European Contract Biomanufacturing Organizations - CbMO Market Outlook

Executive summary

From the exponential growth of the "modern" biotechnology industry in the 1990's the creation of Contract Manufacturing Organizations (CMOs) has followed to supply the increasing needs of production capacity and cost savings. Yet at that time, only a few CMOs existed. Back then in the pharmaceutical industry, only 5% of new drug approvals by the FDA (Food and Drug Administration) were issued from biotechnology companies and in the industrial biotechnology sector most enzymes were still produced by extraction or by chemical synthesis.

166 contract biomanufacturing Organizations were identified in the European biomanufacturing market accounting for 229 production sites located in Europe.

Two kinds of CMOs exist in Europe: 73% "Multipurpose" CMOs and 27% AB-only CMOs for custom monoclonal and polyclonal antibody manufacturing.

49% of Biomanufacturing CMOs are located in Western Europe. More than half of all AB-only biomanufacturers (52%) are located in UK and France. Four main expression systems are used by contract biomanufacturing organizations: microbial, mammalian, transgenic animals and plant cells. Microbial platform still comes out on top of expression system used in Contract biomanufacturing with more than 83% of utilization by Multi-P CMOs, followed by mammalian cell culture (35%).

European contract biomanufacturing organizations supply 72% pharmaceutical, 45% food and 25% feed markets. 37 European CMOs (for 69 production sites) are able to supply commercial bioproducts volumes. These facilities represent 40% of the 172 multi-purpose biomanufacturing sites established in Europe. See also www.contract-biomanufacturing-market.com

 

 

Table of content

Executive Summary

Chapter I - General Information

    Introduction
    The European context
    Objectives
    Methodology
    History of contract manufacturing organizations
        Lonza
        DSM Biologics
        Angel biotechnology
        Lactosan
        Safisis
        National Biomanufacturing Center
    Market served and product types
        The biopharmaceutical segment
            Monoclonal antibodies
            Vaccines
            Recombinant proteins
        The industrial biotechnology segment
            Technical enzymes
            Environment
            Biofuels
        The food segment
        The feed segment
        The cosmetics segment
        The agricultural segment
    Biomanufacturing technologies and processes
        The different production systems
            Microbial fermentation
            Biocatalysis
            Mammalian cell culture
            Transgenic animals
            Transgenic plants
        The upstream process development (UPS)
            Cell line development
            Process development
            Harvest and concentration
        The downstream process development (DSP)
            Purification
            Fill & Finish
    Outsourcing Biomanufacturing
        Make versus buy decision
        Key selection criteria

Chapter II - European Contract BioManufacturing Organizations

    Statistical population
    Situation
        Number of companies
        Location
        Quality assurance and certifications
        Expression platforms
        Segmentation
    Size and Capacity
        Scale
        Production capacity
            Total European production capacity
            Mammalian cell culture capacity
            Microbial fermentation capacity
        Additional services
    Forecast
        The rise of biopharmaceuticals and industrial biotechnology
            Biopharmaceuticals lead the contract manufacturing market
            Increased interest for bio-based processes and materials
        Increasing competition and intellectual property concerns
        From larger bioreactors to additional services
        Emergence of alternative expression systems

Chapter III - The Contract Biomanufacturing Market

    Global Contract Biomanufacturing Market
    The Biopharmaceutical Market
        Market situation and evolution
            Monoclonal antibodies
            Vaccines
            Recombinant proteins
        Contract BioManufacturing companies and offer
    The Food Market
        Market situation and evolution
            Food additives
            Food supplements
                Probiotics
            Processing aids
        Contract biomanufacturing companies and offer
    The Industrial Biotechnology Market
        Market situation and evolution
            Technical enzymes
            Environmental applications
                Bioremediation
                Biopolymers
        Contract biomanufacturing companies and offer
    The Feed Market
        Market situation and evolution
            Feed additives
            Feed enzymes
        Contract biomanufacturing companies and offer
    The Cosmetics Market
        Market situation and evolution
        Contract biomanufacturing companies and offer
    The Bio-Agricultural Market
        Market situation and evolution
            Biopesticides
            Biofertilizers
        Contract biomanufacturing companies and offer

Chapter IV - Key Players

    Lonza
    Boehringer Ingelheim
    DSM Biologics
    Diosynth Biotechnology
    Roche
    Sandoz
    BioVet
    Danisco
    Cambrex
    SAFC Biosciences
    Lallemand

List of Tables:

Table 1 Examples of Biomanufacturing Applications
Table 2 Biopharmaceutical Products
Table 3 List of Therapeutic Monoclonal Antibodies Approved
Table 4 Some Commercial Enzymes and Source Microorganisms
Table 5 Some Detergent Enzymes and Their Action
Table 6 Application of Hydrolase Enzyme in Fabric Preparation
Table 7 Application of Oxidoreductase in Fabric Preparation
Table 8 The Different Types of Food Ingredients
Table 9 Feed Ingredients Manufacturing Deals with European CMOs
Table 10 Selected Ingredients Segments and Leading Products
Table 11 Biopesticide Products and Companies
Table 12 Microbial Expression Systems
Table 13 Methods Used to Develop Chiral Compounds
Table 14 Biocatalysis in Industry-Examples
Table 15 Therapeutic Proteins Produced in the Milk of Transgenic Animals that are Currently in Commercial Development
Table 16 Comparison of Expression Systems
Table 17 Cleanroom Standards
Table 18 Capital Investment Costs for Biopharmaceutical Facilities in Europe
Table 19 CMOs' Key Data
Table 20 Example of Companies Running Multiple Factories
Table 21 CMOs' Average Number of Employees
Table 22 Examples of Regulatory Agencies
Table 23 Comparison of Mammalian Cell Culture Capabilities Between France and the Netherlands (average data)
Table 24 Estimated Requirements for Top Selling Biopharmaceuticals
Table 25 New Biologic License Application (BLA) Approvals, 2009
Table 26 Therapeutic Antibodies Manufacturing Deals with European CMOs
Table 27 Vaccine Manufacturing Deals with European CMOs
Table 28 Recombinant Protein Manufacturing Deals with European CMOs
Table 29 CMOs' Key Data for the Biopharmaceutical Market
Table 30 Biopharmaceutical Key CMOs Using Microbial Fermentation
Table 31 Biopharmaceutical Key CMOs Using Mammalian Cell Culture
Table 32 CMOs' Key data for the Food Market
Table 33 Comparison of R&D Expenditures Between a Pharmaceutical and a Food Company, 2009
Table 34 Food Ingredients Key CMOs
Table 35 CMOs' Key Data for the Industrial Biotechnology Market
Table 36 Industrial Biotechnology Key CMOs
Table 37 CMOs' Key Data for the Feed Market
Table 38 Feed Additives Key CMOs
Table 39 CMOs Key Data for the Cosmetic Market
Table 40 Cosmetic Ingredients Key CMOs
Table 41 CMOs' Key Data for the Bio-Agricultural Market
Table 42 Agricultural Bioproducts Key CMOs

List of Figures:

Figure 1 Industrial Biotechnology Application
Figure 2 Biopolymers Products, Applications and Companies
Figure 3 Probiotic Supplement AlignTM Based on Bifidobacterium infantis
Figure 4 Fungicide Serenade® Based on Bacillus subtilis
Figure 5 The Chiral Technologies Market, 2002 - 2009
Figure 6 Upstream Manufacturing Process Overview
Figure 7 Depth Filtration Pore Design
Figure 8 Downstream Manufacturing Process Overview Example
Figure 9 Recombinant Therapeutic Protein's Probability of Successful Development
Figure 10 Critical Factors When Outsourcing Biomanufacturing
Figure 11 History of CMOs' Establishment
Figure 12 European CMOs' Facilities Localization by Country
Figure 13 European CMOs Mapping
Figure 14 Nationality of CMOs established in Europe
Figure 15 Contract Biomanufacturing Facilities Certifications
Figure 16 Biosafety Accredited European Biomanufacturing Facilities
Figure 17 Expression Systems Utilization Ratios, all CMOs considered
Figure 18 Expression Systems Utilization Ratios, Multi-P versus AB-only CMOs
Figure 19 Number of Production Sites By Contract BioManufacturing Market Segment and By Type of CMOs
Figure 20 Contract Biomanufacturing Served Market, by Expression System Type (Total 143 Microbial sites + 60 Mammalian sites)
Figure 21 Products Manufactured Using Mammalian Cell Culture
Figure 22 number of production microbial fermentation site by type of product (Total 143 sites)
Figure 23 CMOs' Production Scales
Figure 24 European CMOs' Total Available Production Capacity
Figure 25 CMO's Mammalian Production Capacity
Figure 26 Mammalian Production Capacities, Sites and Companies by Country (Top 5)
Figure 27 Mammalian Production Capacities, Sites and Companies, by Country (Last 12)
Figure 28 Comparison of Contract Biomanufacturing Capability Between France and the Netherlands
Figure 29 CMO's Microbial Production Capacity
Figure 30 Microbial Production Capacities, Sites and Companies by Country (Top 10)
Figure 31 Microbial Production Capacities, Sites and Companies by Country (Last 15)
Figure 32 CMOs' Additional Services
Figure 33 CMOs' Fill & Finish Services
Figure 34 Number of Approved Biotech Drugs and Global Biotech Revenues, 1990 - 2005
Figure 35 The Triple-P Bottom Line
Figure 36 Fermentation Volume Required Depending on Yield and Market Demand
Figure 37 European Contract Biomanufacturing Organizations Business Positioning and Potential Market Sizes
Figure 38 The Contract Biomanufacturing Market, 2005 - 2015
Figure 39 The Contract Biomanufacturing Market, 2007
Figure 40 The European Biotechnology Market in 2008
Figure 41 The Biopharmaceutical Market, 2005 - 2009
Figure 42 Sales of Monoclonal Antibodies Produced by CMOs Versus In-house
Figure 43 Recombinant Proteins Market Size Growth to 2010
Figure 44 Sales Forecasts for Top20 Recombinant Proteins, by Product Class
Figure 45 Nationality of CMOs Established in Europe, Supplying the Biopharmaceutical Market
Figure 46 Expression Systems Used for Biopharmaceutical Production
Figure 47 Biopharmaceutical Outsourcing Evolution, 2003-2006
Figure 48 European CMOs' Biopharmaceuticals Production Sites and Capacities Using Microbial Fermentation, by Country
Figure 49 European CMOs' Biopharmaceutical Production Sites and Capacities Using Mammalian Cell Culture, by Country
Figure 50 Number of GMP and non-GMP Production Sites, by Product Class
Figure 51 CMOs' Capacity of Supplying Clinical Lots
Figure 52 Global Food Bio-Ingredients Market, 2007
Figure 53 The Food Additives Market
Figure 54 Global Food Supplement Market, 2006
Figure 55 The Probiotics Market, 2007-2013
Figure 56 The Food Processing Enzymes Market, 2004-2008
Figure 57 Nationality of CMOs Established in Europe, Supplying the Food Market
Figure 58 European CMOs' Food Ingredients Production Sites and Capacities, by Country
Figure 59 Number of Production Sites Supplying the Food Market, by Type of Expression System and Scale
Figure 60 CMOs Certifications for the Food Market
Figure 61 The Industrial Biotechnology Market, 2010
Figure 62 The Global Industrial Enzymes Market, 2002 - 2012
Figure 63 The Global Technical Enzymes Market, 2002 - 2012
Figure 64 The U.S Environmental Biotechnology for Waste Treatment Market, 2006 - 2012
Figure 65 Annual Bioplastics Production Capacity, 2007 - 2011
Figure 66 The Global Biopolymer Market, 2007 - 2012
Figure 67 Nationality of CMOs Established in Europe, Supplying the Industrial Biotechnology Market
Figure 68 European CMOs' Industrial Biotechnology Production Sites and Capacities, by Country
Figure 69 Number of Production Sites Supplying the Industrial Biotechnology Market, by Type of Expression System and Scale
Figure 70 CMOs Certifications for the Industrial Biotechnology Market
Figure 71 Top 10 Countries in Industrial Feed Production by Region, 2005
Figure 72 Global Feed Bio-Ingredient Market, 2010
Figure 73 The World Animal Feed Additives Market, 2010 - 2015
Figure 74 Nationality of CMOs Established in Europe, Supplying the Feed Ingredients Market
Figure 75 European CMOs' Feed Ingredients Production Sites and Capacities, by Country
Figure 76 Number of Production Sites Supplying the Feed Market, by Type of Expression System and Scale
Figure 77 Economies of Scale
Figure 78 CMOs Certifications for the Feed Market
Figure 79 Cosmetic ingredients market, 2008
Figure 80 Global Consumption of Personal Care Ingredients
Figure 81 Nationality of CMOs Established in Europe, Supplying the Cosmetic Ingredients Market
Figure 82 European CMOs' Cosmetic Ingredients Production Sites and Capacities, by Country
Figure 83 Number of Production Sites Supplying the Cosmetic Market, by Type of Expression System and Scale
Figure 84 CMOs Certifications for the Cosmetic Market
Figure 85 The Agricultural Bioproducts Market, 2009
Figure 86 The Global Pesticide Market, 2003 - 2014
Figure 87 Nationality of CMOs Established in Europe, Supplying the Bio-Agricultural Market
Figure 88 European CMOs' Agricultural Bioproducts Production Sites and Capacities, by Country
Figure 89 Number of Production Sites Supplying the Bio-Agricultural Market, by Type of Expression System and Scale
Figure 90 CMOs Certifications for the Bio-Agricultural Market

 

 

Publication date: Number of pages: Price:
2011-03-09 190 4990 euros