案的需求

生物製劑在疾病治療中的日益普及極大地推動了對全面安全測試解決方案的需求。隨著生物製劑不斷革新癌症、自體免疫疾病和罕見疾病等疾病的治療方法,確保其安全性和有效性已變得至關重要。例如,FDA 報告生物藥物核准量激增,目前生物製劑佔所有新藥核准量的近 30%。世界衛生組織 (WHO) 等組織強調了嚴格的安全測試方案對於防止污染和確保病人安全的重要性。進入市場的生物相似藥數量不斷增加也凸顯了強力的安全測試的必要性,因為這些產品必須符合與其參考生物製劑相同的嚴格標準。

生物製劑安全測試市場 - 關鍵見解

根據我們的研究分析師分享的分析,預計全球市場在預測期內(2024-2032 年)每年將以 11.2% 左右的複合年成長率成長

根據產品類型細分,預計試劑盒和試劑將在 2023 年顯示最大的市場佔有率

根據測試方法細分,快速測試是 2023 年的主導類型

依檢測類型細分,2023年內毒素檢測為主導類型

按地區分類,北美是 2023 年的主要收入來源

生物製品安全測試市場-細分分析:

全球生物製品安全測試市場根據產品類型、測試方法、測試類型、最終用戶和地區進行細分。

市場依產品類型分為四類:儀器、試劑盒和試劑、服務和軟體。試劑盒和試劑因其在測試過程中的重要作用而具有最高優先級,其次是儀器因其關鍵功能。其次是服務,提供專業知識,而軟體的優先順序最低,支援資料管理。

根據測試方法,市場分為三類:傳統測試、快速測試和體外測試。快速測試因其能夠快速提供結果的效率而被優先考慮,其次是體外測試,它提供精確且受控的環境。傳統測試的優先順序最低,通常非常耗時且不太先進。

生物製品安全測試市場-地理洞察

北美在市場上佔據主導地位,這得益於主要生物製藥公司的存在、先進的醫療基礎設施以及 FDA 等機構建立的嚴格監管框架。歐洲緊隨其後,其中德國、英國和法國等國家由於其強大的製藥業和遵守歐洲藥品管理局 (EMA) 制定的嚴格安全標準而處於領先地位。在亞太地區,由於生物製藥研究投資增加、醫療保健支出增加以及生物相似藥的興起,特別是在中國、日本和印度等國家,該市場正在迅速擴張。該地區不斷變化的監管環境,例如日本的 PMDA 和中國的 NMPA,也促進了市場的成長。同時,在醫療基礎設施改善和生物製品安全檢測意識不斷提高的推動下,拉丁美洲、中東和非洲市場正在逐步發展,儘管與其他地區相比速度較慢。

生物製品安全測試市場-競爭格局:

Thermo Fisher Scientific、Merck KGaA 和 Charles River Laboratories 等領先公司佔據市場主導地位,提供全面的安全檢測服務和產品,包括無菌檢測、內毒素檢測和支原體檢測。這些產業巨頭不斷投資研發,以增強測試能力並擴大產品組合。此外,Sartorius AG 和 Lonza Group 等公司正專注於收購較小的公司並建立合作夥伴關係,以加強其市場地位並獲得新興技術。競爭格局的另一個特點是新參與者的進入,特別是在亞太地區,當地公司正在利用成本優勢和不斷成長的生物製藥市場。隨著監管要求的收緊和生物製品需求的增加,競爭預計將進一步加劇,推動安全測試方法的進步,並推動公司透過品質和創新來脫穎而出。

最新進展:

2022年12月,藥明生物在上海成立了新的生物安全檢測中心,增強了其在生物製藥領域的能力。該設施旨在支持開發更安全、更有效的療法來應對全球健康挑戰。

2024 年 7 月,SGS 北美公司擴大了林肯郡卓越中心的生物製品測試能力,增強了儀器和專業知識。該設施支持生物製藥公司進行藥物開發,確保遵守監管指南並加速生物製品的市場進入。

目錄

第 1 章:生物製品安全測試市場概述

  • 研究範圍
  • 市場預估年份

第 2 章:執行摘要

  • 市場片段
    • 按產品類型分類的生物製品安全測試市場片段
    • 按測試方法分類的生物製品安全測試市場片段
    • 按測試類型分類的生物製劑安全測試市場片段
    • 最終用戶的生物製品安全測試市場片段
    • 按國家/地區分類的生物製品安全測試市場片段
    • 按地區分類的生物製品安全測試市場片段
  • 競爭洞察

第 3 章:生物製劑安全測試主要市場趨勢

  • 生物製品安全測試市場促進因素
    • 市場促進因素的影響分析
  • 生物製品安全測試市場限制
    • 市場限制影響分析
  • 生物製品安全測試市場機會
  • 生物製品安全測試市場未來趨勢

第 4 章:生物製品安全測試產業研究

  • PEST分析
  • 波特五力分析
  • 成長前景圖
  • 規範架構分析

第 5 章:生物製劑安全測試市場:COVID-19 影響分析

  • COVID-19 之前的影響分析
  • COVID-19 後影響分析
    • 表現最佳的市場區隔
    • 邊際成長市場區隔
    • 最寬鬆的市場區隔
    • 邊際損失市場區隔

第 6 章:生物製品安全測試市場格局

  • 2023 年生物製品安全測試市場佔有率分析
  • 按主要製造商分類的故障數據
    • 既有參與者分析
    • 新興參與者分析

第 7 章:生物製品安全測試市場 - 按產品類型

  • 概述
    • 按產品類型分類的細分市場佔有率分析
    • 儀器儀表
    • 試劑盒和試劑
    • 服務
    • 軟體

第 8 章:生物製劑安全測試市場 - 依測試方法

  • 概述
    • 按測試方法分類的細分市場佔有率分析
    • 傳統測試
    • 快速測試
    • 體外測試

第 9 章:生物製劑安全測試市場 - 按測試類型

  • 概述
    • 按測試類型分類的細分市場佔有率分析
    • 無菌檢測
    • 內毒素檢測
    • 支原體檢測
    • 生物負載測試
    • 殘留宿主污染物檢測

第 10 章:生物製劑安全測試市場 - 按最終用戶

  • 概述
    • 按最終用戶分類的細分市場佔有率分析
    • 製藥與生物技術公司
    • 合約研究組織 (CRO)
    • 學術及研究機構
    • 監管機構

第 11 章:生物製品安全測試市場 - 按地理位置

  • 介紹
    • 按地理位置分類的細分市場佔有率分析
  • 北美洲
    • 概述
    • 北美生物製品安全測試主要製造商
    • 北美市場規模和預測(按國家)
    • 北美市場規模和預測(按產品類型)
    • 北美市場規模和預測(按測試方法)
    • 北美市場規模和預測(按測試類型)
    • 北美市場規模和預測(按最終用戶)
    • 美國
    • 加拿大
  • 歐洲
    • 概述
    • 歐洲生物製品安全測試主要製造商
    • 歐洲市場規模和預測(按國家)
    • 歐洲市場規模和預測(按產品類型)
    • 歐洲市場規模和預測(按測試方法)
    • 歐洲市場規模和預測(按測試類型)
    • 歐洲市場規模和預測(按最終用戶)
    • 德國
    • 義大利
    • 英國
    • 法國
    • 俄羅斯
    • 荷蘭
    • 瑞典
    • 波蘭
    • 歐洲其他地區
  • 亞太地區 (APAC)
    • 概述
    • 亞太地區生物製品安全測試主要製造商
    • 亞太地區市場規模與預測(按國家)
    • 亞太地區市場規模與預測(依產品類型)
    • 按測試方法分類的亞太市場規模和預測
    • 按測試類型分類的亞太市場規模和預測
    • 亞太地區市場規模和預測(按最終用戶)
    • 印度
    • 中國
    • 日本
    • 韓國
    • 澳洲
    • 泰國
    • 印尼
    • 菲律賓
    • 亞太地區其他地區
  • 拉丁美洲
    • 概述
    • 拉丁美洲生物製品安全測試主要製造商
    • 拉丁美洲市場規模與預測(按國家)
    • 拉丁美洲市場規模與預測(按產品類型)
    • 拉丁美洲市場規模和預測(按測試方法)
    • 拉丁美洲市場規模和預測(按測試類型)
    • 拉丁美洲市場規模和預測(按最終用戶)
    • 巴西
    • 墨西哥
    • 阿根廷
    • 哥倫比亞
    • 拉丁美洲其他地區
  • 中東和非洲
    • 概述
    • 中東和非洲生物製品安全測試主要製造商
    • 中東和非洲市場規模及預測(按國家)
    • 中東和非洲市場規模及預測(按產品類型)
    • 中東和非洲市場規模及預測(按測試方法)
    • 中東和非洲市場規模及預測(按測試類型)
    • 中東和非洲市場規模和預測(按最終用戶)
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 以色列
    • 土耳其
    • 阿爾及利亞
    • 埃及
    • MEA 的其餘部分

第12章:主要供應商分析-生物製劑安全檢測產業

  • 競爭儀表板
  • 公司簡介
    • BioOutsource Ltd. (Sartorius)
    • Cambrex Corporation
    • Charles River Biopharmaceutical Services
    • Charles River Laboratories International, Inc.
    • Cytovance Biologics Inc.
    • Eurofins Lancaster Laboratories
    • Eurofins Scientific SE
    • InvivoGen
    • Lonza Group Ltd.
    • Merck KGaA
    • Pace Analytical Services, LLC
    • Sartorius AG
    • SGS SA
    • Thermo Fisher Scientific Inc.
    • Toxikon Corporation
    • WuXi AppTec
    • Others

第 13 章:360 度分析師視角

第 14 章:附錄

  • 研究方法
  • 參考
  • 縮寫
  • 免責聲明
  • 聯絡我們
簡介目錄
Product Code: ANV3718

REPORT HIGHLIGHT

Biologics Safety Testing Market size was valued at USD 3,876.43 Million in 2023, expanding at a CAGR of 11.2% from 2024 to 2032.

The Biologics Safety Testing Market, essential for ensuring the safety and efficacy of biologic products, encompasses various assays and protocols to detect contaminants and ensure compliance with regulatory standards. The increasing adoption of biologics in disease treatment, advancements in cell culture technology, and stringent regulatory frameworks are contributing to the expansion of this market. However, the high costs associated with safety testing procedures and the complexity of biological products pose significant challenges. Despite these challenges, the market presents opportunities in the form of technological advancements in testing methods and the rising demand for biosimilars. Notably, the biologics sector accounts for over 40% of the pharmaceutical pipeline, highlighting the growing need for comprehensive safety testing solutions.

Biologics Safety Testing Market- Market Dynamics

Growing Adoption of Biologics in Disease Treatment Fuels Demand for Comprehensive Safety Testing Solutions

The rising adoption of biologics in disease treatment is significantly driving the need for comprehensive safety testing solutions. As biologics continue to revolutionize therapies for conditions like cancer, autoimmune disorders, and rare diseases, ensuring their safety and efficacy has become paramount. For instance, the FDA has reported a surge in biologic drug approvals, with biologics now representing nearly 30% of all new drug approvals. Organizations like the World Health Organization (WHO) have emphasized the importance of rigorous safety testing protocols to prevent contamination and ensure patient safety. The increasing number of biosimilars entering the market also underscores the need for robust safety testing, as these products must meet the same stringent standards as their reference biologics.

Biologics Safety Testing Market- Key Insights

As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 11.2% over the forecast period (2024-2032)

Based on product type segmentation, Kits & Reagents was predicted to show maximum market share in the year 2023

Based on Test Method segmentation, Rapid Tests were the leading type in 2023

Based on Test Type segmentation, Endotoxin Testing was the leading type in 2023

Based on region, North America was the leading revenue generator in 2023

Biologics Safety Testing Market- Segmentation Analysis:

The Global Biologics Safety Testing Market is segmented based on Product Type, Test Method, Test Type, End-User, and Region.

The market is divided into four categories based on product type: Instruments, Kits & Reagents, Services, and Software. Kits & Reagents hold the highest priority due to their essential role in testing processes, followed by Instruments for their critical function. Services come next, offering specialized expertise, while Software holds the lowest priority, supporting data management.

The market is divided into three categories based on Test Methods: Traditional Tests, Rapid Tests, and In Vitro Tests. Rapid Tests are prioritized for their efficiency in delivering quick results, followed by In Vitro Tests, which offer precise and controlled environments. Traditional Tests hold the lowest priority, often being time-consuming and less advanced.

Biologics Safety Testing Market- Geographical Insights

North America dominates the market, supported by the presence of major biopharmaceutical companies, advanced healthcare infrastructure, and stringent regulatory frameworks established by agencies like the FDA. Europe follows closely, with countries like Germany, the UK, and France leading due to their robust pharmaceutical sectors and adherence to strict safety standards set by the European Medicines Agency (EMA). In Asia-Pacific, the market is rapidly expanding, fueled by increasing investments in biopharmaceutical research, growing healthcare expenditure, and the rise of biosimilars, particularly in countries like China, Japan, and India. The region's evolving regulatory landscape, such as Japan's PMDA and China's NMPA, is also contributing to market growth. Meanwhile, Latin America and the Middle East & Africa are witnessing gradual market development, driven by improving healthcare infrastructure and rising awareness of biologics safety testing, albeit at a slower pace compared to other regions.

Biologics Safety Testing Market- Competitive Landscape:

Leading companies like Thermo Fisher Scientific, Merck KGaA, and Charles River Laboratories dominate the market, offering a comprehensive range of safety testing services and products, including sterility testing, endotoxin testing, and mycoplasma detection. These industry giants continually invest in R&D to enhance their testing capabilities and expand their portfolios. Additionally, companies like Sartorius AG and Lonza Group are focusing on acquiring smaller firms and forming partnerships to strengthen their market position and access emerging technologies. The competitive landscape is also marked by the entry of new players, particularly in the Asia-Pacific region, where local companies are leveraging cost advantages and growing biopharmaceutical markets. As regulatory requirements tighten and the demand for biologics increases, the competition is expected to further intensify, driving advancements in safety testing methods and pushing companies to differentiate themselves through quality and innovation.

Recent Developments:

In December 2022, WuXi Biologics launched a new biosafety testing center in Shanghai, enhancing its capabilities in the biopharmaceutical sector. This facility aims to support the development of safer and more effective therapies for global health challenges.

In July 2024, SGS North America expanded its biologics testing capabilities at Lincolnshire Center of Excellence, enhancing instrumentation and expertise. This facility supports biopharmaceutical companies in drug development, ensuring compliance with regulatory guidelines and accelerating market entry for biologics products.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

GLOBAL BIOLOGICS SAFETY TESTING MARKET KEY PLAYERS- DETAILED COMPETITIVE INSIGHTS

  • BioOutsource Ltd. (Sartorius)
  • Cambrex Corporation
  • Charles River Biopharmaceutical Services
  • Charles River Laboratories International, Inc.
  • Cytovance Biologics Inc.
  • Eurofins Lancaster Laboratories
  • Eurofins Scientific SE
  • InvivoGen
  • Lonza Group Ltd.
  • Merck KGaA
  • Pace Analytical Services, LLC
  • Sartorius AG
  • SGS S.A.
  • Thermo Fisher Scientific Inc.
  • Toxikon Corporation
  • WuXi AppTec
  • Others

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT TYPE- MARKET ANALYSIS, 2019 - 2032

  • Instruments
  • Kits & Reagents
  • Services
  • Software

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST METHOD- MARKET ANALYSIS, 2019 - 2032

  • Traditional Tests
  • Rapid Tests
  • In Vitro Tests

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE- MARKET ANALYSIS, 2019 - 2032

  • Sterility Testing
  • Endotoxin Testing
  • Mycoplasma Testing
  • Bioburden Testing
  • Residual Host Contaminant Detection

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY END-USER- MARKET ANALYSIS, 2019 - 2032

  • Pharmaceutical & Biotechnology Companies
  • Contract Research Organizations (CROs)
  • Academic & Research Institutes
  • Regulatory Bodies

GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY REGION- MARKET ANALYSIS, 2019 - 2032

  • North America
  • The U.S.
  • Canada
  • Europe
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Russia
  • Netherlands
  • Sweden
  • Poland
  • Rest of Europe
  • Asia Pacific
  • India
  • China
  • South Korea
  • Japan
  • Australia
  • Thailand
  • Indonesia
  • Philippines
  • Rest of APAC
  • Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Rest of LATAM
  • The Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Israel
  • Turkey
  • Algeria
  • Egypt
  • Rest of MEA

Table of Contents

1. Biologics Safety Testing Market Overview

  • 1.1. Study Scope
  • 1.2. Market Estimation Years

2. Executive Summary

  • 2.1. Market Snippet
    • 2.1.1. Biologics Safety Testing Market Snippet by Product Type
    • 2.1.2. Biologics Safety Testing Market Snippet by Test Method
    • 2.1.3. Biologics Safety Testing Market Snippet by Test Type
    • 2.1.4. Biologics Safety Testing Market Snippet by End-User
    • 2.1.5. Biologics Safety Testing Market Snippet by Country
    • 2.1.6. Biologics Safety Testing Market Snippet by Region
  • 2.2. Competitive Insights

3. Biologics Safety Testing Key Market Trends

  • 3.1. Biologics Safety Testing Market Drivers
    • 3.1.1. Impact Analysis of Market Drivers
  • 3.2. Biologics Safety Testing Market Restraints
    • 3.2.1. Impact Analysis of Market Restraints
  • 3.3. Biologics Safety Testing Market Opportunities
  • 3.4. Biologics Safety Testing Market Future Trends

4. Biologics Safety Testing Industry Study

  • 4.1. PEST Analysis
  • 4.2. Porter's Five Forces Analysis
  • 4.3. Growth Prospect Mapping
  • 4.4. Regulatory Framework Analysis

5. Biologics Safety Testing Market: COVID-19 Impact Analysis

  • 5.1. Pre-COVID-19 Impact Analysis
  • 5.2. Post-COVID-19 Impact Analysis
    • 5.2.1. Top Performing Segments
    • 5.2.2. Marginal Growth Segments
    • 5.2.3. Top Looser Segments
    • 5.2.4. Marginal Loss Segments

6. Biologics Safety Testing Market Landscape

  • 6.1. Biologics Safety Testing Market Share Analysis, 2023
  • 6.2. Breakdown Data, by Key Manufacturer
    • 6.2.1. Established Players' Analysis
    • 6.2.2. Emerging Players' Analysis

7. Biologics Safety Testing Market - By Product Type

  • 7.1. Overview
    • 7.1.1. Segment Share Analysis, By Product Type, 2023 & 2032 (%)
    • 7.1.2. Instruments
    • 7.1.3. Kits & Reagents
    • 7.1.4. Services
    • 7.1.5. Software

8. Biologics Safety Testing Market - By Test Method

  • 8.1. Overview
    • 8.1.1. Segment Share Analysis, By Test Method, 2023 & 2032 (%)
    • 8.1.2. Traditional Tests
    • 8.1.3. Rapid Tests
    • 8.1.4. In Vitro Tests

9. Biologics Safety Testing Market - By Test Type

  • 9.1. Overview
    • 9.1.1. Segment Share Analysis, By Test Type, 2023 & 2032 (%)
    • 9.1.2. Sterility Testing
    • 9.1.3. Endotoxin Testing
    • 9.1.4. Mycoplasma Testing
    • 9.1.5. Bioburden Testing
    • 9.1.6. Residual Host Contaminant Detection

10. Biologics Safety Testing Market - By End-User

  • 10.1. Overview
    • 10.1.1. Segment Share Analysis, By End-User, 2023 & 2032 (%)
    • 10.1.2. Pharmaceutical & Biotechnology Companies
    • 10.1.3. Contract Research Organizations (CROs)
    • 10.1.4. Academic & Research Institutes
    • 10.1.5. Regulatory Bodies

11. Biologics Safety Testing Market- By Geography

  • 11.1. Introduction
    • 11.1.1. Segment Share Analysis, By Geography, 2023 & 2032 (%)
  • 11.2. North America
    • 11.2.1. Overview
    • 11.2.2. Biologics Safety Testing Key Manufacturers in North America
    • 11.2.3. North America Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
    • 11.2.4. North America Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
    • 11.2.5. North America Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
    • 11.2.6. North America Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
    • 11.2.7. North America Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.2.8. U.S.
      • 11.2.8.1. Overview
      • 11.2.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.2.8.3. U.S. Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.2.8.4. U.S. Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.2.8.5. U.S. Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.2.8.6. U.S. Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.2.9. Canada
      • 11.2.9.1. Overview
      • 11.2.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.2.9.3. Canada Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.2.9.4. Canada Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.2.9.5. Canada Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.2.9.6. Canada Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
  • 11.3. Europe
    • 11.3.1. Overview
    • 11.3.2. Biologics Safety Testing Key Manufacturers in Europe
    • 11.3.3. Europe Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
    • 11.3.4. Europe Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
    • 11.3.5. Europe Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
    • 11.3.6. Europe Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
    • 11.3.7. Europe Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.8. Germany
      • 11.3.8.1. Overview
      • 11.3.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.8.3. Germany Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.8.4. Germany Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.8.5. Germany Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.8.6. Germany Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.9. Italy
      • 11.3.9.1. Overview
      • 11.3.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.9.3. Italy Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.9.4. Italy Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.9.5. Italy Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.9.6. Italy Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.10. United Kingdom
      • 11.3.10.1. Overview
      • 11.3.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.10.3. United Kingdom Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.10.4. United Kingdom Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.10.5. United Kingdom Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.10.6. United Kingdom Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.11. France
      • 11.3.11.1. Overview
      • 11.3.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.11.3. France Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.11.4. France Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.11.5. France Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.11.6. France Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.12. Russia
      • 11.3.12.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.12.2. Russia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.12.3. Russia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.12.4. Russia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.12.5. Russia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.13. Netherlands
      • 11.3.13.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.13.2. Netherlands Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.13.3. Netherlands Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.13.4. Netherlands Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.13.5. Netherlands Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.14. Sweden
      • 11.3.14.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.14.2. Sweden Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.14.3. Sweden Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.14.4. Sweden Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.14.5. Sweden Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.15. Poland
      • 11.3.15.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.15.2. Poland Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.15.3. Poland Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.15.4. Poland Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.15.5. Poland Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.3.16. Rest of Europe
      • 11.3.16.1. Overview
      • 11.3.16.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.3.16.3. Rest of the Europe Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.3.16.4. Rest of the Europe Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.3.16.5. Rest of the Europe Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.3.16.6. Rest of the Europe Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
  • 11.4. Asia Pacific (APAC)
    • 11.4.1. Overview
    • 11.4.2. Biologics Safety Testing Key Manufacturers in Asia Pacific
    • 11.4.3. Asia Pacific Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
    • 11.4.4. Asia Pacific Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
    • 11.4.5. Asia Pacific Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
    • 11.4.6. Asia Pacific Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
    • 11.4.7. Asia Pacific Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.8. India
      • 11.4.8.1. Overview
      • 11.4.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.8.3. India Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.8.4. India Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.8.5. India Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.8.6. India Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.9. China
      • 11.4.9.1. Overview
      • 11.4.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.9.3. China Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.9.4. China Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.9.5. China Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.9.6. China Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.10. Japan
      • 11.4.10.1. Overview
      • 11.4.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.10.3. Japan Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.10.4. Japan Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.10.5. Japan Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.10.6. Japan Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.11. South Korea
      • 11.4.11.1. Overview
      • 11.4.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.11.3. South Korea Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.11.4. South Korea Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.11.5. South Korea Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.11.6. South Korea Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.12. Australia
      • 11.4.12.1. Overview
      • 11.4.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.12.3. Australia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.12.4. Australia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.12.5. Australia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.12.6. Australia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.13. Thailand
      • 11.4.13.1. Overview
      • 11.4.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.13.3. Thailand Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.13.4. Thailand Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.13.5. Thailand Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.13.6. Thailand Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.14. Indonesia
      • 11.4.14.1. Overview
      • 11.4.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.14.3. Indonesia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.14.4. Indonesia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.14.5. Indonesia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.14.6. Indonesia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.15. Philippines
      • 11.4.15.1. Overview
      • 11.4.15.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.15.3. Philippines Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.15.4. Philippines Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.15.5. Philippines Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.15.6. Philippines Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.4.16. Rest of APAC
      • 11.4.16.1. Overview
      • 11.4.16.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.4.16.3. Rest of APAC Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.4.16.4. Rest of APAC Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.4.16.5. Rest of APAC Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.4.16.6. Rest of APAC Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
  • 11.5. Latin America
    • 11.5.1. Overview
    • 11.5.2. Biologics Safety Testing Key Manufacturers in Latin America
    • 11.5.3. Latin America Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
    • 11.5.4. Latin America Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
    • 11.5.5. Latin America Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
    • 11.5.6. Latin America Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
    • 11.5.7. Latin America Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.5.8. Brazil
      • 11.5.8.1. Overview
      • 11.5.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.5.8.3. Brazil Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.5.8.4. Brazil Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.5.8.5. Brazil Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.5.8.6. Brazil Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.5.9. Mexico
      • 11.5.9.1. Overview
      • 11.5.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.5.9.3. Mexico Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.5.9.4. Mexico Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.5.9.5. Mexico Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.5.9.6. Mexico Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.5.10. Argentina
      • 11.5.10.1. Overview
      • 11.5.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.5.10.3. Argentina Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.5.10.4. Argentina Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.5.10.5. Argentina Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.5.10.6. Argentina Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.5.11. Colombia
      • 11.5.11.1. Overview
      • 11.5.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.5.11.3. Colombia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.5.11.4. Colombia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.5.11.5. Colombia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.5.11.6. Colombia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.5.12. Rest of LATAM
      • 11.5.12.1. Overview
      • 11.5.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.5.12.3. Rest of LATAM Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.5.12.4. Rest of LATAM Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.5.12.5. Rest of LATAM Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.5.12.6. Rest of LATAM Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
  • 11.6. Middle East and Africa
    • 11.6.1. Overview
    • 11.6.2. Biologics Safety Testing Key Manufacturers in Middle East and Africa
    • 11.6.3. Middle East and Africa Market Size and Forecast, By Country, 2019 - 2032 (US$ Million)
    • 11.6.4. Middle East and Africa Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
    • 11.6.5. Middle East and Africa Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
    • 11.6.6. Middle East and Africa Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
    • 11.6.7. Middle East and Africa Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.8. Saudi Arabia
      • 11.6.8.1. Overview
      • 11.6.8.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.8.3. Saudi Arabia Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.8.4. Saudi Arabia Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.8.5. Saudi Arabia Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.8.6. Saudi Arabia Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.9. United Arab Emirates
      • 11.6.9.1. Overview
      • 11.6.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.9.3. United Arab Emirates Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.9.4. United Arab Emirates Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.9.5. United Arab Emirates Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.9.6. United Arab Emirates Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.10. Israel
      • 11.6.10.1. Overview
      • 11.6.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.10.3. Israel Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.10.4. Israel Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.10.5. Israel Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.10.6. Israel Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.11. Turkey
      • 11.6.11.1. Overview
      • 11.6.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.11.3. Turkey Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.11.4. Turkey Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.11.5. Turkey Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.11.6. Turkey Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.12. Algeria
      • 11.6.12.1. Overview
      • 11.6.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.12.3. Algeria Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.12.4. Algeria Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.12.5. Algeria Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.12.6. Algeria Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.13. Egypt
      • 11.6.13.1. Overview
      • 11.6.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.13.3. Egypt Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.13.4. Egypt Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.13.5. Egypt Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.13.6. Egypt Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)
    • 11.6.14. Rest of MEA
      • 11.6.14.1. Overview
      • 11.6.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2019 - 2032, (US$ Million)
      • 11.6.14.3. Rest of MEA Market Size and Forecast, By Product Type, 2019 - 2032 (US$ Million)
      • 11.6.14.4. Rest of MEA Market Size and Forecast, By Test Method, 2019 - 2032 (US$ Million)
      • 11.6.14.5. Rest of MEA Market Size and Forecast, By Test Type, 2019 - 2032 (US$ Million)
      • 11.6.14.6. Rest of MEA Market Size and Forecast, By End-User, 2019 - 2032 (US$ Million)

12. Key Vendor Analysis- Biologics Safety Testing Industry

  • 12.1. Competitive Dashboard
  • 12.2. Company Profiles
    • 12.2.1. BioOutsource Ltd. (Sartorius)
    • 12.2.2. Cambrex Corporation
    • 12.2.3. Charles River Biopharmaceutical Services
    • 12.2.4. Charles River Laboratories International, Inc.
    • 12.2.5. Cytovance Biologics Inc.
    • 12.2.6. Eurofins Lancaster Laboratories
    • 12.2.7. Eurofins Scientific SE
    • 12.2.8. InvivoGen
    • 12.2.9. Lonza Group Ltd.
    • 12.2.10. Merck KGaA
    • 12.2.11. Pace Analytical Services, LLC
    • 12.2.12. Sartorius AG
    • 12.2.13. SGS S.A.
    • 12.2.14. Thermo Fisher Scientific Inc.
    • 12.2.15. Toxikon Corporation
    • 12.2.16. WuXi AppTec
    • 12.2.17. Others

13. 360 Degree Analyst View

14. Appendix

  • 14.1. Research Methodology
  • 14.2. References
  • 14.3. Abbreviations
  • 14.4. Disclaimer
  • 14.5. Contact Us