薬事アウトソーシング市場レポート：サービス別、企業規模別、カテゴリー別、適応症別、ステージ別、エンドユーザー別、地域別、2024～2032年

世界の薬事アウトソーシング市場規模は2023年に77億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに151億米ドルに達し、2024～2032年の間に7.6%の成長率（CAGR）を示すと予測しています。進化する複雑な規制、産業のグローバリゼーション、リソースの最適化、継続的な技術の進歩、専門的な専門知識の必要性、迅速な承認の必要性などが、市場を推進する主要要因の一部です。

薬事アウトソーシングとは、企業が薬事コンプライアンスや文書化業務を外部の専門サービス・プロバイダーに委託することです。この取り決めでは、特に医薬品、バイオテクノロジー、医療機器など規制の厳しい業界の企業は、規制関連業務を自社に代わって管理する第三者の専門家や企業を雇う。これには、製品登録、品質保証、政府規制の遵守、規制当局への必要書類の提出といった業務が含まれます。これらの業務をアウトソーシングすることで、企業は規制の枠組みに精通した専門家の専門知識を活用し、プロセスを合理化し、諸経費を削減し、進化する規制基準を確実に遵守することができ、最終的には市場参入と製品承認を促進することができます。

世界の薬事アウトソーシング市場は、主に医薬品、医療機器、飲食品（F&B）を含む様々な業界において、政府や規制機関が課す規制要件が複雑化・厳格化していることから、大きな成長を遂げています。さらに、企業が最新の規制変更とコンプライアンス基準に精通した専門家集団にアクセスできるようにするための製品採用の拡大が、それによってタイムリーな承認と市場参入を確実なものにしており、市場の成長に寄与しています。さらに、市場のグローバリゼーションによって企業の地理的範囲が拡大し、多数の国際規制への準拠が必要となったことも、市場の成長を後押ししています。さらに、地域間の多様な規制ニーズに対応するスケーラブルなソリューションを提供するアウトソーシングのニーズが高まっていることも、市場拡大に寄与しています。これとは別に、コスト効率と業務の柔軟性に対する新たな動向は、企業が外部の規制サービスを活用する原動力となっており、諸経費を削減しながらコアコンピタンスに集中することを可能にし、市場拡大への前向きな展望を生み出しています。

薬事アウトソーシング市場傾向/促進要因：

規制状況の複雑化

薬事アウトソーシングの主要促進要因のひとつは、さまざまなセクターで規制環境がますます複雑化し、進化し続けていることです。医薬品、バイオテクノロジー、医療機器、飲食品などの業界は、製品の安全性、有効性、品質基準の遵守を保証するために厳しい規制を受けています。これらの規制に対応するためには、専門的な知識と継続的なモニタリングが必要です。薬事業務をアウトソーシングすることで、企業は、地域や国際的な規制の枠組みのニュアンスを理解することに特化した専門家の専門知識を活用することができます。これとは別に、これらの専門家は、企業が複雑な規則の網の目をくぐり抜け、製品がコンプライアンス基準を満たしていることを確認するのを支援し、最終的に市場参入と製品承認を促進します。

市場のグローバリゼーションの拡大

薬事アウトソーシングの成長に拍車をかけているもうひとつの重要な要因は、市場のグローバリゼーションです。世界に事業を展開する企業は、地域や国によって異なる多様な規制要件に直面します。こうした規制への対応は、特に社内の薬事関連リソースが限られている企業にとっては、気の遠くなるような作業になりかねないです。アウトソーシングは、このような多様な規制ニーズに効率的に対応するための拡大性のあるソリューションを記載しています。薬事アウトソーシング企業は、多くの場合、世界的プレゼンスを有しており、異なる市場の特定の要件を満たすために自社の製品やプロセスを適合させることで、市場参入と国際的な成長を可能にする企業を支援することができます。

コスト効率と業務生産性への注目の高まり

コスト効率と業務重視の必要性により、企業は外部の薬事サービスを活用するようになっています。社内に薬事チームを維持するためには、給与、トレーニング、インフラストラクチャーなど、多額の間接費がかかります。薬事業務をアウトソーシングすることで、企業はこれらの固定費を削減し、資源配分の柔軟性を得ることができます。このアプローチにより、企業はリソースを研究開発（R&D）、マーケティング、生産などのコアコンピタンスに振り向けることができます。薬事業務を専門のアウトソーシング・パートナーに任せることで、企業は業務を合理化し、効率を高め、市場力学により効果的に対応することができます。

目次

第1章 序文

第2章 調査範囲と調査手法

• 調査の目的
• ステークホルダー
• データソース
  • 一次情報
  • 二次情報
• 市場推定
  • ボトムアップアプローチ
  • トップダウンアプローチ
• 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

• 概要
• 主要業界動向

第5章 世界の薬事アウトソーシング市場

• 市場概要
• 市場実績
• COVID-19の影響
• 市場予測

第6章 市場内訳：サービス別

• 規制コンサルティング
• 法的代理
• 規制文書の作成と出版
• 製品登録と臨床試験申請
• その他

第7章 市場内訳：企業規模別

• 小規模
• 中規模
• 大規模

第8章 市場内訳：カテゴリー別

• ジェネリック医薬品
• 革新的医薬品
• 生物製剤
• バイオシミラー
• 医療機器
  • 市場動向
  • 主要タイプ
    • 治療
    • 診断
  • 市場予測
• その他

第9章 市場内訳：適応症別

• 腫瘍学
• 神経学
• 心臓病学
• 免疫学
• その他

第10章 市場内訳：ステージ別

• 前臨床
• 臨床
• PMA（市販後承認）

第11章 市場内訳：エンドユーザー別

• 医療機器企業
• 製薬会社
• バイオテクノロジー企業

第12章 市場内訳：地域別

• 北米
  • 米国
  • カナダ
• アジア太平洋
  • 中国
  • 日本
  • インド
  • 韓国
  • オーストラリア
  • インドネシア
  • その他
• 欧州
  • ドイツ
  • フランス
  • 英国
  • イタリア
  • スペイン
  • ロシア
  • その他
• ラテンアメリカ
  • ブラジル
  • メキシコ
  • その他
• 中東・アフリカ
  • 市場動向
  • 市場内訳：国別
  • 市場予測

第13章 SWOT分析

• 概要
• 強み
• 弱み
• 機会
• 脅威

第14章 バリューチェーン分析

第15章 ポーターのファイブフォース分析

• 概要
• 買い手の交渉力
• 供給企業の交渉力
• 競合の程度
• 新規参入業者の脅威
• 代替品の脅威

第16章 価格分析

第17章 競合情勢

• 市場構造
• 主要企業
• 主要企業のプロファイル
  • Charles River Laboratories International Inc.
  • Covance Inc（Laboratory Corporation of America Holdings）
  • Freyr
  • ICON Plc
  • Medpace Holdings Inc
  • Parexel International Corporation
  • Pharmaceutical Product Development LLC
  • Promedica International-A California Corporation
  • Wuxi AppTec Co. Ltd.

List of Figures

• Figure 1: Global: Regulatory Affairs Outsourcing Market: Major Drivers and Challenges
• Figure 2: Global: Regulatory Affairs Outsourcing Market: Sales Value (in Billion US$), 2018-2023
• Figure 3: Global: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Billion US$), 2024-2032
• Figure 4: Global: Regulatory Affairs Outsourcing Market: Breakup by Services (in %), 2023
• Figure 5: Global: Regulatory Affairs Outsourcing Market: Breakup by Company Size (in %), 2023
• Figure 6: Global: Regulatory Affairs Outsourcing Market: Breakup by Category (in %), 2023
• Figure 7: Global: Regulatory Affairs Outsourcing Market: Breakup by Indication (in %), 2023
• Figure 8: Global: Regulatory Affairs Outsourcing Market: Breakup by Stage (in %), 2023
• Figure 9: Global: Regulatory Affairs Outsourcing Market: Breakup by End User (in %), 2023
• Figure 10: Global: Regulatory Affairs Outsourcing Market: Breakup by Region (in %), 2023
• Figure 11: Global: Regulatory Affairs Outsourcing (Regulatory Consulting) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 12: Global: Regulatory Affairs Outsourcing (Regulatory Consulting) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 13: Global: Regulatory Affairs Outsourcing (Legal Representation) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 14: Global: Regulatory Affairs Outsourcing (Legal Representation) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 15: Global: Regulatory Affairs Outsourcing (Regulatory Writing and Publishing) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 16: Global: Regulatory Affairs Outsourcing (Regulatory Writing and Publishing) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 17: Global: Regulatory Affairs Outsourcing (Product Registration and Clinical Trial Applications) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 18: Global: Regulatory Affairs Outsourcing (Product Registration and Clinical Trial Applications) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 19: Global: Regulatory Affairs Outsourcing (Other Services) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 20: Global: Regulatory Affairs Outsourcing (Other Services) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 21: Global: Regulatory Affairs Outsourcing (Small) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 22: Global: Regulatory Affairs Outsourcing (Small) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 23: Global: Regulatory Affairs Outsourcing (Medium) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 24: Global: Regulatory Affairs Outsourcing (Medium) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 25: Global: Regulatory Affairs Outsourcing (Large ) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 26: Global: Regulatory Affairs Outsourcing (Large ) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 27: Global: Regulatory Affairs Outsourcing (Generic Drugs) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 28: Global: Regulatory Affairs Outsourcing (Generic Drugs) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 29: Global: Regulatory Affairs Outsourcing (Innovator Drugs) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 30: Global: Regulatory Affairs Outsourcing (Innovator Drugs) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 31: Global: Regulatory Affairs Outsourcing (Biologic Drugs) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 32: Global: Regulatory Affairs Outsourcing (Biologic Drugs) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 33: Global: Regulatory Affairs Outsourcing (Biosimilars) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 34: Global: Regulatory Affairs Outsourcing (Biosimilars) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 35: Global: Regulatory Affairs Outsourcing (Medical Devices) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 36: Global: Regulatory Affairs Outsourcing (Medical Devices) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 37: Global: Regulatory Affairs Outsourcing (Other Categories) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 38: Global: Regulatory Affairs Outsourcing (Other Categories) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 39: Global: Regulatory Affairs Outsourcing (Oncology) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 40: Global: Regulatory Affairs Outsourcing (Oncology) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 41: Global: Regulatory Affairs Outsourcing (Neurology) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 42: Global: Regulatory Affairs Outsourcing (Neurology) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 43: Global: Regulatory Affairs Outsourcing (Cardiology) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 44: Global: Regulatory Affairs Outsourcing (Cardiology) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 45: Global: Regulatory Affairs Outsourcing (Immunology) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 46: Global: Regulatory Affairs Outsourcing (Immunology) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 47: Global: Regulatory Affairs Outsourcing (Other Indications) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 48: Global: Regulatory Affairs Outsourcing (Other Indications) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 49: Global: Regulatory Affairs Outsourcing (Preclinical) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 50: Global: Regulatory Affairs Outsourcing (Preclinical) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 51: Global: Regulatory Affairs Outsourcing (Clinical) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 52: Global: Regulatory Affairs Outsourcing (Clinical) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 53: Global: Regulatory Affairs Outsourcing (PMA -Post Market Authorization) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 54: Global: Regulatory Affairs Outsourcing (PMA -Post Market Authorization) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 55: Global: Regulatory Affairs Outsourcing (Medical Device Companies) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 56: Global: Regulatory Affairs Outsourcing (Medical Device Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 57: Global: Regulatory Affairs Outsourcing (Pharmaceutical Companies) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 58: Global: Regulatory Affairs Outsourcing (Pharmaceutical Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 59: Global: Regulatory Affairs Outsourcing (Biotechnology Companies) Market: Sales Value (in Million US$), 2018 & 2023
• Figure 60: Global: Regulatory Affairs Outsourcing (Biotechnology Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 61: North America: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 62: North America: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 63: United States: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 64: United States: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 65: Canada: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 66: Canada: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 67: Asia-Pacific: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 68: Asia-Pacific: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 69: China: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 70: China: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 71: Japan: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 72: Japan: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 73: India: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 74: India: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 75: South Korea: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 76: South Korea: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 77: Australia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 78: Australia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 79: Indonesia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 80: Indonesia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 81: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 82: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 83: Europe: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 84: Europe: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 85: Germany: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 86: Germany: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 87: France: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 88: France: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 89: United Kingdom: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 90: United Kingdom: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 91: Italy: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 92: Italy: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 93: Spain: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 94: Spain: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 95: Russia: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 96: Russia: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 97: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 98: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 99: Latin America: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 100: Latin America: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 101: Brazil: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 102: Brazil: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 103: Mexico: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 104: Mexico: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 105: Others: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 106: Others: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 107: Middle East and Africa: Regulatory Affairs Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
• Figure 108: Middle East and Africa: Regulatory Affairs Outsourcing Market: Breakup by Country (in %), 2023
• Figure 109: Middle East and Africa: Regulatory Affairs Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
• Figure 110: Global: Regulatory Affairs Outsourcing Industry: SWOT Analysis
• Figure 111: Global: Regulatory Affairs Outsourcing Industry: Value Chain Analysis
• Figure 112: Global: Regulatory Affairs Outsourcing Industry: Porter's Five Forces Analysis

List of Tables

• Table 1: Global: Regulatory Affairs Outsourcing Market: Key Industry Highlights, 2023 and 2032
• Table 2: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Services (in Million US$), 2024-2032
• Table 3: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Company Size (in Million US$), 2024-2032
• Table 4: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Category (in Million US$), 2024-2032
• Table 5: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Indication (in Million US$), 2024-2032
• Table 6: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Stage (in Million US$), 2024-2032
• Table 7: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by End User (in Million US$), 2024-2032
• Table 8: Global: Regulatory Affairs Outsourcing Market Forecast: Breakup by Region (in Million US$), 2024-2032
• Table 9: Global: Regulatory Affairs Outsourcing Market: Competitive Structure
• Table 10: Global: Regulatory Affairs Outsourcing Market: Key Players

The global regulatory affairs outsourcing market size reached US$ 7.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 15.1 Billion by 2032, exhibiting a growth rate (CAGR) of 7.6% during 2024-2032. The evolving and complex regulations, globalization of industries, resource optimization, ongoing technological advancements, specialized expertise requirements, and the need for rapid approvals are some of the major factors propelling the market.

Regulatory affairs outsourcing is the practice of companies delegating their regulatory compliance and documentation tasks to external specialized service providers. In this arrangement, businesses, particularly those in highly regulated industries such as pharmaceuticals, biotechnology, and medical devices, hire third-party experts or firms to manage regulatory affairs on their behalf. This encompasses activities like product registration, quality assurance, compliance with government regulations, and submission of required documentation to regulatory authorities. Outsourcing these tasks allows companies to tap into the expertise of professionals well-versed in regulatory frameworks, streamline processes, reduce overhead costs, and ensure adherence to evolving regulatory standards, ultimately facilitating market entry and product approval.

The global regulatory affairs outsourcing market is experiencing substantial growth primarily due to the increasingly complex and stringent regulatory requirements imposed by governments and regulatory bodies across various industries, including pharmaceuticals, medical devices, and food and beverages (F&B). Moreover, the expanding product adoption to enable companies to access a pool of professionals well-versed in the latest regulatory changes and compliance standards, thereby ensuring timely approvals and market access, is contributing to the market growth. Additionally, the globalization of markets has expanded the geographical reach of businesses, necessitating compliance with a multitude of international regulations, thereby bolstering the market growth. Furthermore, the growing need for outsourcing to provide a scalable solution to address diverse regulatory needs across regions is aiding in market expansion. Apart from this, the emerging trend toward cost-efficiency and operational flexibility drives companies to leverage external regulatory services, allowing them to focus on core competencies while mitigating overhead expenses, creating a positive outlook for market expansion.

Regulatory Affairs Outsourcing Market Trends/Drivers:

Increasing complexity in the regulatory landscape

One of the primary drivers of regulatory affairs outsourcing is the increasingly intricate and ever-evolving regulatory environment across various sectors. Industries such as pharmaceuticals, biotechnology, medical devices, and food and beverages (F&B) are subject to strict regulations to ensure product safety, efficacy, and compliance with quality standards. Keeping up with these regulations demands specialized knowledge and continuous monitoring. Outsourcing regulatory affairs allows companies to tap into the expertise of professionals who specialize in understanding the nuances of regional and international regulatory frameworks. Apart from this, these experts help businesses navigate the complex web of rules and ensure that their products meet compliance standards, ultimately facilitating market entry and product approval.

Expanding globalization of markets

Another pivotal factor fueling the growth of regulatory affairs outsourcing is the globalization of markets. As businesses expand their operations globally, they encounter a diverse array of regulatory requirements that vary by region and country. Complying with these regulations can be an intimidating task, especially for companies with limited in-house regulatory resources. In confluence with this, outsourcing provides a scalable solution to address these diverse regulatory needs efficiently. Regulatory affairs outsourcing firms often have a global presence and can assist businesses in adapting their products and processes to meet the specific requirements of different markets, thereby enabling market access and international growth.

Rising focus on cost-efficiency and operational productivity

Cost efficiency and the need for operational focus are driving companies to leverage external regulatory services. Maintaining an in-house regulatory affairs team involves substantial overhead costs, including salaries, training, and infrastructure. Outsourcing regulatory affairs allows organizations to reduce these fixed costs and gain flexibility in resource allocation. This approach enables companies to redirect resources towards core competencies such as research and development (R&D), marketing, and production. By entrusting regulatory activities to specialized outsourcing partners, businesses can streamline their operations, increase efficiency, and respond more effectively to market dynamics.

Regulatory Affairs Outsourcing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global regulatory affairs outsourcing market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on services, company size, category, indication, stage and end user.

Breakup by Services:

Regulatory Consulting

Legal Representation

Regulatory Writing and Publishing

Product Registration and Clinical Trial Applications

Others

Regulatory writing and publishing dominate the market

The report has provided a detailed breakup and analysis of the market based on the services. This includes regulatory consulting, legal representation, regulatory writing and publishing, product registration and clinical trial applications, and others. According to the report, regulatory writing and publishing represented the largest segment.

The demand for regulatory writing and publishing outsourcing is driven by the growing complexity of regulatory documentation, which necessitates specialized expertise and resources. As regulatory requirements become more intricate and region-specific, businesses seek external partners with in-depth knowledge of document preparation and submission processes. Besides this, the need for rapid approvals and market access compels companies to outsource these critical tasks to ensure accurate, compliant, and timely submissions. Furthermore, the adoption of electronic submission systems and the digital transformation of regulatory processes create demand for outsourcing providers with the technological infrastructure and proficiency required for efficient electronic document preparation and publishing.

Breakup by Company Size:

Small

Medium

Large

Medium holds the largest share of the market

A detailed breakup and analysis of the market based on the company size have also been provided in the report. This includes small, medium, and large. According to the report, medium accounted for the largest market share.

Another key factor driving the global regulatory affairs outsourcing market is the rising demand for specialized expertise and resource optimization in medium-sized companies. Medium-sized firms often face resource constraints and may lack an in-house regulatory affairs team with comprehensive knowledge of evolving regulations. Outsourcing enables them to access a pool of experienced regulatory professionals without the overhead costs of maintaining a full-time team. Additionally, as these companies expand into new markets, they require adaptable regulatory support to navigate diverse and complex regulatory landscapes, making outsourcing an efficient and strategic choice to ensure compliance, market entry, and growth.

Breakup by Category:

Generic Drugs

Innovator Drugs

Biologic Drugs

Biosimilars

Medical Devices

Therapeutic

Diagnostic

Others

Medical devices dominate the market

The report has provided a detailed breakup and analysis of the market based on the category. This includes generic drugs, innovator drugs, biologic drugs, biosimilars, medical devices (therapeutic and diagnostic), and others. According to the report, medical devices represented the largest segment.

The medical devices sector is subject to rigorous and evolving regulatory requirements globally, requiring specialized expertise to navigate. Outsourcing offers access to regulatory professionals who possess in-depth knowledge of medical device regulations, ensuring compliance and quicker approvals. Besides this, the constant innovation in medical device technology demands efficient and timely submissions to bring new products to market. Outsourcing streamlines regulatory processes, allowing companies to focus on R&D, thereby fueling the market's growth. Moreover, as the medical device market expands internationally, outsourced services provide support in adapting products to diverse regulatory environments, making outsourcing indispensable for market entry and sustained growth in this sector.

Breakup by Indication:

Oncology

Neurology

Cardiology

Immunology

Others

Oncology holds the largest share of the market

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes oncology, neurology, cardiology, immunology, and others. According to the report, oncology accounted for the largest market share.

The unique challenges and rapid advancements in this therapeutic area are impelling the demand for regulatory affairs outsourcing in the field of oncology. Oncological products often undergo accelerated development and require expedited regulatory pathways due to their potential life-saving nature. This demands specialized knowledge of oncology-specific regulations and fast-track approval processes, which outsourcing partners can provide. Furthermore, the increasing complexity of oncology clinical trials and the need for comprehensive data management and submissions necessitate outsourcing to experts who can navigate these intricate regulatory landscapes, ensuring timely approvals and market access for critical oncology treatments.

Breakup by Stage:

Preclinical

Clinical

PMA (Post Market Authorization)

Clinical dominates the market

The report has provided a detailed breakup and analysis of the market based on the stage. This includes preclinical, clinical, and post market authorization (PMA). According to the report, clinical represented the largest segment.

The surging complexity and resource-intensive nature of clinical trials are contributing to the increasing demand for regulatory affairs outsourcing at the clinical stage. Companies engaging in clinical research must adhere to stringent regulatory requirements to ensure the safety, security, and efficacy of investigational products. Outsourcing offers access to regulatory professionals with specialized knowledge of clinical trial regulations and documentation, helping companies navigate this intricate landscape efficiently. Concurrently, the need for rapid study initiation and adherence to evolving regulatory standards drives the demand for outsourced support in protocol development, submissions, and compliance, ensuring that clinical trials progress smoothly and meet regulatory milestones effectively.

Breakup by End User:

Medical Device Companies

Pharmaceutical Companies

Biotechnology Companies

Pharmaceutical companies hold the largest share of the market

A detailed breakup and analysis of the market based on the end-user have also been provided in the report. This includes medical device, pharmaceutical, and biotechnology companies. According to the report, pharmaceutical companies accounted for the largest market share.

The pharmaceutical industry's evolving landscape represents the key factor aiding in market expansion. With an increasing emphasis on innovative drug development and stringent regulatory oversight, pharmaceutical firms require specialized expertise to navigate the complex regulatory pathways. Outsourcing provides access to regulatory professionals well-versed in pharmaceutical regulations, speeding up the approval process and ensuring compliance. Moreover, the demand for global market access and the need to adapt to regional regulatory variations make outsourcing an attractive option. It enables pharmaceutical companies to focus on core research and development activities while external partners handle regulatory affairs efficiently and effectively.

Breakup by Region:

North America

United States

Canada

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

Asia-Pacific exhibits a clear dominance, accounting for the largest regulatory affairs outsourcing market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, Asia-Pacific accounted for the largest market share.

The increasing globalization of the pharmaceutical, healthcare, and life sciences sectors across the Asia Pacific has led to a surge in demand for regulatory services to navigate diverse regulatory landscapes across the region. Concurrent with this, the rising number of clinical trials and research activities in the region necessitates expertise in local regulatory requirements, making outsourcing an efficient solution for pharmaceutical and biotech companies looking to expand their presence. Furthermore, cost-efficiency plays a pivotal role as companies seek to optimize resources without compromising on compliance, making regulatory affairs outsourcing an attractive option in the Asia Pacific region.

Competitive Landscape:

The competitive landscape of the global regulatory affairs outsourcing market is characterized by a dynamic and diverse array of players vying for market share. Large multinational contract research organizations (CROs) hold prominent positions, offering comprehensive regulatory services across various industries and geographies. These industry giants leverage their extensive global networks, robust technology platforms, and deep regulatory expertise to cater to the diverse needs of clients. Additionally, niche and specialized regulatory affairs outsourcing firms focus on specific industries or regions, offering tailored solutions and in-depth regulatory knowledge. Emerging players, including startups and regional service providers, are also gaining traction by capitalizing on market niches and innovative service offerings. The competitive landscape is further shaped by strategic collaborations, mergers, and acquisitions as companies seek to expand their service portfolios and geographic reach.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Charles River Laboratories International Inc.

Covance Inc (Laboratory Corporation of America Holdings)

Freyr

ICON Plc

Medpace Holdings Inc.

Parexel International Corporation

Pharmaceutical Product Development LLC

Promedica International- A California Corporation

Wuxi AppTec Co. Ltd.

Recent Developments:

In February 2021, ICON plc announced the acquisition of PRA Health Sciences, Inc. in a cash and stock transaction valued at USD 12 billion approximately. This acquisition has strengthened the medical affairs service offering of the company.

Key Questions Answered in This Report:

• How has the global regulatory affairs outsourcing market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the global regulatory affairs outsourcing market?
• What are the key regional markets?
• What is the breakup of the market based on the services?
• What is the breakup of the market based on the company size?
• What is the breakup of the market based on the category?
• What is the breakup of the market based on the indication?
• What is the breakup of the market based on the stage?
• What is the breakup of the market based on the end user?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the industry?
• What is the structure of the global regulatory affairs outsourcing market and who are the key players?
• What is the degree of competition in the industry?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Regulatory Affairs Outsourcing Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Services

• 6.1 Regulatory Consulting
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Legal Representation
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Regulatory Writing and Publishing
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast
• 6.4 Product Registration and Clinical Trial Applications
  • 6.4.1 Market Trends
  • 6.4.2 Market Forecast
• 6.5 Others
  • 6.5.1 Market Trends
  • 6.5.2 Market Forecast

7 Market Breakup by Company Size

• 7.1 Small
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Medium
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Large
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast

8 Market Breakup by Category

• 8.1 Generic Drugs
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Innovator Drugs
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Biologic Drugs
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Biosimilars
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast
• 8.5 Medical Devices
  • 8.5.1 Market Trends
  • 8.5.2 Major Types
    • 8.5.2.1 Therapeutic
    • 8.5.2.2 Diagnostic
  • 8.5.3 Market Forecast
• 8.6 Others
  • 8.6.1 Market Trends
  • 8.6.2 Market Forecast

9 Market Breakup by Indication

• 9.1 Oncology
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Neurology
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Cardiology
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Immunology
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast
• 9.5 Others
  • 9.5.1 Market Trends
  • 9.5.2 Market Forecast

10 Market Breakup by Stage

• 10.1 Preclinical
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Clinical
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 PMA (Post Market Authorization)
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast

11 Market Breakup by End User

• 11.1 Medical Device Companies
  • 11.1.1 Market Trends
  • 11.1.2 Market Forecast
• 11.2 Pharmaceutical Companies
  • 11.2.1 Market Trends
  • 11.2.2 Market Forecast
• 11.3 Biotechnology Companies
  • 11.3.1 Market Trends
  • 11.3.2 Market Forecast

12 Market Breakup by Region

• 12.1 North America
  • 12.1.1 United States
    • 12.1.1.1 Market Trends
    • 12.1.1.2 Market Forecast
  • 12.1.2 Canada
    • 12.1.2.1 Market Trends
    • 12.1.2.2 Market Forecast
• 12.2 Asia-Pacific
  • 12.2.1 China
    • 12.2.1.1 Market Trends
    • 12.2.1.2 Market Forecast
  • 12.2.2 Japan
    • 12.2.2.1 Market Trends
    • 12.2.2.2 Market Forecast
  • 12.2.3 India
    • 12.2.3.1 Market Trends
    • 12.2.3.2 Market Forecast
  • 12.2.4 South Korea
    • 12.2.4.1 Market Trends
    • 12.2.4.2 Market Forecast
  • 12.2.5 Australia
    • 12.2.5.1 Market Trends
    • 12.2.5.2 Market Forecast
  • 12.2.6 Indonesia
    • 12.2.6.1 Market Trends
    • 12.2.6.2 Market Forecast
  • 12.2.7 Others
    • 12.2.7.1 Market Trends
    • 12.2.7.2 Market Forecast
• 12.3 Europe
  • 12.3.1 Germany
    • 12.3.1.1 Market Trends
    • 12.3.1.2 Market Forecast
  • 12.3.2 France
    • 12.3.2.1 Market Trends
    • 12.3.2.2 Market Forecast
  • 12.3.3 United Kingdom
    • 12.3.3.1 Market Trends
    • 12.3.3.2 Market Forecast
  • 12.3.4 Italy
    • 12.3.4.1 Market Trends
    • 12.3.4.2 Market Forecast
  • 12.3.5 Spain
    • 12.3.5.1 Market Trends
    • 12.3.5.2 Market Forecast
  • 12.3.6 Russia
    • 12.3.6.1 Market Trends
    • 12.3.6.2 Market Forecast
  • 12.3.7 Others
    • 12.3.7.1 Market Trends
    • 12.3.7.2 Market Forecast
• 12.4 Latin America
  • 12.4.1 Brazil
    • 12.4.1.1 Market Trends
    • 12.4.1.2 Market Forecast
  • 12.4.2 Mexico
    • 12.4.2.1 Market Trends
    • 12.4.2.2 Market Forecast
  • 12.4.3 Others
    • 12.4.3.1 Market Trends
    • 12.4.3.2 Market Forecast
• 12.5 Middle East and Africa
  • 12.5.1 Market Trends
  • 12.5.2 Market Breakup by Country
  • 12.5.3 Market Forecast

13 SWOT Analysis

• 13.1 Overview
• 13.2 Strengths
• 13.3 Weaknesses
• 13.4 Opportunities
• 13.5 Threats

14 Value Chain Analysis

15 Porters Five Forces Analysis

• 15.1 Overview
• 15.2 Bargaining Power of Buyers
• 15.3 Bargaining Power of Suppliers
• 15.4 Degree of Competition
• 15.5 Threat of New Entrants
• 15.6 Threat of Substitutes

16 Price Analysis

17 Competitive Landscape

• 17.1 Market Structure
• 17.2 Key Players
• 17.3 Profiles of Key Players
  • 17.3.1 Charles River Laboratories International Inc.
    • 17.3.1.1 Company Overview
    • 17.3.1.2 Product Portfolio
    • 17.3.1.3 Financials
    • 17.3.1.4 SWOT Analysis
  • 17.3.2 Covance Inc (Laboratory Corporation of America Holdings)
    • 17.3.2.1 Company Overview
    • 17.3.2.2 Product Portfolio
    • 17.3.2.3 SWOT Analysis
  • 17.3.3 Freyr
    • 17.3.3.1 Company Overview
    • 17.3.3.2 Product Portfolio
  • 17.3.4 ICON Plc
    • 17.3.4.1 Company Overview
    • 17.3.4.2 Product Portfolio
    • 17.3.4.3 Financials
    • 17.3.4.4 SWOT Analysis
  • 17.3.5 Medpace Holdings Inc
    • 17.3.5.1 Company Overview
    • 17.3.5.2 Product Portfolio
    • 17.3.5.3 Financials
    • 17.3.5.4 SWOT Analysis
  • 17.3.6 Parexel International Corporation
    • 17.3.6.1 Company Overview
    • 17.3.6.2 Product Portfolio
    • 17.3.6.3 SWOT Analysis
  • 17.3.7 Pharmaceutical Product Development LLC
    • 17.3.7.1 Company Overview
    • 17.3.7.2 Product Portfolio
    • 17.3.7.3 Financials
    • 17.3.7.4 SWOT Analysis
  • 17.3.8 Promedica International- A California Corporation
    • 17.3.8.1 Company Overview
    • 17.3.8.2 Product Portfolio
  • 17.3.9 Wuxi AppTec Co. Ltd.
    • 17.3.9.1 Company Overview
    • 17.3.9.2 Product Portfolio