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

Overview

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.

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?