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市場調査レポート
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1301010

薬事(レギュラトリーアフェアーズ)の市場規模、シェア、動向分析レポート:サービス別、カテゴリー別、サービスプロバイダ別、企業規模別、製品ステージ別、適応症別、最終用途別、地域別、セグメント予測、2023年~2030年

Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Categories, By Service Provider, By Company Size, By Product Stage, By Indication, By End-use, By Region, And Segment Forecasts, 2023 - 2030

出版日: | 発行: Grand View Research | ページ情報: 英文 175 Pages | 納期: 2~10営業日

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価格
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本日の銀行送金レート: 1USD=155.76円
薬事(レギュラトリーアフェアーズ)の市場規模、シェア、動向分析レポート:サービス別、カテゴリー別、サービスプロバイダ別、企業規模別、製品ステージ別、適応症別、最終用途別、地域別、セグメント予測、2023年~2030年
出版日: 2023年06月08日
発行: Grand View Research
ページ情報: 英文 175 Pages
納期: 2~10営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

薬事(レギュラトリーアフェアーズ)市場の成長と動向

GrandView Research, Inc.の最新レポートによると、世界の薬事(レギュラトリーアフェアーズ)市場は、2023年から2030年にかけてCAGR 8.7%で拡大し、2030年には270億米ドルに達する見込みです。

同市場の成長に寄与すると予想される要因としては、事業活動や地域によって変化する規制要件、規制当局による承認の迅速化に伴う臨床試験や医薬品承認の増加、規制当局向けソフトウェアの技術進歩などが挙げられます。また、個別化医薬品の進化、企業が中核的な事業活動に集中する必要性の高まり、経済的・市場競争的圧力なども市場の成長に寄与している要因です。

COVID-19感染と闘うために必要なワクチンや医療製品を迅速に開発するために、製薬会社と規制当局が手を組みました。規制当局は、臨床試験中の患者や人員の安全を確保し、データの完全性と適正な実験室業務が維持されるよう、多くの予防措置を講じています。バイオシミラー、希少疾病用医薬品、個別化医薬品、コンパニオン診断薬、適応試験デザインなどの市場の成長は、これらの分野における規制当局の専門性に対する需要を押し上げると予測されます。企業が新たな分野に進出するにつれ、規制を遵守する必要性が高まり、薬事業務の専門知識を有する専門サービスプロバイダーに対する需要が高まっています。シムレクト、ベクティビックス、ミルセラ、キネレットなどの生物製剤の特許切れにより、バイオシミラーの需要と開発が増加し、薬事サービスの需要に寄与しています。

個別化医療市場で主導権を握るため、複数の企業が提携や新製品開拓に積極的に取り組んでおり、薬事業務の支援が必要であることを示しています。例えば、2020年5月、Regeneron Pharmaceuticals, Inc.は、個別化医療とヒト遺伝学の進歩を設計するためにColorado Center for Personalized Medicineと提携しました。

薬事(レギュラトリーアフェアーズ)市場レポートハイライト

  • サービス別では、レギュラトリーライティング&パブリッシング部門が2022年の売上高シェア36.6%で市場を独占しました。これは、大中規模の医療機器およびバイオ医薬品企業別これらのサービスのアウトソーシングの増加によるものです。
  • 適応症別では、がん領域が2022年に32.9%と最大の売上シェアを占めました。このセグメントシェアは、安全で効果的な治療に対するニーズを生み出しているがんの高い有病率に起因しています。
  • 最終用途に基づくと、製薬会社セグメントは2023年から2030年にかけて9.0%の最高成長率を記録すると予測されています。承認済み医薬品数の増加が、同分野の成長の主な要因です。
  • 企業規模別では、中堅企業セグメントが2022年の世界市場を席巻し、同年の全体売上高の47.0%超という最大シェアを占めました。薬事(レギュラトリーアフェアーズ)市場に参入する中堅企業が増加しています。そのため、2022年および2022年全体では、このセグメントが大きなシェアを占めています。
  • カテゴリ別に見ると、生物製剤セグメントは分析期間中に8.0%の安定した成長率が見込まれます。生物学的製剤のパイプラインの増加は、薬事サービスへの需要をさらに押し上げ、したがって、このセグメントの成長を支えています。
  • 製品ステージ別では、前臨床部門が分析期間中9.4%の急成長を記録すると予測されています。このセグメントの高成長は、主に世界中で低分子化合物やバイオシミラーのパイプラインが増加しているためです。
  • サービスプロバイダー分野では、アウトソーシング分野が分析期間中10.3%の急成長を記録すると予測されています。このセグメントの高成長は、費用対効果の高い受託サービスに対する需要の高まり別ところが大きいです。
  • アジア太平洋地域は、規制状況の改善とバイオ医薬品企業別ベンチャー活動の活発化により、予測期間中9.3%の急成長が見込まれています。

目次

第1章 調査手法と範囲

  • 市場セグメンテーションと範囲
  • 地域の範囲
  • 推定・予測のタイムライン
  • 目的
  • 調査手法
  • 情報調達
  • 情報またはデータ分析
  • 市場の形成と検証
  • モデル詳細
  • 二次情報のリスト
  • 略語のリスト

第2章 エグゼクティブサマリー

  • 市場の見通し
  • セグメントの見通し
  • 競合考察

第3章 薬事(レギュラトリーアフェアーズ)市場変数、動向、範囲

  • 市場系統の見通し
    • 親市場の見通し
    • 関連/補助的な市場見通し
  • 市場力学
    • 市場促進要因分析
    • 市場抑制要因分析
    • 業界の課題
    • 主要取引と戦略的提携の分析
    • バイオテクノロジーおよび先端治療用医薬品(ATMP)の主要取引および戦略的提携の分析
  • 薬事(レギュラトリーアフェアーズ)市場分析ツール
    • 業界分析- ポーターの分析
    • PESTEL分析
    • SWOT分析
    • COVID-19感染症の影響分析

第4章 薬事(レギュラトリーアフェアーズ)市場:サービスの推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、サービス別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、サービス別:変動分析
    • 規制コンサルティング
    • 法定代理人
    • 規制の作成と発行
    • 製品登録と臨床試験申請
    • その他の規制サービス

第5章 薬事(レギュラトリーアフェアーズ)市場:カテゴリの推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、カテゴリ別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、カテゴリ別:変動分析
    • 薬物
    • 生物製剤
    • 医療機器

第6章 薬事(レギュラトリーアフェアーズ)市場:適応症の推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、適応症別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、適応症別:変動分析
    • 腫瘍
    • 神経
    • 心臓病
    • 血液
    • 免疫
    • その他

第7章 薬事(レギュラトリーアフェアーズ)市場:サービスプロバイダーセグメントの推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、サービスプロバイダーセグメント別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、サービスプロバイダーセグメント別:変動分析
    • 社内
    • アウトソーシング

第8章 薬事(レギュラトリーアフェアーズ)市場:企業規模の推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、企業規模別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、企業規模別:変動分析
    • 小型
    • 中型
    • 大企業

第9章 薬事(レギュラトリーアフェアーズ)市場:製品ステージの推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、製品ステージ別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、製品ステージ別:変動分析
    • 前臨床
    • 臨床
    • PMA

第10章 薬事(レギュラトリーアフェアーズ)市場:最終用途の推定・動向分析

  • 薬事(レギュラトリーアフェアーズ)市場、最終用途別:セグメントダッシュボード
  • 薬事(レギュラトリーアフェアーズ)市場、最終用途別:変動分析
    • 医療機器企業
    • 製薬会社
    • バイオテクノロジー企業

第11章 薬事(レギュラトリーアフェアーズ)市場:地域推定・動向分析

  • 地域市場シェア分析、2022年および2030年
  • 地域市場ダッシュボード
  • 世界の地域市場のスナップショット
  • 北米
    • 市場推計・予測、2018年から2030年(収益)
    • 米国
    • カナダ
  • 欧州
    • 英国
    • ドイツ
    • フランス
    • イタリア
    • スペイン
    • ロシア
    • トルコ
    • オランダ
    • スイス
    • スウェーデン
  • アジア太平洋地域
    • 日本
    • インド
    • 中国
    • 韓国
    • オーストラリア
    • タイ
    • インドネシア
    • マレーシア
    • シンガポール
    • 台湾
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • アルゼンチン
    • コロンビア
    • チリ
  • 中東とアフリカ
    • 南アフリカ
    • サウジアラビア
    • アラブ首長国連邦
    • エジプト
    • イスラエル

第12章 競合情勢

  • 市場参入企業の分類
    • イノベーター
    • マーケットリーダー
    • 新興プレイヤー
    • 企業の市場シェア分析、2022年
  • 企業プロファイル
    • Accell Clinical Research, LLC
    • Genpact
    • Criterium, Inc.
    • ICON plc
    • Promedica International
    • WuXi AppTec
    • Medpace
    • Charles River Laboratories
    • Labcorp Drug Development
    • Parexel International Corporation
    • Freyr
    • Pharmalex GmbH
    • NDA Group AB
    • Pharmexon
    • Qvigilance
    • BlueReg
    • Cambridge Regulatory Services
    • VCLS

第13章 Kolの解説/主要な推奨事項

図表

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of Abbreviations
  • Table 3 Global regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 4 Global regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 5 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 6 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 7 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 8 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 9 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 10 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 11 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 12 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 13 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 14 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 15 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 16 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 17 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 18 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 19 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 20 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 21 Global regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 22 North America regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 23 North America regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 24 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 25 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 26 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 27 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 28 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 29 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 30 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 31 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 32 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 33 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 34 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 35 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 36 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 37 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 38 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 39 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 40 North America Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 41 U.S. regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 42 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 43 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 44 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 45 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 46 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 47 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 48 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 49 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 50 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 51 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 52 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 53 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 54 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 55 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 56 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 57 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 58 U.S. Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 59 Canada regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 60 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 61 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 62 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 63 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 64 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 65 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 66 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 67 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 68 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 69 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 70 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 71 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 72 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 73 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 74 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 75 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 76 Canada Regulatory Affairs Market, by End-use, 2018 - 2030 (USD Million)
  • Table 77 Europe regulatory affairs market, by region, 2018 - 2030 (USD Million)
  • Table 78 Europe regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 79 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 80 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 81 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 82 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 83 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 84 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 85 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 86 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 87 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 88 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 89 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 90 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 91 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 92 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 93 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 94 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 95 Europe regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 96 U.K. regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 97 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 98 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 99 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 100 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 101 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 102 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 103 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 104 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 105 Regulatory affairs market, by Biosimilar, 2018 - 2030 (USD Million)
  • Table 106 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 107 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 108 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 109 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 110 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 111 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 112 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 113 U.K. regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 114 Germany regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 115 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 116 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 117 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 118 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 119 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 120 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 121 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 122 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 123 Regulatory affairs market, by Biosimilars, 2018 - 2030 (USD Million)
  • Table 124 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 125 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 126 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 127 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 128 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 129 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 130 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 131 Germany regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 132 France regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 133 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 134 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 135 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 136 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 137 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 138 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 139 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 140 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 141 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 142 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 143 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 144 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 145 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 146 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 147 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 148 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 149 France regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 150 Italy regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 151 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 152 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 153 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 154 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 155 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 156 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 157 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 158 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 159 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 160 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 161 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 162 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 163 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 164 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 165 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 166 Italy Regulatory Affairs Market, By End-Use, 2018 - 2030 (USD Million)
  • Table 167 Spain Regulatory Affairs Market, By Service, 2018 - 2030 (USD Million)
  • Table 168 Regulatory Affairs Market, By Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
  • Table 169 Regulatory Affairs Market, By Category, 2018 - 2030 (USD Million)
  • Table 170 Regulatory Affairs Market, By Drugs, 2018 - 2030 (USD Million)
  • Table 171 Regulatory Affairs Market, By Innovator, 2018 - 2030 (USD Million)
  • Table 172 Regulatory Affairs Market, By Generics, 2018 - 2030 (USD Million)
  • Table 173 Regulatory Affairs Market, By Biologics, 2018 - 2030 (USD Million)
  • Table 174 Regulatory Affairs Market, By Biotech, 2018 - 2030 (USD Million)
  • Table 175 Regulatory Affairs Market, By ATMP, 2018 - 2030 (USD Million)
  • Table 176 Regulatory Affairs Market, By BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 177 Regulatory Affairs Market, By Medical Devices, 2018 - 2030 (USD Million)
  • Table 178 Regulatory Affairs Market, By Diagnostics, 2018 - 2030 (USD Million)
  • Table 179 Regulatory Affairs Market, By Therapeutics, 2018 - 2030 (USD Million)
  • Table 180 Regulatory Affairs Market, By Indication, 2018 - 2030 (USD Million)
  • Table 181 Regulatory Affairs Market, By Product Stage, 2018 - 2030 (USD Million)
  • Table 182 Regulatory Affairs Market, By Service Provider, 2018 - 2030 (USD Million)
  • Table 183 Regulatory Affairs Market, By Company Size, 2018 - 2030 (USD Million)
  • Table 184 Spain Regulatory Affairs Market, By End-Use, 2018 - 2030 (USD Million)
  • Table 185 Russia Regulatory Affairs Market, By Service, 2018 - 2030 (USD Million)
  • Table 186 Regulatory Affairs Market, By Regulatory Writing & Publishing, 2018 - 2030 (USD Million)
  • Table 187 Regulatory Affairs Market, By Category, 2018 - 2030 (USD Million)
  • Table 188 Regulatory Affairs Market, By Drugs, 2018 - 2030 (USD Million)
  • Table 189 Regulatory Affairs Market, By Innovator, 2018 - 2030 (USD Million)
  • Table 190 Regulatory Affairs Market, By Generics, 2018 - 2030 (USD Million)
  • Table 191 Regulatory Affairs Market, By Biologics, 2018 - 2030 (USD Million)
  • Table 192 Regulatory Affairs Market, By Biotech, 2018 - 2030 (USD Million)
  • Table 193 Regulatory Affairs Market, By ATMP, 2018 - 2030 (USD Million)
  • Table 194 Regulatory Affairs Market, By BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 195 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 196 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 197 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 198 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 199 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 200 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 201 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 202 Russia regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 203 Turkey regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 204 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 205 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 206 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 207 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 208 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 209 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 210 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 211 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 212 Table 210 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 213 Table 211 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 214 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 215 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 216 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 217 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 218 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 219 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 220 Turkey regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 221 Netherlands regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 222 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 223 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 224 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 225 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 226 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 227 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 228 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 229 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 230 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 231 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 232 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)
  • Table 233 Regulatory affairs market, by Therapeutics, 2018 - 2030 (USD Million)
  • Table 234 Regulatory affairs market, by Indication, 2018 - 2030 (USD Million)
  • Table 235 Regulatory affairs market, by Product Stage, 2018 - 2030 (USD Million)
  • Table 236 Regulatory affairs market, by Service Provider, 2018 - 2030 (USD Million)
  • Table 237 Regulatory affairs market, by Company Size, 2018 - 2030 (USD Million)
  • Table 238 The Netherlands regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 239 Switzerland regulatory affairs market, by service, 2018 - 2030 (USD Million)
  • Table 240 Regulatory affairs market, by Regulatory writing & publishing, 2018 - 2030 (USD Million)
  • Table 241 Regulatory affairs market, by Category, 2018 - 2030 (USD Million)
  • Table 242 Regulatory affairs market, by Drugs, 2018 - 2030 (USD Million)
  • Table 243 Regulatory affairs market, by Innovator, 2018 - 2030 (USD Million)
  • Table 244 Regulatory affairs market, by Generics, 2018 - 2030 (USD Million)
  • Table 245 Regulatory affairs market, by Biologics, 2018 - 2030 (USD Million)
  • Table 246 Regulatory affairs market, by Biotech, 2018 - 2030 (USD Million)
  • Table 247 Regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 248 Regulatory affairs market, by BIOSIMILARS, 2018 - 2030 (USD Million)
  • Table 249 Regulatory affairs market, by Medical Devices, 2018 - 2030 (USD Million)
  • Table 250 Regulatory affairs market, by Diagnostics, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 QFD modeling for market share assessment
  • Fig. 6 Market formulation & validation
  • Fig. 10 Regulatory affairs market segmentation
  • Fig. 11 Market driver relevance analysis (Current & future impact)
  • Fig. 12 Percentage of Clinical Trial Registered in Different Regions (November 2022)
  • Fig. 13 Personalized medicine approved by the FDA
  • Fig. 14 Market restraint relevance analysis (Current & future impact)
  • Fig. 15 SWOT
  • Fig. 16 Porter's five forces analysis
  • Fig. 17 SWOT analysis, by factor (political & legal, economic and technological)
  • Fig. 18 Usage/adoption of cloud technology for regulatory space
  • Fig. 19 Regulatory affairs market service outlook: Segment dashboard
  • Fig. 20 Regulatory affairs market: service movement analysis
  • Fig. 21 Regulatory consulting market, 2018 - 2030 (USD Million)
  • Fig. 22 Legal representation market, 2018 - 2030 (USD Million)
  • Fig. 23 Regulatory writing and publishing market, 2018 - 2030 (USD Million)
  • Fig. 24 Product registration and clinical trial application market, 2018 - 2030 (USD Million)
  • Fig. 25 Other regulatory services market, 2018 - 2030 (USD Million)
  • Fig. 26 Regulatory affairs market service provider outlook: Segment dashboard
  • Fig. 27 Regulatory affairs market: service provider movement analysis
  • Fig. 28 In-house regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 29 Outsourcing regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 30 Regulatory affairs market company size outlook: Segment dashboard
  • Fig. 31 Regulatory affairs market: Company size movement analysis
  • Fig. 32 Small companies based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 33 Medium sized company based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 34 Large companies based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 35 Regulatory affairs market categories outlook: Segment dashboard
  • Fig. 36 Regulatory affairs market: Categories movement analysis
  • Fig. 37 Drugs based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 38 Biologics based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 39 Medical devices based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 40 Regulatory affairs product stage outlook: Segment dashboard
  • Fig. 41 Regulatory affairs market: Product stage movement analysis
  • Fig. 42 Preclinical based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 43 Clinical based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 44 PMA based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 45 Regulatory affairs market indication outlook: Segment dashboard
  • Fig. 46 Regulatory affairs market: indication movement analysis
  • Fig. 47 Oncology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 48 Neurology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 49 Cardiology based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 50 Immunology indication based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 51 Other indication based regulatory affairs market, 2018 - 2030 (USD Million)
  • Fig. 52 Regulatory affairs market end-use outlook: Segment dashboard
  • Fig. 53 Regulatory affairs market: end-use movement analysis
  • Fig. 54 Medical device companies market, 2018 - 2030 (USD Million)
  • Fig. 55 Pharmaceutical companies market, 2018 - 2030 (USD Million)
  • Fig. 56 Biotechnology companies market, 2018 - 2030 (USD Million)
  • Fig. 57 Regional market: Key takeaways
  • Fig. 58 Regional outlook, 2021 & 2030
  • Fig. 59 North America market, 2018 - 2030 (USD Million)
  • Fig. 60 U.S. market, 2018 - 2030 (USD Million)
  • Fig. 61 Canada market, 2018 - 2030 (USD Million)
  • Fig. 62 Europe market, 2018 - 2030 (USD Million)
  • Fig. 63 UK market, 2018 - 2030 (USD Million)
  • Fig. 64 Germany market, 2018 - 2030 (USD Million)
  • Fig. 65 France market, 2018 - 2030 (USD Million)
  • Fig. 66 Italy market, 2018 - 2030 (USD Million)
  • Fig. 67 Spain market, 2018 - 2030 (USD Million)
  • Fig. 68 Russia market, 2018 - 2030 (USD Million)
  • Fig. 69 Turkey market, 2018 - 2030 (USD Million)
  • Fig. 70 Netherlands market, 2018 - 2030 (USD Million)
  • Fig. 71 Switzerland market, 2018 - 2030 (USD Million)
  • Fig. 72 Sweden market, 2018 - 2030 (USD Million)
  • Fig. 73 Asia Pacific market, 2018 - 2030 (USD Million)
  • Fig. 74 Japan market, 2018 - 2030 (USD Million)
  • Fig. 75 China market, 2018 - 2030 (USD Million)
  • Fig. 76 India market, 2018 - 2030 (USD Million)
  • Fig. 77 Australia market, 2018 - 2030 (USD Million)
  • Fig. 78 South Korea market, 2018 - 2030 (USD Million)
  • Fig. 79 Indonesia market, 2018 - 2030 (USD Million)
  • Fig. 80 Malaysia market, 2018 - 2030 (USD Million)
  • Fig. 81 Singapore market, 2018 - 2030 (USD Million)
  • Fig. 82 Thailand market, 2018 - 2030 (USD Million)
  • Fig. 83 Taiwan market, 2018 - 2030 (USD Million)
  • Fig. 84 Latin America market, 2018 - 2030 (USD Million)
  • Fig. 85 Brazil market, 2018 - 2030 (USD Million)
  • Fig. 86 Mexico market, 2018 - 2030 (USD Million)
  • Fig. 87 Argentina market, 2018 - 2030 (USD Million)
  • Fig. 88 Colombia market, 2018 - 2030 (USD Million)
  • Fig. 89 Chile market, 2018 - 2030 (USD Million)
  • Fig. 90 MEA market, 2018 - 2030 (USD Million)
  • Fig. 91 South Africa market, 2018 - 2030 (USD Million)
  • Fig. 92 Saudi Arabia market, 2018 - 2030 (USD Million)
  • Fig. 93 UAE market, 2018 - 2030 (USD Million)
  • Fig. 94 Egypt market, 2018 - 2030 (USD Million)
  • Fig. 95 Israel market, 2018 - 2030 (USD Million)
  • Fig. 96 Key Strategies
  • Fig. 97 Market participant categorization
  • Fig. 98 Organization Structure - Accell Clinical Research, LLC
  • Fig. 99 SWOT - Accell Clinical Research, LLC
  • Fig. 100 Financial performance of Genpact
  • Fig. 101 Organization Structure - Genpact Ltd
  • Fig. 102 SWOT - Genpact
  • Fig. 103 Organization Structure - Criterium, Inc.
  • Fig. 104 SWOT -CRITERIUM, INC.
  • Fig. 105 Organization Structure - Promedica International
  • Fig. 106 SWOT - Promedica International
  • Fig. 107 Financial performance of WuXi AppTec
  • Fig. 108 Organization Structure -WuXi AppTec
  • Fig. 109 SWOT - Wuxi AppTec
  • Fig. 110 Financial performance of Medspace
  • Fig. 111 Organization Structure - Medpace
  • Fig. 112 SWOT - Medpace
  • Fig. 113 Financial performance of Charles River Laboratories
  • Fig. 114 Organization Structure - Charles River Laboratories International, Inc.
  • Fig. 115 SWOT - Charles River Laboratories International, Inc
  • Fig. 116 Financial performance of ICON plc
  • Fig. 117 Organization Structure - ICON plc
  • Fig. 118 SWOT - ICON plc
  • Fig. 119 Financial performance of Laboratory Corporation of America Holdings
  • Fig. 120 Organization Structure -Laboratory Corporation of America Holdings
  • Fig. 121 SWOT - Laboratory Corporation of America Holdings
  • Fig. 122 Organization Structure - PAREXEL International Corporation
  • Fig. 123 SWOT - Parexel International Corporation
  • Fig. 124 Organization Structure - Freyr
  • Fig. 125 SWOT - Freyr
目次
Product Code: GVR-4-68039-065-9

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market is expected to reach USD 27.0 billion by 2030, expanding at a CAGR of 8.7% from 2023 to 2030, according to a new report by Grand View Research, Inc. The factors expected to contribute to the growth of this market include changing regulatory requirements based on business activities and geographies, an increase in clinical trials & drug approvals along with accelerated regulatory approval, and technological advancement in regulatory software. Also, the evolution of personalized medicines, the increasing need for companies to focus on core business activities, and economic and competitive pressures are other factors that are contributing to the growth of the market.

The pharmaceutical and regulatory agencies joined forces to rapidly develop vaccines and medical products required to fight against the COVID-19 infection. The regulatory authorities take numerous precautions to ensure patient and personnel safety during a clinical trial, as well as data integrity and good laboratory practices are maintained. Growth in markets for biosimilars, orphan drugs, personalized medicines, companion diagnostics, and adaptive trial designs is projected to boost the demand for regulatory specialization in these areas. As companies venture into newer fields, the growing need to comply with regulations is boosting the demand for specialized service providers with expertise in regulatory affairs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services.

Several companies are actively involved in collaborations and new product development to gain leadership in the personalized medicine market, indicating a need for supportive regulatory affairs. For instance, in May 2020, Regeneron Pharmaceuticals, Inc. collaborated with Colorado Center for Personalized Medicine to design advancements in personalized medicine and human genetics.

Regulatory Affairs Market Report Highlights

  • In terms of services, the regulatory writing & publishing segment dominated the market in 2022 with a revenue share of 36.6%. This is due to an increase in the outsourcing of these services by large- and mid-size medical device and biopharmaceutical companies
  • Based on indications, the oncology segment accounted for the largest revenue share, 32.9%, in 2022. The segment share is attributed to the high prevalence of cancer, which is creating the need for safe and effective treatments
  • Based on end-use, the pharmaceutical companies segment is anticipated to witness the highest growth rate of 9.0% from 2023 to 2030. A rise in the number of approved pharmaceutical products is the key factor responsible for the segment's growth
  • Based on company size, the medium-sized companies segment dominated the global market in 2022 and accounted for the largest share of more than 47.0% of the overall revenue in the same year. An increasing number of medium-sized companies are penetrating the regulatory affairs market. Thereby, the segment held the lion's share in 2022 and across.
  • Based on category, the biologics segment is anticipated to witness a stable growth rate of 8.0% during the analysis timeframe. The increasing pipeline of biologics to further boosts demand for its regulatory services, thus supporting segmental growth.
  • Based on the product stage segment, the preclinical segment is anticipated to register the fastest growth of 9.4% across the analysis period. The high growth of the segment is majorly due to the increasing pipeline of small molecules and biosimilars across the globe.
  • Based on the service provider segment, the outsourcing segment is anticipated to register the fastest growth of 10.3% across the analysis period. The high growth of the segment is majorly due to the increasing demand for cost-effective contract services.
  • Asia Pacific is projected to witness the fastest growth rate of 9.3% during the forecast period on account of the improved regulatory landscape and growing venture activities by biopharmaceutical companies.

Table of Content

Chapter 1. Research Methodology And Scope

  • 1.1. Market Segmentation & Scope
    • 1.1.1. Segment Definitions
    • 1.1.2. Services
    • 1.1.3. Categories
    • 1.1.4. Indication
  • 1.2. Regional Scope
  • 1.3. Estimates And Forecast Timeline
  • 1.4. Objectives
    • 1.4.1. Objective - 1
    • 1.4.2. Objective - 2
    • 1.4.3. Objective - 3
  • 1.5. Research Methodology
  • 1.6. Information Procurement
    • 1.6.1. Purchased Database
    • 1.6.2. GVR's Internal Database
    • 1.6.3. Secondary Sources
    • 1.6.4. Primary Research
  • 1.7. Information Or Data Analysis
    • 1.7.1. Data Analysis Models
  • 1.8. Market Formulation & Validation
  • 1.9. Model Details
    • 1.9.1. Commodity Flow Analysis
    • 1.9.2. Parent Market Analysis
  • 1.10. List Of Secondary Sources
  • 1.11. List Of Abbreviations

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. Regulatory Affairs Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Changing Regulatory Landscape
      • 3.2.1.2. Entry Of Companies Into The Global Market
      • 3.2.1.3. Life Science Companies Focusing On Their Core Competencies
      • 3.2.1.4. Economic And Competitive Pressures
      • 3.2.1.5. Demand For The Faster Approval Process For Breakthrough Drugs And Devices
      • 3.2.1.6. Growth In Emerging Areas Such As Personalized Medicine, Biosimilars, And Orphan Drugs
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Risk Associated With Data Security
      • 3.2.2.2. Monitoring Issues And Lack Of Standardization
    • 3.2.3. Industry Challenges
      • 3.2.3.1. Managing Relationships
    • 3.2.4. Major Deals and Strategic Alliances Analysis
      • 3.2.4.1. Acquisition
      • 3.2.4.2. Joint Venture
      • 3.2.4.3. Expansions
      • 3.2.4.4. Partnerships & Collaborations
      • 3.2.4.5. Technology Advancements & Service Launches
    • 3.2.5. Major Deals and Strategic Alliances Analysis of Biotech & Advanced Therapy Medicinal Products (ATMPs)
  • 3.3. Regulatory Affairs Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Supplier Power
      • 3.3.1.2. Buyer Power
      • 3.3.1.3. Substitution Threat
      • 3.3.1.4. Threat Of New Entrant
      • 3.3.1.5. Competitive Rivalry
    • 3.3.2. PESTEL Analysis
    • 3.3.3. SWOT Analysis
    • 3.3.4. COVID-19 Impact Analysis
      • 3.3.4.1. COVID-19 Impact on Clinical Trials Services
      • 3.3.4.2. COVID-19 Impact on Regulatory Services
      • 3.3.4.3. COVID-19 Impact on Key Players
      • 3.3.4.3.1. Medpace
      • 3.3.4.3.2. Icon Plc
      • 3.3.4.3.3. Charles River Laboratories
      • 3.3.4.3.4. Labcorp Drug Development
      • 3.3.4.4. Post COVID-19 Market Scenario

Chapter 4. Regulatory Affairs Market: Services Estimates & Trend Analysis

  • 4.1. Regulatory Affairs Market, By Services: Segment Dashboard
  • 4.2. Regulatory Affairs Market, By Services: Movement Analysis
  • 4.3. Regulatory Affairs Market Estimates & Forecasts, By Services, 2018 - 2030
    • 4.3.1. Regulatory Consulting
      • 4.3.1.1. Regulatory Consulting Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.2. Legal Representation
      • 4.3.2.1. Legal Representation Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.3. Regulatory Writing and Publishing
      • 4.3.3.1. Regulatory Writing and Publishing Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 4.3.3.2. Writing
      • 4.3.3.2.1. Writing Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 4.3.3.3. Publishing
      • 4.3.3.3.1. Publishing Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.4. Product Registration and Clinical Trial Application
      • 4.3.4.1. Product Registration and Clinical Trial Application Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 4.3.5. Other Regulatory Services
      • 4.3.5.1. Other Regulatory Services Regulatory Affairs Market, 2018 to 2030 (USD Million)

Chapter 5. Regulatory Affairs Market: Categories Estimates & Trend Analysis

  • 5.1. Regulatory Affairs Market, By Categories: Segment Dashboard
  • 5.2. Regulatory Affairs Market, By Categories: Movement Analysis
  • 5.3. Regulatory Affairs Market Estimates & Forecasts, By Categories, 2018 - 2030
    • 5.3.1. Drugs
      • 5.3.1.1. Drugs Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2. Innovator
      • 5.3.1.2.1. Innovator Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.2. Preclinical
      • 5.3.1.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.3. Clinical
      • 5.3.1.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.2.4. PMA
      • 5.3.1.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3. Generics
      • 5.3.1.3.1. Generics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.2. Preclinical
      • 5.3.1.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.3. Clinical
      • 5.3.1.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.1.3.4. PMA
      • 5.3.1.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 5.3.2. Biologics
      • 5.3.2.1. Biologics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2. Biotech
      • 5.3.2.2.1. Biotech Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.2. Preclinical
      • 5.3.2.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.3. Clinical
      • 5.3.2.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.2.4. PMA
      • 5.3.2.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3. ATMP
      • 5.3.2.3.1. ATMP Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.2. Preclinical
      • 5.3.2.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.3. Clinical
      • 5.3.2.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.3.4. PMA
      • 5.3.2.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4. Biosimilars
      • 5.3.2.4.1. Biosimilars Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.2. Preclinical
      • 5.3.2.4.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.3. Clinical
      • 5.3.2.4.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.2.4.4. PMA
      • 5.3.2.4.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
    • 5.3.3. Medical Devices
      • 5.3.3.1. Medical Devices Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2. Diagnostics
      • 5.3.3.2.1. Diagnostics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.2. Preclinical
      • 5.3.3.2.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.3. Clinical
      • 5.3.3.2.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.2.4. PMA
      • 5.3.3.2.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3. Therapeutics
      • 5.3.3.3.1. Therapeutics Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.2. Preclinical
      • 5.3.3.3.2.1. Preclinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.3. Clinical
      • 5.3.3.3.3.1. Clinical Regulatory Affairs Market, 2018 to 2030 (USD Million)
      • 5.3.3.3.4. PMA
      • 5.3.3.3.4.1. PMA Regulatory Affairs Market, 2018 to 2030 (USD Million)

Chapter 6. Regulatory Affairs Market: Indication Estimates & Trend Analysis

  • 6.1. Regulatory Affairs Market, By Indication: Segment Dashboard
  • 6.2. Regulatory Affairs Market, By Indication: Movement Analysis
  • 6.3. Regulatory Affairs Market Estimates & Forecasts, By Indication, 2018 - 2030
    • 6.3.1. Oncology
      • 6.3.1.1. Oncology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.2. Neurology
      • 6.3.2.1. Neurology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.3. Cardiology
      • 6.3.3.1. Cardiology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.4. Hematology
      • 6.3.4.1. Hematology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.5. Immunology
      • 6.3.5.1. Immunology Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 6.3.6. Others
      • 6.3.6.1. Others Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 7. Regulatory Affairs Market: Service Provider Segment Estimates & Trend Analysis

  • 7.1. Regulatory Affairs Market, By Service Provider Segment: Segment Dashboard
  • 7.2. Regulatory Affairs Market, By Service Provider Segment: Movement Analysis
  • 7.3. Regulatory Affairs Market Estimates & Forecasts, By Service Provider Segment, 2018 - 2030
    • 7.3.1. In-house
      • 7.3.1.1. In-house Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 7.3.2. Outsourcing
      • 7.3.2.1. Outsourcing Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 8. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

  • 8.1. Regulatory Affairs Market, By Company Size: Segment Dashboard
  • 8.2. Regulatory Affairs Market, By Company Size: Movement Analysis
  • 8.3. Regulatory Affairs Market Estimates & Forecasts, By Company Size, 2018 - 2030
    • 8.3.1. Small-sized
      • 8.3.1.1. Small-sized Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 8.3.2. Medium-sized
      • 8.3.2.1. Medium-sized Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 8.3.3. Large Companies
      • 8.3.3.1. Large Companies Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 9. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

  • 9.1. Regulatory Affairs Market, By Product Stage: Segment Dashboard
  • 9.2. Regulatory Affairs Market, By Product Stage: Movement Analysis
  • 9.3. Regulatory Affairs Market Estimates & Forecasts, By Product Stage, 2018 - 2030
    • 9.3.1. Preclinical
      • 9.3.1.1. Preclinical Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 9.3.2. Clinical
      • 9.3.2.1. Clinical Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 9.3.3. PMA
      • 9.3.3.1. PMA Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 10. Regulatory Affairs Market: End-use Estimates & Trend Analysis

  • 10.1. Regulatory Affairs Market, By End-use: Segment Dashboard
  • 10.2. Regulatory Affairs Market, By End-use: Movement Analysis
  • 10.3. Regulatory Affairs Market Estimates & Forecasts, By End-use, 2018 - 2030
    • 10.3.1. Medical Device Companies
      • 10.3.1.1. Medical Device Companies Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 10.3.2. Pharmaceutical Companies
      • 10.3.2.1. Pharmaceutical Companies Regulatory Affairs Market 2018 to 2030 (USD Million)
    • 10.3.3. Biotechnology Companies
      • 10.3.3.1. Biotechnology Companies Regulatory Affairs Market 2018 to 2030 (USD Million)

Chapter 11. Regulatory Affairs Market: Regional Estimates & Trend Analysis

  • 11.1. Regional Market Share Analysis, 2022 & 2030
  • 11.2. Regional Market Dashboard
  • 11.3. Global Regional Market Snapshot
  • 11.4. North America
    • 11.4.1. Market Estimates and Forecast, 2018 - 2030 (Revenue, USD Million)
    • 11.4.2. U.S.
      • 11.4.2.1. Key Country Dynamics
      • 11.4.2.2. Competitive Scenario
      • 11.4.2.3. Regulatory Framework
      • 11.4.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030
    • 11.4.3. Canada
      • 11.4.3.1. Key Country Dynamics
      • 11.4.3.2. Competitive Scenario
      • 11.4.3.3. Regulatory Framework
      • 11.4.3.4. Canada Market Estimates and Forecasts, 2018 - 2030
  • 11.5. Europe
    • 11.5.1. UK
      • 11.5.1.1. Key Country Dynamics
      • 11.5.1.2. Competitive Scenario
      • 11.5.1.3. Regulatory Framework
      • 11.5.1.4. UK Market Estimates and Forecasts, 2018 - 2030
    • 11.5.2. Germany
      • 11.5.2.1. Key Country Dynamics
      • 11.5.2.2. Competitive Scenario
      • 11.5.2.3. Regulatory Framework
      • 11.5.2.4. Germany Market Estimates and Forecasts, 2018 - 2030
    • 11.5.3. France
      • 11.5.3.1. Key Country Dynamics
      • 11.5.3.2. Competitive Scenario
      • 11.5.3.3. Regulatory Framework
      • 11.5.3.4. France Market Estimates and Forecasts, 2018 - 2030
    • 11.5.4. Italy
      • 11.5.4.1. Key Country Dynamics
      • 11.5.4.2. Competitive Scenario
      • 11.5.4.3. Regulatory Framework
      • 11.5.4.4. Italy Market Estimates and Forecasts, 2018 - 2030
    • 11.5.5. Spain
      • 11.5.5.1. Key Country Dynamics
      • 11.5.5.2. Competitive Scenario
      • 11.5.5.3. Regulatory Framework
      • 11.5.5.4. Spain Market Estimates and Forecasts, 2018 - 2030
    • 11.5.6. Russia
      • 11.5.6.1. Key Country Dynamics
      • 11.5.6.2. Competitive Scenario
      • 11.5.6.3. Regulatory Framework
      • 11.5.6.4. Russia Market Estimates and Forecasts, 2018 - 2030
    • 11.5.7. Turkey
      • 11.5.7.1. Key Country Dynamics
      • 11.5.7.2. Competitive Scenario
      • 11.5.7.3. Regulatory Framework
      • 11.5.7.4. Turkey Market Estimates and Forecasts, 2018 - 2030
    • 11.5.8. Netherlands
      • 11.5.8.1. Key Country Dynamics
      • 11.5.8.2. Competitive Scenario
      • 11.5.8.3. Regulatory Framework
      • 11.5.8.4. Netherlands Market Estimates and Forecasts, 2018 - 2030
    • 11.5.9. Switzerland
      • 11.5.9.1. Key Country Dynamics
      • 11.5.9.2. Competitive Scenario
      • 11.5.9.3. Regulatory Framework
      • 11.5.9.4. Switzerland Market Estimates and Forecasts, 2018 - 2030
    • 11.5.10. Sweden
      • 11.5.10.1. Key Country Dynamics
      • 11.5.10.2. Competitive Scenario
      • 11.5.10.3. Regulatory Framework
      • 11.5.10.4. Sweden Market Estimates and Forecasts, 2018 - 2030
  • 11.6. Asia Pacific
    • 11.6.1. Japan
      • 11.6.1.1. Key Country Dynamics
      • 11.6.1.2. Competitive Scenario
      • 11.6.1.3. Regulatory Framework
      • 11.6.1.4. Japan Market Estimates and Forecasts, 2018 - 2030
    • 11.6.2. India
      • 11.6.2.1. Key Country Dynamics
      • 11.6.2.2. Competitive Scenario
      • 11.6.2.3. Regulatory Framework
      • 11.6.2.4. India Market Estimates and Forecasts, 2018 - 2030
    • 11.6.3. China
      • 11.6.3.1. Key Country Dynamics
      • 11.6.3.2. Competitive Scenario
      • 11.6.3.3. Regulatory Framework
      • 11.6.3.4. China Market Estimates and Forecasts, 2018 - 2030
    • 11.6.4. South Korea
      • 11.6.4.1. Key Country Dynamics
      • 11.6.4.2. Competitive Scenario
      • 11.6.4.3. Regulatory Framework
      • 11.6.4.4. South Korea Market Estimates and Forecasts, 2018 - 2030
    • 11.6.5. Australia
      • 11.6.5.1. Key Country Dynamics
      • 11.6.5.2. Competitive Scenario
      • 11.6.5.3. Regulatory Framework
      • 11.6.5.4. Australia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.6. Thailand
      • 11.6.6.1. Key Country Dynamics
      • 11.6.6.2. Competitive Scenario
      • 11.6.6.3. Regulatory Framework
      • 11.6.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030
    • 11.6.7. Indonesia
      • 11.6.7.1. Key Country Dynamics
      • 11.6.7.2. Competitive Scenario
      • 11.6.7.3. Regulatory Framework
      • 11.6.7.4. Indonesia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.8. Malaysia
      • 11.6.8.1. Key Country Dynamics
      • 11.6.8.2. Competitive Scenario
      • 11.6.8.3. Regulatory Framework
      • 11.6.8.4. Malaysia Market Estimates and Forecasts, 2018 - 2030
    • 11.6.9. Singapore
      • 11.6.9.1. Key Country Dynamics
      • 11.6.9.2. Competitive Scenario
      • 11.6.9.3. Regulatory Framework
      • 11.6.9.4. Singapore Market Estimates and Forecasts, 2018 - 2030
    • 11.6.10. Taiwan
      • 11.6.10.1. Key Country Dynamics
      • 11.6.10.2. Competitive Scenario
      • 11.6.10.3. Regulatory Framework
      • 11.6.10.4. Taiwan Market Estimates and Forecasts, 2018 - 2030
  • 11.7. Latin America
    • 11.7.1. Brazil
      • 11.7.1.1. Key Country Dynamics
      • 11.7.1.2. Competitive Scenario
      • 11.7.1.3. Regulatory Framework
      • 11.7.1.4. Brazil Market Estimates and Forecasts, 2018 - 2030
    • 11.7.2. Mexico
      • 11.7.2.1. Key Country Dynamics
      • 11.7.2.2. Competitive Scenario
      • 11.7.2.3. Regulatory Framework
      • 11.7.2.4. Mexico Market Estimates and Forecasts, 2018 - 2030
    • 11.7.3. Argentina
      • 11.7.3.1. Key Country Dynamics
      • 11.7.3.2. Competitive Scenario
      • 11.7.3.3. Regulatory Framework
      • 11.7.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030
    • 11.7.4. Colombia
      • 11.7.4.1. Key Country Dynamics
      • 11.7.4.2. Competitive Scenario
      • 11.7.4.3. Regulatory Framework
      • 11.7.4.4. Colombia Market Estimates and Forecasts, 2018 - 2030
    • 11.7.5. Chile
      • 11.7.5.1. Key Country Dynamics
      • 11.7.5.2. Competitive Scenario
      • 11.7.5.3. Regulatory Framework
      • 11.7.5.4. Chile Market Estimates and Forecasts, 2018 - 2030
  • 11.8. Middle East & Africa
    • 11.8.1. South Africa
      • 11.8.1.1. Key Country Dynamics
      • 11.8.1.2. Competitive Scenario
      • 11.8.1.3. Regulatory Framework
      • 11.8.1.4. South Africa Market Estimates and Forecasts, 2018 - 2030
    • 11.8.2. Saudi Arabia
      • 11.8.2.1. Key Country Dynamics
      • 11.8.2.2. Competitive Scenario
      • 11.8.2.3. Regulatory Framework
      • 11.8.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030
    • 11.8.3. UAE
      • 11.8.3.1. Key Country Dynamics
      • 11.8.3.2. Competitive Scenario
      • 11.8.3.3. Regulatory Framework
      • 11.8.3.4. UAE Market Estimates and Forecasts, 2018 - 2030
    • 11.8.4. Egypt
      • 11.8.4.1. Key Country Dynamics
      • 11.8.4.2. Competitive Scenario
      • 11.8.4.3. Regulatory Framework
      • 11.8.4.4. Egypt Market Estimates and Forecasts, 2018 - 2030
    • 11.8.5. Israel
      • 11.8.5.1. Key Country Dynamics
      • 11.8.5.2. Competitive Scenario
      • 11.8.5.3. Regulatory Framework
      • 11.8.5.4. Israel Market Estimates and Forecasts, 2018 - 2030

Chapter 12. Competitive Landscape

  • 12.1. Market Participant Categorization
    • 12.1.1. Innovators
    • 12.1.2. Market Leaders
    • 12.1.3. Emerging Players
    • 12.1.4. Company Market Share Analysis, 2022
  • 12.2. Company Profiles
    • 12.2.1. Accell Clinical Research, LLC
      • 12.2.1.1. Company Overview
      • 12.2.1.2. Financial Performance
      • 12.2.1.3. Service Benchmarking
      • 12.2.1.4. Strategic Initiatives
    • 12.2.2. Genpact
      • 12.2.2.1. Company Overview
      • 12.2.2.2. Financial Performance
      • 12.2.2.3. Service Benchmarking
      • 12.2.2.4. Strategic Initiatives
    • 12.2.3. Criterium, Inc.
      • 12.2.3.1. Company Overview
      • 12.2.3.2. Financial Performance
      • 12.2.3.3. Service Benchmarking
      • 12.2.3.4. Strategic Initiatives
    • 12.2.4. ICON plc
      • 12.2.4.1. Company Overview
      • 12.2.4.2. Financial Performance
      • 12.2.4.3. Service Benchmarking
      • 12.2.4.4. Strategic Initiatives
    • 12.2.5. Promedica International
      • 12.2.5.1. Company Overview
      • 12.2.5.2. Financial Performance
      • 12.2.5.3. Service Benchmarking
      • 12.2.5.4. Strategic Initiatives
    • 12.2.6. WuXi AppTec
      • 12.2.6.1. Company Overview
      • 12.2.6.2. Financial Performance
      • 12.2.6.3. Service Benchmarking
      • 12.2.6.4. Strategic Initiatives
    • 12.2.7. Medpace
      • 12.2.7.1. Company Overview
      • 12.2.7.2. Financial Performance
      • 12.2.7.3. Service Benchmarking
      • 12.2.7.4. Strategic Initiatives
    • 12.2.8. Charles River Laboratories
      • 12.2.8.1. Company Overview
      • 12.2.8.2. Financial Performance
      • 12.2.8.3. Service Benchmarking
      • 12.2.8.4. Strategic Initiatives
    • 12.2.9. Labcorp Drug Development
      • 12.2.9.1. Company Overview
      • 12.2.9.2. Financial Performance
      • 12.2.9.3. Service Benchmarking
      • 12.2.9.4. Strategic Initiatives
    • 12.2.10. Parexel International Corporation
      • 12.2.10.1. Company Overview
      • 12.2.10.2. Financial Performance
      • 12.2.10.3. Service Benchmarking
      • 12.2.10.4. Strategic Initiatives
    • 12.2.11. Freyr
      • 12.2.11.1. Company Overview
      • 12.2.11.2. Financial Performance
      • 12.2.11.3. Service Benchmarking
      • 12.2.11.4. Strategic Initiatives
    • 12.2.12. Pharmalex GmbH
      • 12.2.12.1. Company Overview
      • 12.2.12.2. Financial Performance
      • 12.2.12.3. Service Benchmarking
      • 12.2.12.4. Strategic Initiatives
    • 12.2.13. NDA Group AB
      • 12.2.13.1. Company Overview
      • 12.2.13.2. Financial Performance
      • 12.2.13.3. Service Benchmarking
      • 12.2.13.4. Strategic Initiatives
    • 12.2.14. Pharmexon
      • 12.2.14.1. Company Overview
      • 12.2.14.2. Financial Performance
      • 12.2.14.3. Service Benchmarking
      • 12.2.14.4. Strategic Initiatives
    • 12.2.15. Qvigilance
      • 12.2.15.1. Company Overview
      • 12.2.15.2. Financial Performance
      • 12.2.15.3. Service Benchmarking
      • 12.2.15.4. Strategic Initiatives
    • 12.2.16. BlueReg
      • 12.2.16.1. Company Overview
      • 12.2.16.2. Financial Performance
      • 12.2.16.3. Service Benchmarking
      • 12.2.16.4. Strategic Initiatives
    • 12.2.17. Cambridge Regulatory Services
      • 12.2.17.1. Company Overview
      • 12.2.17.2. Financial Performance
      • 12.2.17.3. Service Benchmarking
      • 12.2.17.4. Strategic Initiatives
    • 12.2.18. VCLS
      • 12.2.18.1. Company Overview
      • 12.2.18.2. Financial Performance
      • 12.2.18.3. Service Benchmarking
      • 12.2.18.4. Strategic Initiatives

Chapter 13. Kol Commentary/Key Recommendations