Latin America Healthcare Regulatory Affairs Outsourcing Market Size By Application (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies), By Product (Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation), And Forecast

Latin America Healthcare Regulatory Affairs Outsourcing Market Size And Forecast

Latin America Healthcare Regulatory Affairs Outsourcing Market size was valued at USD 467.09 Million in 2024 and is projected to reach USD 969.27 Million by 2031, growing at a CAGR of 10.54% during the forecast period 2024-2031.

Regulatory affairs outsourcing services have a wide range of applications across mid-size pharmaceutical companies, large pharmaceutical companies, biotechnology companies, medical device manufacturers, and food & beverage companies. Thus, the demand for healthcare regulatory affairs outsourcing services is growing over the insourcing or handling of healthcare regulatory affairs on-premises during the forecasted period. The Latin America Healthcare Regulatory Affairs Outsourcing Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Latin America Healthcare Regulatory Affairs Outsourcing Market Definition

Healthcare regulatory affairs outsourcing refers to the services provided by contract research organizations (CROs) or outsourcing companies to offer regulatory approvals, regulatory writing & publishing, and clinical trial registrations, amongst others. Healthcare regulatory affairs outsourcing services integrate newly developed technologies (analytics and insights), medical devices (instruments, monitoring devices, surgical instruments, etc.), and efficient regulatory approval procedures for drugs and biological products. Healthcare regulatory affairs outsourcing services offer various benefits over insourcing or handling healthcare regulatory affairs on-premises.

The advantages offered by healthcare regulatory affairs outsourcing include greater flexibility in operations, a swifter regulatory process, and better freedom to focus on the critical processes and core functions of the business, such as product development, technological advancements, product launches, promotional activities, and advertisement, amongst others. There are different services such as regulatory writing & publishing, regulatory submissions, clinical trial applications, product registrations, regulatory consulting and legal representation, and others.

Regulatory affairs outsourcing services have a wide range of applications across mid-size pharmaceutical companies, large pharmaceutical companies, biotechnology companies, medical device manufacturers, and food & beverage companies. Thus, the demand for healthcare regulatory affairs outsourcing services is growing over the insourcing or handling of healthcare regulatory affairs on-premises during the forecasted period.

Latin America Healthcare Regulatory Affairs Outsourcing Market Overview

The prevalence of different chronic diseases, including cancer, cardiovascular diseases, autoimmune diseases, neurological disorders, and others, is growing across the Latin American region. In Latin America, the number of new cancer cases is rising as there were 1,470,274 new cancer cases with death cases of around 713,414, as stated by the Global Cancer Incidence, Mortality and Prevalence (GLOBOCAN) Report, 2020. Across all ages of the Latin American population, prostate cancer is the most common. Furthermore, in Brazil, there were 592,212 new cancer cases in 2020, with death cases of 259,949. According to the International Agency for Research on Cancer, World Health Organization, the number of prevalent cancer cases from 2016 to 2020 was 1,563,761. The Brazilian government is taking initiatives to control various diseases.

Regulatory affairs outsourcing services offer various benefits over in-sourced processing as the whole and sole responsibility to handle the regulatory affairs goes to the CROs or the outsourcing organizations. However, the regulatory affairs outsourcing services incur high costs to businesses across Latin America. According to the Pharmaceutical Regulatory AffairsOpen Access, regulatory affairs outsourcing provides values and advantages; nevertheless, it can be expensive as it incurs a high cost to the company. For giant and prominent key players, the high outsourcing cost doesn’t matter much. But it does matter for the new entrants, small-sized and mid-sized companies across the healthcare and life-sciences industry.

The life science and biologics industry across Latin America is going through a revolutionary phase as the major countries such as Brazil and Argentina are taking initiatives to reduce various chronic diseases and develop the COVID-19 vaccines for the Latin American population. Brazil has started producing its own COVID-19 vaccines at the Fiocruz-Bio-Manguinhos vaccine production lab. Brazil produced the first Covid-19 vaccine doses on 14th February with active pharmaceutical ingredients from Brazil. Brazil was created in a new vaccine production facility run by the Oswaldo Cruz Foundation (Fiocruz) and the Immunobiological Technology Institute (Instituto de Tecnologia em Imunobiológicos, or Bio-Manguinhos), in partnership with AstraZeneca. It is forecasted to produce 120 million Covid-19 doses by the middle of 2022 at this new vaccine development site. Bio-Manguinhos is also one of the two major institutes in Latin America producing mRNA vaccines under a technology-transfer agreement with the World Health Organization and partners.

Latin America Healthcare Regulatory Affairs Outsourcing MarketSegmentation Analysis

The Latin America Healthcare Regulatory Affairs Outsourcing Market is segmented on the basis of Application, Product, and Geography.

Latin America Healthcare Regulatory Affairs Outsourcing Market, By Application

• Mid-Size Pharmaceutical Companies
• Large Pharmaceutical Companies
• Medical Devices Manufacturer
•  Biotechnology Companies
• Food & Beverage Companies

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Based on Application, the market is bifurcated into Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Medical Devices Manufacturer, Biotechnology Companies, and Food & Beverage Companies. The Mid-Size Pharmaceutical Companies segment is accounted for the largest market share in 2021 and is projected to grow at a CAGR of 11.14% during the forecast period. It is projected that the presence of multiple established mid-sized providers, mainly privately held ones, will help to increase this sector’s share.

Furthermore, the lack of resources among medium-sized pharmaceutical and medical device businesses to build an internal regulatory affairs team fuels the need for regulatory affairs outsourcing. To reduce total manufacturing costs, full-time regulatory affairs outsourcing models are increasingly being adopted as the demand for effective pharmaceutical product development and manufacturing grows. Small and medium-sized businesses are using regulatory consultants to oversee their outsourcing of regulatory activities in new countries. To stay afloat in the fierce competition, pharmaceutical businesses are actively attempting to increase productivity and efficiency, streamline clinical trials, and adhere to stricter regulations and quality assurance standards.

Latin America Healthcare Regulatory Affairs Outsourcing Market, By Product

• Regulatory Writing and Publishing
• Regulatory Consulting and Legal Representation
• Regulatory Submissions
• Clinical Trial Applications
• Product Registrations

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Based on Product, the Latin America Healthcare Regulatory Affairs Outsourcing Market has been segmented into Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation, Regulatory Submissions, Clinical Trial Applications, Product Registrations, and Others. The Regulatory Writing and Publishing segment is accounted for the largest market share and is projected to grow at the highest CAGR of 11.04% during the forecast period. Due to the widespread usage of these services from the initial phases of product development to the premarket approval stage, the regulatory writing and publication segment had the largest market share.

Various regulatory documents, including those related to biostatistics, medical affairs, quality control, regulatory, and clinical operations, are needed for regulatory submissions. The industry is expanding due to the rising demand for regulatory writing and publishing services to create regulatory file documents in a standard, thorough, trustworthy, and convincing manner. The growing need for top-notch paperwork to enable swift drug approvals in developing nations is the primary driver of the regulatory writing and publishing market.

Key Players

The “Latin America Healthcare Regulatory Affairs Outsourcing Market” study report will provide a valuable insight with an emphasis on the market including some of the major players such as Merck & Co., Inc., Labcorp Drug Development (Covance), IQVIA, ICON, GenPact Ltd, and Others. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the players mentioned above.

Key Developments

• In June 2022, Through a real-world data partnership with HealthVerity, Labcorp strengthens its clinical trial and drug development capabilities.
• In June 2019, For FSP, Parexel introduces an improved integrated outsourcing delivery model. The whole range of outsourcing solutions, from full service to functional to a hybrid approach, are offered by Parexel FSP to biopharmaceutical clients in a variety of specialist disciplines, including Clinical, Data Management, Safety, Regulatory, and Medical Affairs.

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• Qualitative and quantitative analysis of the ma