Preclinical CROs Market Size and Growth 2031

Preclinical CROs Market Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Service (Bio-analysis & DMPK Studies, Toxicology, and Other Services), End User (Biopharmaceutical Companies, Government & Academic Institutes, and Medical Device Companies), and Geography

  • Report Code : TIPRE00003316
  • Category : Pharmaceuticals
  • No. of Pages : 150
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Preclinical CROs Market Trends, Size and Forecast by 2031

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The Preclinical CROs Market size was estimated to be US$ 5.52 billion in 2023 and is expected to reach US$ 11.19 billion by 2031; it is estimated to record a CAGR of 9.2% till 2031. Increasing number of clinical trials are likely to remain key Preclinical CROs Market trends.

Preclinical CROs Market Analysis

Rising prevalence of rare diseases and rising number of outsourcing activities by the pharmaceutical companies to CROs for drug development is fueling the growth of the pre-clinical CROs market. Also, improvements in pre-clinical development result in reduced costs as well as timelines is driving the pre-clinical CROs market growth. For example, pharma companies reduce the time they take to reach FIH application by 40% or more, with drugs progressing from candidate nomination to the start of clinical trials in little as 12 to 15 months. Such timelines not only provide patients with rapid access to innovative medicines but also provides pharma companies to account for high revenue targets with a longer period of drug exclusivity in the market.

Preclinical CROs Market Overview

A pre-clinical CRO, or preclinical contract research organization, provides the experience, knowledge, and skill required to take a pharmaceutical product or medical device from the drawing board to distribution. Majority of the sponsoring organizations do not have the requisite facilities and staff for conducting tests under special supervision and appropriate set-up for particular drugs and medical devices and thus choose to contract research of this kind.

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Preclinical CROs Market: Strategic Insights

pre-clinical-cros-market
Market Size Value inUS$ 4,282.2 Million in 2018
Market Size Value byUS$ 8,412.9 Million by 2027
Growth rateCAGR of 8.1% from 2019-2027
Forecast Period2019-2027
Base Year2018
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Preclinical CROs Market Drivers and Opportunities

Increasing Preference for CROs  

As clinical trials are increasingly becoming complex procedures as it is important to properly execute and oversee the operations that are occurring in the research-based organization. To avoid the errors due to improper execution, research-based organization are outsourcing the clinical trials to develop their products. CROs assist in the successful implementation of clinical trials through the services offered using high-quality facilities and deep subject matter expertise. CROs have begun acting as a backbone of the clinical trial industry through their efficient and cost-effective operations that benefit trial sponsors. According to the blog published on Thermo Fisher Scientific, in 2022, approximately 3 out of 4 clinical trials were carried out by CROs. CROs not only reassure the drug developers’ clinical programs but they also provide a wealth of expertise, drive time and cost efficiencies, and deliver customized, high-quality data. Development of cost-effective solutions and decrease in errors in CROs during drug development process is also driving the growth of the preclinical CROs market.

Rising Biosimilar and Biologics – An Opportunity of Preclinical CROs Market

Biotherapeutics is the fastest growing sector in the pharmaceutical industry. The efficacy and safety of biotherapeutics associated with the ability to treat various untreatable diseases is majorly driving the growth of the biosimilars and biologics. Technological advancement and significant improvement in the understanding of diseases such as cancer, rheumatoid arthritis among others is creating a demand for the development of biosimilars and biologics. Pharmaceutical and biopharmaceutical companies are investing majorly for the research and development activities to develop innovative and advanced biological molecules. Companies are capitalizing on their expertise in biologics manufacturing to generate more revenue by fulfilling the unmet conditions. In recent years, there has been an increase in the biologics license application (BLA). Biologics are large complex molecules, up to 1,000 times the size of small molecule generic drugs. Before a new biopharmaceutical product gets marketed in the US, the FDA must approve an NDA for a new drug or a BLA for a biologic. The steps required before the FDA will approve an NDA or BLA generally includes preclinical studies followed by multiple stages of clinical trials. In order to save the in-house cost and time required for these testing services throughout the development process of the biologics and biosimilars in the initial stages, the companies prefer to outsource these services to the pre-clinical CROs. This is expected to be a potential opportunity for the growth of the pre-clinical CROs across the globe in the coming years.

Preclinical CROs Market Report Segmentation Analysis

Key segments that contributed to the derivation of the Preclinical CROs Market analysis are service, and end user.

  • Based on service, the Preclinical CROs Market is segmented into bio-analysis and DMPK studies, toxicology, and other services. The toxicology segment held the largest market share in 2023.
  • By end user, the Preclinical CROs Market is segmented into biopharmaceutical companies, government and academic institutes, and medical device companies. The biopharmaceutical companies segment held the largest market share in 2023.

Preclinical CROs Market Share Analysis by Geography

The geographic scope of the Preclinical CROs Market report is mainly divided into five regions: North America, Asia Pacific, Europe, Middle East & Africa, and South & Central America.

North America has dominated the Preclinical CROs Market. The growth of this market is primarily driven by increasing expenditure of research and development expenditures. Moreover, various pharmaceutical companies are facing short profit margins due to patent expiry due to which the spurring manufacturers have initiated to reduce the in-house R&D activities by outsourcing these studies through contract research organizations. This is responsible for pre-clinical CROs to experience a significant growth. The confrontation of biotechnology and pharmaceutical companies to lower the drug development costs is expected to propel the pre-clinical CROs market in North America. Additionally, rise in demand of services and medicines in areas of orphan and rare diseases is expected to stimulate the drug manufacturers to consult specialist therapeutics and global site relationships through CROs to help them design smarter medicines and recruit patients for clinical trials. Moreover, Asia Pacific is anticipated to record the highest CAGR in the coming years. 

Preclinical CROs Market Report Scope

Preclinical CROs Market News and Recent Developments

The Preclinical CROs Market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for healthcare fraud analytics and strategies:

  • QPS, a global contract research organisation headquartered in the US, has opened a second preclinical research facility in Taipei, Taiwan. The 2,793-square-foot facility will facilitate a research expansion into additional toxicology studies and a newly launched capability in pharmacology studies. (Source: Cision US Inc, Press Release, 2022)

Preclinical CROs Market Report Coverage and Deliverables

The “Preclinical CROs Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering below areas:

  • Market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
  • Market dynamics such as drivers, restraints, and key opportunities
  • Key future trends
  • Detailed PEST/Porter’s Five Forces and SWOT analysis
  • Global and regional market analysis covering key market trends, major players, regulations, and recent market developments
  • Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments
  • Detailed company profiles
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Service, End User, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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