The global bioanalytical testing services market size was valued at USD 1.32 billion in 2021. It is expected to reach USD 4.36 billion by 2030, growing at a CAGR of 14.2% during the forecast period (2022–2030).
The preference for outsourcing analytical testing, growth of R&D activities, and the focus on the analytical testing of biologics and biosimilars are among the key factors driving the market. Pharmaceutical firms benefit from outsourcing research as it reduces the need for labor and installation of costly production units.
In the past few years, biopharmaceutical companies have been significantly outsourcing resources to contract research organizations (CROs)to minimize costs, mitigate hazards, and achieve efficiency. Bioanalytical testing is a key process for the drug development value chain, recognizing associated risks with safety and efficacy both in pre-clinical and clinical stages. Bioanalytical research during drug development and lead optimization stage is performed in-house by pharmaceuticals. In contrast, later stages, such as long-term toxicity and phase II tests are outsourced. This is chiefly because the outsourcing of bioanalytical testing for final phases demands fewer method modifications, thereby lowering the cost of the new process developed by the CRO.
Drug safety and effectiveness tend to be the key bottlenecks for developing safe, cost-effective therapies. Thus, CROs in this space occupies a remarkable position within the framework of drug development. The bioanalytical testing of large molecules has been a significant challenge for the pharmaceutical industry as the old techniques used for classical drugs cannot be adapted to large molecules due to their high molecular weight and complex structure. This has enabled the development of techniques such as Ligand Binding Assays (LBA), Maldi-TOF-MS, size exclusion affinity chromatography, and HRMS.
CROs address the needs of industries by introducing these services through mergers/acquisitions or expansions, which pharmaceutical companies can leverage. For instance, in November 2016, Sartorius Stedim Biotech released a novel bioanalytical testing laboratory in the U.S., which was designed to meet the growing demand for specialized assay platforms for the company's BioOutsource brand in North America and promote the ongoing expansion of the unique service offering. Globally, the demand for outsourcing pharmaceutical analytical research is rising due to competition for disease-specific drugs within the pharmaceutical industry. Today, most regulated bioanalysis is outsourced and has broadened in scope as large molecule drugs have become a significant part of umpteen organizations' drug development pipelines.
Bioanalytical testing is a comparatively new sector, fragmented, and largely composed of niche players. Lengthy drug approval procedures and financial issues result in a lower return on investment, which is increasing companies' preference for outsourcing these services. The primary regulatory guidance for developing and validating analytical methods include the International Conference on Harmonization (ICH) guidance Q2 (R1) Validation of Analytical Procedures: Text and Methodology. In July 2015, the FDA released the latest Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics, which serves as a complement to the ICH Q2 (R1). Other useful guidance documents include ICH Q3A – Q3D Impurities and ICH Q6A – Q6B Specifications.
The FDA expects drug developers to follow the guidelines and provide superior analytical details on drugs and process developments, as demonstrated in the CMC data. Analytical service providers with experience and a track record of regulatory compliance can be of great help to drug developers in terms of formulating CMC documents with sufficient data for regulatory submissions.
The bioanalytical testing services market is projected to gain traction during the forecast period as the market is backed by the presence of diverse drug manufacturers that are actively working to develop reliable, accurate, and robust analytical methods in order to safeguard quality and safety. Apart from this, contract manufacturers offering biologics and biosimilars at affordable prices are projected to observe significant demand as developing sophisticated analytical testing to assess and monitor quality requires a broader set of expertise and equipment, generally beyond the capacity of any pharmaceutical company. To that end, the outsourcing level of analytical tests for biologics is projected to surge considerably over the next five years.
Studies conducted by BioPlan Associates indicate that about 70% of bio manufacturers outsource at least some of their bioprocessing activities. The results from the study imply that the most commonly outsourced activity is analytical testing due to the need for highly specialized personnel and equipment required to perform assays. Hence, the adoption of full-time equivalent agreements (FTE) and increasing outsourcing of analytical testing services to contract pharma companies drive market growth.
Among the segments by test type, the cell-based assays segment held the highest market share in 2019 and is expected to dominate the market during the forecast period. Cell-based assays are primarily used for biological research, such as drug product efficacy and mechanism of action. They are ideal for researching living cells by taking different parameters into account, which include the study of pharmacokinetics and pharmacodynamics. These assays are extensively used by pharmaceutical companies, academic research institutes, biotechnology companies, government institutions, and contract research organizations.
Increasing research activities in drug development, technological advancements, burgeoning demand for biological drugs, and surging government spending drive the cell-based assay segment. The cell viability assay segment, on the other hand, is growing significantly on account of the increasing demand for measuring cellular metabolism and enzyme activity.
The virology testing segment is expected to exhibit the fastest growth during the forecast period. Virology testing caters to the evolving needs of the healthcare sector and comprises cell bank characterization derived from cell lines, including human or rodent origin, detection viruses derived from animal products, and screening of virus vectors/vaccines. Also, few players offer species-specific viral PCR assays, such as standard and qPCR techniques available for RNA and DNA viruses, rapid, sensitive, and specific broad-range PCR assays for adenoviruses, herpesviruses, papillomaviruses, polyomaviruses, and retroviral enzyme activity.
Based on the application, the market is segmented into oncology, infectious diseases, cardiology, neurology, gastroenterology, and others. As of 2019, the oncology segment held the largest market share, and it is projected to grow with a CAGR of 15.7% during the forecast period. The contract development and manufacturing organizations segment, on the other hand, is projected to grow with the fastest CAGR of 15.4%.
North America dominates the bioanalytical testing service market, backed by the presence of top manufacturing centers, high-end pharmaceutical products, and prominent players. Some of the development and launches by these firms are listed below.
The U.S. spearheads the bioanalytical testing service market on account of the increasing patient pool of chronic diseases and the rising adoption of peptides and other large molecule therapeutics. As per the International Diabetes Federation, in 2019, about 48 million adults in North America lived with diabetes, which contributed to the demand for novel (large molecule compounds) peptide therapeutics, such as dipeptidyl peptidase 4 (DPP-4) inhibitors and glucagon-like peptide 1(GLP-1).
List of key bioanalytical testing services market companies
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