藥品無菌檢測市場- 副產品（試劑盒和試劑）、測試（膜過濾、快速微生物[ATP 生物發光、基於螢光]）、樣本（無菌藥物、生物製劑和治療藥物）、類型、最終用戶、全球預測（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個工作天內

價格

簡介目錄

在嚴格的監管要求、對品質控制的日益重視以及對生物製藥和無菌藥品的需求不斷成長的推動下，預計 2024 年至 2032 年藥品無菌檢測市場規模的複合年成長率將達到 10.8%。

最近，無菌測試已成為製藥業的基礎，以確保產品不受微生物污染且使用安全。例如，2022年10月，Tema Sinergie開發了一種新型藥物隔離器，用於在無菌條件下對無菌粉末（API）進行取樣，以滿足大量無菌藥品的無菌取樣和大型容器處理的需求。世界各地的監管機構，例如美國 FDA 和歐洲 EMA，正在強制執行嚴格的不孕症測試計劃，以確保產品的安全性和有效性。

藥物配方（包括生物製劑和個人化藥物）日益複雜和多樣化，需要專門的無菌測試方法來準確檢測甚至低水平的污染物。新型藥物輸送系統（例如注射劑和植入物）的日益普及也凸顯了對可靠的不孕症檢測解決方案的需求，以在整個生產過程中提供資源完整性。醫療保健成本的增加，特別是在新興市場，刺激了對學名藥的需求，從而促進了市場的成長。

產業分為產品、測試、類型、樣品、最終用戶和地區。

根據產品，服務領域的藥品無菌檢測市場價值預計在 2024 年至 2032 年期間大幅成長，這得益於其提供專業知識、監管合規性和檢測操作效率的能力。製藥公司越來越依賴外包不孕症檢測服務來創造尖端領域和專業知識。外包無菌測試使製造商能夠最佳化成本、簡化營運並將內容重點放在研究、開發和製造等核心能力上，從而促進該細分市場的成長。

由於個人化藥物製劑對嚴格品質保證的迫切需求，到 2032 年，複合藥房最終用戶領域的藥物無菌檢測行業將顯著成長。這些藥房根據個別患者的需求生產定製藥物，通常需要有機藥物以確保患者的安全和療效。無菌測試有助於確保這些產品中不存在微生物污染物，同時滿足監管標準的要求，並降低患者感染或不良事件的風險。

由於嚴格的監管標準、強大的藥品製造基礎設施以及對生物製藥研發活動的投資不斷增加，預計歐洲藥品無菌檢測產業將在 2024-2032 年大幅成長。歐洲國家遵循歐洲藥品管理局 (EMA) 等當局製定的嚴格法規，該機構強制執行嚴格的不孕症檢測計劃，以確保藥品安全且有效率。歐洲慢性病的高盛行率和不斷上漲的醫療費用增加了對學名藥的需求，進一步刺激了該地區市場的成長。

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
- 荷蘭
- 歐洲其他地區
亞太地區
- 中國
- 日本
- 印度
- 澳洲
- 韓國
- 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
- 阿拉伯聯合大公國
- 中東和非洲其他地區

第 11 章：公司簡介

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.

簡介目錄

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