Regulatory Affairs Market Size, Share & Trends Analysis Report By Categories (Drugs, Biologics), By Company Size (Small, Large), By Type, By Services, By Product Stage, By Indication, By End Use, By Region, And Segment Forecasts, 2024 - 2030

Regulatory Affairs Market Size & Trends

The regulatory affairs market size was estimated at USD 15.00 billion in 2023 and is projected to grow at a CAGR of 8.2% from 2024 to 2030. The market's growth is mainly due to advancements in immunotherapies, orphan drugs, specialty therapies, and personalized medicines coupled with constant changes in regulatory requirements. Moreover, the increasing prevalence of chronic diseases, which require effective therapies and vaccines, drives the need for proper guidelines to maintain effectiveness, safety, and quality.

Furthermore, the growing focus of market players on strategic initiatives such as collaborations, partnerships, mergers, and acquisitions is further contributing to the market's growth. For instance, in March 2023, PROMETRIKA, LLC. expanded its strategic regulatory consulting services, which aim to offer guidance and support to clinical plans and ensure high efficiency and quality.

In addition, during the pandemic, the demand for drugs was significantly high, which accelerated the clinical development process and subsequently increased the regulatory process for creating a safe and effective environment for conducting clinical trials. In addition, the regulatory authorities demonstrated flexibility in developing COVID-19 drugs while maintaining high quality, tolerability, and effectiveness. The authorities have also released several guidelines, such as emergency use authorization for the drugs that could be used for the treatment. Thus, introducing new guidelines while maintaining proper efficacy and quality has further contributed to the market growth.

In addition, low production and manufacturing costs, availability of skilled labor at relatively lower costs, and tax benefits in emerging countries such as Brazil, China, India, and others contribute to revolutionizing the regulatory landscape. The aforementioned factors create significant opportunities for medical device and biopharmaceutical companies to outsource their activities, further boosting the demand for these services in these regions. The healthcare industry is constantly working towards developing new therapies by advancing fields such as specialty drugs, personalized medicine, and target gene therapies, which are used to treat specific diseases. Thus, constant developments in this field have contributed to the market growth.

Industry Concentration & Characteristics

The market is experiencing a high degree of innovation as it adapts to the evolving landscape of the healthcare and pharmaceutical industries. The market is witnessing significant advancements in regulatory consulting, legal representation, writing and publishing, product registration, and clinical trial applications.

The market is characterized by the high impact of regulations. Stringent regulations boost the demand for regulatory affairs services, as companies need toensure proper compliance to operate effectively.

The globalization of biopharmaceutical and medical device companies' outsourcing and expansion into emerging markets drives the market. The increasing complexity of regulations and healthcare reforms has increased the demand for regulatory affairs services.

Key players are adopting this strategy to expand their service offerings and offer a comprehensive service suite.

The industry is witnessing significant regional expansion. Outsourcing companies are increasingly present in emerging economies with lower operational costs and a skilled workforce.

Type Insights

The outsourcing segment dominated the market with a share of 58.16% in 2023. The segment's growth is mainly due to the growing focus of pharmaceutical and medical device companies on outsourcing their activities, which allows them to access specialized expertise and resources they may not have in-house. In addition, outsourcing provides flexibility for companies to scale their operations based on project needs without the fixed costs associated with maintaining an in-house team. Thus, these factors contribute to market growth.

The in-house segment is projected to witness considerable growth during the forecast year owing to the growing number of small and medium-sized companies that lack the infrastructure and funding to support an in-house regulatory affairs department. Moreover, these firms face difficulties hiring a skilled workforce because of budget constraints.

Service Insights

The regulatory writing & publishing segment dominated the market, accounting for 36.41% of the global revenue in 2023. The segment's growth is attributed to factors such as increased outsourcing of services by medical devices and biopharmaceutical companies. These companies outsource their regulatory writing and publishing segment to focus more on their core competencies and properly manage their internal resources. Therefore,  big pharmaceutical and medical device companies would create significant demand for outsourcing activities, further driving the segment's growth.

The legal representation segment is expected to witness the highest CAGR of 10.6% over the forecast period owing to constant changes in the regulatory scenario in the healthcare industry and the introduction of healthcare reforms majorly in emerging countries. Constant changes in these activities drive the need to outsource legal activities as it becomes challenging for companies to keep up with current regulations. For instance, a sponsor should have a registered entity in the EU to conduct clinical trials in Europe. Furthermore, several companies focus on expanding their geographic footprint, further contributing to the segment’s growth. For instance, in February 2023, Freyr entered into a contractual agreement with Avicenna.AI,a medical device company. The company aims to outsource its registration and legal representation services to Avicenna.AI in Argentina.

Categories Insights

The medical devices segment dominated the market with a share of 41.05% in 2023. The segment's growth can be attributed to factors such as constant technological advancements and the increasing focus of market players on outsourcing medical device activities so they can focus more on their core competencies. Furthermore, significant advancements in material sciences, growing demand for wearable medical devices, and difficulties of drug-device combinations also contribute to the segment’s growth.

The biologics segment is projected to witness considerable growth at a CAGR of 9.1% from 2024 to 2030. The segment's growth is mainly attributed to increasing research and development activities by pharmaceutical and biotechnology companies, which require proper environmental conditions for product development. Product manufacturing is an important process where a small change in environmental conditions can hugely affect the cells and structure of a biological product. Therefore, proper outsourcing services are required to maintain a zero-error margin, further contributing to the segment’s growth.

Indication Insights

The oncology segment dominated the market with a share of 32.77% in 2023. The growth of the segment is mainly due to the increasing prevalence of cancer, which requires effective and safe treatment options. According to the data published by the American Cancer Society in January 2023, approximately 2,001,140 new cancer cases will be registered in the U.S. in 2024. Thus, increasing cancer cases would increase the demand for better treatment options, further boosting the pharmaceutical companies' research and development activities. Merck is constantly working towards developing new cancer therapies and expanding its existing oncology product portfolio. Thus, the aforementioned factors would increase the company's product pipeline, further increasing the demand for efficient regulatory affairs services.

The immunology segment is projected to witness the highest CAGR of 11.4% from 2024 to 2030. The increasing focus on immunotherapy as a promising treatment option for various diseases, including cancer and autoimmune disorders, has led to a surge in the development and regulatory approval of immunotherapeutic drugs. Moreover, advancements in immunology research have resulted in the development of innovative cell and gene therapies and biologics, further boosting the demand for regulatory affairs. These cutting-edge technologies necessitate specialized knowledge and strategic planning to facilitate market authorization and commercialization. Thus, these factors are contributing to the segment’s growth.

Product Stage Insights

The clinical studies segment dominated the market with a share of 46.75% in 2023. The increasing prevalence of chronic diseases coupled with the emergence of new diseases will increase the demand for better treatment options, further growing the number of clinical trials conducted globally to meet the growing needs of the patients. Thus, increasing clinical trial activities would boost the demand for proper regulations to ensure that studies are carried out transparently, the trials are authenticated, effectively exposed to humans, and exhibit credible data.

The preclinical segment is projected to witness the highest CAGR of 10.6% from 2024 to 2030. The preclinical product stage is an important phase in developing new drugs, biologics, and medical devices, where regulatory affairs play an important role in ensuring compliance with all the requirements. The increasing demand for new product development would increase the need for innovative treatments and therapies, which would further contribute to the growth of the preclinical product stage segment.

Company Size Insights

The medium-sized company segment dominated the market with a share of 47.05% in 2023. The market's growth is mainly due to several mid-sized established firms, mainly privately held. These companies have a strong geographic foothold in selected and multiple markets globally and offer overall regulatory affairs services.

The large-scale segment is projected to witness the highest CAGR of 10.2% from 2024 to 2030. The segment's growth is mainly due to the large biopharmaceutical and medical device companies that tend to outsource their activities to these Usages as they offer a wide range of regulatory affairs services, and they have their presence across several countries, making it easy to operate the business in every region. Moreover, large pharma companies prefer to enter a long-term collaboration with Usages to avoid disruptions in their operations. Thus, these factors contribute to market growth.

End Use Insights

The pharmaceutical companies segment dominated the market in 2023 with a market share of 38.79%. The segment's growth is mainly due to growing research and development activities coupled with increased approved pharmaceutical products. For instance, according to the data published by the U.S. FDA in January 2022, approximately 50 new drugs were launched in 2021. Therefore, a growing number of product launches and commercialization is projected to increase the demand for registration,licensing, product approval, and others.

The biotechnology segment is projected to witness the highest CAGR of 9.7% over the forecast period. The segment's growth is mainly due to significant demand for biologics, growing investment in biologics manufacturing, and advanced healthcare infrastructure. These factors would require proper regulatory affairs services such as GMP practices, patent filings, audit and validation, and quality and assurance, further boosting the demand for outsourcing services.

Regional Insights

The regulatory affairs market in North America is anticipated to grow at a CAGR of 8.2% from 2024 to 2030. The region's market growth is mainly due to constant research and development by the market players. Growing product pipelines and their subsequent approval would also contribute to the region’s market growth. Moreover, stringent processes and growing R&D expenditure in North America are anticipated to increase the demand for outsourcing regulatory affairs services for large biopharmaceuticals.

The U.S. regulatory affairs market is anticipated to experience significant growth over the forecast period. The healthcare technologies and treatments in the U.S. are highly dynamic, and companies are constantly innovating new therapies and products that require regulatory approval. This is one of the factors driving the regulatory affairs services in the U.S.

Asia Pacific Regulatory Affairs Market Trends

Asia Pacific dominated the market and accounted for a 37.82% share in 2023. The growth in the region is a      ttributed to factors such as an enhanced regulatory landscape, an increasing number of clinical trials, a growing number of pharmaceutical companies, and the availability of skilled workers in the region. Furthermore, the growing demand for medical devices and biosimilars is projected to contribute to the market growth. For instance, Biocon is constantly working towards developing new therapeutic drugs that are projected to be launched in the coming years. This would increase the demand for regulatory assistance, further contributing to market growth.

China Regulatory Affairs Market Trends

The regulatory affairs market in China is anticipated to experience significant growth over the forecast period.China is one of the most attractive markets for the biopharmaceutical industry. The growing geriatric population and a large middle-income population are increasing the demand for innovative and cost-effective medicines, which is expected to attract major biopharmaceutical and medical device companies in this region. Thus, these factors would contribute to the region's market growth.

Japan regulatory affairs market dominated the Asia Pacific market owing to rising demand for new and cost-effective medicines, which may attract investments from biopharmaceutical companies in this region. Rising demand for generics due to government support and improvement in approval processes are expected to increase market entrants, thereby propelling the demand for regulatory affairs services in this region. An increase in the cost of R&D and pricing pressure are expected to restrain the market growth in this region.

The regulatory affairs market in India is anticipated to experience considerable growth over the forecast period. The growth is mainly due to the country's growing number of clinical trials due to its diverse population and cost-effective research opportunities. The number of clinical trials registered in India has been on the rise, leading to an increased demand for regulatory affairs services to assist the complex approval processes.

Europe Regulatory Affairs Market Trends

The regulatory affairs market in Europe is anticipated to grow over the forecast period owing to prominent players in the region and increasing demand for regulatory affairs. Legal representation, consulting, product registration & clinical trial applications, regulatory writing & publishing, and other services are among the key services offered in the European market. Companies increasingly outsource these services to specialized providers to ensure compliance with evolving regulations and streamline operations.

The UK regulatory affairs market is projected to witness the fastest growth in the coming years. The demand for generic products has also grown considerably due to government support for generics over branded drugs. This trend attracts various small—and mid-size biopharmaceutical and medical device companies to enter the UK, thereby increasing the demand for regulatory support services.

The regulatory affairs market in Germany is expected to grow considerably over the forecast period. The presence of a skilled and experienced workforce is also one of the primary factors expected to drive the market in Germany, as productivity rates are much higher than the average of EU15 countries.

MEA Regulatory Affairs Market Trends

The regulatory affairs market in MEA is projected to grow at a lucrative rate owing to the increasing prevalence of chronic diseases such as cardiovascular diseases and cancer. The increasing cases would drive the demand for better treatment options, further driving the need for more robust regulatory frameworks to ensure the safety and efficacy of new treatments and diagnostic tools. Thus, the aforementioned factors would drive the region's demand for regulatory affairs services.

The Saudi Arabia regulatory affairs market is projected to witness the fastest growth rate owing to growing government support, such as increasing investment in the country’s healthcare infrastructure, as part of its Vision 2030 initiative. This includes enhancing regulatory frameworks to ensure compliance with international standards, which are crucial for attracting foreign investment and improving local manufacturing capabilities.

Key Regulatory Affairs Company Insights

Key players operating in the market are undertaking various initiatives to strengthen their market presence and increase the reach of their products and services. Strategies such as expansion activities and partnerships play a key role in propelling the market growth.

Recent Developments

• In January 2024, iuvo BioScience acquired Promedica International to expand its ophthalmic clinical CRO services.

• In September 2023, Freyr entered into a partnership agreement with the PKG Group LLC. The partnership aims to navigate stringent regulatory procedures and accelerate submission activities in a quick turnaround time.

• In January 2023, AmerisourceBergen Corporation acquired PHARMALEX GMBH to advance its specialty services and pharma manufacturer service offerings.

Regulatory Affairs Market Report Scope

Global Regulatory Affairs Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and analyzes the latest industry trends in each sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the regulatory affairs market report based on services, categories, indications, stages, types, company size, End Use, and region:

• Type Outlook (Revenue, USD Billion, 2018 - 2030­)

  • In-house

  • Outsourced

• Services Outlook (Revenue, USD Billion, 2018 - 2030)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing & Publishing

    • Writing

    • Publishing

  • Product Registration & Clinical Trial Applications

  • Other Services

• Categories Outlook (Revenue, USD Billion, 2018 - 2030)

  • Drugs

  • Innovator

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Generics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Biologics

  • Biotech

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • ATMP

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Biosimilars

    • Preclinical

    • Clinical

    • Pre-Market Approval (PMA)

  • Medical Devices

  • Diagnostics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

  • Therapeutics

  • Preclinical

  • Clinical

  • Pre-Market Approval (PMA)

• Indication Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

  • Neurology

  • Cardiology

  • Immunology

  • Others

• Product Stage Outlook (Revenue, USD Billion, 2018 - 2030)

  • Preclinical

  • Clinical studies

  • PMA

• Company Size Outlook (Revenue, USD Billion, 2018 - 2030)

  • Small

  • Medium

  • Large

• End Use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Medical Device Companies

  • Pharmaceutical Companies

  • Biotechnology Companies

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

  • U.S.

  • Canada

  • Mexico

  • Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Norway

  • Netherlands

  • Switzerland

  • Sweden

  • Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Indonesia

  • Malaysia

  • Singapore

  • Thailand

  • Taiwan

  • Latin America

  • Brazil

  • Argentina

  • Colombia

  • Chile

  • MEA

  • South Africa

  • Saudi Arabia

  • UAE

  • Egypt

  • Israel

  • Kuwait