無菌測試市場 - 按產品、測試、類型、應用程式、最終用戶、全球預測

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個工作天內

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簡介目錄

在慢性病盛行率上升的推動下，無菌檢測市場在 2024 年至 2032 年期間的複合年成長率預計將達到 10.6%。根據世界衛生組織稱，如果目前的趨勢持續下去，到2050 年，心血管疾病、癌症、糖尿病和呼吸系統疾病等非傳染性疾病(NCD) 可能佔預計每年9,000 萬死亡人數的86%，比2019年增加90%。嚴格的無菌測試確保了這些醫療產品的安全性和有效性。

慢性病管理通常涉及使用注射藥物、植入物和其他無菌醫療器械，所有這些都需要嚴格的無菌測試。因此，對解決慢性病的安全可靠的醫療解決方案的需求不斷成長，正在推動市場擴張。

此外，重點是減少測試週轉時間。快速微生物方法和自動化測試系統擴大被採用來簡化無菌測試過程，從而能夠更快地檢測污染物並加快產品的商業化。這將提振未來幾年的市場前景。

無菌檢測市場根據測試、類型、應用、最終用途、產品和地區進行分類。

由於許多製藥和生物技術公司將其無菌測試要求外包給專業服務供應商，服務領域將在預測期內快速成長。這些提供者提供一系列測試服務，包括常規無菌測試、方法開發和驗證、環境監測和微生物測試。外包這些服務使公司能夠利用專業實驗室的專業知識和先進設施，確保遵守監管標準，同時降低營運成本和周轉時間。

直接接種測試領域將在 2032 年之前受到關注，因為它簡單且能夠測試各種產品，包括注射藥物、眼用溶液和其他腸胃外製劑。此方法對於檢測需氧和厭氧微生物非常有效，確保全面的無菌評估。它的應用在膜過濾不可行的情況下至關重要，例如粘性或含有顆粒的樣品。直接接種的採用是由於其可靠性、易用性和符合監管指南的推動。

在中國、印度、日本和韓國等國家製藥和生物技術產業快速成長的推動下，到 2032 年，亞太地區無菌檢測產業將以良好的速度成長。該地區對醫療基礎設施的投資不斷增加，加上對高品質醫療產品的需求不斷成長，推動了嚴格無菌測試的需求。此外，支持生命科學產業發展的有利政府措施和政策正在為市場成長創造有利的環境。

主要趨勢
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 英國
- 法國
- 西班牙
- 義大利
- 歐洲其他地區
亞太地區
- 中國
- 日本
- 印度
- 澳洲
- 亞太地區其他地區
拉丁美洲
- 巴西
- 墨西哥
- 拉丁美洲其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 中東和非洲其他地區

第 11 章：公司簡介

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

簡介目錄

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