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米国の薬事申請市場の規模・シェア・動向分析レポート：サービス別、カテゴリー別、適応症別、製品ステージ別、サービスプロバイダー別、企業規模別、最終用途別、セグメント予測、2024年-2030年

U.S. Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Category, By Indication, By Product Stage, By Service Provider, By Company Size, By End-use, And Segment Forecasts, 2024 - 2030
出版日: | 発行: Grand View Research | ページ情報: 英文 80 Pages | 納期: 2～10営業日

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価格
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米国の薬事申請市場の規模・シェア・動向分析レポート：サービス別、カテゴリー別、適応症別、製品ステージ別、サービスプロバイダー別、企業規模別、最終用途別、セグメント予測、2024年-2030年
出版日: 2024年05月23日
発行: Grand View Research
ページ情報: 英文 80 Pages
納期: 2～10営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

米国の薬事申請市場の成長と動向：

Grand View Research, Inc.の最新レポートによると、米国の薬事規制市場は2030年までに77億1,000万米ドルに達し、予測期間中にCAGR 9.0%で拡大すると予測されています。

規制状況は常に進化し複雑化しており、新しい法律やガイドラインが定期的に導入されています。この複雑さが、こうした複雑な要件に対応できる薬事専門家の需要を押し上げています。

企業が世界に事業を拡大するにつれ、国によって規制が異なるため、法規制の遵守はより困難になっています。薬事専門家は、企業が国際的な規制の枠組みをナビゲートし、市場へのアクセスを確保するのを支援します。例えば、2024年1月のロイター通信の更新によると、2024年には米国の多くの法律事務所が合併契約を結ぶと予想されています。ストックトン＆キルパトリック・タウンゼントは最近、中小企業との合併を発表しました。また、フェニックスに設立された中堅企業のフェネモア・クレイグは、今年シアトルへの進出を発表しました。

規制機関は患者の安全と製品の品質を最優先し、企業が遵守しなければならない厳しい規制を定めています。薬事担当者は、承認プロセスを迅速化しながら、製品がこれらの基準を満たしていることを保証するために不可欠です。ヘルスケア産業が拡大し競合が増加する中、企業は規制を効率的に遵守することで優位に立つ必要があります。薬事業務の専門知識は、規制要件を満たしながら製品をより早く上市するための競争優位性となります。

米国薬事申請市場レポートハイライト

  • 中堅・大手の医療機器およびバイオ医薬品企業によるこれらのサービスのアウトソースが増加しているため、2023年には薬事ライティングおよび出版がサービス分野で16%以上のシェアを占めました。
  • 法律代理分野は、予測期間中に最も速いCAGRで成長すると予想されます。
  • 医療機器分野は2023年に最大の市場シェアを占めました。これは、製薬企業による医療機器のアウトソーシングが増加し、本来の業務に集中できるようになったためです。
  • 2023年の市場収益シェアは、腫瘍学が最大でした。これは、がん患者の有病率が増加しており、効果的で安全な治療法の選択に対する需要が高まっていることに起因しています。
  • 免疫学分野は、いくつかの神経疾患、心血管系疾患、炎症性疾患、腫瘍性疾患の治療を促進する能力により、予測期間中に10.5％のCAGRで最速の成長が見込まれています。
  • 臨床研究は、新たな疾病の発生と慢性疾患の増加により、2023年に最大の市場収益シェアを占めました。
  • アウトソーシングサービスプロバイダーは、2023年に最大の市場収益シェアを占め、予測期間中に最も速いCAGRで成長すると予測されます。
  • 中堅企業が2023年に最大の市場収益シェアを占めたが、これは中堅企業、特に非上場企業の存在によるものであり、同分野の成長を促進すると予測されます。
  • 製薬企業セグメントは2023年に市場を独占し、予測期間中に最も速いCAGRで成長すると予測されています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の薬事申請市場の変数、動向、範囲

  • 市場系統の見通し
    • 親市場の見通し
    • 関連/付随市場の見通し
  • 市場力学
    • 市場牽引要因分析
    • 市場抑制要因分析
  • 米国規制業務市場分析ツール
    • 業界分析- ポーターのファイブフォース分析
    • PESTEL分析

第4章 米国の薬事申請市場：サービスの推定・動向分析

  • サービス市場シェア、2023年と2030年
  • セグメントダッシュボード
  • 米国の薬事申請市場のサービス展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 薬事コンサルタント
  • 法的代理
  • 薬事ライティング・パブリッシング
  • 製品申請・臨床試験アプリケーション
  • その他サービス

第5章 米国の薬事申請市場：カテゴリーの推定・動向分析

  • カテゴリー市場シェア、2023年と2030年
  • セグメントダッシュボード
  • 米国規制業務市場カテゴリー別展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 薬剤
  • バイオロジクス
  • バイオシミラー
  • 医療機器

第6章 米国の薬事規制市場：適応症の推定・動向分析

  • 適応症市場シェア、2023年および2030年
  • セグメントダッシュボード
  • 米国の薬事規制市場（適応症別）の見通し
  • 2018年から2030年までの市場規模と予測および動向分析
  • オンコロジー
  • 神経
  • 循環器
  • イムノロジー
  • その他

第7章 米国の薬事申請市場：製品段階の推定・動向分析

  • 製品ステージの市場シェア、2023年と2030年
  • セグメントダッシュボード
  • 米国薬事申請市場：製品ステージ別展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 前臨床
  • 臨床研究
  • PMA

第8章 米国の薬事申請市場：サービスプロバイダーの推定・動向分析

  • サービスプロバイダーの市場シェア、2023年と2030年
  • セグメントダッシュボード
  • 米国規制業務市場サービスプロバイダーの展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 社内
  • アウトソース

第9章 米国の薬事申請市場：企業規模の推定・動向分析

  • 企業規模市場シェア、2023年と2030年
  • セグメントダッシュボード
  • 企業規模別米国薬事申請市場の見通し
  • 2018年から2030年までの市場規模と予測および動向分析
  • 小規模
  • 中規模
  • 大規模

第10章 米国の薬事申請市場：最終用途の推定・動向分析

  • 最終用途市場シェア、2023年および2030年
  • セグメントダッシュボード
  • 最終用途別米国薬事申請市場展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 医療機器企業
  • 製薬企業
  • バイオテクノロジー企業

第11章 米国の薬事申請市場：地域推定・動向分析

  • 地域別市場シェア、2023年および2030年
  • 地域別米国薬事申請市場展望
  • 2018年から2030年までの市場規模と予測および動向分析
  • 西部
  • 中西部
  • 北東部
  • 南西部
  • 南東部

第12章 競合情勢

  • 主要市場参入企業による最近の動向と影響分析
  • 企業/競合の分類
  • ベンダー情勢
  • 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（MA）Corporation
    • Freyr
    • Pharmalex GmbH
    • NDA Group AB
    • Qvigilance
    • BlueReg
    • Cambridge Regulatory Services
    • VCLS
図表

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. regulatory affairs market, by services, 2018 - 2030 (USD Million)
  • Table 3 U.S. regulatory affairs market, by writing & publishing, 2018 - 2030 (USD Million)
  • Table 4 U.S. regulatory affairs market, by category, 2018 - 2030 (USD Million)
  • Table 5 U.S. regulatory affairs market, by drugs, 2018 - 2030 (USD Million)
  • Table 6 U.S. regulatory affairs market, by innovator, 2018 - 2030 (USD Million)
  • Table 7 U.S. regulatory affairs market, by generics, 2018 - 2030 (USD Million)
  • Table 8 U.S. regulatory affairs market, by biologics, 2018 - 2030 (USD Million)
  • Table 9 U.S. regulatory affairs market, by biotech, 2018 - 2030 (USD Million)
  • Table 10 U.S. regulatory affairs market, by ATMP, 2018 - 2030 (USD Million)
  • Table 11 U.S. regulatory affairs market, by biosimilars, 2018 - 2030 (USD Million)
  • Table 12 U.S. regulatory affairs market, by medical devices, 2018 - 2030 (USD Million)
  • Table 13 U.S. regulatory affairs market, by diagnostics, 2018 - 2030 (USD Million)
  • Table 14 U.S. regulatory affairs market, by therapeutics, 2018 - 2030 (USD Million)
  • Table 15 U.S. regulatory affairs market, by indication, 2018 - 2030 (USD Million)
  • Table 16 U.S. regulatory affairs market, by product stage, 2018 - 2030 (USD Million)
  • Table 17 U.S. regulatory affairs market, by service provider, 2018 - 2030 (USD Million)
  • Table 18 U.S. regulatory affairs market, by company size, 2018 - 2030 (USD Million)
  • Table 19 U.S. regulatory affairs market, by end-use, 2018 - 2030 (USD Million)
  • Table 20 U.S. regulatory affairs market, by region, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Value-chain-based sizing & forecasting
  • Fig. 6 QFD modeling for market share assessment
  • Fig. 7 Market formulation & validation
  • Fig. 8 U.S. regulatory affairs market: market outlook
  • Fig. 9 U.S. regulatory affairs competitive insights
  • Fig. 10 Parent market outlook
  • Fig. 11 Related/ancillary market outlook
  • Fig. 12 Penetration and growth prospect mapping
  • Fig. 13 U.S. regulatory affairs market driver impact
  • Fig. 14 U.S. regulatory affairs market restraint impact
  • Fig. 15 U.S. regulatory affairs market: Services movement analysis
  • Fig. 16 U.S. regulatory affairs market: Services outlook and key takeaways
  • Fig. 17 Regulatory consulting market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 18 Legal representation estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 19 Regulatory writing & publishing market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 20 Writing estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 21 Publishing market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 22 Product Registration & Clinical Trial Applications market estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 23 Others services estimates and forecast, 2018 - 2030 (USD Million)
  • Fig. 24 U.S. regulatory affairs market: Category movement Analysis
  • Fig. 25 U.S. regulatory affairs market: Category outlook and key takeaways
  • Fig. 26 Drugs market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 27 Innovator market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 28 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 29 Generics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 30 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 31 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 32 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 33 Biologics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 34 Biotech market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 35 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 36 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 37 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 38 ATMP market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 39 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 40 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 41 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 42 Biosimilars market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 43 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 44 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 45 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 46 Medical Devices market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 47 Diagnostics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 48 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 49 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 50 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 51 Therapeutics market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 52 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 53 Clinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 54 Pre-Market Approval (PMA) market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 55 U.S. regulatory affairs market: indication movement analysis
  • Fig. 56 U.S. regulatory affairs market: indication outlook and key takeaways
  • Fig. 57 Oncology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 58 Neurology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 59 Cardiology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 60 Immunology market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 61 Others market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 62 U.S. regulatory affairs market: product stage outlook and key takeaways
  • Fig. 63 Preclinical market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 64 Clinical studies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 65 PMA market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 66 U.S. regulatory affairs market: service provider outlook and key takeaways
  • Fig. 67 In-house market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 68 Outsourced market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 69 U.S. regulatory affairs market: company size outlook and key takeaways
  • Fig. 70 Small market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 71 Medium market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 72 Large market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 73 U.S. regulatory affairs market: end-use outlook and key takeaways
  • Fig. 74 Medical device companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 75 Pharmaceutical companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 76 Biotechnology companies market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 77 U.S. regulatory affairs market: Regional movement analysis
  • Fig. 78 U.S. regulatory affairs market: Regional outlook and key takeaways
  • Fig. 79 West market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 80 Midwest market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 81 Northeast market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 82 Southwest market estimates and forecasts, 2018 - 2030 (USD Million)
  • Fig. 83 Southeast market estimates and forecasts, 2018 - 2030 (USD Million)
目次
Product Code: GVR-4-68040-278-3

U.S. Regulatory Affairs Market Growth & Trends:

The U.S. regulatory affairs market is anticipated to reach USD 7.71 billion by 2030 and is anticipated to expand at a CAGR of 9.0% during the forecast period, according to a new report by Grand View Research, Inc. The regulatory landscape constantly evolves and becomes more complex, with new laws and guidelines being introduced regularly. This complexity drives the demand for regulatory affairs professionals who can navigate these intricate requirements.

As the company expands its operations globally, regulatory compliance becomes more challenging due to varying regulations across different countries. Regulatory affairs professionals help organizations navigate international regulatory frameworks and ensure market access. For instance, as per Reuters update of Jan 2024, many U.S. law corporations are expected to enter into merger agreements in 2024. Stockton & Kilpatrick Townsend recently announced a merger with smaller companies. In addition, Fennemore Craig, a Phoenix-founded medium-sized company, announced its expansion into Seattle in the current year.

Regulatory bodies prioritize patient safety and product quality, leading to stringent regulations that companies must adhere to. Regulatory affairs professionals are vital in ensuring products meet these standards while expediting the approval process. As the healthcare industry expands and competition increases, companies must stay ahead by complying with regulations efficiently. Regulatory affairs expertise becomes a competitive advantage in launching products faster while meeting regulatory requirements.

U.S. Regulatory Affairs Market Report Highlights:

  • Regulatory writing & publishing dominated the services segment with more than 16% share in 2023 owing to increasing outsources of these services by mid- and large size medical device and biopharmaceutical firms.
  • The legal representation segment is expected to grow at the fastest CAGR over the forecast period.
  • The medical devices segment held the largest market share in 2023. This is attributable to the rising outsource activities of medical devices by pharmaceutical firms allowing them to focus on their underlying competencies.
  • Oncology accounted for the largest market revenue share in 2023.This can be attributed to the growing prevalence of cancer cases, encouraging a demand for effective and safe treatment selections.
  • The immunology segment is expected to grow at the fastest CAGR of 10.5% during the forecast period owing to its capability to facilitate the treatment of several neurological, cardiovascular, inflammatory, and oncological diseases.
  • Clinical studies accounted for the largest market revenue share in 2023 owing to the growing incidences of new diseases and the increasing occurrence of chronic illnesses.
  • Outsourced service provider accounted for the largest market revenue share in 2023 and is anticipated to grow at the fastest CAGR over the forecast period.
  • The medium size companies accounted for the largest market revenue share in 2023 owing to the existence of several mid-sized recognized providers, specifically privately held, is anticipated to promote to the segment's growth.
  • The pharmaceutical companies segment dominated the market in 2023 and is anticipated to grow at the fastest CAGR over the forecast period attributing to the expansion in the number of authorized pharmaceutical products.

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Service
    • 1.2.2. Category
    • 1.2.3. Indication
    • 1.2.4. Product Stage
    • 1.2.5. Service Provider
    • 1.2.6. Company Size
    • 1.2.7. End-use
    • 1.2.8. Estimates and forecasts timeline
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased database
    • 1.4.2. GVR's internal database
    • 1.4.3. Secondary sources
    • 1.4.4. Primary research
  • 1.5. Information or Data Analysis
    • 1.5.1. Data analysis models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Volume price analysis (Model 2)
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Service outlook
    • 2.2.2. Category outlook
    • 2.2.3. Indication outlook
    • 2.2.4. Product stage outlook
    • 2.2.5. Service provider outlook
    • 2.2.6. Company size outlook
    • 2.2.7. End-use outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. 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
    • 3.2.2. Market restraint analysis
  • 3.3. U.S. 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
      • 3.3.2.1. Political landscape
      • 3.3.2.2. Technological landscape
      • 3.3.2.3. Economic landscape

Chapter 4. U.S. Regulatory Affairs Market: Service Estimates & Trend Analysis

  • 4.1. Service Market Share, 2023 & 2030
  • 4.2. Segment Dashboard
  • 4.3. U.S. Regulatory Affairs Market by Service Outlook
  • 4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 4.4.1. Regulatory Consulting
      • 4.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.2. Legal Representation
      • 4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.3. Regulatory Writing & Publishing
      • 4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.4.3.1.1. Writing
      • 4.4.3.1.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 4.4.3.1.2. Publishing
      • 4.4.3.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.4. Product Registration & Clinical Trial Applications
      • 4.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 4.4.5. Other Services
      • 4.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. U.S. Regulatory Affairs Market: Category Estimates & Trend Analysis

  • 5.1. Category Market Share, 2023 & 2030
  • 5.2. Segment Dashboard
  • 5.3. U.S. Regulatory Affairs Market by Category Outlook
  • 5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 5.4.1. Drugs
      • 5.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2. Innovator
      • 5.4.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.2. Preclinical
      • 5.4.1.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.3. Clinical
      • 5.4.1.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.2.4. Pre-Maker Approval (PMA)
      • 5.4.1.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3. Generics
      • 5.4.1.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.2. Preclinical
      • 5.4.1.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.3. Clinical
      • 5.4.1.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.1.3.4. Pre-Maker Approval (PMA)
      • 5.4.1.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.2. Biologics
      • 5.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2. Biotech
      • 5.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.2. Preclinical
      • 5.4.2.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.3. Clinical
      • 5.4.2.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.2.4. Pre-Maker Approval (PMA)
      • 5.4.2.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3. ATMP
      • 5.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.2. Preclinical
      • 5.4.2.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.3. Clinical
      • 5.4.2.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.2.3.4. Pre-Maker Approval (PMA)
      • 5.4.2.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.3. Biosimilars
      • 5.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.2. Preclinical
      • 5.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.3. Clinical
      • 5.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.3.4. Pre-Maker Approval (PMA)
      • 5.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.4. Medical Devices
      • 5.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2. Diagnostics
      • 5.4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.2. Preclinical
      • 5.4.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.3. Clinical
      • 5.4.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.2.4. Pre-Maker Approval (PMA)
      • 5.4.4.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3. Therapeutics
      • 5.4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.2. Preclinical
      • 5.4.4.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.3. Clinical
      • 5.4.4.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
      • 5.4.4.3.4. Pre-Maker Approval (PMA)
      • 5.4.4.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 6.1. Indication Market Share, 2023 & 2030
  • 6.2. Segment Dashboard
  • 6.3. U.S. Regulatory Affairs Market by Indication Outlook
  • 6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 6.4.1. Oncology
      • 6.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2. Neurology
      • 6.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.3. Cardiology
      • 6.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.4. Immunology
      • 6.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.5. Others
      • 6.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. U.S. Regulatory Affairs Market: Product Stage Estimates & Trend Analysis

  • 7.1. Product Stage Market Share, 2023 & 2030
  • 7.2. Segment Dashboard
  • 7.3. U.S. Regulatory Affairs Market by Product Stage Outlook
  • 7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 7.4.1. Preclinical
      • 7.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 7.4.2. Clinical studies
      • 7.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 7.4.3. PMA
      • 7.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 8. U.S. Regulatory Affairs Market: Service Provider Estimates & Trend Analysis

  • 8.1. Service Provider Market Share, 2023 & 2030
  • 8.2. Segment Dashboard
  • 8.3. U.S. Regulatory Affairs Market by Service Provider Outlook
  • 8.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 8.4.1. In-house
      • 8.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 8.4.2. Outsourced
      • 8.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 9. U.S. Regulatory Affairs Market: Company Size Estimates & Trend Analysis

  • 9.1. Company Size Market Share, 2023 & 2030
  • 9.2. Segment Dashboard
  • 9.3. U.S. Regulatory Affairs Market by Company Size Outlook
  • 9.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 9.4.1. Small
      • 9.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 9.4.2. Medium
      • 9.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 9.4.3. Large
      • 9.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

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

  • 10.1. End-use Market Share, 2023 & 2030
  • 10.2. Segment Dashboard
  • 10.3. U.S. Regulatory Affairs Market by End-use Outlook
  • 10.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
    • 10.4.1. Medical Device Companies
      • 10.4.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 10.4.2. Pharmaceutical Companies
      • 10.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 10.4.3. Biotechnology Companies
      • 10.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 11. U.S. Regulatory Affairs Market: Region Estimates & Trend Analysis

  • 11.1. Regional Market Share, 2023 & 2030
  • 11.2. U.S. Regulatory Affairs Market by Region Outlook
  • 11.3. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the Following
    • 11.3.1. West
      • 11.3.1.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.2. Midwest
      • 11.3.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.3. Northeast
      • 11.3.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.4. Southwest
      • 11.3.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 11.3.5. Southeast
      • 11.3.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 12. Competitive Landscape

  • 12.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 12.2. Company/Competition Categorization
  • 12.3. Vendor Landscape
    • 12.3.1. List of key distributors and channel partners
    • 12.3.2. Key customers
    • 12.3.3. Key company market share analysis, 2023
  • 12.4. Company Profiles
    • 12.4.1. Accell Clinical Research, LLC
      • 12.4.1.1. Company overview
      • 12.4.1.2. Financial performance
      • 12.4.1.3. Product benchmarking
      • 12.4.1.4. Strategic initiatives
    • 12.4.2. Genpact
      • 12.4.2.1. Company overview
      • 12.4.2.2. Financial performance
      • 12.4.2.3. Product benchmarking
      • 12.4.2.4. Strategic initiatives
    • 12.4.3. CRITERIUM, INC.
      • 12.4.3.1. Company overview
      • 12.4.3.2. Financial performance
      • 12.4.3.3. Product benchmarking
      • 12.4.3.4. Strategic initiatives
    • 12.4.4. ICON plc
      • 12.4.4.1. Company overview
      • 12.4.4.2. Financial performance
      • 12.4.4.3. Product benchmarking
      • 12.4.4.4. Strategic initiatives
    • 12.4.5. Promedica International
      • 12.4.5.1. Company overview
      • 12.4.5.2. Financial performance
      • 12.4.5.3. Product benchmarking
      • 12.4.5.4. Strategic initiatives
    • 12.4.6. WuXi AppTec
      • 12.4.6.1. Company overview
      • 12.4.6.2. Financial performance
      • 12.4.6.3. Product benchmarking
      • 12.4.6.4. Strategic initiatives
    • 12.4.7. Medpace
      • 12.4.7.1. Company overview
      • 12.4.7.2. Financial performance
      • 12.4.7.3. Product benchmarking
      • 12.4.7.4. Strategic initiatives
    • 12.4.8. Charles River Laboratories
      • 12.4.8.1. Company overview
      • 12.4.8.2. Financial performance
      • 12.4.8.3. Product benchmarking
      • 12.4.8.4. Strategic initiatives
    • 12.4.9. Labcorp Drug Development
      • 12.4.9.1. Company overview
      • 12.4.9.2. Financial performance
      • 12.4.9.3. Product benchmarking
      • 12.4.9.4. Strategic initiatives
    • 12.4.10. Parexel International (MA) Corporation
      • 12.4.10.1. Company overview
      • 12.4.10.2. Financial performance
      • 12.4.10.3. Product benchmarking
      • 12.4.10.4. Strategic initiatives
    • 12.4.11. Freyr
      • 12.4.11.1. Company overview
      • 12.4.11.2. Financial performance
      • 12.4.11.3. Product benchmarking
      • 12.4.11.4. Strategic initiatives
    • 12.4.12. Pharmalex GmbH
      • 12.4.12.1. Company overview
      • 12.4.12.2. Financial performance
      • 12.4.12.3. Product benchmarking
      • 12.4.12.4. Strategic initiatives
    • 12.4.13. NDA Group AB
      • 12.4.13.1. Company overview
      • 12.4.13.2. Financial performance
      • 12.4.13.3. Product benchmarking
      • 12.4.13.4. Strategic initiatives
    • 12.4.14. Qvigilance
      • 12.4.14.1. Company overview
      • 12.4.14.2. Financial performance
      • 12.4.14.3. Product benchmarking
      • 12.4.14.4. Strategic initiatives
    • 12.4.15. BlueReg
      • 12.4.15.1. Company overview
      • 12.4.15.2. Financial performance
      • 12.4.15.3. Product benchmarking
      • 12.4.15.4. Strategic initiatives
    • 12.4.16. Cambridge Regulatory Services
      • 12.4.16.1. Company overview
      • 12.4.16.2. Financial performance
      • 12.4.16.3. Product benchmarking
      • 12.4.16.4. Strategic initiatives
    • 12.4.17. VCLS
      • 12.4.17.1. Company overview
      • 12.4.17.2. Financial performance
      • 12.4.17.3. Product benchmarking
      • 12.4.17.4. Strategic initiatives