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Chromatography in Pharmaceuticals and Biotechnology: Global Markets

November 2018 | 336 pages | ID: C7C8D804FF9EN
BCC Research

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Report Scope:

According to the BCC Research report BIO011G Separation Systems for Commercial Biotechnology, chromatography accounted for nearly 21% of the overall market in 2015. In another BCC report, MST034E Global Markets for Reagents for Chromatography, the market that was valued at $7.6 billion in 2014 is estimated to reach $10.7 billion by 2019, growing at a compound annual growth rate (CAGR) of 5.2% through 2019. Chromatography is a valuable tool particularly in the pharmaceutical and biotechnology sectors as it can provide highly sensitive information about product quality and purity. The implementation of process analytical technology has also given a boost to this market. The growing demands of biopharmaceuticals, particularly monoclonal antibodies, biosimilar drugs and others have also necessitated biotechnology and biopharmaceutical industries to invest in high-throughput bioprocessing and downstream processing instruments. The advances in technology for the development of improved systems, innovative and disposable columns, better-performing resins, and other accessories are helping this market to grow significantly.

This BCC report provides a comprehensive analysis of the chromatography market in the global context, including market forecasts and sales through 2023. The report includes assessment of the chromatography market by segmenting it into the broad categories of instruments and reagents followed by thorough analyses of various techniques of chromatography for each category. These include liquid chromatography (ion-exchange, hydrophobic-interaction, size-exclusion, flash), high-pressure liquid chromatography (HPLC)/ultra-high-pressure liquid chromatography (UHPLC), thin layer chromatography, gas chromatography, supercritical fluid chromatography and affinity chromatography. This study surveys the chromatography market in all the geographic regions including North America, Europe and emerging markets. The emerging markets include countries such as India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America and others. BCC Research has analyzed the chromatography market by applications in the pharmaceutical and biotechnology sectors.

Chromatography is a continuously evolving technique, and its success is dependent on the innovations in technology. Therefore, this report discusses the emerging trends in chromatography technology, particularly the instruments and the reagents. It also features the new developments and new product launches in the global market.

The report provides relevant patent analyses and comprehensive profiles of market players in the industry. The Industry Structure chapter focuses on the important chromatography instruments and reagent manufacturers and suppliers, their market shares and product offerings. The chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.

BCC’s new report on chromatography elaborates on the strengths, weaknesses, threats and opportunities of the global chromatography market. Any regulatory changes or new initiatives are also highlighted.

Excluded from this report are the applications of chromatography in industries other than pharmaceutical and biotechnology such as chemicals, food and beverage, environment, oil and gas and others. Also, instruments and reagents for capillary electrophoresis and solid phase extraction (SPE) are not included. The sales for LC/MS instruments are not included as part of this study, although the systems are referred to in this report to show the uptake of liquid chromatography instruments in related applications.

Report Includes:
  • 47 data tables and 44 additional tables
  • An overview of the global market for chromatography in pharmaceuticals and biotechnology applications
  • Analyses of global market trends with data from 2016 and 2017, estimates for 2018, and projections of compound annual growth rates (CAGRs) through 2023
  • Characterization and quantification of market potential for chromatography instruments and reagents by technology type, application and geographical region
  • Identification of the segments that should experience high growth during the time frame covered
  • Information on competitor initiatives, and information pertaining to research and development status of chromatography in pharmaceuticals and biotechnology
  • Coverage of significant patents and their allotments in each category
  • Comprehensive profiles of major players in the industry, including Bio-Rad Laboratories Inc., Danaher Corp., MilliporeSigma, Qiagen, N.V., Scion Instruments and Thermo Fisher Scientific Inc.
CHAPTER 1 INTRODUCTION

Study Goals and Objectives
Reasons for Doing This Study
Scope of the Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

CHAPTER 2 SUMMARY AND HIGHLIGHTS

Key Findings of the Report

CHAPTER 3 MARKET AND TECHNOLOGY BACKGROUND

Principles of Chromatography
Stationary Phase
Mobile Phase
Analyte
A Typical Chromatography Process
History of Chromatography
Applications Overview
Downstream Processing
Analytical Characterization of Proteins
Drug Discovery and Development
Pharmaceutical Analysis
Clinical Analysis/Diagnostics
Chromatography Instruments
Chromatography Systems/Chromatographs
Columns and Column Accessories
Detectors
Fraction Collectors
Injectors and Autosamplers
Pumps
Accessories
Chromatography Reagents
Packing Material (Resin)
Solvents
Buffers
Derivatives
Modifiers
Chromatography Standards
Chromatography Software
Classification of Chromatography
Based on Scale of Chromatography
Based on Type of Stationary Phase
Based on Type of Mobile Phase
Types of Chromatography
Liquid Chromatography
High-Performance Liquid Chromatography (HPLC)/Ultra High-Performance Liquid Chromatography (UHPLC)
Thin Layer Chromatography (TLC)
Gas Chromatography (GC)
Supercritical Fluid Chromatography (SFC)
Affinity Chromatography

CHAPTER 4 MARKET BREAKDOWN BY TECHNOLOGY TYPE

Market by Chromatography Product Types
Market Revenue
Market Shares
Market Analysis of Chromatography Instruments Segment
Market by Chromatography Technology Types
Market Overview
Market Revenue
Market Shares
Market Analysis of Chromatography Reagents Segment
Market by Chromatography Technology Type
Market Overview
Market Revenue
Market Shares

CHAPTER 5 MARKET BREAKDOWN BY APPLICATION

Market by Application
Market Revenue
Market Shares
Drug Discovery and Development
Market Overview
Market Revenue
Market Shares
Downstream Processing
Market Overview
Market Developments
Market Revenue
Market Shares
Proteomics
Market Overview
Market Revenue
Market Shares
Diagnostics
Market Overview
Market Revenue
Market Shares
Pharmaceutical Analysis
Market Overview
Market Revenue
Market Shares
Metabolomics
Market Overview
Market Revenue
Market Shares

CHAPTER 6 MARKET BREAKDOWN BY REGION

Market by Geographical Region
Market Revenue
Market Shares
Gas Chromatography
Market Overview
Market Revenue
Market Shares
Thin Layer Chromatography
Market Overview
Market Revenue
Market Shares
Supercritical Fluid Chromatography
Market Overview
Market Revenue
Market Shares
Liquid Chromatography
Market Overview
Market Revenue
Market Shares
High-Performance Liquid Chromatography/Ultra High-Performance Liquid Chromatography (HPLC/UHPLC)
Market Overview
Market Revenue
Market Shares
Affinity Chromatography
Market Overview
Market Revenue
Market Shares

CHAPTER 7 INDUSTRY STRUCTURE

Regulatory and Compliance
Overview
Industry Structure
Industry Trends in Chromatography Market
Consumable Bundle Offerings
Mergers and Acquisitions
Collaborations and Partnerships
Buying and Selling Chromatography Products
Leading Manufacturers/Suppliers of Chromatography Instruments and Reagents
Gas Chromatography (GC)
Supercritical Fluid Chromatography (SFC)
Thin Layer Chromatography (TLC)
Liquid Chromatography (LC)
High-Performance Liquid Chromatography (HPLC)/Ultra-Performance Liquid Chromatography (UPLC)
Affinity Chromatography

CHAPTER 8 PATENT REVIEW

Patents in Chromatography Market
Patent Analysis
Patents by Year
Patents by Category
Patents by Type
Patents by Company
Patents by Country
Patents by Assignee

CHAPTER 9 NEW DEVELOPMENTS/REGULATORY ASPECTS

New Developments
New Developments in Chromatography Instruments
New Developments in Chromatography Reagents
Regulatory Aspects
Guidelines Related to Analytical Method Validation -- General Concepts
Guidelines Related to Downstream Processing -- General Concepts
Guidelines Related to Chromatography Data Integrity

CHAPTER 10 TECHNOLOGY TRENDS

Emerging Trends in Chromatography Instruments
Miniaturization of Chromatography Columns and Systems
Disposable/Pre-packed Columns
Membrane Technology
Rapid and High-Throughput Separations
Microfluidic Chromatography
Multi-Dimensional Chromatography
Continuous Chromatography
Novel Detectors
Trends in Chromatography Data Systems (CDSs)
Emerging Trends in Chromatography Reagents
Novel Chromatography Resins
Affinity Resins
Improved Buffers
High-Purity Solvents
Emerging Trends in Chromatography Applications
Application of GC-VUV in Residual Solvent Characterization
Integration of Chromatography for High-Throughput Drug Discovery and Chemical Syntheses Studies
Application of UHPLC-MS/MS for Identifying DNA/RNA Modifications
Multi-Dimensional Chromatography is a Promising Method for Identification of the Nucleoside Modifications
Application of 2D-LC in Quality Control
Application of 2D-LC in Characterization of Antibody-Drug Conjugates (ADCs)
Developments in the Purification of Bi-specific Antibodies

CHAPTER 11 ANALYSIS OF MARKET OPPORTUNITIES

Strengths of Chromatography Market
Rising Incidence of Diseases
Growing Demand for Biopharmaceuticals
New Product Launches
Increased Government Spending
Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs)
Mergers and Acquisitions
Challenges of Chromatography Market
Lack of Skilled Labor
Cost of Equipment
Protein A Resins
Scale-up of Chromatography Processes
Continuous Chromatography
Opportunities for Chromatography Market
Emerging Markets
Technological Advances
Process Analytical Technology (PAT) Initiative
Novel Protein A Resins
Multi-Dimensional Chromatography and Process Intensification
Threats for Chromatography Market
Government Regulations
Competition

CHAPTER 12 COMPANY PROFILES

&^%gh ABBKINE SCIENTIFIC CO. LTD.
&^%gh AB SCIEX LLC
&^%gh ADS BIOTEC INC.
&^%gh ADVANCED MATERIALS TECHNOLOGY INC.
&^%gh ADVENT CHEMBIO PVT. LTD.
&^%gh ADVION INC.
&^%gh AGILENT TECHNOLOGIES, INC.
&^%gh ANAWA TRADING AG
&^%gh ANTEC SCIENTIFIC
&^%gh ASYNT LTD.
&^%gh BIO-LAB LTD.
&^%gh BIO-RAD LABORATORIES INC.
&^%gh BIOTAGE AB
&^%gh BIOTOOLOMICS LTD.
&^%gh BISCHOFF CHROMATOGRAPHY
&^%gh BRUKER CORP.
&^%gh CAMAG CHEMIE-ERZEUGNISSE & ADSORPTIONSTECHNIK AG
&^%gh CECIL INSTRUMENTS LTD.
&^%gh CHIRAL TECHNOLOGIES INC.
&^%gh DAISO FINE CHEM USA INC.
&^%gh DANAHER CORP.
&^%gh ES INDUSTRIES, INC.
&^%gh FINAR LTD.
&^%gh GE HEALTHCARE LIFE SCIENCES
&^%gh GILSON INC.
&^%gh GL SCIENCES INC.
&^%gh HAMILTON CO.
&^%gh HICHROM LTD.
&^%gh HITACHI HIGH-TECHNOLOGIES CORP.
&^%gh IMTAKT USA
&^%gh JASCO INC.
&^%gh JSR LIFE SCIENCES
&^%gh KNAUER WISSENSCHAFTLICHE GERATE GMBH
&^%gh LABOMATIC INSTRUMENTS AG
&^%gh MACHEREY-NAGEL GMBH & CO.
&^%gh MICROSOLV TECHNOLOGY CORP.
&^%gh MILLIPORESIGMA
&^%gh NOVASEP INC.
&^%gh PERKINELMER, INC.
&^%gh PHENOMENEX INC.
&^%gh PUROLITE CORP.
&^%gh QIAGEN, N.V.
&^%gh QUADREX CORP.
&^%gh REGIS TECHNOLOGIES INC.
&^%gh REPLIGEN CORP.
&^%gh RESTEK CORP.
&^%gh ROTACHROM TECHNOLOGIES LTD.
&^%gh SARTORIUS STEDIM BIOTECH GMBH
&^%gh SCION INSTRUMENTS
&^%gh SEPRAGEN CORP.
&^%gh SHIMADZU CORP.
&^%gh SHOWA DENKO K.K.
&^%gh SINO BIOLOGICAL INC.
&^%gh SORBENT TECHNOLOGIES, INC.
&^%gh STEROGENE BIOSEPARATIONS INC.
&^%gh TELEDYNE ISCO
&^%gh TELEDYNE TEKMAR
&^%gh THERMO FISHER SCIENTIFIC INC.
&^%gh TOSOH BIOSCIENCE LLC
&^%gh VUV ANALYTICS INC.
&^%gh W. L. GORE & ASSOCIATES INC.
&^%gh WATERS CORP.
&^%gh YMC AMERICA INC.

CHAPTER 13 GLOSSARY AND ABBREVIATIONS

LIST OF TABLES

Summary Table: Global Market for Chromatography Instruments and Reagents, by Technology Type, Through 2023
Table 1: Timeline of Chromatography
Table 2: Popular Chromatography Systems
Table 3: Column Types for Gas Chromatography
Table 4: Column Types for Liquid Chromatography
Table 5: Properties of Commonly Used Detectors
Table 6: Packing Materials Used in Different Chromatographic Techniques
Table 7: Common Solvents Used in Chromatography
Table 8: Common Buffers Used in Chromatography
Table 9: Common Reagents Employed in Derivatization
Table 10: Popular Chromatography Data Systems
Table 11: Chromatographic Techniques Based on the Stationary Phase
Table 12: Differences Between Gas and Liquid Chromatography
Table 13: Weak and Strong Ion-Exchange Resins
Table 14: Instruments and Reagents Used in Liquid Chromatography
Table 15: Advantages and Disadvantages of HPLC/UHPLC
Table 16: Instruments and Reagents Used in HPLC/UHPLC
Table 17: Advantages and Disadvantages of TLC
Table 18: Instruments and Reagents Used in TLC
Table 19: Advantages and Disadvantages of Gas Chromatography
Table 20: Instruments and Reagents Used in Gas Chromatography
Table 21: Advantages and Disadvantages of SFC
Table 22: Instruments and Reagents Used in Supercritical Fluid Chromatography
Table 23: Advantages and Disadvantages of Affinity Chromatography
Table 24: Instruments and Reagents Used in Affinity Chromatography
Table 25: Global Market for Chromatography, by Product Type, Through 2023
Table 26: Global Market Shares of Chromatography, by Product Type, 2017
Table 27: Global Market for Chromatography Instruments, by Technology Type, Through 2023
Table 28: Global Market Shares of Chromatography Instruments, by Technology Type, 2017
Table 29: Global Market for Chromatography Reagents, by Technology Type, Through 2023
Table 30: Global Market Shares of Chromatography Reagents, by Technology Type, 2017
Table 31: Global Market for Chromatography, by Application, Through 2023
Table 32: Global Market Shares of Chromatography, by Application, 2017
Table 33: Global Market for Chromatography in Drug Discovery and Development, by Region, Through 2023
Table 34: Global Market Shares of Chromatography in Drug Discovery and Development, by Region, 2017
Table 35: Global Market for Chromatography in Downstream Processing, by Region, Through 2023
Table 36: Global Market Shares of Chromatography in Downstream Processing, by Region, 2017
Table 37: Global Market for Chromatography in Proteomics, by Region, Through 2023
Table 38: Global Market Shares of Chromatography in Proteomics, by Region, 2017
Table 39: Global Market for Chromatography in Diagnostics, by Region, Through 2023
Table 40: Global Market Shares of Chromatography in Diagnostics, by Region, 2017
Table 41: Global Market for Chromatography in Pharmaceutical Analysis, by Region, Through 2023
Table 42: Global Market Shares of Chromatography in Pharmaceutical Analysis, by Region, 2017
Table 43: Global Market for Chromatography in Metabolomics, by Region, Through 2023
Table 44: Global Market Shares of Chromatography in Other Applications, by Region, 2017
Table 45: Global Market for Chromatography, by Region, Through 2023
Table 46: Global Market Shares of Chromatography, by Region, 2017
Table 47: Global Market for Gas Chromatography, by Region, Through 2023
Table 48: Global Market Shares of Gas Chromatography, by Region, 2017
Table 49: Global Market for Thin Layer Chromatography, by Region, Through 2023
Table 50: Global Market Shares of Thin Layer Chromatography, by Region, 2017
Table 51: Global Market for Supercritical Fluid Chromatography, by Region, Through 2023
Table 52: Global Market Shares of Supercritical Fluid Chromatography, by Region, 2017
Table 53: Global Market for Liquid Chromatography, by Region, Through 2023
Table 54: Global Market Shares of Liquid Chromatography, by Region, 2017
Table 55: Global Market for HPLC/UHPLC, by Region, Through 2023
Table 56: Global Market Shares of HPLC/UHPLC, by Region, 2017
Table 57: Global Market for Affinity Chromatography, by Region, Through 2023
Table 58: Global Market Shares of Affinity Chromatography, by Region, 2017
Table 59: List of Resin-only Suppliers
Table 60: Mergers and Acquisitions in the Chromatography Market, 2016-2018
Table 61: Collaborations and Partnerships in the Chromatography Market, 2016-2017
Table 62: Leading Manufacturers/Suppliers of GC Instruments and Reagents, 2017
Table 63: Market Shares of Leading Manufacturers/Suppliers of GC Instruments and Reagents, 2017
Table 64: Leading Manufacturers/Suppliers of SFC Instruments and Reagents, 2017
Table 65: Market Shares of Leading Manufacturers/Suppliers of SFC Instruments and Reagents, 2017
Table 66: Leading Manufacturers/Suppliers of TLC Instruments and Reagents, 2017
Table 67: Market Shares of Leading Manufacturers/Suppliers of TLC Instruments and Reagents, 2017
Table 68: Leading Manufacturers/Suppliers of LC Instruments and Reagents, 2017
Table 69: Market Shares of Leading Manufacturers/Suppliers of LC Instruments and Reagents, 2017
Table 70: Leading Manufacturers/Suppliers of HPLC/UPLC Instruments and Reagents, 2017
Table 71: Market Shares of Leading Manufacturers/Suppliers of HPLC/UPLC Instruments and Reagents, 2017
Table 72: Leading Manufacturers/Suppliers of Affinity Chromatography Instruments and Reagents, 2017
Table 73: Market Shares of Leading Manufacturers/Suppliers of Affinity Chromatography Instruments and Reagents, 2017
Table 74: Basic Aspects of Patents
Table 75: Representative Patents in Chromatography, 2016-2018
Table 76: Representative Patents in Chromatography Applications, 2016-2018
Table 77: Numer of Patents Issued for Chromatography, 2016-April 2018
Table 78: Patents Issued for Chromatography, by Category, 2016-April 2018
Table 79: Patents Issued for Chromatography, by Type, 2016-April 2018
Table 80: Patents Issued for Chromatography, by Company, 2016-April 2018
Table 81: Patents Issued for Chromatography, by Country, 2016-April 2018
Table 82: Patents Issued for Chromatography, by Assignee, 2016-April 2018
Table 83: New Product Developments in Chromatography Instruments, 2017-2018
Table 84: New Product Developments in Chromatography Instruments, 2016
Table 85: New Product Developments in Chromatography Reagents, 2016-April 2018
Table 86: List of Federal Agencies and Regulatory Guidelines Related to Chromatography
Table 87: Warning Letters Issued In Lieu of Data Integrity Issues, 2016-2017
Table 88: Applications of 2D-LC in Pharmaceutical and Biotechnology Sectors
Table 89: Abbreviations Used in Chromatography
Table 90: Glossary of Terms Used in Chromatography

LIST OF FIGURES

Summary Figure: Global Market for Chromatography Instruments and Reagents, by Technology Type, 2016-2023
Figure 1: Graphical Representation of a Typical Chromatography System
Figure 2: Classification of Chromatography
Figure 3: Global Market for Chromatography, by Product Type, 2016-2023
Figure 4: Global Market Shares of Chromatography, by Product Type, 2017
Figure 5: Global Market for Chromatography Instruments, by Technology Type, 2016-2023
Figure 6: Global Market Shares of Chromatography Instruments, by Technology Type, 2017
Figure 7: Global Market for Chromatography Reagents, by Technology Type, 2016-2023
Figure 8: Global Market Shares of Chromatography Reagents, by Technology Type, 2017
Figure 9: Global Market for Chromatography, by Application, 2016-2023
Figure 10: Global Market Shares of Chromatography, by Application, 2017
Figure 11: Global Market for Chromatography in Drug Discovery and Development, by Region, 2016-2023
Figure 12: Global Market Shares of Chromatography in Drug Discovery and Development, by Region, 2017
Figure 13: Global Market for Chromatography in Downstream Processing, by Region, 2016-2023
Figure 14: Global Market Shares of Chromatography in Downstream Processing, by Region, 2017
Figure 15: Global Market for Chromatography in Proteomics, by Region, 2016-2023
Figure 16: Global Market Shares of Chromatography in Proteomics, by Region, 2017
Figure 17: Global Market for Chromatography in Diagnostics, by Region, 2016-2023
Figure 18: Global Market Shares of Chromatography in Diagnostics, by Region, 2017
Figure 19: Global Market for Chromatography in Pharmaceutical Analysis, by Region, 2016-2023
Figure 20: Global Market Shares of Chromatography in Pharmaceutical Analysis, by Region, 2017
Figure 21: Global Market for Chromatography in Metabolomics, by Region, 2016-2023
Figure 22: Global Market Shares of Chromatography in Other Applications, by Region, 2017
Figure 23: Global Market for Chromatography, by Region, 2016-2023
Figure 24: Global Market Shares of Chromatography, by Region, 2017
Figure 25: Global Market for Gas Chromatography, by Region, 2016-2023
Figure 26: Global Market Shares of Gas Chromatography, by Region, 2017
Figure 27: Global Market for Thin Layer Chromatography, by Region, 2016-2023
Figure 28: Global Market Shares of Thin Layer Chromatography, by Region, 2017
Figure 29: Global Market for Supercritical Fluid Chromatography, by Region, 2016-2023
Figure 30: Global Market Shares of Supercritical Fluid Chromatography, by Region, 2017
Figure 31: Global Market for Liquid Chromatography, by Region, 2016-2023
Figure 32: Global Market Shares of Liquid Chromatography, by Region, 2017
Figure 33: Global Market for HPLC/UHPLC, by Region, 2016-2023
Figure 34: Global Market Shares of HPLC/UHPLC, by Region, 2017
Figure 35: Global Market for Affinity Chromatography, by Region, 2016-2023
Figure 36: Global Market Shares of Affinity Chromatography, by Region, 2017
Figure 37: Market Shares of Leading Manufacturers/Suppliers of GC Instruments and Reagents, 2017
Figure 38: Market Shares of Leading Manufacturers/Suppliers of SFC Instruments and Reagents, 2017
Figure 39: Market Shares of Leading Manufacturers/Suppliers of TLC Instruments and Reagents, 2017
Figure 40: Market Shares of Leading Manufacturers/Suppliers of LC Instruments and Reagents, 2017
Figure 41: Market Shares of Leading Manufacturers/Suppliers of HPLC/UPLC Instruments and Reagents, 2017
Figure 42: Market Shares of Leading Manufacturers/Suppliers of Affinity Chromatography Instruments and Reagents, 2017
Figure 43: Number of Patents Issued for Chromatography, 2016-April 2018
Figure 44: Patents Issued for Chromatography, by Category, 2016-April 2018
Figure 45: Patents Issued for Chromatography, by Type, 2016-April 2018
Figure 46: Patents Issued for Chromatography, by Assignee, 2016-April 2018
Figure 47: SWOT Analysis of the Chromatography Market


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