What is Safety Evaluation of Drugs? CRO Industry Chain Analysis Nonclinical Safety Evaluation of Drugs Classification and Introduction How large is the global Nonclinical Safety Evaluation of Drugs market? Global Nonclinical Safety Evaluation of Drugs Industry Competitive Landscape (Leading Companies) How large is the Nonclinical Safety Evaluation of Drugs market in China? Nonclinical Safety Evaluation of Drugs Market Competitive Landscape in China Analysis of Nonclinical Safety Evaluation of Drugs Market Trend
Nonclinical Safety Evaluation of Drug or Biologic Combinations Market
Industry Status, Competitive Landscape and Trends Analysis of Global and Chinese Nonclinical Safety Evaluation of Drugs, and further Increase in Market Concentration
What is Safety Evaluation of Drugs?
Safety evaluation of drugs, also known as Nonclinical Safety Evaluation of Drugs, refers to the evaluation of the safety of therapeutic drugs through laboratory studies and in vitro systems in animals, and it is a necessary and important step before a new drug enters final clinical trials and final approval. It mainly includes safety pharmacology test, single dose toxicity test, repeated dose toxicity test, reproductive toxicity test, genotoxicity test, carcinogenicity test, local toxicity test, dependence test, immunogenicity study, immunotoxicity study, toxicokinetic test and other drug safety evaluation research tests.
The primary purpose of the nonclinical (or preclinical) development phase is to determine which therapeutic candidates are most likely to be successful, to assess their safety, and to establish a solid scientific foundation before transitioning to the clinical development phase.
Preclinical drug studies refer to chemical synthesis or natural product purification studies, drug analysis studies, pharmacodynamic, pharmacokinetic and toxicological studies, and pharmacological studies conducted before a drug enters clinical research. Preclinical drug research includes three processes: drug discovery, preclinical drug production and preclinical drug evaluation.
Non-clinical trials are conducted during the drug development phase using animals and/or cells or tissues. It does not involve human tests. The primary goal of non-clinical trials is to determine the safety of a drug. A non-clinical trial will investigate any harmful effects of the drug on the body due to the pharmacology of the drug.
The information from the non-clinical test is used to plan the human clinical trial. It is used to decide what the starting dose should be and the range of doses to be tested. It also suggests what clinical signs should be looked for to detect any adverse reactions.
Analysis of preclinical studies of drugs
|Drug Discovery||Drug target discovery and selection|
|Lead compound discovery|
|Lead compound optimization|
|Preclinical production of drugs||Experimental studies, small and medium volume trial production||Chemical drug production|
|Preclinical evaluation of drugs||Pharmacokinetic studies|
CRO Industry Chain Analysis
CRO is an organization or institution that provides specialized outsourcing services for pharmaceutical companies in the process of drug development. CRO can be further subdivided into preclinical CRO and clinical CRO, which can provide pharmaceutical companies with services including compound synthesis and screening, drug safety and efficacy evaluation studies, clinical trial protocol design, clinical trial data management and biostatistical analysis, clinical phase I to IV trials, registration and post-marketing drug safety monitoring services, etc. The CROs can provide pharmaceutical companies with services including compound synthesis and screening, drug safety and efficacy evaluation, clinical trial protocol design, clinical trial data management and biostatistical analysis, clinical phase I to IV trial services, registration filing and post-marketing drug safety monitoring.
CRO Service Industry Chain
|New drug development||CRO pharmaceutical R&D outsourcing services|
|Disease selection target families||Drug source||Chemical synthesis|
|Gene Function Related Targets||Biological Consulting||Drug modification|
|Compound Screening to Candidate Compounds||Drug Screening||Commissioning of small trials|
|Preclinical||Safety evaluation studies||Pharmacokinetic study services|
|Phase I Clinical, Phase II Clinical BE||Pharmacological Research Services||Other Research Services|
|Phase I Clinical, Phase II Clinical||Phase I-IV clinical trial technical services|
|Phase III Clinical||Clinical trial data management and statistical fractionation|
|Registration and Marketing||Registration and declaration services|
|Post-marketing Testing and Phase IV Clinical||Post-marketing Testing Services||Marketing Services|
What is the size of the global CRO market?
After nearly fifty years of development, the global CRO market has formed a mature and complete business process system, while with the increasingly strict FDA new drug approval system and the increasing complexity of new drug development, pharmaceutical companies have started to outsource more and more R&D work to CRO companies, and the global CRO market is growing rapidly. According to Frost & Sullivan data, the global CRO industry market size grew from $49 billion to $71 billion from 2017 to 2021, with a compound growth rate of 9.7% from 2017-2021, and is expected to reach $118.5 billion in 2026, with a compound growth rate of 10.8% from 2021-2026.
Global CRO Industry Market Size and Growth Rate from 2017-2026 (100 Million USD)
Source: Frost & Sullivan
Nonclinical Safety Evaluation of Drugs Classification and Introduction
|Safety Pharmacology||To observe the effects of drugs on the functions of major vital organs, mainly the central nervous system, respiratory system and circulatory system.|
|Single Dose Toxicity Test||To observe the toxic reactions and death of animals within a certain period of time after a single dose or after multiple doses within 24 hours.|
|Repeated administration toxicity test||To examine the toxicity characteristics of the animals after receiving the drug with repeated administration of higher doses over a longer period of time.|
|Toxicokinetics||Including the following two aspects: 1) methodological development and validation, and 2) blood concentration determination and assessment of the relationship between drug exposure and toxicity in the body.|
|Reproductive toxicity test||To observe the effects of the test drug on the reproductive functions and developmental processes of mammals, and to predict the possible adverse effects on the reproductive functions of the parental generation such as germ cells, conception, pregnancy, delivery and lactation, as well as the adverse effects on the embryo-fetal development and postnatal development of the offspring.|
|Genotoxicity tests||A series of in vitro and in vivo tests are conducted to examine the harmful effects of the test substance on the alteration of the structure and function of biological cells, leading to changes in the genetic information of the organism.|
|Carcinogenicity test||To test whether the test drug induces the risk of developing tumors in animals.|
|Local toxicity test||A test to observe the irritation damage of the drug to the administration site such as skin, mucous membrane, eye, muscle, subcutaneous, etc.|
|Immunogenicity and immunotoxicity tests||A series of immunological tests are designed according to the characteristics of the drug or combined with general toxicity tests to evaluate the effect of the test article on the immune system of the body, including but not limited to active systemic allergic reactions, passive skin allergic reactions and other experimental studies.|
|Special safety tests||Hemolysis test, phototoxicity test, etc.|
How large is the global Nonclinical Safety Evaluation of Drugs market?
According to statistics, the global Nonclinical Safety Evaluation of Drugs market size was $4.08 billion in 2017 and increased to $6.64 billion in 2021, with a compound growth rate of 12.9% from 2017 to 2021, and is expected to reach $16.06 billion in 2026, with a compound growth rate of 19.3% from 2021 to 2026.
Global Nonclinical Safety Evaluation of Drugs Industry Market Size from 2017-2026 (100 Million USD)
Source: Frost & Sullivan
Global Nonclinical Safety Evaluation of Drugs Industry Competitive Landscape (Leading Companies)
After years of development, the global Nonclinical Safety Evaluation of Drugs market has already been oligopolistic by 2022. The two major oligopolies, Charles River and LabCorp, respectively occupy approximately 27.6% and 17.9% of the market share, occupying an absolute competitive advantage in the market.
2022 Global Nonclinical Safety Evaluation of Drugs Industry Market Competitive Landscape
Source: Frost & Sullivan
How large is the Nonclinical Safety Evaluation of Drugs market in China?
In 2017, the Nonclinical Safety Evaluation of Drugs market size was approximately 16.0 100 Million YUAN in China and grew rapidly to 79.6 100 Million YUAN in 2021, with a compound growth rate of 49.3% from 2017 to 2021. The Nonclinical Safety Evaluation of Drugs market size is expected to reach 310.3 100 Million YUAN in 2026, with a compound growth rate of 31.3% from 2021 to 2026 in China.
The Nonclinical Safety Evaluation of Drugs Industry Market Size in China from 2017-2026 (100 Million YUAN)
Source: Frost Sullivan
Nonclinical Safety Evaluation of Drugs Market Competitive Landscape in China
Compared to the global oligopoly of Nonclinical Safety Evaluation of Drugs, the concentration of Nonclinical Safety Evaluation of Drugs in China is still in the stage of increasing. After more than 20 years of development, the Nonclinical Safety Evaluation of Drugs has formed several leading companies in China, such as JOINN Lab, WuXi AppTec, and Enos, etc. In 2021, the Nonclinical Safety Evaluation of Drugs WuXi AppTec has the highest market share of 18.6% in China, which is followed by JOINN Lab with 12.3%. The third place was taken by Enox with a market share of 6.1%.
2022 Nonclinical Safety Evaluation of Drugs Industry Market Competition Pattern in China
Source: Frost & Sullivan
Comparison of Top Companies in Nonclinical Safety Evaluation of Drugs Market in China
WuXi AppTec and JOINN Lab are the leading companies in China’s safety evaluation industry. From the perspective of their operations, WuXi AppTec achieved total revenue of 229.0 100 Million YUAN and net profit of 51.0 100 Million YUAN in 2021. WuXi AppTec focuses on pharmaceuticals in its business operations and their drug testing related business achieved a revenue of 45.25 100 Million YUAN, with a market share 19.76%; JOINN Lab achieved a revenue of 15.2 100 Million YUAN and net profit of 5.6 100 Million YUAN in 2021, and JOINN Lab’s drug non-clinical research services business achieved a revenue of 14.83 100 Million YUAN, with a market share of 97.75%.
Analysis of Nonclinical Safety Evaluation of Drugs Market Trend
Global drug safety evaluation industry concentration further increased
In recent years, The top companies of global safety evaluation of drugs have made a series of mergers and acquisitions and expansions to expand their business with the support of scale and capital. For smaller market players, it has become increasingly difficult to gain market share by carrying out increasingly complex projects for major clients. As a result, the drug safety evaluation services industry is expected to see market consolidation in the future, with the leading players expected to acquire smaller players in the industry, and the industry concentration will continue to increase.
Rapid growth in China’s drug safety evaluation market
China’s pharmaceutical industry is undergoing a strategic transition from generic drugs to innovative drugs, and the innovative drug market is showing good growth trends. With the development of innovative drug formulations, the scope of unconventional routes of administration will be expanded, such as through the eyes, ears and nasal cavity and other special routes of administration. Nonclinical Safety Evaluation of Drugs companies are strengthening their R&D innovation capabilities and launching related drug safety evaluation services, to promote the rapid development of Nonclinical Safety Evaluation of Drugs industry. In addition, with the release of a number of regulatory policies by the Chinese government, the approval process for new drug clinical trial applications is being standardized, driving the overall efficiency of the Nonclinical Safety Evaluation of Drugs process.
Strict accreditation to raise the entry barrier of the drug safety evaluation industry
Drug safety issues are an important factor leading to drug development failures and one of the main reasons for withdrawal problems of marketed drugs. Before entering human clinical trials/marketing, drug candidates are required to undergo comprehensive safety evaluation to reduce the economic loss of drug development failure due to serious toxic reactions, which is therefore of great significance.
As an important part of CRO industry, the global Nonclinical Safety Evaluation of Drugs is growing at the same pace as CRO industry. Since Nonclinical Safety Evaluation of Drugs requires GLP qualification, there is a high entry barrier, and the number of safety evaluation organizations with international qualification is limited, which cannot meet the demand for global new drug development.