DUBLIN–(BUSINESS WIRE)–The “Biologics Development and Manufacturing Testing: Technologies and Global Markets” report has been added to ResearchAndMarkets.com’s offering.

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.

Biologics is 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 the 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 drives 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 the pharmaceutical R&D outsourcing market and stringent regulatory requirements will continue supporting growth in the biologics testing market in the 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 boost the demand for biologics safety testing.

Increasingly, the trend among large biopharmaceutical companies is to outsource the majority of their biologics safety testing needs to smaller, independent laboratories for final analysis and verification. with increased global demand for biologics and with multiple developers targeting the same molecules, there is a clear race to be the first to submission for any biologic molecule. This is driving the need for advanced biologics testing to accelerate and shorten their development and release to market timelines.

Report Includes

  • 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

Key Topics Covered:

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 Custom Research

1.9 Related 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

For more information about this report visit https://www.researchandmarkets.com/r/q4zd23

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