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Preclinical CRO Market - By Service (Bioanalysis & DMPK Studies, Toxicology Testing), By End-use (Biopharmaceutical Companies, Government & Academic Institutes, Medical Device Companies), By Region & Global Forecast, 2023 – 2032

  • Report ID: GMI2860
  • Published Date: Mar 2023
  • Report Format: PDF

Industry Statistics

Preclinical CRO Market size accounted for over USD 5.3 billion in 2022 and is estimated to grow at 7.9% between 2023 and 2032. Technological advancements and rising demand for preclinical CROs are major factors driving the global market growth.

Preclinical CRO Market

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Preclinical CRO is a support center offering expertise in R&D that is necessary for navigating a drug candidate through animal testing and advancing it into the clinical phase. Preclinical research services involve several critical studies to assess drug efficacy and safety in animal models and complete Investigational New Drug (IND) filing studies. Preclinical CRO offer services such as bioanalysis & DMPK studies, toxicology testing and bioequivalence studies among others.

The preclinical CRO industry is primarily driven by increasing early research activities in drug discovery process coupled with rising outsourcing for preclinical CRO services. Conducting preclinical trials, Proof-Of-Concept (POC) and First-In-Human (FIH) as multicenter studies can offer substantial advantages for discovering exact target population and refining recruitment. Thus, preclinical CRO services are vital fragments of effective drug development that will accelerate the market growth in the coming years.

Rising number of outsourcing activities to CROs for drug development in preclinical phase will boost the market growth

Increasing prevalence of chronic disease is one of the key factors that organizations are aiming to develop the drugs for and to prevent such disease. For instance, GeoVax has outsourced their immune-oncology and infectious disease vaccine development to meet the medical needs. Their products have been outsourced for preclinical validations. Such outsourcing activities of drugs will increase the demand for preclinical CROs thereby supplementing the preclinical CRO market growth over the forecast timeframe. Moreover, technology has aided the market to semi-automate or automate current, manual procedures that will increase the demand for preclinical CROs, as companies tend to opt for such technological advancements in research studies. Thus, rising number of outsourcing activities to CROs for preclinical validation will further boost the industry statistics.

Stringent regulatory policies may impede the overall market demand

Stringent regulatory policies for preclinical CROs services may impede the overall industry growth. Various regulatory authorities such as U.S. FDA and European Medicines Agency (EMA) has set international standards including Good Laboratory Practice (GLP) regulations while conducting the preclinical testing. These GLP are based on premises that quality control must be built into preclinical testing in order to eliminate errors. Thus, regulations and standards will hamper the market growth. Furthermore, due to the regulatory policies, high-end tests including genotoxicity are performed in in-house departments of pharmaceutical firms, thereby hindering the market growth.

Bioanalysis & DMPK studies is important in preclinical trials for proper evaluation and analysis of efficacy and safety data for novel drug development that will boost the market forecasts

Global Preclinical CRO Market Share, By Service

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Preclinical CRO market from service segment includes bioanalysis & DMPK studies, toxicology testing and others. The bioanalysis & DMPK studies segment is estimated to reach USD 4.9 billion by 2032. Bioanalysis and DMPK studies are also essential for proper evaluation and analysis of efficacy and safety data for novel drug development. Moreover, the outcomes of non-clinical toxicological and pharmacological studies must be assessed in combination with the results from non-clinical and clinical pharmacokinetic studies. This should be done to deliver beneficial data for safe and suitable conduct of preclinical trials and for further assessment of the mechanism of action in humans. Thus, bioanalysis & DMPK studies is important in preclinical trials, thereby fostering the segment demand.

Increasing investment of biopharmaceutical companies in the development of novel drugs will upsurge the demand for preclinical CRO services

Based on end-use, the preclinical CRO market is segmented into biopharmaceutical companies, government & academic institutes, medical device companies and others. Biopharmaceutical companies segment accounted for over USD 2.8 billion in 2022 and is expected to dominate the market during the analysis period. High growth is owing to increasing prevalence of various chronic diseases such as cancer, cardiac disease, neurological and infectious disease. This is further encouraging biopharmaceutical companies to increase investment in the development of novel drugs that will upsurge the demand for preclinical CRO services. Also, biopharmaceutical companies are adopting strategy to remain competitive and flexible in growing knowledge, advancing technologies, and sustain an uneven economic environment. Adoption of such strategies will be conducive to the market expansion.

Presence of large number of players in the region will boost the North America market statistics

Preclinical CRO Market Size By Region

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North America preclinical CRO market accounted for considerable revenue in 2022 and is poised to exceed USD 4.7 billion by 2032. Presence of large number of market players in the region will boost the North America market outlook. Furthermore, increasing focus of pharmaceutical companies on novel drug development for treatment of various chronic disease is anticipated to boost North America preclinical CRO industry over the forecast period.

Adoption of inorganic growth strategies to create a global footprint will pave growth opportunities for companies operating in the global market

Prominent market players operating in the preclinical CRO industry include Charles River Laboratories, Laboratory Corporation of America Holdings, ICON plc, Pharmaceutical Product Development among others. These industry players majorly concentrate on various strategies including collaborations, acquisitions, mergers and partnerships to create a global footprint and sustain market competition.

Impact of COVID-19 on preclinical CRO market trends

Due to the impact of the COVID-19 pandemic, several large biopharmaceutical companies and medical device companies had placed new trials on hold. Also, numerous small, mid-size, and large enterprises suspended ongoing trials, thereby demonstrating the magnitude of the disruption of the market. Moreover, owing to coronavirus outbreak, various organizations in the industry revised R&D spending for preclinical and clinical trials in comparison to the earlier spending. This has affected outsourcing of preclinical CRO services and further decreased the revenue. However, rapid recovery was anticipated due to the proliferation of new clinical trial approaches or models, that make use of virtual trial tools and evolving regulatory policies.

The preclinical CRO market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 - 2032, for the following segments:

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By Service

  • Bioanalysis & DMPK studies
  • Toxicology testing
  • Others

By End-use

  • Biopharmaceutical companies
  • Government & academic institute
  • Medical device companies
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
  • Latin America
    • Brazil
    • Mexico
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
Authors: Mariam Faizullabhoy, Gauri Wani

Frequently Asked Questions (FAQ) :

Global market for preclinical CRO exceeded a valuation of USD 5 billion in 2022 and is set to progress at more than 7.5% CAGR over the next 10 years owing to increasing R&D expenditure on early-stage development, coupled with the growing number of drugs in the preclinical phase.

Medical device companies segment is anticipated to depict more than 7.5% CAGR between 2023 and 2032 due to the mounting demand for special preclinical CRO services that fulfill the personalized needs of medical device and diagnostics companies.

Toxicology testing segment is projected to surpass USD 4 billion by 2032 as toxicology studies are a legal prerequisite of drug development.

North America preclinical CRO market held more than 43% business share in 2022 on account of consistent drug development and the strong presence of key medical device manufacturers in the region.

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  • Base Year: 2022
  • Companies covered: 10
  • Tables & Figures: 128
  • Countries covered: 15
  • Pages: 104
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