Biopharmaceuticals Manufacturing Consumables Testing Market Analysis Report By Service (Compendial Testing, Laboratory Testing), By Raw Material Type (Excipients, API), And Segment Forecasts, 2018 - 2025

Published: Jul, 2018 | Pages: 139 | Publisher: Grand View Research
Industry: Biotechnology | Report Format: Electronic (PDF)

The global biopharmaceuticals manufacturing consumables testing market size is expected to reach USD 709.92 million by 2025 at a 12.1% CAGR, according to a new report by Grand View Research, Inc. The market is driven by growing need for in-depth assessment of raw materials for successful and rapid launch of the final product. Rising awareness pertaining to internal standards as well as external regulations in the biopharmaceutical industry is also aiding market growth.

In the past few years, there has been a major paradigm shift from small chemical molecules to large biological molecules. As a result, the biopharmaceutical industry is geared toward exploring every aspect involved in the manufacturing process.

Regulatory and quality expectations for best quality raw materials and intermediates continue to increase. This, in turn, has pressurized vendors engaged in manufacturing of excipients and raw materials to invest in standardizing functionality as well as establishing sophisticated processes to consistently address the needs of final product developers.

Further key findings from the report suggest:

• Based on service, compendial and multi-compendial testing held the largest share owing to demand from various manufacturers for raw materials that are compliant to regulatory standards

• Testing services for Active Pharmaceutical Ingredients (APIs) accounted for the largest revenue share owing to presence of a wide range of services in this segment

• Presence of a large number of biologics manufacturing entities in U.S. has resulted in North America dominating the global market in 2017. Rising competitive rivalry amongst market participants is also attributive for the large share of this region

• Asia Pacific is expected to emerge as the fastest growing regional market, fueled primarily by expansion of the contract service industry in several Asian countries. This is partly attributed to low operating costs in these nations

• Key service providers in the market include Eurofins Scientific; Merck KGaA; Charles River; Agilent Technologies; and Catalent, Inc. These service providers are engaged in contract partnerships with major biopharmaceutical manufacturing companies.

 Table of Contents

Chapter 1 Executive Summary
                   1.1 Market Snapshot
Chapter 2 Research Methodology
                   2.1 Information Procurement
                       2.1.1 Purchased Database
                       2.1.2 GVR's Internal Database
                   2.2 Data Analysis
                   2.3 Market Formulation & Validation
                   2.4 Approaches for Market Estimation
                       2.4.1 Approach 1: Commodity Flow & Bottom Up Approach
                       2.4.2 Approach 2: Top Down and Parent Market Analysis
Chapter 3 Market Variables, Trends& Scope
                   3.1 Market Segmentation & Scope
                       3.1.1 Market driver analysis
                           3.1.1.1 Increase in awareness about raw material variability for the production of biologic drugs
                           3.1.1.2 Improvements and innovations in analytical instruments with respect to sensitivity
                           3.1.1.3 Expansion of the contract service industry
                       3.1.2 Market restraint analysis
                           3.1.2.1 Lack of harmonized pharmacopeia standards
                           3.1.2.2 Challenges associated with regulatory standards
                   3.2 Penetration & Growth Prospect Mapping For Service Type, 2017
                   3.3 Swot Analysis, By Factor (Political & Legal, Economic And Technological)
                   3.4 Industry Analysis - Porter's
                   3.5 Inventory Loss Due To Ineffectiveness And Non-Reproducibility
                   3.6 Qualitative Analysis of Novel Tests and Technologies Used for The Testing of Reagents & Consumables During the Production of Biologics
Chapter 4 Global Biopharmaceutical Manufacturing Consumables Testing Market: Service Estimates & Trend Analysis
                   4.1 Global Biopharmaceutical Manufacturing Consumables Testing Market: Service Movement Analysis
                   4.2 Laboratory Testing
                       4.2.1 Global laboratory testing market, 2014 - 2025 (USD Million)
                       4.2.2 Chemical analysis testing
                           4.2.2.1 Global chemical analysis testing market, 2014 - 2025 (USD Million)
                       4.2.3 Enzyme testing
                           4.2.3.1 Global enzyme testing market, 2014 - 2025 (USD Million)
                       4.2.4 Stability testing
                           4.2.4.1 Global stability testing market, 2014 - 2025 (USD Million)
                       4.2.5 Sterility testing
                           4.2.5.1 Global sterility testing market, 2014 - 2025 (USD Million)
                       4.2.6 Other laboratory testing
                           4.2.6.1 Global other laboratory testing market, 2014 - 2025 (USD Million)
                   4.3 Custom Testing/Customer Proprietary Testing
                       4.3.1 Global custom testing/customer proprietary testing market, 2014 - 2025 (USD Million)
                   4.4 Compendial & Multi Compendial Laboratory Testing
                       4.4.1 Global compendial & multi compendial laboratory testing market, 2014 - 2025 (USD Million)
Chapter 5 Global Biopharmaceutical Manufacturing Consumables Testing Market: Raw Material Type Estimates & Trend Analysis
                   5.1 Global Biopharmaceutical Manufacturing Consumables Testing Market: Raw Material Type Movement Analysis
                   5.2 Formulation Excipients
                       5.2.1 Global formulation excipients testing market, 2014 - 2025 (USD Million)
                   5.3 Active Pharmaceutical Ingredients (API)
                       5.3.1 Global API testing market, 2014 - 2025 (USD Million)
                   5.4 Compendial Methods (USP / EP / JP) Based Vendor Qualification Program Support
                       5.4.1 Global compendial methods (USP / EP / JP) based vendor qualification program support market, 2014 - 2025 (USD Million)
Chapter 6 Global Biopharmaceutical Manufacturing Consumables Testing: Regional Estimates & Trend Analysis, by Service & Raw Material Type
                   6.1 Global Biopharmaceutical Manufacturing Consumables Testing Market Share by Region, 2017 & 2025
                   6.2 North America
                       6.2.1 Biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
                       6.2.2 U.S.
                           6.2.2.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.2.2.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                       6.2.3 Canada
                           6.2.3.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.2.3.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                   6.3 Europe
                       6.3.1 Biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
                       6.3.2 Germany
                           6.3.2.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.3.2.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                       6.3.3 U.K.
                           6.3.3.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.3.3.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                   6.4 Asia Pacific
                       6.4.1 Biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
                       6.4.2 China
                           6.4.2.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.4.2.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                       6.4.3 India
                           6.4.3.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.4.3.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                   6.5 Latin America
                       6.5.1 Biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
                       6.5.2 Brazil
                           6.5.2.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.5.2.2 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
                   6.6 MEA
                       6.6.1 Biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
                       6.6.2 South Africa
                           6.6.2.1 Biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
                           6.6.2.1 Biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
Chapter 7 Competitive Landscape
                   7.1 Biopharmaceutical Manufacturing Consumables Testing Market: Heat Map & Market Share Analysis
                       7.1.1 Company revenue
                       7.1.2 Service portfolio
                       7.1.3 Segment coverage
                       7.1.4 Marketing strategies
                   7.2 List of Market Leaders & Emerging Companies
                   7.3 Strategy Framework
                   7.4 Market Participation Categorization
                   7.5 Company Profiles
                       7.5.1 Alcami Corporation
                           7.5.1.1 Company overview
                           7.5.1.2 Financial performance
                           7.5.1.3 Product benchmarking
                           7.5.1.4 Strategic Initiatives
                       7.5.2 Merck KGaA
                           7.5.2.1 Company Overview
                               7.5.2.1.1 Sigma-Aldrich Co. LLC
                           7.5.2.2 Financial performance
                           7.5.2.3 Product benchmarking
                           7.5.2.4 Strategic initiatives
                       7.5.3 Eurofins Scientific
                           7.5.3.1 Company overview
                           7.5.3.2 Financial performance
                           7.5.3.3 Product benchmarking
                           7.5.3.4 Strategic initiatives
                       7.5.4 Agilent Technologies
                           7.5.4.1 Company overview
                           7.5.4.2 Financial performance
                           7.5.4.3 Product benchmarking
                       7.5.5 Charles River
                           7.5.5.1 Company overview
                           7.5.5.1 Financial Performance
                           7.5.5.2 Product benchmarking
                           7.5.5.3 Strategic initiatives
                       7.5.6 Catalent, Inc.
                           7.5.6.1 Company overview
                           7.5.6.2 Financial performance
                           7.5.6.3 Product benchmarking
                           7.5.6.4 Strategic initiatives
                       7.5.7 Avomeen Analytical Services
                           7.5.7.1 Company overview
                           7.5.7.2 Financial performance
                           7.5.7.3 Product benchmarking
                       7.5.8 BioSpectra
                           7.5.8.1 Company overview
                           7.5.8.2 Financial performance
                           7.5.8.3 Product benchmarking
                       7.5.9 Pace Analytical Services, LLC
                           7.5.9.1 Company overview
                           7.5.9.2 Financial performance
                           7.5.9.3 Product benchmarking
                           7.5.9.4 Strategic initiatives
                       7.5.10 Gibraltar Laboratories
                           7.5.10.1 Company overview
                           7.5.10.2 Financial performance
                           7.5.10.3 Product benchmarking
                       7.5.11 Pacific BioLabs
                           7.5.11.1 Company overview
                           7.5.11.2 Financial performance
                           7.5.11.3 Product benchmarking
                       7.5.12 Toxikon, Inc.
                           7.5.12.1 Company overview
                           7.5.12.2 Financial performance
                           7.5.12.3 Product benchmarking
                       7.5.13 Activation Laboratories Ltd.
                           7.5.13.1 Company overview
                           7.5.13.2 Financial performance
                           7.5.13.3 Product benchmarking
                       7.5.14 MabPlex Inc.
                           7.5.14.1 Company overview
                           7.5.14.2 Financial performance
                           7.5.14.3 Product benchmarking
                       7.5.15 SGS SA
                           7.5.15.1 Company overview
                           7.5.15.2 Financial performance
                           7.5.15.3 Product benchmarking
                           7.5.15.4 Strategic initiatives
                       7.5.16 Pharmetric Laboratory
                           7.5.16.1 Company overview
                           7.5.16.2 Financial performance
                           7.5.16.3 Product benchmarking
                       7.5.17 Albany Molecular Research Inc.
                           7.5.17.1 Company overview
                           7.5.17.2 Financial performance
                           7.5.17.3 Product benchmarking
                           7.5.17.4 Strategic initiatives
                       7.5.18 Avance Biosciences
                           7.5.18.1 Company overview
                           7.5.18.2 Financial performance
                           7.5.18.3 Product benchmarking
                       7.5.19 Triclinic Labs
                           7.5.19.1 Company overview
                           7.5.19.2 Financial performance
                           7.5.19.3 Product benchmarking
                           7.5.19.4 Strategic initiatives
                       7.5.20 Lonza
                           7.5.20.1 Company overview
                           7.5.20.2 Financial performance
                           7.5.20.3 Product benchmarking
                       7.5.21 Boston Analytical
                           7.5.21.1 Company overview
                           7.5.21.2 Financial performance
                           7.5.21.3 Product benchmarking
                       7.5.22 STERIS
                           7.5.22.1 Company overview
                           7.5.22.2 Financial performance
                           7.5.22.3 Product benchmarking
                           7.5.22.4 Strategic initiatives

List of Tables

TABLE 1 Risk-based matrix for raw material control during development
TABLE 2 Some commercially available portable and handheld instruments
TABLE 3 Potential economic impact of a bioburden incident in biopharmaceutical manufacturing
TABLE 4 Major differences between sterile and nonsterile drugs/biologics
TABLE 5 Post-sterility testing during biologics manufacturing
TABLE 6 Summary of standard industry timelines for various cell-banking tests
TABLE 7 Excipient testing classification
TABLE 8 North America biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 9 North America biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 10 North America biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 11 U.S. biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 12 U.S. biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 13 U.S. biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 14 Canada biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 15 Canada biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 16 Canada biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 17 Europe biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 18 Europe biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 19 Europe biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 20 Germany biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 21 Germany biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 22 Germany biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 23 U.K. biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 24 U.K. biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 25 U.K. biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 26 Asia Pacific biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 27 Asia Pacific biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 28 Asia Pacific biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 29 China biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 30 China biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 31 China biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 32 India biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 33 India biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 34 India biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 35 Latin America biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 36 Latin America biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 37 Latin America biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 38 Brazil biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 39 Brazil biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 40 Brazil biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 41 MEA biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 42 MEA biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 43 MEA biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)
TABLE 44 South Africa biopharmaceutical manufacturing consumables testing market, by service, 2014 - 2025 (USD Million)
TABLE 45 South Africa biopharmaceutical manufacturing consumables testing market, by laboratory testing service, 2014 - 2025 (USD Million)
TABLE 46 South Africa biopharmaceutical manufacturing consumables testing market, by raw material type, 2014 - 2025 (USD Million)

List of Figures

FIG. 1 Market summary
FIG. 2 Market research process
FIG. 3 Information procurement
FIG. 4 Primary research pattern
FIG. 5 Market research approaches
FIG. 6 Value chain based sizing & forecasting
FIG. 7 QFD modelling for market share assessment
FIG. 8 Market trends & outlook
FIG. 9 Market segmentation & scope
FIG. 10 Market driver relevance analysis (Current & future impact)
FIG. 11 Most common types of raw material variability
FIG. 12 Criteria for raw material testing
FIG. 13 Market restraint relevance analysis (Current & future impact)
FIG. 14 Penetration & growth prospect mapping for service type, 2017
FIG. 15 SWOT Analysis, By Factor (political & legal, economic and technological)
FIG. 16 Porter's Five Forces Analysis
FIG. 17 Global inventory loss due to ineffectiveness and non-reproducibility with respect to biological reagents and reference materials (USD Million)
FIG. 18 Estimates for the economics of reproducibility in biological reagents and reference materials
FIG. 19 Global biopharmaceutical manufacturing consumables testing market: Service outlook key takeaways
FIG. 20 Various source of contamination during biomanufacturing
FIG. 21 Global biopharmaceutical manufacturing consumables testing market: Service market movement analysis
FIG. 22 Global laboratory testing market, 2014 - 2025 (USD Million)
FIG. 23 Global chemical analysis testing market, 2014 - 2025 (USD Million)
FIG. 24 Global enzyme testing market, 2014 - 2025 (USD Million)
FIG. 25 Global stability testing market, 2014 - 2025 (USD Million)
FIG. 26 Global sterility testing market, 2014 - 2025 (USD Million)
FIG. 27 Global other laboratory testing market, 2014 - 2025 (USD Million)
FIG. 28 Global custom testing/customer proprietary testing market, 2014 - 2025 (USD Million)
FIG. 29 Compendial and non-compendial testing landscape
FIG. 30 Global compendial & multi compendial laboratory testing market, 2014 - 2025 (USD Million)
FIG. 31 Global biopharmaceutical manufacturing consumables testing market: Raw material type outlook key takeaways
FIG. 32 Global biopharmaceutical manufacturing consumables testing market: Testing by raw material type market movement analysis
FIG. 33 Global formulation excipients testing market, 2014 - 2025 (USD Million)
FIG. 34 Number of active biopharmaceutical ingredients in the development pipeline in Germany as of 2016, by phase
FIG. 35 Global API testing market, 2014 - 2025 (USD Million)
FIG. 36 Global compendial methods (USP / EP / JP) based vendor qualification program support market, 2014 - 2025 (USD Million)
FIG. 37 Regional market place: Key takeaways
FIG. 38 Global biopharmaceutical manufacturing consumables testing market by region: Regional movement analysis
FIG. 39 North America biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 40 U.S. biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 41 Canada biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 42 Europe biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 43 Germany biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 44 U.K. biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 45 Asia Pacific biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 46 Breakdown of Chinese CRO industry, 2015
FIG. 47 China biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 48 India biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 49 Latin America biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 50 Brazil biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 51 MEA biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 52 South Africa biopharmaceutical manufacturing consumables testing market, 2014 - 2025 (USD Million)
FIG. 53 Company market share analysis
FIG. 54 List of companies
FIG. 55 Strategy framework
FIG. 56 Participant categorization