サンプル依頼リスト カート
  • English
  • Korean
  • Traditional Chinese
  • Simplified Chinese
表紙：薬事規制市場：成長、将来展望、競合分析、2023年～2031年
市場調査レポート
商品コード
1443314

薬事規制市場：成長、将来展望、競合分析、2023年～2031年

Pharmaceutical Regulatory Affairs Market - Growth, Future Prospects and Competitive Analysis, 2023 - 2031
出版日: | 発行: Acute Market Reports | ページ情報: 英文 111 Pages | 納期: 即日から翌営業日

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=157.14円
薬事規制市場：成長、将来展望、競合分析、2023年～2031年
出版日: 2024年02月16日
発行: Acute Market Reports
ページ情報: 英文 111 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

薬事規制市場は、2024年から2032年の予測期間中にCAGR 7.5％で成長すると予測されます。市場促進要因として、薬事コンサルティングサービスに対する需要の増加、製品登録や臨床試験申請に対する要求事項の拡大、法定代理業務の重要性の高まりなどが挙げられ、市場を形成する変革的な力が強調されています。薬事関連の文書作成と出版における課題に関する阻害要因は、薬事関連の文書作成に関連する複雑さを意味します。市場セグメンテーションは、薬事コンサルティングサービス、製品登録と臨床試験申請の重要性を明らかにし、製薬業界の多様なニーズに対する微妙な洞察を提供します。地理的動向は北米の優位性を強調し、競合動向は戦略的パートナーシップ、技術投資、競争力を維持するためのサービス多様化の重要性を強調しています。

薬事コンサルティングサービスの需要増加

製薬業界における薬事コンサルティングサービスの需要は、規制の枠組みの複雑さとコンプライアンスの必要性により、大幅な伸びを示しています。業界レポートや市場分析によると、コンサルティングサービスの需要は一貫して増加しており、これは製薬業界が規制要件を乗り越えるために専門家の指導に依存していることを示しています。2024年から2032年までの予測期間中、この分野で最も高い年間平均成長率（CAGR）が見込まれており、進化する規制基準の遵守を確保する上で規制コンサルティングサービスが極めて重要な役割を担っていることが浮き彫りになっています。

製品登録と臨床試験申請の要件拡大

製薬業界では、製品登録と臨床試験申請の要件が拡大しています。規制当局の最新情報や業界動向は、製品承認や臨床試験に必要な精査や文書化が増加していることを裏付けています。製品登録と臨床試験申請に関連する複雑なプロセスを管理するための専門サービスの必要性が業界で認識されていることを反映して、2024年から2032年までの予測期間中、この分野で最も高いCAGRが予想されます。

薬事業務における法定代理業務の重要性の高まり

企業が複雑な規制状況を乗り切る上で法律の専門知識の価値を認識していることから、法律代理業務は医薬品薬事で注目されています。法的手続き、業界出版物、企業戦略などから、規制上の課題に対処するための法定代理人の重要性が高まっていることがうかがえます。2024年から2032年までの予測期間中、この分野で最も高いCAGRが予想されており、これは製薬業界が法規制遵守において法的支援が重要な要素であると認識していることを示しています。

薬事ライティングと出版における課題

薬事業務の全体的な成長にもかかわらず、薬事関連の執筆と出版における課題が顕著な抑制要因として浮上しています。業界考察や専門家の分析によると、規制文書の複雑な性質が企業やサービスプロバイダーに課題をもたらしています。2024年から2032年までの予測期間中、この分野で最も高いCAGRが予想され、薬事関連の文書作成と出版に伴う複雑さに対処する革新的なソリューションの必要性が浮き彫りになっています。業界がこのような課題を克服していく中で、市場関係者にとって規制状況全体への影響は依然として重要な検討事項です。

サービス別市場分析：薬事コンサルティングサービスが市場を独占

2023年、薬事規制市場は薬事コンサルティングサービスからの収益が大きく、この分野が収益とCAGRの両方でリードしています。これは、業界が進化する規制基準へのコンプライアンスを確保するために専門家の指導に依存していることを反映しています。2024年から2032年までの予測期間においてCAGRが最も高いのは、製品登録と臨床試験申請のカテゴリーであり、規制プロセスの管理における専門的サービスに対する需要の増加を示しています。

適応症別市場分析：がん領域が市場を独占

2023年、薬事規制市場はがん領域の適応症から大きな収益が見込まれ、このカテゴリーが収益とCAGRの両方でトップとなった。このことは、がん領域の製品に関連する規制の複雑さと、この治療領域における専門的な規制サービスの必要性を浮き彫りにしています。2024年から2032年までの予測期間においてCAGRが最も高いのは神経領域の適応症であり、これは神経領域に特化した医薬品に対する規制要件の増加が予想されることを示しています。

北米は依然として世界のリーダーであり続ける

地域別では、2023年の薬事規制市場はダイナミックな動向を示し、北米が売上高とCAGRの両方でトップとなった。これは、同地域の堅調な製薬業界と進化する規制状況を反映しています。欧州とアジア太平洋も収益に大きく貢献し、規制要件と薬事サービスに対する需要の増加という世界の動向を示しています。この地理的区分により、市場セグメンテーション市場を形成する地域力学に関する洞察が得られます。

市場シェア拡大のための戦略的パートナーシップとコラボレーション

薬事規制市場の競合情勢は、市場ポジションを強化する戦略を採用する主要企業によって特徴付けられます。QuintilesIMS、Parexel International Corporation、ICON plc、Freyr、IQVIA Inc、WuXi AppTec、Charles River Laboratories、Labcorp Drug Development、Pharmalex GmbH、Pharmexon、Genpactなどの主要企業は、市場機会を活かすために多様な戦略を実施しています。薬事規制市場の主要プレーヤーは、戦略的パートナーシップとコラボレーションを主要戦略として優先しています。パートナーシップの発表や共同イニシアティブの課題から、QuintilesIMSのような企業が規制上の課題を克服するために専門知識を結集していることがうかがえます。2023年、これらの企業は多額の収益を計上し、2024年から2032年までの予測期間中に増加が予測されます。協調的アプローチへの取り組みにより、業界は進化する規制要件に対応し、顧客に包括的ソリューションを提供する最前線に位置しています。技術ソリューションへの投資は、薬事規制市場の主要企業の間で顕著な動向となっています。技術買収やデジタルトランスフォーメーションへの取り組みが、規制プロセスの合理化における技術の役割を業界が認識していることを裏付けています。2023年には、ICON plcのような企業が技術的進歩に多額の投資を行っており、規制業務におけるデジタルソリューションの世界の推進と一致しています。市場が技術革新を受け入れる中、デジタルトランスフォーメーションを優先する企業は競争力を維持し、効率的でコンプライアンスに準拠したソリューションを顧客に提供することが期待されます。

本レポートでお答えする主な質問

薬事規制市場の成長に影響を与える主なミクロおよびマクロ環境要因は何か？

現在および予測期間中の製品セグメントと地域に関する主な投資ポケットは？

2031年までの推定推計・市場予測

予測期間中に最も速いCAGRを占めるセグメントは？

市場シェアの大きいセグメントとその理由は？

中低所得国は薬事規制市場に投資しているか？

薬事規制市場で最大の地域市場はどこか？

アジア太平洋、ラテンアメリカ、中東・アフリカなどの新興市場における市場動向と力学は？

薬事規制市場の成長を促進する主要動向は？

世界の薬事規制市場で存在感を高めるための主要な競合企業とその主要戦略とは？

目次

第1章 序文

  • レポート内容
    • レポートの目的
    • 対象者
    • 主な提供
  • 市場セグメンテーション
  • 調査手法
    • フェーズⅠ-二次調査
    • フェーズⅡ-一次調査
    • フェーズⅢ-有識者レビュー
    • 前提条件
    • 採用したアプローチ

第2章 エグゼクティブサマリー

第3章 薬事規制市場：競合分析

  • 主要ベンダーの市場での位置付け
  • ベンダーが採用する戦略
  • 主要な産業戦略
  • ティア分析：2023 vs 2032

第4章 薬事規制市場：マクロ分析と市場力学

  • イントロダクション
  • 世界の薬事規制市場金額 2022-2032
  • 市場力学
    • 市場促進要因
    • 市場抑制要因
    • 主な課題
    • 主な機会
  • 促進要因と抑制要因の影響分析
  • シーソー分析
  • ポーターのファイブフォースモデル
    • サプライヤーパワー
    • バイヤーパワー
    • 代替品の脅威
    • 新規参入業者の脅威
    • 競争企業間の敵対関係
  • PESTEL分析
    • 政治的情勢
    • 経済情勢
    • テクノロジーの情勢
    • 法的情勢
    • 社会的情勢

第5章 薬事規制市場：サービス別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 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
      • 書き込み
      • 出版
    • 製品登録と臨床試験の申請
    • 他のサービス

第6章 薬事規制市場：カテゴリ別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 薬物
      • 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7章 薬事規制市場：適応症別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 腫瘍学
    • 神経内科
    • 心臓病学
    • 免疫学
    • その他

第8章 薬事規制市場：製品段階別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 前臨床
    • 臨床研究
    • PMA

第9章 薬事規制市場：サービスプロバイダー別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 社内
    • アウトソーシング

第10章 薬事規制市場：企業規模別 2022-2032

  • 市場概要
  • 成長・収益分析：2023 vs 2032
  • 市場セグメンテーション
    • 小
    • 中
    • 大

第11章 北米の薬事規制市場 2022-2032

  • 市場概要
  • 薬事規制市場：サービス別 2022-2032
  • 薬事規制市場：カテゴリ別 2022-2032
  • 薬事規制市場：適応症別 2022-2032
  • 薬事規制市場：製品段階別 2022-2032
  • 薬事規制市場：サービスプロバイダー別 2022-2032
  • 薬事規制市場：企業規模別 2022-2032
  • 薬事規制市場：地域別 2022-2032
    • 北米
      • 米国
      • カナダ
      • その他北米地域

第12章 英国と欧州連合の薬事規制市場 2022-2032

  • 市場概要
  • 薬事規制市場：サービス別 2022-2032
  • 薬事規制市場：カテゴリ別 2022-2032
  • 薬事規制市場：適応症別 2022-2032
  • 薬事規制市場：製品段階別 2022-2032
  • 薬事規制市場：サービスプロバイダー別 2022-2032
  • 薬事規制市場：企業規模別 2022-2032
  • 薬事規制市場：地域別 2022-2032
    • 英国と欧州連合
      • 英国
      • ドイツ
      • スペイン
      • イタリア
      • フランス
      • その他欧州地域

第13章 アジア太平洋の薬事規制市場 2022-2032

  • 市場概要
  • 薬事規制市場：サービス別 2022-2032
  • 薬事規制市場：カテゴリ別 2022-2032
  • 薬事規制市場：適応症別 2022-2032
  • 薬事規制市場：製品段階別 2022-2032
  • 薬事規制市場：サービスプロバイダー別 2022-2032
  • 薬事規制市場：企業規模別 2022-2032
  • 薬事規制市場：地域別 2022-2032
    • アジア太平洋
      • 中国
      • 日本
      • インド
      • オーストラリア
      • 韓国
      • その他アジア太平洋地域

第14章 ラテンアメリカの薬事規制市場 2022-2032

  • 市場概要
  • 薬事規制市場：サービス別 2022-2032
  • 薬事規制市場：カテゴリ別 2022-2032
  • 薬事規制市場：適応症別 2022-2032
  • 薬事規制市場：製品段階別 2022-2032
  • 薬事規制市場：サービスプロバイダー別 2022-2032
  • 薬事規制市場：企業規模別 2022-2032
  • 薬事規制市場：地域別 2022-2032
    • ラテンアメリカ
      • ブラジル
      • メキシコ
      • その他ラテンアメリカ地域

第15章 中東・アフリカの薬事規制市場 2022-2032

  • 市場概要
  • 薬事規制市場：サービス別 2022-2032
  • 薬事規制市場：カテゴリ別 2022-2032
  • 薬事規制市場：適応症別 2022-2032
  • 薬事規制市場：製品段階別 2022-2032
  • 薬事規制市場：サービスプロバイダー別 2022-2032
  • 薬事規制市場：企業規模別 2022-2032
  • 薬事規制市場：地域別 2022-2032
    • 中東・アフリカ
      • GCC
      • アフリカ
      • その他中東・アフリカ地域

第16章 企業プロファイル

  • QuintilesIMS
  • Parexel International Corporation
  • ICON plc
  • Freyr
  • IQVIA Inc
  • WuXi AppTec
  • Charles River Laboratories
  • Labcorp Drug Development
  • Pharmalex GmbH
  • Pharmexon
  • Genpact
  • その他の主要企業
図表

List of Tables

  • TABLE 1 Global Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 2 Global Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 3 Global Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 4 Global Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 5 Global Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 6 Global Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 7 Global Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 8 Global Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 9 Global Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 10 Global Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 11 Global Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 12 Global Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 13 Global Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 14 Global Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)
  • TABLE 15 North America Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 16 North America Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 17 North America Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 18 North America Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 19 North America Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 20 North America Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 21 North America Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 22 North America Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 23 North America Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 24 North America Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 25 North America Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 26 North America Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 27 North America Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 28 North America Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)
  • TABLE 29 UK and European Union Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 30 UK and European Union Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 31 UK and European Union Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 32 UK and European Union Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 33 UK and European Union Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 34 UK and European Union Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 35 UK and European Union Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 36 UK and European Union Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 37 UK and European Union Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 38 UK and European Union Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 39 UK and European Union Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 40 UK and European Union Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 41 UK and European Union Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 42 UK and European Union Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)
  • TABLE 43 Asia Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 44 Asia Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 45 Asia Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 46 Asia Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 47 Asia Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 48 Asia Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 49 Asia Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 50 Asia Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 51 Asia Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 52 Asia Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 53 Asia Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 54 Asia Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 55 Asia Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 56 Asia Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)
  • TABLE 57 Latin America Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 58 Latin America Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 59 Latin America Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 60 Latin America Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 61 Latin America Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 62 Latin America Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 63 Latin America Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 64 Latin America Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 65 Latin America Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 66 Latin America Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 67 Latin America Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 68 Latin America Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 69 Latin America Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 70 Latin America Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)
  • TABLE 71 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Services, 2022-2032, USD (Million)
  • TABLE 72 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Regulatory Writing & Publishing, 2022-2032, USD (Million)
  • TABLE 73 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Category, 2022-2032, USD (Million)
  • TABLE 74 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Drugs, 2022-2032, USD (Million)
  • TABLE 75 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Innovator, 2022-2032, USD (Million)
  • TABLE 76 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Generics, 2022-2032, USD (Million)
  • TABLE 77 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Biologics, 2022-2032, USD (Million)
  • TABLE 78 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Biotech, 2022-2032, USD (Million)
  • TABLE 79 Middle East and Africa Pharmaceutical Regulatory Affairs Market By ATMP, 2022-2032, USD (Million)
  • TABLE 80 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Biosimilars, 2022-2032, USD (Million)
  • TABLE 81 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Indication, 2022-2032, USD (Million)
  • TABLE 82 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Product Stage, 2022-2032, USD (Million)
  • TABLE 83 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Service Provider, 2022-2032, USD (Million)
  • TABLE 84 Middle East and Africa Pharmaceutical Regulatory Affairs Market By Company Size, 2022-2032, USD (Million)

List of Figures

  • FIG. 1 Global Pharmaceutical Regulatory Affairs Market: Market Coverage
  • FIG. 2 Research Methodology and Data Sources
  • FIG. 3 Market Size Estimation - Top Down & Bottom-Up Approach
  • FIG. 4 Global Pharmaceutical Regulatory Affairs Market: Quality Assurance
  • FIG. 5 Global Pharmaceutical Regulatory Affairs Market, By Services, 2023
  • FIG. 6 Global Pharmaceutical Regulatory Affairs Market, By Category, 2023
  • FIG. 7 Global Pharmaceutical Regulatory Affairs Market, By Indication, 2023
  • FIG. 8 Global Pharmaceutical Regulatory Affairs Market, By Product Stage, 2023
  • FIG. 9 Global Pharmaceutical Regulatory Affairs Market, By Service Provider, 2023
  • FIG. 10 Global Pharmaceutical Regulatory Affairs Market, By Company Size, 2023
  • FIG. 11 Global Pharmaceutical Regulatory Affairs Market, By Geography, 2023
  • FIG. 12 Market Geographical Opportunity Matrix - Global Pharmaceutical Regulatory Affairs Market, 2023

FIG. 13Market Positioning of Key Pharmaceutical Regulatory Affairs Market Players, 2023

FIG. 14Global Pharmaceutical Regulatory Affairs Market - Tier Analysis - Percentage of Revenues by Tier Level, 2023 Versus 2032

  • FIG. 15 Global Pharmaceutical Regulatory Affairs Market, By Services, 2023 Vs 2032, %
  • FIG. 16 Global Pharmaceutical Regulatory Affairs Market, By Category, 2023 Vs 2032, %
  • FIG. 17 Global Pharmaceutical Regulatory Affairs Market, By Indication, 2023 Vs 2032, %
  • FIG. 18 Global Pharmaceutical Regulatory Affairs Market, By Product Stage, 2023 Vs 2032, %
  • FIG. 19 Global Pharmaceutical Regulatory Affairs Market, By Service Provider, 2023 Vs 2032, %
  • FIG. 20 Global Pharmaceutical Regulatory Affairs Market, By Company Size, 2023 Vs 2032, %
  • FIG. 21 U.S. Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 22 Canada Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 23 Rest of North America Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 24 UK Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 25 Germany Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 26 Spain Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 27 Italy Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 28 France Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 29 Rest of Europe Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 30 China Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 31 Japan Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 32 India Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 33 Australia Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 34 South Korea Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 35 Rest of Asia Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 36 Brazil Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 37 Mexico Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 38 Rest of Latin America Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 39 GCC Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 40 Africa Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
  • FIG. 41 Rest of Middle East and Africa Pharmaceutical Regulatory Affairs Market (US$ Million), 2022 - 2032
目次
Product Code: 140138-02-24

The pharmaceutical regulatory affairs market is expected to grow at a CAGR of 7.5% during the forecast period of 2024 to 2032. The identified drivers, including increasing demand for regulatory consulting services, expanding requirements for product registration and clinical trial applications, and the rising importance of legal representation, underscore the transformative forces shaping the market. The restraint related to challenges in regulatory writing and publishing signifies the complexities associated with documentation in regulatory affairs. Market segmentation reveals the significance of regulatory consulting services and product registration and clinical trial applications, providing nuanced insights into the diverse needs of the pharmaceutical industry. Geographic trends highlight the dominance of North America, while competitive trends underscore the importance of strategic partnerships, technological investments, and service diversification in maintaining a competitive edge.

Increasing Demand for Regulatory Consulting Services

The demand for regulatory consulting services in the pharmaceutical industry has witnessed substantial growth, driven by the complexities of regulatory frameworks and the need for compliance. Industry reports and market analyses provide evidence of a consistent rise in the demand for consulting services, indicating the pharmaceutical sector's reliance on expert guidance to navigate regulatory requirements. The highest Compound Annual Growth Rate (CAGR) during the forecast period from 2024 to 2032 is anticipated in this segment, highlighting the crucial role of regulatory consulting services in ensuring adherence to evolving regulatory standards.

Expanding Requirements for Product Registration & Clinical Trial Applications

The pharmaceutical landscape has witnessed an expansion in the requirements for product registration and clinical trial applications. Evidences from regulatory updates and industry trends underscore the increasing scrutiny and documentation needed for product approvals and clinical trials. The highest CAGR during the forecast period from 2024 to 2032 is expected in this segment, reflecting the industry's recognition of the need for specialized services to manage the intricate processes associated with product registration and clinical trial applications.

Rising Importance of Legal Representation in Regulatory Affairs

Legal representation has gained prominence in pharmaceutical regulatory affairs, with companies recognizing the value of legal expertise in navigating complex regulatory landscapes. Evidences from legal proceedings, industry publications, and corporate strategies highlight the escalating importance of legal representation in addressing regulatory challenges. The highest CAGR during the forecast period from 2024 to 2032 is anticipated in this segment, signaling the pharmaceutical industry's acknowledgment of legal support as a critical element in regulatory compliance.

Challenges in Regulatory Writing & Publishing

Despite the overall growth in regulatory affairs services, challenges in regulatory writing and publishing have emerged as a notable restraint. Evidences from industry insights and expert analyses indicate that the intricate nature of regulatory documentation poses challenges for companies and service providers. The highest CAGR during the forecast period from 2024 to 2032 is expected in this segment, underscoring the need for innovative solutions to address the complexities associated with regulatory writing and publishing. As the industry navigates these challenges, the impact on the overall regulatory affairs landscape remains a key consideration for market players.

Market Analysis by Services: Regulatory Consulting Services Dominate the Market

In 2023, the pharmaceutical regulatory affairs market demonstrated substantial revenue from regulatory consulting services, with this segment leading in both revenue and CAGR. This reflects the industry's reliance on expert guidance to ensure compliance with evolving regulatory standards. The highest CAGR during the forecast period from 2024 to 2032 is expected in the category of product registration and clinical trial applications, showcasing the increasing demand for specialized services in managing regulatory processes.

Market Analysis by Indication: OncologySegment Dominates the Market

In 2023, the pharmaceutical regulatory affairs market witnessed significant revenue from the oncology indication, with this category leading in both revenue and CAGR. This highlights the regulatory complexities associated with oncology products and the need for specialized regulatory services in this therapeutic area. The highest CAGR during the forecast period from 2024 to 2032 is expected in the neurology indication category, signaling the anticipated growth in regulatory requirements for neurology-focused pharmaceuticals.

North America remains the Global Leader

Geographically, the pharmaceutical regulatory affairs market exhibited dynamic trends in 2023, with North America leading in both revenue generation and the highest CAGR. This reflects the region's robust pharmaceutical industry and the evolving regulatory landscape. Europe and Asia-Pacific also contributed significantly to revenue, showcasing a global trend towards increased regulatory requirements and the demand for regulatory affairs services. This geographic segmentation provides insights into the regional dynamics shaping the pharmaceutical regulatory affairs market.

Strategic Partnerships and Collaborations to Enhance Market Share

The pharmaceutical regulatory affairs market's competitive landscape is marked by key players adopting strategies to enhance their market position. Major companies, including QuintilesIMS, Parexel International Corporation, ICON plc, Freyr, IQVIA Inc, WuXi AppTec, Charles River Laboratories, Labcorp Drug Development, Pharmalex GmbH, Pharmexon, and Genpact, have implemented diverse strategies to capitalize on market opportunities. Leading players in the pharmaceutical regulatory affairs market prioritize strategic partnerships and collaborations as key strategies. Evidences from partnership announcements and collaborative initiatives highlight the efforts of companies like QuintilesIMS to leverage combined expertise in navigating regulatory challenges. In 2023, these companies reported substantial revenues, with a projected increase during the forecast period from 2024 to 2032. The industry's commitment to collaborative approaches positions it at the forefront of addressing evolving regulatory requirements and offering comprehensive solutions to clients. Investment in technological solutions is a notable trend among top players in the pharmaceutical regulatory affairs market. Evidences from technology acquisitions and digital transformation initiatives underscore the industry's recognition of the role of technology in streamlining regulatory processes. In 2023, companies like ICON plc demonstrated significant investments in technological advancements, aligning with the global push for digital solutions in regulatory affairs. As the market embraces technological innovation, companies that prioritize digital transformation are expected to maintain a competitive edge, offering efficient and compliant solutions to clients.

Historical & Forecast Period

This study report represents analysis of each segment from 2021 to 2031 considering 2022 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2023 to 2031.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation ofPharmaceutical Regulatory Affairs market are as follows:

Research and development budgets of manufacturers and government spending

Revenues of key companies in the market segment

Number of end users and consumption volume, price and value.

Geographical revenues generate by countries considered in the report

Micro and macro environment factors that are currently influencing the Pharmaceutical Regulatory Affairs market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Market Segmentation

Services

    • Regulatory Consulting
    • Legal Representation
    • Regulatory Writing & Publishing
  • Writing
  • Publishing
    • Product Registration & Clinical Trial Applications
    • Other Services

Category

    • Drugs
  • Innovator

4 Preclinical

4 Clinical

4 Pre-Market Approval (PMA)

  • Generics

4 Preclinical

4 Clinical

4 Pre-Market Approval (PMA)

    • Biologics
  • Biotech

4 Preclinical

4 Clinical

4 Pre-Market Approval (PMA)

  • ATMP

4 Preclinical

4 Clinical

4 Pre-Market Approval (PMA)

  • Biosimilars

4 Preclinical

4 Clinical

4 Pre-Market Approval (PMA)

Indication

    • Oncology
    • Neurology
    • Cardiology
    • Immunology
    • Others

Product Stage

    • Preclinical
    • Clinical studies
    • PMA

Service Provider

    • In-house
    • Outsourcing

Company Size

    • Small
    • Medium
    • Large

Region Segment (2021-2031; US$ Million)

North America

U.S.

Canada

Rest of North America

UK and European Union

UK

Germany

Spain

Italy

France

Rest of Europe

Asia Pacific

China

Japan

India

Australia

South Korea

Rest of Asia Pacific

Latin America

Brazil

Mexico

Rest of Latin America

Middle East and Africa

GCC

Africa

Rest of Middle East and Africa

Key questions answered in this report

What are the key micro and macro environmental factors that are impacting the growth of Pharmaceutical Regulatory Affairs market?

What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?

Estimated forecast and market projections up to 2031.

Which segment accounts for the fastest CAGR during the forecast period?

Which market segment holds a larger market share and why?

Are low and middle-income economies investing in the Pharmaceutical Regulatory Affairs market?

Which is the largest regional market for Pharmaceutical Regulatory Affairs market?

What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?

Which are the key trends driving Pharmaceutical Regulatory Affairs market growth?

Who are the key competitors and what are their key strategies to enhance their market presence in the Pharmaceutical Regulatory Affairs market worldwide?

Table of Contents

1. Preface

  • 1.1. Report Description
    • 1.1.1. Purpose of the Report
    • 1.1.2. Target Audience
    • 1.1.3. Key Offerings
  • 1.2. Market Segmentation
  • 1.3. Research Methodology
    • 1.3.1. Phase I - Secondary Research
    • 1.3.2. Phase II - Primary Research
    • 1.3.3. Phase III - Expert Panel Review
    • 1.3.4. Assumptions
    • 1.3.5. Approach Adopted

2. Executive Summary

  • 2.1. Market Snapshot: Global Pharmaceutical Regulatory Affairs Market
  • 2.2. Global Pharmaceutical Regulatory Affairs Market, By Services, 2023 (US$ Million)
  • 2.3. Global Pharmaceutical Regulatory Affairs Market, By Category, 2023 (US$ Million)
  • 2.4. Global Pharmaceutical Regulatory Affairs Market, By Indication, 2023 (US$ Million)
  • 2.5. Global Pharmaceutical Regulatory Affairs Market, By Product Stage, 2023 (US$ Million)
  • 2.6. Global Pharmaceutical Regulatory Affairs Market, By Service Provider, 2023 (US$ Million)
  • 2.7. Global Pharmaceutical Regulatory Affairs Market, By Company Size, 2023 (US$ Million)
  • 2.8. Global Pharmaceutical Regulatory Affairs Market, By Geography, 2023 (US$ Million)
  • 2.9. Attractive Investment Proposition by Geography, 2023

3. Pharmaceutical Regulatory Affairs Market: Competitive Analysis

  • 3.1. Market Positioning of Key Pharmaceutical Regulatory Affairs Market Vendors
  • 3.2. Strategies Adopted by Pharmaceutical Regulatory Affairs Market Vendors
  • 3.3. Key Industry Strategies
  • 3.4. Tier Analysis 2023 Versus 2032

4. Pharmaceutical Regulatory Affairs Market: Macro Analysis & Market Dynamics

  • 4.1. Introduction
  • 4.2. Global Pharmaceutical Regulatory Affairs Market Value, 2022 - 2032, (US$ Million)
  • 4.3. Market Dynamics
    • 4.3.1. Market Drivers
    • 4.3.2. Market Restraints
    • 4.3.3. Key Challenges
    • 4.3.4. Key Opportunities
  • 4.4. Impact Analysis of Drivers and Restraints
  • 4.5. See-Saw Analysis
  • 4.6. Porter's Five Force Model
    • 4.6.1. Supplier Power
    • 4.6.2. Buyer Power
    • 4.6.3. Threat Of Substitutes
    • 4.6.4. Threat Of New Entrants
    • 4.6.5. Competitive Rivalry
  • 4.7. PESTEL Analysis
    • 4.7.1. Political Landscape
    • 4.7.2. Economic Landscape
    • 4.7.3. Technology Landscape
    • 4.7.4. Legal Landscape
    • 4.7.5. Social Landscape

5. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)

  • 5.1. Market Overview
  • 5.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 5.3. Market Segmentation
    • 5.3.1. Regulatory Consulting
    • 5.3.2. Legal Representation
    • 5.3.3. Regulatory Writing & Publishing
      • 5.3.3.1. Writing
      • 5.3.3.2. Publishing
    • 5.3.4. Product Registration & Clinical Trial Applications
    • 5.3.5. Other Services

6. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)

  • 6.1. Market Overview
  • 6.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 6.3. Market Segmentation
    • 6.3.1. Drugs
      • 6.3.1.1. Innovator
        • 6.3.1.1.1. Preclinical
        • 6.3.1.1.2. Clinical
        • 6.3.1.1.3. Pre-Market Approval (PMA)
      • 6.3.1.2. Generics
        • 6.3.1.2.1. Preclinical
        • 6.3.1.2.2. Clinical
        • 6.3.1.2.3. Pre-Market Approval (PMA)
    • 6.3.2. Biologics
      • 6.3.2.1. Biotech
        • 6.3.2.1.1. Preclinical
        • 6.3.2.1.2. Clinical
        • 6.3.2.1.3. Pre-Market Approval (PMA)
      • 6.3.2.2. ATMP
        • 6.3.2.2.1. Preclinical
        • 6.3.2.2.2. Clinical
        • 6.3.2.2.3. Pre-Market Approval (PMA)
      • 6.3.2.3. Biosimilars
        • 6.3.2.3.1. Preclinical
        • 6.3.2.3.2. Clinical
        • 6.3.2.3.3. Pre-Market Approval (PMA)

7. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)

  • 7.1. Market Overview
  • 7.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 7.3. Market Segmentation
    • 7.3.1. Oncology
    • 7.3.2. Neurology
    • 7.3.3. Cardiology
    • 7.3.4. Immunology
    • 7.3.5. Others

8. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)

  • 8.1. Market Overview
  • 8.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 8.3. Market Segmentation
    • 8.3.1. Preclinical
    • 8.3.2. Clinical studies
    • 8.3.3. PMA

9. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)

  • 9.1. Market Overview
  • 9.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 9.3. Market Segmentation
    • 9.3.1. In-house
    • 9.3.2. Outsourcing

10. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

  • 10.1. Market Overview
  • 10.2. Growth & Revenue Analysis: 2023 Versus 2032
  • 10.3. Market Segmentation
    • 10.3.1. Small
    • 10.3.2. Medium
    • 10.3.3. Large

11. North America Pharmaceutical Regulatory Affairs Market, 2022-2032, USD (Million)

  • 11.1. Market Overview
  • 11.2. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
  • 11.3. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
  • 11.4. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
  • 11.5. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
  • 11.6. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
  • 11.7. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
  • 11.8.Pharmaceutical Regulatory Affairs Market: By Region, 2022-2032, USD (Million)
    • 11.8.1.North America
      • 11.8.1.1. U.S.
        • 11.8.1.1.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 11.8.1.1.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 11.8.1.1.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 11.8.1.1.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 11.8.1.1.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 11.8.1.1.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 11.8.1.2. Canada
        • 11.8.1.2.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 11.8.1.2.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 11.8.1.2.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 11.8.1.2.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 11.8.1.2.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 11.8.1.2.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 11.8.1.3. Rest of North America
        • 11.8.1.3.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 11.8.1.3.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 11.8.1.3.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 11.8.1.3.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 11.8.1.3.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 11.8.1.3.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

12. UK and European Union Pharmaceutical Regulatory Affairs Market, 2022-2032, USD (Million)

  • 12.1. Market Overview
  • 12.2. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
  • 12.3. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
  • 12.4. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
  • 12.5. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
  • 12.6. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
  • 12.7. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
  • 12.8.Pharmaceutical Regulatory Affairs Market: By Region, 2022-2032, USD (Million)
    • 12.8.1.UK and European Union
      • 12.8.1.1. UK
        • 12.8.1.1.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.1.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.1.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.1.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.1.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.1.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 12.8.1.2. Germany
        • 12.8.1.2.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.2.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.2.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.2.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.2.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.2.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 12.8.1.3. Spain
        • 12.8.1.3.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.3.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.3.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.3.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.3.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.3.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 12.8.1.4. Italy
        • 12.8.1.4.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.4.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.4.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.4.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.4.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.4.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 12.8.1.5. France
        • 12.8.1.5.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.5.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.5.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.5.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.5.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.5.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 12.8.1.6. Rest of Europe
        • 12.8.1.6.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 12.8.1.6.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 12.8.1.6.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 12.8.1.6.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 12.8.1.6.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 12.8.1.6.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

13. Asia Pacific Pharmaceutical Regulatory Affairs Market, 2022-2032, USD (Million)

  • 13.1. Market Overview
  • 13.2. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
  • 13.3. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
  • 13.4. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
  • 13.5. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
  • 13.6. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
  • 13.7. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
  • 13.8.Pharmaceutical Regulatory Affairs Market: By Region, 2022-2032, USD (Million)
    • 13.8.1.Asia Pacific
      • 13.8.1.1. China
        • 13.8.1.1.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.1.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.1.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.1.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.1.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.1.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 13.8.1.2. Japan
        • 13.8.1.2.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.2.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.2.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.2.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.2.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.2.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 13.8.1.3. India
        • 13.8.1.3.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.3.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.3.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.3.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.3.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.3.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 13.8.1.4. Australia
        • 13.8.1.4.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.4.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.4.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.4.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.4.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.4.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 13.8.1.5. South Korea
        • 13.8.1.5.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.5.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.5.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.5.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.5.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.5.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 13.8.1.6. Rest of Asia Pacific
        • 13.8.1.6.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 13.8.1.6.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 13.8.1.6.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 13.8.1.6.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 13.8.1.6.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 13.8.1.6.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

14. Latin America Pharmaceutical Regulatory Affairs Market, 2022-2032, USD (Million)

  • 14.1. Market Overview
  • 14.2. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
  • 14.3. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
  • 14.4. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
  • 14.5. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
  • 14.6. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
  • 14.7. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
  • 14.8.Pharmaceutical Regulatory Affairs Market: By Region, 2022-2032, USD (Million)
    • 14.8.1.Latin America
      • 14.8.1.1. Brazil
        • 14.8.1.1.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 14.8.1.1.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 14.8.1.1.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 14.8.1.1.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 14.8.1.1.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 14.8.1.1.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 14.8.1.2. Mexico
        • 14.8.1.2.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 14.8.1.2.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 14.8.1.2.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 14.8.1.2.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 14.8.1.2.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 14.8.1.2.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 14.8.1.3. Rest of Latin America
        • 14.8.1.3.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 14.8.1.3.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 14.8.1.3.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 14.8.1.3.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 14.8.1.3.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 14.8.1.3.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

15. Middle East and Africa Pharmaceutical Regulatory Affairs Market, 2022-2032, USD (Million)

  • 15.1. Market Overview
  • 15.2. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
  • 15.3. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
  • 15.4. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
  • 15.5. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
  • 15.6. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
  • 15.7. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
  • 15.8.Pharmaceutical Regulatory Affairs Market: By Region, 2022-2032, USD (Million)
    • 15.8.1.Middle East and Africa
      • 15.8.1.1. GCC
        • 15.8.1.1.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 15.8.1.1.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 15.8.1.1.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 15.8.1.1.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 15.8.1.1.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 15.8.1.1.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 15.8.1.2. Africa
        • 15.8.1.2.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 15.8.1.2.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 15.8.1.2.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 15.8.1.2.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 15.8.1.2.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 15.8.1.2.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)
      • 15.8.1.3. Rest of Middle East and Africa
        • 15.8.1.3.1. Pharmaceutical Regulatory Affairs Market: By Services, 2022-2032, USD (Million)
        • 15.8.1.3.2. Pharmaceutical Regulatory Affairs Market: By Category, 2022-2032, USD (Million)
        • 15.8.1.3.3. Pharmaceutical Regulatory Affairs Market: By Indication, 2022-2032, USD (Million)
        • 15.8.1.3.4. Pharmaceutical Regulatory Affairs Market: By Product Stage, 2022-2032, USD (Million)
        • 15.8.1.3.5. Pharmaceutical Regulatory Affairs Market: By Service Provider, 2022-2032, USD (Million)
        • 15.8.1.3.6. Pharmaceutical Regulatory Affairs Market: By Company Size, 2022-2032, USD (Million)

16. Company Profile

  • 16.1. QuintilesIMS
    • 16.1.1. Company Overview
    • 16.1.2. Financial Performance
    • 16.1.3. Product Portfolio
    • 16.1.4. Strategic Initiatives
  • 16.2. Parexel International Corporation
    • 16.2.1. Company Overview
    • 16.2.2. Financial Performance
    • 16.2.3. Product Portfolio
    • 16.2.4. Strategic Initiatives
  • 16.3. ICON plc
    • 16.3.1. Company Overview
    • 16.3.2. Financial Performance
    • 16.3.3. Product Portfolio
    • 16.3.4. Strategic Initiatives
  • 16.4. Freyr
    • 16.4.1. Company Overview
    • 16.4.2. Financial Performance
    • 16.4.3. Product Portfolio
    • 16.4.4. Strategic Initiatives
  • 16.5. IQVIA Inc
    • 16.5.1. Company Overview
    • 16.5.2. Financial Performance
    • 16.5.3. Product Portfolio
    • 16.5.4. Strategic Initiatives
  • 16.6. WuXi AppTec
    • 16.6.1. Company Overview
    • 16.6.2. Financial Performance
    • 16.6.3. Product Portfolio
    • 16.6.4. Strategic Initiatives
  • 16.7. Charles River Laboratories
    • 16.7.1. Company Overview
    • 16.7.2. Financial Performance
    • 16.7.3. Product Portfolio
    • 16.7.4. Strategic Initiatives
  • 16.8. Labcorp Drug Development
    • 16.8.1. Company Overview
    • 16.8.2. Financial Performance
    • 16.8.3. Product Portfolio
    • 16.8.4. Strategic Initiatives
  • 16.9. Pharmalex GmbH
    • 16.9.1. Company Overview
    • 16.9.2. Financial Performance
    • 16.9.3. Product Portfolio
    • 16.9.4. Strategic Initiatives
  • 16.10. Pharmexon
    • 16.10.1. Company Overview
    • 16.10.2. Financial Performance
    • 16.10.3. Product Portfolio
    • 16.10.4. Strategic Initiatives
  • 16.11. Genpact
    • 16.11.1. Company Overview
    • 16.11.2. Financial Performance
    • 16.11.3. Product Portfolio
    • 16.11.4. Strategic Initiatives
  • 16.12. Other Notable Players
    • 16.12.1. Company Overview
    • 16.12.2. Financial Performance
    • 16.12.3. Product Portfolio
    • 16.12.4. Strategic Initiatives