Healthcare Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

  • Single User License $3500

Healthcare Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2025

Status : October, 2021 | Medical Devices

Report Digest


Global Healthcare Regulatory Affairs Outsourcing Market: Snapshot

The healthcare regulatory affairs outsourcing market is experiencing significant growth owing to services to Clinical Research Organizations. The rising number of patent expirations along with growing costs of research and development activities are the primary factors influencing the growth of the global healthcare regulatory affairs outsourcing market. Healthcare and biopharmaceutical organizations are likely to team up with numerous outsourcing companies for getting their drugs and devices approved in the global market. The approval time of a drug or device is a time taking process, is expensive, and is also a documentation centric procedure.

As a result of the above, the service providers have been shifting their focus to outsource healthcare regulatory activities for reducing costs and focusing on core competencies. These type of regulatory service providers provide several other services as well such as pharmacovigilance, medical writing, and clinical trials to biotech and many different countries. However, the market is expected to be inhibited by the high fluctuations in price along with hidden expenses in the regulatory services delivered by diverse Clinical Research Organizations. Furthermore, high risks pertaining to organizational information security is likely to challenge the productivity of the healthcare regulatory affairs outsourcing market.

The service providers of healthcare regulatory affairs outsourcing can gain lucrative growth opportunities from emerging economies in Latin America and Asia Pacific owing to the developing infrastructure of these regions and investments in developing healthcare technologies. 

Global Healthcare Regulatory Affairs Outsourcing Market: Overview

Regulatory policies are implemented to ensure that companies comply with certain standards of functioning in relation to their businesses. These policies or regulatory affairs in the healthcare industry are aimed at safeguarding the public health and welfare by ensuring the safety of pharmaceutical and healthcare products. An increasing number of healthcare companies lately are outsourcing their regulatory functions to focus on their core competencies instead. Furthermore, due to the advent of an increasing number of drugs in the clinical development process, regulatory affair outsourcing is gaining more importance in the healthcare sector.

TMR Research, in its new report studies the prevalent prospects for the market. Based on in-depth analysis and exhaustive information obtained through proven research methodologies it also presents refined outlook for the market between 2017 and 2025.

Global Healthcare Regulatory Affairs Outsourcing Market: Trends and Opportunities

An increasing number of healthcare institutes and pharmaceutical companies are outsourcing regulatory affairs to save cost and capitalize on expertise available with the contract research organizations (CROs). Outsourcing healthcare regulatory affairs provides these organizations with the time and resource to focus on their core competencies, which is the chief driver of the global healthcare regulatory affairs outsourcing market.

Currently, regulatory support is available for almost every process across clinical trials such as medical report writing, manufacturing and controls (CMC), data management, regulatory chemistry, country regulatory affairs, labeling and liaison, and regulatory strategy. One of the primary benefits of outsourcing regulatory affairs is cost effectiveness. Outsourcing non-core activities to experts can help companies focus more on their marketing and research and development activities. Hence in the long run companies can benefit from optimized reimbursements, product approval, and increased market share and productivity. Spurred by these factors, the global healthcare regulatory outsourcing market is poised to exhibit strong growth over the forecast period.

Global Healthcare Regulatory Affairs Outsourcing Market: Regional Outlook

Regionally, Asia Pacific, North America, Europe, and Rest of the World constitute the key market segments. Among these, North America emerged dominant as the U.S. held lead in the global healthcare regulatory affairs outsourcing market. Europe trailed North America as leading healthcare institutes therein increased their focus on reducing investment cost and capitalize on the availability of cheap labor. Besides this, the rising concentration on the optimum utilization of resources and gain from accelerated focus on faster product approval.

Owing to the high costs involved in clinical development procedures in developed nations, the emerging countries are more preferred for regulatory affairs outsourcing in the healthcare sector. Asia Pacific for instance is exhibiting impressive CAGR and is fast emerging as a lucrative market for regulatory affairs outsourcing. The growth of Asia Pacific market is spurred due to the availability of a large pool of skilled labor at an affordable price and the increasing number of pharmaceutical companies intending to focus on their core competencies.

Global Healthcare Regulatory Affairs Outsourcing Market: Vendor Landscape

Various companies around the world offer comprehensive knowledge in managing healthcare regulatory affairs. These companies mainly intend to help firms overcome challenges and accelerate clinical processes. Some of the leading players in the market identified by the report are Covance Group Ltd., Parexel International Corporation, Pharmaceutical Product Development, Medelis, Inc., Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace, Inc., and ICON Plc.

The report conducts SWOT analysis on several of these market players to gauge determine their strengths and weaknesses. This analysis also provides insights into the opportunities and threats that potentially lay ahead for these companies over the course of the forecast period.

The reports at TMR Research provide qualitative solutions that break the barriers of doubt or uncertainties when the stakeholders plan to expand their growth reach. The researchers compile the necessary information that enlightens the CXOs about the current growth opportunities in a specific market and enables them to make the most of the opportunities.

TMR Research is a leader in developing well-researched reports. The expertise of the researchers at TMR Research makes the report stand out from others. TMR Research reports help the stakeholders and CXOs make impactful decisions through a unique blend of innovation and analytical thinking. The use of innovation and analytical thinking while structuring a report assures complete and ideal information of the current status of the market to the stakeholders.

TMR Research has rich experience in developing state-of-the-art reports for a wide array of markets and sectors. The brilliance of the experts at TMR Research and their alacrity to conduct thorough research and create phenomenal reports makes TMR Research better than others.

5-Point Growth Formula

The 5-point growth formula developed by TMR Research provides an insight to the stakeholders and CXOs about the current situation in the market. The growth formula makes the report a perfect companion for the stakeholders and CXOs.

The 5-point growth formula includes the following points:

  • Current and Future Threats
  • Accurate Trend Analysis
  • Regional Assessment
  • Industrial Analogy
  • COVID-19 Impact

Current and Future Threats

Along with studying the opportunities necessary for growth, threats are also an important aspect to look upon for the companies and stakeholders in a specific sector. TMR Research studies every negative aspect that will hinder the growth of a specific area of business and includes it in the report. The stakeholders and CXOs will have the benefit of assessing the threat and take the necessary steps to prevent the hindrance caused due to the threats.

Accurate Trend Analysis

Keeping up with the latest trends is crucial in any business or sector. While stakeholders are aware of the trends that are on the surface, TMR Researchers find trends that are deeply entrenched in the particular market or sector. The reports are constantly updated with the latest trends so that the stakeholders and CXOs can derive benefits from the trends and generate good revenues.

Regional Assessment

Demography forms an important part of the growth pattern of all the markets. Diving deep into the demographics enables maximum output from specific areas. The TMR Research team assesses every region and picks out the vital points that have a large impact on the growth of a market.

Industrial Analogy

The analysts at TMR Research conduct an all-round analysis on the competitive landscape of the market. The observations recorded by the analysts are added to the reports so that every stakeholder gets a glimpse of the competitive scenario and frame their business plans according to the situation.

COVID-19 Impact

The COVID-19 outbreak has changed the growth projections of numerous sectors and businesses. The analysts at TMR Research have conducted a conscientious survey on the markets after the pandemic struck. The analysts have put forth their brilliant and well-researched opinions in the report. The opinions will help the stakeholders to plan their strategy accordingly.

The reports offer answers to the top 7 questions that revolve around the growth of the market

  • What are the diverse growth parameters influencing the market?
  • Which regions will contribute largely to the growth of the market
  • What are the recent innovations and technological advancements in the market?
  • What are the emerging trends across the market?
  • How has COVID-19 affected the market?
  • What will be the post-pandemic scenario of the market?
  • What are the major threats that will dent the growth prospects of the market?