Regulatory Affairs Outsourcing Market Size, Share, Growth, Trends, Report 2022-2030

According to Latest Report, the global Regulatory Affairs Outsourcing market was estimated at US$ 6.6 billion in 2020 and it is expected to surpass around US$ 12.9 billion by 2030 and is anticipated to grow at a CAGR of 8.5% during forecast period 2021 to 2030.

Growth Factors

A significant increase in the fixed costs of in-house resources for regulatory affairs and operation activities, like training, technology, specialized knowledge, and facilities, is driving the outsourcing of regulatory affairs functions.

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Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, are creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but, in turn, complicate the operation for healthcare product manufacturing companies. Thus, leading to the regulatory affairs outsourcing to service providers.

Key Findings of Market Report

• The global regulatory affairs outsourcing market is anticipated to be driven by rise in research & development activities in the life sciences industry in the years to come
• High investment in R&D to produce orphan, biosimilar, and generic drugs, greater investment in clinical research, stringent government regulation, increased emphasis on product development to broaden supply, and rise in number of FDA-approved manufacturing plants contribute to the expansion of the global regulatory affairs outsourcing market
• The market offers global as well as mid-sized market participants considerable opportunities, such as increasing marketing efforts and delivering low-cost regulatory services
• The global market is likely to be driven by an increasing pharmaceutical and biotechnology product pipeline in the near future

Report Coverage

Risk Associated with Regulatory Affairs Outsourcing

• Risks associated with outsourcing and data sharing are expected to hamper the growth of the global regulatory outsourcing market during the forecast period. Several outsourcing partners have access to pharmaceutical and other industries sensitive data, which is likely to pose a threat to data sharing and security to the companies.

Increase in Investments by Key Players in Research & Development for Regulatory Affairs Outsourcing

• As new therapies and medicines are introduced to the market, the field of medicine continues to evolve. Several public-private institutes and businesses focus on research in order to discover novel medicines.
• Bayer AG's pharmaceutical division unveiled a cell and gene therapy platform in December 2020. Moreover, expanding pharmaceutical and biotechnology product pipeline is expected to drive market during the forecast period.

Service Insights

On the basis of services, the global market has been further divided into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, and other services. The regulatory writing & publishing segment led the market in 2021 and accounted for the highest share of more than 36.5% of the global revenue. These services are offered from the early stages of product development to the post-marketing authorization phase. The segment is also anticipated to dominate the market during the forecast period owing to the adoption of outsourcing of these services by large- and mid-sized biopharmaceutical and medical device companies.

The legal representation services segment is anticipated to witness the fastest growth rate over the forecast period. This is due to the increasing demand for legal representatives across the globe on account of the globalization of medical devices and pharmaceutical companies. The regulations are very complex and ever-changing. Changing the regulatory landscape in regions, such as Asia Pacific, MEA, and Latin America increases the demand for local experts for legal representation for obtaining regulatory approvals and custom clearance. These factors are promoting the demand for legal representation services globally.

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Company Size Insights

The large companies segment is projected to register the fastest growth rate of more than 9% over the forecast period. Large companies generally prefer to establish long-term relations with their service providers to avoid sudden disruption in their operations and thus, prefer a service provider that can meet their regulatory needs to support their various cross-scale and ramp-up operations. Apart from this, according to an article published by GEP (2020), large-scale pharma companies generally outsource about 50% of their regulatory affairs needs. These factors are contributing to the growth of this segment.

On the basis of company sizes, the market has been divided into small, medium, and large. The medium-sized companies segment accounted for the maximum revenue share in 2021 and is estimated to expand further retaining the leading position over the forecast period. The presence of several mid-sized established providers, especially privately-held ones, is anticipated to contribute to this segment share. Moreover, the medium-sized pharmaceutical and medical device companies do not have enough capital to develop an in-house regulatory affairs team, which is further driving the demand for regulatory affairs outsourcing among medium-sized companies.

Category Insights

On the basis of category, the global market has been further segmented into drugs, biologics, and medical devices. The medical device segment accounted for the largest share of more than 37.5% of the global revenue in 2021. This can be attributed to the fact that medical devices companies are now focusing on their core competencies and outsourcing noncore functions to increase their productivity and operational efficiency. The growing demand for advanced medical devices and new technological advancements in medical devices are further contributing to the growth of the segment.

However, the biologics segment is projected to register the forecast CAGR over the forecast period. The R&D productivity of small molecule drugs is declining, hence the focus is shifting to biologics, which is expected to register productive growth in the years to come. Various pharmaceutical companies are focusing on the development of new biopharmaceutical products to keep up with the industry trends and maintain their position in the global market. In addition, biologics drugs have to follow complex and rigorous regulations, which, in turn, is further driving the demand for regulatory outsourcing for biologics, thereby driving the segment.

Indication Insights

The oncology segment accounted for the largest share of more than 33% of the global revenue in 2021. The recent advances in the biology of cancer and the emergence of new tools for genome analysis have opened a clinical perspective in oncology, which has led to personalized medicine. Scientific progress is driving an increase in the number of personalized medicine products and services subject to regulatory review. Hence, contributing to the market growth. Other indications included in the scope of the study are neurology, cardiology, immunology, and others.

The immunology segment is expected to grow at the fastest CAGR over the forecast.This isdue to its potential in facilitating the treatment of various cardiovascular, neurological, oncological, and inflammatory diseases. The strategic initiatives undertaken by market players for immunology are anticipated to facilitate the segment growth. For instance, in 2020, Eli Lilly entered into an agreement to acquire Dermira’s immunology portfolio. In addition, the COVID-19 pandemic had created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth.

Stage Insights

On the basis of stages, the global market has been divided into preclinical, clinical studies, and PMA. The clinical studies segment accounted for the largest share of more than 46.5% in 2021. This can be attributed to the increasing number of clinical trial registrations over the past few years. According to ClinicalTrials.gov, nearly 401,716 trials were registered in January 2022, as compared to around 325,834 by the end of 2019. Moreover, this rise in the number of biologics, high demand for advanced technologies, and a requirement for personalized orphan drugs & medicine are other factors likely to fuel segment growth during the forecast period.

The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period. The rising demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, and the increasing prevalence of existing diseases, such as CVDs, cancer, and neurological diseases are the key factors contributing to the preclincial segment’s growth. Moreover, stringent regulations related to preclinical studies, laid down by global regulatory bodies, such as International Conference on Harmonization (ICH), WHO, FDA, EMEA (Europe), PMDA (Japan), ANVISA (Brazil), MHRA (UK), & ROEB (Canada), are further driving the demand for regulatory affairs outsourcing agency for preclinical studies.

End-use Insights

On the basis of end uses, the global market has been further segmented into medical device companies, pharmaceutical companies, and biotechnology companies. The pharmaceutical companies end-use segment accounted for the largest share of more than 39% of the global revenue in 2021. The segment is anticipated to expand further at the fastest CAGR retaining its leading market position over the forecast period. This is due to the growth in evolving areas, such as biosimilar, orphan drugs, and personalized medicines, which are creating more demand for regulatory services, thereby boosting the segment growth.

In addition, the significant number of new drugs entering the pharmaceutical industry has further improved the segment growth. The medical device and biotechnology segments both have registered a substantial share in the market in 2021. This can be attributed to the increased demand for biopharmaceuticals, vaccines, advanced medical devices, and others. The growing demand for wearable technologies along with recent epidemic events is further contributing to the share of these segments.

Regional Insight

On the basis of geographies, the market has been further divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The Asia Pacific region accounted for the maximum share of more than 38% of the global revenue in 2021. The region is also projected to witness the fastest CAGR over the forecast period. This can be attributed to the increasing number of clinical trials and the rising number of companies trying to enter markets in developing countries, such as India and China. Furthermore, the availability of a skilled workforce in the region at lower costs compared to the U.S. is another factor expected to propel the regional market growth.

The North America regional market also reported a significant share in the global industry. The presence of key pharmaceutical and medical devices companies and the rise in the R&D spending in the region and some of the key factors driving the market in North America. North America and Europe are expected to be the key markets for regulatory affairs outsourcing owing to the presence of two major international regulatory agencies, the European Medicines Agency (EMA) and U.S. FDA, which regulate more than half of medical devices worldwide.

Key Players

• WuXi AppTec, Inc.
• Medpace
• Pharmaceutical Product Development, LLC (PPD)
• Charles River Laboratories International, Inc.
• ICON plc
• Covance
• Parexel International Corporation, Inc.
• Freyr
• Accell Clinical Research, LLC
• Genpact Ltd.
• Criterium, Inc.
• PRA Health Sciences
• Promedica International

Market Segmentation

• Service Outlook 
  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product Registration & Clinical Trial Applications
  • Other Services
• Company Size Outlook
  • Small
  • Medium
  • Large
• Category Outlook 
  • Drugs
    • Generics
    • Innovators
  • Biologics
    • Biotech
    • ATMPs
    • Biosimilars
  • Medical devices
    • Therapeutic
    • Diagnostic
• Indication Outlook 
  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others
• Stage Outlook 
  • Preclinical
  • Clinical
  • PMA (Post Market Authorization)
• End-user Outlook 
  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies
• Regional Outlook 
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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