The global market for bioanalytical testing services is projected to grow significantly, reaching approximately US$ 10,108.82 million by 2030, up from US$ 4,641.13 million in 2022. This growth represents a compound annual growth rate (CAGR) of 10.2% from 2022 to 2030.
Several factors are propelling this market expansion, including the increasing trend of pharmaceutical companies outsourcing their research and development (R&D) activities, alongside a rising demand for analytical testing of biosimilars and biologics. Nevertheless, the market faces challenges, particularly in the development and validation of bioanalytical methods, which can hinder growth.
Opportunities in the Bioanalytical Testing Services Market
The pharmaceutical industry encompasses critical areas such as research and development, production, and distribution of medicinal products. With a growing global consumption of pharmaceuticals, there is an escalating need for medications to address age-related and chronic diseases. The World Health Organization (WHO) estimates that the global population aged 60 and older will double from 2020 to 2050, reaching around 2.1 billion. This demographic shift is expected to lead to an increase in chronic diseases, including cardiovascular conditions, cancer, hypertension, osteoarthritis, and diabetes. Consequently, chronic diseases have become a focal point for pharmaceutical companies.
Developing new drugs is a complex, costly, and time-consuming endeavor, often taking 10 to 15 years and costing between US$ 1 billion and US$ 2 billion to achieve regulatory approval, according to the United States Congressional Budget Office (CBO). To mitigate the high attrition rates in drug R&D, pharmaceutical firms are increasingly adhering to good manufacturing practices (GMP) as outlined by the US FDA and other regulatory bodies. Many companies are turning to bioanalytical testing services for drug development and assay validation during both clinical and preclinical phases. Generic drug manufacturers, in particular, rely on bioanalytical testing to navigate patent expirations. As the pharmaceutical sector continues to expand, the demand for bioanalytical testing services is expected to rise, creating new opportunities within the bioanalytical testing services market.
Challenges Facing the Bioanalytical Testing Services Market
The process of developing bioanalytical methods is intricate and requires skilled professionals. This complexity introduces various challenges in the development and validation of biological analysis methods. According to Simbec-Orion, a UK-based clinical research organization, FDA reviewers have identified several issues, including analytical challenges, flawed extraction techniques, calculation errors, reporting discrepancies, and sample shipping complications related to bioanalytical testing. Analytical problems can arise during sample preparation and analysis, such as the degradation of analytical columns in high-performance liquid chromatography (HPLC), contamination in the mobile phase, and issues stemming from the complexity of sample matrices in liquid chromatography-mass spectrometry (LCMS). These challenges can impede the validation of bioanalytical tests and compromise quality standards, thereby restricting the growth of the bioanalytical testing services market.
Segment Analysis of the Bioanalytical Testing Services Market
The bioanalytical testing services market is categorized by services into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment dominated the market in 2022 and is projected to exhibit the highest CAGR from 2022 to 2030. These assays are essential for assessing the biological activity (potency) of drug products, understanding mechanisms of action (MOA), and conducting cytotoxicity tests and early-stage proof-of-principal studies. In immunogenicity studies, they help evaluate the neutralization effects of antibodies produced in patients.
When segmented by disease indication, the market includes cardiovascular diseases, neurological disorders (CNS), metabolic disorders, oncology, sexual health, bone diseases, and others. The oncology segment held the largest market share in 2022 and is anticipated to grow at the fastest rate through 2030, driven by advancements in cancer therapies, including pain management and chemotherapy.
In terms of end users, the market is divided into pharmaceutical and biopharmaceutical companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and others. The pharmaceutical and biopharmaceutical companies segment was the largest in 2022 and is expected to see the fastest growth rate from 2022 to 2030. Bioanalytical testing services are crucial for minimizing risks throughout the pharmaceutical production process, from initial development to final product release, thus driving demand in this segment.
Geographical Insights into the Bioanalytical Testing Services Market
North America currently holds the largest share of the global bioanalytical testing services market, while the Asia Pacific region is recognized as the fastest-growing area. The North American market is projected to expand due to the continuous growth of the pharmaceutical industry, an increasing need for novel drug development in response to rising disease incidences, heightened healthcare spending by governments, and a growing trend towards outsourcing for quality assurance in pharmaceutical products. The Asia Pacific region is expected to experience significant growth, particularly in countries like China, India, and Japan, driven by the demand for outsourcing services in cost-effective labor markets. This region presents substantial opportunities for bioanalytical testing service providers in the coming years.
Key sources referenced in the preparation of this report on the bioanalytical testing services market include data from the World Bank, the National Health Service (NHS), the FDA (Food and Drug Administration), the EMA (European Medicines Agency), and the EPA (Environmental Protection Agency).