Aseptic Sampling Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

Aseptic Sampling Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

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 Market TrendsBiotechnology and Pharmaceutical Manufacturers Segment is Expected to Have a Significant Share Over the Forecast Period

In the aseptic sampling market, biotechnology and pharmaceutical manufacturers are expected to have notable growth owing to the growing research and development spending and growing biological and pharmaceutical pipeline. Furthermore, various advantages of aseptic sampling during each stage of the biopharmaceutical manufacturing process help to drive the market through this segment.

The most effective solution has emerged as automatic sampling systems, which can address several issues during the biopharmaceutical manufacturing process with manual sampling methods and provide several additional advantages like real-time data monitoring, a reduction in deviations of about 65%, and an increase in the overall productivity of up to 80%. Hence, with various advantages of aseptic sampling for biotechnology and pharmaceutical manufacturers, the market is expected to grow over the study period.

Furthermore, with the new approvals and launches of aseptic sampling products, the market is expected to grow due to the wide availability of the products for sampling. For instance, in January 2022, Avantor launched the OmniTop Sample Tubes Adjustable Volume Sampling System (AVSS), designed to lower contamination risk and reduce volume loss in bioprocessing operations by enabling technicians to collect the precise amount of media needed to perform routine sampling. Hence, with new launches, the usage of aseptic sampling products increases, which is expected to drive the market through this segment.

North America is Expected to Have Major Share in the Market Over the Forecast Period

North America is projected to have a notable share of the aseptic sampling market and is expected to do the same in the forecast period. Also, the increase in product launches and expansions by key market players and stringent government regulations regarding the safety and quality of various drugs drives the North American aseptic sampling market. The United States is expected to have a significant share owing to the presence of key market players and the rising support of the government for the production and quality of pharma and biotech products.

Key players in the region have been initiating various strategies to retain market share and expand into newer product lines. For instance, in February 2022, Labcorp opened a new diagnostics laboratory in South Bend, Indiana, allowing the company to enhance service levels and offerings to patients and physicians in South Bend and throughout the region. Thus, the establishment of new diagnostics laboratories increases the usage of aseptic sampling in the region, which is expected to drive the market over the study period.

Companies have been engaging in acquisitions, partnerships, and mergers, to strengthen their manufacturing capacities and product portfolio and to provide competitive differentiation. For instance, in November 2021, Pace Analytical Services acquired Basic Laboratory, Inc., a full-service environmental analytical testing company with locations in northern California. Hence, the above-mentioned factors help in expanding the aseptic sampling services and are likely to increase the market growth in the region over the forecast period.

Aseptic Sampling Industry Overview

The aseptic sampling market is moderately competitive and consists of several major players. Some of the market players operating in the market include GEA Group, Gemu Group, W. L. Gore & Associates, Inc, Keofitt A/S, Lonza Group, Merck KGaA, Qualitru Sampling Systems, Saint Gobain, Sartorius Stedim Biotech and Thermo Fisher Scientific among others.

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1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Stringent Government Regulations for Ensuring Drug Safety
4.2.2 Increasing Demand for Biopharmaceuticals to Eliminate the Risk of Contamination
4.3 Market Restraints
4.3.1 Issues Related to Leachable, Extractables and Impurities During Sampling Procedure
4.4 Porter Five Forces
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (Market Size by Value – USD million)
5.1 By Type of Sampling
5.1.1 Manual Aseptic Sampling
5.1.1.1 Bags
5.1.1.2 Bottles
5.1.1.3 Others
5.1.2 Automated Aseptic Sampling
5.2 By Application
5.2.1 Upstream Process
5.2.2 Downstream Process
5.3 By End-User
5.3.1 Biotechnology and Pharmaceutical Manufacturers
5.3.2 Contract Research and Manufacturing Organizations
5.3.3 Others
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Merck KGaA
6.1.2 Sartorius AG (Sartorius Stedim Biotech)
6.1.3 Keofitt A/S
6.1.4 Saint Gobain
6.1.5 GEA Group
6.1.6 Qualitru Sampling Systems
6.1.7 Thermo Fisher Scientific
6.1.8 Gemu Group
6.1.9 W. L. Gore & Associates, Inc
6.1.10 Lonza Group
6.1.11 Bbi-Biotech Gmbh
6.1.12 Advanced Microdevices Pvt. Ltd
7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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