Preclinical CRO Market Size By Service (Bioanalysis & DMPK Studies, Toxicology Testing), By End-use (Biopharmaceutical Companies, Government & Academic Institutes, Medical Device Companies), Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2021 - 2027

Industry trends

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.
 

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.
 

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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.
 

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Rising number of outsourcing activities to CROs for drug development in preclinical phase

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 may impede the overall preclinical CRO market growth

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.
 

Bioanalysis & DMPK studies segment to register significant gains through 2027

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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.
 

Increasing investment of biopharmaceutical companies in the development of novel drugs

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.
 

Presence of large number of players in the North American region

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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.
 

Adoption of inorganic growth strategies by the companies operating in the market

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.
 

Some of the recent industry developments:

• In February 2020, PAREXEL International announced that it has completed the acquisition of Model Answers, a consultancy firm. The company has significant experience in developing preclinical PK and PD models for effectiveness and neutropenia, scaling to first-in-human studies, then supporting Phase I through to NDA submission. This acquisition strategy is expected to enhance their service offering and strengthen its market position.
   
• In May 2019, WuXi AppTec announced that it has acquired Pharmapace, Inc., a U.S. based clinical research services company with expertise of providing high quality biometrics services for all phases of clinical trials, regulatory submissions, and post marketing support. The acquisition aimed to the company’s core biometrics competences and integrated with WuXi Clinical’s other clinical development services This acquisitions enabled company to enhance their service offerings and geographic outreach, thus expanding its market share.
   

The preclinical CRO market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:
 

Market, By Service

• Bioanalysis & DMPK studies
• Toxicology testing
• Others

Market, 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