Single-Use Technologies for Biopharmaceuticals: Global Markets

Single-Use Technologies for Biopharmaceuticals: Global
Markets
Report Details:
Published:January 2013
No. of Pages: 138
Price: Single User License – US$5450

REPORT HIGHLIGHTS
This report provides:
•An overview of biopharmaceutical single-use technologies, which aids the manufacturing process
in overcoming such complex issues as sterilization and critical manufacturing parameters
•Analyses of global market trends, with data from 2011, estimates for 2012, and projections of
compound annual growth rates (CAGRs) through 2017
•In-depth discussion of key market segments, such as membrane adsorbers, bioreactors, mixing,
tangential flow filtration, tubing, connectors, preassembled tubing and rigging, depth filtration,
buffer containers, waste containers, samplers, media bags, and filter cartridges
•Delineation of market application areas, such as monoclonal antibodies, vaccines, gene therapy,
recombinant proteins, blood derivatives, and anticancer drugs
•Identification of supply chain participants, including contract manufacturing organizations,
biopharma operating companies/manufacturing, and systems integrators, and their respective
market shares
•Key restraints in the industry, including leachables and extractables, cost constraints, breakage of
bags, and environmental concerns
•Comprehensive company profiles of existing and potential market players
•Patent analysis.
REPORT SCOPE
INTRODUCTION
STUDY BACKGROUND
Eliminating the risk of contamination is the greatest challenge faced by manufacturers of
biopharmaceuticals, and currently this requires high level monitoring of critical manufacturing
processes. Single-use technology (SUT) aids biopharmaceutical manufacturers in overcoming
this challenge by reducing or eliminating the need for sterilization between batches, thereby
improving operational efficiency. Time to market for biopharmaceutical drugs is extremely
important given the developmental costs involved. Single-use technologies help lower these costs
by reducing the number of validation steps and also shorten the length of the production process.
Growth of single-use technologies in biopharmaceutical manufacturing is expected to be

significant over the forecast period due to the increasing evidence of their cost-saving benefits.
STUDY GOALS AND OBJECTIVES
The objective of the report is to provide an intensive assessment of the market for single-use
technologies specifically used in biopharmaceutical production. Specific goals include:
•Identifying key technologies, applications and end-user segments that are expected to achieve
significant sales by 2017 with respect to single-use technologies.
•Assessing and identifying the key market dynamics that drive and restrain growth, markets that
provide lucrative opportunities and factors that pose challenges to market participants.
•To understand and provide details with respect to market intelligence, key market participants
and top strategies adopted by SUT players.
•Market estimates through 2017.
•Identifying and profiling key companies and patents.
INTENDED AUDIENCE
The report provides an in-depth study of the following supply chain participants: contract
manufacturing organizations, biopharmaceutical companies/manufacturers and system
integrators. The study includes a product portfolio analysis, case studies, market estimates and
recent developments, which will be immensely useful to SUT manufacturers and academia. The
report presents an in-depth-patent analysis of single-use technologies used in the manufacture of
biopharmaceuticals. Single-use technologies currently under investigation or newly approved for
use by the Food and Drug Administration (FDA) are also discussed.
SCOPE AND FORMAT
The report includes the following key market segments:
•Single-use bioreactors (SUBs).
•Membrane adsorbers.
•Mixing.
•Tangential flow filtration.
•Tubing.
•Connectors.
•Preassembled tubing and rigging.
•Depth filtration.
•Buffer containers.
•Waste containers.
•Samplers.
•Media bags.
•Filter cartridges and other key markets.
The study includes the following major elements:
•Executive summary.
•Revenues forecast through 2017.
•Analysis of the key factors influencing market demand.
•Market intelligence.
•Key trends across geographies.

•Key trends, opportunities and market estimates within each of the markets specified.
•General assessment of expected market trends in the longer term (2012 to 2017).
•Competitive environment—Key companies, top strategies and recent developments and market
intelligence.
•Company profiles.
•Patent analysis.
Specifically excluded from the report are market estimates of biopharmaceutical drugs and
devices. However, an overview of the market for biopharmaceutical drugs is given to provide a
holistic view of the market. The report covers only single-use technologies or disposables used in
biopharmaceutical manufacturing. The report also excludes control software or custom designed
software used with single-use biopharmaceutical manufacturing technologies.
INFORMATION SOURCE AND METHODOLOGY
Information sources were derived through both primary and secondary research. Secondary
sources included government websites, industry associations, company websites,
biopharmaceutical magazines and recent conferences. Primary research was conducted to
evaluate the market quantitatively as well as qualitatively and its impact on market growth. The
greatest challenges were in deriving the revenues for micro markets; however, that was achieved
through an intensive study of historical sales, current adoption levels and expected future market
potential validated through primary research.
Growth within the SUT market is significantly varied, as some technologies are increasing at a
compounded annual growth rate (CAGR) of nearly 35% with some technologies increasing at a
CAGR below 5% through the forecast period. Therefore, an analysis of comparative market
growth has been performed.

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Major points covered in Table of Contents of this report include
TABLE OF CONTENTS
Chapter- 1: INTRODUCTION
STUDY BACKGROUND
STUDY GOALS AND OBJECTIVES
INTENDED AUDIENCE
SCOPE AND FORMAT
INFORMATION SOURCE AND METHODOLOGY
ANALYST CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC ONLINE SERVICES
DISCLAIMER
Chapter- 2: SUMMARY
Table Summary : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE

MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, THROUGH 2017
Figure Summary : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE
MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, 2011-2017
Chapter- 3: MARKET OVERVIEW
BRIEF HISTORY OF BIOPROCESS DISPOSABLES
MARKET DYNAMICS
STAINLESS STEEL PROCESSORS VERSUS DISPOSABLES IN BIOPHARMACEUTICAL
MANUFACTURE
BIOPHARMACEUTICAL INDUSTRY TRENDS: STEADY TRANSITION FROM
PHARMACEUTICALS TO BIOPHARMACEUTICALS
Chapter- 4: MARKET BY TECHNOLOGY
MEMBRANE ADSORBER
BIOREACTORS
DISPOSABLE MIXING SYSTEMS
TANGENTIAL FLOW FILTRATION
TUBING AND CONNECTORS
PREASSEMBLED TUBING AND RIGGING
DEPTH FILTRATION
BUFFER CONTAINERS
WASTE CONTAINERS
SAMPLERS
MEDIA BAGS AND FILTER CARTRIDGES
OTHER SINGLE-USE TECHNOLOGIES
Table 4 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY USED IN THE MANUFACTURE
OF BIOPHARMACEUTICALS BY SEGMENT, THROUGH 2017
Chapter- 5: MARKET BY APPLICATION
MONOCLONAL ANTIBODIES
VACCINES
GENE THERAPY
RECOMBINANT PROTEINS
BLOOD DERIVATIVES
ANTICANCER DRUGS
OTHERS
Table 26 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY FOR USE IN
BIOPHARMACEUTICAL MANUFACTURE BY APPLICATION, THROUGH 2017
Chapter- 6: MARKET BY END USERS
CMOS VERSUS BIOPHARMACEUTICAL MANUFACTURERS
R&D
GMP
Table 34 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE
MANUFACTURE OF BIOPHARMACEUTICALS BY END USER, 2012–2017

Chapter- 7: MARKET STRATEGIES AND COMPETITIVE ENVIRONMENT
PRODUCT LAUNCHES: TOP STRATEGY
TOP COMPANIES FOCUS ON COLLABORATIONS THROUGH MERGERS AND
ACQUISITIONS AND AGREEMENTS
ANALYSIS BY COMPANY
Chapter- 8: GEOGRAPHIC ANALYSIS, LEGISLATION AND GOVERNMENT INITIATIVES-
FOCUS ON EMERGING ECONOMIES
THE AMERICAS
EUROPE
ASIA
Chapter- 9: COMPANY PROFILES
ADVANCED SCIENTIFICS INC.
ADVANTAPURE
APPLIKON BIOTECHNOLOGY
ATMI LIFESCIENCES
ATOLL
BARBLOCK
BIOPHARMA DYNAMICS
BIOPURE
BOSCH PACKAGING
CELLON
CHARTER MEDICAL
CMC BIOLOGICS
COLDER PRODUCTS CO.
DOW CORNING
EMD MILLIPORE
FINESSE SOLUTIONS
GE HEALTHCARE
GORE
IS SUPPLIES
NOVASEP
PALL CORP.
PENDOTECH
RENOLIT
REPLIGEN BIOPROCESSING
SAINT GOBAIN
SARTORIUS
TARPON BIOSYSTEMS
XCELLEREX
Chapter- 10: APPENDIX ONE: GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS,
AND U.S. PATENTS FOR SUT, 2010 TO 2012
Table 92 : GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS BY GEOGRAPHIC

REGION, THROUGH 2017
Table 93 : GLOBAL MARKET FOR PREPARATION BUFFER CONTAINERS BY GEOGRAPHIC
Table 94 : U.S. PATENTS FOR SUT, 2010 TO 2012
Table 95 : EUROPEAN SUT PATENTS, 2010 TO 2012
Chapter- 11: APPENDIX TWO: LIST OF ACRONYMS
LIST OF TABLES
Summary Table : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE
Table 1 : DEVELOPMENTS IN SINGLE-USE TECHNOLOGIES
Table 2 : SUT GAP ANALYSIS
Table 3 : BIOREACTOR FACILITY COSTS: SINGLE-USE VERSUS STAINLESS STEEL
SYSTEMS
Table 4 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY USED IN THE MANUFACTURE
OF BIOPHARMACEUTICALS BY SEGMENT, THROUGH 2017
Table 5 : GLOBAL MARKET FOR MEMBRANE ADSORBERS BY GEOGRAPHIC REGION,
2012–2017
Table 6 : GLOBAL MARKET FOR BIOREACTORS BY TECHNOLOGY, THROUGH 2017
Table 7 : GLOBAL MARKET FOR BIOREACTORS BY GEOGRAPHIC REGION, THROUGH 2017
Table 8 : GLOBAL MARKET FOR SEED BIOREACTORS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 9 : GLOBAL MARKET FOR PRODUCTION BIOREACTORS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 10 : GLOBAL MARKET FOR DISPOSABLE MIXING SYSTEMS BY GEOGRAPHIC
Table 11 : GLOBAL MARKET FOR TANGENTIAL FLOW FILTRATION SYSTEMS BY
GEOGRAPHIC REGION, THROUGH 2017
Table 12 : GLOBAL MARKET FOR TUBING BY GEOGRAPHIC REGION, THROUGH 2017
Table 13 : GLOBAL MARKET FOR CONNECTORS BY GEOGRAPHIC REGION, 2012–2017
Table 14 : GLOBAL MARKET FOR PREASSEMBLED TUBING AND RIGGING BY
GEOGRAPHIC REGION, THROUGH 2017
Table 15 : GLOBAL MARKET DEPTH FILTRATION SYSTEMS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 16 : GLOBAL MARKET FOR BUFFER CONTAINERS BY EQUIPMENT TYPE, THROUGH
2017
Table 17 : GLOBAL MARKET FOR BUFFER CONTAINERS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 18 : GLOBAL MARKET FOR WASTE CONTAINERS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 19 : GLOBAL MARKET FOR SAMPLERS BY GEOGRAPHIC REGION, THROUGH 2017
Table 20 : GLOBAL MARKET FOR MEDIA BAGS BY TYPE, THROUGH 2017
Table 21 : GLOBAL MARKET FOR MEDIA BAGS BY GEOGRAPHIC REGION, 2012–2017

Table 22 : GLOBAL MARKET FOR FILLED MEDIA BAGS BY GEOGRAPHIC REGION,
THROUGH 2017
Table 23 : GLOBAL MARKET FOR DRY MEDIA BAGS BY GEOGRAPHIC REGION, THROUGH
2017
Table 24 : GLOBAL MARKET FOR FILTER CARTRIDGES BY GEOGRAPHIC REGION,
THROUGH 2017
Table 25 : GLOBAL MARKET FOR OTHER SINGLE-USE TECHNOLOGIES BY GEOGRAPHIC
Table 26 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGY FOR USE IN
BIOPHARMACEUTICAL MANUFACTURE BY APPLICATION, THROUGH 2017
PRODUCTION OF MONOCLONAL ANTIBODIES, THROUGH 2017
PRODUCTION OF VACCINES, THROUGH 2017
Table 29 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN GENE THERAPY,
THROUGH 2017
PRODUCTION OF RECOMBINANT PROTEIN, THROUGH 2017
MANUFACTURE OF BLOOD DERIVATIVES, THROUGH 2017
MANUFACTURE OF ANTICANCER DRUGS, THROUGH 2017
Table 33 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN OTHER
APPLICATION AREAS, THROUGH 2017
MANUFACTURE OF BIOPHARMACEUTICALS BY END USER, 2012–2017
Table 35 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BY
BIOPHARMACEUTICAL CMOS, THROUGH 2017
Table 36 : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED BY
BIOPHARMACEUTICAL MANUFACTURERS BY REGION, THROUGH 2017
MANUFACTURE OF BIOPHARMACEUTICALS BY END USER SEGMENT, THROUGH 2017
Table 38 : GLOBAL R&D SPENT ON SINGLE-USE TECHNOLOGIES USED IN THE
Table 39 : GLOBAL EXPENDITURES ON GOOD MANUFACTURING PRACTICES FOR
SINGLE-USE TECHNOLOGIES USED IN THE MANUFACTURE OF BIOPHARMACEUTICALS
BY REGION, THROUGH 2017
Table 40 : COMPANY STRATEGIES
Table 41 : COMPANY ANNOUNCEMENTS, 2006 TO JULY 2012
Table 42 : ADVANCED SCIENTIFICS INC.: PRODUCT PORTFOLIO
Table 43 : ADVANTAPURE: PRODUCT PORTFOLIO
Table 44 : ADVANTAPURE: RECENT DEVELOPMENTS, 2011–2012

Table 45 : APPLIKON BIOTECHNOLOGY: PRODUCT PORTFOLIO
Table 46 : APPLIKON BIOTECHNOLOGY: RECENT DEVELOPMENTS
Table 47 : ATMI LIFESCIENCES: PRODUCT PORTFOLIO
Table 48 : ATMI LIFESCIENCES: RECENT DEVELOPMENTS, 2006-2012
Table 49 : ATMI LIFESCIENCES: FINANCIALS, 2008–2010
Table 50 : ATOLL: PRODUCT PORTFOLIO
Table 51 : BARBLOCK: PRODUCT PORTFOLIO
Table 52 : BIOPHARMA DYNAMICS: PRODUCT PORTFOLIO
Table 53 : BIOPURE: PRODUCT PORTFOLIO
Table 54 : BIOPURE: RECENT DEVELOPMENTS
Table 55 : BOSCH PACKAGING: PRODUCT PORTFOLIO
Table 56 : BOSCH PACKAGING: RECENT DEVELOPMENTS
Table 57 : CELLON: PRODUCT PORTFOLIO
Table 58 : CELLON: RECENT DEVELOPMENTS
Table 59 : CHARTER MEDICAL: PRODUCT PORTFOLIO
Table 60 : CHARTER MEDICAL: RECENT DEVELOPMENTS
Table 61 : CMC BIOLOGICS: SERVICES
Table 62 : CMC BIOLOGICS: RECENT DEVELOPMENTS
Table 63 : COLDER PRODUCTS COMPANY: PRODUCT PORTFOLIO
Table 64 : COLDER PRODUCTS CO.: RECENT DEVELOPMENTS, 2011-2012
Table 65 : DOW CORNING: PRODUCT PORTFOLIO
Table 66 : DOW CORNING: RECENT DEVELOPMENTS, 2009-2011
Table 67 : EMD MILLIPORE: PRODUCT PORTFOLIO
Table 68 : EMD MILLIPORE: RECENT DEVELOPMENTS, 2006-2012
Table 69 : FINESSE SOLUTIONS: PRODUCT PORTFOLIO
Table 70 : FINESSE SOLUTIONS: RECENT DEVELOPMENTS, 2009-2011
Table 71 : GE HEALTHCARE: PRODUCT PORTFOLIO
Table 72 : GORE: PRODUCT PORTFOLIO
Table 73 : GORE: RECENT DEVELOPMENTS, 2011-2012
Table 74 : IS SUPPLIES: PRODUCT PORTFOLIO
Table 75 : NOVASEP: PRODUCT PORTFOLIO
Table 76 : NOVASEP: RECENT DEVELOPMENTS, 2011-2012
Table 77 : PALL CORP. PRODUCT PORTFOLIO
Table 78 : PALL CORP.: RECENT DEVELOPMENTS, 2011-2012
Table 79 : PENDOTECH: PRODUCT PORTFOLIO
Table 80 : PENDOTECH: RECENT DEVELOPMENTS, 2011-2012
Table 81 : RENOLIT: PRODUCT PORTFOLIO
Table 82 : RENOLIT: RECENT DEVELOPMENTS
Table 83 : REPLIGEN BIOPROCESSING: PRODUCT PORTFOLIO
Table 84 : SAINT GOBAIN: PRODUCT PORTFOLIO
Table 85 : SAINT GOBAIN: RECENT DEVELOPMENTS, 2011-2012
Table 86 : SARTORIUS: PRODUCT PORTFOLIO

Table 87 : SARTORIUS: RECENT DEVELOPMENTS, 2011-2012
Table 88 : SARTORIUS: FINANCIALS
Table 89 : TARPON BIOSYSTEMS: PRODUCT PORTFOLIO
Table 90 : XCELLEREX: PRODUCT PORTFOLIO
Table 91 : XCELLEREX: RECENT DEVELOPMENTS, 2011-2012
Table 92 : GLOBAL MARKET FOR STORAGE BUFFER CONTAINERS BY GEOGRAPHIC
Table 93 : GLOBAL MARKET FOR PREPARATION BUFFER CONTAINERS BY GEOGRAPHIC
Table 94 : U.S. PATENTS FOR SUT, 2010 TO 2012
Table 95 : EUROPEAN SUT PATENTS, 2010 TO 2012
LIST OF FIGURES
Summary Figure : GLOBAL MARKET FOR SINGLE-USE TECHNOLOGIES USED IN THE
MANUFACTURE OF BIOPHARMACEUTICALS BY GEOGRAPHIC REGION, 2011-2017
Figure 1 : EVOLUTION OF SINGLE-USE TECHNOLOGIES USED IN BIOPHARMACEUTICAL
MANUFACTURING
Figure 2 : COST OF NEW DRUG DEVELOPMENT, 1997-2013
Figure 3 : GROWTH ANALYSIS OF THE SUT MARKET
Figure 4 : THE U.S. AND EUROPEAN PATENTS ON SINGLE-USE TECHNOLOGIES, 2010-2012
Figure 5 : U.S. PATENTS ON SINGLE-USE TECHNOLOGIES BY YEAR, 2010 TO JUNE 2012
Figure 6 : EUROPEAN PATENTS BY YEAR, 2010 TO JUNE 2012
Figure 7 : BIOPHARMACEUTICAL MANUFACTURE OF MONOCLONAL ANTIBODIES
Figure 8 : SELECTED AVERAGE FACILITY BUDGETS FOR SINGLE-USE DEVICES-
BIOTHERAPEUTICS DEVELOPERS VS. CMOS
Figure 9 : TOP STRATEGIES, 2006-2012
Figure 10 : AGREEMENTS BY COMPANY, 2006-2012
Figure 11 : MERGERS AND ACQUISITIONS BY COMPANY, 2006-2012
Figure 12 : ANALYSIS BY COMPANY 2006-2012

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Single-Use Technologies for Biopharmaceuticals: Global Markets

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