With increasing cases of drugfailure, due to problems associated with pharmacokinetic profiles of candidatetherapies, absorption, distribution,metabolism and excretion (ADME) properties and inherent toxicity, industry players areactively looking for more advanced solutions.
Accordingto the US Food and Drug Administration (USFDA), less than 10% ofinvestigational new drug (IND) candidates progress beyond the submission of anew drug application (NDA); this implies that majority of the drug / therapycandidates fail to reach the market owing to unacceptable safety and efficacyprofiles and the problems associated with their pharmacokinetic profiles, ADME propertiesand inherent toxicity. ADME studies are considered to be critical inestablishing the safety and efficacy of drug candidates.
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Nearly100 players currently claim to provide in vitro ADME testing services
Nearly60% of these companies are small and mid-sized firms. Further, close to 35% ofthe CROs engaged in this domain, claim to provide services to bothpharmaceutical companies and academic institutes.
Nearly 80% of invitro ADME testing serviceproviders are based in the developed geographies
WithinNorth America, the US has the maximum number of players, whereas, in Europe,most of the service providers are distributed across France, Germany, the UK,and Spain. On the other hand, there are companies that are using this approachfor drug discovery operations, in emerging regions, such as Australia, Indiaand China, as well.
Over 85% companies claim to offer assays for drugmetabolism and elimination testing
Further,nearly 70% companies claim to have capabilities to conduct absorption anddistribution related studies, respectively. It is worth mentioning that about 35%of players presently offer end-to-end drug discovery services.
Nearly95% CROs have received operational approval and certification from the USFDA
Inaddition, companies have received necessary certifications from the EMA (50%), MHLW/ PMDA (15%), ICH (13%), WHO (11%), MHRA (11%), followed by CFDA / MFDS / SFDA (9%)and TGA (4%).
Over 35 acquisitionshave taken place amongst various stakeholders, between 2005-2018
Theaddition of capabilities (primarily related to drug metabolism andpharmacokinetics testing) emerged as the most important value drivers acrossall the acquisitions. Other key value drivers include geographicalconsolidation and geographical expansion.
NorthAmerica and Europe are anticipated to capture over 70% of the market share by2030
WithinNorth America, US is anticipated to hold the 90% of the market share. It isworth mentioning that the market in Asia-Pacific region is anticipated to growat a relatively faster rate (~11%).
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Key Questions Answered
§ Who are the leading CROsoffering in vitro ADME testing services?
§ What are the key servicesbeing offered by in vitro ADME testing service providers?
§ What is the trend ofmergers and acquisitions in this domain?
§ Howis the current and future market opportunity likely to be distributed acrosskey market segments?
§ What are theanticipated future trends related to in vitro ADME testing servicesmarket?
The USD 2.2 billion (by 2030) financial opportunitywithin the vitro ADME testing services market has been analyzed across thefollowing segments:
§ Type of Molecule
§ Small Molecules
§ Type of Service
§ Absorption Testing
§ Distribution Testing
§ Metabolism andElimination Testing
§ Type of Assay
§ Caco-2 PermeabilityAssay
§ PAMPA PermeabilityAssay
§ MDCK PermeabilityAssay
§ Protein Binding Assay
§ Blood Brain BarrierAssay
§ Blood to Plasma Ratio
§ Stability / ClearanceAssay
§ Enzyme InductionAssay
§ Enzyme InhibitionAssay
§ Metabolite Profilingand Screening / Identification Assay
§ Metabolite ProductionAssay
§ Reaction PhenotypingAssay
§ TransporterInteractions Assay
§ Target TherapeuticArea
§ Blood Disorders
§ Gastrointestinal andDigestive Disorders
§ Hormonal Disorders
§ Infectious Diseases
§ Metabolic Disorders
§ Mental Disorders
§ Oncological Disorders
§ Respiratory Disorders
§ Skin Disorders
§ Urogenital Disorders
§ Type of Sponsor
§ Industry Players
§ Non-Industry Players
§ Key GeographicalRegions
§ North America
§ Asia-Pacific and Restof the World
Thereport also features inputs from a number of eminent industry stakeholders. Infact, one of the experts interviewed concurred on the opinion that the drugdevelopers today, prefer to opt for contract service providers that offer arange of capabilities, such as design, synthesis, initial scale-up, in vitro ADME testing, safetypharmacology, under one roof; this guarantees a certain degree of ease ofoperation, and enables sponsors to shortlist and rely on a capable partner fortheir outsourcing requirements.” The report features detailed transcripts of discussionsheld with the following individuals:
§ Dan Close (ChiefScientific Officer, 490 Bio Tech)
Theresearch covers detailed profiles and assesses product portfolios of severalcompanies, including (illustrative list,no selection criteria):
§ Albany MolecularResearch (AMRI)
§ Charles RiverLaboratories
§ PharmaceuticalProduct Development (PPD)
§ RTI International
§ Eurofins Scientific
§ Tecan Group
§ GVK Biosciences
§ Sai Life Sciences
§ Shanghai Medicilon
§ WuXi AppTec
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