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生物学的安全性試験サービスの世界市場：市場規模・シェア・動向分析 (サービス別・用途別・最終用途別・地域別)、セグメント別予測 (2025年～2030年)

Biological Safety Testing Services Market Size, Share & Trends Analysis Report By Services (Sterility Testing Services, Endotoxin Testing Services), By Application, By End-use, By Region, And Segment Forecasts, 2025 - 2030

出版日
ページ情報
英文 150 Pages
納期
2～10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サービスの世界市場：市場規模・シェア・動向分析 (サービス別・用途別・最終用途別・地域別)、セグメント別予測 (2025年～2030年)
出版日: 2025年02月11日
発行: Grand View Research
ページ情報: 英文 150 Pages
納期: 2～10営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

生物学的安全性試験サービス市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、世界の生物学的安全性試験サービスの市場規模は2030年までに63億3,000万米ドルに達し、予測期間中にCAGR 11.78％で成長すると予測されています。

同市場は、コスト削減、無菌性保証への注目の高まり、新しい医薬品、治療法、医療機器の開発の高まりなど、生物学的安全性試験サービスに提供される利点に起因しています。加えて、厳しい規制要件、患者の安全性重視の高まり、バイオテクノロジーの進歩、慢性疾患や感染症の流行増加は、市場成長の要因の一部です。

生物学的安全性試験サービス業界は、生物製剤、細胞・遺伝子治療、ワクチンの需要増加により急成長を遂げています。市場のその他の主な動向としては、CDMO (医薬品開発・製造業務受託機関) やCRO (医薬品開発業務受託機関) による生物学的安全性試験サービスの拡大、バイオ医薬品の研究開発（R&D）への投資の増加などが挙げられます。

さらに、FDA、EMA、ICHによる厳しい規制要件により、製品の安全性、有効性、コンプライアンスを確保するために生物学的安全性試験が不可欠となっています。このため、効率と倫理遵守の向上を目的としたウイルスクリアランス、無菌性、エンドトキシン、マイコプラズマ、バイオバーデン試験の必要性が高まっています。このため、市場関係者の多くは、生物学的製剤の新たなパイプラインに費用対効果が高く専門的な知識を求めるバイオセーフティ試験のアウトソーシングをますます進めるようになっています。さらに、自動化、次世代シークエンシング（NGS）、リアルタイムPCR、AI主導型分析などの技術革新により、試験の精度、スピード、規制コンプライアンスが向上しています。したがって、生物学的安全性試験サービスは、業界の複雑な規制および品質管理のニーズを満たすために、予測期間中に進化すると予想されます。

戦略的パートナーシップと製品発売の加速も市場成長の原動力となっています。例えば、2024年4月、メルクは初のオールインワンで検証済みの遺伝子安定性アッセイであるAptegra CHO Genetic Stability Assayを発表しました。全ゲノムシークエンシングとバイオインフォマティクスを活用したこの技術革新は、バイオセーフティ試験の効率を高め、商業生産への迅速な移行を可能にします。

生物学的安全性試験サービス市場：分析概要

  • 2024年はバイオバーデン試験サービス分野が市場を独占しました。このセグメントの成長は、医療機器や医薬品の無菌性保証への注目の高まりと、製品の安全性に対する関心の高まりに起因しています。これらのサービスは、試験ユニットの微生物品質や清浄度を判定し、それによって効果的な除染に必要な滅菌プロセスを決定するために積極的に利用されています。
  • 用途別では、ワクチン・治療薬分野が2024年に最大の市場シェアを占めました。厳しい規制シナリオ、ワクチンと生物学的治療薬に対する需要の高まり、自動化、次世代シーケンシング（NGS）の急速な導入、コンプライアンスと製品の安全性を確保するAI主導の分析が、この分野の成長を牽引しています。
  • 最終用途に基づくと、バイオ医薬品企業セグメントが2024年の市場を独占しました。これは、研究開発投資の増加、製品の安全性と検査への注目の高まり、コスト効率の高いサービス提供の増加、生物学的生産の増加に起因します。
  • 北米市場は、米国やカナダのような国々で医療機器企業や製薬企業の数が増加しているため、2024年には33.15％の最大シェアを占め、北米は推定期間中に急成長を示すと予測されています。米国では、コスト効率の高いサービスを提供する老舗企業が存在することも、市場成長を促進する要因の1つです。

目次

第1章 分析方法・範囲

第2章 エグゼクティブサマリー

第3章 市場の変動要因・傾向・範囲

  • 市場連関の見通し
    • 親市場の見通し
    • 関連/付随市場の見通し
  • 市場力学
    • 市場促進要因の分析
    • 市場抑制要因の分析
    • 市場機会
    • 市場の課題
  • 業界分析ツール
    • ポーターのファイブフォース分析
    • PESTEL分析
    • COVID-19の影響分析

第4章 生物学的安全性試験サービス市場：サービス別の推定・動向分析

  • セグメントダッシュボード
  • 生物学的安全性試験サービス市場：サービス別の変動分析
  • 生物学的安全性試験サービス市場：市場規模の予測と動向分析、サービス別 (2018～2030年)
  • バイオバーデン試験サービス
  • エンドトキシン検査サービス
  • 滅菌検査サービス
  • ウイルス除去・検証サービス
  • 細胞株認証・特性評価試験
  • 残留宿主汚染検査サービス
  • 外来性病原体検出試験サービス
  • その他

第5章 生物学的安全性試験サービス市場：用途別の推定・動向分析

  • セグメントダッシュボード
  • 生物学的安全性試験サービス市場：用途別の変動分析
  • 生物学的安全性試験サービス市場：市場規模の予測と動向分析、用途別 (2018～2030年)
  • ワクチン・治療薬
    • モノクローナル抗体
    • ワクチン
    • 組み換えタンパク質

第6章 生物学的安全性試験サービス市場：最終用途別の推定・動向分析

  • セグメントダッシュボード
  • 生物学的安全性試験サービス市場：最終用途別の変動分析
  • 生物学的安全性試験サービス市場：市場規模の予測と動向分析、最終用途別 (2018～2030年)
  • バイオ医薬品企業
  • 製薬企業
  • 学術研究機関
  • その他

第7章 生物学的安全性試験サービス市場：地域別のビジネス分析

  • 地域ダッシュボード
  • 市場規模の予測と動向分析 (2018～2030年)
  • 北米
  • 欧州
  • アジア太平洋
  • ラテンアメリカ
  • 中東・アフリカ

第8章 競合情勢

  • 企業分類
  • 企業の市場ポジション分析（2024年）
  • 企業プロファイル
    • Charles River Laboratories
    • Lonza Group Ltd.
    • Merck KGaA
    • SGS SA
    • Eurofins Scientific
    • WuXi AppTec
    • Thermo Fisher Scientific Inc.
    • Sartorius AG
    • Toxikon Corporation
    • bioMerieux SA
図表

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 Global Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 4 Global Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 5 Global Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 6 Global Biological Safety Testing Services Market, by Region, 2018 - 2030 (USD Million)
  • Table 7 North America Biological Safety Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 8 North America Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 9 North America Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 10 North America Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 11 U.S. Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 12 U.S. Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 13 U.S. Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 14 Canada Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 15 Canada Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 16 Canada Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 17 Mexico Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 18 Mexico Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 19 Mexico Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 20 Europe Biological Safety Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 21 Europe Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 22 Europe Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 23 Europe Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 24 UK Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 25 UK Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 26 UK Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 27 Germany Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 28 Germany Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 29 Germany Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 30 France Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 31 France Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 32 France Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 33 Italy Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 34 Italy Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 35 Italy Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 36 Spain Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 37 Spain Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 38 Spain Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 39 Denmark Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 40 Denmark Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 41 Denmark Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 42 Sweden Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 43 Sweden Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 44 Sweden Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 45 Norway Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 46 Norway Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 47 Norway Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 48 Asia Pacific Biological Safety Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 49 Asia Pacific Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 50 Asia Pacific Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 51 Asia Pacific Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 52 Japan Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 53 Japan Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 54 Japan Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 55 China Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 56 China Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 57 China Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 58 India Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 59 India Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 60 India Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 61 Australia Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 62 Australia Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 63 Australia Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 64 South Korea Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 65 South Korea Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 66 South Korea Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 67 Thailand Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 68 Thailand Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 69 Thailand Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 70 Latin America Biological Safety Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 71 Latin America Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 72 Latin America Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 73 Latin America Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 74 Brazil Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 75 Brazil Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 76 Brazil Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 77 Argentina Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 78 Argentina Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 79 Argentina Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 80 MEA Biological Safety Testing Services Market, by Country, 2018 - 2030 (USD Million)
  • Table 81 MEA Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 82 MEA Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 83 South Africa Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 84 South Africa Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 85 South Africa Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 86 Saudi Arabia Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 87 Saudi Arabia Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 88 Saudi Arabia Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 89 UAE Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 90 UAE Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 91 UAE Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)
  • Table 92 Kuwait Biological Safety Testing Services Market, by Service, 2018 - 2030 (USD Million)
  • Table 93 Kuwait Biological Safety Testing Services Market, by Application, 2018 - 2030 (USD Million)
  • Table 94 Kuwait Biological Safety Testing Services Market, by End Use, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information Procurement
  • Fig. 3 Market Research Approaches
  • Fig. 4 Value Chain-Based Sizing & Forecasting
  • Fig. 5 Market Formulation & Validation
  • Fig. 6 Biological Safety Testing Services Market Segmentation
  • Fig. 7 Market Snapshot, 2024
  • Fig. 8 Market Trends & Outlook
  • Fig. 9 Market Driver Relevance Analysis (Current & Future Impact)
  • Fig. 10 Market Restraint Relevance Analysis (Current & Future Impact)
  • Fig. 11 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
  • Fig. 12 Porter's Five Forces Analysis
  • Fig. 13 Global Biological Safety Testing Services Market: Service Key Takeaways
  • Fig. 14 Global Biological Safety Testing Services Market: Service Movement Analysis
  • Fig. 15 Global Biological Safety Testing Services Market, for Bioburden Testing Services, 2018 - 2030 (USD Million)
  • Fig. 16 Global Biological Safety Testing Services Market, for Endotoxin Testing Services, 2018 - 2030 (USD Million)
  • Fig. 17 Global Biological Safety Testing Services Market, for Sterility Testing Services, 2018 - 2030 (USD Million)
  • Fig. 18 Global Biological Safety Testing Services Market, for Viral Clearance and Validation Services, 2018 - 2030 (USD Million)
  • Fig. 19 Global Biological Safety Testing Services Market, for Cell Line Authentication and Characterization Tests, 2018 - 2030 (USD Million)
  • Fig. 20 Global Biological Safety Testing Services Market, for Residual Host Contamination Testing Services, 2018 - 2030 (USD Million)
  • Fig. 21 Global Biological Safety Testing Services Market, for Adventitious Agent Detection Testing Services, 2018 - 2030 (USD Million)
  • Fig. 22 Global Biological Safety Testing Services Market, for Others, 2018 - 2030 (USD Million)
  • Fig. 23 Global Biological Safety Testing Services Market: Application Key Takeaways
  • Fig. 24 Global Biological Safety Testing Services Market: Application Movement Analysis
  • Fig. 25 Global Biological Safety Testing Services Market, for Vaccine & Therapeutics, 2018 - 2030 (USD Million)
  • Fig. 26 Global Biological Safety Testing Services Market, for Monoclonal Antibodies, 2018 - 2030 (USD Million)
  • Fig. 27 Global Biological Safety Testing Services Market, for Vaccines, 2018 - 2030 (USD Million)
  • Fig. 28 Global Biological Safety Testing Services Market, for Recombinant Protein, 2018 - 2030 (USD Million)
  • Fig. 29 Global Biological Safety Testing Services Market, for Cell and Gene Therapy, 2018 - 2030 (USD Million)
  • Fig. 30 Global Biological Safety Testing Services Market, for Blood & Blood Products, 2018 - 2030 (USD Million)
  • Fig. 31 Global Biological Safety Testing Services Market, for Tissue & Tissue-based Products, 2018 - 2030 (USD Million)
  • Fig. 32 Global Biological Safety Testing Services Market, for Others, 2018 - 2030 (USD Million)
  • Fig. 33 Global Biological Safety Testing Services Market: End Use Key Takeaways
  • Fig. 34 Global Biological Safety Testing Services Market, End Use Movement Analysis
  • Fig. 35 Global Biological Safety Testing Services Market, for Biopharmaceutical Companies, 2018 - 2030 (USD Million)
  • Fig. 36 Global Biological Safety Testing Services Market, for Pharmaceutical Companies, 2018 - 2030 (USD Million)
  • Fig. 37 Global Biological Safety Testing Services Market, for Academic and Research Institutions, 2018 - 2030 (USD Million)
  • Fig. 38 Global Biological Safety Testing Services Market, for Others, 2018 - 2030 (USD Million)
  • Fig. 39 Regional Marketplace: Key Takeaways
  • Fig. 40 Regional Outlook, 2024 & 2030
  • Fig. 41 North America Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 42 U.S. Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 43 Canada Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 44 Mexico Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 45 Europe Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 46 Germany Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 47 UK Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 48 France Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 49 Italy Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 50 Spain Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 51 Denmark Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 52 Sweden Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 53 Norway Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 54 Asia Pacific Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 55 Japan Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 56 China Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 57 India Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 58 Australia Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 59 South Korea Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 60 Thailand Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 61 Latin America Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 62 Brazil Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 63 Argentina Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 64 Middle East and Africa Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 65 South Africa Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 66 Saudi Arabia Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 67 UAE Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
  • Fig. 68 Kuwait Biological Safety Testing Services Market, 2018 - 2030 (USD Million)
目次
Product Code: GVR-4-68040-517-2

Biological Safety Testing Services Market Growth & Trends:

The global biological safety testing services market size is expected to reach USD 6.33 billion by 2030, growing at a CAGR of 11.78% during the forecast period, according to a new report by Grand View Research, Inc. The market can be attributed to benefits offered to biological safety testing services, such as cost savings, an increased focus on sterility assurance, and the rising development of new pharmaceuticals, therapies, & medical devices. In addition, stringent regulatory requirements, a growing emphasis on patient safety, advancements in biotechnology, and the increasing prevalence of chronic and infectious diseases are some of the factors contributing to the market growth.

The biological safety testing services industry is experiencing rapid growth due to the increasing demand for biologics, cell & gene therapies, and vaccines. Some of the others key trends in the market include the expansion of biological safety testing services by contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), as well as rising investments in biopharmaceutical research and development (R&D).

Moreover, stringent regulatory requirements from the FDA, EMA, and ICH have made biosafety testing essential for ensuring product safety, efficacy, and compliance. This has led to an increasing need for viral clearance, sterility, endotoxin, mycoplasma, and bioburden testing requirements which aims to improve efficiency and ethical compliance. This has led most of the market players to increasingly outsourcing biosafety testing who are seeking cost-effective and specialized expertise with their emerging pipelines for biologic drugs. Furthermore, technological innovations such as automation, next-generation sequencing (NGS), real-time PCR, and AI-driven analytics are enhancing the accuracy, speed, and regulatory compliance of tests. Therefore, biological safety testing services are expected to evolve during the forecast period to meet the complex regulatory and quality control needs of the industry.

The strategic partnerships and accelerating product launches are also driving the market growth. For instance, in Aprill 2024, Merck introduced the Aptegra CHO Genetic Stability Assay, the first all-in-one, validated genetic stability assay. Utilizing whole genome sequencing and bioinformatics, this innovation enhances biosafety testing efficiency, enabling faster transitions to commercial production

Biological Safety Testing Services Market Report Highlights:

  • The bioburden testing services segment dominated the market in 2024. Growth in the segment can be attributed to the increasing focus on sterility assurance of medical devices and pharmaceutical drugs and growing concern for product safety. These services are actively preferred to determine a test unit's microbial quality or cleanliness, thereby determining the sterilization process needed for effective decontamination.
  • Based on application, the vaccine & therapeutics segment held the largest market share in 2024, attributed to the stringent regulatory scenarios, growing demand for vaccines and biologic therapeutics, rapid adoption of automation, next-generation sequencing (NGS), and AI-driven analytics ensuring compliance and product safety drives the segment growth.
  • Based on end use, the biopharmaceutical companies segment dominated the market in 2024. This is attributable to increasing R&D investment, growing focus on product safety and testing, rising cost-efficiency service offerings, and increased biological production.
  • North America market accounted for the largest share of 33.15% in 2024 due to rising number of medical device companies & pharmaceutical companies in countries like the U.S. and Canada, the North America is anticipated to witness rapid growth over the estimated time. The presence of established market players within the region offering cost-efficient services in the U.S. is another factor anticipated to propel market growth.

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Market Definitions
    • 1.2.1. Service Segment
    • 1.2.2. Application Segment
    • 1.2.3. End Use Segment
  • 1.3. Information Analysis
    • 1.3.1. Market Formulation & Data Visualization
  • 1.4. Data Validation & Publishing
  • 1.5. Information Procurement
    • 1.5.1. Primary Research
  • 1.6. Information or Data Analysis
  • 1.7. Market Formulation & Validation
  • 1.8. Market Model
  • 1.9. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Trends and Outlook
  • 3.3. Market Dynamics
    • 3.3.1. Market Driver Analysis
    • 3.3.2. Market Restraint Analysis
  • 3.4. Industry Analysis Tools
    • 3.4.1. Porter's Five Forces Analysis
    • 3.4.2. PESTEL Analysis
    • 3.4.3. COVID-19 Impact Analysis

Chapter 4. Biological Safety Testing Services Market: Service Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. Biological Safety Testing Services Market; Service Movement Analysis
  • 4.3. Biological Safety Testing Services Size & Trend Analysis, by Service, 2018 to 2030 (USD Million)
  • 4.4. Bioburden Testing Services
    • 4.4.1. Bioburden testing services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.5. Endotoxin Testing Services
    • 4.5.1. Endotoxin testing services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.6. Sterility Testing Services
    • 4.6.1. Sterility testing services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.7. Viral Clearance and Validation Services
    • 4.7.1. Viral clearance and validation services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.8. Cell Line Authentication and Characterization Tests
    • 4.8.1. Cell line authentication and characterization tests market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.9. Residual Host Contamination Testing Services
    • 4.9.1. Residual host contamination testing services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.10. Adventitious Agent Detection Testing Services
    • 4.10.1. Adventitious agent detection testing services market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.11. Others
    • 4.11.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. Biological Safety Testing Services Market: Application Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. Biological Safety Testing Services Market; Application Movement Analysis
  • 5.3. Biological Safety Testing Services Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
  • 5.4. Vaccine & Therapeutics
    • 5.4.1. Vaccine & therapeutics market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.2. Monoclonal Antibodies
      • 5.4.2.1. Monoclonal antibodies market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.3. Vaccines
      • 5.4.3.1. Vaccines market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.4. Recombinant Protein
      • 5.4.4.1. Recombinant protein market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Biological Safety Testing Services Market: End Use Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. Biological Safety Testing Services Market; End Use Movement Analysis
  • 6.3. Biological Safety Testing Services Size & Trend Analysis, by End Use, 2018 to 2030 (USD Million)
  • 6.4. Biopharmaceutical Companies
    • 6.4.1. Biopharmaceutical companies market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.5. Pharmaceutical Companies
    • 6.5.1. Pharmaceutical companies market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.6. Academic and Research Institutions
    • 6.6.1. Academic and research institutions market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.7. Others
    • 6.7.1. Others market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. Biological Safety Testing Services Market: Regional Business Analysis

  • 7.1. Regional Dashboard
  • 7.2. Market Size & Forecasts and Trend Analysis, 2018 to 2030
  • 7.3. North America
    • 7.3.1. North America biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.3.2. U.S.
      • 7.3.2.1. Key Country Dynamics
      • 7.3.2.2. Competitive Scenario
      • 7.3.2.3. Regulatory Framework
      • 7.3.2.4. U.S. biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.3.3. Canada
      • 7.3.3.1. Key Country Dynamics
      • 7.3.3.2. Competitive Scenario
      • 7.3.3.3. Regulatory Framework
      • 7.3.3.4. Canada biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.3.4. Mexico
      • 7.3.4.1. Key Country Dynamics
      • 7.3.4.2. Competitive Scenario
      • 7.3.4.3. Regulatory Framework
      • 7.3.4.4. Mexico biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.4. Europe
    • 7.4.1. Europe biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.2. Germany
      • 7.4.2.1. Key Country Dynamics
      • 7.4.2.2. Competitive Scenario
      • 7.4.2.3. Regulatory Framework
      • 7.4.2.4. Germany biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.3. UK
      • 7.4.3.1. Key Country Dynamics
      • 7.4.3.2. Competitive Scenario
      • 7.4.3.3. Regulatory Framework
      • 7.4.3.4. UK biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.4. France
      • 7.4.4.1. Key Country Dynamics
      • 7.4.4.2. Competitive Scenario
      • 7.4.4.3. Regulatory Framework
      • 7.4.4.4. France biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.5. Italy
      • 7.4.5.1. Key Country Dynamics
      • 7.4.5.2. Competitive Scenario
      • 7.4.5.3. Regulatory Framework
      • 7.4.5.4. Italy biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.6. Spain
      • 7.4.6.1. Key Country Dynamics
      • 7.4.6.2. Competitive Scenario
      • 7.4.6.3. Regulatory Framework
      • 7.4.6.4. Spain biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.7. Denmark
      • 7.4.7.1. Key Country Dynamics
      • 7.4.7.2. Competitive Scenario
      • 7.4.7.3. Regulatory Framework
      • 7.4.7.4. Denmark biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.8. Sweden
      • 7.4.8.1. Key Country Dynamics
      • 7.4.8.2. Competitive Scenario
      • 7.4.8.3. Regulatory Framework
      • 7.4.8.4. Sweden biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.4.9. Norway
      • 7.4.9.1. Key Country Dynamics
      • 7.4.9.2. Competitive Scenario
      • 7.4.9.3. Regulatory Framework
      • 7.4.9.4. Norway biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.5. Asia Pacific
    • 7.5.1. Asia Pacific biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.2. Japan
      • 7.5.2.1. Key Country Dynamics
      • 7.5.2.2. Competitive Scenario
      • 7.5.2.3. Regulatory Framework
      • 7.5.2.4. Japan biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.3. China
      • 7.5.3.1. Key Country Dynamics
      • 7.5.3.2. Competitive Scenario
      • 7.5.3.3. Regulatory Framework
      • 7.5.3.4. China biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.4. India
      • 7.5.4.1. Key Country Dynamics
      • 7.5.4.2. Competitive Scenario
      • 7.5.4.3. Regulatory Framework
      • 7.5.4.4. India biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.5. South Korea
      • 7.5.5.1. Key Country Dynamics
      • 7.5.5.2. Competitive Scenario
      • 7.5.5.3. Regulatory Framework
      • 7.5.5.4. South Korea biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.6. Australia
      • 7.5.6.1. Key Country Dynamics
      • 7.5.6.2. Competitive Scenario
      • 7.5.6.3. Regulatory Framework
      • 7.5.6.4. Australia biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.5.7. Thailand
      • 7.5.7.1. Key Country Dynamics
      • 7.5.7.2. Competitive Scenario
      • 7.5.7.3. Regulatory Framework
      • 7.5.7.4. Thailand biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.6. Latin America
    • 7.6.1. Latin America biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.6.2. Brazil
      • 7.6.2.1. Key Country Dynamics
      • 7.6.2.2. Competitive Scenario
      • 7.6.2.3. Regulatory Framework
      • 7.6.2.4. Brazil biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.6.3. Argentina
      • 7.6.3.1. Key Country Dynamics
      • 7.6.3.2. Competitive Scenario
      • 7.6.3.3. Regulatory Framework
      • 7.6.3.4. Argentina biological safety testing services market, 2018 - 2030 (USD Million)
  • 7.7. MEA
    • 7.7.1. MEA biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.7.2. South Africa
      • 7.7.2.1. Key Country Dynamics
      • 7.7.2.2. Competitive Scenario
      • 7.7.2.3. Regulatory Framework
      • 7.7.2.4. South Africa biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.7.3. Saudi Arabia
      • 7.7.3.1. Key Country Dynamics
      • 7.7.3.2. Competitive Scenario
      • 7.7.3.3. Regulatory Framework
      • 7.7.3.4. Saudi Arabia biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.7.4. UAE
      • 7.7.4.1. Key Country Dynamics
      • 7.7.4.2. Competitive Scenario
      • 7.7.4.3. Regulatory Framework
      • 7.7.4.4. UAE biological safety testing services market, 2018 - 2030 (USD Million)
    • 7.7.5. Kuwait
      • 7.7.5.1. Key Country Dynamics
      • 7.7.5.2. Competitive Scenario
      • 7.7.5.3. Regulatory Framework
      • 7.7.5.4. Kuwait biological safety testing services market, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Company Categorization
  • 8.2. Company Market Position Analysis, 2024
  • 8.3. Company Profiles
    • 8.3.1. Charles River Laboratories
      • 8.3.1.1. Company overview
      • 8.3.1.2. Financial performance
      • 8.3.1.3. Service benchmarking
      • 8.3.1.4. Strategic initiatives
    • 8.3.2. Lonza Group Ltd.
      • 8.3.2.1. Company overview
      • 8.3.2.2. Financial performance
      • 8.3.2.3. Service benchmarking
      • 8.3.2.4. Strategic initiatives
    • 8.3.3. Merck KGaA
      • 8.3.3.1. Company overview
      • 8.3.3.2. Financial performance
      • 8.3.3.3. Service benchmarking
      • 8.3.3.4. Strategic initiatives
    • 8.3.4. SGS SA
      • 8.3.4.1. Company overview
      • 8.3.4.2. Financial performance
      • 8.3.4.3. Service benchmarking
      • 8.3.4.4. Strategic initiatives
    • 8.3.5. Eurofins Scientific
      • 8.3.5.1. Company overview
      • 8.3.5.2. Financial performance
      • 8.3.5.3. Service benchmarking
      • 8.3.5.4. Strategic initiatives
    • 8.3.6. WuXi AppTec
      • 8.3.6.1. Company overview
      • 8.3.6.2. Financial performance
      • 8.3.6.3. Service benchmarking
      • 8.3.6.4. Strategic initiatives
    • 8.3.7. Thermo Fisher Scientific Inc.
      • 8.3.7.1. Company overview
      • 8.3.7.2. Financial performance
      • 8.3.7.3. Service benchmarking
      • 8.3.7.4. Strategic initiatives
    • 8.3.8. Sartorius AG
      • 8.3.8.1. Company overview
      • 8.3.8.2. Financial performance
      • 8.3.8.3. Service benchmarking
      • 8.3.8.4. Strategic initiatives
    • 8.3.9. Toxikon Corporation
      • 8.3.9.1. Company overview
      • 8.3.9.2. Financial performance
      • 8.3.9.3. Service benchmarking
      • 8.3.9.4. Strategic initiatives
    • 8.3.10. bioMerieux SA
      • 8.3.10.1. Company overview
      • 8.3.10.2. Financial performance
      • 8.3.10.3. Service benchmarking
      • 8.3.10.4. Strategic initiatives