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Pre-clinical CRO industry analysis

2021-04-09
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(1) Introduction to the pre-clinical CRO industry

The pre-clinical research business of our new drug involves pre-clinical compound screening, pre-clinical phase and clinical phase 1, with pre-clinical phase as the main focus. Pre-clinical research refers to conducting laboratory research and live animal research on candidate drugs obtained in the research phase of the compound under laboratory conditions to observe the biological activity of the compound against the target disease and evaluate its safety. The evaluation mainly includes single-dose toxicity test, multiple-dose toxicity test, reproductive toxicity test, genotoxicity test, carcinogenicity test, local toxicity test, immunogenicity test, dependence test, toxicokinetic test and other tests. Other tests related to the evaluation of drug safety.

From the perspective of the process and specifications of new drug R&D, new drug R&D can be divided into three stages (taking chemical drugs as an example): the first stage is the drug discovery stage; the second stage is the preclinical research of the drug; the third The stage is the clinical trial of the drug, application for new drug certificate, marketing and so on. Any new drug must undergo the discovery and screening of active ingredients to initially determine its potential medical value, and then through sufficient preclinical research to determine whether it is worthy of clinical trials with humans as the test object, and finally pass a strict and reliable Clinical trials to determine whether the new compound can be marketed as a safe and effective drug.

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The globalization of the drug market can realize the global integration of drug R&D technology and drug prices, and at the same time promote healthy competition within the drug market. Whether it is for domestic pharmaceutical companies that want to go global or overseas giants who want to expand the international market, pharmaceutical CRO companies with international qualifications will be the first choice for these pharmaceutical companies.

As an important part of pharmaceutical R&D and production, pre-clinical research of drugs has strict access and data approval standards in all countries. The US FDA has extremely strict quality requirements for GLP inspections and the European Organization for Economic Cooperation and Development OECD’s GLP certification (inspection). After passing the corresponding inspections, the company will also issue corresponding research reports to be successfully related to the US FDA and OECD Member states recognized. Therefore, the research data issued by pre-clinical CRO companies with international GLP qualification certification can be selected by customers for multiple declarations, thereby gaining more customers’ favor.

There are traditional models, innovative models, result-oriented models and risk-sharing models for the cooperation between CRO and enterprises. According to the cooperation methods between CROs and pharmaceutical companies, their business models can be divided into four types: the traditional model of “paying with one hand and delivering with one hand”; the innovative model of “milestone” payment; and the result-oriented model of “clear rewards and punishments”; The risk-sharing model of “sharing risks and sharing benefits”.

The discovery phase of the drug

The discovery phase of drugs is mainly to discover and screen new active ingredients. Obtain new chemical substances through computer drug molecular design or through plants, animals, minerals, microorganisms, marine organisms, etc., and screen and evaluate these substances on specific pharmacological models to discover novel structural types and significant pharmacology Active lead compound. After the discovery of the lead compound, a series of substances similar in structure to the lead compound are obtained through processing, and a quantitative structure-activity relationship study is performed on the substance to optimize the therapeutic index of the compound, and the best compound is selected as a new chemical entity.

Pre-clinical research phase

Generally speaking, pre-clinical research of drugs includes two parts: pharmacy research and drug evaluation research. Its purpose is to systematically evaluate new drug candidates and determine whether they meet the requirements for entering human clinical trials.

Pharmaceutical research: including physical and chemical properties and purity research, pharmaceutical properties research, raw material drug and preparation process research, quality standard research and stability research, etc. The pharmaceutical research of traditional Chinese medicine or natural medicine also includes the source, processing and processing of raw medicinal materials; the pharmaceutical research of biological products includes the quality standards, storage conditions, and genetic stability of starting materials such as bacterial strains, cell strains, and biological tissues. Research and so on.

Drug evaluation research: It can be further subdivided into pharmacodynamic evaluation research, safety evaluation research and animal pharmacokinetic research. Pharmacodynamic evaluation research refers to pharmacological action and mechanism research, safety evaluation research includes general pharmacology, acute toxicity, long-term toxicity, toxicokinetics and special toxicology research, etc. Animal pharmacokinetic research refers to research drug Absorption, distribution, metabolism and excretion in organisms.

After the pre-clinical research is completed, you can start to apply for the drug’s clinical trial approval documents to the national drug regulatory authority, and you can start drug clinical research after approval.

(2) The relationship between the pre-clinical CRO industry and the upstream and downstream industries

The influence of the upstream industry on the preclinical CRO industry and business development

The upstream of the industrial chain of pre-clinical CRO companies is mainly the labor services provided by various professionals required for drug preclinical research services and the sales of laboratory animals and experimental reagents required for preclinical experiments.

Professionals required for pre-clinical research services include topic leaders, technicians, veterinarians, animal breeders, quality assurance specialists, etc. According to the length of working time and familiarity with the field, pre-clinical researchers are divided into senior personnel with rich experience and technical personnel with certain animal experiment knowledge. At present, there are a large number of toxicology, pharmacology, veterinary science and pharmacy students graduated each year in my country, and there are also a large number of existing technical personnel. All of these provide sufficient personnel reserves for the needs of pre-clinical CRO industry technicians. The business operations of the former CRO enterprise do not constitute a significant impact. Senior professionals with rich experience are scarce resources in the pre-clinical CRO industry. Pre-clinical research projects involving senior professionals are superior to projects involving general professionals in terms of service efficiency and quality. At present, the number of senior professionals is limited, which has a certain impact on the development of clinical trial CRO companies.

The preclinical research activities of drugs are mainly carried out through animal experiments, and various experimental reagents are needed for the development of experiments. Among them, experimental reagents are widely used in various chemical research, medical research and related production and operation activities, and their production and supply are generally sufficient, so they will not have a significant impact on pre-clinical CRO companies. However, experimental animals have a great impact on pre-clinical CRO companies. Experimental animals are different from ordinary animals. Experimental animals are required to have the three characteristics of “high sensitivity, consistent response and reproducibility of results.” Different research methods, specific animal experiments and medical research and development processes have higher requirements on laboratory animals, and the quality of laboratory animals directly affects the accuracy of experimental data.

The influence of downstream industries on the preclinical CRO industry and business development

As a service-oriented industry, the downstream end customers of the preclinical CRO industry for its research services are domestic and foreign pharmaceutical companies, as well as some companies and scientific research institutions that conduct drug research. The R&D investment of pharmaceutical companies and drug R&D institutions has a significant impact on the development of the preclinical CRO industry.

Pharmaceutical companies and drug R&D institutions continue to increase R&D investment, carry out new drug R&D activities, and strive to develop innovative drugs with independent intellectual property rights and market competitiveness to maintain their sustained profitability; the state has also successively introduced relevant policies to encourage and support pharmaceuticals Enterprises are accelerating and increasing new drug research and development activities, which determines that the number of drugs that need to carry out preclinical research continues to increase. In this context, the preclinical CRO industry has developed rapidly. At the same time, with the improvement of my country’s preclinical CRO service quality and service level and the manifestation of cost advantages, more and more multinational companies will also choose domestic preclinical CRO companies when looking for offshore CRO partners for their overseas business. All these have had a positive impact on the development of my country’s preclinical CRO industry.

(3) Pre-clinical CRO service content and mode

Pre-clinical new drug research and development services include drug discovery, pharmaceutical research and pre-clinical research. Drug discovery research and development service projects include protein target verification, structural biology, chemical synthesis, compound activity screening and optimization; pharmaceutical research includes API and preparation process research, quality standard and stability research; preclinical research includes pharmacodynamics, pharmacokinetics Kinetics, toxicological safety evaluation research, etc.

Pre-clinical CRO mainly includes new drug discovery, lead compound and active drug intermediate synthesis and process development, formulation research, pharmacodynamic evaluation, pharmacokinetics and safety evaluation research services, etc., and the difficulty of technological innovation in research methods at each stage of work Larger, requires CRO companies to have rich experience accumulation and strong technical optimization capabilities.

The pre-clinical CRO service mode usually has three main cooperation modes: product customization mode, design research and development mode, and joint research mode.

Service modelFeature description
1Product customization modeAccording to the customer’s project characteristics or needs, adopt corresponding technical routes to complete customized services such as compound synthesis and protein expression
2Design R&D ModeAccording to the individual needs of customers, starting from the source of molecular targets or candidate compounds, design relevant technical routes for them, develop key technologies, implement the whole process of research and development, and provide one-stop preclinical research services
3Joint research modelThe company and its customers adopt the FTE model to form a joint R&D team to solve the technical problems of their R&D projects

The business process of pre-clinical CRO services includes key links such as project negotiation, project evaluation, contract signing, design plan, trial implementation, project delivery and after-sales service.

(4) Development strategy of preclinical CRO companies in my country

With the loosening of innovative drug policies and the shift in international CRO demand and other macro-environmental changes, the earlier established local CRO companies such as WuXi AppTec, Wise Chemicals, Tigermed, Boji Pharma, have occupied the leading echelon in the domestic industry. In terms of pre-clinical research, major pre-clinical CRO companies such as WuXi AppTec, Kanglong Chemical, Zhaoyan New Drug, and Medicilon have the ability to directly participate in international competition.
Many companies focusing on pre-clinical services, such as Zhaoyan New Drug, Zhongmei Guanke, Medicilon and Innos (National Shanghai New Drug Safety Evaluation and Research Center), have accumulated many long-term cooperative customers with many years of business experience, and have passed high The provision of quality experimental animal models and animal experiments maintains its long-term competitive advantage.

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