United States Bioanalytical Testing Services Market to Grow with a CAGR of 9.41% through 2030
Increasing
focus on biosimilars and biologics testing, and stringent regulatory
requirements for drug approval processes, is expected to
drive the United States Bioanalytical Testing Services Market growth in the
forecast period, 2026-2030
According to
TechSci Research report, “United States Bioanalytical Testing Services
Market – By Region and Competition, Forecast & Opportunities, 2030F”,
the United States Bioanalytical Testing Services Market was valued at USD 2.03 Billion in
2024 and is expected to reach USD 3.49 Billion by 2030 with a CAGR of 9.41%. The United States bioanalytical
testing services market is undergoing significant transformation, supported by
an increasing emphasis on drug safety and efficacy validation during all phases
of clinical research. A surge in drug approvals and growing complexity in
molecular structures have intensified the demand for specialized testing
techniques such as immunogenicity testing, metabolite profiling, and
trace-level quantification. The pharmaceutical industry's focus on minimizing
late-stage failures has made early-phase analytical support critical.
Outsourcing to Contract Research Organizations (CROs) is on the rise, driven by
the need for cost control, specialized expertise, and scalable operations.
These collaborations are also enabling faster timelines for investigational new
drug (IND) submissions and new drug applications (NDAs), accelerating product
development cycles.
Emerging
testing approaches like hybrid LC-MS/MS assays and novel bioanalytical
platforms are reshaping service delivery in the market. These tools offer
higher sensitivity, specificity, and throughput, making them essential in
handling biologics, peptides, and nucleic acid-based therapeutics. The shift
toward decentralized trials and remote patient monitoring is increasing the
relevance of real-time sample analysis and mobile sample collection services.
Industry players are increasingly focusing on method development and validation
tailored for novel delivery systems such as nanoparticles and gene therapies.
The push for flexible, end-to-end testing models and quality control procedures
is a key trend shaping the operational landscape.
As
the regulatory environment becomes more harmonized globally, there is a notable
opportunity for U.S.-based bioanalytical testing service providers to serve as
preferred partners for multinational clinical trials. The growing need for
accelerated development of orphan drugs and rare disease therapies is expected
to drive demand for niche bioanalytical capabilities. Expansion of biopharma
manufacturing in the U.S. offers further room for localized testing
partnerships. Investment in workforce training, AI-driven data management, and
automation technologies presents significant potential to optimize testing
workflows. These opportunities, if capitalized on, can elevate the role of U.S.
providers in the global drug development ecosystem.
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The United
States Bioanalytical Testing Services Market is segmented into molecule, test, workflow,
end user, regional distribution, and company.
Based on the Workflow,
Sample Collection and Preparation emerged as the fastest growing segment in the
United States Bioanalytical Testing Services Market during the forecast period.
This is due to the increasing demand for high-quality, accurate sample
analysis. This phase is critical in ensuring the reliability of bioanalytical
testing results, as it directly impacts the quality and consistency of
subsequent analysis. With the growth of personalized medicine, drug
development, and clinical trials, there is an increasing need for sophisticated
and efficient sample collection and preparation techniques to handle complex
biological samples. Moreover, advancements in technology and automation have
significantly improved the efficiency and accuracy of sample collection and
preparation, making it a key focus area for companies in the bioanalytical
testing services market. Innovations such as integrated systems for sample
handling, automated sample processing, and advanced diagnostic tools have
streamlined workflows, reducing human error and increasing throughput. This
allows laboratories to handle larger volumes of samples, making the process
more cost-effective and faster.
Based
on the Region, West emerged as the fastest growing region in the United
States Bioanalytical Testing Services Market during the forecast period. This is due to a combination of
factors that foster innovation and demand in this area. The region is home to
numerous pharmaceutical and biotechnology companies, as well as cutting-edge
research institutions, which heavily rely on bioanalytical testing services for
drug development and clinical trials. This has resulted in a higher
concentration of demand for bioanalytical testing services in the West, driving
market growth. Additionally, the West boasts a robust healthcare infrastructure
and a significant presence of contract research organizations (CROs) that
support the bioanalytical testing services industry. The region's established
position as a hub for biotechnology, coupled with favorable regulatory
environments and access to funding for research and development, has encouraged
the expansion of bioanalytical testing services. The West's diverse population
also contributes to an increased need for personalized medicine, which further
drives the demand for advanced bioanalytical testing.
Major
companies operating in United States Bioanalytical Testing Services Market are:
- Thermo
Fisher Scientific, Inc.
- ICON
plc
- Charles
River Laboratories International, Inc.
- Laboratory
Corporation of America Holdings
- IQVIA
Inc.
- Syneos
Health
- SGS
SA
- Intertek
Group Plc
- Pace
Analytical Services, LLC
- Medpace
Holdings, Inc.
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“The United States Bioanalytical Testing
Services Market is expanding due to the increasing complexity of drug
development processes, requiring advanced bioanalytical testing services to
ensure accurate results. As pharmaceutical and biopharmaceutical companies
continue to innovate with new drug formulations, the demand for specialized
testing solutions grows. This includes the need for more precise testing
methods to analyze drug interactions, pharmacokinetics, and safety profiles
during the clinical development stages. The rise of personalized medicine and
gene therapies further emphasizes the need for advanced bioanalytical testing
to tailor treatments to individual patients. These factors are driving the
market growth in the forecast period.,” said Mr. Karan Chechi, Research
Director of TechSci Research, a research-based management consulting firm.
“United States
Bioanalytical Testing Services Market By Molecule (Small Molecule, Large
Molecule), By Test (ADME, Pharmacokinetics (PK), Pharmacodynamics (PD),
Bioavailability, Bioequivalence, Biomarker Testing, Cell-based Assay, Virology
Testing, Others), By Workflow (Sample Collection and Preparation, Method
Development and Validation, Sample Analysis, Other Processes), By End User
(Pharma & BioPharma Companies, CDMO, CRO, Others), By Region, Competition, Forecast & Opportunities, 2020-2030F”,
has evaluated the future growth potential of United States Bioanalytical
Testing Services Market and provides statistics & information on market
size, structure and future market growth. The report intends to provide
cutting-edge market intelligence and help decision makers take sound investment
decisions. Besides, the report also identifies and analyzes the emerging trends
along with essential drivers, challenges, and opportunities in United States Bioanalytical
Testing Services Market.
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