At a Crossroads, Pharma Clients Seek Flexibility, Efficiency in CRO Market

At a Crossroads, Pharma Clients Seek Flexibility, Efficiency in CRO Market

Kalorama Information also offers the reportProteomics Research Markets: Instruments (Mass Spectrometry, Liquid Chromatography, Electrophoresis), Disease Areas (Oncology, Cardio/Blood, Neurology, Other) Market Share and Trendsfor market insights into selected products used in biomarker and drug discovery research.

Tracked through seven editions of Kalorama Information’s Outsourcing in Drug Discovery, pharmaceutical research and development (R&D) is now pinned between building market pressures and an explosion in the number of techniques and technological platforms necessary to advance drug candidates. For the first time ever, the global pharmaceutical industry in 2010 cut its R&D budget; subsequent R&D spending growth has been tepid relative to the previous decade with additional industry cuts in 2014 and 2015. With a mantra of “fail early, fail cheaply” for handling high drug candidate attrition rates, pharmaceutical companies are outsourcing increasingly specialized work in drug development, especially as their in-house capabilities have been downsized. In the seventh edition of Outsourcing in Drug Discovery, Kalorama Information analyzes key areas of market growth for contract research organizations (CROs) in terms of services in the drug development process.

New market realities and inefficiencies of past R&D models have prompted downsizing in pharmaceutical in-house R&D. As blockbuster drugs face patent expiration and exposure to the generics market, new molecular entities (NMEs) will be responsible for future revenue streams in pharma, though many will be too specialized to be sold in equally large patient markets. Pharmaceutical companies have responded by cutting costs, particularly the gargantuan costs accrued in the drug development pipeline. Biopharmaceuticals and NMEs also face future profit constraints from cost containment measures pursued by U.S. payers and the rising costs for drug development processes related to their increasing complexity.

In the interest of “failing early”, pharmaceutical companies are expected to prioritize spending in the biology services segment of the outsourcing market. In this segment, CROs are responsible for target identification and validation using complex, technique-dependent strategies.  For many pharmaceutical and biotechnology companies, outsourcing target identification and validation processes is a cost-effective way to gain valuable time in the drug discovery process, as well as gain access to expertise and new technology. CRO expertise in target discovery through validation will be particularly valuable with techniques in targeted mass spectrometry (MS) techniques such as data-independent acquisition (DIA) and quantitative proteomics using SRM/MRM experiments. Applied earlier in the discovery process, these techniques can winnow the body of candidate protein targets prior to time-consuming and costly differential analysis run on hundreds of samples during validation. Other biology services CROs offer pharma clients include protein fractionation and purification; in silico relative quantitation, structural modeling and interaction modeling of targets; NMR; X-ray crystallography; and functional genomics.

 “Failing cheaply” more often than not requires determining the bioavailability and toxicity (ADME/Tox) profiles of candidate compounds early in the drug discovery process. Over 80% of drug attrition cases are results of unsuitable bioavailability or toxicity. ADME/Tox profiling are considered lead optimization services. Of the wide variety of techniques and technologies employed in lead optimization, ADME/Tox is one of the most promising in widening the bottlenecks in the drug discovery process. Typically ADME/Tox is performed after the drug has been developed, during animal testing or in-vivo assays. However, performing ADME/Tox earlier in the drug discovery cycle can help predict if a compound will survive in-vivo evaluations. Thus, performing ADME/Tox earlier has proved valuable in detecting and waylaying problems before the compound enters the more expensive preclinical testing phase. CROs have demonstrated that their proprietary techniques for early ADME/Tox accurately forecast a compound’s performance in later animal studies. Consequently, lead optimization services are projected as another leading area of growth in the outsourcing market along with biology services.