Bioanalytical Testing Services Continue to Gain Traction with Flourishing Clinical Trials Landscape, and Faster Drug Approvals
Bioanalysis that involves quantitative measurement of biological molecules, and xenobiotics plays a critical role in supporting the drug development, and clinical research in pharmaceuticals, vaccines, and biopharmaceuticals industries. Bioanalytical testing services are majorly used in the development, and validation of bioanalytical methods in tissue specimens, and body fluids. These tests serve a supportive role throughout the drug development cycle, i.e., from pre-clinical to post-market studies. Till the early 21st century, a majority of bioanalysis was being performed on small molecule drugs. Adoption of liquid chromatography-mass spectrometry (LC-MS) was the main impactful market event. With the advent of cell and gene therapy, and rich pipelines of novel biological agents in their mid-late stages, there will be the critically growing need for bioanalysis, which indicates thriving growth prospects of the global bioanalytical testing services market. The Food and Drug Administration (FDA) approved 309 new drugs between 2011 and 2018, an average of 38 per year. In 2018, FDA approved 59 new drugs – an all-time high. In the US alone, 18,000+ clinical trials are actively recruiting patients, which again warrants a strong breeding ground for the bioanalytical testing service providers.
Stringent Regulatory Norms Encourage a Trend of Outsourcing Bioanalytical Testing Services
Growing stringency of the global regulatory norms, and complexity around new drug development have been driving the outsourcing trend in the pharmaceutical analytical testing services landscape. Moreover, manufacturers ought to stay abreast with fast-paced regulatory dynamics. For instance, the guidelines set by the International Council for Harmonization (ICH) are frequently updated. The industry is transforming with advent of newly developed techniques, viz. flow cytometry, ligand binding assays, and immunoaffinity assays, which support the development of biologics. Adoption of systems such as high-resolution mass spectrometry, nanoflow LC-MS, and microflow LC-MS systems is increasing with each passing day with an objective to support large molecule development. This is thus encouraging the establishment of new bioanalytical labs, and facilities each year with more overheads, and operational costs. Skilled resources run these lab assays is an industry challenge, whereas employees need holistic support with in-the-lab training programmes, and processes that help them perform efficiently.
Staggering statistics are published in the public domain over productivity of bioanalytical testing contract research organisations (CROs) in North America. North American CROs spend 21,500 hours a year managing their paper-based processes, with 12 dedicated analysts, and a quality assurance (QA) team to review every paper record to find deviations, require days to locate records for regulatory audits. One North American Multinational CRO (just one site) - runs over 400 studies a year processing 300,000-400,000 samples a year. The organisation spends over 214,000 hours a year managing their paper processes, with 124 analysts, and a dedicated QA team, further taking several days, or even weeks to locate records for audits. Canadian CROs run over 300 studies a year. They spend over 120,000 hours managing paper processes. There are losses of over $1 Mn in revenue annually due to retests, and $740,000 a month on account of the productivity loss.
Bioanalytical Testing Services Receive an Impetus with Growing Demand for Novel Biologics, and Preference for QbD Approach
The growth of the bioanalytical testing services market is primarily attributed to the rising focus on the analytical testing of large molecules (biologics, and biosimilars), growing R&D spending in the drug development, thriving trend of outsourced analytical testing, and rising adoption of the Quality by Design (QbD) approach. Newly developed biosimilars, and combination molecules have resulted in an increased demand for electrophoresis, and immunoassays. With pharmaceutical R&D activities picking up pace across geographies, the demand for bioanalytical labs is also witnessing a healthy rise worldwide. While FDA approved 39 speciality drugs in 2018 alone, the highest ever, the current speciality drugs pipeline looks promising, with new entries set to increase speciality drug spending even further. CROs diversified expertise vis-à-vis drug developers with regards to clinical trials across geographies, and speciality drug development are the key factors behind the soaring demand for the CROs bioanalytical testing services. Growing adoption of QbD is likely to provide time- and cost-effective outcomes, which is expected to create lucrative opportunities for market expansion during the forecast period. Key restraints that are expected to hamper bioanalytical testing services market include the dearth of skilled professionals, and high expenses associated with drug discovery.
Small Molecule Leading Segment; Biologics Exhibit Robust Growth
The small molecule segment dominated the market for bioanalytical testing services, accounting for the largest revenue share in 2020. Most of the branded, and generic drug agents are of the small molecule category, whereas multiple blockbuster drugs are on the verge of patent expiry. Bioanalytical testing plays a critical role in proving the efficacy of generic drugs against branded ones, which will continue to sustain the demand throughout the forecast period. On the other and, large molecule bioanalytical testing services are anticipated to exhibit robust growth over the forecast period, attributing to a rich pipeline, and exponential demand growth of biologics. Additionally, testing these molecules requires sophisticated infrastructure with the technical know-hows, and advanced analytical instruments generally available with bioanalytical services providers. The outsourcing of bioanalytical testing services for these molecules is thus likely to be a prevailing trend in the global market in long run.
Oncology Remains a Dominating Segment for Bioanalytical Testing Service Providers
Bioanalytical testing services are widely employed in almost all the therapeutic indication areas, viz. oncology, infectious diseases, cardiology, neurology, and gastroenterology. However, oncology is the most attractive application area in terms of remunerative opportunity for bioanalytical testing services market players. Numerous clinical trials are afoot in the oncology space as the prevalence of cancers is exploding. With constantly rising burden of cancers on the global healthcare system, and both governments, and private institutions increasingly focusing on developing novel cancer therapies, the demand for bioanalytical testing services will continue to be on an upswing. Basis the type of services in demand, adoption of serology, immunogenicity, and neutralising antibodies in drug development procedures has been consistently soaring over the recent past.
Infectious Disease Prevalence Sustains Need for Bioanalytical Testing Services
Rapidly increasing prevalence of infectious diseases has been pushing the need for bioanalytical testing services. As the world grapples with the COVID-19 pandemic, the key issue of addressing rapid drug or vaccine development without compromising on safety has resurfaced on the global health system platforms. The battle against SARS-CoV-2 has entered the next phase characterised by an even greater spreading, and damaging capabilities of the virus. COVID-19 diagnostics has been playing a pivotal role since the beginning of the pandemic and the World Health Organization (WHO) has prioritised COVID-19 testing since the pandemic has been declared. The demand for subsequent bioanalytical testing services will soar in near future.
Global Bioanalytical Testing Services Market: Key Players
Some of the market leaders in the global bioanalytical testing services landscape include Charles River, IQVIA, Inc., Eurofins Scientific, Medpace, WuXi AppTec, SGS SA, Laboratory Corporation of America Holdings, PRA Health Sciences, PPD, Inc., Intertek Group plc., Lotus Labs Pvt. Ltd., Syneos Health, ICON plc., Frontage Labs, Almac Group, PAREXEL International Corporation, Celerion, Altasciences, BioAgilytix Labs, and LGS Limited.
Key Elements Included In The Study: Global Bioanalytical Testing Services Market
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