メディカルライティングの世界市場規模：タイプ別、用途別、エンドユーザー別、地域範囲別および予測

メディカルライティングの市場規模と予測

メディカルライティング市場規模は、2024年に45億米ドルと評価され、2026～2032年にかけてCAGR 11.05%で成長し、2032年には967万米ドルに達すると予測されます。

メディカルライティングとは、科学研究や医療情報をわかりやすく簡潔に表現するプロセスです。

研究紙製、規制関連書類、臨床検査プロトコール、患者教育資料、製薬会社のマーケティング資料など、幅広い出版物の執筆・編集を行っています。

メディカル・ライティングは、医薬品や医療機器の承認、臨床検査、研究結果の科学的な伝達、医療製品やサービスのマーケティングなど、規制上の目的で使用されることがほとんどです。

メディカルライティングの世界市場力学

メディカルライティング市場を形成している主要市場力学は以下の通りです。

主要市場促進要因

臨床検査の増加：世界の臨床検査数の増加は、メディカルライティング市場の主要促進要因です。2024年7月現在、ClinicalTrials.govによると、全米50州と220カ国で45万件を超える検査が登録されています。FDAによると、治験薬（IND）申請件数は過去10年間で継続的に増加しており、年間成長率は7%に達しています。このような臨床検査の増加により、膨大な書類作成、プロトコル、報告書が必要となり、メディカルライティングサービスの需要が高まっています。

慢性疾患の有病率の上昇：慢性疾患の世界の蔓延は、医療文書や患者教育ツールの需要を促進しています。世界保健機関（WHO）によると、慢性疾患は世界全体の死亡原因の71%を占めており、その主要原因は心血管疾患、がん、呼吸器疾患、糖尿病です。例えば、国際糖尿病連合は、2021年には5億3,700万人の成人が糖尿病に罹患し、2045年には7億8,300万人に増加すると予測しています。このような開発により、研究、治療ガイドライン、患者教育をサポートするメディカルライティングの需要が高まっています。

製薬・バイオ産業の成長：製薬産業とバイオテクノロジー産業の成長は、メディカルライティング市場の主要な促進要因です。米国研究製薬工業協会（PhRMA）は、バイオ医薬品産業が2021年に1,023億米ドルを研究開発に投資すると推定しています。FDAは2021年に50の新薬を認可し、高い認可率を維持しています。このセグメントの成長には、薬事申請、研究紙製、マーケティング資料など、幅広いメディカルライティングサービスが必要です。

主要課題

高い技術性：メディカル・ライティングは高度に専門的であるため、複雑な科学的・医療的概念を十分に理解しなければならないという課題があります。確かな科学的知識を持たないライターは、質の高い情報を書くのに苦労し、ミスや誤解を招きます。このように専門的な知識が求められるため、メディカルライターのなり手が少なくなり、企業は産業の厳しい要件に見合う経験豊富な人材を採用することが難しくなっています。

激しい競合情勢：メディカルライティング市場は競争が激しく、多くのフリーライターや企業が同一のサービスを提供しています。この飽和状態がコストを引き下げ、ライターや企業に差別化のプレッシャーを与えています。その結果、収益性を維持することが難しくなり、特に評判が確立され、広範な顧客ネットワークを持つ大企業と効果的に競争する手段を持たない小規模なエージェンシーにとってはなおさらです。

主要動向

レギュラトリーライティング需要の増加薬事ライティング産業は、医薬品の承認件数の増加や、製品開発サイクル全体を通じた正確な文書化の必要性により、大幅に増加すると予測されています。保健当局が定める厳格な要件により、膨大なペーパーワークが必要となり、規制対応メディカルライティングサービスの需要が高まっています。

メディカルライティングのアウトソーシングへのシフト：製薬産業やバイオテクノロジー産業では、メディカルライティングのニーズを専門のサービスプロバイダにアウトソーシングするケースが増えています。アウトソーシングには、有能なメディカルライターへのアクセス、費用対効果、タスク管理の柔軟性といった利点があります。この動向により、高品質なメディカルライティングを維持しながら、自社のコアとなる強みに集中することが可能になります。

高まるメディカルジャーナリズムの重要性：医療ジャーナリズムは、健康問題を調査、報告し、多くの読者に伝えます。健康情報の重要性が拡大し、医療の急速な進歩も相まって、健康関連の情報を効果的に表現できるライターへの需要が高まっています。

当社のレポートには、実用的なデータや将来を見据えた分析が含まれており、ピッチの作成、ビジネスプランの作成、プレゼンテーションの構築、企画書の作成に役立ちます。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主要調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 メディカルライティング市場：タイプ別

• クリニカルライティング
• レギュラトリーライティング
• サイエンティフィックライティング
• 医療ジャーナリズム
• 医療教育
• 医療マーケティング

第5章 メディカルライティング市場：エンドユーザー別

• 製薬・バイオテクノロジー企業
• CRO（医薬品開発業務受託機関）
• 医療機器メーカー
• 学術機関
• 政府機関

第6章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第7章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第8章 競合情勢

• 主要企業
• 市場シェア分析

第9章 企業プロファイル

• Paraxel International
• IQVIA
• Laboratory Corporation of America Holdings
• Icon Plc
• Cardinal Health
• Certara
• Freyr Solutions
• InClin Inc.
• Indegene
• InFocusRX
• Makrocare
• Nucleus Global
• OMICS International
• Quanticate

第10章 市場展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第11章 市場展望付録

• 略語リスト
• 供給源と参考文献

Medical Writing Market Size and Forecast

Medical Writing Market size was valued at USD 4.50 Billion in 2024 and is projected to reach USD 9.67 Million by 2032, growing at a CAGR of 11.05% from 2026 to 2032.

Medical writing is the process of expressing scientific research and medical information in a straightforward, brief, and understandable manner.

It entails writing and editing a wide range of publications, such as research papers, regulatory paperwork, clinical trial protocols, patient education materials, and marketing materials for pharmaceutical corporations.

Medical writing is mostly used for regulatory purposes such as drug and device approvals, clinical trials, scientific communication of research findings, and marketing of medical products and services.

Global Medical Writing Market Dynamics

The key market dynamics that are shaping the medical writing market include:

Key Market Drivers

Increasing number of Clinical Trials: The expanding number of clinical trials worldwide is a major driver of the medical writing market. As of July 2024, ClinicalTrials.gov reports that over 450,000 studies have been registered in all 50 states and 220 countries. According to the FDA, the number of Investigational New Drug (IND) applications has continuously increased over the last decade, with an annual growth rate of 7%. This increase in clinical trials needs significant paperwork, protocols, and reports, which fuels the demand for medical writing services.

Rising Prevalence of Chronic Diseases: The growing prevalence of chronic diseases globally is driving demand for medical documentation and patient education tools. According to the World Health Organization (WHO), chronic diseases account for 71% of all deaths worldwide, with cardiovascular disease, cancer, respiratory disease, and diabetes being the primary causes. For example, the International Diabetes Federation projects that 537 million adults had diabetes in 2021, with that figure expected to climb to 783 million by 2045. This development is driving an increasing demand for medical writing to support research, treatment guidelines, and patient education.

Growing Pharmaceutical and Biotechnology Industry: The growth of the pharmaceutical and biotechnology industries is a major driver of the medical writing market. The Pharmaceutical Research and Manufacturers of America (PhRMA) estimates that the biopharmaceutical industry invested $102.3 billion in R&D in 2021. The FDA authorized 50 new medications in 2021, maintaining its high approval rate. This sector growth requires a wide spectrum of medical writing services, including regulatory filings, research papers, and marketing materials.

Key Challenges:

High Technical Nature: Medical writing's highly technical character presents a challenge, requiring a thorough comprehension of complicated scientific and medical concepts. Writers without a solid scientific background struggle to write high-quality information, resulting in mistakes or misinterpretations. This requirement for specialized expertise reduces the pool of qualified medical writers, making it harder for businesses to recruit experienced workers who match the industry's stringent requirements.

Fierce Competitive Landscape: The medical writing market is highly competitive, with many freelance writers and firms providing identical services. This saturation pulls costs down and puts more pressure on writers and businesses to differentiate themselves. As a result, maintaining profitability becomes difficult, especially for smaller agencies that lack the means to effectively compete with larger firms with established reputations and extensive client networks.

Key Trends:

Increasing Demand for Regulatory Writing: The regulatory writing industry is predicted to increase significantly, driven by the increasing number of medicinal approvals and the necessity for precise documentation throughout the product development cycle. Strict requirements set by health authorities necessitate significant paperwork, increasing demand for regulated medical writing services.

Shift Towards Outsourcing Medical Writing: Pharmaceutical and biotechnology industries are increasingly outsourcing their medical writing needs to specialized service providers. Outsourcing provides advantages such as access to a pool of qualified medical writers, cost-effectiveness, and flexibility in task management. This trend enables businesses to focus on their core strengths while maintaining high-quality medical writing.

Growing Importance of Medical Journalism: Medical journalism investigates, reports, and communicates health issues to a large audience. The expanding relevance of health information, combined with rapid advances in medicine, has created a demand for writers who can effectively express health-related material.

Our reports include actionable data and forward-looking analysis that help you craft pitches, create business plans, build presentations and write proposals.

Global Medical Writing Market Regional Analysis

Here is a more detailed regional analysis of the medical writing market:

North America:

According to Verified Market Research, North America is estimated to dominate the medical writing market over the forecast period. North America, notably the United States, has a large number of pharmaceutical and biotechnology companies, which drives up demand for medical writing services. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the US biopharmaceutical industry directly employs over 800,000 people and supports 4.7 million jobs throughout the economy. According to the U.S. Food and Drug Administration (FDA), 55 innovative medications were approved in 2024, keeping the approval rate high. This high level of industry activity needs considerable medical writing for regulatory submissions, clinical trial paperwork, and marketing materials.

Furthermore, the complicated and strict regulatory landscape in North America, especially in the United States, fuels the demand for specialized medical writing services. The FDA received 7,194 Investigational New Drug (IND) applications in fiscal year 2022, representing a 6% increase over the previous year. In addition, the FDA's Center for Drug Evaluation and Research (CDER) received 140 new drug applications (NDAs) and biologics license applications (BLAs) in 2022. This regulatory activity necessitates considerable documentation, such as clinical trial reports, regulatory submissions, and safety reports, which benefits the regional medical writing market.

Asia Pacific:

The Asia Pacific region is estimated to exhibit the highest growth during the forecast period. The Asia Pacific region is experiencing considerable growth in clinical trials, which is boosting demand for medical writing services. According to ClinicalTrials.gov, China has over 80,000 registered clinical studies by 2024, second only to the United States. According to the Japan Pharmaceutical Manufacturers Association, Japan's clinical trial industry will expand by 8.2% in 2024. This increase in clinical research activities is driving up demand for protocol writing, clinical study reports, and regulatory submissions, thereby strengthening the region's medical writing market.

Furthermore, the increased incidence of chronic diseases in Asia Pacific is a major driver of the medical writing market. According to the World Health Organization's Western Pacific Region office, noncommunicable diseases (NCDs) account for 89% of all fatalities in the region. According to the International Diabetes Federation, 206 million adults in the Western Pacific region, which includes much of Asia, had diabetes in 2021, with that figure expected to rise to 260 million by 2045. This high disease load needs significant medical documentation, patient education materials, and research papers, which are driving the region's medical writing market.

Europe:

Europe region is estimated to exhibit substantial growth during the forecast period. Europe's tight regulatory environment in the pharmaceutical and medical device industries is a major driver of the medical writing market. According to the European Medications Agency (EMA), 89 medications, including 41 new active ingredients, were proposed for marketing authorization in 2024. The enormous volume of approvals, along with the sophisticated documentation required by the EU's regulatory framework, creates a demand for professional medical writers. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the pharmaceutical industry invests around €39 billion per year on research and development in Europe, needing extensive paperwork and regulatory submissions.

Furthermore, the clinical trial market in Europe is expanding rapidly, which is benefiting medical writers. According to the European Clinical Trials Register, the EU/EEA will have over 42,000 registered clinical trials by 2024. According to the European Commission, the EU's Clinical Trials Regulation, which came into effect in January 2022, aims to streamline the assessment and supervision processes for clinical trials across the EU, potentially increasing the number of trials done there. The increase in clinical research activities is driving up the demand for protocol drafting, clinical study reports, and other trial-related paperwork.

Global Medical Writing Market: Segmentation Analysis

The Global Medical Writing Market is segmented based on Type, Application, End-User, and Geography.

Medical Writing Market Segmentation Analysis

Medical Writing Market, By Type

• Clinical Writing
• Scientific Writing
• Regulatory Writing
• Others

Based on Type, the Medical Writing Market is segmented into Clinical Writing, Scientific Writing, Regulatory Writing, and Others. The clinical writing segment is estimated to dominate the medical writing market due to the vital role clinical writing plays in the drug development process, which includes the creation of critical documents such as clinical research protocols and trial reports. The growing global number of clinical trials, along with severe regulatory documentation requirements, strengthens clinical writing's position as the market leadership.

Medical Writing Market, By Application

• Medical Education
• Medical Journalism
• Medico Marketing
• Others

Based on Application, the Medical Writing Market is segmented into Medical Education, Medical Journalism, Medico Marketing, and Others. The medical journalism segment is estimated to dominate the medical writing market. This dominance is driven by the public's growing desire for accurate and easily accessible health information. As health issues gain traction, medical journalists play an important role in translating complex medical concepts into digestible articles for non-experts. The rise of digital platforms has increased the demand for accurate medical journalism, cementing its position as the market's highest application.

Medical Writing Market, By End-User

• Pharmaceutical Companies
• CROs
• Others

Based on End-User, the Medical Writing Market is divided into Pharmaceutical Companies, CROs, and Others. The contract research organizations (CROs) segment is estimated to dominate the market over the forecast period. Pharmaceutical and biotechnology businesses are increasingly outsourcing clinical trials and regulatory writing services to CROs, which is driving this dominance. Because these organizations specialize in handling complex clinical research processes, they require considerable medical writing support for documentation, submissions, and reporting, cementing their position as the market's main end-user segment.

Medical Writing Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World

Based on Geography, the medical writing market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America is estimated to dominate during the forecasted period. The existence of significant pharmaceutical and biotechnology businesses, a strong focus on regulatory compliance, and a high demand for clinical trials all contribute to the region's medical writing market growth. The United States makes a considerable contribution to the North American industry, with healthcare spending anticipated to exceed USD 6.0 trillion by 2027.

Key Players

• The "Medical Writing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Paraxel International, IQVIA, Laboratory Corporation of America Holdings, Icon Plc, Cardinal Health, Certara, Freyr Solutions, InClin, Inc., Indegene, InFocusRX, Makrocare, Nucleus Global, OMICS International, and Quanticate.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Medical Writing Market Recent Developments
• In January 2020, Nuvisan Pharma Services GmbH and Co KG (Germany), a leading CRO/CDMO, announced the acquisition of Inamed GmbH (Germany), a global Contract Research Organization.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Medical Writing Market, By Type

• Clinical writing
• Regulatory writing
• Scientific writing
• Medical journalism
• Medical education
• Medico-marketing

Medical Writing Market, By Application

• Medical Education
• Medical Journalism
• Medico Marketing
• Others

5. Medical Writing Market, By End User

• Pharmaceutical and biotechnology companies
• Contract research organizations (CROs)
• Medical device companies
• Academic institutions
• Government agencies

6. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

7. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

8. Competitive Landscape

• Key Players
• Market Share Analysis

9. Company Profiles

• Paraxel International
• IQVIA
• Laboratory Corporation of America Holdings
• Icon Plc
• Cardinal Health
• Certara
• Freyr Solutions
• InClin Inc.
• Indegene
• InFocusRX
• Makrocare
• Nucleus Global
• OMICS International
• Quanticate

10. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

11. Appendix

• List of Abbreviations
• Sources and References