Aseptic Sampling Market Size, Share & Trends Analysis Report By Type (Manual Sampling, Automated Sampling), By Technique, By Application (Downstream Processing, Upstream Processing), By End-use, By Region, And Segment Forecasts, 2024 - 2030

Aseptic Sampling Market Size & Trends

The global aseptic sampling market size was estimated at USD 942.53 million in 2023 and is expected to expand at a compound annual growth rate (CAGR) of 7.72% from 2024 to 2030. Growing population across the globe, the rising demand for personalized medicines, and the growing technological development are anticipated to boost the market growth of aseptic sampling. The growing investments in research & development activities, and growing number of vaccines & drug development, as well as rising awareness towards risks of contamination are further projected to impel the growth of the market over the forecast period.

The COVID-19 pandemic has positively influenced the market, particularly in the pharmaceutical and biotech sectors. With the heightened focus on vaccine development and treatment manufacturing, there has been an increased demand for aseptic sampling technologies to ensure sterile processes. This upsurge in demand has exhibited market opportunities for companies in the market. Additionally, the prominence of maintaining stringent hygiene standards in response to the pandemic has prompted industries to invest in advanced aseptic sampling solutions, driving growth and innovation in the sector.

According to a WHO article, in 2021, the supply of vaccine doses reached approximately 16 billion, with a total value of USD 141 billion. Moreover, in 2019, approximately 5.8 billion doses of vaccine doses were produced and supplied with a total market value of USD 38 billion during the same period. Thus, a significant increase was attributed mainly to the production of COVID-19 vaccines, thereby impacted the market growth during the forecast period.

The increasing demand in the pharmaceuticals and biotechnology sectors has a direct and significant impact on the aseptic sampling industry. With the growing global population and the need for healthcare solutions, pharmaceutical companies are often scaling up the production volumes. Thus, the increasing production anticipates boosting the growth of aseptic sampling methods to ensure consistent product quality and safety.

Furthermore, the development and production of advanced therapies, such as cell and gene therapies, involve complex processes that require accurate aseptic techniques. In November 2023, GenScript ProBio and the CAR-T therapy specialist, Curocell, has enterned into a strategic partnership Memorandum of Understanding (MOU) for the manufacturing of viral vectors essential for advancing the next generation of CAR-T therapy. With innovative therapies becoming more prevalent, the demand for specialized aseptic sampling methods is expected to rise.

Market Concentration & Characteristics

The rising trend toward personalized medicine has led to a more diverse range of pharmaceutical products, for specific aseptic sampling techniques to boost the production of various drug development. This is attributed to the growing number of research and development activities to ensure better quality drugs. The development of personalized medicine requires extensive research and development efforts, including the exploration of new biomarkers and diagnostic tools. Aseptic sampling is essential in research settings to maintain the quality of biological samples used in the discovery and development of personalized therapies.

In October 2023, Saphetor SA collaborated with ICON to initiate a novel approach for promoting the planning and implementation of clinical trials in the precision medicine and rare diseases sector. This collaboration is focused on maximizing the potential and enhancing insights into the epidemiology, prevalence, and geographic trends of genetic mutations. This, in turn, aims to bolster patient recruitment and refine the overall clinical trial strategy. Thus, these strategic initiatives and clinical trials are projected to impel the growth of the aseptic sampling industry.

End-use Insights

Pharmaceutical & biotechnology companies held a dominant share in 2023. The utilization of aseptic sampling process by pharmaceutical & biotechnology companies involves analysis of the manufacturing process to monitor both physical and chemical quality attributes. It also extends to quality control and the assessment of the stability of active ingredients in pharmaceuticals. The optimized yields, reduced downtime, accelerated process development and scale-up, along with reduced human intervention leading to minimal errors are the factors that are anticipated to drive the growth of the market.

CMOs & CROs is expected to be the fastest-growing segment over the forecast period. Aseptic sampling allows for the adaptation to diverse processes and products. In addition, the growing demand for biologics and other complex medicines, which require strict control of product sterility and purity. Aseptic sampling further contributes to minimizing losses arising from processes, reducing errors, and eliminating batch failures. These factors are anticipated to propel the adoption of aseptic sampling in CMOs and CROs, thus, impelling market growth during the forecast future.

Regional Insights

North America held the largest market share of 37.6% in 2023. This can be attributed to the presence of major pharmaceutical & biotechnology companies and growing spending on R&D activities for various biopharmaceutical development. In addition, the growing technological advancements in aseptic sampling systems and well-established healthcare infrastructure to enhance product quality are a few of the factors expected to fuel growth. In addition, the growing number of research activities and clinical trials in the region are further projected to impel the growth of the market.

Asia Pacific is projected to grow at the fastest CAGR from 2024 to 2030. This can be attributed to the increasing government investments in biotechnology sector and regulatory initiatives in pharmaceutical and biotechnology manufacturing development. For instance, in August 2023, the Japanese health ministry has given its endorsement to the first domestically developed COVID-19 vaccine by the pharmaceutical company Daiichi Sankyo. Officials have stated that the ministry will promptly move forward to grant approval for the nation's inaugural homegrown coronavirus vaccine. Thus, the rising government initiatives are anticipated to boost the market growth in the region.

China accounted for the largest share of the aseptic sampling industry in the Asia Pacific region in 2023 due to its rapidly growing pharmaceutical and biotechnology sectors, driven by a burgeoning population and increasing healthcare investments. Further, the country's emphasis on stringent quality standards, coupled with a robust regulatory framework, has spurred the demand for advanced aseptic sampling technologies.

Type Insights

Manual aseptic sampling accounted for the largest share of 53.53% in 2023. Manual methods allow for a high degree of customization based on the specific needs of a particular sampling situation. Researchers & companies can adjust techniques and tools depending on the type of sample and the environment, providing a level of flexibility that may be challenging to achieve with automated systems. In October 2022, Tema Sinergie launched a new pharmaceutical isolator, that is the Aseptic Sampling Isolator (AP-IS Series), due to the demand for aseptic sampling of significant amounts of sterile active ingredients. This solution is designed to facilitate the manual aseptic sampling of sterile powders (API) and the handling of substantial containers.

The automated sampling segment is expected to grow at the fastest rate over the forecast period. The increasing efficiency, accuracy, & adherence to aseptic conditions minimize the risk of contamination which is associated with human handling. This is one of the major factors expected to drive the market. Moreover, the continuous advancements in automation technology have led to the development of more advanced and reliable aseptic sampling systems, which is contributing to increasing adoption for better processing.

In April 2022, MilliporeSigma announced the acquisition of the MAST platform from Lonza, an advanced automated bioreactor sampling system, anticipating in enhancing bio-processing capabilities. Hence, these strategic initiatives are projected to propel the market growth of automated aseptic sampling.

Technique Insights

In-line sampling technique accounted for the largest share in 2023. The in-line sampling technique offers both qualitative and quantitative data. Various process parameters, including pH, dissolved CO₂, dissolved oxygen, ORP (redox potential), as well as conductivity and temperature measurements, are evaluated immediately to (programmable logic controller) PLC/ (Supervisory Control and Data Acquisition) SCADA systems for automated control.

This in-line sampling technique enables the measurement of these parameters throughout the process run, spanning weeks to months, without requiring manual intervention. Thus, ensuring the provision of dependable and precise data in industrial manufacturing processes. These factors are expected to contribute to the advancement of pharmaceutical applications in aseptic sampling process. While the on-line segment is expected to grow at the fastest rate owing to the reduced product variability, automated feedback incorporating quality control attributes, and the elimination of delays typically associated with alternative monitoring approaches.

Application Insights

Downstream processing sampling technique accounted for the largest market share in 2023 and is anticipated to grow at the fastest CAGR from 2024 to 2030. Downstream processing is an important component in the production of biopharmaceuticals, which includes the isolation and purification of therapeutic proteins, antibodies, and other biologics. Aseptic sampling is essential during the downstream processing phase to ensure the sterility and quality of the final product.

Moreover, downstream processing includes complex procedures such as chromatography, filtration, and purification. Aseptic sampling is incorporated at various stages to monitor and control the process, ensuring that the final product meets quality specifications. These factors are expected to contribute to the growth of the segment over the forecast period.

Key Companies & Market Share Insights

Danaher Corporation, Thermo Fisher Scientific, Merck KGaA and Sartorius are some of the dominant players operating in the aseptic sampling industry.

• Danaher Corporation has a global presence and operates from over 119 locations in approximately 100 countries.

• Thermo Fisher Scientific operates and markets across three reportable segments such as life sciences, healthcare, and analytical solutions.

• Merck KGaA has a global presence in more than 66 countries. The company operates at over 96 production sites and has reached more than 120 markets through direct sales and distributors.

• KEOFITT A/S, Qualitru Sampling Systems, and Lonza Group are some of the emerging market players functioning in the aseptic sampling sector.

• KEOFITT A/S’s sales force works in over 50 offices across the U.S., Asia, and Europe, and supplies advanced filtration solutions to a diverse range of end users including pharmaceutical and biotechnology companies.

• Qualitru Sampling Systems offers a comprehensive range of sampling solutions ensuring product integrity and sterility throughout the sampling process.

Recent Developments

• In January 2023,908 Devices launched MAVEN, a device that enables real-time monitoring and regulation of glucose and lactate concentrations in bioprocesses, empowering biopharmaceutical companies to make informed decisions for enhanced process control and optimization.

• In January 2022, Avantor introduced an aseptic sampling system specifically tailored for high-integrity product sampling applications, including monoclonal antibodies (mAbs) and processes related to cell and gene therapy.

Aseptic Sampling Market Report Scope

Global Aseptic Sampling Market Report Segmentation

This report forecasts revenue growth at global, regional and country levels, and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global aseptic sampling market report based on type, technique, application, end-use, and region.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Manual Aseptic Sampling

    • Valves

    • Bags

    • Bottles

    • Other Accessories

  • Automated Aseptic Sampling

• Technique Outlook (Revenue, USD Million, 2018 - 2030)

  • Off-line Sampling Technique

  • On-line Sampling Technique

  • In-line Sampling Technique

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Downstream Processing

  • Upstream Processing

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical & Biotechnology Companies

  • CMOs & CROs

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait