バイオプロセスバリデーションの世界市場-2022-2029

市場力学

バイオ医薬品の世界の需要の増加が、バイオプロセスバリデーション市場の需要を押し上げると予想される

バイオ医薬品の膨大な需要は、研究開発関連投資への加速度的な集中によって促進されています。バイオプロセスバリデーションサービスのアウトソーシングに対する高い需要、医療業界のバイオ医薬品および製薬業界を超えて製品の認証や試験を管理する厳しい安全および品質規制は、優良製造規範との合意を維持するために、世界のバイオプロセスバリデーション産業の成長を推進する重要な要因となっています。

抽出物と浸出物に関する問題が、バイオプロセスバリデーションの世界市場を抑制すると予想される

シングルユース技術は近年、バイオプロセス開発およびバイオ医薬品製造に広く採用されています。このような技術の利点は十分に認識されていますが、製品の品質や患者の健康に影響を及ぼす可能性があるため、シングルユースシステムの構成要素からの抽出物や浸出物に関する大きな懸念が存在します。通常、抽出物や溶出物が製品の流れに移行する可能性や患者への潜在的なリスクを評価するために、リスクアセスメントが必要とされます。予測期間中は、抽出物や浸出物に関連する問題が、バイオプロセスバリデーションの世界市場の成長を抑制すると予想されます。

新興市場への進出がバイオプロセスバリデーションの世界市場に新たな機会をもたらすと予想される

アジア地域では、中国がバイオプロセスバリデーションの有望な市場であり、インドがそれに続いています。この市場の成長は、政府の好意的な支援、民間投資の増加、高齢者人口の増加、アジア新興国へのアウトソーシングの増加傾向に起因していると考えられます。インド、日本、ブラジルは、市場参加者の新たな収益源になると予想されます。また、バイオ製造インフラへの投資が多いことも、これらの市場の高成長ポテンシャルの主な要因となっています。新興市場が提供する新たな機会は、世界市場の成長を後押しするものと期待されています。

バイオプロセスバリデーションに関する政府の厳しい規制は、バイオプロセスバリデーションの世界市場に課題をもたらすと予想されます。

バリデーションは、製薬およびバイオテクノロジー企業が一般消費者向けに安全な医薬品を一貫して製造していることを確認するための規制要件です。企業は、規制当局による監査などの際に、バリデーション活動の証拠を提出できなければなりません。バイオプロセスバリデーションに関する政府の規制は複雑であるため、より幅広い用途に採用することができず、世界のバイオプロセスバリデーション市場の成長にとって課題となっています。

目次

第1章 調査手法と調査範囲

• 調査手法
• 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

• テストタイプ別市場内訳
• プロセス別市場内訳
• エンドユーザー別市場内訳
• 地域別市場内訳

第4章 市場力学

• 市場影響要因
• 促進要因
  • オペレーションとプロセスの実現可能性
  • バイオ医薬品や製薬業界における製品認証や試験を規定する厳しい安全・品質規制
• 抑制要因
  • 政府別規制
• 影響分析
• 機会

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 法規制分析
• 価格設定分析
• 製品分析
• COVID-19影響度分析

第6章 試験タイプ別

• 抽出物/浸出物検査サービス
• 微生物検査サービス
• 完全性試験サービス
• 物理化学試験サービス
• 適合性試験サービス
• その他

第7章 プロセス別

• メディア容器・袋
• 凍結・解凍用バッグ
• フィルターエレメント
• その他

第8章 エンドユーザー別

• 製薬会社
• バイオテクノロジー企業
• その他

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ地域

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A（合併・買収）分析

第11章 企業プロファイル

• Cobetter Filtration Equipments Co., Ltd.
  • 企業概要
  • 製品ポートフォリオと説明
  • 主な発展状況
  • 財務概要
• SGS S.A.
• DOC S.r.l.
• Thermo Fisher Scientific
• Toxikon Corporation
• Sartorius Stedim Biotech
• Eurofins Scientific
• Pall Corporation
• MEISSNER FILTRATION PRODUCTS, INC.
• Merck KGaA（*List is not exhaustive）

第12章 DataM

Market Overview

Bioprocess Validation Market size was valued at USD 224,687.30 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 11.20% over the forecast period 2022 to 2029.

Bioprocess Validation is a process that involves collecting documentary evidence to ensure that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. An important part of bioprocess validation requires evaluating active pharmaceutical ingredients (APIs) and possible contaminants, such as mycoplasma, bacteria, endotoxin, and others, during the development and manufacture processes of animal disinfectants or other biological products.

Market Dynamics

Increasing global demand for biopharmaceuticals is expected to boost the demand for the bioprocess validation market

The huge demand for biopharmaceuticals is facilitated by an accelerating focus on research and development-related investments. High demand for outsourcing bioprocess validation services, stringent safety and quality regulations governing product certifications and testing beyond the biopharmaceutical and pharmaceutical industries in the healthcare industry to maintain the agreement with good manufacturing practices are the important factors propelling the growth of the global bioprocess validation industry.

Issues related to extractables and leachables are expected to restrain the global bioprocess validation market

Single-use technology has been adopted widely in bioprocess development and biopharmaceutical manufacturing in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractable and leachable from the components of single-use systems owing to their potential effect on product quality and patient health. A risk assessment is normally required to assess the probability of extractable and leachables migrating into the product stream and their potential risk to the patient. During the forecast period, the issues related to extractables and leachables are expected to restrain the growth of the global market for bioprocess validation.

Expansion into emerging markets is expected to generate new opportunities for the global bioprocess validation market

In the Asian region, China is a high-potential market for bioprocess validation, followed by India. The growth in this market can be attributed to favorable government support, rising private investments, a growing geriatric population, and a rising trend of outsourcing to emerging Asian countries. India, Japan, and Brazil are expected to be the new revenue pockets for market players. Also, the high investment in bio-manufacturing infrastructure is a key factor responsible for the high-growth potential of these markets. The new opportunities offered by the emerging markets are expected to boost the growth of the global market.

Stringent government regulations on bioprocess validation are expected to present challenges for the global market for bioprocess validation

Validation is a regulatory requirement for pharmaceutical and biotechnology companies to confirm that they consistently manufacture safe medicines for the public. Companies must be able to provide proof of validation activities when requested, such as during an audit by regulatory agencies. The complexity of government regulations for bioprocess validation prevents its adoption for a wider range of applications and presents a challenge to the growth of the global bioprocess validation market.

Market Segmentation:

The scope of the report covers segmentation based on test type, process component, end-user and region. The global bioprocess validation market is segmented by test type into extractables/leachables testing services, microbiological testing services, integrity testing services, physiochemical testing services, compatibility testing services and others. The global market is segmented by process component into media containers and bags, freezing and thawing process bags, filter elements, bioreactors and others. The global market is segmented by end-user into pharmaceutical companies, biotechnology companies, contract development and manufacturing organizations and others. The global market is segmented by region into North America, South America, Europe, Asia-Pacific, Middle East and Africa.

Pharmaceutical Companies: Pharmaceutical companies have a large share of the end-user segment, which can majorly be attributed to the increasing production of biopharmaceuticals and the corresponding increase in the number of impurities to be checked for, the stringency of standards and regulations regarding the quality and validity of bioprocesses involved in the production

Biotechnology Companies: The biotechnology sector is experiencing rapid growth due to favorable governmental policies. Government initiatives are oriented towards modernizing the drug regulatory pathway, standardizing clinical studies, improving reimbursement policies, and speeding up the product approval process, thereby offering lucrative growth opportunities to the market.

Contract Development & Manufacturing Organizations: With developments in the pharmaceutical industry, leading contract development and manufacturing organizations (CDMOs) aim to seek and bridge capability gaps. CDMOs offering multiple services increase convenience, save time, and enhance cost efficiency as pharmaceutical companies have to only deal with a single entity. The relationship also creates opportunities for the CDMOs to sell more services to the same customer and lock in products at earlier stages of their life cycles

Others: The segment mainly includes laboratories and research institutes. Process-related cell-derived impurities such as buffer components, antibiotics, surfactants, anti-foaming agents, process enhancing agents, catalysts, or compounds that leach from contact materials can impede research projects. Therefore, process validation studies require a broad set of testing capabilities and expertise.

Regional Classification:

According to the DataM Intelligence market research report, the global bioprocess validation market is divided into;

North America - United States, and Canada

South America - Brazil, Argentina, Peru, Chile, and Rest of the South American countries

Europe - UK, Germany, Italy, France, Spain, Russia, and the rest of the European countries

Asia-Pacific - China, India, Japan, South Korea, Singapore, Australia, Malaysia, and the Rest of the Asia Pacific countries

Middle East and Africa - UAE, KSA, Qatar, South African Countries, and the Rest of the Middle East countries

Competitive Landscape:

The global bioprocess validation market is moderately competitive with several international and regional players. The major players adopt several growth strategies such as licensing activities, collaborations, mergers and acquisitions, government tie-ups, and joint ventures, thereby contributing to the growth of the global bioprocess validation market.

Major Companies:

Some key companies contributing to the growth of the global bioprocess validation market include Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Sartorius Stedim Biotech, Merck KGaA, Meissner Filtration Products, Inc., Eurofins Scientific, Boston Analytical and Danaher Corporation (Pall Corporation), among others.

Recent Developments in the Industry:

In July 2022, Vaccizone, a vaccine manufacturer, announced a partnership with Exothera, a biotechnology research company, to use Exothera's scale-X technology to develop Vaccizone's COVID-19 vaccine with expedited bioprocess validation.

In June 2022, Alder Therapeutics announced a deal to help with the bioprocess validation for NorthX Biologics, a Swedish biotech company. The deal will enable NorthX Biologics to expand into pluripotent stem cell research.

In June 2022, the Jefferson Institute for Bioprocessing (JIB) announced the commencement of its bio technician training and validation program at the Budd Bioworks research space in Philadelphia, U.S.

COVID-19 Impact Analysis

COVID-19 had a significant impact on the market. The pandemic caused significant manufacturing and supply-chain operations disruptions due to various precautionary lockdowns and other governmental restrictions globally. Because validation is required at all stages of drug development to monitor accuracy, efficiency, and safety, demand for bioprocess validation increased during the pandemic. The pandemic has increased the demand for bioprocess validation and is expected to positively impact the bioprocess validation market growth.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Market Definition and Overview

3. Executive Summary

• 3.1. Market Snippet by Test Type
• 3.2. Market Snippet by Process
• 3.3. Market Snippet by End-User
• 3.4. Market Snippet by Region

4. Market Dynamics

• 4.1. Market Impacting Factors
• 4.2. Drivers
  • 4.2.1. Feasibility of operations and processes
  • 4.2.2. The stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries
• 4.3. Restraints
  • 4.3.1. Government regulation
• 4.4. Impact Analysis
• 4.5. Opportunity

5. Industry Analysis

• 5.1. Porter's Five Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Regulatory Analysis
• 5.4. Pricing Analysis
• 5.5. Product Analysis
• 5.6. COVID-19 Impact Analysis

6. By Test Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 6.1.2. Market Attractiveness Index, By Test Type
• 6.2. Extractables/Leachables Testing Services *
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
• 6.3. Microbiological Testing Services
• 6.4. Integrity Testing Services
• 6.5. Physiochemical Testing Services
• 6.6. Compatibility Testing Services
• 6.7. Others

7. By Process

• 7.1. Introduction
  • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 7.1.2. Market Attractiveness Index, By Process
• 7.2. Media containers and bags
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
• 7.3. Freezing and thawing process bags
• 7.4. Filter elements
• 7.5. Others

8. By End-User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
  • 8.1.2. Market Attractiveness Index, By End-User
• 8.2. Pharmaceutical Companies
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis, US$ Mn, 2016-2025 and Y-o-Y Growth Analysis (%), 2019-2027
• 8.3. Biotechnology Companies
• 8.4. Others

9. By Region

• 9.1. Introduction
• 9.2. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Region
• 9.3. Market Attractiveness Index, By Region
• 9.4. North America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 9.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 9.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
  • 9.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. U.S.
    • 9.4.6.2. Canada
    • 9.4.6.3. Mexico
• 9.5. Europe
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 9.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 9.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
  • 9.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. Germany
    • 9.5.6.2. U.K.
    • 9.5.6.3. France
    • 9.5.6.4. Rest of Europe
• 9.6. South America
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 9.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 9.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User
  • 9.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.6.6.1. Brazil
    • 9.6.6.2. Argentina
    • 9.6.6.3. Rest of South America
• 9.7. Asia Pacific
  • 9.7.1. Introduction
  • 9.7.2. Key Region-Specific Dynamics
  • 9.7.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 9.7.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 9.7.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End-User
  • 9.7.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 9.7.6.1. China
    • 9.7.6.2. India
    • 9.7.6.3. Japan
    • 9.7.6.4. Australia
    • 9.7.6.5. Rest of Asia Pacific
• 9.8. Middle East and Africa
  • 9.8.1. Introduction
  • 9.8.2. Key Region-Specific Dynamics
  • 9.8.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Test Type
  • 9.8.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Process
  • 9.8.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By End User

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Cobetter Filtration Equipments Co., Ltd.*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Key Developments
  • 11.1.4. Financial Overview
• 11.2. SGS S.A.
• 11.3. DOC S.r.l.
• 11.4. Thermo Fisher Scientific
• 11.5. Toxikon Corporation
• 11.6. Sartorius Stedim Biotech
• 11.7. Eurofins Scientific
• 11.8. Pall Corporation
• 11.9. MEISSNER FILTRATION PRODUCTS, INC.
• 11.10. Merck KGaA (*List is not exhaustive)

12. DataM Intelligence

• 12.1. Appendix
• 12.2. About Us and Services
• 12.3. Contact Us