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藥品監管事務市場，按服務、按類別、按產品階段、按適應症、服務提供者、按國家和地區 - 2023-2030 年行業分析、市場規模、市場佔有率和預測
市場調查報告書
商品編碼
1419028

藥品監管事務市場，按服務、按類別、按產品階段、按適應症、服務提供者、按國家和地區 - 2023-2030 年行業分析、市場規模、市場佔有率和預測

Pharmaceutical Regulatory Affairs Market, By Services, By Category, By Product stage, By Indication, Service Provider, By Country, and By Region - Industry Analysis, Market Size, Market Share & Forecast from 2023-2030
出版日期: | 出版商: AnalystView Market Insights | 英文 277 Pages | 商品交期: 2-3個工作天內

價格

報告要點

2022年藥品監管事務市場規模為138.154億美元，2023年至2030年複合CAGR為8.5%。

藥品監理事務市場-市場動態

製藥和生物技術行業的擴張以及對藥物開發的日益重視預計將推動藥品監管事務市場的成長。

製藥公司正在積極尋求全球市場擴張。為了進入新市場，他們必須遵守不同國家的各種監管要求。監管事務專業人員的角色對於應對這些複雜的監管環境、確保產品符合必要的標準並獲得銷售批准至關重要。根據醫藥統計，2021年美國醫藥產業收入達5,500億美元。此外，美國人同年在藥品上的支出為5,769億美元。對藥物發現和開發的日益關注導致向監管機構提交的新藥申請和提交數量增加。目前，市場上有超過 40,000 種 FDA 批准的藥物。對細胞和基因療法等先進療法以及個人化醫療的日益重視，為監管事務市場帶來了機會。然而，值得注意的是，嚴格的監管要求可能會帶來挑戰並限制市場的成長。

藥品監管事務市場-關鍵見解

  • 根據我們的研究分析師分享的分析，預計全球市場在預測期內（2023-2030 年）每年將以 8.5% 左右的CAGR成長
  • 根據服務細分，監管寫作和出版預計將在 2022 年顯示最大的市場佔有率
  • 從品類細分來看，2022年藥品為主導品類
  • 依產品階段分類，2022年臨床研究為主導類型
  • 根據適應症細分，腫瘤學是2022年的主導類型
  • 根據服務提供者細分，外包是 2022 年的主導類型
  • 按地區分類，北美是 2022 年的主要收入來源

藥品監理事務市場-細分分析：

全球藥品監管事務市場根據服務、類別、產品階段、適應症、服務提供者和地區進行細分。

市場根據服務分為五類：監管諮詢、法律代表、監管寫作和出版（寫作、出版）、產品註冊和臨床試驗類別以及其他服務。監管寫作和出版在市場上佔有重要地位。它在監管事務中發揮著至關重要的作用，包括準備、彙編和提交產品批准和上市後活動所需的各種監管文件。監管撰寫者的責任是將複雜的科學和臨床資料轉化為符合監管標準的結構良好且全面的文件。另一方面，監管發布涉及對這些文件進行格式化、組織以及以指定的電子格式向衛生當局提交。

市場依類別分為兩類：藥物和生物製劑。藥品細分市場佔據主導地位。藥品監管事務部門在藥品上市過程中扮演至關重要的角色。它涉及透過監管途徑、確保遵守法規以及促進與衛生當局的有效溝通。這確保了藥物的開發和銷售方式優先考慮患者的安全性和有效性。

根據產品階段，市場分為三類：臨床前、臨床研究和 PMA。市場主要由臨床研究領域主導。監管專業人員在確保臨床試驗符合監管標準方面發揮著至關重要的作用，從而促進安全有效的藥品的開發。作為臨床試驗申辦者和監管機構之間的中間人，他們在向市場推出新療法方面發揮關鍵作用。

市場根據適應症分為四類：腫瘤學、神經學、心臟病學、免疫學和其他。腫瘤學領域主導市場。監管事務專家與腫瘤藥物開發團隊密切合作，制定監管策略，以解決癌症治療開發中遇到的獨特障礙。腫瘤藥物有可能獲得快速通道、突破性治療或孤兒藥等特殊稱號。監管事務專業人員在獲得這些指定以加速開發和監管程序方面發揮著至關重要的作用。

市場根據服務提供者分為兩類：內部和外包。該市場主要由外包領域主導。在這一領域，外包公司負責管理監管文件的編制、格式化和向衛生當局的提交。此外，公司可以選擇外包監管流程中新技術的實施，例如電子提交工具或人工智慧應用程式。

藥品監理事務市場-地理洞察

該市場在地理上廣泛分佈於北美、拉丁美洲、歐洲、亞太地區、中東和非洲。這些區域根據參與商業活動的國家進一步分類。亞太地區預計將引領市場成長，這主要是由於其對先進療法和個人化醫療的日益關注。該地區非常重視生物製劑、基因療法和個人化醫療等先進療法。監管事務專業人員在促進這些創新療法的開發、註冊和市場准入方面發揮著至關重要的作用，從而促進了監管事務市場的整體成長。中國擁有超過14億人口，面臨開發新療法特別是基因療法的迫切需求，因為中國估計有5,700萬名遺傳疾病患者，每年新增癌症病例超過400萬例。在預測期內，由於歐洲和北美地區進行的臨床試驗數量不斷增加，以及涉足這些地區的生物製藥公司不斷增加，預計這些地區也將推動市場成長。

藥品監理事務市場-競爭格局：

製藥業是一個不斷發展和研究驅動的行業，深受一系列複雜法規的影響。這些法規旨在促進藥物設計和生產的研究和創新，保護消費者免受藥物造成的潛在傷害，並規範公共和私營部門的藥物支出。然而，實現這些目標有時會產生衝突，需要在生產者和消費者的利益之間進行仔細的平衡。為了因應這一監管環境，專業顧問公司、合約研究組織 (CRO) 和製藥公司的內部部門提供監管事務服務。這些服務提供了一種經濟高效且便捷的選擇，可以為消費者組織團隊提供必要的工具和知識，使其成為監管專業人士並在競爭中保持領先地位。在這個市場中，競爭可能會以開發和採用簡化監管合規流程的技術的形式出現，例如監管資訊管理系統（RIMS）和電子提交工具。

最近的發展：

2023 年 9 月，全球領先的監管解決方案和服務供應商 Freyr Solutions 很高興地宣布與 PKG Group LLC 建立策略夥伴關係。此次合作已成功向美國食品藥物管理局 (US FDA) 提交 PKG 集團的 III 類藥物主文件 (DMF)。 Freyr 為 III 類 DMF 註冊支援提供了全面的服務，包括對文件的全面分析、eCTD 格式檔案的彙編以及整個提交過程中的專家指導。此外，Freyr 還提供了管理美國 FDA 查詢的協助，確保了無縫且高效的提交流程。

目錄

第1章：藥品監理事務市場概述

  • 研究範圍
  • 市場預估年份

第 2 章：執行摘要

  • 市場片段
    • 藥品監理事務市場片段（按服務）
    • 按類別分類的藥品監管事務市場片段
    • 按產品階段分類的藥品監理事務市場片段
    • 按適應症分類的藥品監管事務市場片段
    • 服務提供者的藥品監管事務市場片段
    • 按國家/地區分類的藥品監管事務市場片段
    • 按地區分類的藥品監管事務市場片段
  • 競爭洞察

第 3 章：藥品監理事務主要市場趨勢

  • 藥品監管事務市場促進因素
    • 市場促進因素的影響分析
  • 藥品監理事務市場限制
    • 市場限制影響分析
  • 藥品監管事務市場機會
  • 藥品監理事務市場未來趨勢

第 4 章：藥品監管事務產業研究

  • PEST分析
  • 波特五力分析
  • 成長前景圖
  • 規範架構分析

第 5 章：藥品監理事務市場：COVID-19 影響分析

  • COVID-19 之前的影響分析
  • COVID-19 後影響分析
    • 表現最佳的市場區隔
    • 邊際成長市場區隔
    • 最寬鬆的市場區隔
    • 邊際損失市場區隔

第 6 章：藥品監理事務市場格局

  • 2022 年藥品監理事務市場佔有率分析
  • 按主要製造商分類的故障數據
    • 既有參與者分析
    • 新興參與者分析

第 7 章：藥品監理事務市場 - 按服務

  • 概述
    • 按服務分類的細分市場佔有率分析
    • 監理諮詢
    • 法律代表
    • 監理寫作與出版（寫作、出版）
    • 產品註冊及臨床試驗服務
    • 其他

第 8 章：藥品監理事務市場 - 按類別

  • 概述
    • 按類別分類的細分市場佔有率分析
    • 藥品
      • 創新者
      • 泛型
      • 生物製劑
      • 生物技術
      • ATMP
      • 生物相似藥

第 9 章：藥品監理事務市場 - 按產品階段

  • 概述
    • 細分市場佔有率分析，依產品階段
    • 臨床前
    • 臨床研究
    • 聚甲基丙烯酸甲酯

第 10 章：藥品監理事務市場 - 依適應症分類

  • 概述
    • 按指標分類的細分市場佔有率分析
    • 臨床前
    • 臨床研究
    • 聚甲基丙烯酸甲酯

第 11 章：藥品監管事務市場 - 按服務提供者

  • 概述
    • 按服務提供者分類的細分市場佔有率分析
    • 內部
    • 外包

第 12 章：藥品監管事務市場 - 按地理位置

  • 介紹
    • 按地理位置分類的細分市場佔有率分析
  • 北美洲
    • 概述
    • 北美藥品監管事務主要製造商
    • 北美市場規模和預測（按國家）
    • 北美市場規模和預測（按服務）
    • 北美市場規模和預測（按類別）
    • 北美市場規模與預測，按產品階段
    • 北美市場規模和預測（按指標）
    • 北美市場規模和預測（按服務提供者）
    • 美國
    • 加拿大
  • 歐洲
    • 概述
    • 歐洲藥品監管事務主要製造商
    • 歐洲市場規模和預測（按國家）
    • 歐洲市場規模和預測（按服務）
    • 歐洲市場規模和預測（按類別）
    • 歐洲市場規模與預測，依產品階段
    • 歐洲市場規模與預測（按指標）
    • 歐洲市場規模和預測（按服務提供者）
    • 德國
    • 義大利
    • 英國
    • 法國
    • 俄羅斯
    • 荷蘭
    • 瑞典
    • 波蘭
    • 歐洲其他地區
  • 亞太地區 (APAC)
    • 概述
    • 亞太地區藥品監管事務主要製造商
    • 亞太地區市場規模與預測（按國家）
    • 亞太地區市場規模與預測（按服務）
    • 亞太地區市場規模和預測（按類別）
    • 亞太地區市場規模與預測（依產品階段）
    • 亞太地區市場規模與預測（依指標）
    • 亞太地區市場規模和預測（按服務提供者）
    • 印度
    • 中國
    • 日本
    • 韓國
    • 澳洲
    • 泰國
    • 印尼
    • 菲律賓
    • 亞太地區其他地區
  • 拉丁美洲
    • 概述
    • 拉丁美洲藥品監管事務主要製造商
    • 拉丁美洲市場規模與預測（按國家）
    • 拉丁美洲市場規模與預測（按服務）
    • 拉丁美洲市場規模和預測（按類別）
    • 拉丁美洲市場規模與預測，依產品階段
    • 拉丁美洲市場規模與預測（按指標）
    • 拉丁美洲市場規模和預測（按服務提供者）
    • 巴西
    • 墨西哥
    • 阿根廷
    • 哥倫比亞
    • 拉丁美洲其他地區
  • 中東和非洲
    • 概述
    • 中東和非洲藥品監管事務主要製造商
    • 中東和非洲市場規模及預測（按國家）
    • 中東和非洲市場規模及預測（按服務）
    • 中東和非洲市場規模及預測（按類別）
    • 中東和非洲市場規模及預測（按產品階段）
    • 中東和非洲市場規模及預測（依指標）
    • 中東和非洲市場規模及預測（按服務提供者）
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 以色列
    • 土耳其
    • 阿爾及利亞
    • 埃及
    • MEA 的其餘部分

第 13 章：主要供應商分析 - 藥品監管事務產業

  • 競爭儀表板
  • 公司簡介
    • Freyr
    • IQVIA Inc
    • ICON plc
    • WuXi AppTec
    • Charles River Laboratories
    • Labcorp Drug Development
    • Parexel International Corporation
    • Pharmalex GmbH
    • Pharmexon
    • Genpact

第 14 章：360 度分析師視角

第 15 章：附錄

  • 研究方法論
  • 參考
  • 縮寫
  • 免責聲明
  • 聯絡我們
Product Code: ANV2093

REPORT HIGHLIGHT

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

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

Pharmaceutical Regulatory Affairs Market- Market Dynamics

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

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

Pharmaceutical Regulatory Affairs Market- Key Insights

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

Pharmaceutical Regulatory Affairs Market- Segmentation Analysis:

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

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

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

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

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

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

Pharmaceutical Regulatory Affairs Market- Geographical Insights

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

Pharmaceutical Regulatory Affairs Market- Competitive Landscape:

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

Recent Developments:

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

SCOPE OF THE REPORT

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

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET KEY PLAYERS

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

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY SERVICES

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

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY CATEGORY

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

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY PRODUCT STAGE

  • Preclinical
  • Clinical Studies
  • PMA

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY INDICATION

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY SERVICE PROVIDERS

  • In-house
  • Outsourcing

GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS MARKET, BY REGION

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

Table of Contents

1. Pharmaceutical Regulatory Affairs Market Overview

  • 1.1. Study Scope
  • 1.2. Market Estimation Years

2. Executive Summary

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

3. Pharmaceutical Regulatory Affairs Key Market Trends

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

4. Pharmaceutical Regulatory Affairs Industry Study

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

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

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

6. Pharmaceutical Regulatory Affairs Market Landscape

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

7. Pharmaceutical Regulatory Affairs Market - By Service

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

8. Pharmaceutical Regulatory Affairs Market - By Category

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

9. Pharmaceutical Regulatory Affairs Market - By Product stage

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

10. Pharmaceutical Regulatory Affairs Market - By Indication

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

11. Pharmaceutical Regulatory Affairs Market - By Service Providers

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

12. Pharmaceutical Regulatory Affairs Market- By Geography

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

13. Key Vendor Analysis- Pharmaceutical Regulatory Affairs Industry

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

14. 360 Degree Analyst View

15. Appendix

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

List of Tables

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

List of Figures

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