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表紙：薬事規制市場：サービス別、カテゴリー別、製品ステージ別、適応症別、サービスプロバイダー別、国別、地域別- 産業分析、市場規模、市場シェア、2023年～2030年予測
市場調査レポート
商品コード
1419028

薬事規制市場：サービス別、カテゴリー別、製品ステージ別、適応症別、サービスプロバイダー別、国別、地域別- 産業分析、市場規模、市場シェア、2023年～2030年予測

Pharmaceutical Regulatory Affairs Market, By Services, By Category, By Product stage, By Indication, Service Provider, By Country, and By Region - Industry Analysis, Market Size, Market Share & Forecast from 2023-2030
出版日: | 発行: AnalystView Market Insights | ページ情報: 英文 277 Pages | 納期: 2～3営業日

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価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=156.58円
薬事規制市場：サービス別、カテゴリー別、製品ステージ別、適応症別、サービスプロバイダー別、国別、地域別- 産業分析、市場規模、市場シェア、2023年～2030年予測
出版日: 2024年01月21日
発行: AnalystView Market Insights
ページ情報: 英文 277 Pages
納期: 2～3営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

レポートハイライト

薬事規制の市場規模は2022年に138億1,540万米ドルとなり、2023年から2030年にかけてCAGR 8.5%で拡大

薬事規制市場の市場力学

薬事規制市場の成長は、製薬業界とバイオテクノロジー業界の拡大、および医薬品開発重視の高まりによって牽引されると予測されます。

製薬会社は、市場でのプレゼンスの世界な拡大を積極的に追求しています。新市場に参入するためには、各国のさまざまな規制要件を遵守しなければならないです。薬事専門家の役割は、このような複雑な規制状況を乗り切り、製品が必要な基準を満たし、販売承認を得られるようにするために不可欠です。Pharmaceutical Statisticsによると、米国の製薬業界が生み出す収益は2021年に5,500億米ドルに達しました。また、アメリカ人は同年、5,769億米ドルを医薬品に費やしました。創薬と医薬品開発にますます注力するようになった結果、規制当局への新薬申請と提出の数が増えています。現在、FDAが承認した医薬品は4万種類以上あります。個別化医療とともに、細胞治療や遺伝子治療などの先端療法が重視されるようになっていることは、薬事規制市場にチャンスをもたらしています。しかし、厳しい規制要件が課題となり、市場の成長を制限する可能性があることには注意が必要です。

薬事規制市場-セグメンテーション分析：

世界の薬事規制市場は、サービス、カテゴリー、製品ステージ、適応症、サービスプロバイダー、地域に基づいてセグメント化されます。

市場は、サービスに基づいて5つのカテゴリに分かれています：レギュラトリーコンサルティング、法務代理、レギュラトリーライティング＆パブリッシング（執筆、出版）、製品登録＆臨床試験カテゴリー、その他サービス。Regulatory Writing &Publishingは市場で重要な位置を占めています。製品承認および市販後活動に必要な多様な規制文書の作成、編集、提出を含む薬事業務において重要な役割を果たしています。レギュラトリーライターの責任は、複雑な科学的データや臨床データを、規制基準に準拠した、構造化された包括的な文書に変換することです。一方、レギュラトリーパブリッシングでは、これらの文書をフォーマット化、整理し、指定された電子フォーマットで保健当局に提出します。

市場は、カテゴリーに基づいて2つに分類されます：医薬品と生物製剤です。医薬品分野が市場を独占しています。薬事規制部門は、医薬品の市場導入プロセスにおいて重要な役割を果たします。規制当局との効果的なコミュニケーションを促進し、規制を確実に遵守することです。これにより、患者にとっての安全性と有効性を最優先した方法で医薬品が開発・販売されることが保証されます。

市場は、製品ステージに基づいて3つのカテゴリーに分けられる：市場は主に臨床試験セグメントで占められています。規制当局の専門家は、臨床試験が規制基準に準拠していることを保証し、それによって安全性と有効性を兼ね備えた医薬品の創出を促進するという重要な役割を担っています。臨床試験のスポンサーと規制当局の仲介役として、新しい治療法の市場導入に極めて重要な役割を果たしています。

市場は適応症別に4つのカテゴリーに分けられる：腫瘍学、神経学、循環器学、免疫学、その他です。市場を独占しているのはオンコロジー分野です。レギュラトリー・アフェアーズの専門家は、がん治療薬の開発チームと密接に協力し、がん治療薬の開発で遭遇する特有の障害に取り組む規制戦略を策定しています。がん治療薬は、ファスト・トラック、ブレークスルー・セラピー、希少疾病用医薬品といった特別な指定を受ける可能性があります。薬事専門家は、開発および規制手続きを加速させるために、これらの指定を確保する上で重要な役割を果たしています。

市場はサービスプロバイダーによって2つのカテゴリーに分けられる：インハウスとアウトソーシングです。市場は主にアウトソーシングセグメントが支配的です。このセグメントでは、アウトソーシング企業が、薬事関連文書の取りまとめ、書式設定、保健当局への提出の管理を担っています。さらに企業は、電子申請ツールや人工知能アプリケーションなど、規制プロセスにおける新技術の導入をアウトソーシングする選択肢もあります。

薬事規制市場-地理的洞察

この市場は、北米、ラテンアメリカ、欧州、アジア太平洋、中東・アフリカに地理的に広がっています。これらの地域は、事業活動に関与する国に基づいてさらに分割されます。アジア太平洋地域は、主に先進治療と個別化医療への注目が高まっていることから、市場の成長をリードすると予想されます。この地域では、生物製剤、遺伝子治療、個別化医療などの先進治療が重視されています。薬事業務の専門家は、これらの革新的な治療法の開発、登録、市場参入を促進する上で重要な役割を担っており、薬事業務市場全体の成長に貢献しています。14億人以上の人口を抱える中国では、遺伝性疾患の患者が5,700万人、新たながん患者が年間400万人以上いると推定されるため、遺伝子治療を中心とした新たな治療薬の開発が急務となっています。予測期間中、欧州と北米も、これらの地域で実施される臨床試験の数が増加し、これらの地域に進出するバイオ医薬品企業の存在感が高まっていることから、市場の成長を牽引すると予想されます。

薬事規制市場-競合情勢：

製薬業界は常に進化を続ける研究主導のセクターであり、複雑な規制の影響を大きく受けています。これらの規制は、医薬品の設計や製造における研究や技術革新を促進し、医薬品による潜在的な危害から消費者を守り、官民両部門における医薬品への支出を規制することを目的としています。しかし、これらの目的を達成するためには、時に矛盾が生じることもあり、生産者と消費者の利益のバランスを慎重にとる必要があります。この規制状況を乗り切るために、専門のコンサルティング会社、医薬品開発業務受託機関（CRO）、製薬会社の社内部門が薬事サービスを提供しています。これらのサービスは、規制の専門家として卓越し、競争に勝ち残るために必要なツールと知識を消費者組織のチームに装備させるための、費用対効果が高く便利な選択肢を提供するものです。この市場では、薬事情報管理システム（RIMS）や電子申請ツールなど、薬事コンプライアンスプロセスを合理化する技術の開拓や採用という形で競争が生じる可能性があります。

目次

第1章 薬事規制の市場概要

  • 調査範囲
  • 市場推定年数

第2章 エグゼクティブサマリー

  • 市場内訳
  • 競合考察

第3章 薬事規制に関する主要な市場動向

  • 市場促進要因
  • 市場抑制要因
  • 市場機会
  • 今後の市場動向

第4章 薬事規制業界の調査

  • PEST分析
  • ポーターのファイブフォース分析
  • 成長見通しのマッピング
  • 規制枠組みの分析

第5章 薬事規制市場：COVID-19の影響分析

  • COVID-19以前の影響分析
  • COVID-19後の影響分析

第6章 薬事規制市場の情勢

  • 薬事規制市場シェア分析、2022年
  • 主要メーカー別の内訳データ
    • 既存企業の分析
    • 新興企業の分析

第7章 薬事規制市場- サービス別

  • 概要
    • サービス別セグメントシェア分析
    • 規制コンサルティング
    • 法定代理人
    • 規制に関する執筆と出版（執筆、出版）
    • 製品登録および臨床試験サービス
    • その他

第8章 薬事規制市場- カテゴリー別

  • 概要
    • カテゴリ別セグメントシェア分析
    • 薬剤
      • イノベーター
      • ジェネリック
      • 生物製剤
      • バイオテクノロジー
      • ATMP
      • バイオシミラー

第9章 薬事規制市場- 製品段階別

  • 概要
    • 製品段階別セグメントシェア分析
    • 前臨床
    • 臨床研究
    • PMA

第10章 薬事規制市場- 適応症別

  • 概要
    • 適応症別セグメントシェア分析
    • 前臨床
    • 臨床研究
    • PMA

第11章 薬事規制市場- サービスプロバイダー別

  • 概要
    • サービスプロバイダー別のセグメントシェア分析
    • 社内
    • 業務委託

第12章 医薬品規制問題市場-地域別

  • イントロダクション
  • 北米
    • 概要
    • 北米の主要メーカー
    • 米国
    • カナダ
  • 欧州
    • 概要
    • 欧州の主要メーカー
    • ドイツ
    • イタリア
    • 英国
    • フランス
    • ロシア
    • オランダ
    • スウェーデン
    • ポーランド
    • その他
  • アジア太平洋（APAC）
    • 概要
    • アジア太平洋地域の主要メーカー
    • インド
    • 中国
    • 日本
    • 韓国
    • オーストラリア
    • タイ
    • インドネシア
    • フィリピン
    • その他
  • ラテンアメリカ
    • 概要
    • ラテンアメリカの主要メーカー
    • ブラジル
    • メキシコ
    • アルゼンチン
    • コロンビア
    • その他
  • 中東とアフリカ
    • 概要
    • 中東およびアフリカの主要メーカー
    • サウジアラビア
    • アラブ首長国連邦
    • イスラエル
    • トルコ
    • アルジェリア
    • エジプト
    • その他

第13章 主要ベンダー分析- 薬事規制関連業界

  • 競合ダッシュボード
  • 企業プロファイル
    • Freyr
    • IQVIA Inc
    • ICON plc
    • WuXi AppTec
    • Charles River Laboratories
    • Labcorp Drug Development
    • Parexel International Corporation
    • Pharmalex GmbH
    • Pharmexon
    • Genpact

第14章 アナリストの全方位展望

図表

List of Tables

  • TABLE List of data sources
  • TABLE Market drivers; Impact Analysis
  • TABLE Market restraints; Impact Analysis
  • TABLE Pharmaceutical Regulatory Affairs Market: Service Snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Service
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Service 2018-2030 (USD Million)
  • TABLE Pharmaceutical Regulatory Affairs Market: Category Snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Category
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Category 2018-2030 (USD Million)
  • TABLE Pharmaceutical Regulatory Affairs Market: Product stage Snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Product stage
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Product stage 2018-2030 (USD Million)
  • TABLE Pharmaceutical Regulatory Affairs Market: Indication Snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Indication
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Indication 2018-2030 (USD Million)
  • TABLE Pharmaceutical Regulatory Affairs Market: Service Providers Snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Service Providers
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Service Providers 2018-2030 (USD Million)
  • TABLE Pharmaceutical Regulatory Affairs Market: Regional snapshot (2022)
  • TABLE Segment Dashboard; Definition and Scope, by Region
  • TABLE Global Pharmaceutical Regulatory Affairs Market, by Region 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Country, 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Service, 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Category, 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Product stage, 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Indication, 2018-2030 (USD Million)
  • TABLE North America Pharmaceutical Regulatory Affairs Market, by Service Providers, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Country, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Service, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Category, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Product stage, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Indication, 2018-2030 (USD Million)
  • TABLE Europe Pharmaceutical Regulatory Affairs Market, by Service Providers, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Country, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Service, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Category, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Product stage, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Indication, 2018-2030 (USD Million)
  • TABLE Asia Pacific Pharmaceutical Regulatory Affairs Market, by Service Providers, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Country, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Service, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Category, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Product stage, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Indication, 2018-2030 (USD Million)
  • TABLE Latin America Pharmaceutical Regulatory Affairs Market, by Service Providers, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Country, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Service, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Category, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Product stage, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Indication, 2018-2030 (USD Million)
  • TABLE Middle East and Africa Pharmaceutical Regulatory Affairs Market, by Service Providers, 2018-2030 (USD Million)

List of Figures

  • FIGURE Pharmaceutical Regulatory Affairs Market Segmentation
  • FIGURE Market research methodology
  • FIGURE Value chain analysis
  • FIGURE Porter's Five Forces Analysis
  • FIGURE Market Attractiveness Analysis
  • FIGURE COVID-19 Impact Analysis
  • FIGURE Pre & Post COVID-19 Impact Comparision Study
  • FIGURE Competitive Landscape; Key company market share analysis, 2022
  • FIGURE Service segment market share analysis, 2022 & 2030
  • FIGURE Service segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Category segment market share analysis, 2022 & 2030
  • FIGURE Category segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Product stage segment market share analysis, 2022 & 2030
  • FIGURE Product stage segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Indication segment market share analysis, 2022 & 2030
  • FIGURE Indication segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Service Providers segment market share analysis, 2022 & 2030
  • FIGURE Service Providers segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Regional segment market share analysis, 2022 & 2030
  • FIGURE Regional segment market size forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE North America Pharmaceutical Regulatory Affairs Market share and leading players, 2022
  • FIGURE Europe Pharmaceutical Regulatory Affairs Market share and leading players, 2022
  • FIGURE Asia Pacific Pharmaceutical Regulatory Affairs Market share and leading players, 2022
  • FIGURE Latin America Pharmaceutical Regulatory Affairs Market share and leading players, 2022
  • FIGURE Middle East and Africa Pharmaceutical Regulatory Affairs Market share and leading players, 2022
  • FIGURE North America market share analysis by country, 2022
  • FIGURE U.S. Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Canada Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Europe Pharmaceutical Regulatory Affairs Market share analysis by country, 2022
  • FIGURE Germany Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Spain Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Italy Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE France Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE UK Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Russia Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Netherlands Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Sweden Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Poland Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Rest of the Europe Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Asia Pacific Pharmaceutical Regulatory Affairs Market share analysis by country, 2022
  • FIGURE India Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE China Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Japan Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE South Korea Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Australia Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Thailand Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Indonesia Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Phillipines Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Rest of APAC Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Latin America Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Latin America Pharmaceutical Regulatory Affairs Market share analysis by country, 2022
  • FIGURE Brazil Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Mexico Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Argentina Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Colombia Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Rest of LATAM Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Middle East and Africa Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Middle East and Africa Pharmaceutical Regulatory Affairs Market share analysis by country, 2022
  • FIGURE Saudi Arabia Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE United Arab Emirates Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Israel Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Turkey Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Algeria Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Egypt Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
  • FIGURE Rest of MEA Pharmaceutical Regulatory Affairs Market size, forecast and trend analysis, 2018 to 2030 (USD Million)
目次
Product Code: ANV2093

REPORT HIGHLIGHT

Pharmaceutical Regulatory Affairs Market size was valued at USD 13,815.4 Million in 2022, expanding at a CAGR of 8.5% from 2023 to 2030.

Pharmaceutical Regulatory Affairs professionals play a crucial role in ensuring compliance with laws and regulations within the industry. Their main objective is to guarantee the safety, effectiveness, and quality of pharmaceutical products. The pharmaceutical industry is highly regulated, and regulatory affairs professionals are essential in the development of drugs, acting as the primary communication channel between the company and regulatory agencies such as the FDA. They are responsible for staying updated on the ever-expanding and intricate regulatory landscape. In addition to their knowledge of legal and regulatory environments, these professionals also possess expertise in clinical research protocols.

Pharmaceutical Regulatory Affairs Market- Market Dynamics

The growth of the Pharmaceutical Regulatory Affairs market is anticipated to be driven by the expansion of Pharma and Biotech industries, as well as the increasing emphasis on drug development.

Pharmaceutical companies are actively pursuing global expansion of their market presence. In order to enter new markets, they must adhere to various regulatory requirements in different countries. The role of regulatory affairs professionals is vital in navigating these intricate regulatory landscapes, ensuring that products meet the necessary standards and obtain approval for sale. According to Pharmaceutical Statistics, the revenue generated by the U.S. pharmaceutical industry reached USD 550 billion in 2021. Additionally, Americans spent USD 576.9 billion on medicine in the same year. The increasing focus on drug discovery and development has resulted in a higher number of new drug applications and submissions to regulatory agencies. Currently, there are more than 40,000 FDA-approved drugs available in the market. The growing emphasis on advanced therapies, such as cell and gene therapies, along with personalized medicine, presents opportunities for the regulatory affairs market. However, it is important to note that stringent regulatory requirements may pose challenges and restrict the growth of the market.

Pharmaceutical Regulatory Affairs Market- Key Insights

  • As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 8.5% over the forecast period (2023-2030)
  • Based on Services segmentation, Regulatory Writing & Publishing was predicted to show maximum market share in the year 2022
  • Based on Category segmentation, Drugs was the leading type in 2022
  • Based on Product stage segmentation, Clinical Studies was the leading type in 2022
  • Based on Indication segmentation, Oncology was the leading type in 2022
  • Based on Service providers segmentation, Outsourcing was the leading type in 2022
  • On the basis of region, North America was the leading revenue generator in 2022

Pharmaceutical Regulatory Affairs Market- Segmentation Analysis:

The Global Pharmaceutical Regulatory Affairs Market is segmented on the basis of Services, Category, Product stage, Indication, Service provider and Region.

The market is divided into five categories based on Services: Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing (Writing, Publishing), Product Registration & Clinical Trial Category and Other Services. Regulatory Writing & Publishing holds a significant position in the market. It plays a crucial role in Regulatory Affairs, encompassing the preparation, compilation, and submission of diverse regulatory documents necessary for product approval and post-marketing activities. The responsibility of regulatory writers is to transform intricate scientific and clinical data into well-structured and comprehensive documents that adhere to regulatory standards. On the other hand, regulatory publishing involves the formatting, organizing, and submission of these documents in the specified electronic formats to health authorities.

The market is divided into two categories based on Category: Drugs and Biologics. Drugs segment dominates the market. The The Pharmaceutical Regulatory Affairs sector plays a crucial role in the process of introducing drugs to the market. It involves navigating through regulatory pathways, ensuring adherence to regulations, and facilitating effective communication with health authorities. This ensures that drugs are developed and marketed in a way that prioritizes the safety and effectiveness for patients.

The market is divided into three categories based on Product stage: Preclinical, Clinical Studies and PMA.The market is primarily dominated by the Clinical Studies segment. Regulatory professionals play a crucial role in ensuring that clinical trials comply with regulatory standards, thereby facilitating the creation of pharmaceutical products that are both safe and effective. Acting as intermediaries between clinical trial sponsors and regulatory authorities, they play a pivotal role in the introduction of new therapies to the market.

The market is divided into four categories based on Indication: Oncology, Neurology, Cardiology, Immunology and Others. Oncology segment dominates the market. Regulatory Affairs experts work closely with oncology drug development teams to formulate regulatory strategies that tackle the distinctive obstacles encountered in the development of cancer treatments. Oncology drugs have the potential to receive special designations like Fast Track, Breakthrough Therapy, or Orphan Drug status. Regulatory Affairs professionals play a crucial role in securing these designations to accelerate the development and regulatory procedures.

The market is divided into two categories based on Service Provider: In-house and Outsourcing. The market is primarily dominated by the outsourcing segment. Within this segment, outsourcing firms are responsible for managing the compilation, formatting, and submission of regulatory documents to health authorities. Additionally, companies have the option to outsource the implementation of new technologies in regulatory processes, such as electronic submission tools or artificial intelligence applications.

Pharmaceutical Regulatory Affairs Market- Geographical Insights

This market is geographically widespread across North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. These regions are further divided based on the countries involved in business activities. The Asia Pacific region is expected to lead the market growth, primarily due to its increasing focus on Advanced Therapies and Personalized Medicine. In this region, there is a significant emphasis on advanced therapies such as biologics, gene therapies, and personalized medicine. Regulatory affairs professionals play a vital role in facilitating the development, registration, and market access of these innovative therapies, thereby contributing to the overall growth of the regulatory affairs market. With a population of over 1.4 billion, China faces an urgent demand for the development of new therapeutics, especially gene therapies, as it has an estimated 57 million people with genetic diseases and over 4 million new cancer cases annually. During forecast period, Europe and North America are also expected to drive market growth due to the increasing number of clinical trials conducted in these regions and the growing presence of biopharmaceutical companies venturing into these areas.

Pharmaceutical Regulatory Affairs Market- Competitive Landscape:

The pharmaceutical industry is a constantly evolving and research-driven sector that is heavily influenced by a complex set of regulations. These regulations aim to foster research and innovation in drug design and production, safeguard consumers from potential harm caused by drugs, and regulate the expenditure on drugs in both public and private sectors. However, achieving these objectives can sometimes create conflicts and necessitate a careful balance between the interests of producers and consumers. To navigate this regulatory landscape, specialized consulting firms, contract research organizations (CROs), and in-house departments of pharmaceutical companies offer regulatory affairs services. These services provide a cost-effective and convenient option for equipping consumer organizational teams with the necessary tools and knowledge to excel as regulatory professionals and stay ahead of the competition. In this market, competition may arise in the form of the development and adoption of technologies that streamline regulatory compliance processes, such as regulatory information management systems (RIMS) and electronic submission tools.

Recent Developments:

On September 2023, Freyr Solutions, the leading global provider of Regulatory solutions and services, is pleased to announce its strategic partnership with PKG Group LLC. This collaboration has resulted in the successful submission of PKG Group's Type III Drug Master File (DMF) to the US Food and Drug Administration (US FDA). Freyr has provided a comprehensive range of services for the Type III DMF registration support, including a thorough analysis of the documents, compilation of the dossier in eCTD format, and expert guidance throughout the submission process. Additionally, Freyr has offered assistance in managing queries from the US FDA, ensuring a seamless and efficient submission process.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET KEY PLAYERS

  • Freyr
  • IQVIA Inc
  • ICON plc
  • WuXi AppTec
  • Charles River Laboratories
  • Labcorp Drug Development
  • Parexel International Corporation
  • Pharmalex GmbH
  • Pharmexon
  • Genpact

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY SERVICES

  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing (Writing, Publishing)
  • Product Registration & Clinical Trial Categorys
  • Other

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY CATEGORY

  • Drugs
  • Innovator
  • Generics
  • Biologics
  • Biotech
  • ATMP
  • Biosimilars

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY PRODUCT STAGE

  • Preclinical
  • Clinical Studies
  • PMA

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY INDICATION

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY SERVICE PROVIDERS

  • In-house
  • Outsourcing

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY REGION

  • North America
  • The U.S.
  • Canada
  • Europe
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Russia
  • Netherlands
  • Sweden
  • Poland
  • Rest of Europe
  • Asia Pacific
  • India
  • China
  • South Korea
  • Japan
  • Australia
  • Thailand
  • Indonesia
  • Philippines
  • Rest of APAC
  • Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Rest of LATAM
  • The Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Israel
  • Turkey
  • Algeria
  • Egypt
  • Rest of MEA

Table of Contents

1. Pharmaceutical Regulatory Affairs Market Overview

  • 1.1. Study Scope
  • 1.2. Market Estimation Years

2. Executive Summary

  • 2.1. Market Snippet
    • 2.1.1. Pharmaceutical Regulatory Affairs Market Snippet by Service
    • 2.1.2. Pharmaceutical Regulatory Affairs Market Snippet by Category
    • 2.1.3. Pharmaceutical Regulatory Affairs Market Snippet by Product stage
    • 2.1.4. Pharmaceutical Regulatory Affairs Market Snippet by Indication
    • 2.1.5. Pharmaceutical Regulatory Affairs Market Snippet by Service Providers
    • 2.1.6. Pharmaceutical Regulatory Affairs Market Snippet by Country
    • 2.1.7. Pharmaceutical Regulatory Affairs Market Snippet by Region
  • 2.2. Competitive Insights

3. Pharmaceutical Regulatory Affairs Key Market Trends

  • 3.1. Pharmaceutical Regulatory Affairs Market Drivers
    • 3.1.1. Impact Analysis of Market Drivers
  • 3.2. Pharmaceutical Regulatory Affairs Market Restraints
    • 3.2.1. Impact Analysis of Market Restraints
  • 3.3. Pharmaceutical Regulatory Affairs Market Opportunities
  • 3.4. Pharmaceutical Regulatory Affairs Market Future Trends

4. Pharmaceutical Regulatory Affairs Industry Study

  • 4.1. PEST Analysis
  • 4.2. Porter's Five Forces Analysis
  • 4.3. Growth Prospect Mapping
  • 4.4. Regulatory Framework Analysis

5. Pharmaceutical Regulatory Affairs Market: COVID-19 Impact Analysis

  • 5.1. Pre-COVID-19 Impact Analysis
  • 5.2. Post-COVID-19 Impact Analysis
    • 5.2.1. Top Performing Segments
    • 5.2.2. Marginal Growth Segments
    • 5.2.3. Top Looser Segments
    • 5.2.4. Marginal Loss Segments

6. Pharmaceutical Regulatory Affairs Market Landscape

  • 6.1. Pharmaceutical Regulatory Affairs Market Share Analysis, 2022
  • 6.2. Breakdown Data, by Key Manufacturer
    • 6.2.1. Established Players' Analysis
    • 6.2.2. Emerging Players' Analysis

7. Pharmaceutical Regulatory Affairs Market - By Service

  • 7.1. Overview
    • 7.1.1. Segment Share Analysis, By Service, 2022 & 2030 (%)
    • 7.1.2. Regulatory Consulting
    • 7.1.3. Legal Representation
    • 7.1.4. Regulatory Writing & Publishing (Writing, Publishing)
    • 7.1.5. Product Registration & Clinical Trial services
    • 7.1.6. Other

8. Pharmaceutical Regulatory Affairs Market - By Category

  • 8.1. Overview
    • 8.1.1. Segment Share Analysis, By Category, 2022 & 2030 (%)
    • 8.1.2. Drugs
      • 8.1.2.1. Innovator
      • 8.1.2.2. Generics
      • 8.1.2.3. Biologics
      • 8.1.2.4. Biotech
      • 8.1.2.5. ATMP
      • 8.1.2.6. Biosimilars

9. Pharmaceutical Regulatory Affairs Market - By Product stage

  • 9.1. Overview
    • 9.1.1. Segment Share Analysis, By Product stage, 2022 & 2030 (%)
    • 9.1.2. Preclinical
    • 9.1.3. Clinical Studies
    • 9.1.4. PMA

10. Pharmaceutical Regulatory Affairs Market - By Indication

  • 10.1. Overview
    • 10.1.1. Segment Share Analysis, By Indication, 2022 & 2030 (%)
    • 10.1.2. Preclinical
    • 10.1.3. Clinical Studies
    • 10.1.4. PMA

11. Pharmaceutical Regulatory Affairs Market - By Service Providers

  • 11.1. Overview
    • 11.1.1. Segment Share Analysis, By Service Providers, 2022 & 2030 (%)
    • 11.1.2. In-house
    • 11.1.3. Outsourcing

12. Pharmaceutical Regulatory Affairs Market- By Geography

  • 12.1. Introduction
    • 12.1.1. Segment Share Analysis, By Geography, 2022 & 2030 (%)
  • 12.2. North America
    • 12.2.1. Overview
    • 12.2.2. Pharmaceutical Regulatory Affairs Key Manufacturers in North America
    • 12.2.3. North America Market Size and Forecast, By Country, 2018 - 2030 (US$ Million)
    • 12.2.4. North America Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
    • 12.2.5. North America Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
    • 12.2.6. North America Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
    • 12.2.7. North America Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
    • 12.2.8. North America Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.2.9. U.S.
      • 12.2.9.1. Overview
      • 12.2.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.2.9.3. U.S. Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.2.9.4. U.S. Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.2.9.5. U.S. Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.2.9.6. U.S. Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.2.9.7. U.S. Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.2.10. Canada
      • 12.2.10.1. Overview
      • 12.2.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.2.10.3. Canada Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.2.10.4. Canada Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.2.10.5. Canada Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.2.10.6. Canada Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.2.10.7. Canada Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
  • 12.3. Europe
    • 12.3.1. Overview
    • 12.3.2. Pharmaceutical Regulatory Affairs Key Manufacturers in Europe
    • 12.3.3. Europe Market Size and Forecast, By Country, 2018 - 2030 (US$ Million)
    • 12.3.4. Europe Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
    • 12.3.5. Europe Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
    • 12.3.6. Europe Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
    • 12.3.7. Europe Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
    • 12.3.8. Europe Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.9. Germany
      • 12.3.9.1. Overview
      • 12.3.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.9.3. Germany Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.9.4. Germany Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.9.5. Germany Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.9.6. Germany Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.9.7. Germany Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.10. Italy
      • 12.3.10.1. Overview
      • 12.3.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.10.3. Italy Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.10.4. Italy Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.10.5. Italy Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.10.6. Italy Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.10.7. Italy Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.11. United Kingdom
      • 12.3.11.1. Overview
      • 12.3.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.11.3. United Kingdom Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.11.4. United Kingdom Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.11.5. United Kingdom Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.11.6. United Kingdom Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.11.7. United Kingdom Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.12. France
      • 12.3.12.1. Overview
      • 12.3.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.12.3. France Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.12.4. France Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.12.5. France Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.12.6. France Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.12.7. France Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.13. Russia
      • 12.3.13.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.13.2. Russia Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.13.3. Russia Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.13.4. Russia Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.13.5. Russia Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.13.6. Russia Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.14. Netherlands
      • 12.3.14.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.14.2. Netherlands Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.14.3. Netherlands Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.14.4. Netherlands Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.14.5. Netherlands Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.14.6. Netherlands Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.15. Sweden
      • 12.3.15.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.15.2. Sweden Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.15.3. Sweden Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.15.4. Sweden Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.15.5. Sweden Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.15.6. Sweden Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.16. Poland
      • 12.3.16.1. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.16.2. Poland Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.16.3. Poland Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.16.4. Poland Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.16.5. Poland Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.16.6. Poland Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.3.17. Rest of Europe
      • 12.3.17.1. Overview
      • 12.3.17.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.3.17.3. Rest of the Europe Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.3.17.4. Rest of the Europe Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.3.17.5. Rest of the Europe Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.3.17.6. Rest of the Europe Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.3.17.7. Rest of the Europe Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
  • 12.4. Asia Pacific (APAC)
    • 12.4.1. Overview
    • 12.4.2. Pharmaceutical Regulatory Affairs Key Manufacturers in Asia Pacific
    • 12.4.3. Asia Pacific Market Size and Forecast, By Country, 2018 - 2030 (US$ Million)
    • 12.4.4. Asia Pacific Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
    • 12.4.5. Asia Pacific Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
    • 12.4.6. Asia Pacific Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
    • 12.4.7. Asia Pacific Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
    • 12.4.8. Asia Pacific Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.9. India
      • 12.4.9.1. Overview
      • 12.4.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.9.3. India Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.9.4. India Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.9.5. India Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.9.6. India Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.9.7. India Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.10. China
      • 12.4.10.1. Overview
      • 12.4.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.10.3. China Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.10.4. China Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.10.5. China Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.10.6. China Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.10.7. China Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.11. Japan
      • 12.4.11.1. Overview
      • 12.4.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.11.3. Japan Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.11.4. Japan Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.11.5. Japan Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.11.6. Japan Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.11.7. Japan Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.12. South Korea
      • 12.4.12.1. Overview
      • 12.4.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.12.3. South Korea Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.12.4. South Korea Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.12.5. South Korea Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.12.6. South Korea Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.12.7. South Korea Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.13. Australia
      • 12.4.13.1. Overview
      • 12.4.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.13.3. Australia Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.13.4. Australia Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.13.5. Australia Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.13.6. Australia Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.13.7. Australia Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.14. Thailand
      • 12.4.14.1. Overview
      • 12.4.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.14.3. Thailand Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.14.4. Thailand Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.14.5. Thailand Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.14.6. Thailand Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.14.7. Thailand Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.15. Indonesia
      • 12.4.15.1. Overview
      • 12.4.15.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.15.3. Indonesia Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.15.4. Indonesia Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.15.5. Indonesia Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.15.6. Indonesia Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.15.7. Indonesia Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.16. Philippines
      • 12.4.16.1. Overview
      • 12.4.16.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.16.3. Philippines Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.16.4. Philippines Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.16.5. Philippines Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.16.6. Philippines Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.16.7. Philippines Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.4.17. Rest of APAC
      • 12.4.17.1. Overview
      • 12.4.17.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.4.17.3. Rest of APAC Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.4.17.4. Rest of APAC Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.4.17.5. Rest of APAC Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.4.17.6. Rest of APAC Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.4.17.7. Rest of APAC Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
  • 12.5. Latin America
    • 12.5.1. Overview
    • 12.5.2. Pharmaceutical Regulatory Affairs Key Manufacturers in Latin America
    • 12.5.3. Latin America Market Size and Forecast, By Country, 2018 - 2030 (US$ Million)
    • 12.5.4. Latin America Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
    • 12.5.5. Latin America Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
    • 12.5.6. Latin America Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
    • 12.5.7. Latin America Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
    • 12.5.8. Latin America Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.5.9. Brazil
      • 12.5.9.1. Overview
      • 12.5.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.5.9.3. Brazil Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.5.9.4. Brazil Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.5.9.5. Brazil Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.5.9.6. Brazil Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.5.9.7. Brazil Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.5.10. Mexico
      • 12.5.10.1. Overview
      • 12.5.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.5.10.3. Mexico Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.5.10.4. Mexico Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.5.10.5. Mexico Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.5.10.6. Mexico Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.5.10.7. Mexico Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.5.11. Argentina
      • 12.5.11.1. Overview
      • 12.5.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.5.11.3. Argentina Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.5.11.4. Argentina Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.5.11.5. Argentina Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.5.11.6. Argentina Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.5.11.7. Argentina Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.5.12. Colombia
      • 12.5.12.1. Overview
      • 12.5.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.5.12.3. Colombia Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.5.12.4. Colombia Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.5.12.5. Colombia Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.5.12.6. Colombia Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.5.12.7. Colombia Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.5.13. Rest of LATAM
      • 12.5.13.1. Overview
      • 12.5.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.5.13.3. Rest of LATAM Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.5.13.4. Rest of LATAM Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.5.13.5. Rest of LATAM Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.5.13.6. Rest of LATAM Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.5.13.7. Rest of LATAM Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
  • 12.6. Middle East and Africa
    • 12.6.1. Overview
    • 12.6.2. Pharmaceutical Regulatory Affairs Key Manufacturers in Middle East and Africa
    • 12.6.3. Middle East and Africa Market Size and Forecast, By Country, 2018 - 2030 (US$ Million)
    • 12.6.4. Middle East and Africa Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
    • 12.6.5. Middle East and Africa Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
    • 12.6.6. Middle East and Africa Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
    • 12.6.7. Middle East and Africa Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
    • 12.6.8. Middle East and Africa Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.9. Saudi Arabia
      • 12.6.9.1. Overview
      • 12.6.9.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.9.3. Saudi Arabia Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.9.4. Saudi Arabia Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.9.5. Saudi Arabia Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.9.6. Saudi Arabia Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.9.7. Saudi Arabia Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.10. United Arab Emirates
      • 12.6.10.1. Overview
      • 12.6.10.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.10.3. United Arab Emirates Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.10.4. United Arab Emirates Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.10.5. United Arab Emirates Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.10.6. United Arab Emirates Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.10.7. United Arab Emirates Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.11. Israel
      • 12.6.11.1. Overview
      • 12.6.11.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.11.3. Israel Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.11.4. Israel Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.11.5. Israel Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.11.6. Israel Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.11.7. Israel Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.12. Turkey
      • 12.6.12.1. Overview
      • 12.6.12.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.12.3. Turkey Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.12.4. Turkey Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.12.5. Turkey Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.12.6. Turkey Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.12.7. Turkey Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.13. Algeria
      • 12.6.13.1. Overview
      • 12.6.13.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.13.3. Algeria Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.13.4. Algeria Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.13.5. Algeria Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.13.6. Algeria Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.13.7. Algeria Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.14. Egypt
      • 12.6.14.1. Overview
      • 12.6.14.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.14.3. Egypt Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.14.4. Egypt Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.14.5. Egypt Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.14.6. Egypt Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.14.7. Egypt Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)
    • 12.6.15. Rest of MEA
      • 12.6.15.1. Overview
      • 12.6.15.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2018 - 2030, (US$ Million)
      • 12.6.15.3. Rest of MEA Market Size and Forecast, By Service, 2018 - 2030 (US$ Million)
      • 12.6.15.4. Rest of MEA Market Size and Forecast, By Category, 2018 - 2030 (US$ Million)
      • 12.6.15.5. Rest of MEA Market Size and Forecast, By Product stage, 2018 - 2030 (US$ Million)
      • 12.6.15.6. Rest of MEA Market Size and Forecast, By Indication, 2018 - 2030 (US$ Million)
      • 12.6.15.7. Rest of MEA Market Size and Forecast, By Service Providers, 2018 - 2030 (US$ Million)

13. Key Vendor Analysis- Pharmaceutical Regulatory Affairs Industry

  • 13.1. Competitive Dashboard
  • 13.2. Company Profiles
    • 13.2.1. Freyr
    • 13.2.2. IQVIA Inc
    • 13.2.3. ICON plc
    • 13.2.4. WuXi AppTec
    • 13.2.5. Charles River Laboratories
    • 13.2.6. Labcorp Drug Development
    • 13.2.7. Parexel International Corporation
    • 13.2.8. Pharmalex GmbH
    • 13.2.9. Pharmexon
    • 13.2.10. Genpact

14. 360 Degree Analyst View

15. Appendix

  • 15.1. Research Methodology
  • 15.2. References
  • 15.3. Abbreviations
  • 15.4. Disclaimer
  • 15.5. Contact Us