全球药品无菌检测市场规模、份额、成长分析，按类型（内部和外包）、按样本（药品、医疗器材）- 2024-2031 年产业预测

Global Pharmaceutical Sterility Testing Market Size, Share, Growth Analysis, By Type(In-house, and Outsourcing), By Sample(Pharmaceuticals, Medical Devices) - Industry Forecast 2024-2031

出版日期: 2024年04月06日 | 出版商:

SkyQuest | 英文 219 Pages | 商品交期: 3-5个工作天内

价格

简介目录

2022年，全球药品无菌检测市场规模为14.8亿美元，预计将从2023年的16.6亿美元成长到2031年的41.0亿美元，在预测期内（2024-2031年）复合年增长率为12% 。

对高品质药品的需求、对药物安全性和有效性的日益重视以及无菌检测的监管要求是推动全球药品无菌检测市场的主要因素。透过检查活微生物的存在，药物无菌测试可确保药物和其他药品的功效和安全性。监管机构强制要求进行无菌测试，以确保药物和其他医疗用品不受微生物污染，这可能会对患者造成严重的负面影响。药品无菌检测市场主要由三个因素驱动：对高品质药品的需求、对药物安全性和有效性的日益重视以及无菌检测的监管要求。为了确保其安全性和有效性，美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构强制要求所有药物和医疗产品都经过无菌测试。因此，近年来对药物无菌测试的需求显着增加。药品无菌检测产业发展的主要障碍是与检测商品和服务相关的高昂费用。无菌检测过程复杂且耗时，需要熟练的工人和精密的设备。这可以阻止一些企业进入该行业并限制其扩张。药品日益复杂化是药品无菌检测产业面临的主要障碍之一。

市场概况
北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 欧洲其他地区
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
拉丁美洲
- 巴西
- 拉丁美洲其他地区
中东和非洲 (MEA)
- 海湾合作委员会国家
- 南非
- MEA 的其余部分

竞争格局

前 5 名玩家比较
2021 年关键参与者的市场定位
主要市场参与者所采取的策略
最佳制胜策略
近期市集活动
主要公司市占率（%），2021年

主要公司简介

Charles River Laboratories International, Inc. (US)
Eurofins Scientific (Luxembourg)
Merck KGaA (Germany)
Thermo Fisher Scientific Inc. (US)
SGS SA (Switzerland)
WuXi AppTec (China)
bioMA(C)rieux SA (France)
Nelson Laboratories, LLC (US)
Pace Analytical Services, LLC (US)
Toxikon Corporation (US)
Sartorius AG (Germany)
STERIS plc (US)
Microbac Laboratories, Inc. (US)
North American Science Associates, Inc. (US)
Gibraltar Laboratories (US)
Boston Analytical, Inc. (US)
Analytical Lab Group (US)
Becton, Dickinson and Company (US)
Pacific Biolabs (US)
Dynatec Labs (US)

简介目录

Product Code: SQMIG35I2168

Global Pharmaceutical Sterility Testing Market size was valued at USD 1.48 billion in 2022 and is poised to grow from USD 1.66 billion in 2023 to USD 4.10 billion by 2031, growing at a CAGR of 12% during the forecast period (2024-2031).

The need for high-quality pharmaceutical goods, the growing emphasis on drug safety and efficacy, and the regulatory requirements for sterility testing are the main factors driving the global pharmaceutical sterility testing market. By checking for the presence of live microorganisms, pharmaceutical sterility testing ensures the efficacy and safety of medications and other pharmaceutical items. Regulatory bodies mandate sterility testing to guarantee that medications and other medical supplies are free of microbiological contamination, which can have grave negative consequences on patients. The market for pharmaceutical sterility testing is primarily driven by three factors: the need for high-quality pharmaceutical goods, the growing emphasis on drug safety and efficacy, and the regulatory requirements for sterility testing. To guarantee its safety and effectiveness, regulatory bodies like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) mandate that all medications and medical products undergo sterility testing. Consequently, there has been a notable surge in the need for pharmaceutical sterility testing in recent times. The primary impediment to the growth of the pharmaceutical sterility testing industry is the exorbitant expenses associated with testing goods and services. The process of sterility testing is intricate and time-consuming, requiring skilled workers and sophisticated equipment. This can prevent some businesses from entering the industry and restrict its expansion. The growing complexity of pharmaceutical goods is one of the main obstacles facing the pharmaceutical sterility testing sector.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Pharmaceutical Sterility 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 Pharmaceutical Sterility Testing Market Segmental Analysis

The global pharmaceutical sterility testing market is segmented on the basis of type, application, and region. Based on type, the market is segmented into in-house, and outsourcing. In terms of sample, the market is grouped into pharmaceuticals, medical devices, and biopharmaceuticals. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Drivers of the Global Pharmaceutical Sterility Testing Market

Because biologics and biosimilar medications are so successful in treating critical illnesses including cancer, neurological conditions, and infectious diseases, there has been a surge in demand for these medications in recent years. As a result, there is a growing need for pharmaceutical sterility testing to guarantee the security and effectiveness of these goods. The market for pharmaceutical sterility testing has expanded as a result of the approval of multiple biosimilar medications in recent years, including Adalimumab, Rituximab, and Trastuzumab.

Restraints in the Global Pharmaceutical Sterility Testing Market

Many clients may find the high expense of pharmaceutical sterility testing services to be a major deterrent, particularly in developing nations or environments with limited resources. In order to meet FDA standards, small and medium-sized pharmaceutical and medical device firms prefer to outsource sterility testing because they may not have the resources to perform high-quality tests.

Market Trends of the Global Pharmaceutical Sterility Testing Market

The pharmaceutical industry is seeing an increase in the use of quick microbial detection technologies due to their ability to expedite results and reduce testing durations. It is expected that this trend will continue in the years to come.

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 Pharmaceutical Sterility Testing Market by Type

Market Overview
In-house
and Outsourcing

Global Pharmaceutical Sterility Testing Market by Sample

Market Overview
Pharmaceuticals
Medical Devices
and Biopharmaceuticals

Global Pharmaceutical Sterility 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

Charles River Laboratories International, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Eurofins Scientific (Luxembourg)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SGS SA (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
bioMA(C)rieux SA (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nelson Laboratories, LLC (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pace Analytical Services, LLC (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Toxikon Corporation (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
STERIS plc (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Microbac Laboratories, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
North American Science Associates, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Gibraltar Laboratories (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Boston Analytical, Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Analytical Lab Group (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Becton, Dickinson and Company (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pacific Biolabs (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Dynatec Labs (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments