Bioanalytical Testing Services Market Size to Hit US$ 7.69 Billion by 2030

Latest Study on “Bioanalytical Testing Services Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2022-2030”.

The global Bioanalytical Testing Services market size is expected to be worth around US$ 7.69 billion by 2030, according to a new report by Nova one advisor.

The global Bioanalytical Testing Services market size was valued at US$ 3.65 billion in 2021 and is anticipated to grow at a CAGR of 8.7% during forecast period 2022 to 2030.

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The increasing rate of outsourcing R&D activities by several biopharmaceutical companies to streamline their core competencies is one of the major factors supporting the market growth. In addition, the outbreak of COVID-19 has further boosted the demand for pharma-analytical testing services as the rapid surge in SARS-CoV-2 infection cases has significantly augmented the production of a larger batch of COVID-19 vaccines across the globe.

Furthermore, the growing demand for pharmaceutical products across the globe has resulted in a surge of pipeline drugs that require bioanalytical testing for development, thus augmenting the market growth. In addition, the market is expected to witness considerable growth over the forecast period owing to the increasing number of contract manufacturing companies expanding their development capacities across the globe. Hence, the growing volume of batch production of biologics is further supported by such initiatives. The outbreak of COVID-19 infection has further offered lucrative growth opportunities for the market to flourish amidst the pandemic. The outbreak of the COVID-19 virus has resulted in a sudden robust demand for appropriate vaccines, which requires extensive analytical testing.

To meet the rapid demand, major pharmaceutical companies have approached the contract development and manufacturing organizations for fast-track analysis and development of the appropriate drug in the treatment of COVID-19 infection, thus boosting the growth of bioanalytical testing services across the globe, also, major pharmaceutical giants are focusing on expanding bioanalytical testing capabilities to ensure rapid production of COVID-19 vaccines, which, in turn, supported significant growth in revenue generation during 2020.

For instance, in February 2021, Nexelis, a provider of advanced assay development and laboratory testing services, has signed an asset purchase agreement with GlaxoSmithKline (GSK) to acquire GSK’s Good Clinical Laboratory Practices (GCLP)-certified clinical bioanalytical laboratory located in Marburg, Germany, with an aim to enhance its vaccines production capacities. In terms of molecules, the market is classified into small and large molecules. The large molecules segment is further segmented into LC-MS studies, immunoassays, and others based on test type. The small molecule-based bioanalytical testing services are estimated to hold the highest share over the forecast period.

Branded and generic drug compounds are mostly small molecules. In addition, these molecules bind easily with the targets present in intracellular regions. These factors are expected to fuel segment growth. On the other hand, large molecule bioanalytical testing services are expected to grow at the fastest rate during the forecast period. A strong biologic and amino acid-based product pipeline is expected to propel the overall market growth. For instance, major pharmaceutical companies, such as AstraZeneca, reported a total of 17 new molecular entities in their late-stage pipeline, among them majority are large molecule biologics.

Report Scope of the Bioanalytical Testing Services Market

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Key Takeaways:

• By molecule, the U.S. Bioanalytical Testing Services market was valued at USD 1.9 Billion in 2021 and expected to witness growth at a CAGR of 8.9% from 2022 to 2030.
• The small molecule segment accounted for the largest revenue share of over 56% in 2021. The high demand for generic drug development boosts the segment growth
• The bioequivalance segment is estimated to witness the fastest CAGR during the forecast period
• An increasing rate of drug manufacturing outsourcing services is estimated to fuel the growth of this segment
• The sample preparation segment held a significant market share in 2021 and is estimated to expand further at the fastest CAGR from 2022 to 2030
• North America was the largest regional market in2021 due to the strong presence of several pharmaceutical players in the U.S.
• On the other hand, the market in Asia Pacific is projected to register the fastest CAGR from 2022 to 2030

Molecule Insights

On the basis of molecules, the global market has been segmented into small and large molecules. The small molecule segment accounted for the largest revenue share of 56.4% in 2021. Contract Research Organizations (CROs) provide various testing services for small molecules. For instance, Pacific BioLabs offers testing services, such as High-Performance Liquid Chromatography (HPLC) with different detectors, Mass Spectrometry LC-MS, LC-MS/MS, and TOFMS, Ultraviolet-Visible Spectroscopy (UV-Vis). These tests can help sponsors in developing and lot-release testing of small molecule products.

Moreover, generic and branded drug compounds are mostly small molecules. In addition, generic manufacturers have to conduct and submit bioanalytical testing results due to increasing patent expiration. This, in, turn, drives the adoption of bioanalytical testing for small molecules. On the other hand,the large molecule segment is expected to register the fastest CAGR over the analysis period. This is due to a rich pipeline of amino acid-based molecules or biologics. In addition, testing these molecules requires advanced analytical instruments, and infrastructure, which is available with bioanalytical services providers. Hence, outsourcing bioanalytical testing of these molecules is likely to be the prevailing trend over the forecast duration.

Pharmacokinetics (PK) is the branch of pharmacology related to the fate of a drug after administration. The majority of the outsourcing CROs are adopting novel methods for the quantification of PK parameters. For instance, SGS offers the Dry Blood Spot (DBS) technology, which provides plenty of advantages over traditional methods. The absence of post-collection processing, minimal sample requirements, convenient sample storage & shipment, and low biohazard risks are the benefits of the DBS method.Hence, the introduction and adoption of advanced technology pertaining to pharmacokinetics studies are anticipated to boost the segment growth.

Workflow Insights

In terms of workflow, the sample analysis segment dominated the market and accounted for the largest revenue share of more than 45.9% in 2021. Sample analysis plays an important role in the drug development and marketing stages. This workflow helps in the quantitation of impurities, assessing the stability of drug molecules, and identification of impurities present in the sample. Hence, the growing rate of drug development is one of the crucial factors boosting the demand for sample analysis, thus augmenting the segment’s share. Sample preparation is an analytical step that contains extraction procedures to help extract the component required from the matrix.

The process varies based on the degree of selectivity, convenience, speed, and configurations of the extraction phase. Nontraditional extraction technologies are being introduced to address the growing demand for automation, reduction of solvent use, and miniaturization. These technologies result in on-site in situ and in vivo implementation. Proper sample preparation helps in minimizing the matrix risks, assay variability, and thus, provides cleaner samples. Therefore, the integrity of the samples must be aligned from the time of collection to the moment of analysis to avoid challenges and to enhance the bioanalysis.

Test Insights

On the basis of tests, the global market has been segmented into Absorption Distribution Metabolism Excretion (ADME), Pharmacokinetics (PK), Pharmacodynamics (PD), bioavailability, bioequivalence, and other test types. The bioavailability segment accounted for the highest share of more than 18.9% of the global revenue in 2021 owing to the high demand for such services in generic drug development. Furthermore, the growing consumer concern about self-care is boosting the consumption of pharmaceutical products.

Therefore, to tackle the rising demand for pharmaceutical products, end users are promoting in-house tests and expanding testing capabilities in various locations. For instance, in December 2018, SGS, a biopharmaceutical analytical and bioanalytical contract solutions provider, invested USD 3.95 million for expanding its bioanalytical testing capabilities in Poitiers, France, through two projects. Therefore, the growing accessibility to bioanalytical testing through various end users is expected to drive the segment’s growth.

Regional Insights

On the basis of geographies, the market has been segmented into North America, Asia Pacific, Latin America, Europe, and Middle East & Africa. North America dominated the global market in 2021 and accounted for the largest revenue share of more than 46.2%. The regional market is estimated to expand further at a steady CAGR retaining the dominant position throughout the forecast period. This growth can be attributed to an increase in the number of pharmaceutical industries in countries, such as the U.S. and Canada. The strong presence of a number of major market players is another key factor expected to contribute to the growth of the regional market.

Europe is estimated to register the second-fastest CAGR from 2022 to 2030 while Asia Pacific is estimated to be the fastest-growing regional market over the forecast period. This growth is mainly credited to the rising demand for outsourcing services in comparatively immature markets. Outsourcing services in this region are typically supported by delivery centers in countries like China, Manila, and India. China, in particular, is gaining popularity as a delivery location for onshore and nearshore clients that are based out of Japan.

Key Companies & Market Share Insights

Collaborations, service portfolio expansion and mergers and acquisitions are key strategic undertakings by market players. The key companies are also expanding their position in the market by providing various types of services, assay validations, launching new methods for method development, and other laboratory solutions. Moreover, due to the COVID-19 pandemic, several companies are expanding their capability and capacity to provide testing services for new viral threats using advanced and rapid testing platforms. These expansions are estimated to have a positive impact on the market. In addition, in October 2021, SGS announced the expansion of its Glasgow biosafety testing facility.

The investment and expansion project began in March 2021 and was completed in September, adding 550m2 and 16 BSL-2 laboratories to their facility. In June 2021, Eurofins Scientific announced that its subsidiary Eurofins Clinical Testing U.S. Holdings, Inc. has entered into an agreement to acquire DNA Diagnostics Center (“DDC”), a leader in consumer genetic testing. In September 2017, Eurofins Scientific signed an agreement to acquire EAG Laboratories, a leading global scientific services company providing analytical testing and consulting solutions to a diverse and demanding set of end markets, from Odyssey Investment Partners. Some of the key players in the global bioanalytical testing services market are:

• PPD, Inc.
• ICON Plc
• Charles River Laboratories International
• Covance, Inc.
• IQVIA
• Syneos Health
• SGS SA
• Toxikon
• Intertek Group Plc
• Pace Analytical Services LLC

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 2030. For this study, Nova one advisor, Inc. has segmented the global Bioanalytical Testing Services market

• Molecule
  • Small Molecule
  • Large Molecule
    • LC-MS Studies
    • Immunoassays
      • PK
      • ADA
      • Others
    • Others
• Test
  • ADME
    • In-Vivo
    • In-Vitro
  • PK
  • PD
  • Bioavailability
  • Bioequivalence
  • Others
• Workflow
  • Sample Preparation
    • Protein Precipitation
    • Liquid-Liquid Extraction
    • Solid Phase Extraction
  • Sample Analysis
    • Hyphenated technique
    • Chromatographic technique
    • Electrophoresis
    • Ligand Binding Assay
    • Mass Spectrometry
    • Nuclear Magnetic Resonance
  • Other Work flow Processes
• Therapeutic Area
  • Oncology
  • Neurology
  • Metabolic Disorders
  • Hematology
  • Immunology
  • Orthopedics
  • Others
• End-user
  • Pharmaceutical and Biotechnology Companies
  • Contract Development and Manufacturing Organization
  • Contract Research Organization
  • Others

Regional Segmentation

• Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia]
• Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey, Switzerland]
• North America [United States, Canada, Mexico]
• South America [Brazil, Argentina, Columbia, Chile, Peru]
• Middle East & Africa [GCC, North Africa, South Africa]

Objectives of the Study

• To define, describe, and forecast the Bioanalytical Testing Services market based on type, technology, application, end user, and region
• To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
• To strategically analyze micromarkets with respect to individual growth trends, prospects, and contributions to the total market
• To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
• To forecast the size of the market segments with respect to five major regions, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa
• To profile key market players and comprehensively analyze their product portfolios, market shares, and core competencies
• To track and analyze competitive developments, such as product launches, expansions, acquisitions, agreements, and collaborations in the Bioanalytical Testing Services market

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