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生技設備

市場調查報告書

商品編碼

1455093

全球生物製品安全測試市場規模、佔有率、成長分析（依測試、依應用、依最終用途）- 2024-2031 年產業預測

Global Biologics Safety Testing Market Size, Share, Growth Analysis, By Test, By Application, By End-use - Industry Forecast 2024-2031

出版日期: 2024年03月20日 | 出版商:

SkyQuest | 英文 219 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

2022年，全球生物製品安全測試市場規模為47.0億美元，預計將從2023年的52.5億美元成長到2031年的127.2億美元，在預測期內（2024-2031年）複合年成長率為11.70% 。

生物安全測試涵蓋一系列細緻的程序，對於確保生物來源產品的安全至關重要，特別是生物製藥和醫療器材。其主要目標是透過仔細檢查污染和不良生物效應等因素來評估和減輕與這些產品相關的潛在風險。遵守嚴格的監管標準對於確保生物材料的純度、效力和整體安全性至關重要。無菌檢測、內毒素評估和細胞檢測等技術在徹底評估這些產品、確認其符合嚴格的安全標準並確保其適合臨床應用和公共衛生保護方面發揮著至關重要的作用。

市場概況
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 歐洲其他地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 拉丁美洲其他地區
中東和非洲 (MEA)
- 海灣合作理事會國家
- 南非
- MEA 的其餘部分

競爭格局

前 5 名企業比較
2021 年關鍵參與者的市場定位
主要市場參與者所採取的策略
最佳制勝策略
近期市集活動
主要公司市佔率（%），2021年

主要公司簡介

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

簡介目錄

Product Code: SQMIG35A2786

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.

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