Large Molecule Bioanalytical Technologies Market Size [2031]

Report Description

Large Molecule Bioanalytical Technologies Market Outlook 2031

The global large molecule bioanalytical technologies market size was USD 6.4 Billion in 2022 and is likely to reach USD 14.3 Billion by 2031, expanding at a CAGR of 13.7% during 2023–2031. The market growth is attributed to the high demand for the bioanalytical testing services. Increasing demand for bioanalytical testing services is expected to boost the large molecule bioanalytical technologies market in the coming years.

Bioanalytical testing is an essential part of the drug development process, especially for large-molecule bioanalytical. Bioanalysis is defined as a quantitative measurement of a therapeutic modality or its metabolites in biological samples that include blood, plasma, serum, urine, and tissue extracts. Bioanalytical studies are an integral part of pharmacokinetic (PK), pharmacodynamic (PD) studies, and the evaluation of drug toxicity.

• In July 2022, Worldwide Clinical Trials Inc. announced the extension of its service offerings to include large molecule capabilities, now integrated seamlessly into its preexisting clinical pharmacology and pharmacokinetics business unit.

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The market report finds that the COVID-19 pandemic fueled the large molecule bioanalytical technologies market. Several research organizations and bio-manufacturers have turned their focus to the development of COVID-19 infection treatments, which increases the demand for bioanalytical testing tools. Increasing demand for vaccine stability testing resulting from extensive R&D activities aimed at developing an effective and safe vaccine, which boosts the market.

Impact of Artificial Intelligence in Large Molecule Bioanalytical Technologies Market

Artificial intelligence (AI) technologies are expected to fuel the large molecule bioanalytical technologies market in the coming years. AI is the game changer in the field of drug discovery, especially in the area of large molecule bioanalytical research. AI is applied to predict the structure of proteins, which is a crucial step in designing safe new therapies.

Machine learning (ML) and predictive algorithms are focusing on large molecules such as antibodies creating a new era in which drug discovery is getting fast and efficient. AI is used in laboratory medicine to enable the effective use of resources, avoid unnecessary tests, improve patient safety, and alert for abnormal results. This, in turn, is likely to boost the AI technologies in the market in the coming years.

Large Molecule Bioanalytical Technologies Market Dynamics

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Major Drivers

The ongoing trend of Quality by Design (QbD) and the increasing acceptance of the healthcare sector is expected to drive the large molecule bioanalytical technologies market. QbD is a systematic approach to designing quality into test methodology which results in the generation of robust methodologies, with understood performance characteristics.

QbD enables to identify of critical stages of production, diving the possibility of their effective control and risk management. The application of QbD in bioanalytic offers a systematic framework to achieve consistently validated, robust assay and life cycle management.

Existing Restraints

Lack of standardization is expected to hamper the market. Biopharmaceutical companies outsource only low-end bioanalytical testing functions and prefer to conduct high-end operations in-house. The limited availability of skilled professionals is anticipated to hinder the market. The development of large molecule bioanalytical technologies requires skilled professionals to handle the complex nature of large molecules.

Emerging Opportunities

Increasing research & development activities in the biopharmaceutical industry is expected to create lucrative opportunities for the market players. During the pandemic, the expansion of manufacturing and R&D activities by key players led to the increase in the demand for bioanalytical testing services. The use of advanced technologies in vaccine and cell gene therapy development has led to significant growth in the market.

Analytical testing is one of the most outsourced activities, as it requires highly specialized personnel and equipment to conduct assays, which is expected to create opportunities in the market.

Scope of Large Molecule Bioanalytical Technologies Market Report

The market report includes an assessment of the market trends, market segments, and regional markets. Overview and dynamics have also been included in the report.

Large Molecule Bioanalytical Technologies Market Segment Insights

Type Segment Analysis

Based on type, the large molecule bioanalytical technologies market is divided into products and services. The products segment is further divided into instruments, consumables & accessories, and reagents & kits. The products segment is expected to expand at a significant pace during the projection period, owing to the increasing adoption of QC labs and rising technological advancements.

The segment growth is further attributed to the incidence of a wide array of instruments for biopharmaceutical applications such as the determination of protein content, identification of impurities, and measuring stability resulting in maximum revenue generation by instruments. Several companies are launching new instruments for the development of biotherapeutics is expected to boost the segment in the market.

The services segment is anticipated to hold a key share of the market in the coming years, due to the increasingly strict regulatory framework for the use of reagents, vectors, and excipients. The segment growth is attributed to drug manufacturers collaborating with several companies that offer analytical testing services.

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Application Segment Analysis

In terms of application, the global market is segregated into biologics, cell & nucleic acid therapy, viral vector, gene therapy, and nanoparticles & polymers. The biologics segment is further divided into type and technology. The type subsegment is fragmented into vaccines, monoclonal antibodies, and recombinant proteins. The technology subsegment is divided into western blot, spectrometer, capillary electrophoresis, isoelectric focusing, and others.

The cell & nucleic acid therapy segment is split into chromatography, ELISA assays, flow cytometry, and others. The viral vector segment is divided into sanger, NGS, dynamic & static light scattering, and others. The gene therapy segment is categorized as luminescent assays, SDS-page or capillary gel electrophoresis, and others. The nanoparticles & polymers segment classified as fluorescence spectrometry, laser diffraction, and others.

The biologics segment is projected to register a considerable CAGR during the forecast period, owing to the increasing demand for monoclonal antibodies and vaccines. The vaccines subsegment has witnessed rapid growth, during the pandemic. Extensive efforts for R&D of a safe and effective vaccine have led to a rapid increase in demand for vaccine stability testing.

Continuous demand for analytical testing services for vaccine quality assurance, as several vaccines for other life-threatening diseases have developed and are in the development phase. This, in turn, is likely to boost the biologics segment in the market.

• In September 2023, Eurofins CDMO Alphora Inc. launched its biological initiative, as a part of its vision to diversify and grow within the contract development and manufacturing industry in North America. The multi-phase initiative aims to establish a facility at the 2070 Hadwen site within the Sheridan Research Park campus in Mississauga, Canada.

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Technology Segment Analysis

On the basis of technology, the large molecule bioanalytical technologies market is segmented into chromatography, electrophoresis, western blot, mass spectrometry, DNA sequencing, and others. The mass spectrometry segment is expected to account for a major share of the market in the coming years, due to the rising penetration of services and products and advanced instruments and tools.

Fluorescence spectroscopy (FS), surface plasmon, circular dichroism (CD), and nuclear magnetic resonance (NMR) spectroscopy are the advanced spectroscopic technologies that are increasingly gaining traction in the structural analysis of proteins. Thus, in turn, is likely to boost the mass spectroscopy segment in the market.

• In April 2023, Waters Corporation launched the next-generation Xevo TQ Absolute IVD mass spectrometer. The powerful analytical performance of the Xevo TQ Absolute IVD mass spectrometer is up to five times more sensitive for qualifying clinical analytes than similar commercial instruments on the market.

The chromatography segment is anticipated to register a robust growth rate during the forecast period, owing to the continuous increase in the pharmaceutical industry. The segment growth is further attributed to the high usage of advanced therapies coupled with large-scale integration of liquid chromatography in downstream processing.

Chromatography is a powerful technique that is used in large-molecule bioanalytical to separate and identify different biomolecules such as peptides and proteins in the sample. High-performance liquid chromatography (HPLC) is one of the most commonly used chromatography technologies in large molecule bioanalysis.

Regional Analysis

In terms of region, the global large molecule bioanalytical technologies market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the projection period, owing to the increasing incidence of large-scale biopharmaceutical manufacturing services coupled with rising biopharmaceutical research & development in the US.

The regional segment growth is further attributed to the increasing incidence of strict government regulatory framework for biologics increases the significance of bioanalytical testing.

The market in Asia Pacific is anticipated to expand at a rapid pace in the coming years, due to the increasing focus on developing biologics and rising investments in R&D activities. Increasing number of clinical trials, which increases the demand for large-scale molecule bioanalytical technologies market. The regional market growth is further attributed to the several contract research organizations are expanding their footprints in China at the forefront.

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