Bioanalytical testing services of various types are demanded by pharmaceutical companies in ensuring safety and efficacy of the drug molecules. Past few decades have seen the rise in popularity of bioanalytical method validation in ensuring reliability in the pharmacokinetic (PK) data. The role of the validation programs has been well established in the academia, industry, and regulatory agencies. Contract research organizations have been increasingly leaning on bioanalytical testing services for small and large molecules. Broadly, major service types can comprise cell-based assays, virology testing, method development, and optimization. Key techniques adopted by service providers are tandem mass spectrometry and nuclear magnetic resonance spectroscopy.
The study on the bioanalytical testing services market presents a critical assessment of the regulatory frameworks shaping the avenues for investments by pharmaceuticals in the market. Major trends in regulatory expectations in developed markets are scrutinized and the insights the report offers are backed by industry facts Technological advances and emerging dynamic of the life sciences industries that are expected to have long-ranging impacts on the market are analyzed. The researchers also strives to present analytics-drive assessment of current and emerging opportunities in various key service segments and the potential revenues streams in some of the developing and developed regions of the world.
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Bioanalytical Testing Services Market: Key Trends
The growing pharmaceutical industry investment on outsourcing analytical testing is a key trend in the bioanalytical testing services market. A large proportion of the investments have been witnessed in the services that pertain to serology, immunogenicity, and neutralizing antibodies. The growing role of bioanalytical testing with good accuracy and precision, specificity and sensitivity in drug development programs has also shaped the contours of the market. Oncology is emerging as a markedly lucrative segment in the bioanalytical testing services market. Increasing focus of CROs on bioanalytical testing services for biosimilars and biologics has also spurred the demand. Advances in clinical pharmacology has helped boost the pace of new drug development. Hence, pre-clinical stages witness a growing demand for bioanalytical testing services. Rise in research and development of novel drug ingredients that are more disease centric has also boosted the demand in the bioanalytical testing services market.
However, there exist significant challenges in the use of bioanalysis techniques for macromolecules and small molecules. These are attracting pharma companies in bioanalytical testing services market who have been consolidating their biologic drugs pipelines. The concerns have spurred CROs and service providers to look for better methods, characteristically that are based on Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
Bioanalytical Testing Services Market: Competitive Dynamics and Key Developments
Technological advances in the platforms used for quantification of macromolecules are key to understanding of PK/PD relationship in clinical stages of drug development in bioanalytical testing services market. The adoption of automation technologies have enabled service providers obtain exposure-response data or relationships on several pharmacodynamics (PD) endpoints. Such developments have also set the tone for unveiling innovative services in the bioanalytical testing services market.
Some of the key players in the bioanalytical testing services market are;
- Pace Analytical Services, LLC
- Intertek group, Toxikon, Inc.
- SGS SA
- Syneos Health
- ICON plc, Covance Inc.
- PRA Health Sciences
Bioanalytical Testing Services Market: Regional Assessment
On the regional front, Asia Pacific has been emerging as the hotbed of opportunities for pharmaceutical companies. They are sourcing bioanalytical validation services in drug making by getting into deals and collaborations with the CROs in the region. The growing presence of CROs in Asia is one of the key stimulant for the rise in demand for various bioanalytical testing services. Rise in R&D in oncology drugs in North America has made the regional market an attractive one in the global bioanalytical testing services market.
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