North America Medical Writing Market Report (2021-2031) by Scope, Segmentation, Dynamics, and Competitive Analysis

The North America medical writing market size is expected to reach US$ 3,128.66 million by 2031 from US$ 1,333.39 million in 2023. The market is estimated to record a CAGR of 11.3% from 2023 to 2031.

Executive Summary and North America Medical Writing Market Analysis:

The North American medical writing market is driven by increasing regulatory requirements, a growing number of clinical trials, and the expanding pharmaceutical and biotech sectors. Stricter compliance standards from regulatory bodies such as the United States Food and Drug Administration (US FDA) also contribute to the demand for accurate medical documentation. Additionally, the trend of outsourcing medical writing tasks further boosts the market growth.

North America Medical Writing Market Strategic Insights

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North America Medical Writing Market Segmentation Analysis

Key segments that contributed to the derivation of the medical writing market analysis are type, application, and end user.

• By type, the medical writing market is segmented into clinical writing, regulatory writing, and scientific writing. The clinical writing held the largest share of the market in 2023.
• By application, the medical writing market is segmented into medical journalism, medical education, and medico marketing. The medical journalism held the largest share of the market in 2023.
• By end user, the medical writing market is bifurcated into pharmaceutical and biotechnology companies, and contract research organizations. The pharmaceutical and biotechnology companies held a larger share of the market in 2023.

North America Medical Writing Market Outlook

Regulatory authorities require detailed information on methodologies followed during all phases of product development to approve products in the biopharmaceutical and pharmaceutical industries. Further, insurance providers require all necessary information about drugs to determine reimbursement policies. Therefore, it becomes a challenging task for biopharmaceutical and pharmaceutical companies to keep up with the industry norms.

The medical writers involved in medical writing are exposed to different tasks that provide valuable insights into protocol design. The data generated from clinical trials reflects all the required information about product labeling, providing summaries for statistical and highly complex data and also offering suggestions for process improvements in understandable language devoid of jargon. The information contained in medical writings is clarified before disclosing the trial results to the public. Medical writers are capable of quickly processing and analyzing the information as per the required rules and regulations by implementing solutions to accelerate the document developing process, thereby allowing to speed up the entire process of drug development. Owing to these benefits, medical writing is gaining significant importance in seeking regulatory approvals without hassles.

North America Medical Writing Market Country Insights

Based on country, the North America medical writing market comprises the US, Canada, and Mexico. The US held the largest share in 2023.

The US medical writing market is driven by regulatory demands, clinical trial growth, and expansion of pharmaceutical and biotech industries.

• Regulatory Demands: With increased drug approvals, such as the 55 new drugs approved by the Center for Drug Evaluation and Research (CDER) in 2023, the need for precise regulatory documentation has surged. Medical writers play a crucial role in preparing clinical study reports, regulatory submissions, and other compliance documents.
• Clinical Trials Growth: The US is a major hub for clinical trials, particularly in oncology, rare diseases, and immunology. The growing number of trials drives the need for medical writers to support trial protocols, regulatory filings, and clinical reports. 
• Pharma & Biotech Expansion: The US is home to leading pharmaceutical companies such as Pfizer, Johnson & Johnson, and Merck, fueling the demand for regulatory submissions, clinical trial reports, and product labeling, in turn expanding the medical writing market.

IQVIA, Parexel, Syneos Health, and Covance are among the key players operating in the market. Market players adopt inorganic growth strategies for market expansion. For instance, Parexel, one of the largest clinical research organizations (CROs) in the world, offers a comprehensive range of clinical development services from Phase I to IV. They have partnered with Palantir Technologies Inc., a leader in building Artificial Intelligence (AI) systems, to create a multi-year strategic alliance aimed at enhancing and accelerating the delivery of safe and effective clinical trials for biopharmaceutical clients. Through this collaboration, Parexel will utilize Palantir’s Foundry and Artificial Intelligence Platform (AIP) to enhance its clinical data platform, focusing on increasing the efficiency of clinical trials while ensuring the highest standards of safety and regulatory compliance.

North America Medical Writing Market Report Highlights

North America Medical Writing Market Company Profiles

Some of the key players operating in the market include Cactus Communications, Parexel International Corp, Certara Inc., Freyr LLC, Quanticate International Ltd, SIRO Clinpharm Pvt Ltd, ProPharma Group, Caidya, Wipro Ltd, SGS SA, Laboratory Corp of America Holdings, TUNECT, Indegene Ltd, Evidera, Syner-G BioPharma Group, EMTEX BV, BioAgile Therapeutics Private Limited, Tata Consultancy Services Ltd, InClin, and TransPerfect Life Sciences, among others. These players are adopting various strategies such as expansion, product innovation, and mergers and acquisitions to provide innovative products to their consumers and increase their market share.

North America Medical Writing Market Research Methodology :

The following methodology has been followed for the collection and analysis of data presented in this report:

• Secondary Research

The research process begins with comprehensive secondary research, utilizing both internal and external sources to gather qualitative and quantitative data for each market. Commonly referenced secondary research sources include, but are not limited to:

• Company websites, annual reports, financial statements, broker analyses, and investor presentations.
• Industry trade journals and other relevant publications.
• Government documents, statistical databases, and market reports.
• News articles, press releases, and webcasts specific to companies operating in the market.

Note: All financial data included in the Company Profiles section has been standardized to USD. For companies reporting in other currencies, figures have been converted to USD using the relevant exchange rates for the corresponding year.

• Primary Research

The Insight Partners conducts a significant number of primary interviews each year with industry stakeholders and experts to validate its data analysis, and gain valuable insights. These research interviews are designed to:

• Validate and refine findings from secondary research.
• Enhance the expertise and market understanding of the analysis team.
• Gain insights into market size, trends, growth patterns, competitive dynamics, and future prospects.

Primary research is conducted via email interactions and telephone interviews, encompassing various markets, categories, segments, and sub-segments across different regions. Participants typically include:

• Industry stakeholders: Vice Presidents, business development managers, market intelligence managers, and national sales managers
• External experts: Valuation specialists, research analysts, and key opinion leaders with industry-specific expertise

North America Medical Writing Market Country and Regional Insights