市場調査レポート
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肝毒性・薬物性肝障害(DILI)検査の世界市場 - 予測(2024年~2031年)Hepatotoxicity and Drug-Induced Liver Injury Testing Market - Forecast(2024 - 2031) |
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肝毒性・薬物性肝障害(DILI)検査の世界市場 - 予測(2024年~2031年) |
出版日: 2023年12月01日
発行: IndustryARC
ページ情報: 英文 112 Pages
納期: 2~3営業日
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世界の肝毒性・薬物性肝障害(DILI)検査の市場規模は、2028年までに3億3,480万米ドルに達し、2023年~2028年にCAGRで6.34%の成長が見込まれています。
市場は、医薬品承認の増加や医薬品の安全性確保の必要性、薬物性肝障害(DILI)の増加、個別化医療の重視など、さまざまな要因によって牽引されています。
市場は製薬産業に加えて、学術研究機関、臨床研究所、医薬品開発と毒性学に携わる開発業務受託機関(CRO)にもサービスを提供しています。市場は、薬物開発活動の増加、薬物の安全性に関する意識の高まり、患者の安全性を確保するためのより正確で信頼性の高い検査手法の必要性により、今後数年間で大きく成長すると予測されています。
珍しいが死に至る可能性のある肝臓病として、薬物性肝障害(DILI)があり、これはOTC、処方薬、ハーブおよびサプリメント(HDS)に関連しています。ハーブおよびサプリメント(HDS)を含む補完療法に関連した肝障害の可能性を認識する人が増えています。
2019年のJournal of Hepatologyの発表によると、HDS製品に関連したDILIに関する疫学調査は現在のところほとんどありません。2005年のスペインのDILI登録では、ハーブ療法はイソニアジドと並んでDILIの頻度で第9位でした。米国のDrug-Induced Liver Injury Network(DILIN)によると、HDS製品はDILI症例全体の16%に関与していると考えられています。この割合は2004年~2005年の7%から2013年~2014年に20%に増加しています。この推定値は、アイスランドの有望な研究で発見されたHDS関連肝毒性の有病率16%に匹敵します。
HDS市場の拡大と保険政策の変化による処方薬の入手性が、DILIの増加に寄与している可能性が高いです。DILIの実際の発生率を把握することは困難です。肝毒性に関する知識が深まり、毒性の低い代替薬が入手できるようになったにもかかわらず、肝薬物反応の絶対頻度は減少が見られません。薬を処方通りに使用した場合、予期せぬかたちで薬物性の肝毒性が多量に発生する特異な事象が起こります。
当レポートでは、世界の肝毒性・薬物性肝障害(DILI)検査市場について調査し、市場シェア、促進要因、セグメント、地域、主要企業などの分析を提供しています。
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
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 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.
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