Bioanalytical Testing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Services (Pharmacokinetics, Biomarkers, Immunogenicity, Virology Testing, Cell-based assays, and

Bioanalytical Testing Services Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Services (Pharmacokinetics, Biomarkers, Immunogenicity, Virology Testing, Cell-based assays, and Others); Disease Indication (Cardiovascular, Neurological Disorders, Metabolic Disorders, Autoimmune Disorders, Respiratory Diseases, Oncology, Sexual Health, Bone Disease, and Others); End User [Pharmaceutical and Biopharmaceutical Companies, Contract Research Organization (CRO), Contract Development And Manufacturing Organization (CDMO), and Others], and Geography  (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)

The global bioanalytical testing services market is expected to reach US$ 10,108.82 million in 2030 from US$ 4,641.13 million in 2022. The market is estimated to grow with a CAGR of 10.2% from 2022 to 2030.

The key factors driving the market's growth are increasing outsourcing of R&D activities by pharmaceutical companies and the high demand for analytical testing of biosimilars and biologics. However, challenges in developing and validating bioanalytical methods are hampering the market's growth to a certain extent.

Market Opportunities of Bioanalytical Testing Services Market

The research & development, production, and distribution of medicinal drugs and other pharmaceutical products are the major areas of the pharmaceutical industry. Global pharmaceutical consumption is rising with the increasing need for drugs to treat age-related diseases and chronic diseases. According to the WHO, the elderly population aged 60 or above is projected to double from 2020 to 2050, reaching ~2.1 billion by 2050. A rise in the geriatric population would contribute to a surge in incidences of chronic diseases, such as cardiovascular diseases, cancer, hypertension, osteoarthritis, and diabetes mellitus. Thus, chronic diseases have been a major area of focus for pharmaceutical companies.

New drug development is a resource-, cost-, and time-intensive process, where later clinical stages result in significant costs. As per the United States Congressional Budget Office (CBO), it takes over 10–15 years and costs around US$ 1–2 billion to discover a drug and obtain regulatory approval. Therefore, to lower the attrition rate in drug research & development, pharmaceutical companies are focusing on following the good manufacturing practices (GMP) set by the US FDA and other major regulatory organizations. Several pharmaceutical companies are opting for bioanalytical testing services for drug development and validation of assays in both clinical and preclinical stages. Generics and branded drug compounds are mostly small molecules. Generics manufacturers conduct and submit bioanalytical testing results to overcome the issue of patent expiration. Thus, with the uninterrupted proliferation of the pharmaceutical industry, bioanalytical testing service providers are likely to experience a continuous rise in demand for their services in the future, which would lead to new growth opportunities in the bioanalytical testing services market.

Factors Hampering Bioanalytical Testing Services Market

Developing bioanalytical methods is a complex process that necessitates a dexterous approach by skilled professionals. As a result, several challenges are associated with the development and validation of biological analysis methods. According to Simbec-Orion, a UK-based clinical research organization for complex clinical studies, FDA reviewers have outlined challenges such as analytical issues, flawed extraction techniques, calculation problems, reporting issues, and sample shipping issues related to bioanalytical testing methods. Various analytical issues may arise during the sample preparation and analysis stage; these include deterioration of analytical columns in HPLC; contamination in the mobile phase; issues arising from the complexity of sample matrices in LCMS; and contamination of other stages of LCMS. These hamper the bioanalytical test validation and simultaneously affect the quality standards, thereby limiting the growth of the bioanalytical testing services market.

Bioanalytical Testing Services Market: Segmental Overview

Based on services, the bioanalytical testing services market is segmented into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment held the largest market share in 2022. Furthermore, the same segment is anticipated to register the highest CAGR from 2022 to 2030. Cell-based assays are commonly used to determine the biological activity (potency) of the drug product or drug substance and discover the mechanism of action (MOA), as well as for cytotoxicity testing and early-stage proof-of-principal studies. While in immunogenicity studies, it helps in determining drug neutralization effect of antibodies produced in the patient's body.

Based on disease indication, the bioanalytical testing services market is segmented into cardiovascular, neurological disorders (CNS), metabolic disorders, oncology, sexual health, bone disease, and others. In 2022, the oncology segment held the market's largest share. Also, the same segment is expected to grow in demand at the fastest CAGR from 2022 to 2030, owing to the advances in oncology for pain relief, chemotherapy, and other therapies.

Based on end users, the bioanalytical testing services market is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations (CRO), contract development and manufacturing organization (CDMO), and others. In 2022, the pharmaceutical and biopharmaceutical companies segment held the largest market share. Furthermore, the same segment is expected to witness growth in demand at the fastest CAGR from 2022 to 2030. The bioanalytical test services aim to eliminate the risks involved from the beginning of the pharmaceutical production to the final product release. Thus, the cruciality of bioanalytical testing services in drug discovery and development drives the bioanalytical testing services market for the pharmaceutical and biopharmaceutical companies segment.

Bioanalytical Testing Services Market: Geographical Overview

North America holds the largest share of the global bioanalytical testing services market, whereas the Asia Pacific is the fastest-growing region. The market in North America is expected to grow during the forecast period owing to the uninterrupted growth of the pharmaceuticals industry, the increasing need for developing novel drugs due to an upsurge in the incidences of various diseases, rising healthcare expenditure by governments, and a growing preference for outsourcing activities for the quality assurance of pharmaceutical products. Asia Pacific registered the highest CAGR in the global bioanalytical testing services testing market. The market in the region is expected to grow significantly in countries, including China, India, and Japan, in the coming years. The Asia Pacific market is expected to grow due to the increasing demand for outsourcing services in the low-cost labor markets. Therefore, the region holds huge potential for the bioanalytical testing services market players to grow during the forecast period.

A few of the major primary and secondary sources referred to while preparing the report on the bioanalytical testing services market are the World Bank Data, National Health Service (NHS), FDA (Food and Drug Administration), EMA (European Medicines Agency), and EPA (Environmental Protection Agency).