Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Services, By Category (Pharmaceuticals, Medical Devices), By Company Size, By Indication, By Product Stage, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Research Methodology

A three-pronged approach was followed for deducing the regulatory affairs outsourcing market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for regulatory affairs outsourcing market to gather the most reliable and current information possible.

• We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
• We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
• We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
• We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
• We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of regulatory affairs outsourcing market data depending on the type of information we’re trying to uncover in our research.

• Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

• Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

• Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

• Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

• Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

• Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

• This step also entails the finalization of the report scope and data representation pattern.

• Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Regulatory Affairs Outsourcing Market Categorization:

The regulatory affairs outsourcing market was categorized into seven segments, namely services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Regulatory Submission, Regulatory Operations), company size (Small, Medium, Large), category (Pharmaceuticals, Medical Device), indication (Oncology, Neurology, Cardiology, Immunology), stage (Preclinical, Clinical, Post Market Authorization), end-use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Segment Market Methodology:

The regulatory affairs outsourcing market was segmented into services, company size, category, indication, stage, end-use, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

• Demand estimation of each product across countries/regions summed up to from the total market.

• Variable analysis for demand forecast.

• Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

• Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

• Used extensively for new product forecasting or analyzing penetration levels.

• Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

• Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

• This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The regulatory affairs outsourcing market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into thirty-eight countries, namely, the U.S.; Canada; the UK; Germany; France; Italy; Spain; Russia; Turkey; Netherlands; Switzerland; Sweden; Europe CIS Countries; Japan; China; India; Australia; South Korea; Indonesia; Malaysia; Singapore; Thailand; Taiwan; CIS Countries; Brazil; Mexico; Argentina; Colombia; Chile; South Africa; Saudi Arabia; UAE; Egypt; Israel.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Regulatory affairs outsourcing market companies & financials:

The regulatory affairs outsourcing market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

• Accell Clinical Research, LLC. - Accell Clinical Research, LLC is a privately held international Clinical Research Organization (CRO). It majorly operates in the domestic market, although it also offers services to countries, such as the U.S. Baltic states and Ukraine. The company serves industry participants, such as biotech & pharma producers, manufacturers of nutrition products, and medical device manufacturers. Their U.S. office focuses on biopharmaceutical end-users. The regulatory services have been part of their portfolio since 2014. The company offers services, such as regulatory support, quality assurance, project management, authorization procurement, and clinical supply management. It provides services that comply with local and ICH-GCP guidelines.

• GenPact Ltd. - Genpact is an international service provider that drives digitally enabled intelligent and digital-led innovation operations for clients, guided by their experience in running thousands of processes for over hundreds of Global Fortune 500 companies. The company operates through various segments that include: healthcare, high tech, life sciences, insurance, commercial banking, retail banking, capital markets, and industrial manufacturing. It serves more than 750 clients across more than 70 countries. The company has 9 operating centers in the U.S., 14 in Europe, and 4 in Japan & Australia. However, Genpact is into pharmaceutical services is gradually trying to enter medical devices market. Its subsidiary Genpact Regulatory Affairs Ltd. is located in the UK. The company enters into various strategic alliances with companies, such as Hitachi and Pharmalink, to increase its product offerings.

• Criterium, Inc. - Criterium, Inc. is a renowned clinical research organization that provides regulatory consultancy and clinical trial services. In 2012, it ventured into the Indian market to deliver in-country services. They also have presence in countries, such as Mexico, South Africa, Israel, and Russia. The company provides Interactive Voice Response (IVR) services for ensuring higher control and efficiency in clinical studies. The firm’s Oncology Consortia focuses on translational research to develop new cancer therapies.

• Promedica International - Promedica International is a privately held company providing regulatory and clinical expertise services to biotechnology, pharmaceutical, and medical device companies. The company offers services, such as clinical study management, strategic consulting, medical writing, research compliance & education, and data management. Regulatory services include training programs on good clinical practices, development of clinical Standard Operating Procedures (SOP), and FDA audit support service.

• WuXi AppTec, Inc. - WuXi AppTec offers an open-access technology platform for medical devices, biopharmaceutical, & pharmaceutical companies with operations in China and the U.S. The company offering includes discovery & development service. Discovery service comprises of discovery chemistry, discovery biology, pharmacology, safety pharmacology, pharmacokinetics, and bioanalysis. Development services include analytical development, commercial manufacturing, and pharmaceutical development. The company also provides preclinical services like toxicology testing, safety pharmacology and bioanalysis. WuXi AppTec. operates as a subsidiary of WuXi PharmaTech (Cayman) Inc. The company also many other subsidiaries through which they cater to specific geographies or categories. For instance, Wuxi Biologics offers regulatory affairs service for Biologics in China.

• Medpace - Medpace is contract research organization that provides clinical development services for pharmaceutical, biologics, and medical device companies. The company’s clinical development services include management of medical & global regulatory affairs, clinical trial management, medical writing, pharmacovigilance, and core laboratory & quality assurance services. The company’s regulatory affairs services include regulatory strategies for early stage development and regulatory writing for clinical studies. It also provides regulatory approval services and post-market support services, such as literature reviews, clinical study reports, market approvals, vigilance writing, and post-market registries.

• Charles River Laboratories International, Inc. - Charles River Laboratories International, Inc. (Criver) is the provider of clinical laboratory services and preclinical services for pharmaceutical, and biotechnology industries. Charles operates through three segments: Research Models and Services (RMS), Discovery and Safety Assessment (DSA), and Manufacturing Support. Its DSA segment offerings include bioanalysis, drug metabolism, toxicology, and pharmacokinetics services. It caters its product & services to biotechnology & pharmaceutical companies, medical device companies, hospitals, clinics, and academic institutions.

• ICON Plc - ICON Plc offers its services to biotechnological, pharmaceutical, government, and public health organizations. It is recognized as the world’s leading provider for contract research organization services. The company operates across 99 locations in 40 countries. In addition, it offers consulting, development, and commercialization services to pharmaceutical industries. ICON plc specializes in the management and analysis of programs that support clinical development.

• Covance, Inc. - Covance, Inc. is a global contract research organization and offers a vast list of services inclusive of regulatory affairs. Covance drug development includes all the preclinical and clinical Services of discovery and development phase. Services provided by the company are research models, analysis, lead optimization, clinical testing & development, commercialization, and pharmaceutical consulting. The company has presence in around 60 countries. In February 2015, the company was acquired by LabCorp. of American Holdings.

• PAREXEL International Corporation, Inc. - PAREXEL International Corporation offers services, such as clinical research, medical communications, consulting, advanced technology products & services, and commercialization. These services are used by pharmaceutical, medical device, and biotechnological companies globally. The company operates in three segments, namely PAREXEL Consulting Services, Clinical Research Services (CRS), and PAREXEL Informatics. The services offered by the CRS segment are biostatistics, clinical trial management, clinical logistics, patient disease registries, and observational studies.

Value chain-based sizing & forecasting

Supply Side Estimates

• Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

• Segment revenue determination via variable analysis and penetration modeling.

• Competitive benchmarking to identify market leaders and their collective revenue shares.

• Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

• Identifying parent markets and ancillary markets

• Segment penetration analysis to obtain pertinent

• revenue/volume

• Heuristic forecasting with the help of subject matter experts

• Forecasting via variable analysis

Regulatory Affairs Outsourcing Market Report Objectives:

• Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

• Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

• Understanding market estimates and forecasts (with the base year as 2022, historic information from 2018 to 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Regulatory Affairs Outsourcing Market Report Assumptions:

• The report provides market value for the base year 2022 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

• The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

• We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

• All market estimates and forecasts have been validated through primary interviews with the key industry participants.

• Inflation has not been accounted for to estimate and forecast the market.

• Numbers may not add up due to rounding off.

• Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

• Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

• Latin America includes Central American countries and the South American continent

• Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

• Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

• Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.