Contract research organization is a kind of academic or commercial service that provides professional services in the process of basic medicine and clinical medicine research and development for pharmaceutical companies, medical institutions, small and medium-sized medical device R&D companies, and even various government funds through contracts. Scientific institutions. In the beginning, the contract research organization was limited to clinical services, and later expanded to the entire process of drug research and development, from compound screening to post-marketing drug promotion, with a wide range of services that can meet the different needs of drug research and development companies. The most notable feature of contract research organization is its specialization and high efficiency. As a kind of external resource that can be borrowed by pharmaceutical companies, it is helpful for pharmaceutical companies to increase the concentration of resources and form the advantages of scale within the company. Greatly improve the speed of pharmaceutical companies' new drugs on the market, and reduce the management and R&D costs of pharmaceutical companies.
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Development Status and Prospect Forecast of Pre-clinical Contract Research Organization Industry
According to the nature of the work, contract research organizations can be roughly divided into pre-clinical research and clinical research. Pre-clinical research of drugs for drug registration, mainly including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation technology, inspection methods, quality indicators, stability, pharmacology, toxicology, and animals Pharmacokinetics, etc. Traditional Chinese medicine preparations also include the source, processing and processing of raw medicinal materials, and biological products also include the source of starting materials, quality standards, storage conditions, biological characteristics, genetic stability, and immunology of bacteria, cell strains, biological tissues, etc. Research and so on. According to the requirements of drug registration application materials, pre-clinical research can be summarized as two major aspects: Bioanalysis and DMPK research, and toxicology testing. As of 2019, the Institute of Bioanalysis and DMPK has a market share of 53.36%; the market share of toxicology testing is 28.41%.
The research and development of new drugs is a huge and complicated system engineering with high technology, high risk, high investment and long period. In the United States, a new drug costs approximately US$350 million from laboratory discovery to market entry. The high failure rate of new compounds means that the more the subsequent development stage, the greater the investment risk. As far as a global phase III clinical trial is concerned, its cost generally exceeds 10 million U.S. dollars. To survive and develop in an environment of increasingly fierce competition and stricter management, pharmaceutical companies must try their best to shorten the new drug research and development market, and at the same time, control costs while reducing the risk of failure. Contract research organizations are a more important social division of labor in the pharmaceutical field. The product of specialization and risk averaging.
As an external resource that pharmaceutical companies can borrow, contract research organizations can help companies quickly organize a highly specialized clinical research team with rich clinical research experience in a short period of time, so that companies can effectively solve the low tide of drug development. The problem of waste of resources and insufficient internal resources during peak periods, so that the number of employees and management costs are reasonably and stably controlled to a minimum, and the management costs of the entire pharmaceutical company can be reduced. It is with these unique advantages that contract research organizations can provide technical support and professional services to the pharmaceutical industry in these areas. As of 2019, the global pre-clinical contract research organization industry market value was 4.323 billion U.S. dollars. In the future, with the continuous development of social economy and the advent of the aging era, people will have higher and higher requirements for medical services. In order to meet market demand, pharmaceutical companies are facing the pressure to continuously produce new compounds and new technologies. In this context, the market value of preclinical contract research organizations that are inseparable from the pharmaceutical industry is expected to continue to rise.
The contract research organization originated in the United States in the early 1980s and developed rapidly. In the 1990s, the sharp price cuts of generic drugs further intensified market competition. Various pharmaceutical companies stepped up their efforts in innovation and research, which intensified the industry’s dependence on R&D outsourcing. U.S. contract research organizations entered a period of vigorous development. At the same time, contract research Research organizations have developed significantly in depth and breadth on a global scale, corporate mergers and acquisitions have increased, and giant companies have begun to take shape. Nowadays, some international contract research organizations have established branches in dozens of countries and regions around the world, forming a strong transnational clinical research network. In recent years, due to the application and development of IT systems, the organization and implementation of global clinical research have been strengthened. Test ability and experience. The contract research organization industry in developed countries has developed earlier and faster, and is technologically far ahead of most developing countries. As of 2019, North America has a market share of 35.66%, ranking first; Europe has a market share of 30.28%, ranking second.
The Impact of COVID-19 on Preclinical Contract Research Organizations
The new crown pneumonia epidemic is raging around the world, which is a huge blow to the medical security systems of all countries. In 2021, the new crown epidemic has repeated fluctuations. With the normalization of epidemic prevention and control, various political powers have expressed that they will continue to prepare for emergency medical supplies and prepare for long-term coexistence with the new crown pneumonia virus. For the more backward countries, the chronic shortage of medical personnel and the low vaccination rate have caused the country to face a long-term health and economic situation. The epidemic has forced countries to pay attention to the upgrading of medical security systems in response to health emergencies and the advent of an aging age. These all mean that the market's demand for pre-clinical contract research organizations will continue to increase.
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