Preclinical CRO Market Size, Share & Trends Analysis Report By Service (Toxicology Testing, Bioanalysis & DMPK Studies), By End Use (Biopharmaceutical Companies, Government & Academic Institutes), By Region And Segment Forecasts, 2024 - 2030

Research Methodology

A three-pronged approach was followed for deducing the preclinical CRO 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 preclinical CRO 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 preclinical CRO 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.

Preclinical CRO Market Categorization:

The preclinical CRO market was categorized into four segments, namely service (Bioanalysis and DMPK studies, Toxicology Testing, Compound Management, Chemistry, Safety Pharmacology), model type (Patient Derived Organoid Model, Patient derived xenograft model), end-use (Biopharmaceutical Companies, Government and Academic Institutes, Medical Device Companies), and region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

Segment Market Methodology:

The preclinical CRO market was segmented into service, model type, 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 preclinical CRO 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 twenty-seven countries, namely, the U.S.; Canada; Germany; the UK; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; Singapore; Philippines; Indonesia; Malaysia; Australia; Thailand; South Korea; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

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.

Preclinical CRO market companies & financials:

The preclinical CRO 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:

• WuXi AppTec (WAI) - WuXi AppTec, Inc. (WAI) is the provider of contract research & development outsourcing services for medical device, biotechnology, and pharmaceutical companies. Its pharmaceutical services include safety pharmacology, pharmacokinetics, bio-analysis, drug metabolism, and medicinal & analytical chemistry. WAI also offers biocompatibility testing, pre-clinical services, toxicology testing, package & validation testing, genetic toxicology, and material characterization services. It operates as a subsidiary of WuXi PharmaTech (Cayman) Inc. WAI has a strategic collaboration with REGENXBIO Inc., and MedImmune, LLC, and has a medical device testing center in China.

• Labcorp - In 1995, the merger of National Health Laboratory Holdings, Inc. and Roche Biomedical Laboratories, Inc. created Laboratory Corporation of America Holdings (LabCorp). It is involved in the development of genetic test solutions based on microarray, NGS, and PCR technology. The company serves more than 220,000 clients across 60 countries. Its clients include hospitals, physicians, employers, governmental agencies, and other independent clinical laboratories. Its diagnostic business segment offers gene-based tests for HIV drug-resistance assays, HPV, and molecular genetic testing for cystic fibrosis. It provides a menu of over 4,700 tests in the areas of diagnostic genetics, allergies, cardiovascular diseases, coagulation, women's health, oncology, endocrinology, infectious diseases, pain management, toxicology, and pharmacogenetics. This company has a geographical presence in 100 countries.

• Eurofins Scientific SE - Eurofins Scientific SE (Eurofins) is a provider of pre-clinical services across the globe. Eurofins has a portfolio of 150,000 analytical methods for the evaluation of composition, authenticity, and purity of biological substances. It also provides agro-testing, consumer product testing, environment testing, medical device testing, and chemical registration & authorization services. Eurofins caters its portfolio of services to pharmaceutical, consumer products, food, and the environment with a network of 375 laboratories in 44 countries.

• Medpace Holdings, Inc. - Medpace Holdings Inc. (Medpace) is a 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. Its regulatory affairs services include regulatory strategies for early-stage development and regulatory writing for clinical studies. Medpace also provides regulatory approval services and post-market support services such as clinical study reports, literature reviews, market approvals, post-market registries, and vigilance writing.

• Charles River Laboratories International, Inc. - Charles River Laboratories International, Inc. offers solutions and services in research, clinical support, drug discovery, safety & efficacy assessment, and process manufacturing services to biotechnology, government, pharmaceutical, and academic organizations around the world. Its therapeutic areas include cardiovascular, inflammation, musculoskeletal, respiratory, and CNS metabolic diseases, as well as oncology & ophthalmology. Its product portfolio includes biomarkers, cellular therapeutics, biosimilars, and vaccines. The company is involved in providing services for agrochemicals, chemicals & veterinary medicine, dairy, food & beverage, dialysis, compounding pharmacy, home & beauty, medical devices, nutraceuticals, and dietary supplements. It operates in Australia, Canada, China, Finland, France, Germany, India, Ireland, Italy, Japan, the Netherlands, South Korea, Spain, the UK, and the U.S. Charles River Laboratories, Inc. operates as a subsidiary of Charles River Laboratories International, Inc.

• Intertek Group Plc (IGP) - Intertek Group Plc (IGP) is a provider of quality and safety solutions. IGP operates through three reportable segments: Product, Trade, and Resources. Its product segment’s key offerings include bio-pharmaceutical services, protein structure analysis, impurity testing, inspection & certification services, laboratory testing, quality & performance testing, and sustainability analysis. Its trade and resources segment offers technical services, analytical testing services, calibration, and asset integrity services. IGP caters its services to the life sciences, food, pharmaceuticals, and healthcare industries. It has a presence in 1,000 locations in over 100 countries.

• SGS S.A. (SGS) - SGS SA (SGS) provides clinical research services, quality assurance, inspection, testing, and certification services across the world. SGS operates through nine reportable segments: Agriculture, Food & Life, Minerals, Oil, Gas & Chemicals, Consumer Retail, Certification and Business Enhancement, Industrial, Environment, Health and Safety, Transportation, and Governments and Institutions. Under clinical research services, it offers clinical development consultancy, pharmaco-vigilance and drug safety services, and early-phase clinical services (patent & clinical trials, and bio-equivalence & bio-availability studies. It also provides verification & certification services to enable its customer’s products in line with international standards, outsourcing, consulting, and data analytic services. SGS caters its services through the network of 2,600 offices and laboratories.

• Pharmaceutical Product Development, LLC (PPD) - Pharmaceutical Product Development, LLC, (PPD) is a U.S.-based pre-clinical outsourcing company. PPD offers services such as discovery & development, post-approval services, and a compound partnering program. Investors such as Carlyle Group, in affiliation with Hellman & Friedman, increased funding by USD 3.9 billion. PPD also provides pharmacology and toxicological testing services for preclinical studies to biopharmaceutical and medical device companies. The company has a presence in more than 46 countries. It caters to pharmaceutical, medical devices, & biotechnology companies, government organizations, and academic institutions. In 2021, PPD was acquired by Thermo Fisher Scientific, Inc.

• PRA Health Sciences (PRA) - PRA Health Sciences, Inc. (PRA) is a contract research organization, which provides clinical development services to biotechnology & pharmaceutical companies, globally. PRA operates through two segments namely: Clinical Research and Data Solutions. Its key offerings under the clinical research segment are bioanalysis, clinical trials, medical writing, quality assurance, safety & risk management, biostatistics, and late-phase services. Under Data Solutions, PRA offers consulting, analytics, and technology solutions. The company changed its name from PRA Global Holdings, Inc. to PRA Health Sciences, Inc. The company was acquired by ICON plc.

• Crown Bioscience - Crown Bioscience is a platform technology firm that provides drug discovery & development services in the fields of oncology, metabolic diseases, cardiovascular, and inflammation to biopharmaceutical companies. Owing to special attention to immunotherapy research, the company offers various syngeneic models along with xenografts for in vivo oncology studies. The company develops world-leading preclinical efficacy models and provides in vivo & in vitro testing services. It has facilities worldwide, including in the U.S., the UK, Taiwan, & China.

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

Preclinical CRO 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.

Preclinical CRO 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.