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.

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 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 Overcapacity and/or outdated facilities are usually shut down permanently.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.

Biotherapies and other advanced pharmaceuticals or 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.

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.

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.

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

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.

Thank you for reading this story

Read my other articles about medical and healthcare business trends, content marketing and digital strategy, brand and product management, consumer wellness, managed care and market access strategy. Contact me today for your healthcare content writing and content strategy needs for medical, business, academic, patient and consumer healthcare audiences.

I have over 20 years of experience in the healthcare industry producing valuable healthcare content for audiences and customers spanning physicians, nurses, pharmacists plus pharmaceutical companies, medical technology manufacturers, healthcare provider organizations, managed care, investors, consumers and other stakeholders.

Visit and connect…

LinkedIn

Twitter

Bare Sky Marketing Blog

Bare Sky Marketing Examples

Google My Business

As a healthcare content writer, my work aligns with an organization’s voice, brand, SEO elements, marketplace and objectives. It establishes trust in their company and recognized value in its products and services that generates revenue.

This experience was earned through working at Walgreens, Pfizer, AbelsonTaylor, TAP (Takeda Abbott Partnership), Hospira Worldwide and Boston Software Systems. ​

To a large degree, my professional interests emulate my family which includes doctors, nurses, physician assistants and other clinicians plus those that are working in healthcare administration and commercial enterprises.

Bare Sky Marketing LinkedIn Business Profile

See this article on Slide Share!

Authentic, fact-based healthcare content marketing writing for medical, business, academic, patient and consumer audiences https://www.BareSkyMarketing.com/

Get the Medium app

A button that says 'Download on the App Store', and if clicked it will lead you to the iOS App store
A button that says 'Get it on, Google Play', and if clicked it will lead you to the Google Play store