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市場調査レポート
商品コード
1455093
生物製剤安全性試験の世界市場規模、シェア、成長分析、試験別、用途別、最終用途別-産業予測、2024～2031年Global Biologics Safety Testing Market Size, Share, Growth Analysis, By Test, By Application, By End-use - Industry Forecast 2024-2031 |
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| 生物製剤安全性試験の世界市場規模、シェア、成長分析、試験別、用途別、最終用途別-産業予測、2024～2031年 |
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出版日: 2024年03月20日
発行: SkyQuest
ページ情報: 英文 219 Pages
納期: 3～5営業日
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- 全表示
- 概要
- 目次
生物製剤安全性試験の世界市場規模は、2022年に47億米ドルと評価され、2023年の52億5,000万米ドルから2031年には127億2,000万米ドルに成長し、予測期間（2024～2031年）のCAGRは11.70％で成長する展望です。
生物製剤安全性試験には、生物製剤起源に由来する製品、特にバイオ医薬品や医療機器の安全性を保証するために不可欠な、幅広い細心の手順が含まれます。その主要目的は、汚染や生物製剤の悪影響などの要因を注意深く調べることによって、これらの製品に関連する潜在的なリスクを評価し、軽減することです。厳格な規制基準の遵守は、生物製剤材料の純度、力価、全体的な安全性を確保するために不可欠です。無菌試験、エンドトキシン評価、細胞ベースアッセイなどの技術は、これらの製品を徹底的に評価し、厳格な安全基準への準拠を確認し、臨床応用や公衆衛生保護への適合性を確保する上で重要な役割を果たしています。
目次
エグゼクティブサマリー
- 市場概要
- 繁栄と衰退
調査手法
- 情報調達
- セカンダリとプライマリデータソース
- 市場規模の推定
- 市場の前提条件と制限
親市場の分析
- 市場概要
- 市場規模
- 市場力学
- 促進要因
- 機会
- 抑制要因
- 課題
主要市場の考察
- 技術分析
- 価格分析
- サプライチェーン分析
- バリューチェーン分析
- 市場のエコシステム
- IP分析
- 貿易分析
- スタートアップ分析
- 原材料の分析
- イノベーションマトリクス
- パイプライン製品の分析
- マクロ経済指標
- 主要投資の分析
- 主要成功要因
- 競合の程度
市場力学と展望
- 市場力学
- 促進要因
- 機会
- 抑制要因
- 課題
- 規制情勢
- ポーターの分析
- 将来の混乱についての特別な考察
生物製剤安全性試験の世界市場：試験別
- 市場概要
- エンドトキシン試験
- 無菌試験
- 外来性病原体検出試験
- その他
生物製剤安全性試験の世界市場：用途別
- 市場概要
- 血液と血液ベースの製品
- ワクチンと治療法
- 幹細胞
- その他
生物製剤安全性試験の世界市場：最終用途別
- 市場概要
- 製薬会社・バイオテクノロジー会社
- 受託開発・製造会社
- 研究・学術
- その他
生物製剤安全性試験の世界市場規模：地域別
- 市場概要
- 北米
- 米国
- カナダ
- 欧州
- ドイツ
- スペイン
- フランス
- 英国
- その他の欧州地域
- アジア太平洋
- 中国
- インド
- 日本
- 韓国
- その他のアジア太平洋
- ラテンアメリカ
- ブラジル
- その他のラテンアメリカ地域
- 中東・アフリカ
- GCC諸国
- 南アフリカ
- その他中東・アフリカ地域
競合情勢
- 上位5社の比較
- 主要企業の市場ポジショニング（2021年）
- 主要市場企業が採用した戦略
- 主要成功戦略
- 市場における最近の活動
- 主要企業の市場シェア（2021年）
主要企業プロファイル
- Cytovance Biologics
- Eurofins Scientific
- Merck KGaA
- Biomerieux SA
- Lonza
- Promega Corporation
- Thermo Fisher Scientific
- WuXi AppTec
- Nelson Laboratories, LLC
- Almac Group
- GenScript
- InvivoGen
- Toxikon
- Maravai LifeSciences
Global Biologics Safety Testing Market size was valued at USD 4.70 billion in 2022 and is poised to grow from USD 5.25 billion in 2023 to USD 12.72 billion by 2031, growing at a CAGR of 11.70% during the forecast period (2024-2031).
Biological safety testing encompasses a wide range of meticulous procedures vital for guaranteeing the safety of products sourced from biological origins, particularly biopharmaceuticals and medical devices. Its primary objective is to evaluate and mitigate potential risks associated with these products by carefully examining factors such as contamination and adverse biological effects. Adherence to strict regulatory standards is essential to ensure the purity, potency, and overall safety of biological materials. Techniques like sterility testing, endotoxin assessment, and cell-based assays play crucial roles in thoroughly assessing these products, confirming their compliance with stringent safety criteria and ensuring their suitability for clinical application and public health protection.
Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biologics Safety Testing Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.
Global Biologics Safety Testing Market Segmental Analysis
The global Biologics Safety Testing market is segmented on the basis of test, application, end-use, and region. Based on Test, it is divided into Endotoxin Test, Bioburden Tests, Sterility Test, Adventitious Agent Detection Test, Others. Based on Application, it is divided into Blood & Blood-based Products, Gene Therapy, Vaccines & Therapeutics, Stem Cells, Others. Based on End-use, it is divided into Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia, Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Drivers of the Global Biologics Safety Testing Market
The significant growth observed in the pharmaceutical and biotechnology fields, driven by substantial investments in research and development, marks a crucial era in healthcare advancement. These sectors are leading the way in developing pharmaceuticals, biologics, and vaccines to tackle a wide range of healthcare challenges, particularly in combating complex diseases. This surge in innovation underscores the heightened need for rigorous safety assessments, with biological safety testing playing a pivotal role in ensuring patient safety.
Restraints in the Global Biologics Safety Testing Market
Biologics and biosimilars constitute an innovative class of drugs sourced from living organisms, providing effective therapies for a wide range of conditions such as cancer, diabetes, rheumatoid arthritis, and diverse inflammatory disorders.
Market Trends of the Global Biologics Safety Testing Market
Global regulatory authorities have intensified their oversight of biopharmaceuticals, placing significant importance on patient safety and product quality. These rigorous regulations require comprehensive safety assessments, making biological safety testing a fundamental aspect of the drug approval process. Pharmaceutical and biotech companies must rigorously comply with these evolving standards to ensure product approval and market access. The growing focus on compliance drives a surge in demand for testing services, solidifying the crucial role of biological safety testing in this regulatory landscape.
Table of Contents
Executive Summary
- Market Overview
- Wheel of Fortune
Research Methodology
- Information Procurement
- Secondary & Primary Data Sources
- Market Size Estimation
- Market Assumptions & Limitations
Parent Market Analysis
- Market Overview
- Market Size
- Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
Key Market Insights
- Technology Analysis
- Pricing Analysis
- Supply Chain Analysis
- Value Chain Analysis
- Ecosystem of the Market
- IP Analysis
- Trade Analysis
- Startup Analysis
- Raw Material Analysis
- Innovation Matrix
- Pipeline Product Analysis
- Macroeconomic Indicators
- Top Investment Analysis
- Key Success Factor
- Degree of Competition
Market Dynamics & Outlook
- Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
- Regulatory Landscape
- Porters Analysis
- Competitive rivalry
- Threat of Substitute Products
- Bargaining Power of Buyers
- Threat of New Entrants
- Bargaining Power of Suppliers
- Skyquest Special Insights on Future Disruptions
- Political Impact
- Economic Impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Global Biologics Safety Testing Market by Test
- Market Overview
- Endotoxin Test
- Sterility Test
- Adventitious Agent Detection Test
- and Others
Global Biologics Safety Testing Market by Application
- Market Overview
- Blood & Blood-based Products
- Vaccines & Therapeutics
- Stem Cells
- and Others
Global Biologics Safety Testing Market by End-use
- Market Overview
- Pharmaceutical and Biotechnology Companies
- Contract Development and Manufacturing Companies
- Research and Academia
- and Others
Global Biologics Safety Testing Market Size by Region
- Market Overview
- North America
- USA
- Canada
- Europe
- Germany
- Spain
- France
- UK
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
- Latin America
- Brazil
- Rest of Latin America
- Middle East & Africa (MEA)
- GCC Countries
- South Africa
- Rest of MEA
Competitive Landscape
- Top 5 Player Comparison
- Market Positioning of Key Players, 2021
- Strategies Adopted by Key Market Players
- Top Winning Strategies
- By Development
- By Company
- By Year
- Recent Activities in the Market
- Key Companies Market Share (%), 2021
Key Company Profiles
- Cytovance Biologics
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Eurofins Scientific
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Merck KGaA
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Biomerieux SA
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Lonza
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Promega Corporation
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Thermo Fisher Scientific
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- WuXi AppTec
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Nelson Laboratories, LLC
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Almac Group
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- GenScript
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- InvivoGen
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Toxikon
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Maravai LifeSciences
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
