THE GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET SIZE WAS VALUED AT USD 8.2 BILLION IN 2021 AND IS EXPECTED TO REACH USD 16.8 BILLION BY 2027, GROWING AT A CAGR OF 12.73%.

Global Regulatory Affairs Outsourcing Market Size, Share, & Trends Analysis Report by

  • Product
    • Small Molecule Drugs
    • Biologics
    • Medical Devices
    • Others
  • Company Size: Small & Mid-Sized Companies, and Large-sized Companies
  • End-User: Pharma & Biotech Companies, Medical Device Companies, and Other Companies
  • Service-Type: Pre-Authorization, Marketing Authorization, and Post-Authorization
  • Geography: North America, Europe, APAC, Latin America, and Middle East & Africa

Industry Analysis, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast.

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Most Exhaustive Report

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345 Pages

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151 Tables

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170 Charts

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5 Regions

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19 Countries

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32 Companies

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5 Market Segment

REGULATORY AFFAIRS OUTSOURCING MARKET REPORT SCOPE

Report Attribute Details
Market Size (2027) USD 8.2 Billion
Market Size (2021) USD 16.8 Billion
CAGR (2022-2027) 12.73%
Base Year 2021
Forecast Year 2022-2027
Market Segments Product, Company Size, End-user, Service Type
Geographic Analysis North America, Europe, APAC, Latin America, and Middle East & Africa
Countries Covered US, Canada, Germany, France, UK, Italy, Spain, China, Japan, Australia, South Korea, India, Brazil, Mexico, Argentina, Turkey, Saudi Arabia, UAE, and South Africa

MARKET INSIGHTS

The global regulatory affairs outsourcing market was valued at USD 8.2 billion in 2021 and is expected to reach USD 16.8 billion by 2027, growing at a CAGR of 12.73%. Regulatory Affairs (RA) is a profession in regulated industries such as pharmaceuticals, medical devices, energy, and banking. Regulatory work has specific implications for the healthcare industry (pharmaceuticals, medical devices, biologics, functional foods). Whether a large multinational pharmaceutical company or a small, innovative biotechnology company, most companies have a dedicated department with regulatory expertise. It is a relatively new profession born from the desire of governments to protect public health by managing the safety and efficacy of products in areas such as pharmaceuticals, medical devices, nutraceuticals, food/dietary supplements, and probiotics.

Regulatory bodies/agencies are responsible for protecting public health by ensuring the safety, efficacy, and safety of human and veterinary drug products, biopharmaceuticals, and medical devices, and ensuring the safety of food supply and products that emit radiation.

REGULATORY AFFAIRS OUTSOURCING MARKET SCENARIO

RA serves as the interface between the regulatory authorities and companies, acts as the channel of communication with the regulatory authorities as to the approval process proceeds, and ensures that the approval will be executed effectively. RA outsourcing companies help biopharma and MedTech companies handle regulatory approval workflows flexibly, productively, and efficiently. Regulatory affairs service providers offer comprehensive services to companies, from strategic regulatory advice to regulatory maintenance and lifecycle support. It is the responsibility of RA outsourcing companies to keep abreast of current legislation, guidelines, and other regulatory intelligence.

  • Across the world, there have been growing cases of chronic illness or infectious diseases, patent expirations of prescription biologics, developments of biosimilars/orphan drugs and cell and gene therapy products, brand extensions, easy accessibility of OTC drugs across various platforms, economic and social factors, increasing healthcare expenditures, and advancements in regulatory affairs outsourcing, which are increasing the demand for regulatory affairs outsourcing services.
  • The healthcare industry is witnessing new compounds originating outside the companies ultimately responsible for marketing them. For instance, around one-third of approved drugs commercialized by big pharma/biotech companies were sourced from outside a decade ago. Approximately 50% to 70% of large companies' pipeline molecules are currently sourced outside.
  • In recent years, both pharma and medical device industries have witnessed many M&As, with oncology, orthopedic, and cardiovascular diseases being a particular area of interest. For instance, the pharma industry saw around 2,880 deals worth more than $1 trillion between 2014 and the first half of 2019 in gene therapy, immuno-oncology, microbiome, and orphan drugs.
  • The healthcare regulatory affairs outsourcing market is highly competitive and competes with traditional CROs and in-house regulatory affairs departments in pharma/biotech and medical device companies.

Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines

  • Over the last two decades, a transformation has occurred in treating many chronic and highly complex diseases like autoimmune disorders, cancer, and diabetes, introducing biopharmaceuticals.
  • Over the next five years, it is expected that the number of biosimilars and their market authorization will increase significantly as top-selling biologics such as Herceptin (Trastuzumab; Roche/Genentech), Enbrel (Etanercept; Amgen), Humalog (Insulin Lispro;), MabThera (Ritziximab; Roche, Basel), and Aranep (Darbepoetin Alpha; Amgen) go off patent.
  • Pfizer has agreed with Biocon (India) to produce biosimilar insulin. Eli Lilly and AstraZeneca have announced plans to produce biosimilars, and Boehringer Ingelheim has established a specialized business to develop and sell biosimilars.
  • Another challenge for pharmaceutical companies and other life sciences companies is anticipating the regulation of personalized medicine such as gene therapy and cell therapy. As R&D related to human cell and gene therapy grows rapidly, all stakeholders need to be aware of regulatory changes quickly.

The emergence of Virtual Trials and Virtual Communication

  • Many regulatory authorities around the globe issued guidance documents containing information on how trials could continue during the pandemic, which includes the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and Singapore's Health Science Authority.
  • The COVID-19 pandemic has energized the ascent of clinical trials without clinical sites and made way for proceeding with these inventive models after the general well-being emergency has blurred.
  • A constellation of emerging technology and services has permitted the relocation of clinical-trial activities closer to patients. Without in-person visits, investigators can maintain relationships with study participants using electronic consent, telehealthcare, remote patient monitoring, and electronic clinical outcome assessments (eCOAs).
  • Before the pandemic, an Industry Standard Research survey in December 2019 found that 38% of pharma and contract research organizations (CROs) expected virtual trials to be a major part of their portfolios, and 48% expected to run a trial with most activities taking place in participants' homes.
  • Sponsors and service providers attempting to execute decentralized trials must manage technological and approach uncertainties while balancing the demands of each stakeholder group and providing a good, distinctive experience.

Changing Regulatory Landscape

  • In recent years, life sciences companies have faced increasing pressure, including regulatory requirements, technological advances, and pricing pressure. COVID-19 has only provided more reasons for modernizing compliance and improving values and partnerships within the organization and with external stakeholders.
  • A recent global survey of pharmaceutical company CEOs reveals that regulations are being scrutinized for many aspects of business, including sales and marketing practices, government reporting of drug prices, privacy controls, and clinical practice.
  • Changes in the regulation viewed it as one of the top three disruptive business trends facing pharmaceutical and life sciences companies. Large pharmaceutical companies recognize these changes as the greatest threat to their potential future growth.
  • Contract research organizations (CROs) are well experienced and have updated on all changes in regulatory affairs in the pharmaceutical or the medical device industry. Thus, the pharmaceutical and medical devices companies are increasingly outsourcing the regulatory affairs activities to CROs.

GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET SEGMENTS

The small molecules drugs market size will cross USD 3 billion in 2022. For many decades, small molecule drug compounds have been the mainstay of the pharmaceutical industry. Small molecule drugs continue to play an essential role in developing new therapies globally. The demand for small molecule drugs remains high, with around 97% of the commercial drugs available in the market classified as small molecules.

The biologics segment will likely witness a faster growth rate due to a surge in demand for biopharmaceuticals like mAbs, vaccines, cell & gene therapies, recombinant proteins, etc. 

Major Biologics & Their Revenue in 2019 & 2020

  • In 2020, one of the key companies, AbbVie, has sold around USD 19.8 billion worth of HUMIRA drugs compared to USD 19.1 billion in 2019, which shows an increment of almost 3.5% in sales.
  • Johnson & Johnson sold approximately USD 7.7 billion worth of STELARA drugs in 2020, compared to USD 6.3 billion in 2019, representing a more than 21% increase in sales.
  • In 2020, Merck & Co. sold around USD 14 billion worth of KEYTRUDA drugs, up from USD 11 billion in 2019. This is a more than 29% increase in sales.

The small & mid-sized companies reported a major share of around 63.73% of the global regulatory affairs outsourcing market. Small and Medium-sized companies are leading because small and Medium-sized pharmaceutical companies outsource about 90% and 75% of their regulatory requirements. These companies often face resource and technology shortages and partner with suppliers on a project basis.

The pharma & biotech companies market reported a major share of around 65.19%. Pharmaceutical and biotechnology companies have partnered with contract research organizations (CROs) for outsourcing needs, including regulatory services. Most companies choose CROs for outsourcing regulatory services. They believe that regulatory outsourcing companies have the conceptual and technical expertise to achieve efficient results.

The pre-authorization market reported a major share of around 55.48% of the global regulatory affairs outsourcing market. US and EU health authorities require most regulatory applications to be received in ICH harmonized CTD format in the current regulatory era. A thorough submission approach and standardized CTD document templates enable effective regulatory submissions and subsequent lifecycle management with shorter and cost-effective parameters.

The North American region dominates the regulatory affairs outsourcing market with around 33% of the market share. The US is the major revenue contributor to the North American regulatory affairs outsourcing market and accounted for around 91% in 2021. The region's growth is primarily attributed to the increasing number of chronic diseases, development of biologics & biosimilars, increasing healthcare expenditures, and increasing innovation & advancements in regulatory affairs outsourcing.

Frequently Asked Questions

What will be the size of the Regulatory Affairs Outsourcing Market by 2028?

The regulatory affairs outsourcing market size is projected to reach USD 16.8 billion by 2028.

What are the factors driving the market growth?

Changing regulatory landscape, increasing use of digital platforms/solutions in regulatory affairs, and the impact of strict government regulations are some of the major factors driving the regulatory affairs outsourcing market growth.

Who are the key vendors in the regulatory affairs outsourcing industry?

Genpact, Freyr, ICON, IQVIA, Medpace, and Parexel International are some of the key players in the industry.

Which region holds the highest growth rate in the regulatory affairs outsourcing industry?

North America holds the highest growth rate in the global regulatory affairs outsourcing market.

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The global regulatory affairs outsourcing market size is expected to reach USD 16.8 billion by 2027, growing at a CAGR of 12.73%.

The following factors will drive the global regulatory affairs outsourcing market growth during the forecast period:

  • Increasing Use of Digital Platforms/Solutions in Regulatory Affairs
  • Changing Regulatory Landscape
  • Rising Demand For Fast Drug & Medical Device Approvals
  • Impact of Strict Government Regulations

The study considers a detailed scenario of the present global regulatory affairs outsourcing market and its dynamics for 2022−2027. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent ones operating in the industry.

Base Year: 2021

Forecast Year: 2022-2027

Key Vendors

  • Genpact
    • Business Overview
    • Product Offerings
    • Key Strategies
    • Key Strengths
    • Key Opportunities
  • Labcorp Drug Development
  • Freyr
  • ICON
  • IQVIA
  • Medpace
  • Parexel International
  • PPD

Other Prominent Vendors

  • Accenture
    • Business Overview
    • Product Offerings
  • BlueReg
  • Intertek Group
  • Lachman Consultants
  • NDA Group
  • ProPharma Group
  • PharmaLex
  • Pharmexon
  • Promedica International
  • CRITERIUM
  • Dicentra
  • Nuventra Pharma Sciences
  • PharmaLeaf
  • MAVEN REGULATORY SOLUTIONS
  • Global Regulatory Partners
  • Sofpromed
  • Charles River Laboratories
  • Cambridge Regulatory Services
  • APC Group
  • Real Regulatory
  • Voisin Consulting Life Sciences (VCLS)
  • Regulatory Pharma Net
  • Biomapas
  • REGENOLD

Segmentation by Product

  • Small Molecule Drugs
  • Biologics
  • Medical Devices
  • Others

Segmentation by Company Size

  • Small & Mid-Sized Companies
  • Large-sized Companies

Segmentation by End-User

  • Pharma & Biotech Companies
  • Medical Device Companies
  • Other Companies

Segmentation by Service Type

  • Pre-Authorization
  • Marketing Authorization
  • Post-Authorization

Segmentation by Region

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
  • APAC
    • China
    • Japan
    • Australia
    • South Korea
    • India
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • Turkey
    • Saudi Arabia
    • UAE
    • South Africa

1 RESEARCH METHODOLOGY

2 RESEARCH OBJECTIVES

3 RESEARCH PROCESS

4 SCOPE & COVERAGE

4.1 MARKET DEFINITION

4.1.1 INCLUSIONS

4.1.2 EXCLUSIONS

4.1.3 MARKET ESTIMATION CAVEATS

4.2 BASE YEAR

4.3 SCOPE OF THE STUDY

4.4 MARKET SEGMENTATION

4.4.1 MARKET SEGMENTATION BY PRODUCT

4.4.2 MARKET SEGMENTATION BY COMPANY SIZE

4.4.3 MARKET SEGMENTATION BY END-USER

4.4.4 MARKET SEGMENTATION BY SERVICE TYPE

4.4.5 MARKET SEGMENTATION BY GEOGRAPHY

5 REPORT ASSUMPTIONS & CAVEATS

5.1 KEY CAVEATS

5.2 CURRENCY CONVERSION

5.3 MARKET DERIVATION

6 MARKET AT A GLANCE

7 INTRODUCTION

7.1 OVERVIEW

7.1.1 THE NEED FOR REGULATORY AFFAIRS

7.1.2 ROLE OF REGULATORY BODIES/AGENCIES

7.1.3 REASONS TO OUTSOURCE REGULATORY AFFAIRS

8 MARKET OPPORTUNITIES & TRENDS

8.1 INCREASING DEVELOPMENT OF BIOSIMILARS, ORPHAN DRUGS, AND PERSONALIZED MEDICINES

8.2 IMPACT OF COVID-19

8.3 ADVANCEMENTS IN REGULATORY AFFAIRS SERVICES

8.4 EMERGENCE OF VIRTUAL TRIALS & VIRTUAL COMMUNICATION

9 MARKET GROWTH ENABLERS

9.1 INCREASING USE OF DIGITAL PLATFORMS/SOLUTIONS IN REGULATORY AFFAIRS

9.2 CHANGING REGULATORY LANDSCAPE

9.3 RISING DEMAND FOR FAST DRUG & MEDICAL DEVICE APPROVALS

9.4 STRICT GOVERNMENT REGULATIONS

10 MARKET RESTRAINTS

10.1 CONCERNS OVER DATA BREACHES & PRIVACY ISSUES AMONG END-USERS

10.2 DEARTH OF SKILLED PROFESSIONALS IN REGULATORY AFFAIRS OUTSOURCING

10.3 LACK OF STANDARDIZATION & MONITORING ISSUES IN REGULATORY AFFAIRS

11 MARKET LANDSCAPE

11.1 MARKET OVERVIEW

11.2 MARKET SIZE & FORECAST

11.2.1 INSIGHTS BY GEOGRAPHY

11.2.2 INSIGHTS BY PRODUCT

11.2.3 INSIGHTS BY COMPANY SIZE

11.2.4 INSIGHTS BY END-USER

11.2.5 INSIGHTS BY SERVICE TYPE

11.3 FIVE FORCES ANALYSIS

11.3.1 THREAT OF NEW ENTRANTS

11.3.2 BARGAINING POWER OF SUPPLIERS

11.3.3 BARGAINING POWER OF BUYERS

11.3.4 THREAT OF SUBSTITUTES

11.3.5 COMPETITIVE RIVALRY

12 PRODUCT

12.1 MARKET SNAPSHOT & GROWTH ENGINE

12.2 MARKET OVERVIEW

12.3 SMALL MOLECULE DRUGS

12.3.1 MARKET OVERVIEW

12.3.2 MARKET SIZE & FORECAST

12.3.3 SMALL MOLECULE DRUGS: GEOGRAPHY SEGMENTATION

12.4 BIOLOGICS

12.4.1 MARKET OVERVIEW

12.4.2 MARKET SIZE & FORECAST

12.4.3 BIOLOGICS: GEOGRAPHY SEGMENTATION

12.5 MEDICAL DEVICES

12.5.1 MARKET OVERVIEW

12.5.2 MARKET SIZE & FORECAST

12.5.3 MEDICAL DEVICES: GEOGRAPHY SEGMENTATION

12.6 OTHERS

12.6.1 MARKET OVERVIEW

12.6.2 MARKET SIZE & FORECAST

12.6.3 OTHERS: GEOGRAPHY SEGMENTATION

13 COMPANY SIZE

13.1 MARKET SNAPSHOT & GROWTH ENGINE

13.2 MARKET OVERVIEW

13.3 SMALL & MID-SIZED COMPANIES

13.3.1 MARKET OVERVIEW

13.3.2 MARKET SIZE & FORECAST

13.3.3 SMALL & MID-SIZED COMPANIES: GEOGRAPHY SEGMENTATION

13.4 LARGE-SIZED COMPANIES

13.4.1 MARKET OVERVIEW

13.4.2 MARKET SIZE & FORECAST

13.4.3 LARGE-SIZED COMPANIES: GEOGRAPHY SEGMENTATION

14 END-USER

14.1 MARKET SNAPSHOT & GROWTH ENGINE

14.2 MARKET OVERVIEW

14.3 PHARMA & BIOTECH COMPANIES

14.3.1 MARKET OVERVIEW

14.3.2 MARKET SIZE & FORECAST

14.3.3 PHARMA & BIOTECH COMPANIES: GEOGRAPHY SEGMENTATION

14.4 MEDICAL DEVICE COMPANIES

14.4.1 MARKET OVERVIEW

14.4.2 MARKET SIZE & FORECAST

14.4.3 MEDICAL DEVICE COMPANIES: GEOGRAPHY SEGMENTATION

14.5 OTHER COMPANIES

14.5.1 MARKET OVERVIEW

14.5.2 MARKET SIZE & FORECAST

14.5.3 OTHER COMPANIES: GEOGRAPHY SEGMENTATION

15 SERVICE TYPE

15.1 MARKET SNAPSHOT & GROWTH ENGINE

15.2 MARKET OVERVIEW

15.3 PRE-AUTHORIZATION

15.3.1 MARKET OVERVIEW

15.3.2 MARKET SIZE & FORECAST

15.3.3 PRE-AUTHORIZATION: GEOGRAPHY SEGMENTATION

15.4 MARKETING AUTHORIZATION

15.4.1 MARKET OVERVIEW

15.4.2 MARKET SIZE & FORECAST

15.4.3 MARKETING AUTHORIZATION: GEOGRAPHY SEGMENTATION

15.5 POST-AUTHORIZATION

15.5.1 MARKET OVERVIEW

15.5.2 MARKET SIZE & FORECAST

15.5.3 POST-AUTHORIZATION: GEOGRAPHY SEGMENTATION

16 GEOGRAPHY

16.1 MARKET SNAPSHOT & GROWTH ENGINE

16.2 GEOGRAPHIC OVERVIEW

17 NORTH AMERICA

17.1 MARKET OVERVIEW

17.2 MARKET SIZE & FORECAST

17.2.1 NORTH AMERICA: PRODUCT SEGMENTATION

17.2.2 NORTH AMERICA: COMPANY SIZE SEGMENTATION

17.2.3 NORTH AMERICA: END-USER SEGMENTATION

17.2.4 NORTH AMERICA: SERVICE TYPE SEGMENTATION

17.3 KEY COUNTRIES

17.3.1 US: MARKET SIZE & FORECAST

17.3.2 CANADA: MARKET SIZE & FORECAST

18 EUROPE

18.1 MARKET OVERVIEW

18.2 MARKET SIZE & FORECAST

18.2.1 EUROPE: PRODUCT SEGMENTATION

18.2.2 EUROPE: COMPANY SIZE SEGMENTATION

18.2.3 EUROPE: END-USER SEGMENTATION

18.2.4 EUROPE: SERVICE TYPE SEGMENTATION

18.3 KEY COUNTRIES

18.3.1 GERMANY: MARKET SIZE & FORECAST

18.3.2 FRANCE: MARKET SIZE & FORECAST

18.3.3 UK: MARKET SIZE & FORECAST

18.3.4 ITALY: MARKET SIZE & FORECAST

18.3.5 SPAIN: MARKET SIZE & FORECAST

19 APAC

19.1 MARKET OVERVIEW

19.2 MARKET SIZE & FORECAST

19.2.1 APAC: PRODUCT SEGMENTATION

19.2.2 APAC: COMPANY SIZE SEGMENTATION

19.2.3 APAC: END-USER SEGMENTATION

19.2.4 APAC: SERVICE TYPE SEGMENTATION

19.3 KEY COUNTRIES

19.3.1 JAPAN: MARKET SIZE & FORECAST

19.3.2 CHINA: MARKET SIZE & FORECAST

19.3.3 SOUTH KOREA: MARKET SIZE & FORECAST

19.3.4 INDIA: MARKET SIZE & FORECAST

19.3.5 AUSTRALIA: MARKET SIZE & FORECAST

20 LATIN AMERICA

20.1 MARKET OVERVIEW

20.2 MARKET SIZE & FORECAST

20.2.1 LATIN AMERICA: PRODUCT SEGMENTATION

20.2.2 LATIN AMERICA: COMPANY SIZE SEGMENTATION

20.2.3 LATIN AMERICA: END-USER SEGMENTATION

20.2.4 LATIN AMERICA: SERVICE TYPE SEGMENTATION

20.3 KEY COUNTRIES

20.3.1 BRAZIL: MARKET SIZE & FORECAST

20.3.2 MEXICO: MARKET SIZE & FORECAST

20.3.3 ARGENTINA: MARKET SIZE & FORECAST

21 MIDDLE EAST & AFRICA

21.1 MARKET OVERVIEW

21.2 MARKET SIZE & FORECAST

21.2.1 MIDDLE EAST & AFRICA: PRODUCT SEGMENTATION

21.2.3 MIDDLE EAST & AFRICA: COMPANY SIZE SEGMENTATION

21.2.4 MIDDLE EAST & AFRICA: END-USER SEGMENTATION

21.2.6 MIDDLE EAST & AFRICA: SERVICE TYPE SEGMENTATION

21.3 KEY COUNTRIES

21.3.1 TURKEY: MARKET SIZE & FORECAST

21.3.2 SAUDI ARABIA: MARKET SIZE & FORECAST

21.3.3 SOUTH AFRICA: MARKET SIZE & FORECAST

21.3.4 UAE: MARKET SIZE & FORECAST

22 COMPETITIVE LANDSCAPE

22.1 COMPETITION OVERVIEW

22.2 MARKET SHARE ANALYSIS

22.2.1 FREYR

22.2.2 GENPACT

22.2.3 ICON

22.2.4 IQVIA

22.2.5 LABCORP DRUG DEVELOPMENT

22.2.6 MEDPACE

22.2.7 PPD

22.2.8 PAREXEL

23 KEY COMPANY PROFILES

23.1 GENPACT

23.1.1 BUSINESS OVERVIEW

23.1.2 SERVICE OFFERINGS

23.1.3 KEY STRATEGIES

23.1.4 KEY STRENGTHS

23.1.5 KEY OPPORTUNITIES

23.2 LABCORP DRUG DEVELOPMENT

23.2.1 BUSINESS OVERVIEW

23.2.2 SERVICE OFFERINGS

23.2.3 KEY STRATEGIES

23.2.4 KEY STRENGTHS

23.2.5 KEY OPPORTUNITIES

23.3 FREYR

23.3.1 BUSINESS OVERVIEW

23.3.2 SERVICE OFFERINGS

23.3.3 KEY STRATEGIES

23.3.4 KEY STRENGTHS

23.3.5 KEY OPPORTUNITIES

23.4 ICON

23.4.1 BUSINESS OVERVIEW

23.4.2 SERVICE OFFERINGS

23.4.3 KEY STRATEGIES

23.4.4 KEY STRENGTHS

23.4.5 KEY OPPORTUNITIES

23.5 IQVIA

23.5.1 BUSINESS OVERVIEW

23.5.2 SERVICE OFFERINGS

23.5.3 KEY STRATEGIES

23.5.4 KEY STRENGTHS

23.5.5 KEY OPPORTUNITIES

23.6 MEDPACE

23.6.1 BUSINESS OVERVIEW

23.6.2 SERVICE OFFERINGS

23.6.3 KEY STRATEGIES

23.6.4 KEY STRENGTHS

23.6.5 KEY OPPORTUNITIES

23.7 PAREXEL INTERNATIONAL

23.7.1 BUSINESS OVERVIEW

23.7.2 SERVICE OFFERINGS

23.7.3 KEY STRATEGIES

23.7.4 KEY STRENGTHS

23.7.5 KEY OPPORTUNITIES

23.8 PPD

23.8.1 BUSINESS OVERVIEW

23.8.2 SERVICE OFFERINGS

23.8.3 KEY STRATEGIES

23.8.4 KEY STRENGTHS

23.8.5 KEY OPPORTUNITIES

24 OTHER PROMINENT VENDORS

24.1 ACCENTURE

24.1.1 BUSINESS OVERVIEW

24.1.2 SERVICE OFFERINGS

24.2 BLUEREG

24.2.1 BUSINESS OVERVIEW

24.2.2 SERVICE OFFERINGS

24.3 INTERTEK GROUP

24.3.1 BUSINESS OVERVIEW

24.3.2 SERVICE OFFERINGS

24.4 LACHMAN CONSULTANTS

24.4.1 BUSINESS OVERVIEW

24.4.2 SERVICE OFFERINGS

24.5 NDA GROUP

24.5.1 BUSINESS OVERVIEW

24.5.2 SERVICE OFFERINGS

24.6 PROPHARMA GROUP

24.6.1 BUSINESS OVERVIEW

24.6.2 SERVICE OFFERINGS

24.7 PHARMALEX

24.7.1 BUSINESS OVERVIEW

24.7.2 SERVICE OFFERINGS

24.8 PHARMEXON

24.8.1 BUSINESS OVERVIEW

24.8.2 SERVICE OFFERINGS

24.9 PROMEDICA INTERNATIONAL

24.9.1 BUSINESS OVERVIEW

24.9.2 SERVICE OFFERINGS

24.10 CRITERIUM

24.10.1 BUSINESS OVERVIEW

24.10.2 SERVICE OFFERINGS

24.11 DICENTRA

24.11.1 BUSINESS OVERVIEW

24.11.2 SERVICE OFFERINGS

24.12 NUVENTRA PHARMA SCIENCES

24.12.1 BUSINESS OVERVIEW

24.12.2 SERVICE OFFERINGS

24.13 PHARMALEAF

24.13.1 BUSINESS OVERVIEW

24.13.2 SERVICE OFFERINGS

24.14 MAVEN REGULATORY SOLUTIONS

24.14.1 BUSINESS OVERVIEW

24.14.2 SERVICE OFFERINGS

24.15 GLOBAL REGULATORY PARTNERS

24.15.1 BUSINESS OVERVIEW

24.15.2 SERVICE OFFERINGS

24.16 SOFPROMED

24.16.1 BUSINESS OVERVIEW

24.16.2 SERVICE OFFERINGS

24.17 CHARLES RIVER LABORATORIES

24.17.1 BUSINESS OVERVIEW

24.17.2 SERVICE OFFERINGS

24.18 CAMBRIDGE REGULATORY SERVICES

24.18.1 BUSINESS OVERVIEW

24.18.2 SERVICE OFFERINGS

24.19 APC GROUP

24.19.1 BUSINESS OVERVIEW

24.19.2 SERVICE OFFERINGS

24.20 REAL REGULATORY

24.20.1 BUSINESS OVERVIEW

24.20.2 SERVICE OFFERINGS

24.21 VOISIN CONSULTING LIFE SCIENCES (VCLS)

24.21.1 BUSINESS OVERVIEW

24.21.2 SERVICE OFFERINGS

24.22 REGULATORY PHARMA NET

24.22.1 BUSINESS OVERVIEW

24.22.2 SERVICE OFFERINGS

24.23 BIOMAPAS

24.23.1 BUSINESS OVERVIEW

24.23.2 SERVICE OFFERINGS

24.24 REGENOLD

24.24.1 BUSINESS OVERVIEW

24.24.2 SERVICE OFFERINGS

25 REPORT SUMMARY

25.1 KEY TAKEAWAYS

25.2 STRATEGIC RECOMMENDATIONS

26 QUANTITATIVE SUMMARY

26.1 MARKET BY PRODUCT

26.1.1 NORTH AMERICA: PRODUCT SEGMENTATION

26.1.2 EUROPE: PRODUCT SEGMENTATION

26.1.3 APAC: PRODUCT SEGMENTATION

26.1.4 LATIN AMERICA: PRODUCT SEGMENTATION

26.1.5 MIDDLE EAST & AFRICA: PRODUCT SEGMENTATION

26.2 MARKET BY COMPANY SIZE

26.2.1 NORTH AMERICA: COMPANY SIZE SEGMENTATION

26.2.2 EUROPE: COMPANY SIZE SEGMENTATION

26.2.3 APAC: COMPANY SIZE SEGMENTATION

26.2.4 LATIN AMERICA: COMPANY SIZE SEGMENTATION

26.2.5 MIDDLE EAST & AFRICA: COMPANY SIZE SEGMENTATION

26.3 MARKET BY END-USER

26.3.1 NORTH AMERICA: END-USER SEGMENTATION

26.3.2 EUROPE: END-USER SEGMENTATION

26.3.3 APAC: END-USER SEGMENTATION

26.3.4 LATIN AMERICA: END-USER SEGMENTATION

26.3.5 MIDDLE EAST & AFRICA: END-USER SEGMENTATION

26.4 MARKET BY SERVICE TYPE

26.4.1 NORTH AMERICA: SERVICE TYPE SEGMENTATION

26.4.2 EUROPE: SERVICE TYPE SEGMENTATION

26.4.3 APAC: SERVICE TYPE SEGMENTATION

26.4.4 LATIN AMERICA: SERVICE TYPE SEGMENTATION

26.4.5 MIDDLE EAST & AFRICA: SERVICE TYPE SEGMENTATION

26.5 MARKET BY GEOGRAPHY

26.5.1 DRUGS: GEOGRAPHY SEGMENTATION

26.5.2 BIOLOGICS: GEOGRAPHY SEGMENTATION

26.5.3 MEDICAL DEVICES: GEOGRAPHY SEGMENTATION

26.5.4 OTHERS: GEOGRAPHY SEGMENTATION

26.5.5 SMALL & MID-SIZED COMPANIES: GEOGRAPHY SEGMENTATION

26.5.6 LARGE-SIZED COMPANIES: GEOGRAPHY SEGMENTATION

26.5.7 PHARMA & BIOTECH COMPANIES: GEOGRAPHY SEGMENTATION

26.5.8 MEDICAL DEVICE COMPANIES: GEOGRAPHY SEGMENTATION

26.5.9 OTHER COMPANIES: GEOGRAPHY SEGMENTATION

26.5.10 PRE-AUTHORIZATION: GEOGRAPHY SEGMENTATION

26.5.11 MARKETING AUTHORIZATION: GEOGRAPHY SEGMENTATION

26.5.12 POST-AUTHORIZATION: GEOGRAPHY SEGMENTATION

27 APPENDIX

27.1 ABBREVIATIONS

LIST OF EXHIBITS

EXHIBIT 1 SEGMENTATION OF GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET

EXHIBIT 2 MARKET SIZE CALCULATION APPROACH 2021

EXHIBIT 3 ROLES OR INTERACTIONS OF RA

EXHIBIT 4 IMPACT OF INCREASING DEVELOPMENT OF BIOSIMILARS, ORPHAN DRUGS, AND PERSONALIZED MEDICINES

EXHIBIT 5 IMPACT OF COVID-19

EXHIBIT 6 LEVERAGING CLOUD TECHNOLOGY FOR REGULATORY AFFAIRS OUTSOURCING

EXHIBIT 7 OUTSOURCING IN REGULATORY AFFAIRS

EXHIBIT 8 IMPACT OF ADVANCEMENTS IN REGULATORY AFFAIRS SERVICES

EXHIBIT 9 IMPACT OF EMERGENCE OF VIRTUAL TRIALS & VIRTUAL COMMUNICATION

EXHIBIT 10 IMPACT OF INCREASING USE OF DIGITAL PLATFORMS /SOLUTIONS IN REGULATORY AFFAIRS

EXHIBIT 11 IMPACT OF CHANGING REGULATORY LANDSCAPE

EXHIBIT 12 IMPACT OF RISING DEMAND FOR FAST DRUG & MEDICAL DEVICE APPROVALS

EXHIBIT 13 IMPACT OF STRICT GOVERNMENT REGULATIONS

EXHIBIT 14 IMPACT OF CONCERNS OVER DATA BREACHES & PRIVACY ISSUES AMONG END-USERS

EXHIBIT 15 IMPACT OF DEARTH OF SKILLED PROFESSIONALS IN REGULATORY AFFAIRS OUTSOURCING

EXHIBIT 16 IMPACT OF LACK OF STANDARDIZATION & MONITORING ISSUES IN REGULATORY AFFAIRS

EXHIBIT 17 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET 2021–2027 ($ MILLION)

EXHIBIT 18 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY

EXHIBIT 19 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT

EXHIBIT 20 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE

EXHIBIT 21 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER

EXHIBIT 22 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE

EXHIBIT 23 FIVE FORCES ANALYSIS 2021

EXHIBIT 24 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 25 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT

EXHIBIT 26 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT: INCREMENTAL GROWTH

EXHIBIT 27 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT: ABSOLUTE GROWTH

EXHIBIT 28 FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA (FSSAI) REGULATIONS FOR THE FOLLOWING CATEGORIES OF FUNCTIONAL FOODS

EXHIBIT 29 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SMALL MOLECULE DRUGS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 30 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SMALL MOLECULE DRUGS 2021–2027 ($ MILLION)

EXHIBIT 31 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 32 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY BIOLOGICS: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 33 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY BIOLOGICS 2021–2027 ($ MILLION)

EXHIBIT 34 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 35 USFDA MEDICAL DEVICE CLASSIFICATION

EXHIBIT 36 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 37 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE MARKET 2021–2027 ($ MILLION)

EXHIBIT 38 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 39 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER PRODUCTS MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 40 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER PRODUCTS MARKET 2021–2027 ($ MILLION)

EXHIBIT 41 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 42 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 43 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE

EXHIBIT 44 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE: INCREMENTAL GROWTH

EXHIBIT 45 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE: ABSOLUTE GROWTH

EXHIBIT 46 GLOBAL REGULATORY AFFAIRS OUTSOURCING SMALL & MID-SIZED COMPANIES MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 47 GLOBAL REGULATORY AFFAIRS OUTSOURCING SMALL & MID-SIZED COMPANIES MARKET 2021–2027 ($ MILLION)

EXHIBIT 48 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 49 GLOBAL REGULATORY AFFAIRS OUTSOURCING LARGE-SIZED COMPANIES MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 50 GLOBAL REGULATORY AFFAIRS OUTSOURCING LARGE-SIZED COMPANIES MARKET 2021–2027 ($ MILLION)

EXHIBIT 51 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 52 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 53 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER

EXHIBIT 54 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER: INCREMENTAL GROWTH

EXHIBIT 55 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER: ABSOLUTE GROWTH

EXHIBIT 56 GLOBAL REGULATORY AFFAIRS OUTSOURCING PHARMA & BIOTECH COMPANIES MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 57 GLOBAL REGULATORY AFFAIRS OUTSOURCING PHARMA & BIOTECH COMPANIES MARKET 2021–2027 ($ MILLION)

EXHIBIT 58 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 59 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE COMPANIES MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 60 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE COMPANIES MARKET 2021–2027 ($ MILLION)

EXHIBIT 61 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 62 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER COMPANIES MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 63 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER COMPANIES MARKET 2021–2027 ($ MILLION)

EXHIBIT 64 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 65 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 66 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE

EXHIBIT 67 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE: INCREMENTAL GROWTH

EXHIBIT 68 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE: ABSOLUTE GROWTH

EXHIBIT 69 GLOBAL REGULATORY AFFAIRS OUTSOURCING PRE-AUTHORIZATION MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 70 GLOBAL REGULATORY AFFAIRS OUTSOURCING PRE-AUTHORIZATION MARKET 2021–2027 ($ MILLION)

EXHIBIT 71 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 72 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKETING AUTHORIZATION MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 73 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKETING AUTHORIZATION MARKET 2021–2027 ($ MILLION)

EXHIBIT 74 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 75 PRODUCT LIFECYCLE MANAGEMENT SERVICE

EXHIBIT 76 GLOBAL REGULATORY AFFAIRS OUTSOURCING POST-AUTHORIZATION MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 77 GLOBAL REGULATORY AFFAIRS OUTSOURCING POST-AUTHORIZATION MARKET 2021–2027 ($ MILLION)

EXHIBIT 78 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 79 INCREMENTAL GROWTH BY GEOGRAPHY 2021 & 2027

EXHIBIT 80 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY

EXHIBIT 81 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY: KEY COUNTRIES ($ MILLION)

EXHIBIT 82 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY: INCREMENTAL GROWTH

EXHIBIT 83 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY: ABSOLUTE GROWTH

EXHIBIT 84 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET: KEY COUNTRIES

EXHIBIT 85 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 86 REGULATORY AFFAIRS OUTSOURCING MARKET IN NORTH AMERICA 2021–2027 ($ MILLION)

EXHIBIT 87 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 88 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 89 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 90 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 91 INCREMENTAL GROWTH IN NORTH AMERICA 2021 & 2027

EXHIBIT 92 ELDERLY POPULATION AGED OVER 65 YEARS IN THE US ($ MILLION)

EXHIBIT 93 NUMBER OF APPROVED AND LAUNCHED BIOSIMILARS IN THE US

EXHIBIT 94 US FDA’S BIOSIMILAR DEVELOPMENT PROGRAMS

EXHIBIT 95 REGULATORY AFFAIRS OUTSOURCING MARKET IN THE US 2021–2027 ($ MILLION)

EXHIBIT 96 REGULATORY AFFAIRS OUTSOURCING MARKET IN CANADA 2021–2027 ($ MILLION)

EXHIBIT 97 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET: KEY COUNTRIES

EXHIBIT 98 BIOLOGICS AND NON-BIOLOGICS DEVELOPMENT IN EUROPE

EXHIBIT 99 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 100 REGULATORY AFFAIRS OUTSOURCING MARKET IN EUROPE 2021–2027 ($ MILLION)

EXHIBIT 101 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 102 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 103 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 104 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 105 INCREMENTAL GROWTH IN EUROPE 2021 & 2027

EXHIBIT 106 AGING POPULATION IN GERMANY (MILLION)

EXHIBIT 107 REGULATORY AFFAIRS OUTSOURCING MARKET IN GERMANY 2021–2027 ($ MILLION)

EXHIBIT 108 REGULATORY AFFAIRS OUTSOURCING MARKET IN FRANCE 2021–2027 ($ MILLION)

EXHIBIT 109 REGULATORY AFFAIRS OUTSOURCING MARKET IN THE UK 2021–2027 ($ MILLION)

EXHIBIT 110 REGULATORY AFFAIRS OUTSOURCING MARKET IN ITALY 2021–2027 ($ MILLION)

EXHIBIT 111 MARKETING AUTHORIZATION PATHWAY IN SPAIN

EXHIBIT 112 REGULATORY AFFAIRS OUTSOURCING MARKET IN SPAIN 2021–2027 ($ MILLION)

EXHIBIT 113 APAC REGULATORY AFFAIRS OUTSOURCING MARKET: KEY COUNTRIES

EXHIBIT 114 APAC REGULATORY AFFAIRS OUTSOURCING MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 115 REGULATORY AFFAIRS OUTSOURCING MARKET IN APAC 2021–2027 ($ MILLION)

EXHIBIT 116 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 117 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 118 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 119 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 120 INCREMENTAL GROWTH IN APAC 2021 & 2027

EXHIBIT 121 PMDA’S SAFETY TRIANGLE

EXHIBIT 122 REGULATORY AFFAIRS OUTSOURCING MARKET IN JAPAN 2021–2027 ($ MILLION)

EXHIBIT 123 REGULATORY AFFAIRS OUTSOURCING MARKET IN CHINA 2021–2027 ($ MILLION)

EXHIBIT 124 SOUTH KOREA’S TOP CAUSES OF DEATHS PER 100,000 PEOPLE IN 2020

EXHIBIT 125 REGULATORY AFFAIRS OUTSOURCING MARKET IN SOUTH KOREA 2021–2027 ($ MILLION)

EXHIBIT 126 REGULATORY AFFAIRS OUTSOURCING MARKET IN INDIA 2021–2027 ($ MILLION)

EXHIBIT 127 PER CAPITA HEALTHCARE EXPENDITURE IN AUSTRALIA ($)

EXHIBIT 128 REGULATORY AFFAIRS OUTSOURCING MARKET IN AUSTRALIA 2021–2027 ($ MILLION)

EXHIBIT 129 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET: KEY COUNTRIES

EXHIBIT 130 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 131 DRUG PRODUCT REGULATORY HEALTH AUTHORITIES

EXHIBIT 132 REGULATORY AFFAIRS OUTSOURCING MARKET IN LATIN AMERICA 2021–2027 ($ MILLION)

EXHIBIT 133 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 134 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 135 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 136 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 137 INCREMENTAL GROWTH IN LATIN AMERICA 2021 & 2027

EXHIBIT 138 POPULATION AGED 65 AND ABOVE IN BRAZIL (MILLION)

EXHIBIT 139 REGULATORY AFFAIRS OUTSOURCING MARKET IN BRAZIL 2021–2027 ($ MILLION)

EXHIBIT 140 REGULATORY AFFAIRS OUTSOURCING MARKET IN MEXICO 2021–2027 ($ MILLION)

EXHIBIT 141 POPULATION AGED 65 AND ABOVE IN ARGENTINA (% OF TOTAL POPULATION)

EXHIBIT 142 REGULATORY AFFAIRS OUTSOURCING MARKET IN ARGENTINA 2021–2027 ($ MILLION)

EXHIBIT 143 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET: KEY COUNTRIES 2021

EXHIBIT 144 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET: INCREMENTAL & ABSOLUTE GROWTH

EXHIBIT 145 CHALLENGES WITH FUNCTIONAL FOOD REGULATION IN THE MIDDLE EAST & AFRICA

EXHIBIT 146 REGULATORY AFFAIRS OUTSOURCING MARKET IN THE MIDDLE EAST & AFRICA 2021–2027 ($ MILLION)

EXHIBIT 147 INCREMENTAL GROWTH BY PRODUCT 2021 & 2027

EXHIBIT 148 INCREMENTAL GROWTH BY COMPANY SIZE 2021 & 2027

EXHIBIT 149 INCREMENTAL GROWTH BY END-USER 2021 & 2027

EXHIBIT 150 INCREMENTAL GROWTH BY SERVICE TYPE 2021 & 2027

EXHIBIT 151 INCREMENTAL GROWTH IN THE MIDDLE EAST & AFRICA 2021 & 2027

EXHIBIT 152 POPULATION AGED 65 YEARS AND ABOVE IN TURKEY (% OF TOTAL POPULATION)

EXHIBIT 153 REGULATORY AFFAIRS OUTSOURCING MARKET IN TURKEY 2021–2027 ($ MILLION)

EXHIBIT 154 REGULATORY AFFAIRS OUTSOURCING MARKET IN SAUDI ARABIA 2021–2027 ($ MILLION)

EXHIBIT 155 POPULATION AGED 60 AND ABOVE IN SOUTH AFRICA (% TOTAL POPULATION)

EXHIBIT 156 REGULATORY AFFAIRS OUTSOURCING MARKET IN SOUTH AFRICA 2021–2027 ($ MILLION)

EXHIBIT 157 REGULATORY AFFAIRS OUTSOURCING MARKET IN THE UAE 2021–2027 ($ MILLION)

EXHIBIT 158 GENPACT: TOTAL REVENUE 2018-2020 ($ MILLION)

EXHIBIT 159 GENPACT: REVENUE SHARE BY BUSINESS SEGMENTS 2020 (%)

EXHIBIT 160 GENPACT: REVENUE SHARE BY GEOGRAPHY 2020 (%)

EXHIBIT 161 LABCORP DRUG DEVELOPMENT: TOTAL REVENUE 2018–2020 ($ MILLION)

EXHIBIT 162 LABCORP DRUG DEVELOPMENT: REVENUE BY BUSINESS SEGMENTS 2020 (%)

EXHIBIT 163 LABCORP DRUG DEVELOPMENT: REVENUE BY GEOGRAPHY 2020 (%)

EXHIBIT 164 ICON: TOTAL REVENUE 2018–2020 ($ MILLION)

EXHIBIT 165 ICON: REVENUE BY GEOGRAPHY 2020 (%)

EXHIBIT 166 IQVIA: TOTAL REVENUE 2018–2020 ($ MILLION)

EXHIBIT 167 IQVIA: REVENUE SHARE BY GEOGRAPHY 2020 (%)

EXHIBIT 168 IQVIA: REVENUE BY BUSINESS SEGMENTS 2020 (%)

EXHIBIT 169 MEDPACE: TOTAL REVENUE 2018–2020 ($ MILLION)

EXHIBIT 170 MEDPACE: REVENUE SHARE BY CATEGORY 2020 (%)

LIST OF TABLES

TABLE 1 KEY CAVEATS

TABLE 2 CURRENCY CONVERSION 2015−2021

TABLE 3 MAJOR REGULATORY AUTHORITY IN DIFFERENT COUNTRIES

TABLE 4 LIST OF MAJOR BIOLOGICS & BIOSIMILARS

TABLE 5 TOP 10 PHARMA & BIOTECH COMPANIES BY REVENUE 2020

TABLE 6 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 7 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 8 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 9 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 10 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 11 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 12 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 13 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 14 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 15 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 16 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 17 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 18 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 19 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 20 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 21 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 22 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 23 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 24 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 25 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 26 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 27 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 28 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 29 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 30 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 31 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 32 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 33 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 34 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 35 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 36 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 37 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 38 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 39 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 40 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 41 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 42 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 43 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 44 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 45 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 46 GENPACT: MAJOR SERVICE OFFERINGS

TABLE 47 LABCORP DRUG DEVELOPMENT: MAJOR SERVICE OFFERINGS

TABLE 48 FREYR: MAJOR SERVICE OFFERINGS

TABLE 49 ICON: MAJOR SERVICE OFFERINGS

TABLE 50 IQVIA: MAJOR SERVICE OFFERINGS

TABLE 51 MEDPACE: MAJOR PRODUCT OFFERINGS

TABLE 52 PAREXEL INTERNATIONAL: MAJOR PRODUCT OFFERINGS

TABLE 53 PPD: MAJOR PRODUCT OFFERINGS

TABLE 54 ACCENTURE: MAJOR SERVICE OFFERINGS

TABLE 55 BLUEREG: MAJOR SERVICE OFFERINGS

TABLE 56 INTERTEK GROUP: MAJOR SERVICE OFFERINGS

TABLE 57 LACHMAN CONSULTANTS: MAJOR SERVICE OFFERINGS

TABLE 58 NDA GROUP: MAJOR SERVICE OFFERINGS

TABLE 59 PROPHARMA GROUP: MAJOR SERVICE OFFERINGS

TABLE 60 PHARMALEX: MAJOR SERVICE OFFERINGS

TABLE 61 PHARMEXON: MAJOR SERVICE OFFERINGS

TABLE 62 PROMEDICA INTERNATIONAL: MAJOR SERVICE OFFERINGS

TABLE 63 CRITERIUM: MAJOR SERVICE OFFERINGS

TABLE 64 DICENTRA: MAJOR SERVICE OFFERINGS

TABLE 65 NUVENTRA PHARMA SCIENCES: MAJOR SERVICE OFFERINGS

TABLE 66 PHARMALEAF: MAJOR SERVICE OFFERINGS

TABLE 67 MAVEN REGULATORY SOLUTIONS: MAJOR SERVICE OFFERINGS

TABLE 68 GLOBAL REGULATORY PARTNERS: MAJOR SERVICE OFFERINGS

TABLE 69 SOFPROMED: MAJOR SERVICE OFFERINGS

TABLE 70 CHARLES RIVER LABORATORIES: MAJOR SERVICE OFFERINGS

TABLE 71 CAMBRIDGE REGULATORY SERVICES: MAJOR SERVICE OFFERINGS

TABLE 72 APC GROUP: MAJOR SERVICE OFFERINGS

TABLE 73 REAL REGULATORY: MAJOR SERVICE OFFERINGS

TABLE 74 VOISIN CONSULTING LIFE SCIENCES (VCLS): MAJOR SERVICE OFFERINGS

TABLE 75 REGULATORY PHARMA NET: MAJOR SERVICE OFFERINGS

TABLE 76 BIOMAPAS: MAJOR SERVICE OFFERINGS

TABLE 77 REGENOLD: MAJOR SERVICE OFFERINGS

TABLE 78 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 79 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 80 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 81 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 82 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 83 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 84 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 85 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 86 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 87 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 88 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 ($ MILLION)

TABLE 89 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY PRODUCT 2021−2027 (%)

TABLE 90 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 91 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 92 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 93 NORTH AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 94 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 95 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 96 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 97 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 98 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 99 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 100 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 ($ MILLION)

TABLE 101 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY COMPANY SIZE 2021−2027 (%)

TABLE 102 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 103 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 104 REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 105 REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 106 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 107 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 108 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 109 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 110 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 111 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 112 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 ($ MILLION)

TABLE 113 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY END-USER 2021−2027 (%)

TABLE 114 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 115 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 116 REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 117 REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 118 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 119 EUROPE REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 120 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 121 APAC REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 122 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 123 LATIN AMERICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 124 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 ($ MILLION)

TABLE 125 MIDDLE EAST & AFRICA REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICE TYPE 2021−2027 (%)

TABLE 126 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY 2021−2027 ($ MILLION)

TABLE 127 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY 2021−2027 (%)

TABLE 128 GLOBAL REGULATORY AFFAIRS OUTSOURCING DRUGS MARKET 2021−2027 ($ MILLION)

TABLE 129 GLOBAL REGULATORY AFFAIRS OUTSOURCING DRUGS MARKET 2021−2027 (%)

TABLE 130 GLOBAL REGULATORY AFFAIRS OUTSOURCING BIOLOGICS MARKET 2021−2027 ($ MILLION)

TABLE 131 GLOBAL REGULATORY AFFAIRS OUTSOURCING BIOLOGICS MARKET 2021−2027 (%)

TABLE 132 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICES MARKET 2021−2027 ($ MILLION)

TABLE 133 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICES MARKET 2021−2027 (%)

TABLE 134 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER PRODUCTS MARKET 2021−2027 ($ MILLION)

TABLE 135 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER PRODUCTS MARKET 2021−2027 (%)

TABLE 136 GLOBAL REGULATORY AFFAIRS OUTSOURCING SMALL & MID-SIZED COMPANIES MARKET 2021−2027 ($ MILLION)

TABLE 137 GLOBAL REGULATORY AFFAIRS OUTSOURCING SMALL & MID-SIZED COMPANIES MARKET 2021−2027 (%)

TABLE 138 GLOBAL REGULATORY AFFAIRS OUTSOURCING LARGE-SIZED COMPANIES MARKET 2021−2027 ($ MILLION)

TABLE 139 GLOBAL REGULATORY AFFAIRS OUTSOURCING LARGE-SIZED COMPANIES MARKET 2021−2027 (%)

TABLE 140 GLOBAL REGULATORY AFFAIRS OUTSOURCING PHARMA & BIOTECH COMPANIES MARKET 2021−2027 ($ MILLION)

TABLE 141 GLOBAL REGULATORY AFFAIRS OUTSOURCING PHARMA & BIOTECH COMPANIES MARKET 2021−2027 (%)

TABLE 142 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE COMPANIES MARKET 2021−2027 ($ MILLION)

TABLE 143 GLOBAL REGULATORY AFFAIRS OUTSOURCING MEDICAL DEVICE COMPANIES MARKET 2021−2027 (%)

TABLE 144 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER COMPANIES MARKET 2021−2027 ($ MILLION)

TABLE 145 GLOBAL REGULATORY AFFAIRS OUTSOURCING OTHER COMPANIES MARKET 2021−2027 (%)

TABLE 146 GLOBAL REGULATORY AFFAIRS OUTSOURCING PRE-AUTHORIZATION MARKET 2021−2027 ($ MILLION)

TABLE 147 GLOBAL REGULATORY AFFAIRS OUTSOURCING PRE-AUTHORIZATION MARKET 2021−2027 (%)

TABLE 148 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKETING AUTHORIZATION MARKET 2021−2027 ($ MILLION)

TABLE 149 GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKETING AUTHORIZATION MARKET 2021−2027 (%)

TABLE 150 GLOBAL REGULATORY AFFAIRS OUTSOURCING POST-AUTHORIZATION MARKET 2021−2027 ($ MILLION)

TABLE 151 GLOBAL REGULATORY AFFAIRS OUTSOURCING POST-AUTHORIZATION MARKET 2021−2027 (%)

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