In vitro ADME testing services market is likely to be worth USD 2.2 billion by 2030.

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.

Roots Analysis has announced the addition of “In Vitro ADME Testing Services Market, 2019-2030” report to its list of offerings.

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 toxicology testing 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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Key Questions Answered

Who are the leading CROs offering in vitro ADME testing services?
What are the key services being offered by in vitro ADME testing service providers?
What is the trend of mergers and acquisitions in this domain?
How is the current and future market opportunity likely to be distributed across key market segments?
What are the anticipated future trends related to in vitro ADME testing services market?

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
Biologics

Type of Service
Absorption Testing
Distribution Testing
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
Blood Disorders
Cardiovascular Disorders
Gastrointestinal and Digestive Disorders
Hormonal Disorders
Infectious Diseases
Immunological Disorders
Metabolic Disorders
Mental Disorders
Neurological Disorders
Oncological Disorders
Respiratory Disorders
Skin Disorders
Urogenital Disorders
Others

Type of Sponsor
Industry Players
Non-Industry Players

Key Geographical Regions
North America
Europe
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):