Hepatotoxicity and Drug-Induced Liver Injury Testing Market - Forecast(2024 - 2030)

The hepatotoxicity & drug-induced liver injury testing market size is forecast to reach USD 334.8 million by 2028, after growing at a CAGR of 6.34% during 2023-2028. 

The market for hepatotoxicity and drug-induced liver injury (DILI) testing is driven by various factors such as the increasing number of drug approvals and the need to ensure drug safety, the rise in drug-induced liver injuries, and the growing emphasis on personalized medicine. Both hepatotoxicity and DILI testing are important to assess the safety of drugs and to identify potential liver toxicity early in the drug development process. Different types of tests are used in hepatotoxicity and DILI testing, including biomarker-based assays, in vivo and in vitro models, imaging techniques, and genetic testing. Biomarker-based assays, such as liver function tests and liver-specific biomarkers, are commonly used to evaluate liver health and the presence of toxicity. 

In addition to the pharmaceutical industry, the hepatotoxicity and drug-induced liver injury testing market also serves academic research institutions, clinical laboratories, and contract research organizations (CROs) involved in drug development and toxicology. The hepatotoxicity and drug-induced liver injury testing market is projected to witness significant growth in the coming years, driven by increasing drug development activities, rising awareness about drug safety, and the need for more accurate and reliable testing methods to ensure patient safety.

The report “Hepatotoxicity & Drug-induced Liver Injury Testing Market– Forecast (2023-2028)”, by IndustryARC, covers an in-depth analysis of the following segments of the hepatotoxicity & drug-induced liver injury testing market.

By Xenobiotics Type: Drugs, Alcohol, Food additives, Chlorinated solvents, Fungal Toxins, Radioactive isotopes, Environmental toxins, Others

By Technology: ELISA, Rapid Diagnostic Tests, Polymerase Chain Reaction (PCR) tests, Isothermal Nucleic Acid Amplification Technology (INAAT) tests, Imaging Tests (CT, MRI, Ultrasound etc), Others 

By Testing Product: Testing Equipment, Assay Kits, Consumables, Software, Services, Others

By End User: Hospitals, Diagnostic Laboratories, Blood Banks, Medical Research Labs, Pharmaceutical Companies, Others 

By Geography:  North America, Europe, Asia Pacific, South America

• Rising stringent regulatory requirements are driving the hepatotoxicity & drug-induced liver injury testing market. Strict guidelines are established by regulatory bodies like the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) of the United States for the clearance of new medications. Entire safety, effectiveness, and quality reviews are part of the regulatory procedure. Strict laws guarantee that only safe and efficient medications are released onto the market.

• Using QSAR and toxicogenomics to predict drug-induced hepatotoxicity is expected to create more opportunities. These algorithms have been enhanced over time by training with various toxicity data (for example, from the US FDA Human Liver Adverse Effects Database [HLAED]). In reality, QSAR-based models can predict iDILI with sensitivities ranging from 39 to 89%, specificities ranging from 65 to 94%, and accuracies ranging from 59 to 84%.

• The USA is the dominant Country in the hepatotoxicity & drug-induced liver injury testing market. Over 50% of the 2000 acute liver failure cases that occur in the US each year are drug-related (39% are acetaminophen-related, and 13% are idiosyncratic reactions from other medications). Approximately 10% of all instances of acute hepatitis and 2-5% of hospitalized jaundice episodes are related to drugs.

Drugs dominated the hepatotoxicity & drug-induced liver injury testing market in 2022. The primary parameters driving the market are an increasing number of people suffering from diseases, an aging population, and an increasing number of prescriptions. According to the National Health Services, the cost of prescriptions in England increased by 3.46% between 2019-20 and 2020-21.

The rapid expansion and upgrading of existing pharmacies to boost market penetration is favorably influencing industry growth. For example, Rite Aid Corp. established two new stores, relocated five, and finished shop remodeling in 2020, resulting in 1,826 modified stores in fiscal year 2020. Retail and hospital pharmacies are quickly using various automation systems to improve patient safety and provide prompt and accurate services to their patients. E-prescribing, point-of-sale programs, bar code verification, robotic dispensing, automated pill counting, interactive voice response systems, and automated prescription pick-up all make extensive use of automation systems.

Diagnostic Laboratories dominated the hepatotoxicity & drug-induced liver injury testing market in 2022. Comprehensive testing services are made possible in large part by diagnostic laboratories. Specialized testing to evaluate possible hepatotoxicity and drug-induced liver disease is becoming more and more necessary as the pharmaceutical industry develops new medications. The accuracy and sensitivity of hepatotoxicity testing are improved by the use of cutting-edge technology in diagnostic laboratories, such as mass spectrometry, molecular diagnostics, and imaging modalities. This draws in more customers looking for cutting-edge services.

Polymerase Chain Reaction (PCR) tests account for the largest share of the hepatotoxicity & drug-induced liver injury testing market in 2022. Research investigations aimed at comprehending the genetic pathways behind hepatotoxicity and drug-induced liver injury have made considerable use of PCR. PCR is frequently used for validation and additional research when scientists find particular genetic markers linked to these diseases.

Due to the high prevalence of liver diseases and the risk factors that are linked to them, such as obesity and heavy alcohol intake. For example, around 4.8 million Americans have a diagnosis of liver disease, according to the Centers for Disease Control and Prevention's January 2022 update.

Services account for the largest share of the hepatotoxicity & drug-induced liver injury testing market in 2022. The pharmaceutical sector is always working to create novel medications and healing substances. To guarantee the safety of these compounds during preclinical and clinical development, there is a growing need for efficient hepatotoxicity testing in tandem with the increase in therapeutic candidates in the pipeline.

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have strict safety standards for approved drugs. Comprehensive hepatotoxicity testing is an essential part of safety assessments. Adherence to these regulatory requirements is driving the demand for sophisticated testing methodologies. 

The North American hepatotoxicity & drug-induced liver injury testing market dominated the geography segment in 2022 attributed to factors such as the high prevalence of liver diseases, strong healthcare infrastructure, and substantial investments in research and development. For instance, a CMS report states that US health spending increased by 9.7% in 2020 to reach USD 4.1 trillion, or USD 12,530 per person. Over the next 20 to 50 years, it is anticipated that healthcare spending will rise due to projected demographic shifts and higher spending on public pensions. According to the UN Population Division, North America's aging population will grow from 880 million in 2011 to 2 billion by 2050, accounting for 22% of the world's population. Healthcare costs are predicted to rise by 25% by 2030 if current trends continue, primarily due to an aging population. 

An unusual but potentially deadly type of liver illness is drug-induced liver injury (DILI), which is linked to over-the-counter, prescription, and herbal and dietary supplements (HDS). More people are becoming aware of the possible hepatotoxicity linked to complementary therapies including herbal remedies and nutritional supplements (HDS). 

There are presently few epidemiological investigations of DILI connected to HDS products, according to a 2019 Journal of Hepatology publication. Herbal remedies were placed 9th in terms of DILI frequency in the Spanish DILI registry in 2005, on par with isoniazid. According to the US Drug-Induced Liver Injury Network (DILIN), HDS products are thought to be responsible for 16% of DILI cases overall. This percentage increased from 7% in 2004–2005 to 20% in 2013–2014. This estimate is comparable to the 16% prevalence of HDS-associated hepatotoxicity discovered in an Icelandic prospective study.

The growing HDS market and the more readily available prescription drugs as a result of shifting insurance policies are likely to contribute to an increase in DILI instances. It is challenging to ascertain the actual incidence of DILI. The absolute frequency of hepatic drug reactions does not seem to be declining despite growing knowledge of hepatotoxicity and the availability of less toxic substitutes, in line with the expanding number of prescriptions and variety of pharmacological substances accessible. When a medicine is used as prescribed, idiosyncratic events occur when a significant amount of drug-induced hepatotoxicity happens in an unforeseen way.

• Drug-Induced Liver Injury (DILI) Remains a Challenge in Clinical Practice

Drug-induced liver damage (DILI) is still an uncommon diagnosis and a problem in clinical practice. With a 50% fatality rate, DILI accounts for the majority of instances of acute liver failure despite having a low frequency in the general population. Despite the numerous hypothesized processes of DILI, there is no conclusive link between medicines, risk factors, and mechanisms of DILI. There is currently no proven treatment for the particularly dangerous kind of acute liver failure that can result from idiosyncratic hepatotoxicity, which can be quite severe. The available data on risk factors, diagnosis, treatment, and risk-reduction tactics for drug-induced liver damage is compiled in these Clinical Practise Guidelines.

Certain medications seem to be more or less harmful depending on race. For instance, the toxicity of isoniazid (INH) may affect Blacks and Hispanics more frequently. P-450 enzymes regulate the rate of metabolism, which varies depending on the individual. Hepatic medication responses in children are uncommon unless they result from unintentional exposure. Drug-to-drug interactions, lower liver capacity, decreased hepatic blood flow, variations in drug binding, and impaired clearance all put elderly people at higher risk of hepatic damage. 

Furthermore, a poor diet, infections, and repeated hospital stays are significant causes of hepatotoxicity from drugs. Other considerations are genetics, AIDS, malnourishment, and the possibility of medication responses in fasting individuals due to reduced glutathione storage.

Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the hepatotoxicity & drug-induced liver injury testing market. In 2022, the hepatotoxicity & drug-induced liver injury testing market share has been consolidated by the major players accounting for 61% of the share. Major players in the hepatotoxicity & drug-induced liver injury testing market are Mayo Clinic, Eurofins, Syngene, Sigma Aldrich, BioIVT, and Cyprotex among others.

 In February 2023, A division of Evotec, Cyprotex US, LLC, opened a new location in Framingham, Massachusetts, opening the door for the company's ADME-Tox services business to grow significantly more for clients in the US.

 In September 2022, BioIVT, a significant provider of drug discovery and development research models, biospecimens, and research services, acquired XenoTech, a Japanese company that provides products for ADME-Tox in vitro models and contract research services. BioIVT and XenoTech's collaboration expands ADME-Tox and Drug-Drug Interaction research services, as well as a broader range of research products.