The growing number of clinical trials, increasing regulatory complexity, and rapid AI integration in the life sciences sector are driving a radical change in the process of creating and managing medical documentation.
Austin, Nov. 05, 2025 (GLOBE NEWSWIRE) — AI in Medical Writing Market Size & Growth Analysis
According to a report by SNS Insider, the global AI in Medical Writing market was valued at USD 869.05 million in 2024 and is expected to reach USD 2.24 billion by 2032, growing at a CAGR of 12.58% during 2025–2032. The US market was valued at USD 170.73 million in 2024, and will grow to USD 465.27 million by 2032, at a CAGR of 13.40%. This growth is being driven by the increasing number of clinical trials, increasing regulatory documents, and digital transformation in pharmaceutical manufacturing and biotech research.
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Technologies such as natural language processing (NLP), machine learning (ML), and generative AI are revolutionizing the creation, review, and presentation of clinical study reports, regulatory submissions, and scientific writing. The use of AI is increasing in pharmaceutical, biotech, and CRO companies as pressure mounts to speed up the drug approval process and manage complex documentation.
AI in Medical Writing Market Overview
AI in medical writing is used to create, analyze, and standardize regulatory and clinical documentation using advanced computational tools. According to Evaluate Pharma, R&D spending in 2024 was over USD 244 billion, which has led to a huge increase in the demand for documentation for discovery, development, and post-market surveillance.
AI tools are providing solutions to key issues such as the shortage of skilled medical writers, the increasing complexity of documents, and the demand for real-time compliance monitoring. Regulatory bodies are also now adopting AI-assisted structured reporting, making presentation more efficient and accurate.
Generative AI is being used for automated story generation, predictive analytics for data verification, and AI-driven compliance frameworks to align with standards such as ICH E3 and FDA eCTD. Accuracy, speed, scalability, and traceability are emerging as key benefits of AI-enabled authoring platforms.
Major Players in the AI in Medical Writing Market Include:
- Certara Inc.
- Parexel International
- Cactus Communications
- Freyr Solutions
- ICON plc
- IQVIA Inc.
- Syneos Health
- GENINVO Inc.
- Trilogy Writing & Consulting
- Teladoc Health and Other Key Participants
AI in Medical Writing Market Segment Insights
By Type:
The “Typewriting” segment led the market with a 33.02% share in 2024. This was made possible by the increasing use of AI-based transcription and intelligent document conversion systems. These systems increase productivity and reduce manual work by automatically generating medical notes, clinical reports, and patient documents from voice input.
The “Clinical Writing” segment is expected to register the highest CAGR by 2032. The increasing complexity of clinical trials and the increase in regulatory submissions are driving the demand for AI-based tools. CROs and life sciences companies are adopting AI-enabled writing solutions to improve consistency, compliance, and audit readiness.
By End Use:
The pharmaceutical segment accounted for 33.37% of the market share in 2024, as each stage of drug development requires the preparation of a large number of regulatory documents, labeling, and scientific publications.
The highest growth is expected in the medical device segment, as global regulations are becoming stricter and the need for accurate and compliant solutions for post-market surveillance documentation is increasing.
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Regional Analysis
Asia-Pacific at the forefront
Asia-Pacific accounted for about 30.47% of global revenue in 2024 and emerged as the leading regional market. The region is witnessing increasing clinical trials, outsourcing by Western pharmaceutical companies, and widespread use of AI-enabled writing technologies. India’s growing CRO networks and AI-based health startups are developing rapidly due to national digital health programs. China’s investment in AI infrastructure and drug research is also fueling demand.
North America
The region is witnessing consistent growth due to strong healthcare infrastructure, high AI research funding, and adoption by leading pharmaceutical companies. The market is fueled by biopharma R&D spending of over USD 86 billion in 2024 and the presence of companies such as IBM Watson Health, Oracle Health Sciences. FDA’s AI-based document compliance projects are also contributing to the growth.
Europe
Germany and the United Kingdom are leading the way, with pharmaceutical companies and academic institutions seeing increasing adoption of AI-based document management tools. The European Medicines Agency’s focus on digital presentation standards and the proliferation of multilingual AI tools are fueling growth in Europe.
Recent Developments in the AI in Medical Writing Market
- April 2025: Indegene develops generative AI platform for regulatory writing, including real-time compliance checking.
- May 2025: Parexel introduced an AI tool that automates patient narratives and clinical reporting, resulting in 40%-time savings.
- November 2024: France-based Biolevate raises USD 6.42 million in funding for its AI-based medical writing platform.
- May 2024: Indegene launches a complete AI platform called CORTEX.AI, which automates medical writing and regulatory submissions.
Exclusive Sections of the Report (The USPs):
- ADOPTION RATE OF AI IN MEDICAL WRITING – helps you understand how rapidly AI tools are being integrated into regulatory, clinical, and scientific writing workflows across key healthcare markets.
- APPLICATION TRENDS BY REGION – helps you identify regional differences in AI deployment for medical documentation, regulatory submissions, and pharmacovigilance reporting.
- TIME SAVINGS & EFFICIENCY GAINS – helps you measure productivity improvements and turnaround time reductions achieved through automation and NLP-driven content generation.
- COMPLIANCE & ERROR REDUCTION METRICS – helps you assess how AI solutions enhance accuracy, reduce human error, and ensure alignment with global regulatory standards such as EMA and FDA.
- TALENT & WORKFORCE TRENDS – helps you analyze the evolving skill landscape, highlighting the growing demand for hybrid professionals skilled in medical communication and AI tools.
- HEALTHCARE IT SPENDING ON AI – helps you track regional investment patterns across government, commercial, and private sectors, indicating areas of high adoption and funding momentum.
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AI In Medical Writing Market Report Scope
| Report Attributes | Details |
| Market Size in 2024 | USD 869.05 million |
| Market Size by 2032 | USD 2240.06 million |
| CAGR | CAGR of 12.58% From 2025 to 2032 |
| Base Year | 2024 |
| Forecast Period | 2025-2032 |
| Historical Data | 2021-2023 |
| Key Segments | By Type (Clinical Writing, Typewriting, Scientific Writing, and Others)
By End Use (Medical Devices, Pharmaceutical, Biotechnology, and Others) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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