Large Molecule Bioanalytical Technologies Market Size, Share & Trends Analysis Report By Product, By Technology (Chromatography, Electrophoresis), By Application, By Region, And Segment Forecasts, 2021 - 2028

Report Overview

The global large molecule bioanalytical technologies market was valued at USD 5.0 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 13.5% from 2021 to 2028. Along with the ongoing shift in R&D programs for large molecules, there is increasing diversity in the type of therapeutics modality being tested analytically. This ongoing trend toward greater diversity demands a wider set of expertise to assess the quality attributes of the final products, thereby driving the market for large molecule bioanalytical technologies.

Furthermore, the COVID-19 pandemic has created lucrative opportunities for key stakeholders of the market for large molecule bioanalytical technologies. Several CMOs and bio-manufacturers have shifted their business focus to the production of therapeutics against SARS-CoV-2 infection. Thus, demand for bioanalytical testing tools has grown significantly. Several initiatives such as scaling up their production and testing facilities by key players have propelled the revenue generation.

The introduction of Quality by Design (QbD) and its growing acceptance in the field is fueling the necessity for more robust methods of analysis. At the current time, QbD has significantly impacted the work performed in analytical laboratories. The other trend is the identification of measures to expedite the manufacturing process. Improving efficiency in formulation development aspects has alleviated the timelines associated with challenges for analytical processes.

Furthermore, regulatory pressures are playing a vital role in driving a more detailed analysis of final products. These new innovative drugs require thorough biocompatibility, toxicology, and chemical characterization to maintain the efficacy and safety of the products for human consumption. The convergence of biochemical testing with the digital age offers great opportunities as well as poses challenges for analytical testing laboratories.

Deployment of handheld devices for the collection and transmission of analytical data is being studied to advance the market for large molecule bioanalytical technologies. Furthermore, the market is anticipated to be significantly favored with the introduction of real-time analysis of clinical samples and in-process manufacturing samples. The advancements in instrumentation are anticipated to expand the reach of the market for large molecule bioanalytical technologies and would continue to enhance the service offerings of service providers.

Technology Insights

The mass spectrometry segment dominated the market for large molecule bioanalytical technologies and held the largest revenue share of 19.0% in 2020. The increasing penetration of products and services coupled with the introduction of advanced tools and instruments has majorly impacted the revenue generation in this segment. For example, the development of liquid chromatography-mass spectrometry software tools and instruments has enabled in-depth characterization of sequences of antibodies and proteins.

Furthermore, advanced spectroscopic techniques such as Circular Dichroism (CD), fluorescence spectroscopy (FS), Nuclear Magnetic Resonance (NMR) spectroscopy, and surface plasmon resonance are increasingly gaining traction in the structural analysis of proteins. The availability of several products in this segment helps market players capture untapped avenues of the market and boost their market position.

On the other hand, the demand for chromatography tools is continuously growing within the pharmaceutical industry. Increasing usage of advanced therapies coupled with the large-scale integration of liquid chromatography in downstream processing is set to supplement the market growth in the near future.

Application Insights

The biologics segment dominated the market for large molecule bioanalytical technologies and accounted for the largest revenue share of 43.0% in 2020. The major class of modern therapeutics is represented by the biologics segment, and its share is constantly increasing as compared to small molecule drugs. Monoclonal antibodies and vaccines have gained significant traction in the past few years.

Amid the COVID-19 pandemic, the vaccine segment has witnessed rapid growth. Extensive efforts for research and development of a safe and effective vaccine have led to the rapid increase in demand for vaccine stability testing. However, there is a continuous demand for analytical testing services for vaccine quality assurance as several vaccines for other life-threatening diseases have been developed or were in the development phase.

Furthermore, owing to the rising adoption of advanced therapies, the regulatory landscape is constantly evolving, including requirements regarding chemistry, manufacturing, and control (CMC) information. Thus, several companies have shifted their focus on offering a wide range of services for characterization and quality testing of cell and gene therapy-based products, in turn accelerating the segment growth.

Product Insights

The product segment dominated the market for large molecule bioanalytical technologies and accounted for the largest revenue share of 71.0% in 2020. The key contributing factors for the dominance of the segment include new product launches, technological advancements, and growing adoption by QC labs, CROs, and pharmaceutical companies.

The presence of a wide array of instruments for biopharmaceutical applications such as identification of impurities, determination of protein content, and measuring stability has resulted in maximum revenue generation by instruments. In addition, key players operating in the market for large molecule bioanalytical technologies are launching new instruments for supporting the development of biotherapeutics.

The services segment is expected to witness lucrative growth over the forecast period. The primary factor that can be attributed to segment growth is that drug manufacturers are increasingly collaborating with companies that are offering analytical testing services. In addition, the stringent regulatory framework for use of vectors, reagents, and excipients is driving the segment.

Regional Insights

North America dominated the large molecule bioanalytical technologies market and accounted for the largest revenue share of 34.6% in 2020. The presence of large-scale biopharmaceutical manufacturing facilities coupled with the expanding biopharmaceutical R&D in the U.S. has majorly contributed to the dominance of the region. Furthermore, the presence of a stringent regulatory framework for biologics has increased the significance of bioanalytical testing.

The U.S. biopharmaceutical industry is a major contributor to new drugs across the world. It accounts for around 57.0% of all new drugs. Thus, the demand for analytical testing is continuously high in the U.S. leading to significant revenue generation. The Asia Pacific is projected to witness the fastest growth rate throughout the forecast period.

Several CROs are expanding their footprints in Asian countries with China at the forefront. For instance, in October 2020, PPD Inc., a leading global CRO in the U.S., has opened a new laboratory in Suzhou, China. Equipped with a wide range of instruments, this lab offers services for biologics, cell and gene therapies, and small molecules.

Key Companies & Market Share Insights

The market for large molecule bioanalytical technologies has witnessed tremendous growth in the past few years. The increasing number of entities in the cell and gene therapy and biologics arena is anticipated to increase the demand for bioanalytical testing, in turn intensifying the market competition. The market for large molecule bioanalytical technologies is highly fragmented with the presence of substantial market players offering products and services across a wide technology portfolio.

These companies are maintaining their market presence by undertaking several initiatives. For instance, in February 2021, HORIBA launched an innovative and new LabSpec 6 Application, χSTaiN. This new app was developed in collaboration with GreenTropism. The new application is intended to improve the process and analysis of Raman 2D images. Some of the prominent players in the large molecule bioanalytical technologies market include:

• Intertek Group plc.

• Solvias AG

• Bio-Techne Corporation

• Wyatt Technology Corporation

• Precision NanoSystems

• Verder

• Halo Labs

• Charles River Laboratories International, Inc.

• Avomeen

• Merck KGaA

• Cergentis B.V.

• Laboratory Corporation of America Holdings

• SCIEX

• F. Hoffmann-La Roche AG

• Bio-Rad Laboratories, Inc.

Large Molecule Bioanalytical Technologies Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global large molecule bioanalytical technologies market report on the basis of product and service, technology, application, and region:

• Product & Service Outlook (Revenue, USD Million, 2017 - 2028)

  • Products

    • Consumables & Accessories

    • Instruments

    • Reagents & Kits

  • Service

• Technology Outlook (Revenue, USD Million, 2017 - 2028)

  • Electrophoresis

  • Chromatography

  • Mass Spectrometry

  • Western Blot

  • ddPCR, qPCR, RT-PCR

  • ELISA

  • Flow Cytometry

  • Spectrometer

    • UV/VIS

    • CD

    • Raman

    • Laser-induced breakdown spectroscopy

    • Other Spectroscopy techniques

  • Analytical Ultracentrifugation

  • Light scattering (MALS, DLS) & static light scattering

  • DNA Sequencing

  • Other Technologies

• Application Outlook (Revenue, USD Million, 2017 - 2028)

  • Biologics

    • By Type

      • Monoclonal Antibodies (mAbs)

      • Vaccines

      • Recombinant proteins

    • By Technology

      • Spectrometer

      • Western blot

      • Isoelectric focusing

      • Capillary electrophoresis (CE)

      • Peptide mapping and sequencing by LC-MS/MS

      • Peptide fingerprinting by Chromatography and Mass Spectrometry (MS)

      • ddPCR, qPCR, RT-PCR

      • Others

  • Cell & Nucleic Acid Therapy

  • SDS-PAGE or capillary gel electrophoresis

  • Chromatography

  • Mass Spectrometry /LC-MS

  • UV-Vis Spectrometry

  • ddPCR, qPCR, RT-PCR

  • ELISA Assays

  • Fluorescent Assays

  • Luminescent Assays

  • Western blot

  • Flow Cytometry

  • Others

  • Viral Vector

    • Sanger

    • qPCR, ddPCR, & RTPCR

    • ELISA

    • Electrophoresis

    • NGS

    • Mass Spectrometry

    • Chromatography

    • Dynamic & Static Light Scattering

    • Others

  • Gene Therapy

    • SDS-PAGE or capillary gel electrophoresis

    • Chromatography

    • Mass Spectrometry /LC-MS

    • UV-Vis Spectrometry

    • ddPCR, qPCR, RT-PCR

    • ELISA Assays

    • Fluorescent Assays

    • Luminescent Assays

    • Western blot

    • Flow Cytometry

    • Others

  • Nanoparticles & Polymers

    • Dynamic & static light scattering

    • Laser Diffraction

    • Fluorescence spectrometry

    • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • France

    • Italy

    • Spain

    • U.K.

  • Asia Pacific

    • China

    • India

    • Japan

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa