无菌测试市场 - 按产品、测试、类型、应用程式、最终用户、全球预测

Sterility Testing Market - By Product, Test, Type, Application, End-user, Global Forecast

出版日期: 2024年04月12日 | 出版商:

Global Market Insights Inc. | 英文 202 Pages | 商品交期: 2-3个工作天内

价格

简介目录

在慢性病盛行率上升的推动下，无菌检测市场在 2024 年至 2032 年期间的复合年增长率预计将达到 10.6%。根据世界卫生组织称，如果目前的趋势持续下去，到2050 年，心血管疾病、癌症、糖尿病和呼吸系统疾病等非传染性疾病(NCD) 可能占预计每年9,000 万死亡人数的86%，比2019年增加90%。严格的无菌测试确保了这些医疗产品的安全性和有效性。

慢性病管理通常涉及使用注射药物、植入物和其他无菌医疗器械，所有这些都需要严格的无菌测试。因此，对解决慢性病的安全可靠的医疗解决方案的需求不断增长，正在推动市场扩张。

此外，重点是减少测试週转时间。快速微生物方法和自动化测试系统越来越多地被采用来简化无菌测试过程，从而能够更快地检测污染物并加快产品的商业化。这将提振未来几年的市场前景。

无菌检测市场根据测试、类型、应用、最终用途、产品和地区进行分类。

由于许多製药和生物技术公司将其无菌测试要求外包给专业服务供应商，服务领域将在预测期内快速成长。这些提供者提供一系列测试服务，包括常规无菌测试、方法开发和验证、环境监测和微生物测试。外包这些服务使公司能够利用专业实验室的专业知识和先进设施，确保遵守监管标准，同时降低营运成本和周转时间。

直接接种测试领域将在 2032 年之前受到关注，因为它简单且能够测试各种产品，包括注射药物、眼用溶液和其他肠胃外製剂。此方法对于检测需氧和厌氧微生物非常有效，确保全面的无菌评估。它的应用在膜过滤不可行的情况下至关重要，例如粘性或含有颗粒的样品。直接接种的采用是由于其可靠性、易用性和符合监管指南的推动。

在中国、印度、日本和韩国等国家製药和生物技术产业快速成长的推动下，到 2032 年，亚太地区无菌检测产业将以良好的速度成长。该地区对医疗基础设施的投资不断增加，加上对高品质医疗产品的需求不断增长，推动了严格无菌测试的需求。此外，支持生命科学产业发展的有利政府措施和政策正在为市场成长创造有利的环境。

主要趋势
北美洲
- 我们
- 加拿大
欧洲
- 德国
- 英国
- 法国
- 西班牙
- 义大利
- 欧洲其他地区
亚太地区
- 中国
- 日本
- 印度
- 澳洲
- 亚太地区其他地区
拉丁美洲
- 巴西
- 墨西哥
- 拉丁美洲其他地区
中东和非洲
- 南非
- 沙乌地阿拉伯
- 中东和非洲其他地区

第 11 章：公司简介

bioMerieux SA
Charles River Laboratories International Inc.
Merck KGaA
Nelson Laboratories, LLC
Pacific Biolabs
Rapid Micro Biosystems Inc.
Sartorius AG
SGS SA
Thermo Fisher Scientific Inc.
WuXi AppTec

简介目录

Product Code: 4077

The Sterility Testing Market is poised to record a CAGR of 10.6% during 2024-2032, driven by the rising prevalence of chronic diseases. According to WHO, if current trends persist, non-communicable diseases (NCDs) like cardiovascular diseases, cancer, diabetes, and respiratory illnesses could constitute 86% of the projected 90 million annual deaths by 2050, marking a 90% increase from 2019. As the global burden of chronic illnesses continues to escalate, there is an increasing demand for effective pharmaceutical treatments and biologics. The rigorous sterility testing to ensure the safety and efficacy of these medical products.

Chronic disease management often involves the use of injectable drugs, implants, and other sterile medical devices, all of which require stringent sterility testing. Consequently, the growing need for safe and reliable medical solutions to address chronic diseases is driving market expansion.

Further, there is focus on reducing testing turnaround times. Rapid microbiological methods and automated testing systems are increasingly being adopted to streamline the sterility testing process, enabling quicker detection of contaminants and faster commercialization of products. This will bolster the market outlook in the coming years.

The sterility testing market is classified based on test, type, application, end-use, product, and region.

The services segment will grow rapidly over the forecast period, as many pharmaceutical and biotechnology companies outsource their sterility testing requirements to specialized service providers. These providers offer a range of testing services, including routine sterility testing, method development & validation, environmental monitoring, and microbiological testing. Outsourcing these services allows companies to leverage the expertise and advanced facilities of specialized laboratories, ensuring compliance with regulatory standards while reducing operational costs and turnaround times.

The direct inoculation test segment will gain traction through 2032, owing to its simplicity and ability to test a variety of products, including injectable drugs, ophthalmic solutions, and other parenteral preparations. The method is highly effective for detecting both aerobic and anaerobic microorganisms, ensuring comprehensive sterility assessment. Its application is critical in scenarios where membrane filtration is not feasible, such as with viscous or particulate-containing samples. The adoption of direct inoculation is driven by its reliability, ease of use, and compliance with regulatory guidelines.

Asia Pacific sterility testing industry will grow at a decent pace through 2032, driven by the rapid growth of the pharmaceutical and biotechnology sectors in countries like China, India, Japan, and South Korea. The region's increasing investment in healthcare infrastructure, coupled with the rising demand for high-quality medical products, is propelling the need for rigorous sterility testing. Moreover, favorable government initiatives and policies supporting the development of the life sciences sector are creating a conducive environment for market growth.

Chapter 1 Methodology & Scope

1.1 Market scope & definitions
1.2 Research design
- 1.2.1 Research approach
- 1.2.2 Data collection methods
1.3 Base estimates & calculations
- 1.3.1 Base year calculation
- 1.3.2 Key trends for market estimation
1.4 Forecast model
1.5 Primary research and validation
- 1.5.1 Primary sources
- 1.5.2 Data mining sources

Chapter 2 Executive Summary

2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

3.1 Industry ecosystem analysis
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Increasing demand for biopharmaceuticals
  - 3.2.1.2 Increasing outsourcing of sterility testing services
  - 3.2.1.3 Technological advancements in sterility testing
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 Time-consuming testing process
  - 3.2.2.2 Complex regulatory framework
3.3 Growth potential analysis
3.4 Regulatory landscape
3.5 Porter's analysis
3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

4.1 Introduction
4.2 Company matrix analysis
4.3 Competitive analysis of major market players
4.4 Competitive positioning matrix
4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 - 2032 ($ Million)

5.1 Key trends
5.2 Kits & reagents
5.3 Services
5.4 Instruments

Chapter 6 Market Estimates and Forecast, By Test, 2021 - 2032 ($ Million)

6.1 Key trends
6.2 Membrane filtration
6.3 Direct inoculation
6.4 Rapid microbial method
- 6.4.1 ATP bioluminescence
- 6.4.2 Fluorescent -based
- 6.4.3 Solid-phase cytometry
- 6.4.4 Other rapid microbial methods
6.5 Other tests

Chapter 7 Market Estimates and Forecast, By Type, 2021 - 2032 ($ Million)

7.1 Key trends
7.2 In-house
7.3 Outsourced

Chapter 8 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Million)

8.1 Key trends
8.2 Pharmaceutical and biological manufacturing
8.3 Medical devices manufacturing
8.4 Other applications

Chapter 9 Market Estimates and Forecast, By End-User, 2021 - 2032 ($ Million)

9.1 Key trends
9.2 Pharmaceutical & biotechnology companies
9.3 Medical device companies
9.4 CROs and contract testing laboratories
9.5 Other end-users

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

10.1 Key trends
10.2 North America
- 10.2.1 U.S.
- 10.2.2 Canada
10.3 Europe
- 10.3.1 Germany
- 10.3.2 UK
- 10.3.3 France
- 10.3.4 Spain
- 10.3.5 Italy
- 10.3.6 Rest of Europe
10.4 Asia Pacific
- 10.4.1 China
- 10.4.2 Japan
- 10.4.3 India
- 10.4.4 Australia
- 10.4.5 Rest of Asia Pacific
10.5 Latin America
- 10.5.1 Brazil
- 10.5.2 Mexico
- 10.5.3 Rest of Latin America
10.6 Middle East and Africa
- 10.6.1 South Africa
- 10.6.2 Saudi Arabia
- 10.6.3 Rest of Middle East and Africa