Global Aseptic Sampling Market Size (2024 - 2029)

The aseptic sampling market is anticipated to experience significant growth over the forecast period, driven by increased demand for biopharmaceuticals and heightened healthcare spending. The market's expansion is supported by the rising adoption of single-use aseptic sampling products and regulatory measures ensuring drug safety. Despite challenges posed by the COVID-19 pandemic, which disrupted supply chains and slowed pharmaceutical development, the long-term outlook remains positive due to ongoing investments in drug development and research. However, concerns regarding leachable and extractable materials in sampling procedures may pose obstacles to market growth.

Market Size of Global Aseptic Sampling Industry

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Aseptic Sampling Market Summary
Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 10.20 %
Fastest Growing Market Asia Pacific
Largest Market North America
Market Concentration Medium

Major Players

Aseptic Sampling Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Aseptic Sampling Market Analysis

The aseptic sampling market registered a CAGR of nearly 10.2% during the forecast period.

Due to the COVID-19 situation, there were many companies focused on the development of effective vaccines, biologics, and drugs to prevent/cure the disease. This is increased demand for aseptic testing. However, due to the slowdown of development and manufacturing of other pharmaceuticals or biologics coupled with supply chain disruption, the market has witnessed difficulties during the pandemic. Various research studies have been published on the impact of the pandemic on market growth. For instance, a research study published by Science of the Total Environment in June 2021 stated that among the active sampling methods, several sampling devices could be used to assess the airborne virus. However, longer active sampling times may be required to ensure the collection of sufficient airborne viruses for detection by molecular techniques. Hence, the market is expected to have been adversely affected by the pandemic with longer active sampling times and is likely to grow in the long term.

The major factors attributing to the growth of the aseptic sampling market are the rise in the demand for biopharmaceuticals which resulted in the increased adoption of single-use aseptic sampling products. On the other hand, with growing spending on healthcare and drug development by companies and governments all over the world, aseptic sampling is projected to grow notably over the period. According to the United States FDA, in January 2022, CDER averaged 43 novel drug approvals yearly. However, there were about 50 new drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs). This shows the increased drug approvals, which indicate increased usage of aseptic sampling during the studies. In addition, as a result of the increase in expenditure on healthcare, government regulations to ensure drug safety, and R&D activities in the segment increase globally, the aseptic sampling market is expected to grow over the forecast period.

Further, with the growing investment in the development of new drugs and drug abuse research, the demand for aseptic sampling products is expected to increase, which is expected to boost market growth. For instance, as per the report of NIH, United States, in May 2022, the research and development expenditure for drug abuse is expected to increase from USD 1,476 million in 2021 to USD 1,596 million by 2022. Similarly, in June 2022, SK Pharmteco is investing about USD 35 million in the expansion of SK's pharmaceutical manufacturing plant in the Dublin suburb of Swords, Ireland, including a new building. Hence, such investments and expansions are expected to have a significant impact on the growth of the aseptic sampling market.

However, issues related to leachable and extractable plastic materials in the sampling procedure, coupled with the unknown impurities generated during the biopharmaceutical processes due to the employment of high temperatures, are expected to hinder market growth.

Aseptic Sampling Industry Segmentation

As per the scope of the report, aseptic sampling is a sterile method of collecting a sample that is implemented during biopharmaceutical processes to avoid probable contaminations or alterations while sampling the drug for research and analysis. The Aseptic Sampling Market is segmented by Type of Sampling (Manual Aseptic Sampling (Bags, Bottles, and Others) and Automated Aseptic Sampling), Application (Upstream Process and Downstream Process), End-User (Biotechnology and Pharmaceutical Manufacturers, Contract Research and Manufacturing Organizations, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Type of Sampling
Manual Aseptic Sampling
Bags
Bottles
Others
Automated Aseptic Sampling
By Application
Upstream Process
Downstream Process
By End-User
Biotechnology and Pharmaceutical Manufacturers
Contract Research and Manufacturing Organizations
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America
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Global Aseptic Sampling Market Size Summary

The aseptic sampling market is poised for significant growth, driven by the increasing demand for biopharmaceuticals and the adoption of single-use aseptic sampling products. The market experienced challenges during the COVID-19 pandemic due to supply chain disruptions and a slowdown in pharmaceutical development. However, the pandemic also heightened the need for aseptic testing, particularly in vaccine and drug development, which is expected to contribute to long-term market growth. The rise in healthcare spending and regulatory measures to ensure drug safety are further propelling the market. The introduction of automatic sampling systems, which offer real-time data monitoring and improved productivity, is also enhancing the market's appeal to biotechnology and pharmaceutical manufacturers.

North America is anticipated to hold a significant share of the aseptic sampling market, supported by stringent regulatory standards and a robust presence of key market players. The region's market growth is further bolstered by new product launches and expansions by major companies. Strategic activities such as acquisitions and partnerships are helping companies strengthen their manufacturing capabilities and expand their product portfolios. The market is moderately competitive, with several major players like GEA Group, Merck KGaA, and Thermo Fisher Scientific actively participating. These dynamics, along with ongoing investments in drug development and research, are expected to drive the aseptic sampling market's growth over the forecast period.

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Global Aseptic Sampling Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Stringent Government Regulations for Ensuring Drug Safety

      2. 1.2.2 Increasing Demand for Biopharmaceuticals to Eliminate the Risk of Contamination

    3. 1.3 Market Restraints

      1. 1.3.1 Issues Related to Leachable, Extractables and Impurities During Sampling Procedure

    4. 1.4 Porter Five Forces

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

  2. 2. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 2.1 By Type of Sampling

      1. 2.1.1 Manual Aseptic Sampling

        1. 2.1.1.1 Bags

        2. 2.1.1.2 Bottles

        3. 2.1.1.3 Others

      2. 2.1.2 Automated Aseptic Sampling

    2. 2.2 By Application

      1. 2.2.1 Upstream Process

      2. 2.2.2 Downstream Process

    3. 2.3 By End-User

      1. 2.3.1 Biotechnology and Pharmaceutical Manufacturers

      2. 2.3.2 Contract Research and Manufacturing Organizations

      3. 2.3.3 Others

    4. 2.4 Geography

      1. 2.4.1 North America

        1. 2.4.1.1 United States

        2. 2.4.1.2 Canada

        3. 2.4.1.3 Mexico

      2. 2.4.2 Europe

        1. 2.4.2.1 Germany

        2. 2.4.2.2 United Kingdom

        3. 2.4.2.3 France

        4. 2.4.2.4 Italy

        5. 2.4.2.5 Spain

        6. 2.4.2.6 Rest of Europe

      3. 2.4.3 Asia-Pacific

        1. 2.4.3.1 China

        2. 2.4.3.2 Japan

        3. 2.4.3.3 India

        4. 2.4.3.4 Australia

        5. 2.4.3.5 South Korea

        6. 2.4.3.6 Rest of Asia-Pacific

      4. 2.4.4 Middle East and Africa

        1. 2.4.4.1 GCC

        2. 2.4.4.2 South Africa

        3. 2.4.4.3 Rest of Middle East and Africa

      5. 2.4.5 South America

        1. 2.4.5.1 Brazil

        2. 2.4.5.2 Argentina

        3. 2.4.5.3 Rest of South America

Global Aseptic Sampling Market Size FAQs

The Global Aseptic Sampling Market is projected to register a CAGR of 10.20% during the forecast period (2024-2029)

KEOFITT A/S, Saint Gobain, GEA Group, Merck KGaA and Sartorius AG (Sartorius Stedim Biotech) are the major companies operating in the Global Aseptic Sampling Market.

Aseptic Sampling Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)