Zion Market Research has published a new report titled “Healthcare Regulatory Affairs Outsourcing Market by Services (Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications and Services Registrations, Regulatory Consulting and Legal Representation, and Other Regulatory Affairs) and by End-User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, and Food and Beverage Companies): Global Industry Perspective, Comprehensive Analysis and Forecast, 2017 – 2024”. According to the report, global healthcare regulatory affairs outsourcing market was valued at approximately USD 3.37 billion in 2017 and is expected to generate revenue of around USD 7.26 billion by end of 2024, growing at a CAGR of around 11.60% between 2018 and 2024.
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The world has become a global village wherein many companies are in a race to place their new products in the market and gain market share. In such cases, a small delay in gaining market access can lead to a huge loss in terms of revenue generation and market share. The success key to pharmaceutical companies lies in getting timely approval from the regulators. In order to obtain timely approvals, companies rely on regulatory departments to outsource the task to regulatory affairs consulting firms. With the changing customer requirements and regulatory environment, regulatory affairs work seems to be a more beneficial option in terms of both time and money. Regulatory affairs keep on updating with the current regulations and have a vital experience in the field to expedite the approval process.
The healthcare regulatory affairs outsourcing market is fragmented on the basis of services into regulatory writing and publishing, regulatory submissions, legal representation, and regulatory consulting, clinical trial applications and services registrations, and other regulatory affairs. In 2017, regulatory writing and publishing segment held the largest share of the market due to rising trends of outsourcing non-core function by pharma companies. Legal representation is likely to be the fastest growing segment owing to its rising demand in the European region which is gaining market authorization for companies. Globalization of clinical trials in the regions of the Asia Pacific and Latin America is expected to increase the demand for clinical trial application services and product registration market thus contributing to the growth of healthcare regulatory affairs outsourcing market.
Based on the end user, the market is segmented into biotechnology companies, mid-size pharmaceutical companies, medical device companies, large pharmaceutical companies, and food and beverage companies. The biotechnology companies are expected to be the fastest growing end-user segment. Factors such as increasing prevalence of a large number of viral, bacterial, and chronic diseases and patent expiration have provoked many biopharmaceutical companies to develop a large number of new products. With this rising number of products, the demand for product registration services and clinical trial applications is also substantially growing which is further boosting the market growth of healthcare regulatory affairs outsourcing.
Regionally, the market for healthcare regulatory affairs outsourcing market is segmented into Europe, North America, Asia Pacific, the Middle East & Africa, and Latin America. North America and Europe are the leading contributors of the healthcare regulatory affairs outsourcing market due to the presence of regulatory bodies like the European Medicines Agency (EMA) and the FDA in these regions which leads to stringent follow-ups of the authoritarian requirements. North America and Europe together contribute almost 60% of the pharmaceutical sales globally. Moreover, these regions have a large presence of CROs and service providers which propel the market growth.
Some of the leading players in healthcare regulatory affairs outsourcing market include Medpace, Inc., Promedica International, PARAXEL International Corporation, Covance, Inc., Freyr Solutions, Criterium, Inc., Accell Clinical Research, PRA Health Sciences, Inc., Wuxi AppTec, and Quintiles IMS Holdings, Inc. Leading players have realized that timely clinical approvals and marketing from the government bodies are key parameters in new product development. Thus, companies are focused on strengthening their in-house regulatory departments.
This report segments the global healthcare regulatory affairs outsourcing market as follows:
Global Healthcare Regulatory Affairs Outsourcing Market: Services Segment Analysis
- Regulatory Writing and Publishing
- Regulatory Submissions
- Clinical Trial Applications and Services Registrations
- Regulatory Consulting and Legal Representation
- Other Regulatory Affairs
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Global Healthcare Regulatory Affairs Outsourcing Market: End-User Segment Analysis
- Mid-Size Pharmaceutical Companies
- Large Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
- Food and Beverage Companies
Global Healthcare Regulatory Affairs Outsourcing Market: Regional Segment Analysis
- North America
- The U.S.
- Asia Pacific
- Latin America
- The Middle East and Africa