U.S. Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Molecule (Small, Large), By Test (ADME, PD, PK), By Workflow, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The U.S. bioanalytical testing services market size was estimated at USD 1.8 billion in 2023 and is expected to grow at a CAGR of 9.3% from 2024 to 2030. Increased R&D investments and a rising need for biopharmaceutical products are key drivers for the market expansion in the U.S. The demand for specific tests, including electrophoresis, electrochemical & titrimetric assays, and immunoassays, has seen a notable upswing due to the development of combination molecules, biosimilars, and other innovative medicines. Along with this, rapid growth in emerging areas of medicine, such as personalized medicines, orphan drugs, and biosimilars, is expected to propel the bioanalytical testing services market in the country in the coming years.

The U.S. accounted for a revenue share of 41.5% of the global market for bioanalytical testing services in 2023. With the expectation of future outbreaks of infectious diseases growing across the U.S. as well as globally, there is further potential for the strong demand for bioanalytical testing services to address these issues. An important factor contributing to the advancement of this country’s market is the increasing necessity for particular tests in research and development activities, along with the fast-emerging outsourcing trend in the laboratory testing services space. Due to this outsourcing, companies in the economy are boosting their share by providing various types of solutions and services. Pharmaceutical companies are collaborating with other organizations to outsource business activities to improve the cost-efficiency of production and increase their focus on product innovation.

In July 2023, Pfizer Inc. and Flagship Pioneering, Inc. announced a collaboration to forge a portfolio of innovative pharmaceuticals. As per this agreement, Flagship and Pfizer are committing to an initial investment of USD 50 million. The collaboration aims to investigate and cultivate 10 distinct single-asset programs, harnessing the integration of Flagship's extensive ecosystem encompassing over 40 companies dedicated to human health and a range of advanced biotechnology platforms. Bioanalytical testing is crucial in the early stages of drug development to assess pharmacokinetics, pharmacodynamics, and bioavailability. Consequently, such business initiatives are anticipated to boost the market growth.

The FDA plays a crucial role in regulating bioanalytical services, particularly in the context of drug development. Regulations related to pharmaceuticals are governed by the FDA; the Food, Drug, and Cosmetic Act (FD&C Act); the Drug Enforcement Administration (DEA); and the Occupational Safety and Health Administration (OSHA). Bioanalytical services are outsourced to Contract Research Organizations (CROs), and the FDA expects sponsors to provide oversight & ensure that the CROs comply with regulatory requirements. This includes adherence to GLP standards for bioanalytical studies. The country has also witnessed the development of new products and technological advancements in recent years, further encouraging a positive market environment.

Workflow Insights

The sample analysis workflow segment held the leading revenue share of 45.6% in 2023. Within sample analysis, there are different techniques present, including chromatographic technique, hyphenated technique, ligand binding assay, electrophoresis, nuclear magnetic resonance (NMR), and mass spectrometry. Sample analysis helps in determining the concentration of chemical elements or chemical compounds. This workflow aids in properly assessing drug molecule stability, quantitation of impurities, as well as identifying impurities that are present in the sample. Sample analysis can help with Pharmacokinetic (PK) studies, and a noticeable growth in their usage is projected to positively impact market growth during the projection period.

The sample preparation workflow segment is anticipated to advance at the fastest CAGR of 9.7% during the projection period. Being one of the earliest stages of the analytical procedure, selecting a suitable sample preparation technique is vital to obtain accurate and reliable downstream measurements, thus demanding careful consideration. Sample preparation refers to an analytical aspect that consists of extraction procedures that aid in the extraction of the component needed from the matrix. This process differs based on convenience, degree of selectivity, and speed, as well as configurations of the extraction phase.

Test Insights

The bioavailability segment emerged with the largest share of 18.7% in 2023. Besides bioavailability, other notable tests conducted in the industry include ADME, PK (pharmacokinetics), PD (pharmacodynamics), and bioequivalence. Bioavailability refers to the rate and extent to which a drug product’s active drug ingredient or active moiety is absorbed and shows its availability at the location of drug action. Clinical outcomes can be predicted based on relative bioavailability in terms of the drug absorption extent and rate.

In 1984, the Food and Drug Administration (FDA) of the country was given the authority to approve generic drugs as per the Drug Price Competition and Patent Term Restoration Act, based on evidence of average bioequivalence in drug absorption via the conduction of bioavailability and bioequivalence studies. The increasing pace of development of generic drugs in the country has proved to be a major enabler for segment expansion, owing to rising service demand in this space.

Meanwhile, the bioequivalence segment is projected to advance at the fastest CAGR of 9.8% in the coming years. Bioequivalence is a biopharmaceutical parameter that is utilized to conduct the assessment of biological equivalence using in vivo techniques. This parameter assumes a critical nature when drug manufacturers apply generic versions of branded pharmaceuticals. Moreover, two drugs are bioequivalent only if they are equivalent in their rate & extent of systemic availability. In addition, with the emergence of biosimilars, bioequivalence studies are anticipated to gain significant popularity in the coming years.

Molecule Insights

The small molecule segment emerged with a dominant revenue share of 53.4% in 2023 in the U.S. Small-molecule drugs are organic compounds that have a molecular weight less than 900 Da. A majority of small molecules are conventional pharmaceuticals and offer several notable benefits over large molecules. These drugs interact with specific body targets, including receptors, enzymes, or ion channels, and accordingly modify their activity for disease prevention. The small molecule space is witnessing frequent medical breakthroughs, which has helped in driving segment expansion in recent years.

On the other hand, the large molecule segment is projected to advance at the fastest CAGR of 9.9% during the projected timeframe. For large molecules, bioanalytical testing has proven to be a highly challenging activity in the biopharmaceutical industry. As a result, a number of techniques are being utilized, including Ligand Binding Assays, Maldi-TOF-MS, and size exclusion affinity chromatography, among others. Bioanalytical testing in this segment is usually carried out in highly advanced R&D laboratories, and this is followed by a number of other studies in Phase II. On the other hand, studies concerning long-term toxicity are generally outsourced, which is anticipated to remain a major market trend in the coming years.

Key U.S. Bioanalytical Testing Services Company Insights

The fast-advancing market for bioanalytical testing services in the U.S. is defined by the presence of several established companies, along with some notable emerging names that are looking to develop novel solutions and services to drive growth. Pharmaceutical Product Development, Inc. (PPD); Charles River Laboratories International; and Laboratory Corporation of America are some notable organizations that are involved in the bioanalytical testing services industry in the U.S.

• Pharmaceutical Product Development (PPD) is an integral part of Thermo Fisher Scientific, having been acquired by the latter in December 2021. PPD offers services across the entire clinical development space, from scientific discovery to efficacy, safety & healthcare outcome assessment, clinical trial logistics management, and the development & manufacturing of drug products. The company’s clinical development and analytical services segment enable an increase in drug development productivity.

• Charles River Laboratories International provides advanced solutions and services in the areas of clinical support, research, drug discovery, safety & efficacy assessment, and process manufacturing services. The company caters to biotechnology, government, pharmaceutical, and academic organizations based in the U.S. as well as globally. Its therapeutic areas cover cardiovascular, inflammation, musculoskeletal, respiratory, and CNS metabolic diseases, as well as oncology & ophthalmology. The company’s product portfolio includes biomarkers, cellular therapeutics, biosimilars, and vaccines.

Recent Developments

• In February 2024, Thermo Fisher Scientific’s PPD clinical research business unit announced the addition of mycoplasma as well as additional biosafety testing capabilities to the company’s service portfolio at its GMP laboratory located in Middleton, Wisconsin. The newly launched service aims to ensure that biopharmaceutical products are devoid of any contaminants, aiding customers in delivering efficient and safe medicines to patients.

• In February 2024, Celerion announced that it obtained the Clinical Laboratory Improvement Amendments (CLIA) certification for its cutting-edge bioanalytical laboratory in Lincoln, Nebraska. This certification would allow the company’s laboratory to carry out lab-developed tests in specialized segments such as diagnostic immunology.

• In March 2023, Pace Analytical Services, a notable division of the science and technology company Pace, announced the completion of the acquisition of Alpha Analytical LLC, a Massachusetts-based company specializing in environmental lab services.

U.S. Bioanalytical Testing Services Market Report Scope

U.S. Bioanalytical Testing Services Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. bioanalytical testing services market report based on molecule, test, and workflow:

• Molecule Outlook (Revenue, USD Million, 2018 - 2030)

  • Small Molecule

  • Large Molecule

    • LC-MS Studies

    • Immunoassays

    • PK

    • ADA

    • Others

• Test Outlook (Revenue, USD Million, 2018 - 2030)

  • ADME

    • In-Vivo

    • In-Vitro

  • PK

  • PD

  • Bioavailability

  • Bioequivalence

  • Others

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)

  • 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 Workflow Processes