Oncology is the fastest-growing segment in bioanalytical testing, driven by regulatory changes and high cancer prevalence, boosting demand for testing services.
The global bioanalytical testing services market is expected to swell in the coming years as clinical trials and drug development pace ahead with the rapid evolution of the pharmaceutical industry. In 2018, the Food and Drug Administration (FDA) approved 59 new drugs. There are about 18,000+ clinical trials recruiting patients in the U.S. alone. These high numbers are suggestive of incredible potential for the global bioanalytical testing services market to grow at a steady pace between the forecast years of 2022 and 2026. A remarkable development in cell and gene therapy along with promising pipelines of biological agents in their mid-late stages will create a need for bioanalysis, giving the global market a significant impetus.
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Regulatory Stringency to Encourage Global Bioanalytical Testing Services Market
The tightening grip of regulatory norms around drug development has led to massive outsourcing of pharmaceutical analytical testing. As the trend continues with continuous changes in the regulatory framework, manufacturers are focused on developing superior equipment. For instance, the International Council for Harmonization (ICH) guidelines are regularly re-evaluated and updated, pushing manufacturers to make continuous improvements. Newer techniques such as ligand binding assays, flow cytometry, and immunoaffinity assays are transforming the biologics landscape.
Nanoflow LC-MS, high-resolution mass spectrometry, and microflow LC-MS systems are being quickly adopted for large molecule development. All of these factors are expected to ensure the establishment of new bioanalytical labs and facilities, creating higher operational costs and overheads. This is eventually expected to fuel the need to outsource bioanalytical testing.
Novel Biologics Steer Uptake of QbD Approach in Bioanalytical Testing Services
The Quality by Design (QbD) approach is expected to receive tremendous attention in the coming years. Devised to provide time- and cost-effective outcomes, which is crucial for tapping into lucrative opportunities are expected to fuel its demand. Growing investments in research and development activities in the pharmaceutical industry have led to mushrooming bioanalytical labs across the globe. Furthermore, the diversified expertise of drug developers leading to constant clinical trials and rapid speciality drug development will also generate a high demand for CROs bioanalytical testing services. This is expected to translate to focus on QbD approach during the forecast period.
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Infectious Diseases and Oncology to Dominate Global Bioanalytical Testing Services Market
Analysts state that oncology will be the fastest-growing application area of the global bioanalytical testing services market. Several clinal trials and exceptionally high prevalence of cancer are expected to boost this segment in the coming years. The growing burden of cancer on the healthcare system has been driving the pharmaceutical industry to develop novel cancer therapies, which will generate significant demand for immunogenicity and serology along with neutralising antibodies in drug development procedures.
Simultaneously, the relentless prevalence of infectious diseases is expected to push the use of bioanalytical testing services in the upward direction. For instance, the outbreak of COVID-19 made bioanalytical testing services inevitable in the development of vaccines.
The key players shaping the competitive landscape of the global bioanalytical testing services market are Medpace, Charles River, Eurofins Scientific, WuXi AppTec, BioAgilytix Labs, SGS SA, IQVIA, Inc., Laboratory Corporation of America Holdings, PPD, Inc., PRA Health Sciences, Intertek Group plc., Lotus Labs Pvt. Ltd., Syneos Health, Frontage Labs, ICON plc., Almac Group, Celerion, PAREXEL International Corporation, Altasciences, and LGS Limited.
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The article discusses the growth of oncology in the bioanalytical testing services market, driven by clinical trials and regulatory changes.
Oncology is the fastest-growing segment due to high cancer prevalence and demand for novel therapies, boosting testing service needs.
Regulatory changes lead to increased outsourcing of bioanalytical testing services as manufacturers strive to meet updated guidelines.
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