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1542869

全球無菌採樣市場 - 2024-2031

Global Aseptic Sampling Market - 2024-2031

出版日期: 2024年08月26日 | 出版商:

DataM Intelligence | 英文 186 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

概述

2023年，全球無菌取樣市場規模達3.958億美元，預估至2031年將達8.65億美元，2024-2031年預測期間複合年成長率為10.5%。

無菌取樣是一種用於防止取樣方法中污染的方法，涉及使用無菌工具和容器。此方法可確保細菌學結果準確反映取樣時（最好是原始出貨時）批次的狀況。它通常用於線上樣品、環境樣品、散裝容器的產品樣品以及用於微生物分析的未包裝產品。

市場動態：

驅動程式和限制

生物製藥需求上升

生物製藥，包括治療性蛋白質和疫苗，需要嚴格的無菌條件以確保產品品質和病人安全。 FDA、WHO 和 EU GMP 等監管機構強制要求使用無菌採樣技術，包括無菌設備、封閉採樣系統和經過驗證的採樣程序。封閉式無菌取樣系統擴大用於生物製藥生產，以滿足這些要求並降低微生物污染的風險。

這些系統提供多個獨立的採樣應用程式來收集代表性樣品，而不會引入外部污染物。正確的無菌取樣對於監測生物負荷、內毒素和細胞活力等關鍵品質屬性至關重要，使製造商能夠及早發現和解決污染問題，並確保產品安全和品質。

污染風險高

如果不遵循正確的方案，手動和自動無菌取樣都存在樣品污染的風險。在採樣過程中保持無菌環境至關重要，但也可能具有挑戰性，特別是在大規模操作中。

此外，無菌取樣市場面臨的主要挑戰是自動化系統的高成本、可浸出和可萃取污染的風險、對熟練人員進行手動取樣的依賴，以及維持無菌條件以防止樣品污染的整體挑戰

細分市場分析

全球無菌採樣市場根據產品類型、技術、應用、最終用戶和地區進行細分。

該產品類型細分市場的手動無菌取樣約佔無菌取樣市場佔有率的51.3%

此產品類型細分市場的手動無菌取樣約佔51.3%。手動無菌取樣是一種在無菌條件下採集樣本以防止採集過程中污染的技術。它通常用於製藥和生物製藥行業，以驗證流程並支持觀察結果，同時確保產品安全和品質。

市場地域佔有率

預計北美在整個預測期內將佔據總市場佔有率的 38.4% 左右

由於主要製藥和生物技術公司增加研發支出、合作夥伴關係、無菌採樣系統的技術進步以及完善的醫療保健基礎設施等因素，北美在整個預測期內預計將佔據約 38.4% 的總市場佔有率。此外，該地區研究活動和臨床試驗數量的增加預計將進一步推動市場成長。

例如，2023年3月，SinnovaTek子公司FirstWave Innovations與全球軟包裝領導者ProAmpac合作，向市場推出無菌帶嘴袋。此次合作使代包裝商能夠使用 Scholle IPN 的專利無菌配件和 ProAmpac 的短期裝袋功能，在方便、靈活的定製印刷袋中推出無菌、耐儲存的液體食品。

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

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

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)