Biologics Testing Market Poised to Hit $12.84 Billion by 2029 with Accelerating Growth Trends

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Biologics Testing Market Size Growth Forecast: What to Expect by 2025?
The domain of biologics testing has experienced substantial acceleration in recent times, projecting an increase from a valuation of $5.92 billion throughout 2024 to $6.83 billion the following year, exhibiting a compound annual growth rate of 15.4%; this preceding period's momentum was fueled by the proliferation of biologic agents under development, the imposition of rigorous compliance mandates, enhanced quality assurance procedures within bioprocessing activities, escalating financial commitments towards biopharmaceuticals, and the scaling up of biomanufacturing infrastructure.

How Will the Biologics Testing Market Size Evolve and Grow by 2029?
Projections indicate substantial expansion within the biologics testing market over the ensuing years, with its value anticipated to reach $12.84 billion by 2029, driven by a compound annual growth rate (CAGR) of 17.1%. This upward trajectory throughout the predicted timeframe is fueled by several factors, such as the introduction of sophisticated therapeutic options, a rising need for outsourced testing capabilities, the broadening scope of biologics development pipelines, the worldwide scope of biopharmaceutical production, and the growing requirement for accelerated testing methodologies. Key developments shaping this market during the forecast include the adoption of cutting-edge analytical instrumentation, the increasing use of cell-based testing procedures, the implementation of next-generation sequencing (NGS), adherence to quality by design (QBD) frameworks, the incorporation of artificial intelligence (AI), and the development of swifter methods for product clearance.

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What Drivers Are Propelling the Growth of Biologics Testing Market Forward?
The continued expansion observed in both the pharmaceutical sector, which concentrates on creating and producing therapeutics for diverse ailments, and the biotechnology sector, dedicated to leveraging technology within biological and healthcare contexts, is anticipated to serve as a major catalyst for the advancement of the biologics testing market. This rigorous testing regime encompasses procedures designed to detect and measure contaminants, evaluate a drug's steadfastness over time, and gauge the body's immunological reaction to the therapeutic agent. Furthermore, the expansion within these fields has spurred innovation in the methods and instruments used for biologics analysis, resulting in the introduction of novel analytical apparatuses and procedures, thereby enabling testing that is both more precise and more efficient, ultimately shortening the duration and lowering the expense involved in introducing novel biologics products to consumers; highlighting this trend, data from Eurostat, the regulatory authority based in Belgium, indicated that pharmaceutical output within the European Union experienced a substantial upswing, climbing from a value of 36 billion euros (equivalent to 39.4 billion US dollars) in 2021 to 44 billion euros (or 46.7 billion US dollars) by 2023, confirming the robust momentum of this industry, which consequently fuels the demand and development trajectory of the biologics testing landscape.

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Which Emerging Trends Are Transforming the Biologics Testing Market in 2025?
A significant driver propelling growth within the biologics testing sector is the increasing focus on Product Innovations, compelling firms in this arena to integrate novel offerings to maintain competitive standing. As an illustration of this movement, in December of 2022, Charles River Laboratories International, Inc., a prominent research organization based in the United States specializing in non-clinical studies, unveiled the Endosafe Nexus 200, thereby augmenting its extensive portfolio of endotoxin detection solutions. This Nexus 200 represents an advancement in Charles River's technological pathway, featuring a fully automated instrument designed to comply with data integrity standards, and it leverages the established Endosafe Limulus Amebocyte Lysate (LAL) cartridge methodology, facilitating the performance of straightforward or intricate serial dilutions across various testing stages, including raw materials, in-process samples, and finished goods. Operated by Endosafe EndoScan-V software, version 6.1, the platform grants users the capacity to transfer requisite data directly to a Laboratory Information Management System (LIMS) console, simultaneously providing superior security, improved traceability, and more organized data handling through its integrated touchscreen interface.

What Are the Key Segments in the Biologics Testing Market?
The biologics testingmarket covered in this report is segmented -

1) By Product: Reagents And Kits; Instruments; Other Products
2) By Test Type: Endotoxin Test; Sterility Test; Mycoplasma Tests; Bioburden Tests; Residual Host-Cell Proteins And DNA Detection Tests; Virus Safety Test; Other Test Types
3) By Application: Vaccine Development And Manufacturing; Monoclonal Antibodies Development And Manufacturing; Cellular And Gene Therapy Products Development And Manufacturing; Blood And Blood Products Development And Manufacturing; Other Applications

Subsegments:
1) By Reagents And Kits: ELISA Kits; PCR Kits; Cell Culture Reagents; Other Assay Kits
2) By Instruments: Spectrophotometers; Chromatography Systems; Microplate Readers; Other Analytical Instruments
3) By Other Products: Software; Consumables; Reference Standards

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Who Are the Key Players Shaping the Biologics Testing Market's Competitive Landscape?
Major companies operating in the biologics testing market include Charles River Laboratories Inc., Thermo Fisher Scientific Inc., Merck KGaA, SGS Société Générale de Surveillance SA, WuXi AppTec Co. Ltd., Sartorius AG, Cytovance Biologics Inc., Pace Analytical Services Inc., Avance Biosciences Inc., Celgene Corporation, Biomerieux SA, Lonza Group Ltd., Genscript Biotech Corp., Bio-Rad Laboratories Inc., Accugen Laboratories Inc., Gibraltar Laboratories Inc., Jordi Labs, Gilead Sciences Inc., Bioquell Limited, Southern Research, Promega Corporation, Lancaster Laboratories Inc., Toxikon Corporation, Eurofins BioPharma Product Testing, Johnson & Johnson Inc., QIAGEN N.V., GlaxoSmithKline plc, Danaher Corporation, Agilent Technologies Inc., PerkinElmer Inc., Abbott Laboratories, Beckman Coulter Inc., Becton dic*kinson and Company, Roche Holding AG, Novartis AG, Eli Lilly and Company, Pfizer Inc.

What Geographic Markets Are Powering Growth in the Biologics Testing Market?
North America was the largest region in the biologics testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global biologics testing market duirng the forecast period. The regions covered in the biologics testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

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