Accutest Biologics gets global Honour, India’s First Standalone Facility gears up to leverage growing global drug demand 

by Suman Gupta

• ABPL’s quality systems, traceability, zero observation by regulators and GLP certification catapults its credibility and fast track growth 

• Biologics worth USD 100 billion in sales will go off-patent by 2020 making Asia Pacific one-third contributor of bio-similar market 

Mumbai, Aug, 2019:India’s clinical contract research industry, with the current market size of USD 500mn is poised to double over five years and achieve Billion dollar market club. As a leading Indian Contract Research Organisation (CRO) Accutest Biologics Private Limited (ABPL) is all set to leverage the growing global demand for Biologics and Biosimilar drugs. The leading CRO for Biochemical characterization and Bioanalytical services, in support of preclinical and clinical development of Biologics and Biosimilars, ABPL has recently received a global honour with the OECD-Good Laboratory Practice (GLP) certification for the next three years.

National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) had conducted a detailed pre-inspection of the test facility located at Navi Mumbai and this year in May, India’s only standalone test laboratory of ABPL received the GLP certification.

The recent Organisation for Economic Co-operation and Development (OECD)-Good Laboratory Practice (GLP) certification for Bioanalytical services, Biochemical characterization and the In vitro bioassays conducted in its Navi Mumbai facility would act as a powerful catalyst for global pharma companies from the US, Europe, and other emerging markets to get ABPL services.

Dr. Satish Sawant – Founder and CEO, ABPL said, “The Navi Mumbai facility is capable of conducting toxicity studies, mutagenicity studies, analytical and clinical testing. This significant milestone enables us to advance as the global service provider living up to the biopharmaceutical industry expectations and maintaining high-quality deliverables.”

Rising demand for low cost medicines, growth of R&D sourcing, a large number of biologics going off-patent, growing biologics & biosimilar market and removal of regulatory bottlenecks for clinical trials are main growth drivers for the sector. As per industry estimates, biologics worth $100 billion in sales will go off-patent by 2020 and entail huge pipeline for bio-similar drugs. Asia pacific is expected to capture one-third of bio-similar sales in next 5-6 years.

“The certification places ABPL in the select league of CROs that have been awarded such a global honour. It is a matter of pride and privilege for ABPL not only to serve the biopharma industry with established credibility and also to get recognized in all the OECD member countries for mutual acceptance of the data,” said Dr. Mallikarjun Dixit, Test Facility Management at ABPL.

Industry expects the India CRO market to reach around $1 billion by 2023 from $500 Million in 2017, with a CAGR of 12.00%. India is emerging as a top destination for CRO because of the Acceptance of International guidelines and intellectual property rights, Presence of diverse types of climatic conditions thus allowing stability studies to be performed with ease in one destination, Highly experienced, educated and accessible human resource, Presence of diverse ethnic pool thus enabling diverse sample for clinical trials and Low operational cost due to cheap human resource.

The CRO services market is valued at $36 Billion in 2017 and projected to reach to $56 Billion by 2023, at a CAGR of 7.6%.

About Accutest Biologics Private Limited (ABPL):ABPL is a subsidiary of Accutest Research Laboratories Pvt. Ltd., a well-established player in the Clinical CRO Industry for over two decades. It is a state-of-the-art facility offering a one-stop solution for analytical and bioanalytical services from early stage characterization to the late stage clinical evaluation of biologics. Bioanalytical services include Pharmacokinetics, Pharmacodynamics and Immunogenicity assessment of Biologics, bio-therapeutics, biosimilars, vaccines and non-biological complex drugs using high end assay formats ELISA, MSD and GYROS. ABPL also provides in vitroactivity/potency and bioassays services for evaluating the biological activity besides toxicokinetics and related services.

About Accutest Research Laboratories: Accutest Research Laboratories (I) Pvt. Ltd, established in 1998, is one of the leading CROs of India and is a market leader in the BABE segment. It also offers Phase II-IV clinical trials services for drug development companies in India and Internationally. It has state-of-the-art facilities in Navi Mumbai, Ahmedabad and Baroda with more than 400 beds and 38 LCMS-MS

Accutest has a large data bank of 41,000+ volunteers, 700+ validated methods along with strong regulatory track records & numerous accreditations/ approvals from all the major global regulatory agencies like USFDA, EMA, UK-MHRA, WHO, ANVISA (Brazil), MCC (South Africa) and MPRA (Malaysia).