Jul 8, 2020
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
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
A faster-moving healthcare industry has not bypassed contract research organizations, an industry sector representing well over $30 billion in annual commerce. New trends in CRO clinical and commercial practices reflect the changes in the greater healthcare industry. The parallels are unavoidable and perpetually drive growth and innovation in the CRO sector.
Consolidation across the healthcare industry
Consolidation among biotech, pharmaceutical and medical device companies triggers companies to look for cost-cutting opportunities. Redundancies within internal research units are looked at closely and erased or their resources combined. Overcapacity and/or outdated facilities are usually shut down permanently.
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
Advanced pharmaceuticals such as monoclonal antibodies, gene therapies and other biotech drugs, medical devices and diagnostics require more in-depth testing and analysis that innovator companies can’t possibly build, run and maintain all under one ownership.
CROs provide the extra exploration, testing and validation necessary that is supported with ample data to provide insights to manufacturers as well as more demanding, data-hungry regulatory approval agencies.
Post-approval safety monitoring of large scale product use
Following product approval, ongoing oversight of product performance and safety is a pivotal further commitment for many healthcare product manufacturers.
The U.S. Food and Drug Administration (FDA) and other regulators have approved advanced therapies and other products on the condition that additional health and safety studies are conducted to evaluate their performance in larger populations. These are known as postmarketing surveillance programs. CROs are the ideal providers to orchestrate these exercises and studies.
Healthcare product development and manufacturing strategies have changed
Many medical product firms will partner with or license products from startups or firms that purely develop or discover new molecules and other offerings. Whether the arrangement is through licensing or partnerships, ramping up research capabilities is expensive to drive forward quickly into further phases of development.
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
COVID-19 has forced healthcare products companies, healthcare provider organizations, corporations, governments and entire nations to adapt. Companies with robust product pipelines going into 2020 were already heavily relying on CROs to help them progress.
These and other companies are seeking to not only keep their anticipated product development and other initiatives underway but also expedite new ventures focused on thwarting COVID-19 that include:
- antivirals
- blood and plasma-based therapies
- immunizations/vaccines
- respiratory agents
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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