Press Release

Non-Clinical Trials Market to Grow with a CAGR of 6.22% through 2028

Outsourcing of non-clinical trial services to specialized Contract Research Organizations are expected to drive the Global Non-Clinical Trials Market growth in the forecast period, 2024-2028.


According to TechSci Research report, “Non-Clinical Trials Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2028”, the Global Non-Clinical Trials Market stood at USD 9.86 billion in 2022 and is anticipated to grow with a CAGR of 6.22% in the forecast period, 2024-2028, The Global Non-Clinical Trials Market is experiencing unprecedented growth and transformation, fueled by several key market drivers that are reshaping the landscape of pharmaceutical and healthcare industries. Non-clinical trials, also known as preclinical trials, play an instrumental role in evaluating the safety, efficacy, and toxicity of experimental drugs and medical devices before they progress to human testing. One of the foremost drivers of the Global Non-Clinical Trials Market is the escalating demand for groundbreaking pharmaceuticals and medical devices. As the prevalence of various diseases continues to rise, so does the need for innovative therapies and treatments. This has led pharmaceutical and biotechnology companies, as well as academic research institutions, to invest heavily in non-clinical trials to ensure that their products meet rigorous regulatory standards and are safe for human use.The outsourcing of non-clinical trial services to specialized Contract Research Organizations (CROs) has become a prevalent trend in the pharmaceutical and healthcare industries. CROs offer expertise, infrastructure, and cost-effectiveness, making them an attractive option for companies looking to conduct non-clinical trials efficiently. This outsourcing trend has significantly contributed to the market's growth, as CROs play a vital role in conducting these trials on behalf of pharmaceutical giants and emerging biotech companies.

Technological advancements are revolutionizing non-clinical trials. In silico modeling, artificial intelligence, and machine learning are increasingly being used to simulate drug behavior, toxicity, and efficacy. These cutting-edge technologies enable researchers to make more accurate predictions and reduce the reliance on extensive animal testing. By leveraging these tools, pharmaceutical companies can streamline the drug development process, ultimately accelerating time-to-market. Regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have implemented stringent guidelines for non-clinical trials. These regulations require comprehensive testing and documentation of a product's safety profile before it can advance to clinical trials. Meeting these regulatory standards is paramount for market approval, and the demand for compliance services is driving the growth of the Global Non-Clinical Trials Market.


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The biotechnology sector has witnessed remarkable growth in recent years, with a focus on developing innovative therapies, including gene therapies, cell-based therapies, and biologics. These advanced therapies require extensive non-clinical testing to ensure their safety and efficacy. Consequently, the expansion of the biotechnology sector is a significant driver for the Global Non-Clinical Trials Market. The paradigm of healthcare is shifting towards personalized medicine, which tailors’ treatments to individual patients based on their genetic makeup and specific needs. Non-clinical trials play a pivotal role in the development of personalized therapies, as they help identify patient-specific responses, adverse effects, and optimal dosages. This growing emphasis on personalized medicine is spurring an increase in non-clinical trial activities, driving the market forward.


The Global Non-Clinical Trials Market is segmented into Study Type, Therapeutic Area, end-users, regional distribution, and company.

Based on study type, the Global Non-Clinical Trials Market is segmented into Pharmacodynamics (PD) studies, Pharmacokinetics (PK) studies, and Toxicology studies. Based on the treatment, the Toxicology studies segment emerged as the dominant segment in the global market for Global Non-Clinical Trials Market in 2022. Toxicology studies are a fundamental component of non-clinical trials, and they are conducted to assess the safety of drugs and medical devices. These studies involve evaluating the potential toxicity of a substance by examining its effects on living organisms, typically using animal models. The goal is to identify any adverse effects, establish safe dosage levels, and understand the potential risks associated with the product under investigation.

Based on route of Therapeutic Area, the Global Non-Clinical Trials Market is segmented into Oncology, Cardiovascular, Neurology, Immunology, Others. Based on the therapeutic area, the oncology segment emerged as the dominant player in the global market for Global Non-Clinical Trials Market in 2022.  Oncology, which focuses on the study and treatment of cancer, has been a major area of emphasis in pharmaceutical and biomedical research due to the significant global burden of cancer. Non-clinical trials in oncology involve the preclinical evaluation of potential cancer therapies, including novel drugs, immunotherapies, targeted therapies, and various treatment modalities such as chemotherapy and radiation therapy. The high prevalence of cancer and the constant quest for more effective and personalized cancer treatments have driven extensive research and development efforts in the field. Non-clinical trials play a pivotal role in assessing the safety and efficacy of these oncology treatments before they advance to human clinical trials. These trials involve evaluating the impact of potential cancer therapies on tumor growth, metastasis, and overall patient outcomes, while also assessing potential side effects and toxicities.

North America emerged as the dominant player in the global Non-Clinical Trials Market   in 2022, holding the largest market share. North America, particularly the United States, is home to a thriving pharmaceutical and biotechnology sector. The region boasts a large number of pharmaceutical companies, biotech startups, and research institutions that conduct extensive non-clinical trials. These organizations invest heavily in research and development, driving the demand for non-clinical trial services. The region has access to cutting-edge technologies and research infrastructure, including state-of-the-art laboratories and advanced imaging facilities. These resources enable the execution of complex non-clinical trials and contribute to the region's dominance in the market.


Major companies operating in Global Non-Clinical Trials Market are:

  • Labcorp Drug Development
  • Charles River Laboratories
  • PPD (Pharmaceutical Product Development)
  • ICON plc
  • Novartis AG
  • Merck & Co., Inc.
  • AstraZeneca plc
  • Cmic Holdings Co., Ltd
  • ProPharma
  • MorphoSys AG


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 “The Global Non-Clinical Trials Market is poised for substantial growth in the coming years, driven by several overarching factors. Firstly, the relentless demand for innovative pharmaceuticals and medical devices, propelled by the rising global burden of diseases, is a primary growth catalyst. This demand necessitates comprehensive non-clinical trials to ensure the safety and efficacy of these advanced treatments before they reach patients. Also, the strategic outsourcing of non-clinical trial services to Contract Research Organizations (CROs) is a prominent trend that is expected to continue fueling market expansion. Pharmaceutical and biotechnology companies increasingly rely on CROs to leverage specialized expertise, state-of-the-art facilities, and cost-effective trial management, streamlining the drug development process. Furthermore, the adaptation of regulatory frameworks to accommodate innovative approaches and alternative testing methods is fostering flexibility and efficiency in non-clinical trials. This regulatory evolution is expected to encourage researchers to explore new avenues and embrace cutting-edge technologies.” said Mr. Karan Chechi, Research Director with TechSci Research, a research-based management consulting firm.

Non-Clinical Trials Market   - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Study Type (Pharmacodynamics (PD) studies, Pharmacokinetics (PK) studies, Toxicology studies), By Test (In silico, In vitro, In vivo ), By Therapeutic Area (Oncology, Cardiovascular, Neurology, Immunology, Others), By End User (Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), Academic and Government Research Institutes, Others ) By Region and Competition”, has evaluated the future growth potential of Global Non-Clinical Trials Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Non-Clinical Trials Market.


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