세계의 메디컬 라이팅(MW) 분야 AI 시장 : 유형별·전개 방식별·최종 용도별, 지역별 평가, 기회와 예측(2018-2032년)

Global AI in medical writing market is projected to witness a CAGR of 11.61% during the forecast period 2025-2032, growing from USD 845.42 million in 2024 to USD 2035.05 million in 2032. The market's growth can be attributed to the increasing production of regulatory documents, scientific publications, and clinical studies, rising reliance on generative AI, and growing focus on the incorporation of new technologies in different healthcare processes to streamline repetitive tasks and reduce incidences of human error.

Regulatory authorities across the globe are gradually showing openness to AI-assisted documentation, provided that human review is maintained and audit trails are preserved. AI also ensures consistency across sections of a submission, helping teams maintain document integrity even when multiple authors are involved. The growing availability of AI platforms offering plug-and-play solutions for clinical documentation has accelerated adoption among mid-sized CROs and pharmaceutical companies that need to meet tight deadlines without expanding writing teams. By using AI tools that are integrated with electronic data capture (EDC) and trial master file (TMF) systems, companies can automate the flow of data from source to submission.

Due to the increasing awareness and acceptance of different AI tools in medical writing, AI companies across the globe are focusing on launching new models that offer research assistance and are transforming scientific content creation workflow. For instance, in November 2024, AINGENS, LLC introduced the Medical Affairs Content Generator (MACg), an AI-powered medical writing tool that provides citation support, editing, and reference management.

Increasing Investments in AI-Powered Solutions Bolster Market Growth

Substantial investments in AI technologies by pharmaceutical, biotech, and contract research organizations (CROs) are propelling the growth of the market. Companies are increasingly allocating budgets to deploy AI-based platforms that support medical writing, as part of broader digital transformation strategies. With the rising need for multilingual medical documentation and region-specific compliance requirements, global pharmaceutical companies are investing in AI systems capable of handling linguistic and regulatory diversity. Furthermore, AI-based automation enables scalable solutions that can handle the rising volume of documentation stemming from expanding pipelines and increasing post-marketing surveillance needs. The resulting efficiencies are fostering a culture of innovation in regulatory writing and increasing accessibility to medical writing support even among emerging biotech and pharmaceutical companies.

Leading AI companies across the globe are focusing on securing funding to support medical writers in keeping up with new drug launches. For instance, in November 2024, Biolevate raised approximately USD 6.8 million in seed funding to develop solutions that help medical writers keep pace with therapeutic product launches. Such launches are expected to reduce the administrative workload associated with the creation of documents for regulatory bodies, enhancing the efficiency of pharmaceutical professionals, thus providing lucrative growth opportunities for the market.

New Launches Support Market Expansion

Innovations and new launches are allowing biotech and pharmaceutical companies to effectively draft essential documents with the help of sophisticated AI technology. New technologies leverage machine learning and natural language processing to ensure compliance with regulatory standards, enhancing consistency and accuracy in medical content and minimizing human errors. The integration of AI tools is also able to address the increasing complexity of regulatory processes and clinical research, allowing companies to adapt to the digital transformation trends and the evolving requirements of the industry.

The key players in the market are focusing on launching new solutions for industrial applications. For instance, in February 2025, Indegene Inc. launched Cortex, a generative AI platform designed for the life science industry. The platform plays a crucial role in scaling and developing high-value life science applications, including improving the efficiency of medical writing and optimization of the content supply chain. By leveraging large language models, the platform delivers accurate and reliable results, with better ROI and faster turnaround times.

Clinical Writing Witnesses Fastest Growth

The increasing volume and complexity of clinical trial data along with the stringent regulatory requirements is propelling the requirement for consistent and accurate documentation. As of 23rd May 2025, 538,875 studies are registered at ClinicalTrials.gov, the publicly available registry and results database, that is run by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

AI tools are well-suited for addressing the rising requirements for automation of repetitive tasks including report generation and summarization, improving turnaround time, and reducing human error. Furthermore, advancements in machine learning and natural language processing are making AI tools more suitable for handling specialized language requirements of clinical writing. As healthcare and pharmaceutical companies across the globe recognize the benefits of AI in managing clinical documentation, including improved accuracy and efficiency and economic benefits, adoption rates are increasing, propelling the market's demand.

North America Holds Major Market Share

The region's dominance in the market can be attributed to the presence of a favorable regulatory environment, strong presence of pharmaceutical companies, and easy acceptance of new technologies. Health Canada and the United States Food and Drug Administration (FDA) are both acknowledging the potential of AI in medical writing and healthcare documentation, supporting the market's expansion in the region.

Furthermore, the increasing shortage of skilled medical writers in the region is encouraging companies to actively invest in AI and launch now AI-integrated solutions to tackle complex documents and manage the increased workload. For instance, in July 2024, InSilico Medicine launched DORA, an AI assistant for drafting research papers. The AI assistant uses large language models to draft case studies and academic papers, in addition to patents and grants. Such launches are expected to boost productivity and reduce barriers for research professionals with limited resources.

Future Market Scenario (2025-2032F)

The market is expected to witness strong growth opportunities in the coming years owing to the rising complexity of regulatory frameworks and the increasing volume of clinical data. Advancements in generative AI and language models are expected to improve the narrative quality and contextual understanding of AI-written documents. Leading market players are focusing on launching domain-specific AI solutions that cater to diverse therapeutic areas. Furthermore, regulatory bodies across the globe are working on introducing new guidelines for the ethical use of AI in medical writing. Over the period, AI tools are anticipated to not only support content generation but also aid in optimizing submission strategies, ensuring standardization in global documentation processes.

Key Players Landscape and Outlook

The key players in the market are focusing on technological innovations and the integration of generative AI with their regulatory writing software. For instance, in June 2024, Certara, Inc. launched its CoAuthor regulatory writing software for medical writers. The software combines structured content authoring tools, document templates, and generative AI to accelerate the creation of regulatory documents. Such innovations are improving quality, consistency, and efficiency in medical writing by reducing drafting time. This integration allows Certara to strengthen its position in the market by allowing scientists and healthcare professionals to manage regulatory demands and tackle increasing data complexities, thus providing lucrative growth opportunities for the market.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Impact of U.S. Tariffs

4. Executive Summary

5. Global AI in Medical Writing Market Outlook, 2018-2032F

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Type
    • 5.2.1.1. Clinical Writing
    • 5.2.1.2. Regulatory Writing
    • 5.2.1.3. Patient Documentation
    • 5.2.1.4. Scientific Writing
  • 5.2.2. By Deployment Mode
    • 5.2.2.1. On-premises
    • 5.2.2.2. Cloud-based
  • 5.2.3. By End-use
    • 5.2.3.1. Medical Device Companies
    • 5.2.3.2. Pharmaceutical and Biotechnology Companies
    • 5.2.3.3. Academic and Research Institutions
    • 5.2.3.4. Others
  • 5.2.4. By Region
    • 5.2.4.1. North America
    • 5.2.4.2. Europe
    • 5.2.4.3. Asia-Pacific
    • 5.2.4.4. South America
    • 5.2.4.5. Middle East and Africa
  • 5.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 5.3. Market Map Analysis, 2024
  • 5.3.1. By Type
  • 5.3.2. By Deployment Mode
  • 5.3.3. By End-use
  • 5.3.4. By Region

6. North America AI in Medical Writing Market Outlook, 2018-2032F

• 6.1. Market Size Analysis & Forecast
  • 6.1.1. By Value
• 6.2. Market Share Analysis & Forecast
  • 6.2.1. By Type
    • 6.2.1.1. Clinical Writing
    • 6.2.1.2. Regulatory Writing
    • 6.2.1.3. Patient Documentation
    • 6.2.1.4. Scientific Writing
  • 6.2.2. By Deployment Mode
    • 6.2.2.1. On-premises
    • 6.2.2.2. Cloud-based
  • 6.2.3. By End-use
    • 6.2.3.1. Medical Device Companies
    • 6.2.3.2. Pharmaceutical and Biotechnology Companies
    • 6.2.3.3. Academic and Research Institutions
    • 6.2.3.4. Others
  • 6.2.4. By Country Share
    • 6.2.4.1. United States
    • 6.2.4.2. Canada
    • 6.2.4.3. Mexico
• 6.3. Country Market Assessment
  • 6.3.1. United States AI in Medical Writing Market Outlook, 2018-2032F*
    • 6.3.1.1. Market Size Analysis & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share Analysis & Forecast
      • 6.3.1.2.1. By Type
        • 6.3.1.2.1.1. Clinical Writing
        • 6.3.1.2.1.2. Regulatory Writing
        • 6.3.1.2.1.3. Patient Documentation
        • 6.3.1.2.1.4. Scientific Writing
      • 6.3.1.2.2. By Deployment Mode
        • 6.3.1.2.2.1. On-premises
        • 6.3.1.2.2.2. Cloud-based
      • 6.3.1.2.3. By End-use
        • 6.3.1.2.3.1. Medical Device Companies
        • 6.3.1.2.3.2. Pharmaceutical and Biotechnology Companies
        • 6.3.1.2.3.3. Academic and Research Institutions
        • 6.3.1.2.3.4. Others
  • 6.3.2. Canada
  • 6.3.3. Mexico

All segments will be provided for all regions and countries covered

7. Europe AI in Medical Writing Market Outlook, 2018-2032F

• 7.1. Germany
• 7.2. France
• 7.3. Italy
• 7.4. United Kingdom
• 7.5. Russia
• 7.6. Netherlands
• 7.7. Spain
• 7.8. Turkey
• 7.9. Poland

8. Asia-Pacific AI in Medical Writing Market Outlook, 2018-2032F

• 8.1. India
• 8.2. China
• 8.3. Japan
• 8.4. Australia
• 8.5. Vietnam
• 8.6. South Korea
• 8.7. Indonesia
• 8.8. Philippines

9. South America AI in Medical Writing Market Outlook, 2018-2032F

• 9.1. Brazil
• 9.2. Argentina

10. Middle East and Africa AI in Medical Writing Market Outlook, 2018-2032F

• 10.1. Saudi Arabia
• 10.2. UAE
• 10.3. South Africa

11. Demand Supply Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Market Trends and Developments

17. Technological Advancements and Innovation

18. Case Studies

19. Competitive Landscape

• 19.1. Competition Matrix of Top 5 Market Leaders
• 19.2. SWOT Analysis for Top 5 Players
• 19.3. Key Players Landscape for Top 10 Market Players
  • 19.3.1. Indegene Inc.
    • 19.3.1.1. Company Details
    • 19.3.1.2. Key Management Personnel
    • 19.3.1.3. Products and Services
    • 19.3.1.4. Financials (As Reported)
    • 19.3.1.5. Key Market Focus and Geographical Presence
    • 19.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 19.3.2. Suki AI, Inc.
  • 19.3.3. Certara, Inc.
  • 19.3.4. Abridge Al, Inc.
  • 19.3.5. Freyr Software Services Pvt Ltd
  • 19.3.6. IQVIA Inc.
  • 19.3.7. GENINVO
  • 19.3.8. Teladoc Health, Inc.
  • 19.3.9. TrialAssure
  • 19.3.10. Yseop S.A.S

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

20. Strategic Recommendations

21. About Us and Disclaimer