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バイオプロセスバリデーションの市場規模、シェア、動向、予測：検査タイプ、プロセスコンポーネント、エンドユーザー、地域別、2025年～2033年

Bioprocess Validation Market Size, Share, Trends and Forecast by Test Type, Process Component, End User, and Region, 2025-2033

出版日
発行
IMARC
ページ情報
英文 141 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=145.80円
バイオプロセスバリデーションの市場規模、シェア、動向、予測：検査タイプ、プロセスコンポーネント、エンドユーザー、地域別、2025年～2033年
出版日: 2025年06月02日
発行: IMARC
ページ情報: 英文 141 Pages
納期: 2～3営業日
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  • 概要
  • 図表
  • 目次
概要

バイオプロセスバリデーションの世界市場規模は、2024年に3億9,183万米ドルとなりました。今後、IMARC Groupは、市場は2033年までに7億6,167万米ドルに達し、2025年から2033年にかけて7.28%のCAGRを示すと予測しています。現在、北米が市場を独占しており、2024年の市場シェアは38.9%を超えています。バイオ医薬品の生産拡大、厳格な規制要件の実施、急速な技術進歩、製造受託機関（CMO）の著しい成長は、バイオプロセスバリデーション市場シェアを強化する要因の一部です。

世界のバイオプロセスバリデーション市場の需要は、主にバイオ医薬品の生産増加によって大きな成長を遂げています。2023年、欧州医薬品庁（EMA）は77品目のヒト用医薬品を承認したが、そのうち39品目は新規活性物質を含んでおり、強力なバイオ医薬品開発パイプラインを反映しています。この増加傾向は2024年、2025年も続くと予想され、多数の生物学的製剤とバイオシミラーが承認を受けると予想されます。バイオ医薬品の生産拡大により、これらの治療薬の品質、安全性、有効性を保証する厳格なバイオプロセスバリデーションに対する需要がさらに高まっています。プロセスバリデーション、分析法バリデーション、洗浄バリデーションは、特に連続バイオプロセス、シングルユース技術、自動化の採用により製造プロセスが高度化するにつれて、コンプライアンスフレームワークの不可欠な要素になりつつあります。

米国のバイオプロセスバリデーション市場シェアは88.90％を占め、様々な側面から明確な成長を記録しています。特に、米国FDAはバイオ医薬品の製造に厳しい規制を設けており、製品の安全性、有効性、市場での承認を確認するための広範なバリデーションが求められています。その後、2025年1月にFDAによる最新のガイダンスが発表され、バイオマーカーの生物分析法バリデーションは、医薬品のトラブルシューティングと開発中に確立されたプロトコルで厳格な必要性があると認識されています。また、FDAの生物統計局は、バイオ医薬品の市販前審査において、あらゆる医薬品の安全性と有効性を検討するための分析を開発するという大きな役割を担っており、これまで広範に行われてきたバリデーションの確かな証拠を検証する全体が奨励されています。このような規制の進展は、バイオ医薬品の複雑化と相まって、米国における高度なバイオプロセスバリデーションサービスの需要を増加させるでしょう。

バイオプロセスバリデーション市場の動向：

厳しい規制要件

近年、規制当局はバイオ医薬品の安全性と有効性を確保するため、プロセスバリデーションへの注力を強めています。2025年1月、米国食品医薬品局（FDA）は「バイオマーカーのバイオ分析法バリデーション」ガイダンスを発表し、医薬品開発で使用されるバイオ分析法のバリデーションに関する詳細な推奨事項を示しました。同様に、欧州医薬品庁（EMA）は、そのガイドラインの中でプロセスバリデーションを強調し、規制当局への申請における包括的なバリデーションデータの必要性を強調しています。このような厳しい規制要件により、バイオ医薬品企業はバリデーションプロセスに多大な投資を余儀なくされ、バイオプロセスバリデーションの世界市場の成長を促進しています。

技術の進歩

2024年と2025年には、技術の進歩がバイオプロセスバリデーションの世界市場を大きく押し上げました。世界中の政府がいくつかのガイドラインを発表し、バイオプロセスにおける高度なバリデーション技術の必要性が強調されています。さらに、国際整合評議会（ICH）は、生物分析法バリデーションに関するM10ガイドラインを導入し、欧州医薬品庁（EMA）などの規制機関によって採用されています。このガイドラインは、バイオ分析アッセイのバリデーションの枠組みを提供し、バイオプロセスバリデーションにおける革新的技術の採用を促進します。さらに、FDAは2024年3月にISO 17665の初版を採択したが、これは医療機器の滅菌プロセスの開発、バリデーション、および管理のためのガイドラインを確立するものであり、バイオプロセスにおける滅菌バリデーション技術の強化に対するFDAの献身を強調するものです。このような規制の進展は、バイオ医薬品の有効性と安全性を確保するための最先端技術への依存度が高まっていることを浮き彫りにしています。

製造受託機関（CMO）の成長

開発・製造受託機関（CDMO）の拡大は、世界のバイオプロセスバリデーション市場に大きな影響を与えています。過去10年間、CDMOはバイオ医薬品分野で極めて重要な存在であり、FDAおよびEMAが承認した新分子化合物（NME）の80%以上の開発に貢献してきました。2017年以降は、重要なワクチンや治療を含むNMEの55％以上を製造しています。現在、CDMOは欧米市場で流通する医薬品、ワクチン、一般用医薬品の約40％を製造しています。このような大幅な関与は、効率的で適合性の高いバイオプロセスに対するCDMOへの依存が高まっていることを強調するものであり、それによって製品の品質と規制順守を確保するための包括的なバリデーションサービスに対する需要が高まっています。

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 世界のバイオプロセスバリデーション市場

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

第6章 市場内訳：検査タイプ別

  • 抽出物検査サービス
  • 微生物学的検査サービス
  • 生理化学検査サービス
  • 完全性検査サービス
  • 互換性検査サービス
  • その他

第7章 市場内訳：プロセスコンポーネント別

  • フィルターエレメント
  • メディアコンテナとバッグ
  • 凍結・解凍処理バッグ
  • 混合システム
  • バイオリアクター
  • 移送システム
  • その他

第8章 市場内訳：エンドユーザー別

  • 製薬およびバイオテクノロジー企業
  • 受託開発製造組織
  • その他

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
    • 市場内訳：国別

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
    • Almac Group
    • Biozeen
    • Doc S.R.L.
    • Eurofins Scientific
    • Hangzhou Anow Microfiltration Co. Ltd.
    • Hangzhou Cobetter Filtration Equipment Co. Ltd.
    • Hangzhou Tianshan Precision Filter Material Co. Ltd.
    • Meissner Filtration Products, Inc.
    • Merck KGaA
    • Sartorius AG
    • SGS SA
    • Thermo Fisher Scientific Inc.
図表

List of Figures

  • Figure 1: Global: Bioprocess Validation Market: Major Drivers and Challenges
  • Figure 2: Global: Bioprocess Validation Market: Sales Value (in Million USD), 2019-2024
  • Figure 3: Global: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 4: Global: Bioprocess Validation Market: Breakup by Test Type (in %), 2024
  • Figure 5: Global: Bioprocess Validation Market: Breakup by Process Component (in %), 2024
  • Figure 6: Global: Bioprocess Validation Market: Breakup by End User (in %), 2024
  • Figure 7: Global: Bioprocess Validation Market: Breakup by Region (in %), 2024
  • Figure 8: Global: Bioprocess Validation (Extractables Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 9: Global: Bioprocess Validation (Extractables Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 10: Global: Bioprocess Validation (Microbiological Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 11: Global: Bioprocess Validation (Microbiological Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 12: Global: Bioprocess Validation (Physiochemical Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 13: Global: Bioprocess Validation (Physiochemical Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 14: Global: Bioprocess Validation (Integrity Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 15: Global: Bioprocess Validation (Integrity Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 16: Global: Bioprocess Validation (Compatibility Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 17: Global: Bioprocess Validation (Compatibility Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 18: Global: Bioprocess Validation (Other Test Types) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 19: Global: Bioprocess Validation (Other Test Types) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 20: Global: Bioprocess Validation (Filter Elements) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 21: Global: Bioprocess Validation (Filter Elements) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 22: Global: Bioprocess Validation (Media Containers and Bags) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 23: Global: Bioprocess Validation (Media Containers and Bags) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 24: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 25: Global: Bioprocess Validation (Freezing and Thawing Process Bags) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 26: Global: Bioprocess Validation (Mixing Systems) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 27: Global: Bioprocess Validation (Mixing Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 28: Global: Bioprocess Validation (Bioreactors) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 29: Global: Bioprocess Validation (Bioreactors) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 30: Global: Bioprocess Validation (Transfer Systems) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 31: Global: Bioprocess Validation (Transfer Systems) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 32: Global: Bioprocess Validation (Other Process Components) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 33: Global: Bioprocess Validation (Other Process Components) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 34: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 35: Global: Bioprocess Validation (Pharmaceutical and Biotechnology Companies) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 36: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 37: Global: Bioprocess Validation (Contract Development and Manufacturing Organizations) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 38: Global: Bioprocess Validation (Other End Users) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 39: Global: Bioprocess Validation (Other End Users) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 40: North America: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 41: North America: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 42: United States: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 43: United States: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 44: Canada: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 45: Canada: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 46: Asia-Pacific: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 47: Asia-Pacific: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 48: China: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 49: China: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 50: Japan: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 51: Japan: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 52: India: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 53: India: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 54: South Korea: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 55: South Korea: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 56: Australia: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 57: Australia: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 58: Indonesia: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 59: Indonesia: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 60: Others: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 61: Others: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 62: Europe: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 63: Europe: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 64: Germany: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 65: Germany: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 66: France: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 67: France: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 68: United Kingdom: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 69: United Kingdom: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 70: Italy: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 71: Italy: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 72: Spain: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 73: Spain: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 74: Russia: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 75: Russia: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 76: Others: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 77: Others: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 78: Latin America: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 79: Latin America: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 80: Brazil: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 81: Brazil: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 82: Mexico: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 83: Mexico: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 84: Others: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 85: Others: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 86: Middle East and Africa: Bioprocess Validation Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 87: Middle East and Africa: Bioprocess Validation Market: Breakup by Country (in %), 2024
  • Figure 88: Middle East and Africa: Bioprocess Validation Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 89: Global: Bioprocess Validation Industry: SWOT Analysis
  • Figure 90: Global: Bioprocess Validation Industry: Value Chain Analysis
  • Figure 91: Global: Bioprocess Validation Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Bioprocess Validation Market: Key Industry Highlights, 2024 and 2033
  • Table 2: Global: Bioprocess Validation Market Forecast: Breakup by Test Type (in Million USD), 2025-2033
  • Table 3: Global: Bioprocess Validation Market Forecast: Breakup by Process Component (in Million USD), 2025-2033
  • Table 4: Global: Bioprocess Validation Market Forecast: Breakup by End User (in Million USD), 2025-2033
  • Table 5: Global: Bioprocess Validation Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 6: Global: Bioprocess Validation Market: Competitive Structure
  • Table 7: Global: Bioprocess Validation Market: Key Players
目次
Product Code: SR112025A6489

The global bioprocess validation market size was valued at USD 391.83 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 761.67 Million by 2033, exhibiting a CAGR of 7.28% from 2025-2033. North America currently dominates the market, holding a market share of over 38.9% in 2024. The growing production of biopharmaceuticals, implementation of strict regulatory requirements, rapid technological advancements, and significant growth in contract manufacturing organizations (CMOs), are some of the factors bolstering the bioprocess validation market share.

The global bioprocess validation market demand is experiencing significant growth, primarily driven by the increasing production of biopharmaceuticals. In 2023, the European Medicines Agency (EMA) approved 77 medicines for human use, with 39 containing a novel active substance, reflecting a strong biopharmaceutical development pipeline. This upward trend is expected to continue into 2024 and 2025, with numerous biologics and biosimilars anticipated to receive approval. The expansion of biopharmaceutical production further amplifies the demand for rigorous bioprocess validation, which ensures the quality, safety, and efficacy of these therapeutics. Process validation, analytical method validation, and cleaning validation are becoming essential components of compliance frameworks, particularly as manufacturing processes grow more sophisticated with the adoption of continuous bioprocessing, single-use technologies, and automation.

The bioprocess validation market share in the United States is recording clear growth from various aspects, holding 88.90% market share. In particular, the US FDA has issued stringent regulations for any manufacture of biopharmaceuticals, which demand for extensive validation to ascertain product safety, efficacy, and approval in the market. Later on, in January 2025, an updated guidance by the FDA was released, in which bioanalytical method validation for biomarkers has been recognized as a stringent need with established protocols during troubleshooting and development of drugs. Also, yet the FDA's Office of Biostatistics plays to the great role of developing an analysis to consider the safety and efficacy of any medications in biopharmaceutical pre-market reviews, ever the whole of verifying sound evidence of the validations undertaken extensively is encouraged. Such regulatory strides, combined with the growing complexity of the biopharmaceutical products, will increase the demand for advanced bioprocess validation services in the United States.

Bioprocess Validation Market Trends:

Stringent Regulatory Requirements

In recent years, regulatory agencies have intensified their focus on process validation to ensure the safety and efficacy of biopharmaceuticals. In January 2025, the U.S. Food and Drug Administration (FDA) released the "Bioanalytical Method Validation for Biomarkers" guidance, providing detailed recommendations for validating bioanalytical methods used in drug development. Similarly, the European Medicines Agency (EMA) has emphasized process validation in its guidelines, underscoring the necessity for comprehensive validation data in regulatory submissions. These stringent regulatory requirements compel biopharmaceutical companies to invest significantly in validation processes, thereby driving the global bioprocess validation market growth.

Technological Advancements

In 2024 and 2025, technological advancements have significantly bolstered the global bioprocess validation market. Governments worldwide have released several guidelines, which underscores the need for advanced validation techniques in bioprocessing. Additionally, the International Council for Harmonisation (ICH) introduced the M10 guideline on bioanalytical method validation, which has been adopted by regulatory bodies like the European Medicines Agency (EMA). This guideline provides a framework for validating bioanalytical assays, promoting the adoption of innovative technologies in bioprocess validation. Additionally, the FDA's adoption of the first edition of ISO 17665 in March 2024, which establishes guidelines for developing, validating, and controlling medical device sterilization processes, underscores its dedication to enhancing sterilization validation techniques in bioprocessing. These regulatory developments highlight the increasing reliance on cutting-edge technologies to ensure the efficacy and safety of biopharmaceutical products.

Growth in Contract Manufacturing Organizations (CMOs)

The expansion of Contract Development and Manufacturing Organizations (CDMOs) significantly influences the global bioprocess validation market. Over the past decade, CDMOs have been pivotal in the biopharmaceutical sector, contributing to the development of over 80% of New Molecular Entities (NMEs) approved by the FDA and EMA. Since 2017, they have produced more than 55% of NMEs, including critical vaccines and treatments. Currently, CDMOs manufacture approximately 40% of all drug doses, vaccines, and over-the-counter products distributed in Western markets. This substantial involvement underscores the growing reliance on CDMOs for efficient and compliant bioprocesses, thereby driving the demand for comprehensive validation services to ensure product quality and regulatory adherence.

Bioprocess Validation Industry Segmentation:

Analysis by Test Type:

  • Extractables Testing Services
  • Microbiological Testing Services
  • Physiochemical Testing Services
  • Integrity Testing Services
  • Compatibility Testing Services
  • Others

Based on the recent bioprocess validation market forecast, extractables testing services have the lion's share of the market, accounting for the cause of heightened veterinary scrutiny towards ensuring that a product is proven safe and efficacious for bioprocess validation. Regulatory bodies recommend comprehensive extractables and leachables examinations to identify contaminants in manufacturing subcomponents, such as filters and tubing, which directly affect the purity of drugs. These intricate procedures ensure compliance with GMPs and lower the risk of possible side effects for patients. Thanks to the ever-complicated nature of biopharmaceuticals and the burgeoning popularity of single-use systems in manufacturing, demand for extractables testing services is on the rise, and this has consequently solidified their position at the forefront of the market.

Analysis by Process Component:

  • Filter Elements
  • Media Containers and Bags
  • Freezing And Thawing Process Bags
  • Mixing Systems
  • Bioreactors
  • Transfer Systems
  • Others

Filter elements are critical elements in bioprocess validation, with high significance in assuring product purity, sterility, and compliance with guideline standards. Filtration is widely used in biopharmaceutical manufacturing for the removal of particulates, microbial contaminants, and endotoxins in the production of raw materials, intermediates, and final drug formulations. With the increasing production of biologics, vaccines, and gene therapies, there came a lot of demand for better filtration systems. Membrane filters, depth filters, and sterile filters are among the most commonly used filter elements in bioprocessing. Any removed contending into cell culture media, buffer, or a final drug product can guarantee its integrity. The emergence of single-use filtration systems is also in demand owing to their economy on the material used, reduced risk of cross-contamination, and convenience of use under GMP conditions.

Analysis by End User:

  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Organizations
  • Others

As per the latest bioprocess validation market outlook, pharmaceutical and biotechnology companies account for the largest share of the bioprocess validation market, due to rigid quality control measures, compliance with standards, and innovation. These companies devote large amounts of funding to research and development, with a view to bringing biologics, biosimilars, and gene therapies to market. Biologics and gene therapies require extensive validation to show that their use is safe and effective. Increased demand for mAbs, vaccines, cell and gene therapies, and recombinant proteins increases the demand for robust bioprocess validation services. Various regulatory agencies such as U.S. FDA, EMA, and ICH operate under very stringent regulations, requiring biopharmaceutical companies to validate processes-protocols-from upstream fermentation processes to downstream purification-in order to produce reliable products. Any change in the affiliated process parameters will affect the product's consistency, which in turn increases emphasis on validation during drug manufacturing. Advances in single-use bioprocessing systems, automation, and digital biomanufacturing are giving rise to the use of new analytical tools that enable process validation through real-time monitoring.

Regional Analysis:

  • 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 represented the largest share, with about 38.9% of the overall global bioprocess validation market. Factors leading to this region's dominance are majorly attributed to the leading biopharmaceutical companies, stringent regulatory framework, and major investments in R&D. Agencies such as the FDA and Health Canada enforce strict guidelines over the manufacturing of biologics that require some level of validation in order to ensure compliance with GMP. The demands of these agencies directly relay into a demand for validation services, particularly in process development, quality assurance, and risk mitigation. Other factors benefiting North America include an established biopharmaceutical industry, where several big players are investing in new biologics, biosimilars, and gene therapies. The rising adoption of advanced bioprocessing technologies-such as single-use systems, automation, and AI-driven analytics-is giving the necessary boost to this market. Growth of CDMOs in North America has also led to a demand for third-party validation services in compliance with regulatory standards for services confirming operational excellence.

Key Regional Takeaways:

United States Bioprocess Validation Market Analysis

The U.S. bioprocess validation market is expanding due to the strict regulatory requirements by the U.S. Food and Drug Administration (FDA) for biopharmaceutical production. The comprehensive validation studies required in the Biologics License Application (BLA) process have propelled the demand for validation services. The existing robust biopharmaceutical industry, where a large portion of the companies are heavily investing in optimizing their production processes, is driving adoption. The biopharmaceutical industry in the U.S. is a major contributor to the economy, accounting for around 1.6% of the nation's GDP, as per reports. Furthermore, scaling up production around monoclonal antibodies (mAb) and cell and gene therapies will call for the implementation of advanced methodologies for bioprocess validation to guarantee product quality and efficacy. Besides that, investments in research and development (R&D), the provision of government funds, and public-private partnerships bolster innovations in bioprocess validation technologies. Furthermore, the trend towards single-use bioprocessing will offer any rigorous validation required to overcome these sources of contamination and ensure reproducibility an encouraging outlook. Moreover, as biomanufacturing becomes more complex, furthered by the introduction of continuous processes and increased automation, a larger obligation arises for extensive validation protocols. In addition, the validation has to cover all aspects from sourcing raw materials to licensing/batch release of the finished product for automated systems and continuous processes to work reliably. Key players in the country are striving to extend their service offerings to cater to the rising demand from the industry, thereby augmenting market growth.

Europe Bioprocess Validation Market Analysis

A very strong regulatory environment led by the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) creates a highly developed continuum of validation requirements for biologics and biosimilars. The long-established biopharmaceutical sector in the region, especially Germany, the UK, and France, fuels demand for process validation solutions. The growing demand for personalized medicine, cell and gene therapies, and next-generation biologics is leading to the establishment of stringent validation strategies for compliance. The gene therapy market in Europe is projected to grow at 12.8% CAGR during the forecast period of 2024-2032, according to the IMARC Group. Emerging investments and developments in biomanufacturing are pushing the expansion of the validation market. Quality-by-design (QbD) principles and real-time process monitoring initiatives in the European Union further drive trust in robust validation tools. Besides this, with the rising sustainability concerns globally, new validation innovations are founded on minimizing environmental impact, specifically in single-use technologies. Besides this, a supportive network of CDMOs and biopharma clusters in the region complements the validation market. CDMO is a third-party firm that offers specialized services in biomanufacturing like process development, scale-up, and production. As these organizations turn to advanced technologies, they seek to ensure consistency and quality in their processes by implementing robust validation protocols.

Asia Pacific Bioprocess Validation Market Analysis

The Asia Pacific bioprocess validation market is witnessing strong growth on account of the rapid expansion of biopharmaceutical manufacturing in countries like China, India, South Korea, and Japan. In addition, governing agencies in the region are promoting domestic biologics production through financial incentives and favorable regulations, increasing demand for validation services. Besides this, rising healthcare expenditure and a growing patient base drive the need for cost-effective biosimilars, leading manufacturers to focus on robust validation processes to meet international regulatory standards. As per the India Brand Equity Foundation (IBEF), India's public healthcare expenditure reached 1.9% of GDP in the financial year 2024. Moreover, the region's lower operational costs attract global biopharma companies, creating a surge in contract development and manufacturing organization (CDMO) activities, which require stringent process validation. Apart from this, the increasing adoption of single-use bioprocessing systems necessitates validation studies to ensure process reliability. Expansion of research institutes and academic collaborations with industry players further strengthens the market. These partnerships facilitate the exchange of knowledge, bringing cutting-edge scientific discoveries and technological innovations into the biomanufacturing sector. By combining academic expertise with industry experience, these collaborations help develop more efficient, reliable, and cost-effective validation methods. Furthermore, evolving regulatory frameworks, particularly in China and India, are aligning with global standards, reinforcing the necessity of extensive bioprocess validation protocols.

Latin America Bioprocess Validation Market Analysis

The Latin American bioprocess validation market is growing due to increasing biopharmaceutical production in countries like Brazil, Mexico, and Argentina. Government initiatives supporting local biologics manufacturing and biosimilar development drive validation requirements. In line with this, rising investments in biotech startups and CDMOs is contributing to the market expansion. Reports indicate a substantial rise in venture capital investments in biotech across Brazil and Latin America, with Brazil accounting for over 60% of the region's share in 2023. Furthermore, the region is aligning its regulatory frameworks with international standards, prompting manufacturers to enhance validation procedures. Growing demand for vaccines and monoclonal antibodies is boosting process validation needs. Additionally, the rising adoption of single-use bioprocessing systems is increasing the need for validation services to ensure sterility and efficiency.

Middle East and Africa Bioprocess Validation Market Analysis

The growing pharmaceutical and biopharmaceutical manufacturing sectors in the UAE, Saudi Arabia, and South Africa are driving market expansion. In the Middle East and Africa's pharmaceutical industry, 16 M&A deals were announced in Q3 2024, totaling USD 1.8 billion, according to reports. In addition, government initiatives promoting local vaccine and biosimilar production are increasing validation requirements. The region's improving regulatory landscape, with agencies striving to meet global quality standards, is encouraging rigorous validation processes. Furthermore, growing investments in biotechnology research and partnerships with global biopharma companies further support the market growth. Apart from this, the rise in chronic diseases and demand for biologics is pushing manufacturers to adopt validated bioprocessing solutions for quality assurance.

Competitive Landscape:

Key players in the bioprocess validation market are adopting strategic initiatives to reinforce their market presence and address the evolving needs of the biopharmaceutical sector. They are investing in advanced technologies to optimize validation processes while maintaining compliance with strict regulatory requirements. Collaborations and partnerships are being formed to expand service offerings and global reach. Additionally, companies are focusing on integrating digital solutions and automation to improve efficiency and data accuracy in validation procedures. These initiatives indicate a commitment to innovation, quality assurance, and the expansion of capabilities to support the growing complexity of biopharmaceutical products.

The report provides a comprehensive analysis of the competitive landscape in the bioprocess validation market with detailed profiles of all major companies, including:

  • Almac Group, Biozeen
  • Doc S.R.L.
  • Eurofins Scientific
  • Hangzhou Anow Microfiltration Co. Ltd.
  • Hangzhou Cobetter Filtration Equipment Co. Ltd.
  • Hangzhou Tianshan Precision Filter Material Co. Ltd.
  • Meissner Filtration Products, Inc.
  • Merck KGaA
  • Sartorius AG
  • SGS SA
  • Thermo Fisher Scientific Inc.

Key Questions Answered in This Report

  • 1.How big is the bioprocess validation market?
  • 2.What is the future outlook of bioprocess validation market?
  • 3.What are the key factors driving the bioprocess validation market?
  • 4.Which region accounts for the largest bioprocess validation market share?
  • 5.Which are the leading companies in the global bioprocess validation 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 Bioprocess Validation Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Test Type

  • 6.1 Extractables Testing Services
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Microbiological Testing Services
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Physiochemical Testing Services
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast
  • 6.4 Integrity Testing Services
    • 6.4.1 Market Trends
    • 6.4.2 Market Forecast
  • 6.5 Compatibility Testing Services
    • 6.5.1 Market Trends
    • 6.5.2 Market Forecast
  • 6.6 Others
    • 6.6.1 Market Trends
    • 6.6.2 Market Forecast

7 Market Breakup by Process Component

  • 7.1 Filter Elements
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Media Containers and Bags
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Freezing And Thawing Process Bags
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Mixing Systems
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Bioreactors
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast
  • 7.6 Transfer Systems
    • 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 End User

  • 8.1 Pharmaceutical and Biotechnology Companies
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Contract Development and Manufacturing Organizations
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Others
    • 8.3.1 Market Trends
    • 8.3.2 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 Almac Group
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
      • 14.3.1.3 SWOT Analysis
    • 14.3.2 Biozeen
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
    • 14.3.3 Doc S.R.L.
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
    • 14.3.4 Eurofins Scientific
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 Financials
      • 14.3.4.4 SWOT Analysis
    • 14.3.5 Hangzhou Anow Microfiltration Co. Ltd.
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
    • 14.3.6 Hangzhou Cobetter Filtration Equipment Co. Ltd.
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
    • 14.3.7 Hangzhou Tianshan Precision Filter Material Co. Ltd.
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
    • 14.3.8 Meissner Filtration Products, Inc.
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
    • 14.3.9 Merck KGaA
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
      • 14.3.9.3 Financials
      • 14.3.9.4 SWOT Analysis
    • 14.3.10 Sartorius AG
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
      • 14.3.10.3 Financials
      • 14.3.10.4 SWOT Analysis
    • 14.3.11 SGS SA
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 Financials
    • 14.3.12 Thermo Fisher Scientific Inc.
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
      • 14.3.12.3 Financials
      • 14.3.12.4 SWOT Analysis