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U.S. Regulatory Affairs Market Report Highlights
- By service, the regulatory writing and publishing segment dominated the U.S. regulatory affairs market share of over 19.5% in 2024.
- By service, the legal representation segment is expected to grow the fastest during the forecast period.
- By category, the medical devices segment accounted for the largest market revenue share in 2024 and is anticipated to grow at the fastest CAGR over the forecast period.
- By category, the biology segment is anticipated to grow the fastest during the forecast period.
- By indication, the oncology segment accounted for the largest market revenue share in 2025.
- By indication, the immunology segment is expected to be the fastest-growing during the forecast period.
- By product stage, the clinical studies segment accounted for the largest U.S. regulatory affairs market revenue share in 2024.
- By product stage, the preclinical segment is expected to grow fastest during the forecast period.
- By service provider, the outsourced segment accounted for the largest market revenue share in 2024 and is anticipated to grow at the fastest CAGR over the forecast period.
- By company size, the medium-sized segment accounted for the largest market share revenue share in 2024.
- By company size, the large-size companies segment is projected to register the fastest CAGR during the forecast period.
- By end-use, the pharmaceutical companies segment dominated the U.S. regulatory affairs market in 2024 and is anticipated to grow at the fastest CAGR over the forecast period.
The market expansion is estimated to drive the growth of the market in the near future. U.S. companies seeking international approvals (e.g., EMA, MHRA, PMDA) require regulatory expertise to navigate complex global regulations. The rise in the adoption of inorganic growth strategies like mergers and acquisitions to get regulatory bodies' approval is estimated to drive the growth of the U.S. regulatory affairs market in the near future.
Uptake In R&D Investments And Drug Development Drives Growth
Increasing regulatory requirements is estimated to drive the growth of the U.S. regulatory affairs market in the near future. The U.S. Food and Drug Administration and other agencies are continuously updating regulations for pharmaceuticals, medical devices, biologics, and food products, driving demand for regulatory experts. Increasing drug & medical device approvals is estimated to drive the growth of the market in the near future. Growth in the biotech and pharmaceutical sectors, along with accelerated approval pathways, increases the need for regulatory compliance professionals. As companies merge or acquire new products, they need regulatory affairs teams to ensure compliance with evolving legal and regulatory standards.
The expansion of clinical trials is estimated to drive the growth of the U.S. regulatory affairs market in the near future. More clinical trials, including those for personalized medicine and rare diseases, require regulatory oversight, boosting demand for regulatory affairs services. Growing focus on compliance & quality is estimated to drive the growth of the market in the near future. Increased scrutiny from regulators, stricter enforcement, and higher penalties for non-compliance are pushing companies to invest more in regulatory affairs. Regulatory outsourcing trends are estimated to drive the growth of the market in the near future. Many firms, especially small and mid-sized companies, are outsourcing regulatory affairs to specialized consultancies, driving market growth.
U.S. Regulatory Affairs Market Trends
• Emerging Therapeutic Areas: The rise of immunotherapies, orphan drugs, personalized medicines, combination therapies, and specialty therapies has necessitated robust regulatory strategies to ensure quality, efficacy, and safety.
• Regulatory Reforms in the Crypto Industry: Recent developments indicate a shift towards a more lenient regulatory environment for cryptocurrencies. The U.S. Securities and Exchange Commission (SEC) has closed its investigation into Robinhood's crypto trading arm without action, and a lawsuit against Coinbase has been dropped. These actions suggest potential regulatory easing in the crypto sector.
• Expansion of Cross-Margining in U.S. Treasury Markets: The Depository Trust and Clearing Corporation (DTCC) and CME Group plan to expand their cross-margining arrangements to include clearing members' clients by December 2025. This initiative aims to regulate leverage for hedge funds and investors, balancing increased transaction costs from new clearing requirements.
• Deregulation Initiatives: The current administration has issued executive orders to bring independent financial watchdogs under executive control, aiming to reduce regulatory barriers and boost business. This move could impact various sectors, including banking, pharmaceuticals, and mergers and acquisitions.
• Growth in Unauthorized Vape Sales: Despite regulatory efforts, unauthorized flavored disposable vape sales in the U.S. reached approximately $2.4 billion in 2024, accounting for 35% of e-cigarette sales in certain retail venues. This trend highlights challenges in regulatory enforcement and the need for more stringent measures.
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U.S. Regulatory Affairs Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 5.58 Billion |
|
Revenue forecast in 2034 |
USD 12.23 Billion |
|
Growth rate |
CAGR of 9.1% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Services, category, indication, product stage, service provider, company size, end-use |
|
Country scope |
U.S. |
|
Key companies profiled |
Accell Clinical Research, LLC; Genpact; CRITERIUM, INC.; ICON plc; Promedica International; WuXi AppTec; Medpace; Charles River Laboratories; Labcorp Drug Development; Parexel International (MA) Corporation; Freyr; Pharmalex GmbH; NDA Group AB; Qvigilance; BlueReg; Cambridge Regulatory Services; VCLS |
AI integration In The U.S. Regulatory Affairs Market
AI is transforming regulatory affairs by improving efficiency, accuracy, and compliance. The integration of AI in regulatory processes helps pharmaceutical, biotechnology, and medical device companies streamline operations, reduce costs, and accelerate approvals. AI-driven Natural Language Processing (NLP) automates the extraction and formatting of data for regulatory submissions, reducing manual effort. Machine Learning (ML) models identify gaps in compliance documentation, preventing errors that could delay approvals. AI tools help generate reports that align with FDA, EMA, and other regulatory guidelines. AI predicts regulatory risks based on past approvals and rejections, guiding companies to optimize applications. AI-powered analytics assess clinical trial data quality and regulatory compliance, helping to meet FDA requirements faster. AI integration reduces the time needed for FDA’s New Drug Application (NDA) and Biologics License Application (BLA) processes.
AI analyzes historical regulatory decisions to forecast approval probabilities. Chatbots and virtual assistants provide real-time regulatory guidance, improving decision-making. AI-powered platforms benchmark a company’s regulatory submissions against competitors for strategic planning. AI monitors real-world evidence, social media, and EHR data for adverse event detection. Machine learning models predict potential safety issues, allowing for early intervention. Automated reporting ensures compliance with FDA’s adverse event reporting system (FAERS). AI streamlines labelling compliance checks by ensuring consistency with global regulatory requirements. NLP tools translate regulatory documents and align them with region-specific guidelines.
U.S. Regulatory Affairs Market Segment Insights
Service Insights
The regulatory writing & publishing segment held a dominant presence in the U.S. regulatory affairs market in 2024. Regulatory writing and publishing, product registration and clinical trial applications, legal representation, regulatory consultancy, and other services comprise the market. Mid- to large-sized biopharmaceutical and medical device companies are increasingly outsourcing these services. In order to highlight its core capabilities and efficiently manage its internal sources, major pharmaceutical and medical device firms outsource regulatory affairs tasks, such as regulatory writing and publication services.
The legal representation segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. The country's growing healthcare reforms and increasingly complex healthcare legislation are to blame for the growth.
Category Insights
The medical devices segment led the U.S. regulatory affairs market. This can be linked to pharmaceutical companies' increased medical device outsourcing, which frees them up to concentrate on their core skills. Among the drivers expected to fuel this segment's growth are the complexity of drug-device combinations, the growing demand for wearable medical devices, and the quick advances in material sciences.
The biology segment registered its dominance over the market in 2024. The process of creating products in the biotechnology industry is challenging since even small changes to the environment can negatively impact the cells and structure of a biological product. Furthermore, since a contaminated product might be harmful to patients, the production process, materials, and equipment are designed to prevent bacterial contamination during the procedure. As a result, the methods employed throughout the procedure guarantee a sterile and safe product.
Indication Insights
The oncology segment accounted for a significant share of the U.S. regulatory affairs market in 2024. This is explained by the rising number of cancer diagnoses, which is driving up demand for safe and efficient treatment options. Additionally, one of the lucrative areas for biotechnology and pharmaceutical firms is oncology, which boosts the research and development initiatives that the corporations have started. For example, according to a December 2023 Businesswire article, the U.S. Oncology Network announced that it has partnered with Nashville, Tennessee-based SCRI Oncology Partners to expand further. The facility offers patients specialized cancer treatment as well as chances to participate in clinical studies with new drugs.
The immunology segment is anticipated to grow with the highest CAGR in the market during the studied years as a result of its potential to aid in the treatment of a number of cardiovascular, neurological, inflammatory, and cancerous conditions. This is explained by the presence of immune cells throughout the body as well as tissue-specific immune cells in organs. It is anticipated that the robust immunology channel of pharmaceutical and biopharmaceutical businesses will fuel segment expansion.
Product Stage Insights
The clinical studies segment dominated the U.S. regulatory affairs market. It is anticipated that the number of clinical trials carried out to support healthcare needs will increase due to the rising incidence of chronic illnesses and new disorders. These procedures guarantee that clinical trials are carried out clearly and under guidance, resulting in trials that are dependable, successfully presented to people, and present accurate results.
The preclinical segment is projected to expand rapidly in the market in the coming years. In addition to the increasing prevalence of many prevalent diseases, such as cancer, neurological disorders, and cardiovascular diseases (CVDs), the growth is ascribed to the growing demand for novel disease treatments, such as those for Zika virus, Ebola, and COVID-19.
Service Provider Insights
The outsourced segment held a dominant presence in the market. Growth can be attributable to the increasing popularity of these facilities since outsourcing enables healthcare organizations to prioritize planned projects, save costs and staff training times, increase overall efficacy, and provide greater flexibility. Further growth in the outsourced market is anticipated due to the availability of multiple outsourcing models suitable for a wide range of business sizes.
The In-house segment is anticipated to grow with the highest CAGR in the U.S. regulatory affairs market during the studied years. The FDA and other regulatory bodies frequently update compliance requirements, prompting companies to build dedicated in-house teams for faster adaptation. While outsourcing was traditionally preferred, companies are realizing that having an internal team reduces long-term costs, especially for firms with frequent regulatory submissions. The rise of biologics, gene therapies, and digital health products requires specialized knowledge, which companies prefer to retain in-house. In-house teams work closely with R&D, quality assurance, and legal teams, ensuring seamless compliance and reducing risks.
Company Size Insights
The medium-sized company segment registered its dominance over the market in 2024 due to a number of well-known mid-sized providers, particularly privately held ones, who are expected to support the expansion of the market. These companies provide a wide range of services, from a few to full-length, and are well-established in several niche industries worldwide.
The large-size companies segment is expected to grow at the fastest rate in the market during the forecast period of 2024 to 2034. There are many well-known biotechnology, medical device, and pharmaceutical businesses that are large in size. The availability of a broad range of services and the accessibility of these providers across different regions make organization simple.
End-use Insights
The pharmaceutical companies segment dominated the U.S. regulatory affairs market in 2024. The U.S. Food and Drug Administration (FDA) imposes strict requirements on drug development, clinical trials, and approvals, driving high demand for regulatory affairs professionals. The pharmaceutical industry constantly develops new drugs, generics, and biologics, requiring extensive regulatory oversight. Regulations such as the Food, Drug, and Cosmetic Act (FDCA) and the Biologics Control Act create a need for experts to navigate compliance. The growth of biologics and biosimilars necessitates specialized regulatory support, increasing market dominance. Big Pharma companies invest heavily in R&D, necessitating regulatory affairs professionals to oversee new drug applications (NDAs) and biologics license applications (BLAs).
The biotechnology companies segment is projected to expand rapidly in the market over the forecast period. Increasing demand for monoclonal antibodies, gene therapies, and mRNA-based treatments is driving biotech firms to seek regulatory support. The Biologics Price Competition and Innovation Act (BPCIA) has accelerated the U.S. regulatory affairs market, requiring complex regulatory pathways. FDA approvals for CAR-T therapies, CRISPR-based gene editing, and regenerative medicines require specialized regulatory expertise.
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U.S. Regulatory Affairs Market key Company Insights
• Accell Clinical Research, LLC is a contract research organization (CRO) that operates in the U.S. regulatory affairs market, which involves navigating the complex regulatory landscape to ensure compliance with federal and state laws governing the development, testing, and approval of new drugs, devices, and therapies.
• ICON plc is a global provider of drug development solutions, including regulatory affairs services, that plays a significant role in the U.S. Regulatory Affairs market. The company helps pharmaceutical, biotechnology, and medical device companies efficiently navigate the complex regulatory landscape to bring their products to market.
• ProMedica, Cambridge Regulatory Services, and Medpace are other market participants in the U.S. regulatory affairs market.
• ProMedica International is a leading provider of regulatory affairs consulting services in the U.S. The company assists clients in navigating complex regulatory environments and ensuring compliance with various federal and state regulatory requirements.
• Cambridge Regulatory Services specializes in assisting clients with navigating the complex regulatory landscape, ensuring compliance with relevant laws and regulations, and facilitating the approval process for products and services.
U.S. Regulatory Affairs Market Top Key Companies:
• Accell Clinical Research, LLC
• Genpact
• CRITERIUM, INC.
• ICON plc
• Promedica International
• WuXi AppTec
• Medpace
• Charles River Laboratories
• Labcorp Drug Development
• Parexel International (MA) Corporation
• Freyr
• Pharmalex GmbH
• NDA Group AB
• Qvigilance
• BlueReg
• Cambridge Regulatory Services
• VCLS
Recent Developments
• In January 2025, A new guidance agenda outlining the updated and new guidance papers slated for release in 2025 has been prepared by the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA). In addition to addressing new International Council for Harmonization (ICH) themes, many of the updated and new recommendations that are scheduled for release are for generic medications.
• In January 2025, The Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence Executive Order 14110 was revoked on January 20, 2025. Before their goods could be made available to the general population, companies that were creating Al had to submit information about their technology to the federal government.
• In October 2023, the U.S. Integrity and Odds-on Compliance announced a merger to introduce the industry’s first global compliance and integrity solution. The merger aims to deliver continuous innovative governing technology solutions & unique compliance proficiency to the growing gaming and sports betting sphere.
• In February 2023, the U.S. FDA announced acknowledged requests to join the START Pilot Program and chose only three applicants from centers, including the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
U.S. Regulatory Affairs Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Regulatory Affairs Market
U.S. Regulatory Affairs Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. regulatory affairs market report based on services, category, indication, product stage, service provider, company size, end-use, and country:
By Service
• Services Regulatory consulting
• Legal Representation
• Regulatory Writing & Publishing
• Writing
• Publishing
• Product registration & Clinical Trial Applications
• Other Services
By Category
• Drugs
o Innovator
o Preclinical
o Clinical
o Pre-Market Approval (PMA)
o Generics
o Preclinical
o Clinical
o Pre-Market Approval (PMA)
• Biologics
o Biotech
o Preclinical
o Clinical
o Pre-Maker Approval (PMA)
o ATMP
o Preclinical
o Clinical
o Pre-Maker Approval (PMA)
• Biosimilars
• Preclinical
• Clinical
• Pre-Market Approval (PMA)
• Medical Devices
o Diagnostics
o Preclinical
o Clinical
o Pre-Market Approval (PMA)
o Therapeutics
o Preclinical
o Clinical
o Pre-Market Approval (PMA)
By Indication
• Oncology
• Neurology
• Cardiology
• Immunology
• Others
By Product Stage
• Preclinical
• Clinical studies
• PMA
By Service Provider
• In-house
• Outsourced
By Company Size
• Small
• Medium
• Large
By End-use
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies
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