Healthcare Regulatory Affairs Outsourcing Market

Report Overview

[ 170 + Pages Research Report ] Healthcare Regulatory Affairs Outsourcing Market is expected to exceed USD 11.5 billion by 2032 from USD 4.3 billion in 2021 at a CAGR of 9.3% throughout the forecast period i.e. 2022-32.

PRODUCT OVERVIEW

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.

MARKET HIGHLIGHTS

The Healthcare Regulatory Affairs Outsourcing Market is expected to project a notable CAGR of 9.3% in 2032.

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: SEGMENTS

The Clinical Trial Applications segment is expected to grow with a higher CAGR during 2022-32

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.

The Biotechnology Companies segment is expected to grow with a higher CAGR during 2022-32

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

MARKET DYNAMICS

Growth Drivers: Rising Cases of Multiple Diseases and Increasing Product Developments for Clinical Trials

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.

Growth of the Healthcare Industry Worldwide is Fueling the Adoption of Outsource Regulatory Affairs

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.

Restraint: High Costs Associated with the Services Along with Growing Use of Technological Platforms

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.

RECENT DEVELOPMENTS

• A strategic partnership between Paraxel and Kyoto University Hospital was established in October 2021 to increase the chances for clinical research and find effective strategies to support clinical investigations.
• In April 2021, IQVIA declared that it has bought the minority part in Q2 Solutions, a joint venture for central laboratory services, held by Quest Diagnostics.
• Using technology and procedural innovation, Parexel and Veeva Systems announced a strategic agreement in April 2021 to expedite clinical trials. Both companies will gain from the regulatory consultancy services of the other.

HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET: KEY PLAYERS

• Labcorp Drug Development

Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence, SWOT Analysis

• 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
• Other Prominent Players

HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET: REGION

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.

IMPACT OF COVID-19 ON 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.

Healthcare Regulatory Affairs Outsourcing Market is further segmented by region into:

• North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States and Canada
• Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Mexico, Argentina, Brazil, and Rest of Latin America
• Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, Belgium, Hungary, Luxembourg, Netherlands, Poland, NORDIC, Russia, Turkey, and Rest of Europe
• Asia Pacific Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Malaysia, Indonesia, New Zealand, Australia, and Rest of APAC
• Middle East and Africa Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, Israel, GCC, South Africa, and Rest of MENA

HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET REPORT ALSO CONTAINS ANALYSIS ON:

Healthcare Regulatory Affairs Outsourcing Market Segments:

• 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
• Healthcare Regulatory Affairs Outsourcing Market Dynamics
• Healthcare Regulatory Affairs Outsourcing Market Size
• Supply & Demand
• Current Trends/Issues/Challenges
• Competition & Companies Involved in the Market
• Value Chain of the Market
• Market Drivers and Restraints

HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET REPORT SCOPE AND SEGMENTATION

Frequently Asked Questions (FAQ):