North America to Dominate the Healthcare Regulatory Affairs Outsourcing Market

Introduction

The healthcare regulatory affairs outsourcing market’s most prominent drivers are complex regulatory requirements, declining revenues from the lost sales of blockbuster drugs, reduced healthcare costs, and increasing operational costs. Today, several leading regulatory consulting companies are offering their expertise across the complete product life cycle to sustain in the raging competition. Outsourcing of regulatory affairs can be an attractive option for sponsors to gain experience, optimize cost, and enhance productivity. Regulatory outsourcing companies are equipped with real experience and are in a better position to assess regulatory requirements.

The product-specific regulatory advice and strategies, along with healthcare regulatory compliance at the early stages of product development, are essential for product approval. Failure to address the compliance in the early stage of development often leads to delay in the approval process due to inappropriately filed documentation, manufacturing oversights, omitted regulatory studies, and other failures. Healthcare companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. These companies generally outsource regulatory functions to emerging markets, such as the Asia Pacific and MEA to, further driving the market growth

Key Highlights

• The healthcare regulatory affairs outsourcing market was valued at USD 6,530 million in 2019 and is expected to grow with a CAGR of 12.1%. Increasing regulatory pressure and rising demand for speedy approval of new products drive the market growth.
• The regulatory writing and publishing segment holds the maximum share in the regulatory affairs outsourcing market.
• The pharmaceutical segment holds the largest market share due to the increasing adoption of regulatory affairs outsourcing services and strong competition to get new drug approvals.
• The biotechnology segment is projected to gain momentum due to the growing adoption of outsourcing services for regulatory filings to expand their presence in the healthcare market.

Competitive Players

1. Thermo Fisher Scientific Inc
2. Genpact
3. ICON plc
4. Charles River Laboratories
5. Syneos Health
6. Laboratory Corporation of America Holdings
7. IQVIA
8. PAREXEL International Corporation

Recent Developments

• January 2024- A blog exploring the regulatory issues impacting the pharma industry with the experts at Lachman Consultants. The paradigm shift brought about by artificial intelligence (AI) is now materializing, specifically in coordination and harmonization among cross-regulatory agencies. The most recent publication in this field is "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices," a collaborative effort by the U.S. Food and Drug Administration (FDA), the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), and Health Canada to define guiding principles in AI.

Segmentation

1. By Services
   
   1. Regulatory consulting
   2. Legal representation
   3. Regulatory writing
   4. Publishing
   5. Product Registration
   6. Clinical trial applications
2. By End-User
   
   1. Medical device
   2. Pharmaceutical
   3. Biotechnology
   4. Food and beverages