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Biological Safety Testing Services Market Size, Share & Trends Analysis Report By Services (Sterility Testing Services, Endotoxin Testing Services), By Application, By End-use, By Region, And Segment Forecasts, 2025 - 2030
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Biological Safety Testing Services Market Growth & Trends:

The global biological safety testing services market size is expected to reach USD 6.33 billion by 2030, growing at a CAGR of 11.78% during the forecast period, according to a new report by Grand View Research, Inc. The market can be attributed to benefits offered to biological safety testing services, such as cost savings, an increased focus on sterility assurance, and the rising development of new pharmaceuticals, therapies, & medical devices. In addition, stringent regulatory requirements, a growing emphasis on patient safety, advancements in biotechnology, and the increasing prevalence of chronic and infectious diseases are some of the factors contributing to the market growth.

The biological safety testing services industry is experiencing rapid growth due to the increasing demand for biologics, cell & gene therapies, and vaccines. Some of the others key trends in the market include the expansion of biological safety testing services by contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), as well as rising investments in biopharmaceutical research and development (R&D).

Moreover, stringent regulatory requirements from the FDA, EMA, and ICH have made biosafety testing essential for ensuring product safety, efficacy, and compliance. This has led to an increasing need for viral clearance, sterility, endotoxin, mycoplasma, and bioburden testing requirements which aims to improve efficiency and ethical compliance. This has led most of the market players to increasingly outsourcing biosafety testing who are seeking cost-effective and specialized expertise with their emerging pipelines for biologic drugs. Furthermore, technological innovations such as automation, next-generation sequencing (NGS), real-time PCR, and AI-driven analytics are enhancing the accuracy, speed, and regulatory compliance of tests. Therefore, biological safety testing services are expected to evolve during the forecast period to meet the complex regulatory and quality control needs of the industry.

The strategic partnerships and accelerating product launches are also driving the market growth. For instance, in Aprill 2024, Merck introduced the Aptegra CHO Genetic Stability Assay, the first all-in-one, validated genetic stability assay. Utilizing whole genome sequencing and bioinformatics, this innovation enhances biosafety testing efficiency, enabling faster transitions to commercial production

Biological Safety Testing Services Market Report Highlights:

Table of Contents

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Market Variables, Trends, & Scope

Chapter 4. Biological Safety Testing Services Market: Service Estimates & Trend Analysis

Chapter 5. Biological Safety Testing Services Market: Application Estimates & Trend Analysis

Chapter 6. Biological Safety Testing Services Market: End Use Estimates & Trend Analysis

Chapter 7. Biological Safety Testing Services Market: Regional Business Analysis

Chapter 8. Competitive Landscape

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