The global regulatory affairs outsourcing market is estimated to grow at a remarkable CAGR of 10.2% over the forecast period and to reach USD 16.6 billion by 2030.
The global regulatory affairs outsourcing market is estimated to grow at a remarkable CAGR of 10.2% over the forecast period and to reach USD 16.6 billion by 2030.
Growth Factors
The global demand for the regulatory affairs outsourcing services is growing at a burgeoning pace among the pharmaceutical industry owing to the high costs associated with the regulatory affairs operations across the various nations. There are numerous regulations at the domestic and international level that the pharmaceutical companies need to comply with in several nations. The rapidly growing pharmaceutical industry, especially the biopharmaceutical industry is expected to derive the growth of the global regulatory affairs outsourcing market during the forecast period. The medical device manufacturers, drug developers, and diagnosis device manufacturers are increasingly demand the specialized third party services to handle all their regulation compliance matters in order to increase operational efficiency and reduce costs. The rising investments in the research and the development of various new and innovative diagnostic devices and drugs across the globe are expected to foster the growth of the global regulatory affairs outsourcing market.
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Report Highlights:
- Based on the service, the regulatory writing & publication was the dominating segment that accounted for more than 35% of the market share in 2020. The regulatory writing & publication is considered to be an essential part in the research activities conducted by the pharmaceutical companies. There are numerous documents involved that needs to be produced during the clinical trials phase. The regulatory writers are the important link between the regulatory authorities and the drug developers.
- On the basis of category, biologics are expected to show a strong growth rate during the forecast period. The rising investments in the research and development of new life-saving medicines in the biologics industry is the most prominent driving factor. The regulatory requirements during the clinical trials and preclinical trials is an essential aspect served by the third party regulatory service providers.
- By end user, the pharmaceutical company segment dominated the market with more than 37% of the revenue share in 2020. This is attributed to the various regulatory related activities involved in the different phases starting from research till the commercialization of a pharmaceutical medicine.
- On the basis of indication, the oncology segment dominated the global regulatory affairs outsourcing market. The rising investments in the research and development of various drugs and therapeutics for the treatment of cancer has fueled the growth of this segment. The rising prevalence of cancer among the global population is expected to positively impact the market in the forthcoming years.
- Depending on the stage, the clinical segment led the market with over 45% of the market share in 2020. This is solely attributed to the increased volume of drug development and huge number of clinical trials across the developing and developed markets.
- Asia Pacific dominated the market, accounting for a revenue share of around 37% in 2020. Asia Pacific has been successful in attracting huge investments from the top pharmaceutical and medical devices companies owing to the presence of cheap factors of production and favorable government policies. The presence of numerous top pharma companies and research institutes has propelled the growth of the Asia Pacific regulatory affairs outsourcing market. It is also estimated to be the fastest-growing market during the forecast period.
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Future of Regulatory Affairs Outsourcing Market
The growing demand for the cost control in life sciences industry is expected to spur the adoption of the third party regulatory affairsservices. Further, the integration of several software for keeping the track of the numerous regulatory affairs is estimated to offer lucrative growth aspects to the players in the upcoming future. Furthermore, various developmental strategies adopted by the top players like partnerships, collaborations, and mergers is expected to have a significant and positive impact on the market growth.
COVID-19 Impact Analysis:
- The COVID-19 pandemic positively impacted the market growth as the demand for the regulatory affair services increased owing to the increased activities pertaining to the development and clinical trials of drugs, diagnostics, and vaccines for the treatment of the COVID-19 disease across the globe.
- The demand the regulatory affairs third party services is expected to grow owing to the rising investments in the research of the COVID-19 for developing the treatment for the new and upcoming variants of the virus.
Key Developments in the Marketplace:
- In 2019, Accell collaborated with Syntax to grow their client reach in European market.
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
- Latin America
- MEA
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