Home > Healthcare & Medical Devices > Preclinical CRO Market
Preclinical CRO Market size exceeded USD 4.8 billion in 2020 and is poised to grow at over 7.3% between 2021 and 2027. The market growth is primarily driven by increasing early research activities in drug discovery process coupled with rising outsourcing for preclinical CRO services.
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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 demand. Furthermore, innovation in technology to offer efficacy and safety in product development process will drive the preclinical CRO industry expansion.
Report Coverage | Details |
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Base Year: | 2020 |
Market Size in 2020: | USD 4,810.6 Million |
Forecast Period: | 2021 to 2027 |
Forecast Period 2021 to 2027 CAGR: | 7.3% |
2027 Value Projection: | USD 7,861.4 Million |
Historical Data for: | 2016 to 2020 |
No. of Pages: | 104 |
Tables, Charts & Figures: | 127 |
Segments covered: | Service, End-use and Region |
Growth Drivers: |
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Pitfalls & Challenges: |
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Due to the impact of the COVID-19 pandemic, several large biopharmaceutical companies and medical device companies have placed new trials on hold. Also, numerous small, mid-size, and large enterprises have suspended ongoing trials, thereby demonstrating the magnitude of the disruption of the market. Moreover, owing to coronavirus outbreak, various organizations in the industry have revised R&D spending for preclinical and clinical trials in comparison to the earlier spending. This will affect outsourcing of preclinical CRO services and negatively impact the market revenue. However, rapid recovery is anticipated due to the proliferation of new clinical trial approaches or models, that make use of virtual trial tools and evolving regulatory policies.
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 boost the market demand. Furthermore, 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.
Stringent regulatory policies for preclinical CROs services may impede the 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 to eliminate errors. Additionally, due to the regulatory policies, high-end tests including genotoxicity are performed in in-house departments of pharmaceutical firms, hindering the market size growth.
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The bioanalysis & DMPK studies segment value was around USD 2 billion in 2020. 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.
Biopharmaceutical companies segment held more than 52% preclinical CRO market share in 2020 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.
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North America preclinical CRO industry size is predicted to reach USD 3.3 billion by 2027 impelled by presence of large number of market players in the region. For instance, according to the ClinicalTrail.gov report, the number of registered preclinical trials has increased significantly in the recent years. The report also stated that, during the year 2019, there were around 45,445 preclinical studies registered in U.S. only. Moreover, increasing focus of pharmaceutical companies on novel drug development for treatment of various chronic disease is anticipated to fuel the regional industry demand.
Prominent preclinical CRO market players include Charles River Laboratories, Laboratory Corporation of America Holdings, Envigo, 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.
Market, By Service
Market, By End-use
The above information is provided for the following regions and countries: