Automatic Sampling in Biopharmaceutical Applications and the Measurement of CQA, 2022-2035

Automatic Sampling in Biopharmaceutical Applications and the Measurement of CQA, 2022-2035

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:
A detailed assessment of the current market landscape of automatic sampling systems, featuring a detailed analysis of these systems based on several parameters, such as type of monitoring method, type of sampling unit(s), availability of pump / probe, type of module, automated software, type of vessel, vessel fabrication material, type of analyte monitored, type of analyzer, number of sampling vessels, working volume, operating temperature, end user industry, scalability and applications of the system. In addition, the chapter includes analysis of automatic sampling system developers, along with information on their year of establishment, company size, location of headquarters and leading players (in terms of number of systems being offered).
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.

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.

MARKET SEGMENTATION

Automatic Sampling Systems - Market Segmentations
Market Segment Details
Forecast Period 2022 - 2035
Type of Monitoring Method On-line
Off-line
At-line
Bioprocessing Method Upstream
Downstream
Working Volume Less than 10 mL
10-50 mL
51-100 mL
More than 100 mL
Scalability Lab Scale
Pilot Scale
Commercial Scale
Key Geographical Regions North America
Europe
Asia-Pacific and Rest of the World
Source: Roots Analysis

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:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

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

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?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the automatic sampling systems market and its likely evolution in the short-mid to long term.

Chapter 3 provides a brief overview of automatic sampling systems and process analytical technology (PAT) in sampling. Additionally, it features comparison between manual and automatic sampling, need for automatic sampling systems, components of a sampling system, stand-alone versus integrated systems, monitoring methods for critical process parameters and quality attributes, key considerations for automatic sampling and benefits of these systems to biopharmaceutical players. Further, it also highlights the future perspectives in this domain.

Chapter 4 presents an overview of the current market landscape of automatic sampling systems, featuring a detailed analysis of these systems based on several parameters, such as type of monitoring method, type of sampling unit(s), availability of pump / probe, type of module, automated software, type of vessel, vessel fabrication material, type of analyte monitored, type of analyzer, number of sampling vessels, working volume, operating temperature, end user industry, scalability and applications of the system. In addition, the chapter includes analysis of automatic sampling system developers, along with information on their year of establishment, company size, location of headquarters and leading players (in terms of number of systems being offered).

Chapter 5 provides 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).

Chapter 6 includes profiles of the key players engaged in the development of automatic sampling systems (shortlisted on the basis of the company size). Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio, recent developments and an informed future outlook.

Chapter 7 presents an overview of the current market landscape of automatic sample collection / preparation systems, based on a several relevant parameters, such as system category, system classification, type of system, 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).

Chapter 8 includes profiles of the key players engaged in the development of automatic sample collection / preparation systems (shortlisted on the basis of the number of systems manufactured). Each profile features a brief overview of the company, details on its product portfolio, recent developments and an informed future outlook.

Chapter 9 features an in-depth analysis of the patents that have been filed / granted for the automatic sampling systems, since 2016. The analysis also highlights the key trends associated with the patents, such as the type of patent (granted patent, patent application and others), publication year, annual number of granted patents and patent applications, geographical location, CPC symbols, emerging focus areas of the patents, type of organization and leading players (in terms of number of patents granted / filed). In addition, it includes detailed patent benchmarking and valuation analysis based on patent characteristics.

Chapter 10 features analyses of instances wherein companies have entered into partnerships with other stakeholders related to automatic sampling in biopharmaceutical applications and the measurement of CQA and recent events (conferences / seminars / symposiums / webinars / workshops) that were organized by several stakeholders engaged in this domain.

Chapter 11 provides information on the affiliated trends, key drivers and challenges associated with automatic sampling systems, under a reliable SWOT framework. The chapter includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall automatic sampling systems market.

Chapter 12 provides insights on a qualitative analysis highlighting five competitive forces 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.

Chapter 13 features a detailed market forecast of the likely growth of automatic sampling systems, till the year 2035. It also includes insights on the likely distribution of the current and forecasted opportunity across the 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).

Chapter 14 presents a discussion about the transition of biopharmaceutical industry from 1.0 to 5.0, highlighting different horizons of laboratory evolution. Further, it presents the comparison between Industry 4.0 and Industry 5.0.

Chapter 15 is a summary of the overall report, presenting insights on the contemporary market trends and the likely evolution of the automatic sampling systems market.

Chapter 16 provides the transcripts of the interviews conducted with senior representatives of renowned organizations that are engaged in the automatic sampling domain.

Chapter 17 is an appendix, that contains tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix, that contains the list of companies and organizations mentioned in the report.