By: Harsh Parikh --
01 January, 2017
Medical device companies are turning to clinical trials to differentiate their products from competitors and improve adoption in the marketplace. The medical device trials outsourcing is still in budding stage (20-25 percent outsourcing) due to various reasons such as IP-related issues and lesser volume of study. However, it is expected to increase rapidly in near future due to cost-containment pressures, increasing product pipeline and increasing regulatory demands.
Traditionally, the supply base for medical device trials has been those who offer standalone medical device trials. Many global CROs are entering the medical device trials market to serve the increasing demands of the industry, thereby interesting sponsors.
The global medical device market has an annual growth rate of about 7 percent since last 5 years and is valued at $228 billion in 2015. New medical devices are subject to clinical evaluation and regulatory review prior to approval and market launch, with a primary emphasis on clinical safety. Due to increasing cash pressure, many medical device companies are moving from committed costs (Fixed) to more discretionary (Variable) models by outsourcing trial services and trial staffing.
The global medical device CRO market is valued at $5.2 billion in 2015 and is expected to grow at a CAGR of 12.5 percent reaching $7.4 billion by 2018. Since many medical device makers lack the internal resources and expertise to run a complete clinical trial operation in-house, they outsource the services.
As CROs maintain in-house staff, it helps device companies resolve their cost and personnelrelated issues. CROs also provide operational and financial flexibility through various outsourcing models and have regulatory acumen to execute complex device trials. The U.S. market makes up 45-50 percent of the global medical device CRO market and is valued at $2.4 billion in 2015. This market domination is due to its favorable conditions for clinical research and the region’s huge medical devices market of $110 billion, which fuels demand for CROs.