药品无菌检测市场- 副产品（试剂盒和试剂）、测试（膜过滤、快速微生物[ATP 生物发光、基于萤光]）、样本（无菌药物、生物製剂和治疗药物）、类型、最终用户、全球预测（2024 年） - 2032)

Pharmaceutical Sterility Testing Market - By Product (Kits & Reagents), Test (Membrane Filtration, Rapid Microbial [ATP Bioluminescence, Fluorescent-based]), Sample (Sterile Drugs, Biologics & Therapeutics), Type, End-user, Global Forecast (2024 - 2032)

出版日期: 2024年04月18日 | 出版商:

Global Market Insights Inc. | 英文 224 Pages | 商品交期: 2-3个工作天内

价格

简介目录

在严格的监管要求、对品质控制的日益重视以及对生物製药和无菌药品的需求不断增长的推动下，预计 2024 年至 2032 年药品无菌检测市场规模的复合年增长率将达到 10.8%。

最近，无菌测试已成为製药业的基础，以确保产品不受微生物污染且使用安全。例如，2022年10月，Tema Sinergie开发了一种新型药物隔离器，用于在无菌条件下对无菌粉末（API）进行取样，以满足大量无菌药品的无菌取样和大型容器处理的需求。世界各地的监管机构，例如美国 FDA 和欧洲 EMA，正在强制执行严格的不孕症测试计划，以确保产品的安全性和有效性。

药物配方（包括生物製剂和个人化药物）日益复杂和多样化，需要专门的无菌测试方法来准确检测甚至低水平的污染物。新型药物输送系统（例如注射剂和植入物）的日益普及也凸显了对可靠的不孕症检测解决方案的需求，以在整个生产过程中提供资源完整性。医疗保健成本的增加，特别是在新兴市场，刺激了对仿製药的需求，从而促进了市场的成长。

产业分为产品、测试、类型、样品、最终用户和地区。

根据产品，服务领域的药品无菌检测市场价值预计在 2024 年至 2032 年期间大幅成长，这得益于其提供专业知识、监管合规性和检测操作效率的能力。製药公司越来越依赖外包不孕症检测服务来创造尖端领域和专业知识。外包无菌测试使製造商能够优化成本、简化营运并将内容重点放在研究、开发和製造等核心能力上，从而促进该细分市场的成长。

由于个人化药物製剂对严格品质保证的迫切需求，到 2032 年，复合药房最终用户领域的药物无菌检测行业将显着增长。这些药房根据个别患者的需求生产定製药物，通常需要有机药物以确保患者的安全和疗效。无菌测试有助于确保这些产品中不存在微生物污染物，同时满足监管标准的要求，并降低患者感染或不良事件的风险。

由于严格的监管标准、强大的药品製造基础设施以及对生物製药研发活动的投资不断增加，预计欧洲药品无菌检测产业将在 2024-2032 年大幅成长。欧洲国家遵循欧洲药品管理局 (EMA) 等当局製定的严格法规，该机构强制执行严格的不孕症检测计划，以确保药品安全且有效率。欧洲慢性病的高盛行率和不断上涨的医疗费用增加了对仿製药的需求，进一步刺激了该地区市场的成长。

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
- 荷兰
- 欧洲其他地区
亚太地区
- 中国
- 日本
- 印度
- 澳洲
- 韩国
- 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
- 阿联酋
- 中东和非洲其他地区

第 11 章：公司简介

Alcami Corporation
bioMerieux SA
BA Sciences
Charles River Laboratories
Nelson Laboratories, LLC
Merck KGaA
Pacific BioLabs Inc.
Rapid Micro Biosystems Inc.
SGS Societe Generale de Surveillance SA.
STERIS Corporation
Thermo Fisher Scientific Inc.

简介目录

Product Code: 9112

Pharmaceutical sterility testing market size is anticipated to observe 10.8% CAGR from 2024 to 2032, driven by stringent regulatory requirements, the increasing emphasis on quality control, and the rising demand for biopharmaceuticals as well as sterile pharmaceutical products.

Lately, sterility testing has grown fundamental to the pharmaceutical industry for ensuring that products are free from microbial contamination and safe to use. For instance, in October 2022, Tema Sinergie developed a new pharmaceutical isolator for sampling sterile powders (API) under aseptic conditions to meet the needs for aseptic sampling of large volumes of sterile pharmaceuticals and handling of large containers. Regulatory agencies worldwide, such as the FDA in the U.S. and the EMA in Europe are mandating rigorous infertility testing programs to ensure product safety and efficacy.

The growing complexity and diversity of pharmaceutical formulations, including biologics and personalized medicines, are necessitating specialized sterility testing methods to accurately detect even low levels of contaminants. The increasing adoption of new drug delivery systems, such as injectables and implants is also highlighting the need for reliable infertility testing solutions to provide resource integrity throughout the production process. Increasing healthcare costs especially in emerging markets are fueling the demand for generic drugs, adding to the market growth.

The industry is classified into product, test, type, sample, end-user and region.

Based on product, the pharmaceutical sterility testing market value from the services segment is slated to witness substantial growth rate during 2024-2032 favored by their ability for offering specialized expertise, regulatory compliance, and efficiency in testing operations. Pharmaceutical companies are increasingly relying on outsourced infertility testing services to create cutting-edge areas and specialized knowledge. Outsourcing sterility testing allows manufacturers to optimize costs, streamline operations, and focus content on core competencies, such as research, development, and manufacturing, leading to the segment growth.

Pharmaceutical sterility testing industry from the compounding pharmacies end-user segment will grow significantly through 2032, due to the critical need for stringent quality assurance in personalized medication preparations. These pharmacies produce customized medications based on the needs of individual patients, often requiring organic medications to ensure patient safety and efficacy. Sterility testing helps in ensuring the absence of microbial contaminants in these products while meeting the compliance with regulatory standards and reducing the risk of infection or adverse events for patients.

Europe pharmaceutical sterility testing industry is expected to expand at significant rate over 2024-2032 attributed to stringent regulatory standards, robust pharmaceutical manufacturing infrastructure, and the increasing investments in biopharmaceutical R&D activities. European countries follow strict regulations set by authorities, such as the European Medicines Agency (EMA), which mandate a rigorous infertility testing program to ensure that pharmaceutical products are safe and efficient. The high prevalence of chronic diseases and rising healthcare costs in Europe are contributing to the demand for generic medicines, further stimulating the regional 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 Rising prevalence of infectious diseases
  - 3.2.1.2 Increasing outsourcing of sterility testing services
  - 3.2.1.3 Stringent regulatory requirements for pharmaceutical companies
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 Complexity of testing procedures
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 market share analysis
4.3 Company matrix analysis
4.4 Competitive analysis of major market players
4.5 Competitive positioning matrix
4.6 Strategy dashboard

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

5.1 Key trends
5.2 Kits & reagents
5.3 Services
5.4 Instruments

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

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 ($ Mn)

7.1 Key trends
7.2 In-house testing
7.3 Outsourced testing

Chapter 8 Market Estimates and Forecast, By Sample, 2021 - 2032 ($ Mn)

8.1 Key trends
8.2 Sterile drugs
8.3 Biologics and therapeutics

Chapter 9 Market Estimates and Forecast, By End-user, 2021 - 2032 ($ Mn)

9.1 Key trends
9.2 Pharmaceutical & biotechnology companies
9.3 CROs and contract testing laboratories
9.4 Compounding pharmacies
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 Netherlands
- 10.3.7 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 South Korea
- 10.4.6 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 UAE
- 10.6.4 Rest of Middle East and Africa