Automatic Sampling in Biopharmaceutical Applications and the Measurement of CQA 2022: Growing Demand for Biologics and Strict Regulatory Guidelines Bolsters Adoption


Dublin, Dec. 16, 2022 (GLOBE NEWSWIRE) -- The "Automatic Sampling in Biopharmaceutical Applications and the Measurement of CQA: Distribution by Type of Monitoring Method, Bioprocessing Method, Working Volume, Scalability, Key Geographical Regions : Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

The report features an extensive study on the current and future potential of automatic sampling systems.

During each stage of biopharmaceutical manufacturing process, it is essential to ensure that the bioprocess variables and parameters are under control. Sampling is considered to be an important step in the bioprocess. However, there are several challenges associated with conventional, manual aseptic sampling technique, such as high risk of contamination of the sample, high labor costs, operator-to-operator deviations during sampling and sample preparation, lower sample frequency rates and no real-time availability of data.

This has created a demand for systems that allow aseptic sampling and handling of samples, reduce errors, and increase reproducibility. As a result, automatic sampling systems have emerged to be the most appropriate solution as these systems have the potential to address a number of challenges associated with manual sampling method and offer various additional benefits including real-time data monitoring, reduction in deviations by around 65% and increase in the overall productivity up to 80%.

Moreover, automated sampling systems ensure that the processes continue to run within precise limits and make the necessary adjustments, while minimizing the risk of human errors, improving the overall product quality, timely monitoring critical process parameters, bringing tangible cost benefits and increased throughput.

Several companies are actively engaged in the manufacturing of automatic sampling systems and automatic sample preparation systems that can be used across various scale of operations in biopharmaceutical manufacturing. These systems have diverse applications, including bioprocess / analyte monitoring, fraction collection, data management and advanced process control / feedback control in biotechnology, pharmaceutical, chemical, food and cosmetic industries. In addition, automatic sampling systems use process analytical technology (PAT) that can be easily integrated in the bioprocessing unit in order to improve scalability.

Further, the field has witnessed several innovations, constantly evolving guidelines for pharmaceutical bioprocessing, mainly based on automation, digitalization and process transparency. It is also important to highlight that several equipment manufacturers offering user-friendly, controlled, and automated systems, have recently emerged.

Given the rising interest of stakeholders towards technological advancements and adoption of these systems, we believe that the overall market for automatic sampling in biopharmaceutical applications and the measurement of CQA is anticipated to witness substantial growth in the coming years.

Scope of the Report

  • Due to the growing demand for biologics and stringent regulatory guidelines, the biopharmaceutical industry has shifted to using automatic sampling methods, which offer reliable systems for transferring bioprocess samples directly from bioreactors to analytical devices while maintaining the process sterility and integrity. In addition, it features an elaborate discussion on the likely opportunity for the players engaged in this domain, over the next decade. Amongst other elements, the report includes:
  • A detailed assessment of the current market landscape of automatic sampling systems.
  • A competitiveness analysis of automatic sampling systems manufacturers based on various relevant parameters, such as overall experience of the company (in terms of number of years since it was established), product portfolio strength (in terms of number of automatic sampling systems manufactured and type of monitoring method) and portfolio diversity (in terms of type of sampling unit, end user industry, scalability and applications).
  • Elaborate profiles of prominent players engaged in this domain. Each profile includes a brief overview of the company, details related to its financial information (if available), information on product portfolio, recent developments and an informed future outlook.
  • A detailed market landscape of automatic sample collection / preparation systems, based on a several relevant parameters, such as system category, system classification, type of monitoring method, type of sampling unit, type of module, working volume, type of analyzer, end user industry and scalability of the products. In addition, the chapter includes a list of players engaged in developing automatic sample collection / preparation systems along with information on their year of establishment, company size, location of headquarters. Further, it also highlights the leading manufacturers of automatic sample collection / preparation systems (in terms of the number of systems manufactured).
  • Detailed profiles of the players offering automatic sample collection / preparation systems. It includes a brief overview of the company, details of its product portfolio, and a section on recent developments and an informed future outlook.
  • An insightful analysis of the patents filed / granted for automatic sampling systems, since 2016, taking into consideration various relevant parameters, such as type of patent, publication year, geographical location, CPC symbols, emerging focus areas, type of organization, leading players (in terms of number of patents granted / filed in the given time period) and patent characteristics. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis.
  • An analysis of various developments / recent trends related to automatic sampling systems, offering insights on recent global events related to automatic sampling systems, and partnerships and collaborations established within the industry.
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall automatic sampling systems market.
  • A qualitative analysis, highlighting the five competitive forces prevalent in this domain, including threats of new entrants, bargaining power of customers, bargaining power of automatic sampling system manufacturers, threats of substitute products and rivalry among existing competitors.

Key Questions Answered

  • Who are the key players engaged in the development of automatic sampling systems?
  • What is the relative competitiveness of different automatic sampling system manufacturers?
  • Who are the leading manufacturers involved in the automatic sample collection / preparation systems?
  • How has the intellectual property landscape in this domain evolved over the years?
  • What are the key agenda items being discussed in various global events / conferences held in this domain?
  • Which partnership models are most commonly adopted by stakeholders engaged in this industry?
  • How is the current and future market opportunity, likely to be distributed across key market segments?


Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Process Analytical Technology in Sampling
3.3. Manual Sampling versus Automatic Sampling
3.4. Need for Automatic Sampling Systems
3.5. Automatic Aseptic Sampling System
3.6. Components of a Sampling System
3.7. Stand-alone Systems versus Integrated Systems
3.8. Bioprocess Monitoring and Control Methods
3.8.1. At-line Monitoring
3.8.2. In-line Monitoring
3.8.3. Off-line Monitoring
3.8.4. On-line Monitoring
3.9. Key Considerations for Automatic Sampling
3.9.1. Sample Volume
3.9.2. Cell Removal
3.9.3. Sampling Rate
3.9.4. Integration of Analyzers
3.9.5. Feedback to Bioreactor
3.9.6. Flexibility
3.9.7. Transferability
3.9.8. Price
3.10. Benefits of Automatic Sampling Systems
3.11. Standards and Requirements
3.12. Future Innovations

4. MARKET LANDSCAPE: AUTOMATIC SAMPLING SYSTEMS

5. COMPANY COMPETITIVENESS ANALYSIS

6. COMPANY PROFILES: AUTOMATIC SAMPLING SYSTEM MANUFACTURERS
6.1. Chapter Overview
6.2. Agilent Technologies
6.3. Cytiva
6.4. Mettler Toledo
6.5. Pall Corporation
6.6. Shimadzu
6.7. Xylem

7. MARKET LANDSCAPE: AUTOMATIC SAMPLE COLLECTION / PREPARATION SYSTEMS

8. COMPANY PROFILES: AUTOMATIC SAMPLE COLLECTION / PREPARATION SYSTEM MANUFACTURERS
8.1. Chapter Overview
8.2. Agilent Technologies
8.3. Biotage
8.4. Flownamics
8.5. MGI Tech
8.6. SOTAX

9. PATENT ANALYSIS

10. RECENT DEVELOPMENTS

11. SWOT ANALYSIS

12. PORTERS FIVE FORCES ANALYSIS

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS

14. INDUSTRIAL REVOLUTION FROM INDUSTRY 1.0 TO INDUSTRY 5.0

15. CONCLUDING REMARKS

16. EXECUTIVE INSIGHTS

17. APPENDIX 1: TABULATED DATA

18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/3kh9xc

 

Contact Data