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市場調查報告書
商品編碼
1390769

2023-2028 年按產品和服務、測試類型、應用和地區分類的生物安全測試市場報告

Biological Safety Testing Market Report by Product and Services, Test Type, Application, and Region 2023-2028
出版日期: | 出版商: IMARC | 英文 141 Pages | 商品交期: 2-3個工作天內

價格

概要

2022年全球生物安全檢測市場規模達40億美元。展望未來， IMARC Group預計到2028年市場規模將達到80億美元，2022-2028年複合年成長率（CAGR）為12.25%。製藥和生物技術行業的擴張、COVID-19 大流行的影響以及對監管合規性和安全標準的日益重視是推動市場的一些主要因素。

生物安全測試是評估與生物產品、物質或材料（包括藥品、疫苗和醫療器材）相關的安全性和潛在風險的持續過程。該評估涵蓋一系列活動，例如評估微生物、病毒或其他生物製劑污染的可能性，以及檢查這些產品對人類、動物或環境的毒性和潛在不利影響。這是確保生物衍生產品符合監管標準並將對公眾健康和安全造成的風險降至最低的關鍵方面。這種持續的測試過程涉及嚴格的分析和監控，以確保產品在整個生命週期的安全。

在製藥和生物技術行業不斷擴大以及對其產品進行嚴格安全評估的需求不斷增加的推動下，全球生物安全檢測行業正在經歷強勁成長。隨著這些行業不斷創新和開發新藥、疫苗和生物製劑，對全面的生物安全測試的需求不斷增加，以確保產品的有效性和消費者的安全性，從而創造了積極的市場擴張前景。此外，COVID-19 大流行凸顯了疫苗和治療的重要性，進一步刺激了對生物安全檢測服務的需求。此外，世界各地的監管機構越來越強調嚴格安全評估的必要性，這有助於市場的成長。此外，消費者對產品品質和安全性的認知不斷增強，加上個人化醫療的新興趨勢以及基因和細胞療法等先進療法的發展，需要專門的安全測試方案，有助於市場擴張。

生物安全測試市場趨勢/促進因素：

擴大製藥和生物技術領域

由於研發投資的增加，製藥和生技產業正在不斷擴張。這些部門在開發藥物、生物製品和疫苗方面處於領先地位，以滿足各種醫療保健需求，包括複雜疾病。因此，對嚴格安全評估的需求增加，生物安全測試對於確保病人安全至關重要。它涉及對病毒、微生物和內毒素等污染物的徹底評估，確保符合監管和安全標準。同時，疾病性質的不斷演變和產品的不斷創新對安全測試保持著很高的需求，包括對基因和細胞療法等新興療法的專門評估，為市場的成長做出了重大貢獻。

COVID-19 大流行的影響

COVID-19 大流行加速了疫苗和治療方法的開發和部署，對該行業產生了重大影響。這強調了嚴格的安全測試的關鍵作用。除此之外，全球各國政府和監管機構加強了對這些產品的審查，導致對各種檢測服務的需求激增，包括疫苗安全評估、病毒檢測分析以及 COVID-19 診斷和治療的品質控制措施。除此之外，疫情重塑了產業的焦點，凸顯了面對未來健康危機做好準備的必要性，從而維持了市場的成長。

日益重視監理合規

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，使生物安全測試成為藥物核准的一部分。製藥和生物技術公司必須嚴格遵守不斷發展的標準，以獲得產品批准和市場准入，刺激對測試服務的需求，並加強合規生物安全測試的重要性。此外，日益複雜的監管要求，特別是基因和細胞療法等先進療法，凸顯了對專門測試的需求。隨著專門評估適應這些療法的獨特特徵，確保其安全性和有效性並滿足不斷變化的監管要求，這可以維持市場成長。

生物安全檢測產業細分：

IMARC Group提供了對市場報告各細分市場主要趨勢的分析，以及 2023-2028 年全球、區域和國家層面的預測。我們的報告根據產品和服務、測試類型和應用程式對市場進行了分類。

按產品和服務細分：

試劑盒和試劑

儀器

服務

試劑盒和試劑佔大部分市場佔有率

該報告根據產品和服務對市場進行了詳細的細分和分析。這包括試劑盒和試劑、儀器和服務。根據該報告，試劑盒和試劑佔據了最大的部分。

分散測試和即時護理 (POC) 診斷的日益成長的趨勢推動了對方便用戶使用型攜帶式測試套件的需求，這是推動生物安全測試需求的主要因素之一。這些套件使醫療保健專業人員能夠快速有效地執行安全評估，特別是在資源有限的環境中。同時，包括基因組學、蛋白質組學和細胞培養在內的生命科學領域研發活動的擴大，需要持續供應用於各種應用的高品質檢測試劑和試劑盒，從而刺激市場成長。此外，生物污染物可能帶來重大風險的食品和飲料 (F&B) 行業越來越注重確保產品品質和安全，這增加了對微生物分析檢測試劑盒和試劑的需求，從而有助於市場擴張。

按測試類型分類：

內毒素測試

無菌測試

細胞株驗證和表徵測試

生物負載測試

殘留宿主污染物檢測測試

外來因子檢測測試

其他

內毒素檢測市佔率最大

報告中還提供了基於測試類型的詳細市場區隔和分析。這包括內毒素、無菌、細胞株認證和表徵、生物負載、殘留宿主和污染物檢測、外來因子檢測測試等。報告稱，內毒素檢測佔據最大的市場佔有率。

對內毒素檢測的需求不斷成長，主要是由於確保醫療器材和藥品的安全性和有效性的迫切需要推動的，這正在加強全球生物安全檢測市場。內毒素是存在於革蘭氏陰性細菌細胞壁中的有毒物質，進入人體後會導致嚴重的健康併發症。醫療設備（包括植入物和藥物輸送系統）的複雜性和多樣性日益增加，需要對內毒素進行嚴格的測試，以減輕對患者的潛在風險。此外，對基因療法和單株抗體等個人化醫療和生物製藥的日益關注，需要進行細緻的內毒素檢測，以確保這些先進療法的純度和安全性，從而增強市場。除此之外，世界各地的監管機構要求遵守嚴格的內毒素限值，增強了藥品製造和醫療保健環境中對準確可靠的內毒素檢測的需求，從而促進了市場成長。

按應用分類：

疫苗開發

血液製品檢測

細胞和基因治療

組織和組織相關產品測試

幹細胞研究

疫苗研發主導市場

該報告根據應用程式提供了詳細的市場細分和分析。這包括疫苗開發、血液產品測試、細胞和基因治療、組織和組織相關產品測試以及幹細胞研究。報告稱，疫苗開發是最大的部分。

疫苗開發中對生物安全測試的需求主要是由全球對安全有效疫苗的迫切需求所推動的。隨著世界面臨各種傳染病和病毒爆發，包括 COVID-19 大流行，疫苗開發受到前所未有的關注。監管機構要求進行全面的安全評估，以確保疫苗不僅有效，而且不含有害污染物。生物安全測試在此過程中發揮著至關重要的作用，包括評估候選疫苗的潛在病毒和微生物污染物，確保不含內毒素，並評估其供人類使用的整體安全性。此外，新型疫苗技術（例如基於mRNA的疫苗）的出現需要專門的安全性評估，導致對生物安全檢測服務的需求不斷成長。對疫苗安全性的高度重視凸顯了此類測試在維護全球範圍內的公共衛生方面所發揮的關鍵作用。

按地區分類：

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

北美佔據明顯主導地位，佔據最大的生物安全檢測市場佔有率

市場研究報告還對所有主要區域市場進行了全面分析，其中包括北美（美國和加拿大）；亞太地區（中國、日本、印度、韓國、澳洲、印尼等）；歐洲（德國、法國、英國、義大利、西班牙、俄羅斯等）；拉丁美洲（巴西、墨西哥等）；以及中東和非洲。報告稱，北美佔據最大的市場佔有率。

北美擁有強大的製藥和生物技術產業，非常重視研究和開發。新藥、生物製劑和醫療器材的不斷創新和推出需要嚴格的安全性評估，從而推動了對生物安全檢測服務的需求。除此之外，該地區積極主動的監管環境，受到 FDA 和其他監管機構制定的嚴格標準的監管，要求進行全面的安全評估，進一步推動市場成長。此外，為應對新冠肺炎（COVID-19）大流行等公共衛生威脅而進行的持續努力，增加了對疫苗開發和測試的需求，特別是在北美，許多製藥公司和研究機構積極參與疫苗研究和生產。這些因素，加上該地區先進的醫療基礎設施以及對產品品質和安全意識的不斷提高，繼續推動北美生物安全檢測市場的擴張。

競爭格局：

全球生物安全檢測市場的特點是主要參與者之間競爭激烈，該行業在確保藥品、生物製品和醫療器材的安全和品質方面發揮關鍵作用。這一領域的知名公司採取各種策略來維持其市場地位，例如合併、收購和合作，以擴大其服務組合和地理範圍。此外，投資研發以引入創新測試技術和方法是常見策略，使公司能夠走在行業趨勢的最前沿。對個人化醫療和先進療法（例如基因和細胞療法）的日益關注，為專門從事專業安全測試服務的公司提供了成長機會。總體而言，全球生物安全偵測市場的競爭格局以成熟參與者的動態交互作用為特徵。

市場研究報告對競爭格局進行了全面分析。也提供了所有主要公司的詳細資料。市場上的一些主要參與者包括：

先鋒生物科學公司

查爾斯河實驗室

創意百基因

歐陸科技

龍沙集團公司

馬拉威生命科學公司

佩斯分析服務公司

太平洋生物實驗室

賽多利斯公司

通標公司

ViruSure GmbH（旭化成株式會社）

藥明生物

（請注意，這只是關鍵參與者的部分列表，報告中提供了完整列表。）

最近的發展：

2022 年 5 月，Charles River Laboratories 與一家藥物發現技術公司合作開發 Logica，這是一款專門為促進新療法開發而設計的人工智慧 (AI) 工具。

2022 年 5 月，Avance Biosciences 宣布新收購的 26,000 平方英尺實驗室空間竣工。此次擴張將使 Avance 能夠為其生物製藥和 CDMO 客戶提供更廣泛的蛋白質和細胞檢測服務。新設施將專注於蛋白質分析服務，包括 ELISA 測定、蛋白質表徵和免疫測定。

2023 年 9 月，Pace (R) Analytical Services 宣布了一種新的 PFAS 測試方法，可以更快、更低成本地提供可靠的結果。此方法符合 ASTM D8421/EPA 8327 標準，使用同位素稀釋和 LC/MS/MS 分析水樣本和固體樣品中多達 44 種 PFAS 化合物。該方法具有諸如更快地提供結果、減少樣本量和可靠的定量等優點。

本報告回答的關鍵問題：

  • 全球生物安全檢測市場迄今表現如何，未來幾年將如何表現？
  • 全球生物安全檢測市場的促進因素、限制因素和機會是什麼？
  • 每個促進因素、限制因素和機會對全球生物安全檢測市場有何影響？
  • 主要區域市場有哪些？
  • 哪些國家代表了最具吸引力的生物安全檢測市場？
  • 基於產品和服務的市場區隔是什麼？
  • 生物安全檢測市場最具吸引力的產品和服務是什麼？
  • 根據測試類型，市場的細分是什麼？
  • 生物安全檢測市場上最具吸引力的檢測類型是什麼？
  • 基於應用程式的市場區隔是什麼？
  • 生物安全檢測市場最有吸引力的應用是什麼？
  • 全球生物安全檢測市場的競爭格局如何？
  • 全球生物安全檢測市場的主要參與者/公司有哪些？

本報告回答的關鍵問題：

  • 全球生物安全檢測市場迄今表現如何，未來幾年將如何表現？
  • 全球生物安全檢測市場的促進因素、限制因素和機會是什麼？
  • 每個促進因素、限制因素和機會對全球生物安全檢測市場有何影響？
  • 主要區域市場有哪些？
  • 哪些國家代表了最具吸引力的生物安全檢測市場？
  • 基於產品和服務的市場區隔是什麼？
  • 生物安全檢測市場最具吸引力的產品和服務是什麼？
  • 根據測試類型，市場的細分是什麼？
  • 生物安全檢測市場上最具吸引力的檢測類型是什麼？
  • 基於應用程式的市場區隔是什麼？
  • 生物安全檢測市場最有吸引力的應用是什麼？
  • 全球生物安全檢測市場的競爭格局如何？
  • 全球生物安全檢測市場的主要參與者/公司有哪些？

目錄

第 1 章：前言

第 2 章：範圍與方法

  • 研究目的
  • 利害關係人
  • 資料來源
    • 主要資源
    • 二手資料
  • 市場預測
    • 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

  • 概述
  • 主要行業趨勢

第 5 章：全球生物安全檢測市場

  • 市場概況
  • 市場業績
  • COVID-19 的影響
  • 市場預測

第 6 章：按產品和服務分類的市場細分

  • 試劑盒和試劑
    • 市場走向
    • 市場預測
  • 儀器
    • 市場走向
    • 市場預測
  • 服務
    • 市場走向
    • 市場預測

第 7 章：按測試類型分類的市場

  • 內毒素測試
    • 市場走向
    • 市場預測
  • 無菌測試
    • 市場走向
    • 市場預測
  • 細胞株驗證和表徵測試
    • 市場走向
    • 市場預測
  • 生物負載測試
    • 市場走向
    • 市場預測
  • 殘留宿主污染物檢測測試
    • 市場走向
    • 市場預測
  • 外來因子檢測測試
    • 市場走向
    • 市場預測
  • 其他
    • 市場走向
    • 市場預測

第 8 章：按應用分類的市場區隔

  • 疫苗開發
    • 市場走向
    • 市場預測
  • 血液製品檢測
    • 市場走向
    • 市場預測
  • 細胞和基因治療
    • 市場走向
    • 市場預測
  • 組織和組織相關產品測試
    • 市場走向
    • 市場預測
  • 幹細胞研究
    • 市場走向
    • 市場預測

第 9 章：按地區分類的市場區隔

  • 北美洲
    • 美國
      • 市場走向
      • 市場預測
    • 加拿大
      • 市場走向
      • 市場預測
  • 亞太
    • 中國
      • 市場走向
      • 市場預測
    • 日本
      • 市場走向
      • 市場預測
    • 印度
      • 市場走向
      • 市場預測
    • 韓國
      • 市場走向
      • 市場預測
    • 澳洲
      • 市場走向
      • 市場預測
    • 印尼
      • 市場走向
      • 市場預測
    • 其他
      • 市場走向
      • 市場預測
  • 歐洲
    • 德國
      • 市場走向
      • 市場預測
    • 法國
      • 市場走向
      • 市場預測
    • 英國
      • 市場走向
      • 市場預測
    • 義大利
      • 市場走向
      • 市場預測
    • 西班牙
      • 市場走向
      • 市場預測
    • 俄羅斯
      • 市場走向
      • 市場預測
    • 其他
      • 市場走向
      • 市場預測
  • 拉丁美洲
    • 巴西
      • 市場走向
      • 市場預測
    • 墨西哥
      • 市場走向
      • 市場預測
    • 其他
      • 市場走向
      • 市場預測
  • 中東和非洲
    • 市場走向
    • 按國家/地區分類的市場細分
    • 市場預測

第 10 章：SWOT 分析

  • 概述
  • 優勢
  • 弱點
  • 機會
  • 威脅

第 11 章：價值鏈分析

第 12 章：波特五力分析

  • 概述
  • 買家的議價能力
  • 供應商的議價能力
  • 競爭程度
  • 新進入者的威脅
  • 替代品的威脅

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: SR112023A4634

Abstract

The global biological safety testing market size reached US$ 4.0 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 8.0 Billion by 2028, exhibiting a growth rate (CAGR) of 12.25% during 2022-2028. 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 propelling the market.

Biological safety testing is the ongoing process of evaluating the safety and potential risks associated with biological products, substances, or materials, including pharmaceuticals, vaccines, and medical devices. This assessment encompasses a range of activities, such as assessing the potential for contamination by microorganisms, viruses, or other biological agents, as well as examining the toxicity and potential adverse effects of these products on humans, animals, or the environment. It is a critical aspect of ensuring that biologically derived products meet regulatory standards and pose minimal risks to public health and safety. This continuous testing process involves rigorous analysis and monitoring to guarantee product safety throughout its lifecycle.

The global biological safety testing industry is experiencing robust growth driven by the expanding pharmaceutical and biotechnology sectors and the increasing the demand for stringent safety assessments for their products. As these industries continue to innovate and develop new drugs, vaccines, and biologics, the need for comprehensive biological safety testing has intensified to ensure product efficacy and safety for consumers, creating a positive outlook for market expansion. Additionally, the COVID-19 pandemic has accentuated the importance of vaccines and therapeutic treatments, further fueling the demand for biological safety testing services. Moreover, regulatory bodies worldwide are increasingly emphasizing the need for rigorous safety evaluations, which is contributing to the market's growth. Furthermore, the growing awareness of product quality and safety among consumers combined with the emerging trend toward personalized medicine and the development of advanced therapies, such as gene and cell therapies, necessitates specialized safety testing protocols, thereby aiding in market expansion.

Biological Safety Testing Market Trends/Drivers:

Expanding pharmaceutical and biotechnology sectors

The pharmaceutical and biotechnology industries are expanding due to increased investments in research and development. These sectors lead in developing drugs, biologics, and vaccines for various healthcare needs, including complex diseases. Consequently, the demand for stringent safety assessments has risen, with biological safety testing being vital in ensuring patient safety. It involves thorough evaluations for contaminants such as viruses, microbes, and endotoxins, guaranteeing compliance with regulatory and safety standards. 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 market's growth.

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. 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. Apart from this, the pandemic has reshaped the industry's focus, highlighting the need for preparedness in the face of future health crises, thereby sustaining the growth of the market.

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. Pharmaceutical and biotech companies must rigorously adhere to evolving standards to gain product approval and market access, fueling demand for testing services and reinforcing the importance of biological safety testing in compliance. Furthermore, increasingly complex regulatory requirements, especially for advanced therapies like gene and cell therapies, highlight the need for specialized testing. This sustains market growth as specialized assessments adapt to the unique characteristics of these therapies, ensuring their safety and efficacy and meeting evolving regulatory demands.

Biological Safety Testing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on product and services, test type and application.

Breakup by Product and Services:

Kits and Reagents

Instruments

Services

Kits and reagents account for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the product and services. This includes kits and reagents, instruments, and services. According to the report, kits and reagents represented the largest segment.

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, thereby aiding in market expansion.

Breakup 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 hold the largest share in the market

A detailed breakup and analysis of the market based on the test type have also been provided in the report. This includes endotoxin, sterility, cell line authentication and characterization, bioburden, residual host and contaminant detection, adventitious agent detection tests, and others. According to the report, endotoxin tests accounted for the largest market share.

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, which are 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 risks to patients. 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.

Breakup by Application:

Vaccine Development

Blood Products Testing

Cellular and Gene Therapy

Tissue and Tissue-related Products Testing

Stem Cell Research

Vaccine development dominates the market

The report has provided a detailed breakup and analysis of the market based on the application. This includes vaccine development, blood product testing, cellular and gene therapy, tissue and tissue-related product testing, and stem cell research. According to the report, vaccine development represented the largest segment.

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.

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

North America exhibits a clear dominance, accounting for the largest biological safety testing market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

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.

Competitive Landscape:

The global biological safety testing market is characterized by intense competition among key players, driven by the industry's critical role in ensuring the safety and quality 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, investments in research and development to introduce innovative testing technologies and methodologies are common strategies, allowing companies to stay at the forefront of industry trends. 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

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Recent Developments:

In May 2022, Charles River Laboratories collaborated with a drug discovery technology firm on Logica which is an artificial intelligence (AI) tool specially designed to boost the development of new treatments.

In May 2022, Avance Biosciences announced the completion of their newly acquired 26,000 square feet of laboratory space. This expansion will allow Avance to offer a wider range of protein and cell-based assay services to their biopharma and CDMO clients. The new facilities will focus on protein analysis services, including ELISA assays, protein characterization, and immunoassays.

In September 2023, Pace® Analytical Services announced a new PFAS test method that provides reliable results faster and at a lower cost. The method, ASTM D8421/EPA 8327, uses isotope dilution and LC/MS/MS to analyze for up to 44 PFAS compounds in aqueous and solid samples. This method offers advantages such as faster delivery of results, reduced sample size, and reliable quantification.

Key Questions Answered in This Report:

  • How has the global biological safety testing market performed so far, and how will it perform in the coming years?
  • What are the drivers, restraints, and opportunities in the global biological safety testing market?
  • What is the impact of each driver, restraint, and opportunity on the global biological safety testing market?
  • What are the key regional markets?
  • Which countries represent the most attractive biological safety testing market?
  • What is the breakup of the market based on the product and services?
  • Which is the most attractive product and services in the biological safety testing market?
  • What is the breakup of the market based on the test type?
  • Which is the most attractive test type in the biological safety testing market?
  • What is the breakup of the market based on the application?
  • Which is the most attractive application in the biological safety testing market?
  • What is the competitive structure of the global biological safety testing market?
  • Who are the key players/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 US$), 2017-2022
  • Figure 3: Global: Biological Safety Testing Market Forecast: Sales Value (in Billion US$), 2023-2028
  • Figure 4: Global: Biological Safety Testing Market: Breakup by Product and Services (in %), 2022
  • Figure 5: Global: Biological Safety Testing Market: Breakup by Test Type (in %), 2022
  • Figure 6: Global: Biological Safety Testing Market: Breakup by Application (in %), 2022
  • Figure 7: Global: Biological Safety Testing Market: Breakup by Region (in %), 2022
  • Figure 8: Global: Biological Safety Testing (Kits and Reagents) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 9: Global: Biological Safety Testing (Kits and Reagents) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 10: Global: Biological Safety Testing (Instruments) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 11: Global: Biological Safety Testing (Instruments) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 12: Global: Biological Safety Testing (Services) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 13: Global: Biological Safety Testing (Services) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 14: Global: Biological Safety Testing (Endotoxin Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 15: Global: Biological Safety Testing (Endotoxin Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 16: Global: Biological Safety Testing (Sterility Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 17: Global: Biological Safety Testing (Sterility Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 18: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 19: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 20: Global: Biological Safety Testing (Bioburden Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 21: Global: Biological Safety Testing (Bioburden Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 22: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 23: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 24: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 25: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 26: Global: Biological Safety Testing (Other Test Types) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 27: Global: Biological Safety Testing (Other Test Types) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 28: Global: Biological Safety Testing (Vaccine Development) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 29: Global: Biological Safety Testing (Vaccine Development) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 30: Global: Biological Safety Testing (Blood Products Testing) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 31: Global: Biological Safety Testing (Blood Products Testing) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 32: Global: Biological Safety Testing (Cellular and Gene Therapy) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 33: Global: Biological Safety Testing (Cellular and Gene Therapy) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 34: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 35: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 36: Global: Biological Safety Testing (Stem Cell Research) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 37: Global: Biological Safety Testing (Stem Cell Research) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 38: North America: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 39: North America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 40: United States: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 41: United States: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 42: Canada: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 43: Canada: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 44: Asia-Pacific: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 45: Asia-Pacific: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 46: China: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 47: China: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 48: Japan: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 49: Japan: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 50: India: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 51: India: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 52: South Korea: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 53: South Korea: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 54: Australia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 55: Australia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 56: Indonesia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 57: Indonesia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 58: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 59: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 60: Europe: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 61: Europe: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 62: Germany: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 63: Germany: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 64: France: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 65: France: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 66: United Kingdom: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 67: United Kingdom: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 68: Italy: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 69: Italy: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 70: Spain: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 71: Spain: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 72: Russia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 73: Russia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 74: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 75: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 76: Latin America: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 77: Latin America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 78: Brazil: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 79: Brazil: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 80: Mexico: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 81: Mexico: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 82: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 83: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 84: Middle East and Africa: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 85: Middle East and Africa: Biological Safety Testing Market: Breakup by Country (in %), 2022
  • Figure 86: Middle East and Africa: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • 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, 2022 and 2028
  • Table 2: Global: Biological Safety Testing Market Forecast: Breakup by Product and Services (in Million US$), 2023-2028
  • Table 3: Global: Biological Safety Testing Market Forecast: Breakup by Test Type (in Million US$), 2023-2028
  • Table 4: Global: Biological Safety Testing Market Forecast: Breakup by Application (in Million US$), 2023-2028
  • Table 5: Global: Biological Safety Testing Market Forecast: Breakup by Region (in Million US$), 2023-2028
  • Table 6: Global: Biological Safety Testing Market: Competitive Structure
  • Table 7: Global: Biological Safety Testing Market: Key Players