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

Preclinical CROs Market

• 
  CAGR (2023 - 2031)

  9.2%
• Market Size 2023
  US$ 5.52 billion
• Market Size 2031
  US$ 11.19 billion

Market Dynamics

GROWTH DRIVERS

• Increasing Investment in Pharmaceutical R&D

FUTURE TRENDS

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OPPORTUNITIES

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Key Players

• Covance, Inc.
• Charles River
• Eurofins Scientific
• PRA Health Sciences
• WuXi AppTec
• Medpace, Inc.
• Pharmaceutical Product Development, LLC
• Parexel International Corporation
• ICON Plc
• MD Biosciences

Regional Overview

• North America
• Europe
• Asia-Pacific
• South and Central America
• Middle East and Africa

Market Segmentation

Service

• Bio-analysis & DMPK Studies
• Toxicology
• Other Services

End User

• Biopharmaceutical Companies
• Government & Academic Institutes
• Medical Device Companies

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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

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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