Biologics Development and Manufacturing Testing: Technologies and Global Markets

Abstract
Report Scope:

This report aims to provide a comprehensive study of the global market for biologics safety testing, both in terms of quantitative and qualitative data, to help develop business/growth strategies, assess the market landscape, analyze their position in the current marketplace, and make informed business decisions regarding biologics safety testing products and services. Biologics safety testing includes biosafety testing & characterization of raw materials, cell bank & virus seeds, unprocessed bulks/viral harvests, and drug substance/product.

This report segments the global biologics safety testing market by application, test application, testing technology, and region of operations. BCC Research analyses each market and its applications, regulatory environments, technology, market projections, and market share. Industry growth drivers, restraints, trends, and opportunities in the biological safety testing market are also discussed in detail. The report also provides information on the competitive landscape, elaborate company profiles, and the impact of COVID-19 on the biologics safety testing market.

Report Includes:

- 13 data tables and 16 additional tables
- An up-to-date review and analysis of the global markets for biological safety testing and related technologies
- Analyses of the global market trends, with market revenue data for 2019-2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2027
- Discussion of market dynamics that impact the growth for biologics development and manufacturing testing, clinical applications, safety regulations, industry structure, and penetration of technologies within the biotech industry
- Coverage of the technological, economic, and business considerations of global biological safety testing market, with analyses and growth forecasts through 2027
- Estimation of the actual market size and revenue forecast for global biological safety testing market in USD million values, and corresponding market share analysis based on test type, application, technology, and region
- Identification of the companies best positioned to meet the increasing demand for biological safety testing owing to their proprietary technologies, product launches, mergers and acquisitions, and other strategic advantages
- Review of recent industry structure for biomarkers, R&D activities, and analysis of the competitive landscape based on recent developments and segmental revenues
- Descriptive company profiles of the market leading players, including Catalent, Eurofins Scientific, Lonza, Merck, Thermo Fisher Scientific and WuXi AppTec

Content
Table of Contents

Chapter 1 Introduction
1.1 Study Goals and Objectives
1.2 Reasons for Doing This Study
1.3 Scope of Report
1.4 Methodology and Information Sources
1.5 What’s New in This Update?
1.6 Geographic Breakdown
1.7 Analyst's Credentials
1.8 BCC Custom Research
1.9 Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
3.1 Biologics
3.2 Biologics Safety Testing
3.3 Drug Discovery
3.4 Process Development
3.5 Formulation Development
3.6 Manufacturing
3.7 Process Validation
3.8 Stability and Release
3.9 Growth in Biological Manufacturing
Chapter 4 Market Dynamics
4.1 Market Drivers
4.1.1 Significant Growth in Biologics Market
4.1.2 The Need for Speed to Market
4.1.3 Significant Demand for Cell and Gene Therapy Testing Services
4.1.4 Continuous Growth in Biotechnology Industry
4.1.5 Accelerating Biosimilars and Biobetters Market
4.2 Market Restraints
4.2.1 Lack of Trained Personnel
4.3 Key Trends in Biopharmaceutical Industry
4.4 Key Trends In Vivo Testing
4.5 Key Trends in In Vitro Testing
4.6 Key Trends in Analytical Testing Services
Chapter 5 Impact of the COVID-19 Pandemic
5.1 Overview
5.2 Impact on Biologics Safety Testing Market
Chapter 6 Market Breakdown by Application Type
6.1 Biologics Safety Testing Objectives
6.1.1 Cell Bank and Raw Material Safety Testing
6.1.2 Potency Testing
6.1.3 Contamination and Impurity Testing
6.1.4 Lot Release Testing
6.1.5 Product Stability Testing
6.2 Market Revenue Breakdown by Application Type
Chapter 7 Market Breakdown by Type of Test
7.1 Market Overview
7.2 Characterization Studies
7.3 Biosafety Testing
7.3.1 Pyrogen and Endotoxin Testing
7.3.2 Adventitious Agent Detection Testing
7.3.3 Sterility Testing
7.3.4 Bioburden Testing
7.3.5 Residual Host Contaminant (Host Cell Protein) Detection Testing
7.4 Market Revenue Breakdown by Type of Test
7.4.1 Market Revenue from Characterization Studies
7.4.2 Market Revenue from Biosafety Testing by Type of Test
Chapter 8 Market Breakdown by Technology
8.1 In Vivo Safety Testing
8.1.1 Toxicity–LD50 Test
8.1.2 Rabbit Pyrogen Test
8.1.3 Antibody Production Test
8.1.4 General Adventitious Agent Test
8.1.5 Mutagenicity and Carcinogenicity Testing
8.1.6 Toxicokinetics and ADME
8.2 In Vitro (Cell-Based) Safety Testing
8.2.1 Limulus amoebocyte lysate (LAL) Test
8.2.2 Monocyte Activation Test (MAT)
8.2.3 Recombinant Factor C (rFC)
8.2.4 Cell-Based Assays
8.2.5 Cell-Based Bioassay Technology
8.3 Molecular Methods-Based Safety Testing
8.3.1 Polymerase chain reaction (PCR) and quantitative PCR (qPCR)
8.3.2 High-Performance Liquid Chromatography (HPLC)
8.3.3 Mass Spectrometry
8.3.4 Next-generation sequencing (NGS)
8.4 Market Revenue Breakdown by Technology
Chapter 9 Market Breakdown by Region
9.1 Market Revenue Breakdown by Region
9.1.1 North America
9.1.2 Europe
9.1.3 Asia-Pacific
9.1.4 Rest of the World (RoW)
Chapter 10 Competitive Landscape
10.1 Overview
10.2 Strategic Analysis
10.3 Recent Key Developments
Chapter 11 Company Profiles
AVANCE BIOSCIENCES
BSL BIOSERVICE SCIENTIFIC LABORATORIES MUNICH GMBH
CATALENT INC.
CHARLES RIVER LABORATORIES INTERNATIONAL INC.
CYTOVANCE BIOLOGICS
EUROFINS SCIENTIFIC
INTERTEK GROUP PLC
LABORATORY CORPORATION OF AMERICA HOLDINGS
LONZA
MERCK KGAA
SARTORIUS AG
SGS S.A.
THERMO FISHER SCIENTIFIC INC.
WUXI APPTEC

List of Tables
Summary Table : Global Market for Biologics Safety Testing, by Application Type, Through 2027
Table 1 : Definition of Biologics
Table 2 : Biological Products or Biologics Safety Testing, by Drug Development Phase
Table 3 : Global Market for Protein Drugs, Through 2026
Table 4 : Global Pipeline Molecules, by Type, Through 2021
Table 5 : Biotech Funding (Capital Markets/IPOs/VCs), 2005-09 vs. 2020
Table 6 : Global Healthcare R&D Expenditure Growth, by Pharma Size, 2017-2025E*
Table 7 : Key Trends in In Vivo Based Testing
Table 8 : Key Trends in Cell-Based In Vitro Safety Testing
Table 9 : Key Trends in Analytical Testing Services
Table 10 : Total Number of COVID-19 Confirmed Cases and Deaths, by Region, June 2022
Table 11 : COVID-19 Confirmed Cases and Deaths, by Select Country, Dec. 31, 2021
Table 12 : Overview of GMP, GLP Testing Requirement
Table 13 : Lot Release Testing in Different Steps of Bioproduction Process
Table 14 : Typical GMP Lot Release Testing Program
Table 15 : Global Market for Biologics Safety Testing, by Application Type, Through 2027
Table 16 : Analytical Methods used for Determination of Protein Structure
Table 17 : Comparison of Different Pyrogen and Endotoxin Tests
Table 18 : Types of Biosafety Tests
Table 19 : Global Market for Biologics Safety Testing, by Type of Test, Through 2027
Table 20 : Global Market for Biosafety Testing, by Type of Test, Through 2027
Table 21 : Segmentation of Biological Safety Testing Market, by Technology
Table 22 : Global Market for Biologics Safety Testing, by Technology, Through 2027
Table 23 : Segmentation of the Biological Safety Testing Market, by Region
Table 24 : Global Market for Biologics Safety Testing, by Region, Through 2027
Table 25 : Number of Companies in the Life Sciences and Pharmaceutical Industry, with R&D Expenditure in Europe in 2019, by Country
Table 26 : Gross Domestic Spending on R&D, by Country, Through 2019
Table 27 : Competitive Analysis of Biologic Safety Testing Products and Services Providers, 2021
Table 28 : Recent Key Developments, 2020-2022