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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

  • ID: 5441008
  • Report
  • June 2021
  • Region: Global
  • 191 Pages
  • Roots Analysis

FEATURED COMPANIES

  • 3D Biotek
  • BioMarin Pharmaceutical
  • Cytiva
  • GTP Technology
  • Microsoft
  • Samsung Biologics

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?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 3D Biotek
  • BioMarin Pharmaceutical
  • Cytiva
  • GTP Technology
  • Microsoft
  • Samsung Biologics

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Evolution of Continuous Bioprocessing
3.3. Continuous Processing in the Pharmaceutical Industry
3.3.1. Regulatory Landscape
3.3.2. Early Adopters of the Technology
3.3.3. Anticipated Shift from Batch Processing
3.3.4. Advantages of Continuous Processing 
3.3.5. Key Challenges Associated with Continuous Processing
3.3.6. Future Perspectives

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Continuous and Semi-Continuous Bioprocessing: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Type of Manufacturer
4.2.4. Analysis by Scale of Operation
4.2.5. Analysis by Company Size and Type of Manufacturer
4.2.6. Analysis by Location of Headquarters
4.2.7. Analysis of Locations of Continuous and Semi-Continuous Bioprocessing Facilities of Innovators
4.2.8. Analysis of Locations of Continuous and Semi-Continuous Bioprocessing Facilities of Contract Service Providers
4.2.9. Analysis by Type of Facility
4.2.10. Analysis by Type of Bioreactor
4.2.11. Analysis by Stage of Bioprocess
4.2.11.1. Primary Continuous and Semi-Continuous Bioprocessing
4.2.11.2. Secondary Continuous and Semi-Continuous Bioprocessing
4.2.12. Analysis by Types of Biologics Manufactured
4.2.13. Information on Production Capacity 

5. CONTINUOUS BIOPROCESSING IN NORTH AMERICA: COMPANY PROFILES
5.1. Chapter Overview
5.2. AGC Biologics
5.2.1. Continuous and Semi-Continuous Bioprocessing Capabilities
5.2.2. Recent Developments and Future Outlook
5.3. Biogen
5.3.1. Continuous and Semi-Continuous Bioprocessing Capabilities
5.3.2. Recent Developments and Future Outlook
5.4. Bristol-Myers Squibb
5.4.1. Continuous and Semi-Continuous Bioprocessing Capabilities
5.4.2. Recent Developments and Future Outlook
5.5. Sanofi Genzyme
5.5.1. Continuous and Semi-Continuous Bioprocessing Capabilities
5.5.2. Recent Developments and Future Outlook

6. CONTINUOUS BIOPROCESSING IN EUROPE: COMPANY PROFILES
6.1. Chapter Overview
6.2. FUJIFILM Diosynth Biotechnologies
6.2.1. Continuous and Semi-Continuous Bioprocessing Capabilities
6.2.2. Recent Developments and Future Outlook
6.3. Merck KGaA
6.3.1. Continuous and Semi-Continuous Bioprocessing Capabilities
6.3.2. Recent Developments and Future Outlook
6.4. Novasep
6.4.1. Continuous and Semi-Continuous Bioprocessing Capabilities
6.4.2. Recent Developments and Future Outlook
6.5. UCB Pharma
6.5.1. Continuous and Semi-Continuous Bioprocessing Capabilities
6.5.2. Recent Developments and Future Outlook

7. CONTINUOUS BIOPROCESSING IN ASIA-PACIFIC: COMPANY PROFILES
7.1. Chapter Overview
7.2. Enzene Biosciences
7.2.1. Continuous and Semi-Continuous Bioprocessing Capabilities
7.2.2. Recent Developments and Future Outlook
7.3. WuXi Biologics
7.3.1. Continuous and Semi-Continuous Bioprocessing Capabilities
7.3.2. Recent Developments and Future Outlook

8. INITIATIVES OF COMPANIES WITH IN-HOUSE CONTINUOUS BIOPROCESSING CAPABILITIES
8.1. Chapter Overview
8.2. Continuous Manufacturing Initiatives of Leading Companies
8.2.1. AbbVie
8.2.1.1. Partnered Initiatives 
8.2.1.2. In-House Initiatives
8.2.2. Amgen
8.2.2.1. Partnered Initiatives
8.2.2.2. In-House Initiatives
8.2.3. Bristol-Myers Squibb
8.2.3.1. Partnered Initiatives
8.2.3.2. In-House Initiatives
8.2.4. GlaxoSmithKline
8.2.4.1. Partnered Initiatives
8.2.4.2. In-House Initiatives
8.2.5. Merck
8.2.5.1. Partnered Initiatives
8.2.5.2. In-House Initiatives
8.2.6. Novartis
8.2.6.1. Partnered Initiatives
8.2.6.2. In-House Initiatives
8.2.7. Pfizer
8.2.7.1. Partnered Initiatives
8.2.7.2. In-House Initiatives
8.2.8. Roche
8.2.8.1. Partnered Initiatives
8.2.8.2. In-House Initiatives
8.2.9. Sanofi
8.2.9.1. Partnered Initiatives
8.2.9.2. In-House Initiatives

9. CONTINUOUS MANUFACTURING EQUIPMENT FOR BIOLOGICS: MARKET LANDSCAPE
9.1. Chapter Overview
9.2. Continuous Manufacturing Equipment for Biologic Drugs: Overall Market Landscape
9.2.1. Analysis by Type of Equipment
9.2.2. Analysis by Type of Manufacturing Process
9.2.3. Analysis by Stage of Bioprocess
9.2.4. Analysis by Scale of Operation
9.3. Continuous Manufacturing Equipment Providers for Biologics
9.3.1. Analysis by Year of Establishment
9.3.2. Analysis by Company Size
9.3.3. Analysis by Location of Headquarters
9.3.4. Analysis by Prominent Continuous Manufacturing Equipment Providers

10. COST SAVING ANALYSIS
10.1. Chapter Overview
10.2 Technologies Involved in Continuous and Semi-Continuous Bioprocessing
10.3 Cost Saving Potential of Continuous and Semi-Continuous Bioprocessing
10.3.1. Potential Cost Savings in Upstream Processes
10.3.2. Potential Cost Savings in Downstream Processes
10.4. Key Assumptions and Methodology
10.5 Overall Cost Saving Potential of Continuous and Semi-Continuous Bioprocesses, 2021-2030
10.6 Concluding Remarks

11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Methodology
11.3.1. Global, Continuous and Semi-Continuous Bioprocessing Capacity
11.3.2. Analysis by Company Size
11.3.3. Analysis by Type of Manufacturer
11.3.4. Analysis by Company Size and Type of Manufacturer
11.3.4. Analysis by Scale of Operation
11.3.5. Analysis by Location of Headquarters
11.3.6. Analysis by Location of Continuous and Semi-Continuous Bioprocessing Facilities

12. MARKET FORECAST AND OPPORTUNITY ANALYSIS
12.1. Chapter Overview
12.2. Forecast Methodology and Key Assumptions
12.3. Overall Continuous and Semi-Continuous Bioprocessing Market, 2021-2030
12.3.1. Continuous and Semi-Continuous Bioprocessing Market, 2021-2030: Distribution by Type of Manufacturer
12.3.2. Continuous and Semi-Continuous Bioprocessing Market, 2021-2030: Distribution by Company Size
12.3.3. Continuous and Semi-Continuous Bioprocessing Market, 2021-2030: Distribution by Scale of Operation
12.3.4. Continuous and Semi-Continuous Bioprocessing Market, 2021-2030: Distribution by Stage of Bioprocess
12.3.5. Continuous and Semi-Continuous Bioprocessing Market, 2021-2030: Distribution by Key Geographical Regions
12.4. Continuous Upstream Bioprocessing Market, 2021-2030
12.4.1. Continuous Upstream Bioprocessing Market, 2021-2030: Distribution by Type of Manufacturer
12.4.2. Continuous Upstream Bioprocessing Market, 2021-2030: Distribution by Company Size
12.4.3. Continuous Upstream Bioprocessing Market, 2021-2030: Distribution by Scale of Operation
12.4.4. Continuous Upstream Bioprocessing Market, 2021-2030: Distribution by Key Geographical Regions
12.5. Continuous Downstream Bioprocessing Market, 2021-2030
12.5.1. Continuous Downstream Bioprocessing Market, 2021-2030: Distribution by Type of Manufacturer
12.5.2. Continuous Downstream Bioprocessing Market, 2021-2030: Distribution by Company Size
12.5.3. Continuous Downstream Bioprocessing Market, 2021-2030: Distribution by Scale of Operation
12.5.4. Continuous Downstream Bioprocessing Market, 2021-2030: Distribution by Key Geographical Regions

13. CONCLUSION

14. EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. AstraZeneca
14.2.1. Overview of Company / Organization 
14.2.2. Interview Transcript: Jon Coffman, Senior Director of Bioprocess Technology and Engineering
14.3. Enzene Biosciences
14.3.1. Overview of Company / Organization 
14.3.2. Interview Transcript: Himanshu Gadgil, Director and Chief Scientific Officer
14.4. Albany College of Pharmacy and Health Sciences
14.4.1. Overview of Company / Organization 
14.4.2. Interview Transcript: Ehsan Mahdinia, Assistant Professor

15. APPENDIX 1: TABULATED DATA

16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Note: Product cover images may vary from those shown
  • 3D Biotek
  • 3P Biopharmaceuticals
  • AbbVie 
  • ABL Europe
  • Abzena 
  • Accenture 
  • AGC Biologics
  • AIM ImmunoTech 
  • Alexanderwerk 
  • Alvotech
  • Amgen
  • AmpTec
  • Applikon Biotechnology
  • Aprogen
  • AstraZeneca
  • Avid Bioservices (formerly Peregrine Pharmaceuticals)
  • Baxter
  • Bayer
  • bbi-biotech
  • BIBITEC
  • BINEX
  • Biogen
  • BioMarin Pharmaceutical
  • Bionova Scientific
  • BiosanaPharma 
  • Bio-Thera Solutions 
  • Biovian
  • bluebird bio
  • Boehringer Ingelheim BioXcellence 
  • Bonumose 
  • Bristol-Myers Squibb
  • Changchun High & New Technology 
  • Canton Biologics
  • CCHT Biopharmaceutical
  • Celgene 
  • Cell and Gene Therapy Catapult 
  • Cell Culture Company
  • CELLEC Biotek
  • Celonic
  • Centre for Process Innovation (CPI)
  • Cerbios-Pharma
  • CMAC 
  • Cobra Biologics 
  • Codiak BioSciences
  • Coperion
  • Creative Biolabs
  • CSL Behring
  • Cytiva
  • Cytovance Biologics
  • DCI-Biolafitte 
  • DEVEX Verfahrenstechnik
  • DSM Pharmaceutical
  • Durham University
  • Eli Lilly
  • Engage Therapeutics (Acquired by UCB Pharma)
  • Enzene Biosciences
  • Eppendorf
  • Esco Aster
  • ETH Zurich
  • EV Biologics
  • Evotec
  • Exelixis 
  • Exothera
  • Forbius 
  • FUJIFILM Diosynth Biotechnologies
  • Gallus BioPharmaceuticals (Acquired by Patheon)
  • G-CON Manufacturing
  • GEA 
  • Genzyme
  • Global BioTherapeutics (GBT)
  • Glycotope 
  • Goodwin Biotechnology
  • GTP Technology
  • HAL Allergy
  • HALIX 
  • Handl Therapeutics
  • Hemispherx Biopharma
  • HJB
  • Horizon Therapeutics 
  • Janssen Pharmaceuticals
  • Johnson & Johnson 
  • Just-Evotec Biologics
  • KBI Biopharma
  • Kemwell Biopharma
  • Kiadisto 
  • Kymab
  • Lonza
  • Luina Bio
  • Lupin
  • MabSpace Biosciences 
  • Medix Biochemica
  • Merck
  • Merck KGaA
  • Microsoft 
  • MolMed 
  • Mycenax Biotech
  • MyoKardia (acquired by Bristol-Myers Squibb)
  • National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
  • National Resilience 
  • Natrix Separations (Acquired by Merck)
  • Nightstar Therapeutics (acquired by Biogen)
  • Novartis
  • Novasep
  • Novavax 
  • Novo Nordisk
  • Ology Bioservices 
  • OmniBRx Biotechnologies
  • OXGENE (Acquired by WuXi AppTec)
  • PacificGMP
  • Pall Biotech
  • Pall Life Sciences
  • Pfizer
  • Pierre Fabre 
  • PIERRE GUERIN
  • Polymun Scientific
  • ProBioGen
  • Rentschler Biopharma
  • Repligen 
  • Sage Therapeutics 
  • Samsung Biologics
  • Sangamo Therapeutics 
  • Sanofi Genzyme
  • Sartorius
  • Semba Biosciences
  • Servier
  • Shire
  • Sturtevant
  • Syngene
  • Synthecon
  • TA Instruments
  • ThalesNano
  • The Rockefeller University 
  • Thermo Fisher Scientific
  • Tidal Therapeutics (Acquired by Sanofi)
  • Transcenta 
  • Translate Bio
  • UCB Pharma
  • UIC College of Pharmacy
  • Universitas Indonesia 
  • University of Strathclyde
  • Vapourtec
  • Vigene Biosciences 
  • WuXi Biologics
  • WuXi STA 
  • XPure
  • YMC Process Technologies
Note: Product cover images may vary from those shown

 

 

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