• +353-1-415-1241(GMT OFFICE HOURS)
  • 1-800-526-8630(US/CAN TOLL FREE)
  • 1-917-300-0470(EST OFFICE HOURS)
Bioseparation Systems for Global Biopharmaceutical Markets - Product Image

Bioseparation Systems for Global Biopharmaceutical Markets

  • Published: August 2013
  • Region: Global
  • 153 Pages
  • TriMark Publications
Global Markets for Bioseparations for Biopharmaceutical Manufacturing to Jump to $6 Billion by 2018

FEATURED COMPANIES

  • Agilent Technologies
  • Carr Centritech
  • DSM Biologics
  • Knauer
  • M Cuno
  • NuSep Holdings Ltd
  • MORE

Bioseparations systems can be categorized into three types: chromatography, membranes/filters and centrifuges. The demand for single use products is increasing and fueling growth of the global bioseparations market. New biosimilars are driving the increase in global biomanufacturing capacity.

Blockbuster biologics are going off patent, leaving the market open for developing and manufacturing low cost biosimilars. This report provides market revenue size and growth rates for North America, Europe, Asia-Pacific (Japan, South Korea, Singapore) and the emerging BRICs (Brazil, Russia, India, China). Single-use products, manufacturing capacity, applications of bioseparations in downstream processing, downstream processing bottlenecks and emerging bioseparations technologies are covered in detail.

The report also analyzes the competitive landscape, including key players' strengths and weaknesses, opportunities, gaps and industry trends. Detailed tables and charts with sales forecasts and marketshare data are also included.

Scope of the Report

- Single use products
- Manufacturing capacity
- Applications of bioseparations in downstream processing
- Downstream processing bottlenecks
- Emerging bioseparations technologies
- Manufacturing capacity by biopharmaceutical company, CMO and region

1. Introduction
1.1 Statement of Report
1.2 About this Report
1.3 Objectives
1.4 Scope of Report
1.5 Methodology
1.6 Executive Summary

2. Overview
2.1 Introduction
2.2 Biopharmaceutical Industry Environment
2.2.1 Investment in Healthcare Worldwide
2.2.2 Diseases and Development of New Biologics
2.2.3 High Cost of Development and Manufacturing a Biological
2.2.4 Economics and Reimbursement for Biological Therapies
2.2.5 Strict Regulation of Biologics Manufacturing
2.3 Trends in Bioseparations
2.3.1 Single-Use Biomanufacturing Technology is Enabling the Biologics Factory of the Future
2.3.2 Emerging and Disruptive Bioprocessing Technologies Have Potential to Reduce Downstream
Processing Bottlenecks
2.3.3 Asia is Becoming a Global Manufacturing Hub
2.3.4 Contract Manufacturing Organizations Offering ÒBiomanufacturing on DemandÓ
2.3.5 Biosimilars are in Demand Globally
2.4 Global Biomanufacturing Demographics
2.4.1 Global Biologics Producers
2.4.2 Global Biomanufacturing Capacity

3. Biologics in the Development Phase
3.1 Monoclonal Antibodies
3.2 Vaccines
3.3 Veterinary Vaccines
3.4 Recombinant Proteins and Peptides
3.5 Blood Plasma Fractionation
3.6 Cell Therapy
3.7 Gene Therapy
3.8 Antisense

4. Bioseparations Products and Systems
4.1 Chromatography
4.2 Membranes and Filters
4.3 Centrifuges
4.4 Leading Manufacturers of Bioseparations Products and Systems

5. The Biopharmaceutical Manufacturing Process
5.1 Upstream Processing
5.1.1 Host Cell Lines
5.1.2 Bioreactors
5.1.3 Productivity Improvements in Upstream Processing
5.2 Downstream Processing
5.2.1 Remove Insolubles
5.2.2 Isolation
5.2.3 Capture and Purification
5.2.4 Polishing
5.3 Application of Bioseparations Products for Downstream Processing
5.4 Downstream Process Development
5.4.1 Laboratory Development
5.4.2 Pilot and Scale Up
5.4.3 Manufacturing Scale
5.4.4 Process Validation
5.4.5 Role of Bioseparations Vendors in Process Development
5.5 Good Manufacturing Practices and Regulatory Requirements for Manufacture of Biologicals
5.6 Biomanufacturing Cost Considerations
5.7 Downstream Bottlenecks

6. Bioseparation Processes Used for Biologics Manufacturing
6.1 Separation and Purification of Recombinant Proteins from Mammalian Cells
6.1.1 Monoclonal Antibody Therapeutics
6.1.2 Recombinant Erythropoietin
6.2 Separation and Purification of Recombinant Proteins from Microbial Cell Culture
6.2.1 Recombinant Insulin
6.3 Vaccine Purification
6.3.1 Microbial Vaccines and Toxoids
6.3.2 Viral and Capsid Vaccines
6.3.3 Polysaccharide Vaccines and Conjugates (Pneumococcal Vaccines)
6.3.4 Recombinant Protein Vaccines
6.3.5 DNA Vaccines and Gene Therapy
6.3.6 Viral Vector Vaccines
6.4 Plasma Fractionation
6.5 Transgenic Animals and Plants: Emerging Technologies for Producing Biologics
6.5.1 Downstream Processing of Transgenically Produced Biologics
6.5.2 Specialty Bioseparations Products for Purification of Biologics Produced from Transgenic Animals or Plants

7. Global Bioseparation Market Analysis
7.1 The Global Bioseparations Market Size
7.2 Global Bioseparations Market Size by Product
7.3 Bioseparations Market by Consumables and Equipment

8. The Global Bioseparations Market by Region
8.1 North America Bioseparations Market
8.1.1 The Market Situation
8.1.2 Regulatory
8.1.3 Biomanufacturing in North America
8.1.4 New Construction and Capacity
8.1.5 Blood Plasma Fractionation
8.1.6 Vaccines
8.1.7 Biosimilars
8.2 Western Europe Bioseparations Market
8.2.1 Bioseparations Manufacturers in Europe
8.2.2 The Market Situation
8.2.3 Regulatory
8.2.4 Biomanufacturing in Western Europe
8.2.5 Biosimilars
8.2.6 Vaccines
8.2.7 Blood Plasma Fractionation
8.3 Asia-Pacific Bioseparations Markets
8.3.1 Japanese Bioseparations Market
8.3.2 Singaporean Bioseparations Market
8.3.3 South Korean Bioseparations Market
8.4 BRIC Emerging CountriesÕ Bioseparations Markets
8.4.1 Chinese Bioseparations Market
8.4.2 Indian Bioseparations Market
8.4.3 Brazilian Bioseparations Market
8.4.4 Russian Bioseparations Market

9. Competitive Landscape
9.1 GE Healthcare Life Sciences
9.1.1 Strategy
9.1.2 Bioseparations Product Mix and Brands
9.1.3 Platforms and Product Groups
9.1.4 Process Development and Technical Support
9.1.5 New Product Launches
9.2 Merck Millipore
9.2.1 Strategy
9.2.2 Bioseparations Product Mix and Brands
9.2.3 Platforms and Product Groups
9.2.4 Training and Support
9.2.5 New Product Launches
9.3 Pall Corporation
9.3.1 Strategy
9.3.2 Bioseparations Product Mix and Brands
9.3.3 Platforms and Product Groups
9.3.4 Training and Support
9.3.5 New Product Introductions
9.4 Sartorius
9.4.1 Strategy
9.4.2 Bioseparations Product Mix and Brands
9.4.3 Platforms and Product Groups
9.4.4 Training and Support
9.4.5 New Product Launches
9.5 3M CUNO
9.5.1 Strategy
9.5.2 Bioseparations Product Mix and Brands
9.5.3 Training and Support

10. Industry Analysis
10.1 Recent Industry Developments
10.2 Emerging Technologies
10.2.1 Simulated Moving Bed Chromatography/Continuous Countercurrent Flow
10.2.2 Monolith Chromatography
10.2.3 High Performance Tangential Flow
10.2.4 Expanded Bed Adsorption Chromatography
10.2.5 Novel Affinity Separations for Blood Plasma Fractionation
10.3 Gaps and Challenges
10.3.1 Downstream Bottlenecks
10.3.2 Single-Use Technologies in Downstream Processing
10.4 Opportunities
10.4.1 Platform Technologies and Turn Key Biomanufacturing
10.4.2 Bioseparations for Biologics Produced from Transgenic Animals and Genetically
Engineered Plants
10.5 Strategic Recommendations
10.5.1 Competing in the Bioseparations Market
10.5.2 Competing in Emerging and Developing Countries
11. Single-Use Bioseparations Systems and Products
11.1 Drivers and Restrictors for Single Use Technology
11.2 Single-Use Technology for Downstream Purification of Monoclonal Antibodies
11.3 Single-Use Technology For Vaccine Production
11.4 Single-Use Systems and Skids for Downstream Processing
11.5 Pre-Packed Chromatography Columns for Downstream Processing
11.6 Single-Use Membrane Absorbers for Downstream Processing
11.7 Single-Use Tangential Flow Ultrafiltration for Downstream Processing
11.8 Virus Reduction Membranes
11.9 Single-Use Depth Filters for Downstream Processing
11.10 Single-Use Centrifuges for Downstream Processing

12. Chromatography for Bioseparations
12.1 Chromatography Size and Growth
12.2 Chromatography Market Drivers and Restrictors
12.3 Leading Chromatography Manufacturers
12.4 Principle of Separation
12.5 Liquid Chromatography Media
12.5.1 Ion Exchange
12.5.2 Affinity
12.5.3 Immobilized Metal Ion Chromatography
12.5.4 Hydrophobic Interaction Chromatography
12.5.5 Size Exclusion Chromatography or Gel Filtration
12.5.6 Mixed- or Multi-Mode Chromatography
12.6 Advantages and Disadvantage s of Chromatography for Bioseparations
12.7 Leading Manufacturers of Chromatography for Bioseparations

13. Filters and Membranes Used for Bioseparations
13.1 Filtration and Membrane Market Size and Growth
13.2 Filtration and Membrane Market Drivers and Restrictors
13.3 Leading Membrane and Filtration Manufacturers
13.4 Principle of Separation
13.4.1 Normal Flow Filtration
13.4.2 Tangential Flow Filtration of Crossflow
13.5 Membrane and Filter Materials of Construction
13.5.1 Polyethersulfone
13.5.2 Regenerated Cellulose
13.5.3 Cellulose Acetate
13.5.4 Polytetrafluorethylene
13.5.5 Polyvinylidene Difluoride
13.5.6 Nylon
13.5.7 Depth Filtration Media
13.6 Ultrafiltration
13.7 Microfiltration
13.8 Depth Filters
13.9 Membrane Absorbers
13.10 Virus Removal Membranes
13.11 Sterilizing Filters
13.12 Ceramic Membranes and Modules
13.13 Membrane Applications for Biopharmaceutical Manufacturing
13.13.1 Cell Harvesting and Clarification
13.13.2 Concentration and Diafiltration
13.13.3 Purification
13.13.4 Virus Reduction
13.13.5 Endotoxin Removal and Sterile Filtration
13.13.6 Sterile Filtration
13.14 Advantages and Disadvantages of Membranes and Filters
13.14.1 Ultrafiltration
13.14.2 Microfiltration
13.14.3 Depth Filters
13.14.4 Ceramic Membranes
13.14.5 Virus Removal Membranes

14. Industrial Centrifuges for Downstream Processing
14.1 Centrifuge Market Size and Growth
14.2 Principle of Separation
14.3 Centrifuge Types
14.3.1 Disc Stacked Centrifuges
14.3.2 Tubular Bowl Centrifuges
14.3.3 Vertical Basket Centrifuge
14.4 Application of Centrifuges in Downstream Processing
14.4.1 Recovery of Extracellular Recombinant Proteins and Monoclonal Antibodies
14.4.2 Recovery of Intracellular Recombinant Proteins and Inclusion Bodies
14.4.3 Fractionation of Plasma Proteins
14.4.4 Vaccine Production
14.5 Centrifuge Advantages and Disadvantages
14.6 Competition
14.7 Leading Manufacturers and Products
14.7.1 Alfa Laval
14.7.2 Alfa Wasserman
14.7.3 Carr Centritech
14.7.4 Celeros Separations
14.7.5 Flottweg Separation Technology
14.7.6 Hitachi Koki Ltd
14.7.7 New Brunswick
14.7.8 Westfalia

15. Company Profiles
15.1 Agilent Technologies
15.2 Alfa Wassermann Separation Technologies
15.3 Applied Biosystems Corporation (Life Technologies)
15.4 Asahi Kasei
15.5 Bio-Rad Laboratories
15.6 Carr Centritech
15.7 Celeros
15.8 Dow Chemical Company
15.9 DSM Biologics
15.10 Flottweg Separations Technology
15.11 G-Con Manufacturing
15.12 GEA Westfalia Separator Group
15.13 GE Healthcare Life Sciences
15.14 Hitachi Koki Co. LTD
15.15 Knauer
15.16 Kronlab (YMC Europe)
15.17 Life Technologies
15.18 Meissner Filtration Products, Inc.
15.19 Merck Millipore
15.20 3M Cuno
15.20.1 Overview
15.20.2 Operating Segments
15.20.3 Products
15.21 Novasep Life Sciences Manufacturing Solutions
15.22 Novavax
15.23 NuSep Holdings Ltd
15.24 Pall Corporation
15.25 ProMetic Life Sciences Inc.
15.26 Sartorius Stedim Biotech
15.27 SciLog
15.28 Spectrum Laboratories
15.29 Tarpon Biosystems
15.30 Tosoh Bioscience
15.31 U.S. Filter Control Systems, Inc.
15.32 Waters Corporation

INDEX OF TABLES

Table 3.1: Biologics Market Size and Projected Growth by Therapeutic Class
Table 4.1: Comparison of Chromatography, Filtration and Centrifugation for Downstream Processing
Table 4.2: Leading Bioseparations ManufacturersÕ Market Share
Table 4.3: Leading Bioseparations ManufacturersÕ Product Lines
Table 4.4: North American Companies Participating in the Bioseparations Market
Table 4.5: European Companies Participating in the Bioseparations Market
Table 4.6: Asian Companies Participating in the Bioseparations Market
Table 5.1: Optimal Host Cell Line Characteristics
Table 7.1: Bioseparations Systems Market Size and Projected Growth, 2012-2018
Table 7.2: Drivers and Restrictors of the Global Bioseparations Market
Table 7.3: Global Bioseparations Market by Product: Projected Growth 2012-2018
Table 7.4: Global Bioseparations Market: Consumables and Equipment Projected Growth, 2012-2018
Table 8.1: The Global Bioseparations Market by Region: Projected Size, 2012-2018
Table 8.2: North America Bioseparations Market: Projected Size, 2012-2018
Table 8.3: Drivers and Restrictors of the Bioseparation Systems Market in North America
Table 8.4: Largest Biomanufacturing Sites and Capacity in United States
Table 8.5: Major CMOs Manufacturing Capacity in North America
Table 8.6: Western Europe Bioseparations Market: Projected Size, 2012-2018
Table 8.7: Drivers and Restrictors of the Bioseparations Market in Western Europe
Table 8.8: Biomanufacturing Sites and Capacity in Western Europe
Table 8.9: Major CMOs Biomanufacturing Capacity in Western Europe
Table 8.10: Major Vaccine Manufacturing Sites in Western Europe
Table 8.11: Western Europe Blood Fractionation Facilities
Table 8.12: Asia-Pacific Biomanufacturing Market: Projected Size, 2012-2018
Table 8.13: Drivers and Restrictors of the Bioseparations Market in Japan
Table 8.14: Alliances and Manufacturing Capacity of Selected Japanese Biopharmaceutical Companies
Table 8.15: Singaporean Biomanufacturing Capacity
Table 8.16: South Korean Biomanufacturing Capacity
Table 8.17: Emerging CountriesÕ Bioseparations Systems Market Projected by Country 2012-2018
Table 8.18: Chinese Bioseparations Market: Projected Size, 2012-2018
Table 8.19: Drivers and Restrictors of the Bioseparations Market in China
Table 8.21: Indian Bioseparations Market: Projected Size, 2012-2018
Table 8.22: Drivers and Restrictors of the Bioseparations Market in India
Table 8.23: Indian Biomanufacturing Companies and Capacity
Table 8.24: Brazilian Bioseparations Market: Projected Size, 2012-2018
Table 8.25: Drivers and Restrictors of the Bioseparation Systems Market in Brazil
Table 8.26: Russian Bioseparations Market: Projected Size, 2012-2018
Table 8.27: Drivers and Restrictors of the Bioseparation Systems Market in Russia
Table 9.1: GE Healthcare Life Sciences Strengths and Weaknesses
Table 9.2: GE Healthcare Life Sciences Bioseparations Products and Brands
Table 9.3: Merck Millipore Strengths and Weaknesses
Table 9.4: Merck Millipore Bioseparations Products and Brands
Table 9.5: Merck Millipore Mobius Single-Use Platform
Table 9.3: Pall Corporation Strengths and Weaknesses
Table 9.4: Pall Corporation Bioseparations Products and Brands
Table 9.5: Sartorius Strengths and Weaknesses
Table 9.6: Sartorius Bioseparations Products and Brands
Table 9.7: 3M Cuno Strengths and Weaknesses
Table 9.8: 3M Cuno BioseparationsProducts and Brands
Table 11.1: Drivers and Restrictors for Single-Use Technology
Table 11.2: Single-Use Systems for Clinical Scale Downstream Processing
Table 11.3: Pre-Packed Chromatography Columns for Downstream Processing
Table 11.4: Single-Use Membrane Absorbers for Downstream Processing
Table 11.5: Single-Use Tangential Flow Ultrafiltration for Downstream Processing
Table 11.6: Viral Reduction Membranes for Downstream Processing
Table 11.7: Single-Use Depth Filters for Downstream Processing
Table 11.8: Single-Use Centrifuges for Downstream Processing
Table 12.1: Projected Growth for Global Chromatography Market for Bioseparations, 2012-2018
Table 12.2: Chromatography Market Drivers and Restrictors
Table 12.3: Manufacturers of RP-HPLC Chromatography Media for Bioseparations
Table 12.4: Bioseparations by Chromatography Type
Table 12.5: Chromatography Advantages and Disadvantages
Table 12.6: GE Healthcare Life Sciences Process Scale Chromatography Media and Columns
Table 12.7: Merck Millipore Process Scale Chromatography Media and Columns
Table 12.8: Pall Corporation Process Scale Chromatography Media and Columns
Table 12.9: Life Technologies Applied Biosystems Process Scale Chromatography Media and Columns
Table 12.10: Bio-Rad Process Scale Chromatography Media and Columns
Table 12.11: Second Tier CompetitorsÕ Process Scale Chromatography Media and Columns
Table 13.1: Projected Growth of the Global Market for Membranes and Filters for
Bioseparations, 2012-2018
Table 13.2: Drivers and Restrictors Membranes and Filters of For Bioseparations
Table 13.3: Pore Size of Ultrafilters Described by NMWC
Table 13.4: Leading CompaniesÕ Ultrafiltration Membranes
Table 13.5: Leading CompaniesÕ Microporous Membranes
Table 13.6: Leading CompaniesÕ Depth Filters
Table 13.7: Leading CompaniesÕ Membrane Absorbers
Table 13.8: Leading CompaniesÕ Virus Removal Membranes
Table 13.9: Leading Companies Sterilizing Filters
Table 13.10: Application of Membranes and Filters for Biopharmaceutical Manufacturing
Table 13.11: Advantages and Disadvantages of Membranes and Filters
Table 14.1: Projected Growth of the Global Market for Centrifuges for Bioseparations, 2012-2018
Table 14.2: Drivers and Restrictors
Table 14.3: Advantages and Disadvantages of Centrifugation for Cell Harvesting and Clarification
Table 14.4: Leading ManufacturersÕ Centrifuges for Downstream Processing
Table 14.5: Leading ManufacturerÕs Centrifuges for Downstream Processing

INDEX OF FIGURES

Figure 2.1: Global Distribution of Biomanufacturing Capacity
Figure 3.1: Number of Biologicals in Development in the United States
Figure 3.2: Pipeline of Biologics by Therapeutic Class
Figure 4.1: Leading Bioseparations ManufacturerÕs Market Share
Figure 5.1: The Downstream Process for Purifying Biologicals
Figure 6.1: Downstream Isolation and Purification of Monoclonal Antibodies
Figure 6.2: Downstream Purification of Insulin Produced by the Intracellular Proinsulin Process
Figure 6.3: Downstream Processing of Recombinant Protein Produced from Insect Cells
Figure 6.4: Downstream Processing of Plasmid DNA
Figure 7.1: Global Bioseparations Market by Product
Figure 7.2: Global Bioseparations Market by Product: Projected Growth, 2012-2018
Figure 7.3: Global Bioseparations Market: Projected Growth of Consumables and Equipment, 2012-2018
Figure 8.1: Global Bioseparations Market by Region, 2013
Figure 8.2: Global Bioseparations Systems Market by Region, 2018
Figure 8.3: Global Bioseparations Market Projected by Region, 2013-2018
Figure 8.4: Global Bioseparations Market: Projected Growth by Region, 2012-2018
Figure 8.5: Emerging CountriesÕ Bioseparations Market Share by Country
Figure 8.6: Emerging CountriesÕ Bioseparations Market Projected by Country, 2013-2018
Figure 8.7: Emerging CountriesÕ Bioseparations Market Projected Growth by Country, 2012-2018
Figure 12.1: Global Bioseparations Market for Chromatography by Region 2012
Figure 12.2: Process Scale Chromatography Columns
Figure 13.1: Global Bioseparation Market for Membranes and Filters by Region, 2012
Figure 13.2: Image of a Depth Filter
Figure 13.3: Image of a Cross-Section of an Ultrafiltration Membrane
Figure 13.4: Image of the Surface of a Microporous Membrane
Figure 13.5: Installing Depth Filter Modules for Downstram Processing
Figure 13.6: Ceramic Membranes Encapsulated in Stainless Steel Housing
Figure 14.1: Global Bioseparations Market for Centrifuges, 2012
Figure 14.2: Disc Stack Centrifuge
Figure 14.3: Tubular Bowl Centrifuge

'Bioseparation Systems for Global Biopharmaceutical Markets' cites that the global market for bioseparations for biopharmaceutical manufacturing will grow to $6 billion by 2018. While North America and Europe will continue to account for a significant share of revenue, the emerging countries of China, India, Brazil and Russia are rapidly increasing share, growing at a CAGR of 22%.

The demand for single use products is increasing and fueling growth of the global bioseparations market. Blockbuster biologics are going off patent, leaving the market open for developing and manufacturing low cost biosimilars. The Asian countries of India, Singapore, South Korea and China are fast becoming biomanufacturing hubs, producing biosimilars for their own large populations and for Southeast Asia.

Bioseparations systems can be categorized into three types: chromatography, membranes/filters and centrifuges. In this report, each is examined in detail, including market size, drivers and restrictors, competitors and technology. In 2013, chromatography will contribute $1.8 billion to the global bioseparations market. Membranes/filters will contribute $1.4 billion, followed by centrifuges ($400 million).

- Agilent Technologies
- Alfa Wassermann Separation Technologies
- Applied Biosystems Corporation (Life Technologies)
- Asahi Kasei
- Bio-Rad Laboratories
- Carr Centritech
- Celeros
- DSM Biologics
- Dow Chemical Company
- Flottweg Separations Technology
- G-Con Manufacturing
- GE Healthcare Life Sciences
- GEA Westfalia Separator Group
- Hitachi Koki Co LTD
- Knauer
- Kronlab (YMC Europe)
- Life Technologies
- M Cuno
- Meissner Filtration Products, Inc
- Merck Millipore
- Novasep Life Sciences Manufacturing Solutions
- Novavax
- NuSep Holdings Ltd
- Pall Corporation
- ProMetic Life Sciences Inc
- Sartorius Stedim Biotech
- SciLog
- Spectrum Laboratories
- Tarpon Biosystems
- Tosoh Bioscience
- US Filter Control Systems, Inc
- Waters Corporation

Note: Product cover images may vary from those shown

RELATED PRODUCTS

Our Clients

Our clients' logos