Contract Research Organizations (CROs) are having a robust 2020
Contract Research Organizations (CROs) are having a robust 2020
… Contract Research Organizations Embracing New Clinical And Business Opportunities …

2020: A Robust Year For Contract Research Organizations (CROs)

A series of healthcare industry events and trends are reshaping and growing the CRO healthcare industry sector

John G. Baresky

Contract research organizations have been around for decades. They have been the go-to for pharmaceutical, medical device and other companies seeking immediate access to specialized research resources, quality control monitoring and other services. Their role in the healthcare industry and the array of capabilities they possess has multiplied many times over. Based on several factors, 2020 has been a watershed year for many CROs. Many have already become sizable corporate entities and become familiar to numerous individuals outside of the healthcare industry including investors.

Higher financial stakes, advanced clinical sciences new corporate strategies

Consolidation across the healthcare industry

There has been a steady stream of mergers and acquisitions within the CRO sector as well. These help CROs gain scale and sharpen their competitive edge. While there are still plenty of highly specialized CROs, the largest ones have become one-stop shops that can provide an array of research services for even the largest biotech, pharmaceutical or medical device companies.

More complex healthcare products require more research

Post-approval safety monitoring of large scale product use

Healthcare product development and manufacturing strategies have changed

Once products progress beyond the embryonic stage of development, CROs can execute further work on small or large scale evaluations in a shorter amount of time. Startup companies and product development companies and their larger licensing partners do not need to establish and maintain large research units beyond the necessary time they are most needed as CROs can carry on wider-ranging and longer-lasting work if necessary.

The second aspect of clinical and business strategy is the pursuit of additional indications for biotherapies and conventional pharmaceuticals. By earning more approved indications, drugs have more traction in gaining additional market access in hospitals, health systems, PBM, managed care organizations (MCO) and other payer formularies. CROs can help support these additional research programs for products that are already on the market.

A final reflection on clinical and business strategy in pharmaceuticals is biosimilars. Biosimilars are the “generic” duplications of brand biotherapies. The advanced nature of the products in these categories requires a large scale evaluation of clinical performance and data reporting. As many brand biotherapies have been in the market for more than one or two decades, some begin to lose their patent protection. Opportunistic brand and generic drug competitors seek to develop copies of them and launch them into the marketplace.

The search for solutions to the global COVID-19 pandemic has embraced the CRO business sector

  • antivirals
  • blood and plasma-based therapies
  • immunizations/vaccines
  • respiratory agents

These and other therapeutic options span established as well as entirely new products. CROs are shouldering this load of additional work that also brings them more unexpected but welcome revenue. The Centers for Disease Control (CDC) have developed and issued a series of guidelines so CROs and other laboratory-based businesses and institution researching COVID-19 can safely conduct their work and uniformly define clinical statistical details for reporting standards and evaluations. This is in addition to their standard compliance regulations.

There is no doubt the experience of working with such a volatile and complex pathogen such as COVID-19 through crucial timelines and deeply demanding clinical evaluations will further sharpen the abilities, processes and techniques of CROs moving forward.

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