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Validation, Calibration and Standardization in the Life Sciences Market

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    Report

  • 185 Pages
  • April 2019
  • Region: Global
  • BCC Research
  • ID: 4763842
UP TO OFF until Aug 31st 2033

Report Scope:

The scope of this report is broad and covers multiple types of services available, instruments and consumables utilized, ongoing research and development in global validation, calibration and standardization in life sciences market and potential end-users. Global validation, calibration, and standardization in the life sciences market is broken down into instruments and consumables, service type, service providers and end users. Revenue forecasts from 2017 to 2023 are given for each of these four segments, with estimated values derived from the total revenues of companies operating in the market.

The report includes a discussion of the major players across each region in validation, calibration, and standardization in the life sciences market. This report also explains the major drivers and regional dynamics of this market and current trends within the industry.

The report concludes with a special focus on the vendor landscape and includes detailed profiles of the major vendors in this market.

The Report Includes:


  • 85 data tables and 50 additional tables
  • Country-specific data and analysis for the US, Canada, Germany, France, UK, Spain, China, India, Japan, and Australia
  • Explanation of validation and calibration of instruments such as heap filters, pH meters, incubators, autoclaves, HPLC units, and GC units
  • Discussion of ongoing research in treatments of various diseases and susceptibility of various microbes toward traditional medicines as driving factors to the industry
  • Insight into the regulatory compliances in the life science industry
  • Detailed profile of major companies of the industry, including Beckman Coulter, Inc., Biovia (Dassault Systems), Data Sciences International (DSI), IBM and Thermo Fisher Scientific

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Geographic Breakdown
  • Analyst’s Credentials
  • Custom Research
  • Related Reports



Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
  • Introduction
  • Market Potential
  • Regulatory Outlook
  • United States
  • Europe
  • China
  • Japan
  • Investment Analysis
  • Segment Overview
  • Instruments and Consumables
  • By Service Type
  • By Service Provider
  • Geographic Overview
  • North America
  • Asia-Pacific
  • Europe
  • Rest of World



Chapter 4 Market Determinants
  • Strict Regulatory Compliance in the Life Sciences Industry
  • Regulation of Medical Devices
  • Regulation of Environmental Testing
  • Regulation of Medical Devices Containing Drugs
  • Increasing Adoption of GMP for Global Business Opportunities
  • Surging Demand for Accurate Information and Preventive Maintenance of Instruments
  • High Growth in the Pharmaceutical and Biotechnology Market
  • Rising Adoption of Calibration Management Software



Chapter 5 Market Breakdown by Service Provider
  • In-house Validation, Calibration and Standardization in the Life Sciences Market
  • Objectives of Calibration
  • Need for In-house Calibration, Validation and Standardization
  • Benefits of In-house Calibration, Validation and Standardization
  • OEM Validation, Calibration and Standardization in the Life Sciences Market
  • Benefits of OEM Calibration
  • Objective in Selecting Original Equipment Manufacturer Calibration Provider
  • Companies Offering Calibration and Validation Services
  • Third-Party Validation, Calibration and Standardization in the Life Sciences Market
  • Importance of Third-Party Calibration Services
  • Companies Offering Third-Party Calibration and Validation Services
  • National Standards for Calibration Laboratories



Chapter 6 Market Breakdown by Service Type
  • Analytical Technique Validation Parameters
  • Electrotechnical
  • Micro-Ohmmeter/DLRO Calibration
  • Megohmmeter Calibration and Insulation Tester Calibration
  • Power Supply Calibration: AC Power and DC Power
  • Oscilloscope Calibration
  • Electrotechnical Market, by Region
  • Pressure
  • Fluid Flow/Optical
  • Pipettes
  • Thermal
  • Mechanical
  • Others



Chapter 7 Market Breakdown by Instruments and Consumables
  • Instruments
  • Biochemistry Analyzers
  • pH Meters
  • Pressure and Temperature Calibrators
  • Others
  • Consumables
  • Calibration Kits/Sampling Kits
  • Slides
  • Filters
  • Glass Consumables
  • Others



Chapter 8 Market Breakdown by End User
  • Pharmaceutical and Biotechnology Companies
  • Calibration in Pharmaceutical Industry
  • Instrument Calibration in Pharmaceutical Industry
  • Validation in the Pharmaceutical Industry
  • Drivers
  • Research Laboratories
  • Calibration in Research Laboratories
  • Validation in Research Laboratories
  • Clinics and Hospitals
  • Validation in Clinics and Hospitals
  • Calibration in Clinics and Hospitals
  • Contract Research Organizations



Chapter 9 Market Breakdown by Region
  • North America
  • United States
  • Canada
  • Europe
  • United Kingdom
  • France
  • Germany
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
  • Rest of World
  • Latin America
  • Middle East and Africa



Chapter 10 Industry Structure
  • Raw Material Procurement
  • Quality and Technology
  • Terms and Conditions
  • Cost-Effective Components
  • Manufacturing and Development Process
  • Distributors
  • End Users



Chapter 11 Competitive Analysis
Chapter 12 Company Profiles
  • Agile Lifescience Technologies Pvt. Ltd.
  • Autocal Solutions Pvt. Ltd.
  • Beckman Coulter, Inc.
  • Biovia (Dassault Systems)
  • Calibrationlab Bvba
  • CBRE
  • Data Sciences International (Dsi)
  • Endress+Hauser
  • Essco Calibration Laboratory
  • Evolution Scientific
  • IBM
  • Insight Calibration Services
  • J.A. King
  • Karandikar Laboratories Pvt. Ltd.
  • Merck Millipore
  • SGS
  • Tangent Labs
  • Tektronix
  • Telstar Life Science Solutions
  • Thermo Fisher Scientific
  • Transcat, Inc.
  • Trescal
  • Vaisala
  • Valgenesis
  • Verichek Technical Services, Inc.
  • Westport Corp.



List of Tables
Summary Table A: Validation, Calibration and Standardization in the Global Life Sciences Market, by End User, Through 2023
Summary Table B: Validation, Calibration and Standardization in the Global Life Sciences Market, by Region, Through 2023
Table 1: Global Life Science Research and Development Spending, 2014-2016
Table 2: Number of R&D Projects in Drug Development, 2014-2017
Table 3: Validation, Calibration and Standardization in the Global Life Sciences Market, by Instruments and Consumables, Through 2023
Table 4: Validation, Calibration and Standardization in the Global Life Sciences Market, by Service Type, Through 2023
Table 5: GMP Regulations and Preambles
Table 6: Worldwide Total Pharmaceutical R&D Spend, 2015-2022
Table 7: PhRMA Member Company R&D Expenditures, 2010 and 2016
Table 8: Investments in Biotechnology
Table 9: Advantages of Using Calibration Management Software
Table 10: Validation, Calibration and Standardization in the Global Life Sciences Market, by Service Providers, Through 2023
Table 11: Global In-house Service Providers Market, by Region, Through 2023
Table 12: Global OEM Service Providers Market, by Region, Through 2023
Table 13: Global Third-Party Service Providers Market, by Region, Through 2023
Table 14: Third-Party Calibration and Validation Services
Table 15: Validation, Calibration and Standardization in the Global Life Sciences Market, by Service Type, Through 2023
Table 16: Global Electrotechnical Market, by Region, Through 2023
Table 17: North American Electrotechnical Market, by Country, Through 2023
Table 18: Federal Funding for Biomedical and Associated Life Sciences Research, 2016
Table 19: European Electrotechnical Market, by Country, Through 2023
Table 20: Asia-Pacific Electrotechnical Market, by Country, Through 2023
Table 21: Rest of World Electrotechnical Market, by Sub-region, Through 2023
Table 22: Global Pressure Market, by Region, Through 2023
Table 23: North American Pressure Market, by Country, Through 2023
Table 24: European Pressure Market, by Country, Through 2023
Table 25: Asia-Pacific Pressure Market, by Country, Through 2023
Table 26: Rest of World Pressure Market, by Sub-region, Through 2023
Table 27: Global Fluid Flow/Optical Market, by Region, Through 2023
Table 28: North American Fluid Flow/Optical Market, by Country, Through 2023
Table 29: European Fluid Flow/Optical Market, by Country, Through 2023
Table 30: Asia-Pacific Fluid Flow/Optical Market, by Country, Through 2023
Table 31: Rest of World Fluid Flow/Optical Market, by Sub-region, Through 2023
Table 32: Global Pipette Market, by Region, Through 2023
Table 33: North American Pipette Market, by Country, Through 2023
Table 34: European Pipette Market, by Country, Through 2023
Table 35: Asia-Pacific Pipette Market, by Country, Through 2023
Table 36: Rest of World Pipette Market, by Sub-region, Through 2023
Table 37: Global Thermal Market, by Region, Through 2023
Table 38: North American Thermal Market, by Country, Through 2023
Table 39: European Thermal Market, by Country, Through 2023
Table 40: Asia-Pacific Thermal Market, by Country, Through 2023
Table 41: Rest of World Thermal Market, by Sub-region, Through 2023
Table 42: Global Mechanical Market, by Region, Through 2023
Table 43: North American Mechanical Market, by Country, Through 2023
Table 44: European Mechanical Market, by Country, Through 2023
Table 45: Asia-Pacific Mechanical Market, by Country, Through 2023
Table 46: Rest of World Mechanical Market, by Sub-region, Through 2023
Table 47: Global Other Service Type Market, by Region, Through 2023
Table 48: North American Other Service Type Market, by Country, Through 2023
Table 49: European Other Service Type Market, by Country, Through 2023
Table 50: Asia-Pacific Other Service Type Market, by Country, Through 2023
Table 51: Rest of World Other Service Type Market, by Sub-region, Through 2023
Table 52: Validation, Calibration and Standardization in the Global Life Sciences Market, by Instruments and Consumables, Through 2023
Table 53: Validation, Calibration and Standardization in the Global Life Sciences Market, by Instruments, Through 2023
Table 54: Global Pharmaceutical Industry Instruments Market, by Region, Through 2023
Table 55: Global Pharmaceutical Market, 2015 and 2020
Table 56: Different Applications of pH Meter
Table 57: pH Standard Tests and Methods
Table 58: Water and Soil Conductivity Standards and Methods
Table 59: Standard Conductivity Specification for Reagent Grade Water
Table 60: Validation, Calibration and Standardization in the Global Life Sciences Market, by Consumables, Through 2023
Table 61: Global Consumable Market, by Region, Through 2023
Table 62: Biotechnology Investments
Table 63: Validation, Calibration and Standardization in the Global Life Sciences Market, by Calibration Kits/Sampling Kits, Through 2023
Table 64: Validation, Calibration and Standardization in the Global Life Sciences Market, by End User, Through 2023
Table 65: Global Pharmaceutical and Biotechnology Companies Market, by Region, Through 2023
Table 66: Pharmaceutical Quality/Manufacturing Standards (CGMP), 2016-2018
Table 67: Global Research Laboratories Market, by Region, Through 2023
Table 68: List of Recognized Calibration Laboratories for Measurement of Radionuclide Content in Commodities in India
Table 69: Global Clinics and Hospitals Market, by Region, Through 2023
Table 70: Comparison of In-house and Outside Scale Calibration in Hospitals
Table 71: Global Contract Research Organizations Market, by Region, Through 2023
Table 72: Validation, Calibration and Standardization in the Global Life Sciences Market, by Region, Through 2023
Table 73: North American Validation, Calibration and Standardization in the Life Sciences Market, by Country, Through 2023
Table 74: North American Validation, Calibration and Standardization in the Life Sciences Market, by Service Type, Through 2023
Table 75: Global Spending on Medicine, 2011-2021
Table 76: Pharmaceutical R&D Expenditures in the United States, 2000-2015
Table 77: List of Select FDA Drug Recalls
Table 78: Canadian Pharmaceutical Industry R&D Expenditures, 2013-2016
Table 79: European Validation, Calibration and Standardization in the Life Sciences Market, by Country, Through 2023
Table 80: Pharmaceutical R&D Expenditure in Europe, 2000-2017
Table 81: Validation, Calibration and Standardization in the European Life Sciences Market, by Service Type, Through 2023
Table 82: U.K.: Clinical Trials Applications, 2010-2015
Table 83: U.K.: Pharmaceutical R&D Expenditure, 2014-2015
Table 84: German: Pharmaceutical Industry Growth, 2011-2015
Table 85: Pharmaceutical Industry R&D Expenditure in Selected European Countries, 2016
Table 86: Evolution of the Number of Biotech Companies and R&D, 2013 and 2016
Table 87: Validation, Calibration and Standardization in the Asia-Pacific Life Sciences Market, by Country, Through 2023
Table 88: Number of Drug Trials in Asia-Pacific, 2011-2016
Table 89: Asia-Pacific Validation, Calibration and Standardization in the Life Sciences Market, by Service Type, Through 2023
Table 90: India: Pharmaceutical Market, 2011-2017
Table 91: Japan: Pharmaceutical Industry, 2010-2015
Table 92: Number of Clinical Trials in Australia, 2006-2015
Table 93: Increasing R&D Investments in Pharmaceutical Sector in South Korea, 2016-2017
Table 94: Rest of World Validation, Calibration and Standardization in Life Sciences Market, by Region, Through 2023
Table 95: Laboratory Certification and Accreditation in Latin American Countries
Table 96: Rest of World Validation, Calibration and Standardization in Life Sciences Market, by Service Type, Through 2023
Table 97: Global Suppliers to Devices and Instruments in Validation, Calibration and Standardization in the Life Sciences Market
Table 98: Select Manufacturers of Devices and Instruments in Validation, Calibration and Standardization in the Life Sciences Market
Table 99: Select Distributors of Devices and Instruments in Validation, Calibration and Standardization in the Life Sciences Market
Table 100: Total Number of Studies Across the Globe, by Region, 2016
Table 101: Product Comparison Analysis
Table 102: Agile Lifescience Technologies Pvt Ltd.: Product Portfolio
Table 103: Autocal Solutions Pvt. Ltd.: Product Portfolio
Table 104: Beckman Coulter, Inc.: Product Portfolio
Table 105: BIOVIA: Product Portfolio
Table 106: Calibration Lab: Product Portfolio
Table 107: CBRE: Product Portfolio
Table 108: Data Science International (DSI): Product Portfolio
Table 109: Endress+Hauser: Product Portfolio
Table 110: Essco Calibration Laboratory: Product Portfolio
Table 111: Essco Calibration Laboratory: Recent Developments, January 2015-September 2018
Table 112: Evolution Scientific: Product Portfolio
Table 113: IBM: Product Portfolio
Table 114: Insight Calibration Services: Product Portfolio
Table 115: J.A. King: Product Portfolio
Table 116: Karandikar Laboratories Pvt. Ltd.: Product Portfolio
Table 117: Merck Millipore: Product Portfolio
Table 118: Merck Millipore: Recent Developments, January 2015-September 2018
Table 119: SGS: Product Portfolio
Table 120: Tangent Labs: Product Portfolio
Table 121: Tektronix: Product Portfolio
Table 122: Telstar Life Science Solutions: Product Portfolio
Table 123: Thermo Fisher Scientific: Product Portfolio
Table 124: Transcat, Inc.: Product Portfolio
Table 125: Transcat, Inc.: Recent Developments, January 2015-September 2018
Table 126: Trescal: Product Portfolio
Table 127: Trescal: Recent Developments, January 2015-September 2018
Table 128: Vaisala: Product Portfolio
Table 129: Vaisala: Recent Developments, January 2015-September 2018
Table 130: ValGenesis: Product Portfolio
Table 131: ValGenesis: Recent Developments, January 2015-June 2018
Table 132: Verichek Technical Services, Inc.: Product Portfolio
Table 133: WESTport Corp.: Product Portfolio
List of Figures
Summary Figure A: Validation, Calibration and Standardization in the Global Life Sciences Market, by End User, 2017-2023
Summary Figure B: Validation, Calibration and Standardization in the Global Life Sciences Market, by Region, 2017-2023
Figure 1: Global Life Science Research and Development Spending, 2014-2016
Figure 2: Number of R&D Projects in Drug Development, 2014-2017
Figure 3: Validation, Calibration and Standardization in the Global Life Sciences Market, by Instruments and Consumables, 2017-2023
Figure 4: Validation, Calibration and Standardization in the Global Life Sciences Market, by Service Type, 2017-2023
Figure 5: Overview of GMP
Figure 6: Worldwide Total Pharmaceutical R&D Spending, 2015-2022
Figure 7: PhRMA Member Company R&D Expenditures, 2010 and 2016
Figure 8: Segment Overview for Service Providers
Figure 9: Traceability Process for In-house Calibration
Figure 10: Validation Process
Figure 11: Type of Service
Figure 12: Schematic Diagram of Pressure Gauge Calibration
Figure 13: Block Diagram of Fluid Flow Meter
Figure 14: Types of Pipettes
Figure 15: Thermal Calibration Process Flowchart
Figure 16: Applications of Mechanical Testing
Figure 17: Need for Validation, Calibration and Standardization Services in Pharmaceutical Industry
Figure 18: Global Pharmaceutical Market, 2015 and 2020
Figure 19: Applications of Biochemistry Analyzers
Figure 20: Working of Conductivity Meters
Figure 21: Regulatory Compliance in the Life Sciences
Figure 22: Bradford Method for Protein Quantification
Figure 23: End-User Segmentation: Life Science Market
Figure 24: Calibration Process in a Pharmaceutical Company
Figure 25: Calibration Procedures in Pharmaceutical Plant
Figure 26: Steps of Calibration in Pharmaceutical Industry
Figure 27: Types of Validation in Pharmaceutical Industry
Figure 28: Types of Multi-Laboratory Validation Studies
Figure 29: Multi-Laboratory Validation Studies
Figure 30: Reliable Calibration Process
Figure 31: Validation Framework and Projects
Figure 32: Global Spending on Medicine, 2011-2021
Figure 33: Pharmaceutical R&D Expenditures in the United States, 2000-2015
Figure 34: Canadian Pharmaceutical Industry R&D Expenditures, 2013-2016
Figure 35: Pharmaceutical R&D Expenditure in Europe, 2000-2017
Figure 36: U.K.: Clinical Trials Applications, 2010-2015
Figure 37: U.K.: Pharmaceutical R&D Expenditures, 2014-2015
Figure 38: Germany: Pharmaceutical Industry Growth, 2011-2015
Figure 39: Pharmaceutical Industry R&D Expenditure in Selected European Countries, 2016
Figure 40: Evolution of the Number of Biotech Companies and R&D, 2013 and 2016
Figure 41: Number of Drug Trials in Asia-Pacific, 2011-2016
Figure 42: India: Pharmaceutical Market, 2011-2017
Figure 43: Japan: Pharmaceutical Industry, 2010-2015
Figure 44: Number of Clinical Trial in Australia, 2006-2015
Figure 45: Increasing R&D Investments in Pharmaceutical Sector in South Korea, 2016-2017
Figure 46: Industry Structure of Devices and Instruments in Validation, Calibration and Standardization in the Life Sciences Market
Figure 47: Share of Total Number of Studies Across the Globe, by Region, 2016

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Executive Summary

The growth of the pharmaceutical and biotechnology market is one of the key growth factors of validation, calibration and standardization in the life sciences market. Validation, calibration and standardization products and services find applications in maintaining the accuracy of instruments and devices used in research and other activities in laboratories. Research and development spending for new products and technological development has been rising at a rapid pace over the years. Companies and other organizations are working to enhance the efficacy of drugs and advance drug development. For instance, according to Pharmaprojects (U.K.), a drug development database, the total number of pipeline research projects for drug development across the globe reached 14,872 in 2017, rising from 11,307 in 2014.

Further, the rising adoption of software for calibration management is also driving the utilization of services by pharmaceutical and biotechnology companies and other research organizations that reduce the overall time and cost of validation and calibration processes. Software usage ensures that the calibration performed at multiple places remains the same and on time. This helps companies maintain accuracy and quality and reduce errors. Advanced automated software can process multiple units at the same time, making it cost and time effectively. Moreover, the software helps to keep records for future use and trend analysis.

This report provides analyses based on different market segments such as by service type, service providers, instruments and consumables, and end-users. The service type segment is further divided into electrotechnical, pressure, fluid flow/optical, pipette, thermal, mechanical and others.

Companies Mentioned

  • Agile Lifescience Technologies Pvt. Ltd.
  • Autocal Solutions Pvt. Ltd.
  • Beckman Coulter, Inc.
  • Biovia (Dassault Systems)
  • Calibrationlab Bvba
  • CBRE
  • Data Sciences International (Dsi)
  • Endress+Hauser
  • Essco Calibration Laboratory
  • Evolution Scientific
  • IBM
  • Insight Calibration Services
  • J.A. King
  • Karandikar Laboratories Pvt. Ltd.
  • Merck Millipore
  • SGS
  • Tangent Labs
  • Tektronix
  • Telstar Life Science Solutions
  • Thermo Fisher Scientific
  • Transcat, Inc.
  • Trescal
  • Vaisala
  • Valgenesis
  • Verichek Technical Services, Inc.
  • Westport Corp.