全球无菌采样市场 - 2024-2031

概述

2023年，全球无菌取样市场规模达3.958亿美元，预估至2031年将达8.65亿美元，2024-2031年预测期间复合年增长率为10.5%。

无菌取样是一种用于防止取样方法中污染的方法，涉及使用无菌工具和容器。此方法可确保细菌学结果准确反映取样时（最好是原始出货时）批次的状况。它通常用于线上样品、环境样品、散装容器的产品样品以及用于微生物分析的未包装产品。

市场动态：

驱动程式和限制

生物製药需求上升

生物製药，包括治疗性蛋白质和疫苗，需要严格的无菌条件以确保产品品质和病人安全。 FDA、WHO 和 EU GMP 等监管机构强制要求使用无菌采样技术，包括无菌设备、封闭采样系统和经过验证的采样程序。封闭式无菌取样系统越来越多地用于生物製药生产，以满足这些要求并降低微生物污染的风险。

这些系统提供多个独立的采样应用程式来收集代表性样品，而不会引入外部污染物。正确的无菌取样对于监测生物负荷、内毒素和细胞活力等关键品质属性至关重要，使製造商能够及早发现和解决污染问题，并确保产品安全和品质。

污染风险高

如果不遵循正确的方案，手动和自动无菌取样都存在样品污染的风险。在采样过程中保持无菌环境至关重要，但也可能具有挑战性，特别是在大规模操作中。

此外，无菌取样市场面临的主要挑战是自动化系统的高成本、可浸出和可萃取污染的风险、对熟练人员进行手动取样的依赖，以及维持无菌条件以防止样品污染的整体挑战

细分市场分析

全球无菌采样市场根据产品类型、技术、应用、最终用户和地区进行细分。

该产品类型细分市场的手动无菌取样约占无菌取样市场份额的51.3%

此产品类型细分市场的手动无菌取样约占51.3%。手动无菌取样是一种在无菌条件下采集样本以防止采集过程中污染的技术。它通常用于製药和生物製药行业，以验证流程并支持观察结果，同时确保产品安全和品质。

市场地域占有率

预计北美在整个预测期内将占据总市场份额的 38.4% 左右

由于主要製药和生物技术公司增加研发支出、合作伙伴关係、无菌采样系统的技术进步以及完善的医疗保健基础设施等因素，北美在整个预测期内预计将占据约 38.4% 的总市场份额。此外，该地区研究活动和临床试验数量的增加预计将进一步推动市场成长。

例如，2023年3月，SinnovaTek子公司FirstWave Innovations与全球软包装领导者ProAmpac合作，向市场推出无菌带嘴袋。此次合作使代包装商能够使用 Scholle IPN 的专利无菌配件和 ProAmpac 的短期装袋功能，在方便、灵活的定製印刷袋中推出无菌、耐储存的液体食品。

目录

第 1 章：方法与范围

第 2 章：定义与概述

第 3 章：执行摘要

第 4 章：动力学

• 影响因素
  • 司机
    • 生物製药需求上升
    • 无菌取样的进步
  • 限制
    • 污染风险高
  • 机会
  • 影响分析

第 5 章：产业分析

• 波特五力分析
• 供应链分析
• 定价分析
• 监管分析
• 专利分析
• 大环境分析
• SWOT分析
• DMI 意见

第 6 章：依产品类型

• 手动无菌取样
• 自动无菌取样

第 7 章：按技术

• 离线采样技术
• 线上采样技术
• 线上采样技术

第 8 章：按申请

• 上游流程
• 下游流程

第 9 章：最终用户

• 药品製造商
• 合约研究和製造组织
• 研发部门
• 其他的

第 10 章：按地区

• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 义大利
  • 西班牙
  • 欧洲其他地区
• 南美洲
  • 巴西
  • 阿根廷
  • 南美洲其他地区
• 亚太
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 中东和非洲

第 11 章：竞争格局

• 竞争场景
• 市场定位/份额分析
• 併购分析

第 12 章：公司简介

• Danaher Corporation
• 公司概况
• 产品组合和描述
• 财务概览
• 主要进展
• GEA Group
• Gemu Group
• Keofitt
• Merck KGAA
• QualiTru Sampling Systems
• Saint-Gobain
• Sartorius Stedim Biotech
• Thermo Fisher Scientific
• WL Gore & Associates (*LIST NOT EXHAUSTIVE)

第 13 章：附录

Overview

Global Aseptic Sampling Market reached US$ 395.8 million in 2023 and is expected to reach US$ 865 million by 2031, growing at a CAGR of 10.5% during the forecast period 2024-2031.

Aseptic sampling is a method used to prevent contamination in sampling methods, involving the use of sterile tools and containers. This method ensures that bacteriological findings accurately reflect the lot's condition at the time of sampling and, ideally, at the time of the original shipment. It is commonly used for in-line samples, environmental samples, product samples from bulk containers, and unpackaged products for microbial analysis.

Market Dynamics: Drivers & Restraints

Rise in the demand for biopharmaceuticals

Biopharmaceuticals, including therapeutic proteins and vaccines, require strict aseptic conditions to ensure product quality and patient safety. Regulatory agencies like the FDA, WHO, and EU GMP mandate the use of aseptic sampling techniques, including sterile equipment, closed sampling systems, and validated sampling procedures. Closed aseptic sampling systems are increasingly used in biopharmaceutical production to meet these requirements and mitigate the risk of microbial contamination.

These systems provide multiple, independent sampling Applications to collect representative samples without introducing external contaminants. Proper aseptic sampling is crucial for monitoring critical quality attributes like bioburden, endotoxins, and cell viability, allowing manufacturers to detect and address contamination issues early, and ensuring product safety and quality.

High risk of contamination

Both manual and automated aseptic sampling carry the risk of sample contamination if proper protocols are not followed. Maintaining a sterile environment during the sampling process is critical but can be challenging, especially in large-scale operations.

Moreover, the key challenges facing the aseptic sampling market are the high cost of automated systems, the risk of leachable and extractable contamination, the dependency on skilled personnel for manual sampling, and the overall challenge of maintaining sterile conditions to prevent sample contamination

Market Segment Analysis

The global aseptic sampling market is segmented based on product type, technique, application, end-user, and region.

The manual aseptic sampling from the product type segment accounted for approximately 51.3% of the aseptic sampling market share

The manual aseptic sampling from the product type segment accounted for approximately 51.3%. Manual aseptic sampling is a technique used to collect samples in sterile conditions to prevent contamination during the collection process. It is commonly used in the pharmaceutical and biopharmaceutical industries to validate processes and support observations while ensuring product safety and quality.

Market Geographical Share

North America is estimated to hold about 38.4% of the total market share throughout the forecast period

North America is estimated to hold about 38.4% of the total market share throughout the forecast period owing to factors like the major pharmaceutical and biotechnology companies increasing R&D spending, partnerships, technological advancements in aseptic sampling systems, and well-established healthcare infrastructure. Additionally, the increasing number of research activities and clinical trials in the region is projected to further drive market growth.

For instance, in March 2023, FirstWave Innovations, a subsidiary of SinnovaTek, partnered with ProAmpac, a global leader in flexible packaging, to introduce aseptic spouted pouches to the market. The partnership allows co-packers to launch aseptic shelf-stable liquid food in a convenient, flexible custom-printed pouch, using Scholle IPN's patented aseptic-capable fitment, using ProAmpac's short-run pouching capabilities.

Market Segmentation

By Product Type

Manual Aseptic Sampling

Syringes

Bottles

Bags

Accessories

Others

Automated Aseptic Sampling

By Technique

Off-Line Sampling Technique

On-Line Sampling Technique

At-Line Sampling Technique

By Application

Upstream Processes

Downstream Processes

By End-User

Pharmaceutical Manufacturers

Contract Research and Manufacturing Organizations

R&D Departments

Others

By Region

North America

The U.S.

Canada

Mexico

Europe

Germany

UK

France

Italy

Spain

Rest of Europe

South America

Brazil

Argentina

Rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the market include Danaher Corporation, GEA Group, Gemu Group, Keofitt, Merck KGAA, Qualitru Sampling Systems, Saint-Gobain, Sartorius Stedim Biotech, Thermo Fisher Scientific, W. L. Gore & Associates among others.

Key Developments

In June 2024, Syntegon showcased its patented Settle Plate Changer (SPC) at Achema 2024, attracting interest from pharmaceutical manufacturers. This innovative solution automates viable monitoring in the aseptic filling process, ensuring compliance with the latest Annex 1 for new and existing equipment, thereby enhancing the company's offerings.

Why Purchase the Report?

To visualize the global aseptic sampling market segmentation based on product type, technique, application, end-user, and region as well as understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

excel data sheet with numerous data points of the aseptic sampling market level with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping available as Excel consisting of key products of all the major players.

The global aseptic sampling market report would provide approximately 64 tables, 61 figures, and 186 pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product Type
• 3.2. Snippet by Technique
• 3.3. Snippet by Application
• 3.4. Snippet by End User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rise in the demand for biopharmaceuticals
    • 4.1.1.2. Advancements in aseptic sampling
  • 4.1.2. Restraints
    • 4.1.2.1. High risk of contamination
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Patent Analysis
• 5.6. PESTLE Analysis
• 5.7. SWOT Analysis
• 5.8. DMI Opinion

6. By Product Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 6.1.2. Market Attractiveness Index, By Product Type
• 6.2. Manual Aseptic Sampling *
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Automated Aseptic Sampling

7. By Technique

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 7.1.2. Market Attractiveness Index, By Technique
• 7.2. Off-Line Sampling Technique*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. On-Line Sampling Technique
• 7.4. At-Line Sampling Technique

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
• 8.2. Market Attractiveness Index, By Application
• 8.3. Upstream Processes*
  • 8.3.1. Introduction
  • 8.3.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.4. Downstream Processes

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Pharmaceutical Manufacturers*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Contract Research and Manufacturing Organizations
• 9.4. R&D Departments
• 9.5. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. The U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. UK
    • 10.3.7.3. France
    • 10.3.7.4. Italy
    • 10.3.7.5. Spain
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technique
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Danaher Corporation*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. GEA Group
• 12.3. Gemu Group
• 12.4. Keofitt
• 12.5. Merck KGAA
• 12.6. QualiTru Sampling Systems
• 12.7. Saint-Gobain
• 12.8. Sartorius Stedim Biotech
• 12.9. Thermo Fisher Scientific
• 12.10. W. L. Gore & Associates (*LIST NOT EXHAUSTIVE)

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us