According to the US Food and Drug Administration (USFDA), less than 10% of investigational new drug (IND) candidates progress beyond the submission of a new drug application (NDA); this implies that majority of the drug / therapy candidates fail to reach the market owing to unacceptable safety and efficacy profiles and the problems associated with their pharmacokinetic profiles, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity. ADME testing studies are considered to be critical in establishing the safety and efficacy of drug candidates.
What is the current market landscape of in vitro ADME testing service providers?
Nearly 100 CROs, featuring a mix of small-sized (less than 50 employees, 42%), mid-sized (50-200 employees, 17%), large companies (200-1,000 employees, 15%) and very large companies (more than 1,000 employees, 26%), offer contract services for in vitro ADME studies. Around 65% of the CROs claim to have the necessary expertise to conduct studies for testing absorption, distribution, as well as metabolism and elimination profiles of a lead molecule.
Wat is the trend of acquisitions and mergers in this domain?
In order to maintain a competitive edge in the market, CROs are rapidly expanding their capabilities to offer a wider range of in vitro ADME study services, thereby, consolidating their positions. Over 35 acquisitions have taken place amongst various stakeholders in this domain.
What are the likely growth opportunities of the in vitro ADME testing market?
Driven by the increasing demand for effective pharmacological interventions, the in vitro ADME toxicology testing market is poised to grow at a significant pace (9.8%) in the coming years, with developed regions holding the dominant share. Currently, North America holds the largest share (46%) in the overall in vitro ADME testing services market. This is followed by Europe and Asia-Pacific; these account for 25% and 29% share, respectively.
For more details, you can also download the SAMPLE REPORT on ADME testing by Roots Analysis.