USD 6.48 billion
Report ID: SQMIG35D2051 | Region: Global | Published Date: January, 2023 | Pages: 157 | Tables: 174 | Figures: 79
Global Regulatory Affairs Outsourcing Market size was valued at USD 6.48 billion in 2021 and is poised to grow from USD 7 billion in 2022 to USD 13.99 billion by 2030, growing at a CAGR of 8% in the forecast period (2023-2030).
Regulatory affairs, also known as government affairs, is a job that evaluates and monitors the adequacy and efficiency of products in fields such as agrochemicals, cosmetics, pesticides, medical devices, veterinary medicines, pharmaceuticals, and complementary medicines in order to ensure public health. These services are offered by medical device, biotech, and pharmaceutical manufacturers. Regulatory affairs outsourcing firms assist with obtaining regulatory permits on time. Outsourcing regulatory affairs is becoming increasingly prevalent in the healthcare industry. The implementation of regulatory outsourcing methodologies is anticipated to be supported by an increase in regional expansion activities by businesses seeking quick approvals in local markets. The market is expanding due to an increase in R&D operations, coupled with an increase in the number of clinical trial applications and product registrations.
US Regulatory Affairs Outsourcing Market is poised to grow at a sustainable CAGR for the next forecast year.
Global Market Size
USD 6.48 billion
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Global Regulatory Affairs Outsourcing Market is segmented based on the services, company size, category, indication, stage, end-user, and region. Based on services, the Regulatory Affairs Outsourcing Market is segmented into regulatory consulting, regulatory writing & publishing, legal representation, product registration & clinical trial applications, and others. Based on company size, the Regulatory Affairs Outsourcing Market is segmented into small, medium, and large. Based on category, the Regulatory Affairs Outsourcing Market is segmented into drugs, biologics, and medical devices. Based on indication, the Regulatory Affairs Outsourcing Market is segmented into oncology, cardiology neurology, immunology, and others. Based on stage, the Regulatory Affairs Outsourcing Market is segmented into preclinical, clinical, and PMA (Post Market Authorization). Based on end-user, the Regulatory Affairs Outsourcing Market is segmented into medical device companies, pharmaceutical companies, biotechnology companies. Based on region, Regulatory Affairs Outsourcing Market is categorized into North America, Europe, Asia-Pacific, Latin America, and MEA.
Regulatory Affairs Outsourcing Market Analysis by Services
Based on services, regulatory affairs outsourcing market is segmented into regulatory consulting, regulatory writing & publishing, legal representation, product registration & clinical trial applications, and others. The regulatory writing and publishing segment led the market in 2021, with a revenue share of over 36.5%, and is expected to maintain its lead throughout the forecast period. From the initial phases of product development to the post-marketing authorization phase, these services are all available. Due to the increasing use of outsourcing of these services by large and mid-sized biopharmaceutical and medical device companies, this segment is projected to lead the market during the forecast period.
Legal representation is expected to expand with the fastest growth rate during the forecast period. This could be attributed to the proliferation of medical device companies, which has increased demand for legal representation around the world.
Regulatory Affairs Outsourcing Market Analysis by Company Size
Based on company size, the regulatory affairs outsourcing market is segmented into small, medium, and large. The large company segment is expected to grow at the fastest rate of more than 9% during the forecast period. Large companies generally prefer to establish long-term relationships with their service providers in order to avoid sudden disruptions in their operations, and thus prefer a service provider who can fulfil their regulatory needs to encourage their various cross-scale and ramp-up operations.
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In 2021, the Asia Pacific region accounted for more than 38% of global revenue, and is further expected to have the significant market share during the forecast period due to an increase in clinical trials coupled with a spike in the proportion of companies trying to break into markets in emerging economies such as India and China. Furthermore, the availability of a qualified manpower in the region at lower costs than in the US is expected to drive regional market growth.
North America market is anticipated to significantly grow during the projected period owing to the available number of key pharmaceutical & medical device companies coupled with the rise in the research & development activities in the region. The regulatory affairs outsourcing market size is growing as a result of stringent compliances issued by regulatory authorities in North America, which are promoting partnerships among drug developers, clinical research organisations, and contract manufacturing organisations to alleviate potential risks and speed up the approval process.
European market is projected to grow at the highest CAGR due to health care requirements and government funds for scientific efforts in the region over the forecast period. According to the regulatory affairs outsourcing market outlook, several biotech & pharmaceutical firms have begun outsourcing their drug production services to nations such as France, Germany, and Italy, which is driving the market, due to that the market share is increasing. Moreover, medical device and IVD regulatory affairs outsourcing market firms are putting more emphasis on commercializing healthcare company' products while keeping within budget.
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Regulatory Affairs Outsourcing Market Driver
Regulatory Affairs Outsourcing Market Restraint
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Global regulatory affairs outsourcing market is highly competitive and somewhat fragmented. To maintain a competitive edge, the major industry participants are continually implementing various growth strategies. Innovations, mergers, and acquisitions, collaborations and partnerships are adopted by these players to thrive in the competitive market. In order to provide industries with the most effective and economical solutions, the major market players are also continually concentrating on R&D.
Regulatory Affairs Outsourcing Market Top Player's Company Profiles
Regulatory Affairs Outsourcing Market Recent Developments
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected utilizing Primary Exploratory Research backed by the robust Secondary Desk research.
According to our global regulatory affairs outsourcing market analysis, the Asia Pacific region is growing because of the expansion of life sciences companies in countries, such as India & China. Outsourcing of regulatory affairs functions is being driven by a substantial increase in the fixed costs of in-house resources for regulatory affairs and operation activities such as training, technology, specialised knowledge, and facilities during the analysis period. However, many outsourcing partners have access to confidential pharmaceutical or other industry data, which may impede the security and data sharing of companies, resulting in hampering the global market.
|Market size value in 2021||USD 6.48 billion|
|Market size value in 2030||USD 7 billion|
|Forecast Unit (Value)||USD Billion|
|Regions covered||North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)|
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For the Global Regulatory Affairs Outsourcing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Global Regulatory Affairs Outsourcing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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