Pre-Clinical testing in CRO

Preclinical CROs were established to offer expertise and pace for research and development of test products. As this is often necessary for navigating a drug candidate through animal testing and advancing it into the clinical phase. Preclinical research involves the evaluation of potential therapeutic interventions employing In-vivo and In-vitro models. Drug candidates may enter clinical trials based on their effectiveness and safety in diseased models and healthy animals respectively. All drugs require data from various toxicological preclinical studies to support their potential safety in humans before clinical trials can begin.

The preclinical process of drug development is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory models. Rising demands of preclinical services for laboratory testing becoming extremely high, since outsourcing has traditionally been thought of as a short-term strategy to cut back expenses or to provide a company with additional capacities. This understanding has changed throughout in last few years. A CRO as strategic partner could not only offer cost advantages, but also quality improvement and innovation. Today, outsourcing is seen as a method to increase performance in pharmaceutical research via leveraging of core competencies. This is not only true for the area of chemical synthesis but also for other areas of preclinical research.

Preclinical studies are performed using In-vitro, In-vivo, Ex-vivo, and In-silico models to obtain basic information about the safety and biological efficacy of a drug candidate before evaluating it in a final target population, i.e., humans. Preclinical services include but not limited to general toxicity, inhalation toxicity, reproduction & development toxicity, genetic toxicity, immunotoxicity, DMPK, pharmacology, ecotoxicology, biological assays - in vitro/in vivo, analytical, bioanalytical, physio-chemical testing, chemical/drug characterization etc. Preclinical studies can also be designed to identify a lead candidate from several hits, to develop the best one for new drug scale-up, to select the best formulation, to determine the route of exposure, frequency, and duration of exposure and ultimately support the intended clinical trial design. The main goals of preclinical studies in CROs are to get the desired biological effect of a drug to predict treatment outcome in patients (efficacy), and to identify and characterize all toxicities associated with a drug to predict adverse events in humans’ safety and their health.

Global Preclinical CRO Market: The global preclinical CRO market size was valued at USD 4.87 billion in 2021 and is expected to advance at a compound annual growth rate of 7.9% from 2022 to 2030. Increased R&D budget for drug development is leading to rising demand for preclinical contract research organization (CRO) services, thus boosting the market growth during the forecast period. The surge in the number of preclinical trials involving large molecules and the growing need to curb R&D expense is expected to contribute to the growing demand for quality preclinical CRO. The ongoing COVID-19 pandemic initially disrupted preclinical research projects, especially during the first quarter of 2020. Over the years, there has been a notable change in the process of drug approval by the Food and Drug Administration (FDA). Recently, the 21 st Century Cures bill was passed in the U.S., which fastened the approval process for the launch of breakthrough drugs and medical devices. These changes in approval processes are expected to drive innovation and are also anticipated to increase demand for preclinical services, thereby contributing to market growth. In the area of COVID-19 vaccine itself, preclinical studies have been performed at an exponential speed, indicative of the overwhelming role of CROs. Increasing spending on CRO services is expected to boost the market growth significantly during the forecast period. The growing demand for drugs for COVID-19 is further contributing to the market growth. Different organizations across the globe have made significant funding for developing therapeutics and medical devices for COVID-19. For instance, in April 2021, the WHO in the R&D Blueprint of COVID-19 reported that over USD 1,618.5 million was funded for COVID-19 vaccine research. Such initiatives are likely to profit from market growth.

The toxicology testing segment accounted for the largest revenue share of 25.48% of the global preclinical CRO market in 2021, owing to a rise in outsourcing of noncore preclinical CRO studies and high adoption of toxicology tests. Toxicology is one of the key services, which is being outsourced to CROs owing to the improved capabilities of CROs to conduct toxicology tests. The growing rate of outsourcing noncore preclinical studies to the CROs and the growing capabilities of CROs to offer additional value-added services is expected to propel the growth of this segment during the forecast period. The bioanalysis and DMPK (Drug Metabolism and Pharmacokinetics) studies segment are expected to register the fastest CAGR (Compound Annual Growth Rate) of >8 %. The segment is expected to witness productive growth on account of a rise in the demand for pharmacokinetic services to support toxicology tests for IND-enabling studies. In addition, bioanalysis and DMPK studies are vital in the entire drug development process. They are performed in every stage of the drug development process and are not confined to the preclinical phase. These factors are further contributing to the segment growth. The biopharmaceutical companies’ segment is expected to hold the largest market share of 80.89% in 2021. The increasing trend of outsourcing end-to-end services among biopharmaceutical companies, especially amongst the small- and mid-size companies that lack sufficient expertise in the preclinical phase of drug development, is expected to boost the demand for preclinical CRO services in the future.

The inference is that within pharmaceutical research the tendency to outsource services is high, if competencies, expertise, or technologies are not available in-house or where in-house buildup would be too expensive or time consuming. The positive effects of outsourcing are enhanced if the supplier is actively used to supplement existing core competencies. The strategic partnership model guarantees a high internal competence level in the long term. Thus, there is a far greater performance improvement potential in investing in, rather than divesting, research. However, there is high complexity in the processes between service provider and customer, or interfaces, which are difficult to define, and the benefits of outsourcing.

Dabur Research Foundation (DRF) is providing huge service of alternatives to animal testing, analytical testing and genetic toxicity testing on all type of area like agrochemicals, pharmaceuticals, biological products and cosmetics etc., in different area of departments with experienced and qualified scientists according to OECD, ICH, USFDA, NDCT, EPA and other regulatory guidelines. DRF assure to offer efficient, accurate, reliable and economic solutions as the alternative to the animal experimentation.


Global Preclinical CRO Market Report 2022-2030: Toxicology Testing, Bioanalysis & DMPK Studies - Rising R&D Offshoring & Outsourcing Trends -