Share
Healthcare Regulatory Affairs Outsourcing Market by Services (Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications, Product Registrations, Regulatory Consulting and Legal Representation), by End User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Devices Manufacturer, Food & Beverage Companies) and Region - Global Analysis of Market Size, Share & Trends for 2021-2022 and Forecasts to 2032
Healthcare regulatory affairs outsourcing is a sort of regulatory policy used to ensure that firms adhere to particular operational requirements with regard to their operations. These regulations generally work to protect the health and welfare of the general population by maintaining the security of pharmaceutical and healthcare items. Outsourcing of healthcare regulatory affairs often entails professional medical writers, quality control, and publishers providing regulatory documentation writing and publishing, all of which are crucial in producing high-quality documents for clinical research initiatives. In order to cut costs and concentrate on their core capabilities, service providers are now diverting their attention to outsourcing healthcare regulatory services.
The market is primarily driven by the rising incidence of various chronic illnesses and the high expenditures related to research and development activities. The increase in research efforts and the number of patent expirations will both contribute to the growth of the Healthcare Regulatory Affairs Outsourcing Market over the course of the forecast period.
FIGURE: MARKET ANALYSIS OF HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET
Healthcare Regulatory Affairs Outsourcing Market is categorized on the basis of Services into Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications, Product Registrations, Regulatory Consulting and Legal Representation. Over the forecast period, it is anticipated that sales in the clinical trial application area would stay strong. Sales in this sector are growing since there is a growing focus on enhancing efficiency and lowering R&D expenses. Moreover, continued research and development of specialist therapeutic medications in fields like oncology is anticipated to support sales in the years to come.
Healthcare Regulatory Affairs Outsourcing Market is categorized on the basis of End User into Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Devices Manufacturer, and Food & Beverage Companies. Since the demand for regulatory affairs outsourcing services is anticipated to increase significantly over the forecast period, the Biotechnology Companies sector is anticipated to become the market's most lucrative field of application. Demand for regulatory affairs outsourcing services is rising as a result of the growing amount of documentation generated during the manufacturing of drugs and medical devices.
FIGURE: MARKET ANALYSIS OF GLOBAL HEALTHCARE REGULATORY AFFAIRS OUTSOURCING
Numerous chronic diseases, such as cancer and other infectious diseases, are becoming more prevalent, which has prompted biopharmaceutical companies to create a large number of new products, which is a key factor in accelerating the growth of the Healthcare Regulatory Affairs Outsourcing Market. Other important market growth drivers include the development of products in clinical trials, an increase in R&D activities, clinical trial applications, product registration, and drug pipeline, a rising shift toward outcome-based models, and an increase in the number of new drugs entering the pipeline.
Biotechnology and pharmaceutical businesses are being forced by the growth of the global healthcare industry to outsource regulatory activities in order to save costs and take advantage of the expertise offered by contract research groups (CROs). The Healthcare Regulatory Affairs Outsourcing Market is primarily driven by the ability of businesses to save time and enhance their core strengths. Most clinical trial operations, including manufacturing and controls (CMC), medical report writing, data management, regulatory chemistry, country regulatory affairs, labeling & liaison, and regulatory strategy are supported by regulations.
The Healthcare Regulatory Affairs Outsourcing Market is being challenged by the rise in cases when the prices of the services are not made explicit. In addition, it is claimed that the rising usage of technology platforms, such as software for clinical data management, content management, and database & document management, will result in higher costs for the services. Although technological advancements undoubtedly make processes more efficient overall, they also raise expenses, which are preventing the market from expanding throughout the projected period.
Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis
Healthcare Regulatory Affairs Outsourcing Market is segmented based on regional analysis into five major regions: North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. Due to the increasing low labor costs in Asia Pacific, the expanded access to a skilled workforce, the rising number of clinical trials, and the increasing number of businesses attempting to enter markets in nations like China and India, the region holds a dominant position in the Healthcare Regulatory Affairs Outsourcing Market. The need for novel, more potent medications is being driven by the increased incidence of cancer and other chronic diseases, which is expected to drive market growth in this area.
Due to the expanding presence of two main international regulatory bodies in these countries, North America and Europe are likely to experience growth in the healthcare regulatory affairs outsourcing market.
Due to the urgent need for COVID-19 infection treatment caused by the pandemic, regulatory agencies including the U.S. FDA and the European Union (EU) have authorized the use of several COVID-19 testing tools and therapies for emergency purposes. Following the pandemic, it is anticipated that these regulatory agency actions will increase market demand for regulatory affairs outsourcing. Revenue in the Healthcare Regulatory Affairs Outsourcing Market increased in 2021 as several businesses concentrated on the creation of cutting-edge therapies for the treatment of COVID-19 infection.
|
REPORT ATTRIBUTE |
DETAILS |
|
Market Size Value in 2021 |
USD 4.3 billion |
|
Revenue Forecast in 2032 |
USD 11.5 billion |
|
Growth Rate |
CAGR of 9.3% from 2022 to 2032 |
|
Base Year for Estimation |
2021 |
|
Quantitative Units |
Revenue in USD billion and CAGR from 2022 to 2032 |
|
Report Coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments Covered |
Services, End User, and Region |
|
Regional Scope |
North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA) |
|
Key Companies Profiled
|
Labcorp Drug Development, WuXi AppTec, ICON PLC, IQVIA, Pharmaceutical Product Development LLC, Charles River Laboratories International Inc., PAREXEL International Corporation, Medpace Inc., Freyr Solutions, Clinilabs Inc., Sciformix Corporation, The Weinberg Group Inc., Criterium Inc., Promedica International, Accell Clinical Research LLC, and Other Prominent Players. |
The Healthcare Regulatory Affairs Outsourcing Market size was estimated at USD 4.3 billion in 2021 and is expected to reach USD 11.5 billion in 2032.
Healthcare regulatory affairs outsourcing is a sort of regulatory policy used to ensure that firms adhere to particular operational requirements with regard to their operations. These regulations generally work to protect the health and welfare of the general population by maintaining the security of pharmaceutical and healthcare items.
The Clinical Trial Applications and Biotechnology Companies segments accounted for the larger share of the Healthcare Regulatory Affairs Outsourcing Market.
Key players in the Healthcare Regulatory Affairs Outsourcing Market are Labcorp Drug Development, WuXi AppTec, ICON PLC, IQVIA, Pharmaceutical Product Development LLC, Charles River Laboratories International Inc., PAREXEL International Corporation, Medpace Inc., Freyr Solutions, Clinilabs Inc., Sciformix Corporation, The Weinberg Group Inc., Criterium Inc., Promedica International, Accell Clinical Research LLC, and Other Prominent Players.
The Healthcare Regulatory Affairs Outsourcing Market is primarily driven by the rising incidence of various chronic illnesses and the high expenditures related to research and development activities.
Select License Type
Select License Type
FATPOS CLIENT Appriciation DURING THE PROJECT
Working with Fatpos Global, allowed us to take advantage of their knowledge and easy approach, allowing us to collect important data utilizing a variety of techniques. The results were clearly presented and explained, and FG responded to our questions with speed and expertise.
|
Swiss-based global building materials manufacturer |
The analyses and presentations Fatpos Global have produced for us have been of a very high caliber and have allowed us to proactively improve our customer relationship management. They have also done so while maintaining complete anonymity. Without any doubt, we suggest Fatpos Global to you.
|
|
Tech-powered construction company |
We appreciate the team’s punctuality, flexibility in terms of report modification, post report purchase support and pleasant reaction all around. Overall, my experience with this company was nothing but positive, and I couldn't be more grateful for their excellent service. Thank you for all that you do!
|
|
American global management consulting firm |
We are able to concentrate on the topics and implications that are most important to our clients thanks to the adaptability and responsiveness of the team at Fatpos Global. We would highly recommend this company to anyone in need of their services, and I will certainly be using them again in the future.
|
|
Headquartered in Zug, Switzerland, leading supplier of medical and surgical instrument |
To better study our client demographics, develop the ideal product-price architecture, and enhance our target marketing initiatives, we hired Fatpos Global. Every component of the project was completed, and we are very happy with the useful insights and actionable results.
|
|
Kosovan company, A leading organic fertilizers producer |
Thank you for your team's generous assistance, The final report was delivered to me, and I find it to be really helpful. Also, you may be sure that I will get in touch with you if I ever require fresh materials for market research. Gratitude once more.
|
|
German specialty chemicals company based in Cologne, Germany |
