Picture

Questions?

+1-866-353-3335

SEARCH
What are you looking for?
Need help finding what you are looking for? Contact Us
Compare

PUBLISHER: BCC Research | PRODUCT CODE: 1221579

Cover Image

PUBLISHER: BCC Research | PRODUCT CODE: 1221579

Biologics Development and Manufacturing Testing: Technologies and Global Markets

PUBLISHED:
PAGES: 123 Pages
DELIVERY TIME: 1-2 business days
SELECT AN OPTION
PDF & Excel (Single User License)
USD 5500
PDF & Excel (2-5 Users)
USD 6600
PDF & Excel (Site License)
USD 7920
PDF & Excel (Enterprise License)
USD 9504

Add to Cart

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.

Market for commercial production and lot release testing is estimated to increase from $3.7 billion in 2022 to reach $9.1 billion by 2027, at a CAGR of 20.0% from 2022 through 2027.

Market for clinical development testing is estimated to increase from $2.4 billion in 2022 to reach $5.9 billion by 2027, at a CAGR of 19.8% from 2022 through 2027.

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
Product Code: BIO155B

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
Product Code: BIO155B

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
Have a question?
Picture

Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

Picture

Christine Sirois

Manager - Americas

+1-860-674-8796

Questions? Please give us a call or visit the contact form.
Hi, how can we help?
Contact us!