Publication Month: Sep 2019 | Report Code: TIPRE00003316 | No. of Pages: 139 | Category: Pharmaceuticals | Status: Published
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. The growth of the Pre-Clinical CROs in healthcare market is attributed to the increasing R&D expenditures and high cost of drug development process in the developed countries have been boosting the market over the years. However, stringent regulations for conduction of clinical trials and variations in the GMP guidelines across countries around the globe are likely to have a negative impact on the growth of the market in the coming years.
The Pre-Clinical CROs in healthcare market is expected to witness substantial growth post-pandemic. The COVID-19 has affected economies and industries in various countries due to lockdowns, travel bans, and business shutdowns. The COVID-19 crisis has overburdened public health systems in many countries and highlighted the strong need for sustainable investment in health systems. As the COVID-19 pandemic progresses, the healthcare industry is expected to see a drop in growth. The life sciences segment thrives due to increased demand for invitro diagnostic products and rising research and development activities worldwide. However, the medical technologies and imaging segment is witnessing drop in sales due to a smaller number of surgeries being carried out and delayed or prolonged equipment procurement. Additionally, virtual consultations by healthcare professionals are expected to become the mainstream care delivery model post-pandemic. With telehealth transforming care delivery, digital health will continue to thrive in coming years. In addition, disrupted clinical trials and the subsequent delay in drug launches is also expected to pave the way for entirely virtual trials in the future. New technologies such as mRNA is expected to emerge and shift the pharmaceutical industry and market is also expected to witness more vertical integration and joint ventures in coming years.
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Research & development (R&D) is a significant and essential part of a company’s business. Pharmaceutical and biotech companies majorly focus on research and development (R&D) to come up with new molecules for various therapeutic applications with the most significant medical and commercial potential. The companies invest majorly on the R&Ds intending to deliver high quality and innovative products to the market.
R&D investments made by biopharmaceutical companies have increased over the years. According to a report of Pharmaceutical Research and Manufacturers of America (PhRMA), the R&D expenditure of the biopharmaceutical companies has increased from US$49.6 billion in 2012 to US$ 58.8 billion in 2015 Research and development expenditures are usually incurred during processes of discovering, testing, and developing new products, upfront payments, and milestones, improving existing outcomes, as well as demonstrating product efficacy and regulatory compliance before launch. As per the International Federation of Pharmaceutical Manufacturers & Associations, the R&D expenditures in 2014 in the pharmaceuticals and biotechnology industry grew by approximately 8.7% compared to the expenses in 2013. Moreover, in the US, investments for R&D by pharmaceutical companies had grown consistently over the last 15 years. The intensity for R&D by the companies in Japan accounted for about 13.3%, in the US it accounted for approximately 17%, and in the European Union it was registered to be around 13% in the year 2014.
Drug development and discovery is a time-consuming and expensive process. The process from early detection or design to development to regulatory approval can take more than 10 to 15 years. Throughout the development phase of a drug substance, various testing services are required to check the quality and efficacy of the product. Hence, the pharmaceutical and biotech companies prefer to outsource the services to the contract research organizations (CROs) to save the cost and time, which is expected to drive the growth of the market.
A rise in outsourcing activities by pharmaceutical companies has been witnessed during recent years. This trend has been seen as a plan to remain competitive and flexible in a market of exponential growth, sophisticated technologies, and an unstable economic environment. Companies generally outsource R&D tasks which include a broad range of activities such as, fundamental research to late-stage development: hit exploration and lead optimization, target validation, genetic engineering, assay development, safety and efficacy tests in animal models, and clinical trials which involve humans.
The major factors driving the growth of outsourcing activities by companies are, cutting costs, need for innovations, increased speed and agility, and accessing specialized knowledge and technologies. A decreasing percentage of profits has become a primary concern for pharmaceutical companies over the past decade. As per an analysis by PhRMA, around $0.8 to $1.7 billion is estimated to be invested by the pharmaceutical industry in R&D to bring a new drug to market. Hence, with an increase in the R&D expenditure, the need for pre-clinical services is expected to drive the growth of global pre-clinical CROs market.
In terms of service, the Pre-Clinical CROs in healthcare market is segmented into bioanalysis & dmpk studies, toxicology, others. The toxicology segment held a largest share of the market in 2018.
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In terms of end user, the Pre-Clinical CROs in healthcare market is segmented into biopharmaceutical companies, government & academic institutes, medical device companies. In 2018, the biopharmaceutical companies segment held the largest share of the market, by end user.
The Pre-Clinical CROs in healthcare market players are adopting the product launch and expansion strategies to cater to changing customer demands worldwide, which also allows them to maintain their brand name globally.
The List of Companies
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