Drug discovery contract research organizations (CROs) are bolstering their end-to-end capabilities in order to forge partnerships with innovators as R&D outsourcing continues to become more strategic. If drug makers, in earlier days, looked to phase out select non-core aspects of drug discovery and development through outsourcing, today they are looking to outsource the entire process to providers that have the requisite competence. The changing paradigm makes it a compelling case for CROs looking to become part of the R&D strategies of their clientele.

Mounting overall drug development costs and steadily diminishing returns from drug sales are the most obvious reasons for this shift in strategy by innovators. New medicines often fail to live up to high levels of expectations in terms of sales earnings. At the same time, the expenditure to bring a drug to market continues to grow exorbitantly. This is aggravated by an uptick in potential risks coupled with heightened regulatory challenges. The R&D outlay of drug makers is also hit by the declining revenues as the highly profitable drugs lose their patent protection. As much as $215 billion worth of drugs will go off-patent by 2020, says a forecast by Evaluate Pharma.

As a result, new drug discovery poses two basic challenges to the innovators: cut down the R&D cost and push up the success rate. One of the ways to achieve this goal is through speeding up the early-stage drug discovery process. Many firms find it better to outsource functions like target identification and validation to CROs rather than building in-house infrastructure to do the pre-clinical work.

As companies look outside for reliable, long-term partners, CROs are busy designing service models with a broader array of offerings.

“Our customer-centric flexible business model allows our clients multiple entry points. This can include the engagement to build large-scale, high-value and long-term strategic partnerships, allowing us to become an integral part of their R&D strategy,” said Jonathan Hunt, chief executive officer, Syngene International.

Syngene is not limiting its services to discovery and development but working towards evolving into an integrated contract research and manufacturing services (CRAMS) firm. The Bengaluru-based contract services provider is currently setting up a large-scale commercial manufacturing facility at Mangalore, in southern India, as part of the process. 

Syngene, which offers solutions in protein sciences, antibody discovery, cell line engineering, in vitro assays, in vivo disease models and drug metabolism and pharmacokinetics (DMPK) services, to support both large and small molecule discovery, looks at discovery biology as a strategic growth driver, especially in the biologics space.

In May, Syngene entered into a non-exclusive partnering agreement with Zumutor Biologics, an emerging immuno-oncology company from Bengaluru to access the latter’s proprietary naïve human phage/yeast display library.

The deal entitles Syngene to screen target antigens against Zumutor’s human antibody libraries to identify and characterize novel antibody clones. Syngene will develop the leads towards novel biotherapeutics programs for its partners.

In addition to next-generation antibody discovery platforms, Syngene has established strengths in immuno-oncology, cardio-metabolic disorders, neurology and CAR-T cell proof-of-principle studies as part of its discovery biology portfolio. Syngene’s multi-industry list of customers includes BMS, Baxter, Amgen and GSK.

Discovery biology services continue to gather momentum as biotherapeutics expand their market share. Biologics now top the list of the largest selling medicines, pushing back their chemical counterparts. Some estimates show that biologics made up a quarter of the total pharmaceutical market in 2016. They are forecast to grow at a faster pace led largely by the monoclonal antibody segment.

GVK Bio, another integrated contract research and development organization (CRDO), which has developed capabilities in both large and small molecules, offers services in discovery biology, chemistry, formulation development, contract manufacturing and drug repurposing. Headquartered in Hyderabad, GVK Bio partners with academic institutions and research laboratories to find cost-effective R&D solutions.

GVK Bio gained an edge in biological services by acquiring Aragen Bioscience, a U.S.-based preclinical CRO specializing in biologics, back in 2014.

The global market for contract research services, including early and late-stage drug development, is forecast to grow at a CAGR of 9.8% for a five-year period through 2019, according to a report published recently by Infiniti Research. The complexity of today’s therapeutics and diagnostics calls for faster, smarter and much more responsive CROs to manage service requirements.