Ottawa, Feb. 03, 2022 (GLOBE NEWSWIRE) -- The global regulatory affairs outsourcing market size was reached at USD 6.5 billion in 2021. The global regulatory affairs outsourcing market is primarily driven by the globalization and the rising investments by the firms for the expansion. The increased research and development activities adopted by the players operating in the pharmaceutical and medical device industries augments the volume of clinical trials and product registration. This is a major driving force of the global regulatory affairs outsourcing market. The strict government regulations regarding the various medical products and complying to these stringent regulations in various countries is a major challenge to the drug and device manufacturers, which compels them to outsource the regulatory affairs to the third-party service providers.
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Asia Pacific was the dominating market in 2020. The increased presence of pharmaceutical and medical device manufacturers in the countries like China, India, South Korea, and Singapore is one of the primary and the most significant factors that propels the growth of the regulatory affairs outsourcing market. The easy and cheap availability of the factors of production in this region and the favorable government policies to attract FDIs are the major factors that attracts the global players to invest in this region. This rising number of production activities in this region requires a huge volume of regulatory affairs activities including product registration, regulatory writing, and clinical trials, which augments the market growth in this region.
Report Coverage of Regulatory Affairs Outsourcing Market
| Report Highlights | Details | |
| Market Size by 2030 | USD 16.6 Billion | |
| Growth Rate from 2021 to 2030 | 10.2% | |
| Fastest Growing Region | North America | |
| Largest Revenue Holder | Asia Pacific | |
| Base Year | 2021 | |
| Forecast Period | 2021 to 2030 | |
| Companies Covered | ICON Plc, WuXiAppTec, Inc., Medpace, Covance, Genpact Ltd., Freyr, Pharmaceutical Product Development LLC., Criterium, Inc., PRA Health Sciences, Accell Clinical Research, LLC. | |
The rising demand for the cost-reduction in the life sciences industry is augmenting the demand for the third party services for the regulatory affairs. Moreover, the introduction of various software that keeps the track of the various regulatory affairs is expected to provide lucrative growth opportunities to the market players in the foreseeable future.
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The growing focus of the pharmaceutical companies and the medical devices manufacturing companies in the core activities coupled with the growing importance of complying to the regulatory standards is a major factors that is expected to drive the growth of the global regulatory affairs outsourcing market.
Based on service, the regulatory writing & publication segment dominated the market in 2020, garnering over 35% of the market share. The regulatory writing plays an essential role in communicating regarding the research and development works related to the new drugs and new medical devices developed by a company to the regulatory authorities like FDA. Regulatory writing is an integral part of the regulatory affairs activities, which is necessary for the acquisition of approvals in the concerned countries, and hence it captures the huge amount of the market share.
Based on the category, the biologics is estimated to be the most opportunistic segment during the forecast period. The rising investments in the development of various biologic medicines that provides an effective treatment for the chronic diseases like cancer, diabetes, and leukemia is a significant factor that propels the demand for the regulatory affairs outsourcing in order to get market authorization in various nations. Moreover, rising prevalence of chronic diseases among the population is expected to drive the growth of the biologics market, which in turn would propel the growth of the regulatory affairs outsourcing market in the foreseeable future.
Based on end user, the pharmaceutical company segment dominated the market, accounting for over 37% of the market share in 2020. The rapid growth of the biopharmaceuticals across the globe, and development of new and innovative medicines has fostered the growth in the volume of regulatory activities in the past few years. Moreover, the introduction of various blockbuster biopharmaceutical products and increased investments by the government and the private sector has played an influential role in the development of this segment.
Based on the indication, the neurology is estimated to be the most opportunistic segment during the forecast period. The rising prevalence of neurological disorders is boosting the need for the development of new drugs and medical devices. According to the Global Burden of Diseases report, around 95% people were suffering from the neurological disorders in the year 2016. Hence, rising investments in the new drug development for the neurological disorders is expected to foster the growth of this segment.
Based on the stage, the clinical segment dominated the market, accounting for more than 45% of the market share in 2020. The rising demand for the clinical trials among the drug developers and medical device manufacturers has augmented the market growth. According to the ClinicalTrials.gov, around 326,000 clinical trials were registered in 2019 in the US which increased to more than 347,000 clinical trials in 2020.
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In 2019, Accell and Syntax collaborated to expand their client reach in the Europe.The various developmental strategies like collaborations, mergers, acquisitions, and partnerships fosters market growth and offers lucrative growth opportunities to the market players.
Market Segmentation
By Service
- Legal Representation
- Regulatory Consulting
- Product Registration & Clinical Trial Application
- Regulatory Writing & Publication
- Others
By Category
- Biologics
- Drugs
- Medical Devices
By End User
- Medical Device Company
- Biotechnology Company
- Pharmaceutical Company
By Indication
- Neurology
- Oncology
- Immunology
- Cardiology
- Others
By Stage
- Clinical
- Preclinical
- Post Market Authorization
By Geography
- North America
- Europe
- Asia Pacific
- MEA
- Latin America
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