With increasing cases of drug failure, due to problems associated with pharmacokinetic profiles of candidate therapies, absorption, distribution, metabolism and excretion (ADME) properties and inherent toxicity, industry players are actively looking for more advanced solutions.
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, ADME properties and inherent toxicity. ADME studies are considered to be critical in establishing the safety and efficacy of drug candidates.
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Key Market Insights
Nearly 100 players currently claim to provide in vitro ADME testing services
Nearly 60% of these companies are small and mid-sized firms. Further, close to 35% of the CROs engaged in this domain, claim to provide services to both pharmaceutical companies and academic institutes.
Nearly 80% of in vitro ADME testing service providers are based in the developed geographies
Within North 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 approach for drug discovery operations, in emerging regions, such as Australia, India and China, as well.
Over 85% companies claim to offer assays for drug metabolism and elimination testing
Further, nearly 70% companies claim to have capabilities to conduct absorption and distribution related studies, respectively. It is worth mentioning that about 35% of players presently offer end-to-end drug discovery services.
Nearly 95% CROs have received operational approval and certification from the USFDA
In addition, 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 acquisitions have taken place amongst various stakeholders, between 2005-2018
The addition of capabilities (primarily related to drug metabolism and pharmacokinetics testing) emerged as the most important value drivers across all the acquisitions. Other key value drivers include geographical consolidation and geographical expansion.
North America and Europe are anticipated to capture over 70% of the market share by 2030
Within North America, US is anticipated to hold the 90% of the market share. It is worth mentioning that the market in Asia-Pacific region is anticipated to grow at a relatively faster rate (~11%).
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The USD 2.2 billion (by 2030) financial opportunity within the vitro ADME testing services market has been analyzed across the following segments:
Type of Molecule
- Small Molecules
Type of Service
Metabolism and Elimination Testing
- Type of Assay
- Caco-2 Permeability Assay
- PAMPA Permeability Assay
- MDCK Permeability Assay
- Protein Binding Assay
- Blood Brain Barrier Assay
- Blood to Plasma Ratio
- Stability / Clearance Assay
- Enzyme Induction Assay
- Enzyme Inhibition Assay
- Metabolite Profiling and Screening / Identification Assay
- Metabolite Production Assay
- Reaction Phenotyping Assay
- Transporter Interactions Assay
Target Therapeutic Area
Gastrointestinal and Digestive Disorders
Type of Sponsor
Key Geographical Regions
Asia-Pacific and Rest of the World
The report also features inputs from a number of eminent industry stakeholders. In fact, one of the experts interviewed concurred on the opinion that the drug developers today, prefer to opt for contract service providers that offer a range of capabilities, such as design, synthesis, initial scale-up, in vitro ADME testing, safety pharmacology, under one roof; this guarantees a certain degree of ease of operation, and enables sponsors to shortlist and rely on a capable partner for their outsourcing requirements.” The report features detailed transcripts of discussions held with the following individuals:
- Dan Close (Chief Scientific Officer, 490 Bio Tech)
- Sridhar Iyer (Director and Global Head, Business Development, JRF Global) and Sarang Gorte (Assistant Manager, Business Development, JRF Global)
The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, no selection criteria):
- Albany Molecular Research (AMRI)
- Charles River Laboratories
- Pharmaceutical Product Development (PPD)
- RTI International
- Eurofins Scientific
- Tecan Group
- GVK Biosciences
- Sai Life Sciences
- Shanghai Medicilon
- WuXi AppTec
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