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市场调查报告书

商品编码

1673613

药品无菌测试市场规模、份额及成长分析（按类型、测试产品、测试类型、样本、最终用途和地区）－2025-2032 年产业预测

Pharmaceutical Sterility Testing Market Size, Share, and Growth Analysis, By Type (In-House, Outsourcing), By Test Product (Kits and Reagents, Instruments), By Testing Type, By Sample, By End Use, By Region - Industry Forecast 2025-2032

出版日期: 2025年03月01日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5个工作天内

价格

简介目录

2023 年全球药品无菌测试市场规模价值 22 亿美元，预计将从 2024 年的 24.8 亿美元成长到 2032 年的 63.5 亿美元，预测期内（2025-2032 年）的复合年增长率为 12.5%。

全球药品无菌测试市场正在经历强劲成长，这得益于严格的监管要求、对高品质药品的需求不断增长以及对药品安全性和有效性的高度关注。美国FDA 和 EMA 等监管机构强制进行无菌测试，以确保药品不含有害微生物污染，进而保护患者的健康。然而，由于测试程序高成本以及药物配方日益复杂，市场面临挑战。儘管如此，随着许多公司转向合约测试组织外包无菌测试，并受益于专业知识和资源，机会正在出现。此外，个人化医疗和生技药品的需求不断增长预计将进一步推动这一重要市场的成长。

北美洲
- 美国
- 加拿大
欧洲
- 德国
- 西班牙
- 法国
- 英国
- 义大利
- 其他欧洲国家
亚太地区
- 中国
- 印度
- 日本
- 韩国
- 其他亚太地区
拉丁美洲
- 巴西
- 其他拉丁美洲
中东和非洲
- 海湾合作委员会国家
- 南非
- 其他中东和非洲地区

竞争资讯

前五大公司对比
主要企业市场定位（2024年）
主要市场参与者所采取的策略
近期市场趋势
公司市场占有率分析（2024年）
主要企业简介
- 公司详情
- 产品系列分析
- 公司分部份额分析
- 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

Bolzoni Auramo（Italy）
Kaup GmbH & Co. KG（Germany）
Meyer GmbH（Germany）
CAM attachments（Italy）
Durwen GmbH（Germany）
Long Reach Manufacturing（USA）
Liftomatic Material Handling, Inc.（USA）
Brudi Equipment, Inc.（USA）
Hanmare Attachments（South Korea）
Mecalac Attachments（France）
Atlas Polar Company Limited（Canada）
BESSE Attachments（France）
Landoll Corporation（USA）
Rightline Equipment（USA）
Lift Technologies, Inc.（USA）
WIFO Anema BV（Netherlands）
Intermercato AB（Sweden）
CGM Handling（Italy）

结论和建议

简介目录

Product Code: SQMIG35I2168

Global Pharmaceutical Sterility Testing Market size was valued at USD 2.2 billion in 2023 and is poised to grow from USD 2.48 billion in 2024 to USD 6.35 billion by 2032, growing at a CAGR of 12.5% during the forecast period (2025-2032).

The global pharmaceutical sterility testing market is experiencing robust growth, propelled by stringent regulatory requirements, heightened demand for high-quality pharmaceutical products, and a strong focus on drug safety and efficacy. Regulatory bodies like the US FDA and EMA mandate sterility testing to ensure that medications are free from harmful microbial contamination, thus safeguarding patient health. However, the market faces challenges due to the high costs associated with testing procedures and the increasing complexity of pharmaceutical formulations. Nevertheless, opportunities are emerging as many companies turn to contract testing organizations for outsourcing sterility testing, benefiting from specialized expertise and resources. Additionally, the rising demand for personalized medicine and biologics is poised to further drive growth in this essential market.

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 Segments Analysis

Global Pharmaceutical Sterility Testing Market is segmented by Type, Test Product, Testing Type, Sample, End Use and region. Based on Type, the market is segmented into In-House and Outsourcing. Based on Test Product, the market is segmented into Kits and Reagents, Instruments and Services. Based on Testing Type, the market is segmented into Sterility Testing, Bioburden Testing, Bacterial Endotoxin Testing and Rapid Microbial Method. Based on Sample, the market is segmented into Pharmaceuticals, Medical Devices and Biopharmaceuticals. Based on End Use, the market is segmented into Compounding Pharmacies, Medical Device Companies, Pharmaceutical Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Pharmaceutical Sterility Testing Market

The global pharmaceutical sterility testing market is being significantly propelled by the rising demand for biologics and biosimilar drugs, which have proven effective in managing severe health conditions, including cancer, neurological disorders, and various infectious diseases. As the need for these innovative therapies grows, so does the necessity for rigorous pharmaceutical sterility testing to guarantee the safety and efficacy of such products. The recent approval of multiple biosimilars, including Trastuzumab, Rituximab, and Adalimumab, has further enhanced the market growth, reflecting a broader industry trend towards ensuring high-quality and safe therapeutic options for patients worldwide.

Restraints in the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market faces a notable restraint due to the high costs associated with sterility testing services, which can create significant challenges for a wide range of customers, particularly in emerging markets or resource-limited environments. Small and medium-sized pharmaceutical and medical device companies often struggle with the necessary infrastructure to perform reliable sterility testing in-house. As a result, these companies are more inclined to outsource such testing services to ensure compliance with FDA regulations, further highlighting the financial constraints that can hinder their ability to utilize essential sterility testing services effectively.

Market Trends of the Global Pharmaceutical Sterility Testing Market

The Global Pharmaceutical Sterility Testing market is experiencing a notable shift toward the adoption of rapid microbial detection technologies, driven by the industry's need for efficiency and compliance. These advanced technologies significantly reduce testing timelines, enabling faster results while ensuring the sterility of pharmaceutical products. As regulatory bodies emphasize stringent quality control measures, manufacturers are increasingly investing in rapid testing solutions to streamline operations and maintain competitiveness. This trend is projected to continue in the coming years, with the market expanding as companies prioritize innovation to enhance their sterility testing processes, thereby meeting the evolving demands of the pharmaceutical landscape.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2024
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis

Global Pharmaceutical Sterility Testing Market Size by Type & CAGR (2025-2032)

Market Overview
In-House
Outsourcing

Global Pharmaceutical Sterility Testing Market Size by Test Product & CAGR (2025-2032)

Market Overview
Kits and Reagents
Instruments
Services

Global Pharmaceutical Sterility Testing Market Size by Testing Type & CAGR (2025-2032)

Market Overview
Sterility Testing
- Membrane Filtration
- Direct Inoculation
- Product Flush
Bioburden Testing
Bacterial Endotoxin Testing
Rapid Microbial Method
- ATP Bioluminescence
- Fluorescent -Based
- Solid-phase Cytometry
- Others

Global Pharmaceutical Sterility Testing Market Size by Sample & CAGR (2025-2032)

Market Overview
Pharmaceuticals
Medical Devices
Biopharmaceuticals

Global Pharmaceutical Sterility Testing Market Size by End Use & CAGR (2025-2032)

Market Overview
Compounding Pharmacies
Medical Device Companies
Pharmaceutical Companies
Others

Global Pharmaceutical Sterility Testing Market Size & CAGR (2025-2032)

North America (Type, Test Product, Testing Type, Sample, End Use)
- US
- Canada
Europe (Type, Test Product, Testing Type, Sample, End Use)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Type, Test Product, Testing Type, Sample, End Use)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Type, Test Product, Testing Type, Sample, End Use)
- Brazil
- Rest of Latin America
Middle East & Africa (Type, Test Product, Testing Type, Sample, End Use)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2024
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2024
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

Bolzoni Auramo (Italy)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Kaup GmbH & Co. KG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Meyer GmbH (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CAM attachments (Italy)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Durwen GmbH (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Long Reach Manufacturing (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Liftomatic Material Handling, Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Brudi Equipment, Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Hanmare Attachments (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Mecalac Attachments (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Atlas Polar Company Limited (Canada)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BESSE Attachments (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Landoll Corporation (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Rightline Equipment (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lift Technologies, Inc. (USA)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WIFO Anema BV (Netherlands)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Intermercato AB (Sweden)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
CGM Handling (Italy)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments