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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
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INTRODUCTION

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

The 'Automatic Sampling in Biopharmaceutical Applications and the Measurement of CQA, 2022-2035: Distribution by Type of Monitoring Method (On-line, Off-line and At-line), Bioprocessing Method (Upstream and Downstream), Working Volume (Less than 10 mL, 10-50 mL, 51-100 mL and more than 100 mL), Scalability (Lab Scale, Pilot Scale and Commercial Scale), Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035' report features an extensive study on the current and future potential of automatic sampling systems. 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:

One of the key objectives of the report was to estimate the existing market size and the future opportunity for automatic sampling systems, over the coming 13 years. We have provided informed estimates of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of monitoring method (on-line, off-line and at-line), bioprocessing method (upstream and downstream), working volume (less than 10 ml, 10-50 ml, 51-100 ml and more than 100 ml), scalability (lab scale, pilot scale and commercial scale), and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. The information is primarily useful for us to draw out our opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

CHAPTER OUTLINES

TABLE OF CONTENTS

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE: AUTOMATIC SAMPLING SYSTEMS

5. COMPANY COMPETITIVENESS ANALYSIS

6. COMPANY PROFILES: AUTOMATIC SAMPLING SYSTEM MANUFACTURERS

7. MARKET LANDSCAPE: AUTOMATIC SAMPLE COLLECTION / PREPARATION SYSTEMS

8. COMPANY PROFILES: AUTOMATIC SAMPLE COLLECTION / PREPARATION SYSTEM MANUFACTURERS

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

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