Market Trends of Global Regulatory Reporting and Compliance Industry
This section covers the major market trends shaping the Regulatory Reporting & Compliance Market according to our research experts:
The Outsourcing Regulatory Reporting and Compliance Services Segment is Expected to Hold Significant Market Share Over the Forecast Period
Regulatory reporting and compliance outsourcing means contracting with a third party in the form of an agreement or deal for handling those particular segments for the business. The regulatory functions are challenging in a highly regulated industry, and hiring a third party to foresee these functions has become increasingly important to thrive in a competitive and innovative industry such as healthcare. The need to maintain compliance, obtain approval for new products, early release in the market, reporting publishing, and submissions require large budgets. The outsourcing regulatory reporting and compliance market was fueled up by the availability of technologically aided solutions, like automated software and big data management software. In January 2021, Genpact Ltd announced that it acquired 'Enquero,' a data engineering and data-led digital transformation service organization. The acquisition will increase Genpact's ability to leverage data and cloud technologies to drive digital transformation services through advanced analytics. Moreover, organizations, like Celegence and Freyr Solutions, offer a wide range of regulatory services from publishing, labeling, compliance consulting, and regulatory operation management to life science organizations with their software-aided solutions to large organizations. As the integration of information technology to make regulatory reporting and compliance boosts the outsourcing segment, the demand is expected to increase over the forecast period.
North America Holds Major Share in the Market and Expected to Grow in the Forecast Period
North America has a very well-developed, advanced, and regulated healthcare infrastructure. North America dominates the regulatory reporting and compliance market with the most prominent regulatory authority, i.e., the United States Food and Drug Administration (USFDA), and a large presence of multinational pharmaceuticals, biotechnology, and medical device companies engaged in innovative products manufacturing and marketing. The need for advanced regulatory reporting and compliance solutions is increasing, making North America a preferable region by the players.
According to the World Trade Organization (WTO) Report April 2020, the United States was the largest importer of medical products from 2017 to 2019, accounting for 19% of the total world import of medical import. This implies that a larger portion of pharmaceuticals and medical devices organizations from other parts of the world are entering the United States, generating a need for faster regulatory approval from the United States Food and Drug Administration (USFDA) to gain a competitive edge. This is expected to increase the demand for technologically advanced software solution services in the regulatory reporting and compliance market. Thus, a large pool of life science players and technologically advanced infrastructure encourages the players to enter the North American regulatory reporting and compliance market.