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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.
This report includes market data points, ranging from trend
analyses to market estimates & forecasts that you can customize
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 OVERVIEW
The global regulatory affairs outsourcing market is expected to reach $16.8 billion by 2027, growing at a CAGR of 12.73%. Regulatory Affairs 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). Most companies have a dedicated department with regulatory expertise, whether a large multinational pharmaceutical company or a small, innovative biotechnology company. Regulatory affairs outsourcing services are growing rapidly due to pharma/biotech and medical device companies. With increasing drug pipelines, product registrations, clinical trials, and R&D activities, these companies are constantly pressured to obtain timely marketing/clinical approval from regulators in the various regions in which they operate.
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 authorities will accelerate innovations that make healthcare products more effective, safe, and affordable and provide the public with the accurate, scientific information needed to maintain and improve healthcare products and foods.
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
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 technology 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 been updated on all changes in regulatory affairs in the pharmaceutical or medical device industry. Thus, pharmaceutical and medical device companies are increasingly outsourcing their activities to CROs.
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, 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 around 63.73% of the global regulatory affairs outsourcing market share. 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 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 market with around 33% of the market share. The US is the major revenue contributor to the North American market and accounted for around 91% in 2021. The region's growth is primarily attributed to the increasing number of chronic diseases, the development of biologics & biosimilars, increasing healthcare expenditures, and increasing innovation & advancements in the market.
Frequently Asked Questions
What will be the size of the Regulatory Affairs Outsourcing Market by 2028?
What are the factors driving the market growth?
Who are the key vendors in the regulatory affairs outsourcing industry?
Which region holds the highest growth rate in the regulatory affairs outsourcing industry?
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 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
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 (%)
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
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- Free 15% or 4.5 days of customization
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- Free Datasheet worth $1500
- Report accessible by the entire organization
- Free 20% or 6 days of customization
- Free post-sale service assistance
- Continuous support through email and telephone
- Direct access to lead analysts
- Free analyst hour
- Free Upgrade: If an updated report published within 180 days of purchase, you will get the revised report free of charge
Datasheet Licence
- Report accessible by 1 user only
- Free 15% or 32 hours of customization
- Free post-sale service assistance
- Direct access to lead analysts
Frequently Asked Questions
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