Pharma Focus Asia

Large Molecule Bioanalysis- Outsourcing opportunities & Challenges

Sarika Khasnis, Research Analyst, Beroe Inc.

Abstract

The trade group Pharma for large pharmaceuticals has announced that industry has more than 900 biologics under development having different therapeutic area focus. The biologics market is estimated to be approximately $190-200 billion by 2015 with a growth rate of 9.9% from 2010. Increased share of large molecule in Pharma R&D pipeline have increased the demand for more Bioanalytical testing. In this scenario, Pharma companies are increasingly adopting outsourcing (from 26% of Bioanalytical spending in 2011-2012 to 36% in 2012-2013) as a strategy to contain cost, reduce time and access expertise.

Worldwide, nearly 200 biologic medicines have transformed the lives of over 800 million patients with serious illnesses.

“At BioAgilytix, we do not believe in assembly lines as being the most effective way to generate quality data in support of large molecule bioanalysis. We assign a team to each project managed by a BPM (Bioanalytical Porject Manager) that is a veteran scientist. The BPM is the single point of contact between the sponsor and all the activities in the lab. This team will be responsible for all aspects of the project from the assay development, qualification, validation and sample analysis. Since there is no hand off, there is less chnace for mistake and projects are completed on time and on budget.

Business Development Specialist, Large CRO, On bioanalysis services

Introduction

Bioanalytical testing provides a quantitative measure of the active drugs and their metabolites in biological system for the purpose of pharmacokinetics/pharmacodynamics study. It is performed across the value chain of drug development and plays a key role in lead optimization and moving a drug candidate along the development process. The bioanalytical testing during the drug discovery and lead optimization stage is conducted in-house by the pharmaceuticals whereas the later stages such as long-term toxicity and Phase II studies are outsourced. This is mainly because the outsourcing of bioanalytical testing for later stages demands less method modifications thereby reducing the cost of new method development by the CRO.

The growth in small molecule NCEs (New Chemical Entity) has been less than 1% per annum in contrast to that of large molecule NBE (New Biological Entity) which is about 25% from 2000 to 2010. Furthermore the sale of the small molecules is growing at a CAGR of 3.9% and that of large molecules at a CAGR of 10.1% from 2009 to 2015. This growth in the number of molecule development and sales for large molecules indicate that the therapeutics coming into the market over the next 5-10 years would be consisting 30-50% of biologics. Bioanalytical testing of these large molecules has been a challenging task for the pharmaceutical industry as the traditional techniques used for classical drugs are not adaptable to the large molecules having high molecular weight and complex structure. This has led into the advancement of techniques such as Ligand binding assays (LBA), Maldi-TOF-MS, size exclusion affinity chromatography, HRMS etc. that can be used for large molecule bioanalytical testing. The CROs are addressing the industry need by adding these services through mergers/ acquisition or expansion which can be leveraged by the pharmaceuticals.

We have committed significant funds for facility expansion in Shanghai (building of a 5,600 m2 new laboratory in Waigaoqiao Free Trade Zone, was completed in Q4, 2012), In addition, multiple initiatives are underway to enhance current facilities in Beijing to support integrated programs. New, cutting edge capital equipment is being procured for both locations. As a result, we are firmly poised to double our current capacity and size in the next 5 years. Business development, Large CRO, On bioanalysis services.

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