Healthcare Regulatory Affairs Outsourcing Market

Market Overview

The healthcare regulatory affairs outsourcing market size was valued at USD 6,530 million in 2019 and is expected to grow with a CAGR of 12.1%.

The healthcare regulatory affairs outsourcing market is projected to grow at an exponential rate during the forecast period. Healthcare regulatory affairs outsourcing offers a number of services, which include medical writing and publishing of regulatory documentation prepared by experienced medical writers, quality control (QC) auditors, and publishers to develop high-quality documents for research projects regulatory submissions. Other outsourcing services include clinical trial applications, regulatory consulting, quality assurance and compliance, and legal representations.  

Market Dynamics

Stringent Regulations Imposed by the Regulatory Authorities to Drive the Market Growth

Rising investments in the healthcare sector in developed and developing countries and increasing collaboration between drug developers and regulatory outsourcing companies drive market growth. Increasing R&D activities, coupled with patent expirations provide an impetus to the market growth. Globally, increasing regulatory pressure on documentation regarding drug and device manufacturing is subsequently driving the demand for healthcare regulatory affairs outsourcing. The stringent regulations imposed by the regulatory authorities have compelled the SMEs to hire trained and skilled regulatory professionals capable of handling registration, evaluation, and compilation of regulatory compliant documentation, further driving the market growth.

Increasing Demand for Speedy Product Approval to Drive the Market Growth

The healthcare regulatory affairs outsourcing market’s most prominent driver is the increasing need for new product approvals at minimum operational cost. Healthcare regulatory approval processes have become more stringent and time-consuming, which is why market players are striving to obtain approval for their product in the first attempt to gain a competitive edge. Stringent regulations and changing regulatory landscape in developing countries have compelled the companies to establish an in-house regulatory department or outsource the regulatory activities. Increasing investments in regulatory information systems to automate activities such as regulatory publishing and operations provide an impetus to the market growth.  

Segmental Analysis

Regulatory Writing and Publishing Segment Held the Highest Market Share in 2019

The regulatory writing and publishing segment held the highest market share in 2019 as these services are extensively used from the early stages of product development to the premarket approval phase. Regulatory submissions require an array of regulatory documents, such as biostatistics, medical affairs, quality assurance, regulatory, and clinical operations. Increasing demand for regulatory writing and publishing services to develop regulatory filing documents in standard, comprehensive, reliable, and convincing manner drives the segment growth. The regulatory writing and publishing segment is primarily driven by the increasing need for high-quality documents to support timely drug approvals in developing countries.  

Increasing Complexity in Regulations in Healthcare Industries to Drive the Legal Representation Segment

The legal representation segment is expected to witness the fastest growth during the forecast period owing to the increasing demand for legal representatives across the globe. For instance, companies that are locally present in Europe require legal representatives to gain market authorization in Asia-Pacific. Increasing complexity in regulations in healthcare industries is subsequently surging the demand for specialized legal advice on issues, such as licensing, patents, trademarks, and marketing of pharmaceutical products, commercial agreements concerning clinical trials, mergers and acquisitions, business-related approvals, and other regulatory matters.

Product Registration Segment to Witness Significant Growth during the Forecast Period

The product registration segment is expected to witness significant growth during the forecast period. The midsized and small-scale players are approaching clinical research organizations (CROs) for product registration and drug development to reduce the operational cost and gain a competitive edge. For instance, in Brazil and Mexico, product registration must be obtained before any commercial application of pharmaceutical and medical device products.

The clinical trial application segment is expected to grow at the fastest CAGR due to rising demand for clinical trial application services in the emerging markets and increasing investments in R&D activities. The clinical trial application provides comprehensive information about the medicinal products, which enables regulatory authorities to assess the feasible clinical study. Thus, the increasing number of Investigative New Drug (IND) applications and debouching trend of outsourcing clinical trial application service drives the segment growth.

Rising Need for Efficient Manufacturing and Development of Pharmaceutical Products to Drive the Segment Growth

The pharmaceutical segment held the largest market share in 2019 on account of rapid developments in generic ANDA filings, novel drug applications, personalized medicines, companion diagnostics, and adaptive trial designs. The rising need for efficient manufacturing and development of pharmaceutical products is subsequently increasing the adoption of full-time regulatory affairs outsourcing models to minimize the overall manufacturing cost. Small and mid-size companies are employing regulatory consultants to manage their regulatory affairs outsourcing in new territories. The pharmaceutical companies are actively working to improve productivity and efficiency, streamline clinical trials, and meet more rigorous regulatory and quality assurance requirements to sustain in the raging competition, further driving the segment growth.

Impact of covid-19

The COVID-19 pandemic has resulted in delays in regulatory approvals for life sciences products due to delay in regulatory communication and meetings. The work from home imposed by the governments has compelled the players to perform teleconferences, which are expected to delay timelines shared with the clients. The client protocol prohibits the transfer of work to the employees due to data security concerns, further hampering the market growth.

Regional Analysis

Presence of Robust Research Laboratories and Leading Market Players to Drive North America’s Market Growth

North America accounts for the largest share in the healthcare regulatory outsourcing market due to changing regulatory scenarios across the region. The market is largely driven by the presence of robust research laboratories and leading market players, such as Sandoz, Amgen, and Teva Pharmaceutical. In the U.S., more than 40 biosimilar are under development, and nearly 20 biosimilars is ready to be released in the market, further driving the market growth. The region is backed by the presence of large pharmaceutical and biotech companies that are outsourcing regulatory procedures to maintain workload management drives the market growth.

Availability of Skilled Workforce with Technical Expertise to Drive Asia-Pacific’s Market Growth

Asia-Pacific is projected to grow at a significant rate in the healthcare regulatory affairs outsourcing market on account of lower outsourcing cost, availability of skilled workforce, and rapid expansion of healthcare companies. Moreover, an increasing number of clinical trials and the rising number of start-ups in India, South East Asia, and China provide an impetus to the market growth.

Recent Developments

• In April 2019, Charles River Laboratories International, Inc. acquired Citoxlab, a non-clinical Contract Research Organization (CRO) offering regulatory affairs services, and medical device testing service, to expand its product portfolio and strengthened its market position
• In March 2018, Parexel International Corporation introduced PAREXEL's Medical Writing Solutions to offer regulatory services

Healthcare Regulatory Affairs Outsourcing Market Segmentation

By Services

• Regulatory consulting
• Legal representation
• Regulatory writing and publishing
• Product registration and clinical trial applications

By End-User

• Medical device
• Pharmaceutical
• Biotechnology
• Food and beverages

By Region

• North America
• Europe
• Asia-Pacific
• South America
• The Middle East and Africa