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生物学的安全性試験市場レポート：製品・サービス、試験タイプ、用途、地域別、2024年～2032年

Biological Safety Testing Market Report by Product and Services, Test Type, Application, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 145 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=146.99円
生物学的安全性試験市場レポート：製品・サービス、試験タイプ、用途、地域別、2024年～2032年
出版日: 2024年09月10日
発行: IMARC
ページ情報: 英文 145 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の生物学的安全性試験の市場規模は2023年に44億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに116億米ドルに達し、2024年から2032年の間に10.9％の成長率（CAGR）を示すと予測しています。製薬・バイオテクノロジー分野の拡大、COVID-19パンデミックの影響、規制遵守と安全基準の重視の高まりは、市場を推進する主な要因の一部です。

生物学的安全性試験とは、医薬品、ワクチン、医療機器などの生物学的製品、物質、材料に関連する安全性と潜在的リスクを評価する継続的なプロセスです。この評価には、微生物、ウイルス、その他の生物学的病原体による汚染の可能性を評価したり、これらの製品の毒性やヒト、動物、環境に対する潜在的な悪影響を調べたりするなど、さまざまな活動が含まれます。これは、生物学的由来製品が規制基準を満たし、公衆衛生と安全に対するリスクを最小限に抑えることを保証するための重要な側面です。この継続的な試験プロセスには、ライフサイクルを通じて製品の安全性を保証するための厳格な分析とモニタリングが含まれます。

世界の生物学的安全性試験産業は、拡大する製薬・バイオテクノロジー部門と、その製品に対する厳格な安全性評価に対する需要の高まりに牽引され、力強い成長を遂げています。これらの業界が新薬、ワクチン、生物製剤の革新と開発を続けているため、消費者に対する製品の有効性と安全性を確保するための包括的な生物学的安全性試験の必要性が高まっており、市場拡大の明るい見通しが生まれています。さらに、COVID-19パンデミックはワクチンと治療法の重要性を際立たせ、生物学的安全性試験サービスの需要をさらに煽っています。さらに、世界中の規制機関が厳格な安全性評価の必要性を強調するようになっており、これが市場の成長に寄与しています。さらに、消費者の間で製品の品質と安全性に対する意識が高まっていることに加え、個別化医療や遺伝子・細胞治療などの先端治療の市場開拓の動きが活発化していることから、専門的な安全性試験プロトコルが必要とされ、市場の拡大に寄与しています。

生物学的安全性試験市場動向／促進要因：

製薬・バイオテクノロジー分野の拡大

製薬業界とバイオテクノロジー業界は、研究開発への投資の増加により拡大しています。これらのセクターは、複雑な疾患を含む様々なヘルスケアのニーズに対応する医薬品、生物製剤、ワクチンの開発をリードしています。その結果、厳格な安全性評価に対する需要が高まっており、患者の安全を確保する上で生物学的安全性試験は不可欠です。生物学的安全性試験には、ウイルス、微生物、エンドトキシンなどの汚染物質の徹底的な評価が含まれ、規制基準や安全基準への準拠を保証します。同時に、疾病の進化と製品の絶え間ない革新は、遺伝子治療や細胞治療を含む新たな治療法に対する専門的評価を含む安全性試験に対する高い需要を維持し、市場の成長に大きく寄与しています。

COVID-19パンデミックの影響

COVID-19パンデミックは、ワクチンと治療の開発と展開を加速させることにより、業界に大きな影響を与えました。これにより、厳格な安全性試験の重要な役割が強調されました。これに加えて、世界各国の政府や規制当局がこれらの製品に対する監視を強化したため、ワクチンの安全性評価、ウイルス検出アッセイ、COVID-19診断薬や治療薬の品質管理対策など、さまざまな検査サービスに対する需要が急増しました。これとは別に、パンデミックは業界の焦点を再形成し、将来の健康危機に直面した場合の備えの必要性を強調し、それによって市場の成長を持続させています。

規制遵守の重視の高まり

世界の規制機関は、患者の安全性と製品の品質を重視し、バイオ医薬品に対する監視を強化しています。こうした規制は包括的な安全性評価を義務付けており、生物学的安全性試験は医薬品承認に不可欠なものとなっています。製薬会社やバイオテクノロジー企業は、製品承認と市場参入を得るために、進化する基準を厳格に遵守しなければならないため、試験サービスへの需要が高まり、コンプライアンスにおける生物学的安全性試験の重要性が高まっています。さらに、特に遺伝子治療や細胞治療のような先端治療では、規制要件がますます複雑化しており、専門的な試験の必要性が浮き彫りになっています。このため、専門的な評価がこれらの治療法のユニークな特性に適応し、安全性と有効性を確保し、進化する規制上の要求に応えることで、市場の成長が維持されています。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界の生物学的安全性試験市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：製品・サービス別

  • キットと試薬
    • 市場動向
    • 市場予測
  • 機器
    • 市場動向
    • 市場予測
  • サービス
    • 市場動向
    • 市場予測

第7章 市場内訳：試験タイプ別

  • エンドトキシン試験
    • 市場動向
    • 市場予測
  • 無菌試験
    • 市場動向
    • 市場予測
  • 細胞株の認証と特性評価試験
    • 市場動向
    • 市場予測
  • バイオバーデン試験
    • 市場動向
    • 市場予測
  • 残留宿主汚染物質検出試験
    • 市場動向
    • 市場予測
  • 外来性病原体検出試験
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第8章 市場内訳：用途別

  • ワクチン開発
    • 市場動向
    • 市場予測
  • 血液製品試験
    • 市場動向
    • 市場予測
  • 細胞および遺伝子治療
    • 市場動向
    • 市場予測
  • 組織および組織関連製品の試験
    • 市場動向
    • 市場予測
  • 幹細胞調査
    • 市場動向
    • 市場予測

第9章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第10章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第13章 価格分析

第14章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • 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
図表

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$), 2018-2023
  • Figure 3: Global: Biological Safety Testing Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 4: Global: Biological Safety Testing Market: Breakup by Product and Services (in %), 2023
  • Figure 5: Global: Biological Safety Testing Market: Breakup by Test Type (in %), 2023
  • Figure 6: Global: Biological Safety Testing Market: Breakup by Application (in %), 2023
  • Figure 7: Global: Biological Safety Testing Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Biological Safety Testing (Kits and Reagents) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 9: Global: Biological Safety Testing (Kits and Reagents) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 10: Global: Biological Safety Testing (Instruments) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 11: Global: Biological Safety Testing (Instruments) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 12: Global: Biological Safety Testing (Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 13: Global: Biological Safety Testing (Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 14: Global: Biological Safety Testing (Endotoxin Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 15: Global: Biological Safety Testing (Endotoxin Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 16: Global: Biological Safety Testing (Sterility Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 17: Global: Biological Safety Testing (Sterility Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 18: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 19: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 20: Global: Biological Safety Testing (Bioburden Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 21: Global: Biological Safety Testing (Bioburden Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 22: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: Global: Biological Safety Testing (Other Test Types) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: Global: Biological Safety Testing (Other Test Types) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: Global: Biological Safety Testing (Vaccine Development) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 29: Global: Biological Safety Testing (Vaccine Development) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 30: Global: Biological Safety Testing (Blood Products Testing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 31: Global: Biological Safety Testing (Blood Products Testing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 32: Global: Biological Safety Testing (Cellular and Gene Therapy) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 33: Global: Biological Safety Testing (Cellular and Gene Therapy) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 34: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 35: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: Global: Biological Safety Testing (Stem Cell Research) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: Global: Biological Safety Testing (Stem Cell Research) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: North America: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: North America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: United States: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 41: United States: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 42: Canada: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 43: Canada: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 44: Asia-Pacific: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 45: Asia-Pacific: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 46: China: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 47: China: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 48: Japan: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 49: Japan: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 50: India: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 51: India: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 52: South Korea: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 53: South Korea: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 54: Australia: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: Australia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: Indonesia: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: Indonesia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Europe: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: Europe: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Germany: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Germany: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: France: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: France: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: United Kingdom: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: United Kingdom: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Italy: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Italy: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Spain: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Spain: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Russia: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 73: Russia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 75: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 76: Latin America: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 77: Latin America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 78: Brazil: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 79: Brazil: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 80: Mexico: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 81: Mexico: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 82: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 83: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 84: Middle East and Africa: Biological Safety Testing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 85: Middle East and Africa: Biological Safety Testing Market: Breakup by Country (in %), 2023
  • Figure 86: Middle East and Africa: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2024-2032
  • 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, 2023 and 2032
  • Table 2: Global: Biological Safety Testing Market Forecast: Breakup by Product and Services (in Million US$), 2024-2032
  • Table 3: Global: Biological Safety Testing Market Forecast: Breakup by Test Type (in Million US$), 2024-2032
  • Table 4: Global: Biological Safety Testing Market Forecast: Breakup by Application (in Million US$), 2024-2032
  • Table 5: Global: Biological Safety Testing Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 6: Global: Biological Safety Testing Market: Competitive Structure
  • Table 7: Global: Biological Safety Testing Market: Key Players
目次
Product Code: SR112024A4634

The global biological safety testing market size reached US$ 4.4 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 11.6 Billion by 2032, exhibiting a growth rate (CAGR) of 10.9% during 2024-2032. 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 2024-2032. 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(R) 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