Increase research and development activities and develop new products is anticipated to drive the Healthcare Regulatory Affairs Outsourcing Market during the forecast period 2020-2025. Healthcare Regulatory Affairs Outsourcing Market size is 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. 

The Healthcare Regulatory Affairs Outsourcing market is growing at a significant rate as the various countries are gradually increasing their investment in research and development departments. This has led to the development of new products in the industry. With the increasing militancy of the relevant regulatory authorities around the world, an increasing collaboration has been observed between drug developers, Clinical Research Organizations (CRO) and Contract Manufacturing Organizations (CMOs) in order to mitigate risks. Since CROs and CMOs assist companies with such risks, companies are able to focus on their core businesses. Therefore, increased R&D activities along with patent expires have been identified as major factors fueling the growth of the regulatory outsourcing market.

The high demand for services provided by the health care regulatory industry outsourcing market is also a result of increased documentation during drug and device manufacturing. Medium or small-sized pharmaceutical companies face problems such as thorough documentation. Regulatory authorities, due to their strict policies, require the need for trained and skilled regulatory professionals who are able to handle efficiently the recording, evaluation and compilation of scientific data. Subsequently, pharma and biotech companies seek help from regulatory service providers, thus driving market growth. 

North America holds a major share of Healthcare Regulatory Affairs Outsourcing market owing to the increasing number of healthcare institutes and pharmaceutical companies in the countries like Canada, Mexico, and U.S. are outsourcing regulatory affairs to save cost and leverage available expertise with Contract Research Organizations (CROs). Outsourcing healthcare regulatory affairs provide these organizations with the time and resource to focus on their core competencies, which is increasing the growth of the healthcare regulatory affairs outsourcing market. An increasing number of healthcare companies are outsourcing their regulatory functions to focus on their core competencies as an increasing number of drugs are emerging in the clinical development process, and outsourcing of regulatory affairs is gaining more importance in the healthcare sector. Major clinical research organizations and biopharmaceutical companies have their hubs in the North America owing to the advancement in the technology, the demand for efficient supplies is increasing. Rising investments in the healthcare sector, increasing collaboration between drug developers and regulatory outsourcing companies are the factors set to avail new growth opportunity to Healthcare Regulatory Affairs Outsourcing market during 2019-2025.

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Healthcare Regulatory Affairs Outsourcing Market Growth Drivers:
  • Increasing the number of patent expirations:
The rising number of patent expiration along with growing costs of research and development activities are primarily contributed to the growth of the global Healthcare Regulatory Affairs Outsourcing Market. 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. 

Growing Prevalence of Several Chronic Disease:
The growing prevalence of several chronic disease such as cancer and other infectious disease have encouraged biopharmaceutical companies to develop a large number of new products. With the increasing development of products in clinical trials, the demand for clinical trial applications and the product registration services are growing that are driving the market growth. In 2016, according to the International Federation of Pharmaceutical Manufacturers & Associations, 56 new pharmaceutical companies entered into the market, which increased the development of products and helped to develop many new and advanced products. According to the Centers for Disease Control and Prevention in 2016, 9,421 cases of tuberculosis were recorded and according to the National Cancer Institute, in 2016, about 1,685,210 new cases of cancer were diagnosed. So, the government is taking initiatives for the development in healthcare sector and increases the number of biopharmaceutical companies. The rising fixed costs of the internal resources for health care regulatory affairs and operating activities such as training, specialized knowledge, technology, and facilities are driving life science companies to outsource these functions, and the increasing number of clinical trials is also contributing to fuel the market growth.

R&D Investment:
LabCorp signed strategic partnership with Envigo to expand and strengthen Covance's nonclinical drug development, and to design an independent research models provider. 

The Major Players in this Market Include
The major companies in the Healthcare Regulatory Affairs Outsourcing market include Covance Inc, Cardinal Health, Freyr, LabCorp, and Medpace, Inc. In 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. 

The service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies which is a major factor set to buoy the Healthcare Regulatory Affairs Outsourcing market during 2019-2025. 

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