Healthcare Regulatory Affairs Outsourcing Market Forecast (2020-2025)

Healthcare Regulatory Affairs Outsourcing Market size is valued at $2.40 Bn in 2019, and is estimated to reach $3.37 Bn by 2025, growing at CAGR of 7.2% during the forecast period of 2020-2025. Healthcare regulatory affairs outsourcing are the regulatory policies that are implemented to ensure that companies obey with certain performance standards in relation to their business. These policies aim to protect public health and well-being by ensuring the safety of healthcare and pharmaceutical products. Outsourcing of healthcare regulation includes the medical writing and publication of regulatory documents provided by quality control and experienced medical writers and publishers who play a vital role in developing high-quality documentation for clinical research projects. The global Healthcare Regulatory Affairs Outsourcing Market growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. The service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies, which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Report Coverage

The report: “Healthcare Regulatory Affairs Outsourcing Market Forecast (2020-2025)” covers an in-depth analysis of the following segments of the Healthcare Regulatory Affairs Outsourcing Market.

By Service Type: Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others.

By End User: Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies.

By Geography: North America, Europe.

Key Takeaways

• Geographically, North America dominated the market with a share of 54% in the year 2019 owing to the huge number of R&D activities in the field of drug discovery carried out in the region.
• The global demand for the Healthcare Regulatory Affairs Outsourcing Market is owing to the rising number of patent expirations around the globe.
• The prices of the services are not clearly stated, and price fluctuations are estimated to restrain the market growth during the forecast period 2020-2025.
• Detailed analysis on the Strength, Weakness and Opportunities of the prominent players operating in the market will be provided in the Healthcare Regulatory Affairs Outsourcing Market report.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Service Type

The global Healthcare Regulatory Affairs Outsourcing Market based on Mode of Service Type, can be further segmented into Clinical Trial Applications and Product Registrations, Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, and others. Regulatory Writing and Publishing segment registered for the highest revenue of $865m in 2019 and is estimated to grow at highest CAGR of 7.5% over the forecast years 2020-2025. This is owing to the growing demand for the regulatory writing and publishing services to develop the regulatory filing documents in comprehensive, standard, reliable, and convincing manner, which drives the growth of the segment. However, the increasing need for high-quality documents to support timely drug approvals in developing countries is estimated to boost the demand for the segment over the forecast period 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By End User

The global Healthcare Regulatory Affairs Outsourcing Market based on End User, can be further segmented into Biotechnology Companies, Medical Device Companies, and Pharmaceutical Companies. The Pharmaceutical Companies segment registered for highest revenue of $947m in 2019 and projected to grow at the highest CAGR of 6.3% during the forecast period 2020-2025 owing to the increasing need for efficient development and manufacturing of pharmaceutical products, which subsequently increases the adoption of full-time regulatory affairs outsourcing models to minimize the overall manufacturing cost. The Pharmaceutical companies are actively working to improve productivity and efficiency, streamline clinical trials, and meet strict healthcare regulatory outsourcing and quality assurance requirements to keep pace with the high competition, which is driving the segment.

Healthcare Regulatory Affairs Outsourcing Market Segment Analysis - By Geography

The global Healthcare Regulatory Affairs Outsourcing Market based on Geography, can be further segmented into North America, Asia-Pacific, Europe, and Rest of World. North America registered for the highest revenue of $1.30 Bn in 2019 and is set to grow at highest CAGR of 7.7% over the forecast period 2020-2025 owing to the increasing number of R&D activities in the field of drug discovery carried out in the region. It have a large presence of multinational biotech and pharma companies which carry out a large number of clinical trials and also has the well developed and advanced healthcare infrastructure. However, Europe is estimated to outpace all the regions by clocking the highest CAGR of 7.3% during the forecast period 2020-2025 owing to the health care needs and government funding towards research activities. Moreover, many biotech and pharma companies have started outsourcing their drug development services to various countries like Italy, Germany, and France which is further boosting the market growth for healthcare regulatory affairs outsourcing market.

Healthcare Regulatory Affairs Outsourcing Market Drivers

Increasing the number of patent expirations

The global Healthcare Regulatory Affairs Outsourcing industry growth is primarily attributed to the rising number of patent expiration along with growing costs of research and development activities. Biopharmaceutical and healthcare organizations are likely to team up with many outsourcing companies for getting their devices and drugs approved but the approval time of a drug or device is expensive, long time procedure, and is also a documentation centric procedure. So, the service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies which helps to increase the growth of the Global Healthcare Regulatory Affairs Outsourcing Market over the forecast years 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Challenges

Fluctuations in Prices

There is an increase in the instances where prices of the services are not clearly stated in the healthcare regulatory affairs outsourcing market, which is acting as a challenge to the market. Besides, the additional costs are said to be involved in the services with the increasing use of technological platforms such as software for the clinical data management, content management, and database & document management. The technological advances no doubt improves the overall process but adds to the total costs as well which are restraining the market growth during the forecast period 2020-2025.

Healthcare Regulatory Affairs Outsourcing Market Industry outlook:

Product launches, mergers and acquisitions, joint ventures, and geographical expansions are key strategies adopted by players in the Healthcare Regulatory Affairs Outsourcing Market. Key companies of this market Accell Clinical Research, LLC, Charles River Laboratories International, Inc, Clinilabs Inc, Criterium Inc, Covance Inc, Cardinal Health, Freyr, ICON PLc, IQVIA, and Medpace, Inc.

Acquisitions/Product Launches:

• In July 2020, Covance acquired GlobalCare, a global industry leader in patient-centric decentralized clinical trials (DCTs) to flourish the offerings of Covance DCTs into global markets and manage the growing demand for patient-centric trial designs.
• In April 2019, Cardinal Health has acquired mscripts. This acquisition will enhance the capabilities that company deliver to their customers and strengthen the relationship between healthcare provider’s payers, pharmacies and patients.