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Continuous and Semi-Continuous Bioprocessing Market by Type of Manufacturer, Company Size, Scale of Operation, Stage of Bioprocess, Geographical Regions : Industry Trends and Global Forecasts, 2021-2030

Continuous and Semi-Continuous Bioprocessing Market by Type of Manufacturer, Company Size, Scale of Operation, Stage of Bioprocess, Geographical Regions : Industry Trends and Global Forecasts, 2021-2030

  • June 2021
  • 191 pages
  • ID: 6154599
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
For years, the batch and fed-batch processing technique has been the only available solution for biomanufacturing. However, this method is plagued with several shortcomings, such as process inefficiencies, high risk of human errors and low production speeds. Modern biopharmaceuticals demand faster, and more efficient technologies, preferably with seamless transition into succeeding steps; the primary goal, in this regard, being the preservation of sterility. In other words, a continuous bioprocessing approach is better suited to the needs of the aseptic manufacturing paradigm that is required for biologics. In this context, the introduction of perfusion bioreactors in the late 1980s was a revolutionary development within the industry. Presently, there are multiple available technologies that are capable of supporting continuous downstream (including clarification / centrifugation, filtration, and chromatography steps) and upstream bioprocesses (which include cell line development and other pre-fermentation steps). A significant number of biopharmaceutical companies, especially certain big pharma players and large contract manufacturing service providers, claim to have already adopted, or are considering installing, continuous bioprocessing technologies, such as perfusion bioreactors, continuous chromatography and continuous filtration equipment. Continuous flow systems have been proven to address a number of challenges associated with traditional bioprocessing; for instance, they facilitate the lowering of manufacturing costs (by 60%), reduction in buffer use (by 30-50%), optimization of resin consumption (by 70%) in chromatography columns, reduction in product change over time (by 90%), improvement of product consistency across different batches (by 50%), minimizing facility footprints (by 50-70%), reduction in operating expenditure (by 90%) and seamless scale up. All the aforementioned advantages eventually serve to improve overall productivity (by 300-400%).
The current focus of the users of this novel technology is primarily on upgrading individual operations to the continuous mode; as indicated earlier, some companies have already established bioprocessing lines with multiple continuous processes. Cost, (end product) quality, processing speed and operational flexibility are some of the primary driving factors of the gradual shift to continuous bioprocessing. The COVID-19 pandemic has also contributed to accelerating the adoption of continuous flow systems. Some of the existing challenges in this field include complexities related to defining continuous processes (especially those upstream to the fermentation step), and aligning the available equipment to operate as per current GMP requirements. Although an end-to-end continuous bioproduction line is still several years away, we believe that the opportunity for both innovators and service providers engaged in this domain is likely to grow in the foreseen future.

SCOPE OF THE REPORT
The “Continuous and Semi-Continuous Bioprocessing Market by Type of Manufacturer (Innovator / Drug Developer and Contract Service Provider), Company Size (Large, Mid-Sized and Small), Scale of Operation (Preclinical / Clinical and Commercial), Stage of Bioprocess (Upstream and Downstream), Geographical Regions (North America, Europe and Asia Pacific): Industry Trends and Global Forecasts, 2021-2030” report features an extensive study on the companies having continuous and semi-continuous bioprocessing capabilities. The study underlines an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. Amongst other elements, the report includes:
•A detailed review of the overall landscape of the companies that have adopted continuous and semi-continuous bioprocessing, including analyses based on a number of relevant parameters, such as year of establishment, company size, type of manufacturer (innovator / drug developer and contract service provider), scale of operation (preclinical, clinical and commercial), location of headquarters, locations of continuous and semi-continuous bioprocessing facilities of innovators, locations of continuous and semi-continuous bioprocessing facilities of contract service providers, type of facility (modular and conventional), type of bioreactor (single-use and stainless steel), stage of bioprocess (upstream and downstream), primary continuous and semi-continuous bioprocessing (continuous cell culture, continuous clarification / harvesting, continuous purification, process analytical technology and others), secondary continuous and semi-continuous bioprocessing (N-1 stage perfusion, N stage perfusion, continuous concentrated fed-batch, continuous cell retention, continuous centrifugation, continuous chromatography and continuous viral filtration), types of biologics manufactured (antibodies, proteins / peptides, vectors, enzymes and others) and details on the continuous and semi-continuous production capacity.
•Tabulated profiles of the key players offering a wide range of services for the continuous and semi-continuous bioprocessing of products across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, financial information (if available), details on its service portfolio, continuous and semi-continuous bioprocessing related capabilities, scale of operation, stage of bioprocess, types of biologics manufactured, continuous and semi-continuous bioprocessing manufacturing facilities, recent developments and an informed future outlook.
• Key initiatives taken by the leading pharmaceutical companies, taking into consideration both partnered as well as in-house projects.
• A case study to depict the overall landscape of the continuous and semi-continuous bioprocessing equipment providers, based on a number of parameters, such as type of equipment, type of manufacturing process (continuous and batch-continuous), stage of bioprocess (upstream process and downstream process) and scale of operation (preclinical / clinical and commercial).
• An insightful analysis highlighting the cost saving potential associated with the adoption of continuous and semi-continuous bioprocessing technologies.
• A detailed analysis to estimate the global, continuous upstream bioprocessing capacity based on the capacities of various industry stakeholders. The study includes the distribution of capacity, based on company size (small, mid-sized and large), type of manufacturer (innovator / drug developer and contract service provider), scale of operation (preclinical, clinical and commercial), location of headquarters (North America, Europe and Asia-Pacific) and location of continuous and semi-continuous bioprocessing facilities (North America, Europe and Asia-Pacific).

One of the key objectives of the report was to estimate the current market size and the growth opportunities in the continuous and semi-continuous bioprocessing market, over the next decade. Based on different parameters, such as global biopharmaceutical market, cost of goods sold, manufacturing cost of biologics, share of API manufacturing, upstream and downstream costs in biologics manufacturing, we have provided informed estimates on the evolution of the market for the period 2021-2030. In order to provide a detailed future outlook, year-wise projections of the current and forecasted opportunity have been further segmented across [A] type of manufacturer (innovator / drug developer and contract service provider), [B] company size (large, mid-sized and small), [C], scale of operation (preclinical / clinical and commercial), [D] stage of bioprocess (upstream and downstream), and [E] key geographical regions (North America, Europe and Asia-Pacific). In order to account for the uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report are backed by a deep understanding of key insights generated from both secondary and primary research. The perceptions presented in this study were also influenced by discussions held with senior stakeholders in this industry. The report features detailed transcripts of interviews held with the following individuals:
• Jon Coffman (Senior Director of Bioprocess Technology and Engineering, AstraZeneca)
• Ehsan Mahdinia (Assistant Professor, Albany College of Pharmacy and Health Sciences)
• Himanshu Gadgil (Director and Chief Scientific Officer, Enzene Biosciences)

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.

KEY QUESTIONS ANSWERED
• Which are the leading contract manufacturers offering expertise in continuous bioprocessing?
• Which are the leading innovators / drug developers with expertise in continuous bioprocessing?
• In which regions are majority of the continuous and semi-continuous bioprocessing facilities located?
• What is the likely cost saving potential of continuous and semi-continuous bioprocessing technology?
• What is the currently installed global capacity for continuous and semi-continuous bioprocessing?
• How is the current and future market opportunity likely to be distributed across key market segments?

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, medical practice and other associations) to solicit their opinions on emerging trends in the market. This information is primarily beneficial for us to draw opinions 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 laid on forecasting the market till 2030, the report also provides our independent views on various technological and non-commercial trends emerging in the industry. The opinion is solely based on our knowledge, research and understanding of the relevant market trends gathered from various secondary and primary sources.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the continuous and semi-continuous bioprocessing market in the short to mid-term, and long term.

Chapter 3 provides a general introduction to continuous bioprocessing technology. The chapter describes the historical evolution of continuous bioprocessing in the pharmaceutical industry. It features a brief overview of the regulatory landscape, the early adopters of this technology, opportunities and key challenges associated with the adoption of these techniques. The chapter also discusses the future perspectives of the continuous and semi-continuous bioprocessing market.

Chapter 4 provides an overview of the overall landscape of the companies with capabilities for continuous and semi-continuous bioprocessing, including information on around 60 players engaged in this domain. Additionally, it features an in-depth analysis of the companies, based on a number of parameters, such as year of establishment, company size, type of manufacturer (innovator / drug developer and contract service provider), scale of operation (preclinical, clinical and commercial), location of headquarters, location of continuous and semi-continuous bioprocessing facilities of innovators, location of continuous and semi-continuous bioprocessing facilities of contract service providers, type of facility (modular and conventional), type of bioreactor (single-use and stainless steel), stage of bioprocess (upstream and downstream), primary continuous and semi-continuous bioprocessing (continuous cell culture, continuous clarification / harvesting, continuous purification, process analytical technology and others), secondary continuous and semi-continuous bioprocessing (N-1 stage perfusion, N stage perfusion, continuous concentrated fed-batch, continuous cell retention, continuous centrifugation, continuous chromatography and continuous viral filtration), types of biologics manufactured (antibodies, proteins / peptides, vectors, enzymes and others) and details on the continuous and semi-continuous production capacity.

Chapter 5 includes tabulated profiles of the key stakeholder that have adopted the continuous and semi-continuous bioprocessing technologies and are active in the aforementioned market in North America. Each profile features a brief overview of the company, financial information (if available), details on its service portfolio, continuous and semi-continuous bioprocessing related capabilities, scale of operation, stage of bioprocess, types of biologics manufactured, continuous and semi-continuous bioprocessing manufacturing facilities, recent developments and an informed future outlook.

Chapter 6 includes tabulated profiles of the key stakeholder that have adopted the continuous and semi-continuous bioprocessing technologies and are active in the aforementioned market in Europe. Each profile features a brief overview of the company, financial information (if available), details on its service portfolio, continuous and semi-continuous bioprocessing related capabilities, scale of operation, stage of bioprocess, types of biologics manufactured, continuous and semi-continuous bioprocessing manufacturing facilities, recent developments and an informed future outlook.

Chapter 7 includes tabulated profiles of the key stakeholder that have adopted the continuous and semi-continuous bioprocessing technologies and are active in the aforementioned market in Asia-Pacific. Each profile features a brief overview of the company, financial information (if available), details on its service portfolio, continuous and semi-continuous bioprocessing related capabilities, scale of operation, stage of bioprocess, types of biologics manufactured, continuous and semi-continuous bioprocessing manufacturing facilities, recent developments and an informed future outlook.

Chapter 8 highlights the key initiatives taken by the leading pharmaceutical companies (in terms of revenues generated), taking into consideration both partnered as well as in-house projects.

Chapter 9 is a case study providing information on more than 80 continuous manufacturing equipment for biologics. It features a detailed analysis based on the type of equipment, type of manufacturing process (continuous and batch-continuous) and stage of bioprocess (upstream process and downstream process) and the scale of operation (preclinical / clinical and commercial). Further, the chapter provides information on equipment provider(s) along with information on their year of establishment, company size, location of headquarters and key players in this domain.

Chapter 10 presents an insightful analysis of the cost saving potential associated with the adoption of continuous and semi-continuous bioprocessing technologies.

Chapter 11 features a detailed analysis of the global, continuous upstream bioprocessing capacity based on the capacities of various industry stakeholders (as available on their respective company websites). The study examines the distribution of capacity, based on the company size (small, mid-sized and large), type of manufacturer (innovator / drug developer and contract service provider), scale of operation (preclinical, clinical and commercial), location of headquarters (North America, Europe and Asia-Pacific) and location of continuous and semi-continuous bioprocessing facilities (North America, Europe and Asia-Pacific).

Chapter 12 presents an insightful market forecast analysis, highlighting the likely growth of the continuous and semi-continuous bioprocessing market till the year 2030. In order to provide an informed future outlook, our projections have been segmented across [A] type of manufacturer (innovator / drug developer and contract service provider), [B] company size (large, mid-sized and small), [C], scale of operation (preclinical / clinical and commercial), [D] stage of bioprocess (upstream and downstream), and [E] key geographical regions (North America, Europe and Asia-Pacific).

Chapter 13 is a summary of the overall report wherein we have mentioned all the key facts and figures described in the chapters. The chapter also highlights the important evolutionary trends that were identified during our research and are expected to influence the continuous and semi-continuous bioprocessing market in the future.

Chapter 14 contains the interview transcripts of the discussions held with key stakeholders engaged in this domain. In this study, we spoke to Jon Coffman (Senior Director of Bioprocess Technology and Engineering, AstraZeneca), Ehsan Mahdinia (Assistant professor, Albany College of Pharmacy and Health Sciences) and Himanshu Gadgil (Director and Chief Scientific Officer, Enzene Biosciences).

Chapter 15 is an appendix, that contains tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix that provides the list of companies and organizations mentioned in the report.

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