生物製剤の開発と製造試験：技術と世界市場

出版：BCC Research（BCCリサーチ）　出版年月：2023年2月

Biologics Development and Manufacturing Testing: Technologies and Global Markets
生物製剤の開発と製造試験：技術と世界市場

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Report Highlights

The global market for biologics safety testing is estimated to increase from $7.4 billion in 2022 to reach $18.2 billion by 2027, at a compound annual growth rate (CAGR) of 19.9% from 2022 through 2027.

Summary:

Biologics are the fastest growing sector of the pharmaceutical industry. This shift towards commercialization of more biological drugs is mostly due to their high specificity, enhanced efficacy, affinity, solubility, and low toxicity. Biological therapeutic drugs or biologics are inherently variable and difficult to control and measure to assure product safety, identity, quality, purity, and strength. Due to their unique nature, biological products present significant challenges for quality control. Biologics safety testing is a major step in the drug discovery, development, and manufacturing process to ensure sterility, purity, stability, and overall quality of biological agents and processes to produce noncontaminated products. Safety testing reduces risks, shortens time to market, and tests the quality, safety, and performance of products against relevant health, safety, and regulatory standards. Health authorities, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH) require biological products (or biologics) to undergo stringent safety testing throughout development and manufacturing to ensure the final product is effective, safe, and free of contaminants.

The growth in biologics sales and pipeline drive the overall need for biologics clinical development and manufacturing services across the whole spectrum from pre-clinical services to commercial manufacturing. Moreover, the biopharmaceutical industry is experiencing a global shift towards new molecular formats and more complex molecules, including bi- and multispecific antibodies, fusion proteins, and various types of bioconjugates. As these therapies gain complexity in their applications and properties, unique challenges related to their bioavailability and handling arise. Simultaneously, the product landscape is changing rapidly and is becoming more challenging from a regulatory perspective with increased pressure for speed to market, alongside accelerated development pathways and timelines. As the biopharmaceutical industry’s drug research and development needs continue to increase, this in turn drives enhanced opportunities for the biologics safety testing market. The continued expansion of pharmaceutical R&D outsourcing market and stringent regulatory requirements will continue supporting growth in the biologics testing market in coming years.

The predicted increases in the use of biologics worldwide, as well as the increasing number of new biologics entering the market are the two main drivers of growth in the biological safety testing market. Moreover,increasing government support for the pharmaceutical and biotechnology industries will further boostthe demand for biologics safety testing. Increasingly, the trend among large biopharmaceuticalcompanies is to outsource the majority of their biologics safety testing needs to smaller, independentlaboratories for final analysis and verification. with increased global demand for biologics and withmultiple developers targeting the same molecules, there is a clear race to be the first to submission forany biologic molecule. This is driving the need for advanced biologics testing to accelerate and shortentheir development and releas e to market timelines.

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

目次

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
List of Figures
Summary Figure : Global Market for Biologics Safety Testing, by Application Type, 2019-2027
Figure 1 : Overview of the Biomanufacturing Process for a Monoclonal Antibody
Figure 2 : Value Chain Model for Biological Safety Testing and Product Lifecycle
Figure 3 : Phases of Biopharmaceutical Drug Production
Figure 4 : Sales Shares of the Global Pharmaceutical Market: Biologics versus Pharmaceuticals, 2012-2026E*
Figure 5 : Biologics Pipeline Candidates, 2016-2021
Figure 6 : Cell and Gene Therapy Pipeline Growth, by Phase, 2005-2021
Figure 7 : Global Market Shares of COVID-19 Vaccines, by Technology, 2021
Figure 8 : Characterization Testing
Figure 9 : Stages of Biopharmaceutical Production
Figure 10 : Value Chain Model for Biologics Safety Testing and Good Practices
Figure 11 : Global Market for Biologics Safety Testing, by Application Type, 2019-2027
Figure 12 : Global Market Shares of Biologics Safety Testing, by Application Type, 2021
Figure 13 : Global Market for Biologics Safety Testing, by Type of Test, 2019-2027
Figure 14 : Global Market Shares of Biologics Safety Testing, by Type of Test, 2021
Figure 15 : Global Market for Biosafety Testing, by Type of Test, 2019-2027
Figure 16 : Global Market Shares of Biosafety Testing, by Type of Test, 2021
Figure 17 : Overview of In Vivo Test Systems Used in Biosafety Testing of Biologicals
Figure 18 : Benefits of Molecular Techniques
Figure 19 : Pathway to a Biosafety Testing Regime for Biologicals Without the Use of In Vivo Assays
Figure 20 : Global Market for Biologics Safety Testing, by Technology, 2019-2027
Figure 21 : Global Market Shares of Biologics Safety Testing, by Technology, 2021
Figure 22 : Global Market for Biologics Safety Testing, by Region, 2019-2027
Figure 23 : Global Market Shares of Biologics Safety Testing, by Region, 2021
Figure 24 : Average Annual Approvals of New Drugs, by the FDA, 1990-2019
Figure 25 : Number of Innovative Molecules for Clinical Trial Applications in China, by Biotech Companies
Figure 26 : Shares of Most Followed Strategies in the Global Biologics Safety Testing Market, 2020-2022
Figure 27 : Catalent: Annual Revenue, 2019-2021
Figure 28 : Catalent: Revenue Share, by Region, 2021
Figure 29 : Charles River Laboratories: Annual Revenue, 2019-2021
Figure 30 : Charles River Laboratories: Revenue Share, by Region, 2021
Figure 31 : Charles River Laboratories’ Business Segments: Annual Revenue, 2019-2021
Figure 32 : Eurofins Scientific: Annual Revenue, 2019-2021
Figure 33 : Eurofins Scientific: Revenue Share, by Operating Segment, 2021
Figure 34 : Intertek: Annual Revenue, 2019-2021
Figure 35 : Labcorp.: Annual Revenue, 2019-2021
Figure 36 : Labcorp: Revenue Share, by Segment, 2021
Figure 37 : Lonza: Annual Revenue, 2019-2021
Figure 38 : Lonza: Revenue Share, by Segment, 2021
Figure 39 : Lonza: Revenue Share, by Region, 2021
Figure 40 : Merck: Annual Revenue, 2019-2021
Figure 41 : Merck: Revenue Share, by Region, 2021
Figure 42 : Sarotorius AG: Annual Revenue, 2019-2021
Figure 43 : Sarotorius AG: Market Shares, by Business Segment, 2021
Figure 44 : Sarotorius AG: Market Shares, by Region, 2021
Figure 45 : SGS SA: Annual Revenue, 2019-2021
Figure 46 : SGS SA: Revenue Share, by Division, 2021
Figure 47 : SGS SA: Revenue Share, by Region, 2021
Figure 48 : Thermo Fisher Scientific: Annual Revenue, 2019-2021
Figure 49 : Thermo Fisher Scientific: Annual Revenue of Laboratory Products and Biopharma Services Segment, 2019-2021
Figure 50 : Thermo Fisher Scientific: Revenue Share, by Region, 2021
Figure 51 : WuXi AppTec: Annual Revenue, 2019-2021
Figure 52 : WuXi AppTec: Revenue Share, by Platforms, 2021
Figure 53 : WuXi AppTec: Revenue Share, by Region, 2021