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表紙：薬事アウトソーシング市場- 世界の産業規模、シェア、動向、機会、予測、2018-2028年
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1331420

薬事アウトソーシング市場- 世界の産業規模、シェア、動向、機会、予測、2018-2028年

Regulatory Affairs Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Service, By Category, By Company Size, By Indication, By Product Stage, By End Use, By Region and Competition

出版日
ページ情報
英文 118 Pages
納期
2～3営業日
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薬事アウトソーシング市場- 世界の産業規模、シェア、動向、機会、予測、2018-2028年
出版日: 2023年08月01日
発行: TechSci Research
ページ情報: 英文 118 Pages
納期: 2～3営業日
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  • 概要
  • 目次
概要

薬事アウトソーシング市場は、予測期間中に目覚ましい成長を遂げると予測されています。

これは、臨床試験申請や製品登録件数の増加とともに、研究開発活動が活発化していることに起因しています。同様に、医薬品コストを抑制するための各国政府による規制の強化も、経済的・競合的なプレッシャーに貢献し、ライフサイエンス企業の薬事アウトソーシング需要を押し上げると予想されます。2020年、イーライリリーはダーミラの免疫学ポートフォリオを買収する契約を締結しました。さらに、COVID-19のパンデミックはワクチンに対する緊急のニーズを生み出しました。このため、COVID-19用ワクチンの開発は、同分野の成長に好影響を与える可能性が高いです。

規制の複雑化

規制の複雑さは、世界の薬事アウトソーシング市場の成長に重要な役割を果たしています。世界中の規制当局は、ヘルスケア、医薬品、医療機器などさまざまな業界に対する監視の目を強めています。こうした規制の遵守には時間と複雑さが伴い、多大なリソースと専門知識が必要となります。薬事サービスをアウトソーシングすることで、企業は規制の変化を常に把握し、適用される規制を確実に遵守することができます。薬事サービスのプロバイダーは、適用される法律、規制、ガイドラインなど、さまざまな地域の規制状況について幅広い知識を持っています。また、製品登録、臨床試験申請、品質保証など、コンプライアンス関連の活動について専門的なアドバイスを提供することができます。さらに、薬事サービス・プロバイダーは、企業がさまざまな地域の複雑な規制要件に対応できるよう支援することができます。これには、製品表示や包装の要件に関するガイダンスの提供、適正製造規範（GMP）や適正臨床規範（GCP）の遵守の確保などが含まれます。規制関連業務をアウトソーシングすることで、企業は規制要件への不適合から生じるコストのかかるミスのリスクを軽減することができます。このようなミスは、製品承認の遅延、製品リコール、および企業の収益に大きな影響を与えるその他の悪影響につながる可能性があります。

専門知識への需要の高まり

専門的な知識は、世界の薬事アウトソーシング市場の成長における重要な要因となっています。薬事業務は、法律、規制、ガイドラインなど、さまざまな規制の枠組みに関する深い知識を必要とする複雑で専門的な分野です。規制要件がますます複雑化・厳格化するにつれ、企業はコンプライアンスを確保し、コストのかかるミスを回避するための専門知識に対するニーズが高まっています。規制関連業務をアウトソーシングすることで、企業は規制関連業務サービスプロバイダーの専門知識を活用することができます。これらのプロバイダーは、さまざまな地域の規制状況や適用される法律、規制、ガイドラインに関する幅広い知識を有しています。その他の活動（製品登録、臨床試験申請、品質保証など）についても、専門的なアドバイスを提供することができます。

さらに、薬事サービス・プロバイダーは、医療機器、生物製剤、医薬品などの特定分野に特化した専門知識を提供することができます。このような専門知識は、これらの分野における薬事業務の専門知識を社内に持たない企業にとって、特に貴重なものとなります。薬事業務を専門のサービスプロバイダーにアウトソーシングすることで、企業は適用される規制要件を遵守するために必要な専門知識を確実に利用することができます。専門的な知識は、企業が最新の規制動向や変更に対応するのに役立ちます。規制関連業務のサービスプロバイダーは、さまざまな地域における規制の変更を常に監視しており、これらの変更が企業の製品や業務にどのような影響を与えるかについて、専門的なガイダンスを提供することができます。

コスト削減

コスト削減は、世界の薬事アウトソーシング市場の成長における重要な要因です。規制要件の遵守には時間とコストがかかり、多大なリソースと専門知識が必要となります。社内に薬事に関する専門知識を持たない企業は、コンプライアンスを確保するためにスタッフを雇用して教育するか、コストのかかる外部のコンサルタントを利用する必要があるかもしれないです。規制関連業務をアウトソーシングすることで、企業は大幅なコスト削減を実現できます。規制関連業務のサービスプロバイダーは、専門的な専門知識とリソースを提供することができ、多くの場合、社内でスタッフを雇用して訓練したり、外部のコンサルタントを利用したりするよりも低コストで済みます。薬事業務のアウトソーシングは、より柔軟でスケーラブルなアプローチを提供できるため、企業はビジネスのニーズに応じて、薬事業務のリソースを必要に応じて増減させることができます。

薬事業務をアウトソーシングすることで、企業は規制要件への不適合から生じるコストのかかるミスを回避することができます。このようなミスは、製品承認の遅延、製品リコール、および企業の収益に大きな影響を与えるその他の悪影響につながる可能性があります。規制関連業務のアウトソーシングは、企業の業務効率の向上に役立ちます。薬事業務をアウトソーシングすることで、企業は社内のリソースを製品開発やマーケティングなどのコア業務に集中させることができます。これにより、規制要件へのコンプライアンスを確保しつつ、生産性と収益性を向上させることができます。

テクノロジーの進歩

テクノロジーの進歩は、世界の薬事アウトソーシング市場の成長に重要な役割を果たしています。デジタル技術の採用が進んだことで、規制状況の多くの側面が変化し、アウトソーシングサービスプロバイダーに新たな機会が生まれています。市場の成長に影響を与える主な要因の1つは、規制業務プロセスの自動化です。先進的なソフトウェアシステムや人工知能（AI）ツールを使用することで、薬事業務のワークフローを合理化し、コンプライアンス関連業務に必要な時間と労力を削減することができます。例えば、大量の規制関連文書のレビューにAIを活用することで、潜在的な問題を特定し、規制当局への提出書類の精度を向上させることができます。

テクノロジーは、規制関連業務のサービスプロバイダーとその顧客との間のコラボレーションとコミュニケーションの拡大を可能にしました。クラウド別のプラットフォームやその他のコラボレーションツールにより、薬事担当者は場所に関係なく共同作業がしやすくなっています。これにより、効率性が向上し、薬事プロセスに関連する時間とコストを削減することができます。テクノロジーがリアルタイムのデータモニタリングとアナリティクスの活用に影響を与えるもう一つの領域があります。高度なデータ分析ツールは、薬事担当者が新たな規制動向や潜在的なコンプライアンス問題を特定するのに役立ち、問題になる前にこれらの問題に積極的に対処することを可能にします。最後に、テクノロジーは、規制関連業務プロセスにおける透明性と説明責任の向上を可能にしました。デジタルシステムとツールにより、コンプライアンス関連の活動の追跡と監査証跡の提供が容易になり、コンプライアンスの向上とコンプライアンス違反のリスクの低減が実現します。

最近の進展

  • 2021年、WIRB-コペルニクス・グループ（WCG）は、がん領域の臨床試験向けに包括的な薬事・倫理審査サービスを提供する新サービス「WCGオンコロジー」を開始しました。
  • 2020年、キナプス（Syneos Healthの子会社）は、高度なデータ解析とAIを活用して顧客の薬事コンプライアンスプロセスの最適化を支援する新サービス「Kinapse Quality Labs」を開始しました。
  • 2020年、IQVIAは、顧客が薬事申請プロセスをより効率的に管理できるように設計された薬事情報管理ソリューションの新しいスイートを発表しました。
  • 2019年、Qserve GroupはQserveConnectと呼ばれる新しいプラットフォームを立ち上げ、クライアントに薬事戦略、臨床評価、品質管理などの薬事サービスをオンデマンドで提供します。
  • 2019年、アクセンチュアは、企業が規制コンプライアンスをより効果的に管理できるように設計されたデジタルツールとサービスのスイートである「Regulatory and Compliance Analytics Solution」を発表しました。
  • 2018年、Parexelは新しいRegulatory Outsourcingサービスを開始し、顧客が複雑な規制環境をナビゲートし、市場投入までの時間を改善するのを支援するよう設計されています。

利用可能なカスタマイズ

所定の市場データを使用して、TechSci Researchは企業の特定のニーズに応じてカスタマイズを提供します。レポートでは以下のカスタマイズが可能です：

企業情報

  • 追加市場参入企業（最大5社）の詳細分析とプロファイリング

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 薬事アウトソーシングの世界市場展望

  • 市場規模と予測
    • 金額別
  • 市場シェアと予測
    • サービス別（薬事コンサルティング、法務代行、薬事執筆・出版、製品登録・治験申請、薬事申請、薬事業務、その他サービス）
    • カテゴリー別（医薬品、医療機器）
    • 企業規模別（小規模企業、中規模企業、大規模企業）
    • 適応症別（腫瘍学、神経学、循環器学、免疫学、その他の適応症）
    • 製品ステージ別（前臨床、臨床、市販前承認）
    • エンドユース別（医療機器企業、製薬企業、バイオテクノロジー企業）
    • 地域別（北米、欧州、アジア太平洋、南米、中東・アフリカ）
    • 企業別（2022年）
  • 市場マップ
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別

第6章 北米の薬事アウトソーシング市場展望

  • 市場規模・予測
    • 金額別
  • 市場シェアと予測
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別
    • 国別
  • 北米国別分析
    • 米国
    • カナダ
    • メキシコ

第7章 欧州の薬事アウトソーシング市場の展望

  • 市場規模と予測
    • 金額別
  • 市場シェアと予測
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別
    • 国別
  • 欧州国別分析
    • フランス
    • ドイツ
    • 英国
    • イタリア
    • スペイン

第8章 アジア太平洋の薬事アウトソーシング市場の展望

  • 市場規模と予測
    • 金額別
  • 市場シェアと予測
      <
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別
    • 国別
  • アジア太平洋地域国別分析
    • 中国
    • インド
    • 日本
    • 韓国
    • オーストラリア

第9章 南米の薬事アウトソーシング市場の展望

  • 市場規模と予測
    • 金額別
  • 市場シェアと予測
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別
    • 国別
  • 南米：国別分析
    • ブラジル
    • アルゼンチン
    • コロンビア

第10章 中東・アフリカの薬事アウトソーシング市場の展望

  • 市場規模と予測
    • 金額別
  • 市場シェアと予測
    • サービス別
    • カテゴリー別
    • 企業規模別
    • 適応症別
    • 製品ステージ別
    • エンドユース別
    • 国別
  • MEA：国別分析
    • 南アフリカ
    • サウジアラビア
    • アラブ首長国連邦

第11章 市場力学

  • 促進要因
  • 課題

第12章 市場動向と発展

  • 最近の展開
  • 合併・買収
  • 製品発表

第13章 薬事アウトソーシングの世界市場SWOT分析

第14章 ポーターのファイブフォース分析

  • 業界内の競合
  • 新規参入の可能性
  • サプライヤーの力
  • 顧客の力
  • 代替品の脅威

第15章 競合情勢

  • Business Overview
  • Product Offerings
  • Recent Developments
  • Financials（As Reported）
  • Key Personnel
  • SWOT Analysis
    • Accell Clinical Research, LLC.
    • Genpact Ltd.
    • CRITERIUM, INC.
    • Promedica International.
    • WuXi AppTec Co Ltd.
    • Medpace Inc.
    • Charles River Laboratories.
    • ICON plc.
    • Covance, Inc.
    • Parexel International Corporation.
    • Freyr AS
    • PHARMALEX GMBH
    • NDA Group AB
    • Pharmexon Consulting.
    • Qvigilance
    • BlueReg Group.

第16章 戦略的提言

目次
Product Code: 15258

Regulatory Affairs Outsourcing Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to growing research and development activities along with augmenting the volume of clinical trial applications and product registrations. Similarly, growing regulations taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among life science companies. In 2020, Eli Lilly entered into an agreement to acquire Dermira's immunology portfolio. In addition, the COVID-19 pandemic created an urgent need for vaccines. Thus, the development of vaccines for COVID-19 is likely to have a positive impact on segment growth. Increasing globalization

Increasing globalization had a significant impact on the growth of the Global Regulatory Affairs Outsourcing market. As companies expand their operations globally, they are faced with the challenge of complying with different regulatory frameworks in various regions. This challenge has driven the demand for regulatory affairs outsourcing services as companies look for specialized service providers who can help them navigate the complexities of different regulatory frameworks.

One of the key benefits of outsourcing regulatory affairs services is the expertise that service providers can bring to the table. Service providers who specialize in regulatory affairs have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. This expertise is critical in ensuring that companies comply with the applicable regulations and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to focus on their core competencies, such as product development and marketing, while leaving compliance-related activities to be specialized service providers. This can help companies improve their operational efficiency, reduce costs, and improve their bottom line. Furthermore, advancements in technology, such as cloud-based regulatory information management systems, have made it easier for companies to outsource regulatory affairs services across different regions. These systems allow service providers to access and manage regulatory information securely, regardless of location. This has made it easier for companies to work with service providers who are located in different parts of the world.

Rising regulatory complexities

Regulatory complexities play a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory authorities around the world are increasing their scrutiny of various industries, including healthcare, pharmaceuticals, and medical devices. Compliance with these regulations can be time-consuming and complex, requiring significant resources and expertise. Outsourcing regulatory affairs services can help companies stay on top of regulatory changes and ensure compliance with applicable regulations. Regulatory affairs service providers have extensive knowledge of the regulatory landscape in different regions, including the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, quality assurance, and others. Furthermore, regulatory affairs service providers can help companies navigate the complex regulatory requirements of different regions. This includes providing guidance on product labeling and packaging requirements, as well as ensuring compliance with Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs). Outsourcing regulatory affairs services can help companies reduce the risk of costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line.

Growing demand for specialized expertise

Specialized expertise has been a key factor in the growth of the Global Regulatory Affairs Outsourcing Market. Regulatory affairs are a complex and specialized field that requires in-depth knowledge of various regulatory frameworks, including laws, regulations, and guidelines. As regulatory requirements become increasingly complex and stringent, companies are facing a growing need for specialized expertise to ensure compliance and avoid costly mistakes. Outsourcing regulatory affairs services allows companies to tap into the specialized expertise of regulatory affairs service providers. These providers have extensive knowledge of the regulatory landscape in different regions, as well as the applicable laws, regulations, and guidelines. They can provide expert advice on compliance-related activities, such as product registration, clinical trial applications, and quality assurance, among others.

Furthermore, regulatory affairs service providers can provide specialized expertise in specific areas, such as medical devices, biologics, and pharmaceuticals. This expertise can be particularly valuable for companies that lack in-house regulatory affairs expertise in these areas. By outsourcing regulatory affairs services to specialized service providers, companies can ensure that they have access to the expertise they need to comply with the applicable regulatory requirements. Specialized expertise can help companies stay up to date with the latest regulatory developments and changes. Regulatory affairs service providers are constantly monitoring regulatory changes in different regions and can provide expert guidance on how these changes may impact a company's products or operations.

Cost savings

Cost savings is a significant factor in the growth of the Global Regulatory Affairs Outsourcing Market. Compliance with regulatory requirements can be time-consuming and costly, requiring significant resources and expertise. Companies that lack in-house regulatory affairs expertise may need to hire and train staff or use costly external consultants to ensure compliance. Outsourcing regulatory affairs services can provide significant cost savings for companies. Regulatory affairs service providers can offer specialized expertise and resources, often at a lower cost than hiring and training in-house staff or using external consultants. Outsourcing can provide a more flexible and scalable approach to regulatory affairs, allowing companies to scale their regulatory affairs resources up or down as needed, depending on business needs.

Outsourcing regulatory affairs services can help companies avoid costly mistakes that can arise from non-compliance with regulatory requirements. These mistakes can lead to delays in product approvals, product recalls, and other negative consequences that can significantly impact a company's bottom line. Outsourcing regulatory affairs services can help companies improve their operational efficiency. By outsourcing regulatory affairs services, companies can free up internal resources to focus on their core business activities, such as product development and marketing. This can help improve productivity and profitability while still ensuring compliance with regulatory requirements.

Advancements in technology

Advancements in technology have played a significant role in the growth of the Global Regulatory Affairs Outsourcing Market. The increasing adoption of digital technologies has transformed many aspects of the regulatory affairs landscape, creating new opportunities for outsourcing service providers. One major factor that influences the growth of the market is the automation of regulatory affairs processes. The use of advanced software systems and artificial intelligence (AI) tools can help streamline regulatory affairs workflows, reducing the time and effort required to perform compliance-related activities. For example, AI can be used to review large volumes of regulatory documents, helping to identify potential issues and improve the accuracy of regulatory submissions.

Technology has enabled greater collaboration and communication between regulatory affairs service providers and their clients. Cloud-based platforms and other collaboration tools make it easier for regulatory affairs professionals to work together, regardless of their location. This can help improve efficiency and reduce the time and cost associated with regulatory affairs processes. Another area where technology has an impact on the use of real-time data monitoring and analytics. Advanced data analytics tools can help regulatory affairs professionals identify emerging regulatory trends and potential compliance issues, allowing them to proactively address these issues before they become problems. Finally, technology has enabled greater transparency and accountability in the regulatory affairs process. Digital systems and tools make it easier to track compliance-related activities and provide audit trails, improving compliance and reducing the risk of non-compliance.

Recent Development

  • In 2021, WIRB-Copernicus Group (WCG) launched a new service called WCG Oncology, which provides comprehensive regulatory and ethical review services for oncology clinical trials.
  • In 2020, Kinapse (a subsidiary of Syneos Health) launched a new service called Kinapse Quality Labs, which uses advanced data analytics and AI to help clients optimize their regulatory compliance processes.
  • In 2020, IQVIA launched a new suite of regulatory information management solutions designed to help clients manage the regulatory submission process more efficiently.
  • In 2019, Qserve Group launched a new platform called QserveConnect, which provides clients with on-demand access to a range of regulatory affairs services, including regulatory strategy, clinical evaluation, and quality management.
  • In 2019, Accenture launched its Regulatory and Compliance Analytics Solution, a suite of digital tools and services designed to help companies manage regulatory compliance more effectively.
  • In 2018, Parexel launched its new Regulatory Outsourcing service, designed to help clients navigate complex regulatory environments and improve their time to market.

Market Segmentation

Global Regulatory Affairs Outsourcing Market can be segmented by service, category, company size, indication, production stage, end-use, and by region. Based on service, the market can be segmented into regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, and other services. Based on category, the market can be divided into pharmaceutical and medical devices. Based on company size, the market can be segmented into small companies, medium companies, and large companies. Based on indication, the market can be differentiated into oncology, neurology, cardiology, immunology, and other indications. Based on the product stage, the market can be segmented into preclinical, clinical, and premarket approval. Based on end use, the market can be differentiated into medical device companies, pharmaceutical companies, and biotechnology companies.

Market Players

Accell Clinical Research, LLC., Genpact Ltd., CRITERIUM, INC., Promedica International. , WuXi AppTec Co Ltd., Medpace Inc., Charles River Laboratories Inc., ICON plc., Covance, Inc.., Parexel International Corporation., Freyr AS, PHARMALEX GMBH, NDA Group AB, Pharmexon Consulting, Qvigilance, and BlueReg Group are some of the leading players operating in the Global Regulatory Affairs Outsourcing Market.

Report Scope:

In this report, Global Regulatory Affairs Outsourcing market has been segmented into the following categories, in addition to the industry trends, which have also been detailed below:

Regulatory Affairs Outsourcing Market, By Service:

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product registration & clinical trial applications
  • Regulatory Submissions
  • Regulatory Operations
  • Other services

Regulatory Affairs Outsourcing Market, By Category:

  • Pharmaceutical
  • Medical Device

Regulatory Affairs Outsourcing Market, By Company Size:

  • Small Companies
  • Medium Companies
  • Large Companies

Regulatory Affairs Outsourcing Market, By Indication:

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Other Indications

Regulatory Affairs Outsourcing Market, By Product Stage:

  • Preclinical, Clinical
  • Premarket Approval

Regulatory Affairs Outsourcing Market, By End Use:

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Regulatory Affairs Outsourcing Market, By Region:

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • Germany
    • United Kingdom
    • Italy
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market.

Available Customizations:

With the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Regulatory Affairs Outsourcing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 5.2.2. By Category (Pharmaceutical, Medical Device)
    • 5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
    • 5.2.8. By Company (2022)
  • 5.3. Market Map
    • 5.3.1 By Service
    • 5.3.2 By Category
    • 5.3.3 By Company Size
    • 5.3.4 By Indication
    • 5.3.5 By Product Stage
    • 5.3.6 By End Use

6. North America Regulatory Affairs Outsourcing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 6.2.2. By Category (Pharmaceutical, Medical Device)
    • 6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 6.2.7. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Regulatory Affairs Outsourcing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Service
        • 6.3.1.2.2. By Category
        • 6.3.1.2.3. By Company Size
        • 6.3.1.2.4. By Indication
        • 6.3.1.2.5. By Product Stage
        • 6.3.1.2.6. By End Use
    • 6.3.2. Canada Regulatory Affairs Outsourcing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Service
        • 6.3.2.2.2. By Category
        • 6.3.2.2.3. By Company Size
        • 6.3.2.2.4. By Indication
        • 6.3.2.2.5. By Product Stage
        • 6.3.2.2.6. By End Use
    • 6.3.3. Mexico Regulatory Affairs Outsourcing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Service
        • 6.3.3.2.2. By Category
        • 6.3.3.2.3. By Company Size
        • 6.3.3.2.4. By Indication
        • 6.3.3.2.5. By Product Stage
        • 6.3.3.2.6. By End Use

7. Europe Regulatory Affairs Outsourcing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 7.2.2. By Category (Pharmaceutical, Medical Device)
    • 7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 7.2.7. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Regulatory Affairs Outsourcing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Service
        • 7.3.1.2.2. By Category
        • 7.3.1.2.3. By Company Size
        • 7.3.1.2.4. By Indication
        • 7.3.1.2.5. By Product Stage
        • 7.3.1.2.6. By End Use
    • 7.3.2. Germany Regulatory Affairs Outsourcing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Service
        • 7.3.2.2.2. By Category
        • 7.3.2.2.3. By Company Size
        • 7.3.2.2.4. By Indication
        • 7.3.2.2.5. By Product Stage
        • 7.3.2.2.6. By End Use
    • 7.3.3. United Kingdom Regulatory Affairs Outsourcing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Service
        • 7.3.3.2.2. By Category
        • 7.3.3.2.3. By Company Size
        • 7.3.3.2.4. By Indication
        • 7.3.3.2.5. By Product Stage
        • 7.3.3.2.6. By End Use
    • 7.3.4. Italy Regulatory Affairs Outsourcing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Service
        • 7.3.4.2.2. By Category
        • 7.3.4.2.3. By Company Size
        • 7.3.4.2.4. By Indication
        • 7.3.4.2.5. By Product Stage
        • 7.3.4.2.6. By End Use
    • 7.3.5. Spain Regulatory Affairs Outsourcing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Service
        • 7.3.5.2.2. By Category
        • 7.3.5.2.3. By Company Size
        • 7.3.5.2.4. By Indication
        • 7.3.5.2.5. By Product Stage
        • 7.3.5.2.6. By End Use

8. Asia-Pacific Regulatory Affairs Outsourcing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 8.2.2. By Category (Pharmaceutical, Medical Device)
    • 8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 8.2.7. By Country
  • 8.3. Asia-Pacific: Country Analysis
    • 8.3.1. China Regulatory Affairs Outsourcing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Service
        • 8.3.1.2.2. By Category
        • 8.3.1.2.3. By Company Size
        • 8.3.1.2.4. By Indication
        • 8.3.1.2.5. By Product Stage
        • 8.3.1.2.6. By End Use
    • 8.3.2. India Regulatory Affairs Outsourcing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Service
        • 8.3.2.2.2. By Category
        • 8.3.2.2.3. By Company Size
        • 8.3.2.2.4. By Indication
        • 8.3.2.2.5. By Product Stage
        • 8.3.2.2.6. By End Use
    • 8.3.3. Japan Regulatory Affairs Outsourcing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Service
        • 8.3.3.2.2. By Category
        • 8.3.3.2.3. By Company Size
        • 8.3.3.2.4. By Indication
        • 8.3.3.2.5. By Product Stage
        • 8.3.3.2.6. By End Use
    • 8.3.4. South Korea Regulatory Affairs Outsourcing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Service
        • 8.3.4.2.2. By Category
        • 8.3.4.2.3. By Company Size
        • 8.3.4.2.4. By Indication
        • 8.3.4.2.5. By Product Stage
        • 8.3.4.2.6. By End Use
    • 8.3.5. Australia Regulatory Affairs Outsourcing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Service
        • 8.3.5.2.2. By Category
        • 8.3.5.2.3. By Company Size
        • 8.3.5.2.4. By Indication
        • 8.3.5.2.5. By Product Stage
        • 8.3.5.2.6. By End Use

9. South America Regulatory Affairs Outsourcing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 9.2.2. By Category (Pharmaceutical, Medical Device)
    • 9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 9.2.7. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Regulatory Affairs Outsourcing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Service
        • 9.3.1.2.2. By Category
        • 9.3.1.2.3. By Company Size
        • 9.3.1.2.4. By Indication
        • 9.3.1.2.5. By Product Stage
        • 9.3.1.2.6. By End Use
    • 9.3.2. Argentina Regulatory Affairs Outsourcing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Service
        • 9.3.2.2.2. By Category
        • 9.3.2.2.3. By Company Size
        • 9.3.2.2.4. By Indication
        • 9.3.2.2.5. By Product Stage
        • 9.3.2.2.6. By End Use
    • 9.3.3. Colombia Regulatory Affairs Outsourcing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Service
        • 9.3.3.2.2. By Category
        • 9.3.3.2.3. By Company Size
        • 9.3.3.2.4. By Indication
        • 9.3.3.2.5. By Product Stage
        • 9.3.3.2.6. By End Use

10. Middle East and Africa Regulatory Affairs Outsourcing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
    • 10.2.2. By Category (Pharmaceutical, Medical Device)
    • 10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
    • 10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
    • 10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
    • 10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
    • 10.2.7. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Regulatory Affairs Outsourcing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Service
        • 10.3.1.2.2. By Category
        • 10.3.1.2.3. By Company Size
        • 10.3.1.2.4. By Indication
        • 10.3.1.2.5. By Product Stage
        • 10.3.1.2.6. By End Use
    • 10.3.2. Saudi Arabia Regulatory Affairs Outsourcing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Service
        • 10.3.2.2.2. By Category
        • 10.3.2.2.3. By Company Size
        • 10.3.2.2.4. By Indication
        • 10.3.2.2.5. By Product Stage
        • 10.3.2.2.6. By End Use
    • 10.3.3. UAE Regulatory Affairs Outsourcing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Service
        • 10.3.3.2.2. By Category
        • 10.3.3.2.3. By Company Size
        • 10.3.3.2.4. By Indication
        • 10.3.3.2.5. By Product Stage
        • 10.3.3.2.6. By End Use

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Development
  • 12.2. Mergers & Acquisitions
  • 12.3. Product Launches

13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Business Overview
  • 15.2. Product Offerings
  • 15.3. Recent Developments
  • 15.4. Financials (As Reported)
  • 15.5. Key Personnel
  • 15.6. SWOT Analysis
    • 15.6.1 Accell Clinical Research, LLC.
    • 15.6.2 Genpact Ltd.
    • 15.6.3 CRITERIUM, INC.
    • 15.6.4 Promedica International.
    • 15.6.5 WuXi AppTec Co Ltd.
    • 15.6.6 Medpace Inc.
    • 15.6.7 Charles River Laboratories.
    • 15.6.8 ICON plc.
    • 15.6.9 Covance, Inc.
    • 15.6.10 Parexel International Corporation.
    • 15.6.11 Freyr AS
    • 15.6.12 PHARMALEX GMBH
    • 15.6.13 NDA Group AB
    • 15.6.14 Pharmexon Consulting.
    • 15.6.15 Qvigilance
    • 15.6.16 BlueReg Group.

16. Strategic Recommendations