생물학적 안전성 시험 시장 : 제품/서비스, 용도, 시험 유형별 - 세계 예측(2024-2032년)

Biological safety testing market size is set to register 13.6% CAGR during 2024-2032, driven by the rising regulatory scrutiny and stringent safety standards imposed by health authorities worldwide. Regulatory agencies, such as the FDA, EMA, and WHO are mandating the rigorous safety testing of pharmaceutical products, vaccines, and drug products to ensure that it is free from contamination and safe for human use. This emphasis on regulation has led to the strong demand for biosafety testing services and product quality, as manufacturers are seeking to meet these stringent standards.

The expansion of the biopharmaceutical sector due to the growing incidence of chronic diseases and the high demand for generic drugs has created the need for advanced safety testing methods to ensure the efficacy of new therapies. As per the National Institute of Health, around 1 in 3 people suffer from multiple chronic conditions. With the development of new antimicrobial agents, such as monoclonal antibodies, gene therapy and cell-based therapies, there is growing need to develop specialized safety analytical techniques to detect a wide range of contaminants including bacteria, viruses, mycoplasma, and endotoxins.

The biological safety testing industry is segmented into product and services, application, test type and region.

Based on application, the market size from the gene therapy segment is poised to generate substantial revenue by 2032. This is due to the complexity and critical nature of gene therapy, which requires rigorous safety studies to ensure efficacy and safety. As gene therapy involves the use of genes to treat and prevent diseases, strict regulations and careful testing protocols are used to identify any potential contaminants seeds, including viruses, residual host cell DNA, and other contaminants.

Biological safety testing industry from the mycoplasma test type segment is set to grow over the forecast period, backed by the increasing importance of detecting contamination in biopharmaceutical and biotechnology products. Mycoplasmas, which are small, fast-moving organisms without cell walls, can severely affect cell cultures while compromising product quality and safety. Advanced detection methods, such as polymer chain reaction (PCR) and enzyme-linked immunosorbent assays (ELISA) to provide rapid and sensitive detection will also boost the segment growth.

Asia Pacific biological safety testing industry will grow significantly through 2032, attributed to the rapid expansion of the biopharmaceutical sector and the increasing investments in biotechnology R&D activities. In countries, such as China, India and South Korea, strong government support is provided through better funding and regulation to boost the local biotechnology and pharmaceutical sectors. The increasing prevalence of chronic diseases and the subsequent demand for new treatments and vaccines will drive the demand for rigorous biosafety testing to ensure the safety of products, adding to the regional market growth.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360 degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising number of government initiatives and recommendations
    • 3.2.1.2 High R&D investments in clinical research and life sciences research
    • 3.2.1.3 Increasing production of new biologics due to high disease burden
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Time-consuming approval process
• 3.3 Growth potential analysis
• 3.4 Technological landscape
• 3.5 Regulatory landscape
• 3.6 Porter's analysis
• 3.7 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy outlook matrix

Chapter 5 Market Estimates and Forecast, By Product and Services, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Consumables
• 5.3 Instruments
• 5.4 Services
• 5.5 Reagents and kits

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Vaccine and therapeutics
  • 6.2.1 Vaccines
  • 6.2.2 Monoclonal antibodies
  • 6.2.3 Recombinant protein
• 6.3 Blood and blood-based products
• 6.4 Gene therapy
• 6.5 Tissue and tissue-based products
• 6.6 Stem cells

Chapter 7 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Endotoxin tests
• 7.3 Sterility tests
• 7.4 Mycoplasma tests
• 7.5 Bioburden tests
• 7.6 Residual host-cell proteins and DNA detection tests
• 7.7 Virus safety tests
• 7.8 Adventitious agent detection tests
• 7.9 Other test types

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Argentina
  • 8.5.3 Mexico
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 bioMerieux S.A.
• 9.2 Charles River Laboratories International, Inc.
• 9.3 Eurofins Scientific SE
• 9.4 F. Hoffmann-La Roche Ltd
• 9.5 Lonza Group Ltd
• 9.6 Merck KGaA
• 9.7 Samsung Biologics.
• 9.8 Sartorius AG
• 9.9 SGS Societe Generale de Surveillance SA
• 9.10 Thermo Fisher Scientific Inc.