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.
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.
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.
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.
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.
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.
Report Attribute |
Details |
Market size value in 2021 |
USD 6.3 billion |
Revenue forecast in 2028 |
USD 13.9 billion |
Growth Rate |
CAGR of 13.5% from 2021 to 2028 |
Base year for estimation |
2020 |
Historical data |
2017 - 2019 |
Forecast period |
2021 - 2028 |
Quantitative units |
Revenue in USD Million and CAGR from 2021 to 2028 |
Report coverage |
Revenue forecast, company share, competitive landscape, growth factors, and trends |
Segment coverage |
Product & service, technology, application, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
Country scope |
U.S.; Canada; Germany; France; Italy; Spain; U.K.; China; Japan; India; South Korea; Brazil; Mexico; South Africa; Saudi Arabia |
Companies profiled |
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. |
Customization scope |
If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of the customization |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
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
b. The mass spectrometry segment dominated the global large molecule bioanalytical technologies market and held the largest revenue share of 19.0% in 2020.
b. The biologics segment dominated the global large molecule bioanalytical technologies market and accounted for the largest revenue share of 43.0% in 2020.
b. The product segment dominated the global large molecule bioanalytical technologies market and accounted for the largest revenue share of 71.0% in 2020.
b. The global large molecule bioanalytical technologies market was valued at USD 5.05 billion in 2020 and is expected to reach USD 6.30 billion by 2021.
b. The global large molecule bioanalytical technologies market is projected to grow at a CAGR of 13.5% and is expected to reach USD 13.92 billion by 2028.
b. North America dominated the large molecule bioanalytical technologies market with a share of 34.62% in 2020. This can be attributed to the presence of strong research as well as the commercial base for biopharmaceutical manufacturing.
b. Some key technology suppliers operating in the large molecule bioanalytical technologies market include Agilent Technologies; PerkinElmer, Inc.; Bruker; Thermo Fisher Scientific, Inc.; and Shimadzu Corporation.
b. Key factors driving the market growth include technological advancements in life science tools & analytical instruments, the rising collaboration between operating stakeholders & rising advancements, automation & expansion in laboratory facilities.
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