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全球肝毒性/药物性肝损伤 (DILI) 检测市场 - 预测（2024-2031 年）

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1403879

全球肝毒性/药物性肝损伤 (DILI) 检测市场 - 预测（2024-2031 年）

Hepatotoxicity and Drug-Induced Liver Injury Testing Market - Forecast(2024 - 2031)

出版日期: 2023年12月01日 | 出版商:

IndustryARC | 英文 112 Pages | 商品交期: 2-3个工作天内

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简介目录

预计2028年，全球肝毒性/药物性肝损伤（DILI）检测市场规模将达3.348亿美元，2023年至2028年复合年增长率为6.34%。

该市场受到多种因素的推动，包括药物审批的增加和确保药物安全的需要、药物性肝损伤（DILI）发生率的增加以及对个人化医疗的重视。

除製药业外，该市场还服务于涉及药物开发和毒理学的学术研究机构、临床实验室和合约研究组织（CRO）。由于药物开发活动的增加、药物安全意识的提高以及对更准确和可靠的测试方法的需求以确保患者安全，预计该市场在未来几年将显着增长。

重点

更严格的监管要求正在推动市场发展。欧洲药品管理局 (EMA) 和美国食品药物管理局 (FDA) 等监管机构对于批准新药有严格的指导方针。整体安全性、有效性和品质审查是监管过程的一部分。严格的法律确保只有安全有效的药物才能进入市场。
使用 QSAR 和毒理基因组学来预测药物引起的肝毒性有望创造更多机会。随着时间的推移，透过使用各种毒性数据（例如美国 FDA 的人类肝臟不良反应资料库 (HLAED)）进行训练，这些演算法得到了增强。事实上，基于 QSAR 的模型可以预测 iDILI，其灵敏度为 39-89%，特异性为 65-94%，准确度为 59-84%。
美国是肝毒性/药物性肝损伤（DILI）检测市场的主导国家。美国每年发生的 2,000 例急性肝衰竭病例中，超过 50% 与药物相关（39% 与对乙酰氨基酚相关，13% 与其他药物相关的特异性反应）。大约 10% 的急性肝炎病例和 2% 至 5% 的黄疸住院病例与药物有关。

驱动因素 - 肝毒性/药物性肝损伤 (DILI) 测试市场

对草药和补充疗法的需求不断增加

药物性肝损伤 (DILI) 是一种罕见但可能致命的肝病，它与非处方药、处方药、草药和补充剂 (HDS) 有关。越来越多的人开始意识到补充疗法（包括草药和补充剂 (HDS)）可能导致肝损伤。

根据 2019 年Journal of Hepatology发表的文章，目前很少有与 HDS 产品相关的 DILI 的流行病学研究。在 2005 年西班牙 DILI 登记中，草药疗法与异烟□一起在 DILI 发生率中排名第九。根据美国Drug-Induced Liver Injury Network（DILIN）的数据，HDS 产品被认为涉及所有 DILI 病例的 16%。这一比例从2004-2005年的7%增加到2013-2014年的20%。这一估计值与冰岛一项前瞻性研究中发现的 HDS 相关肝毒性 16% 的盛行率相当。

增加处方药的供应

由于保险政策的变化，HDS 市场的扩大和处方药的供应可能会导致 DILI 的增加。DILI 的实际发生率很难确定。儘管人们对肝毒性的认识不断增加，并且出现了毒性较小的替代药物，但肝臟药物反应的绝对频率并未降低。当按处方使用药物时，会发生一种独特的事件，即意外地发生大量药物引起的肝毒性。

该报告调查了全球肝毒性和药物性肝损伤 (DILI) 检测市场，并提供了市场份额、驱动因素、细分市场、地区和主要参与者的分析。

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.

Report Coverage

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

Key Takeaways

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.

By Xenobiotics Type - Segment Analysis

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.

End User - Segment Analysis

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.

Technology Type - Segment Analysis

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.

Testing Product Type - Segment Analysis

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.

Geography - Segment Analysis

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.

Drivers - Hepatotoxicity & Drug-induced Liver Injury Testing Market

Increasing Demand for Herbal and Complementary Medicines Hepatotoxicity

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.

Increased Availability of Prescription Medications

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.

Challenges - Hepatotoxicity & Drug-induced Liver Injury Testing Market

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.

Risk Factors for Drug-Induced Liver Injury

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.

Market Landscape

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.

Developments:

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.

1. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Market Overview

1.1 Definitions and Scope

2. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Executive Summary

3. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Landscape

3.1.1 Market Share Analysis- Major Companies
3.1.2 Product Benchmarking- Major Companies
3.1.3 Top 5 Financials Analysis
3.1.4 Patent Analysis- Major Companies
3.1.5 Pricing Analysis

4. Hepatotoxicity & Drug-induced Liver Injury Testing Market - Startup companies Scenario Premium Premium

4.1 Top startup company Analysis by
- 4.1.1 Investment
- 4.1.2 Revenue
- 4.1.3 Product Portfolio
- 4.1.4 Venture Capital and Funding Scenario

5. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Industry Market Entry Scenario Premium Premium

5.1 Regulatory Framework Overview
5.2 New Business and Ease of Doing business index
5.3 Successful Venture Profiles
5.4 Customer Analysis - Major companies

6. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Market Forces

6.1 Market Drivers
6.2 Market Constraints
6.3 Porters five force model
- 6.3.1 Bargaining power of suppliers
- 6.3.2 Bargaining powers of customers
- 6.3.3 Threat of new entrants
- 6.3.4 Rivalry among existing players
- 6.3.5 Threat of substitutes

7. Hepatotoxicity & Drug-induced Liver Injury Testing Market -Strategic analysis

7.1 Value chain analysis
7.2 Opportunities analysis
7.3 Suppliers and Distributors Analysis

8. Hepatotoxicity & Drug-induced Liver Injury Testing Market- By Xenobiotics Type (Market Size -$ Million)

8.1 Drugs
8.2 Alcohol
8.3 Food Additives
8.4 Chlorinated Solvents
8.5 Fungal Toxins
8.6 Radioactive isotopes
8.7 Environmental toxins
8.8 Others

9. Hepatotoxicity & Drug-induced Liver Injury Testing Market- By Technology Type (Market Size -$ Million)

9.1 ELISA
9.2 Rapid Diagnostic Tests
9.3 Polymerase Chain Reaction (PCR) tests
9.4 Isothermal Nucleic Acid Amplification Technology (INAAT) tests
9.5 Imaging Tests (CT, MRI, Ultrasound etc)
9.6 Others

10. Hepatotoxicity & Drug-induced Liver Injury Testing Market- By Testing Product (Market Size -$ Million)

10.1 Testing Equipment
10.2 Assay Kits
10.3 Consumables
10.4 Software
10.5 Services
10.6 Others

11. Hepatotoxicity & Drug-induced Liver Injury Testing Market- By End User (Market Size -$ Million)

11.1 Hospitals
11.2 Diagnostic Laboratories
11.3 Blood Banks
11.4 Medical Research Labs
11.5 Pharmaceutical Companies
11.6 Others

12. Hepatotoxicity & Drug-induced Liver Injury Testing Market- By Geography (Market Size -$ Million)

12.1 North America
- 12.1.1 USA
- 12.1.2 Canada
- 12.1.3 Mexico
12.2 South America
- 12.2.1 Brazil
- 12.2.2 Argentina
- 12.2.3 Rest of SA
12.3 Europe
- 12.3.1 UK
- 12.3.2 Germany
- 12.3.3 France
- 12.3.4 Italy
- 12.3.5 Netherlands
- 12.3.6 Spain
- 12.3.7 Russia
- 12.3.8 Denmark
- 12.3.9 Rest of Europe
12.4 Asia-Pacific
- 12.4.1 China
- 12.4.2 Australia
- 12.4.3 Japan
- 12.4.4 South Korea
- 12.4.5 India
- 12.4.6 Taiwan
- 12.4.7 Rest of APAC

13. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Entropy

13.1 New Product Launches
13.2 M&A's, Collaborations, JVs and Partnerships

14. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Industry/Segment Competition Landscape Premium

14.1 Company Benchmarking Matrix- Major Companies
14.2 Market Share at Global Level- Major companies
14.3 Market Share by Key Region- Major companies
14.4 Market Share by Key Country- Major companies
14.5 Market Share by Key Product Type- Major companies

15. Hepatotoxicity & Drug-induced Liver Injury Testing Market- Key Company List by Country Premium Premium

16. Hepatotoxicity & Drug-induced Liver Injury Testing Market Company Profiles - Product Portfolio, Financials, M&A, and Developments

16.1 Eurofins
16.2 Sigma Aldrich
16.3 Mayo Clinic
16.4 Syngene International Ltd
16.5 Visikol Inc (BICO)
16.6 Cyprotex
16.7 BioIVT
16.8 XenoTech
16.9 Hemogenix Inc
16.10 Hamilton Company

"*Financials would be provided on a best-efforts basis for private companies"

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License/价格

全球肝毒性/药物性肝损伤 (DILI) 检测市场 - 预测（2024-2031 年）

Hepatotoxicity and Drug-Induced Liver Injury Testing Market - Forecast(2024 - 2031)

重点

驱动因素 - 肝毒性/药物性肝损伤 (DILI) 测试市场

对草药和补充疗法的需求不断增加

增加处方药的供应

目录

第一章肝毒性/药物性肝损伤（DILI）检测市场—市场概述

第二章肝毒性/药物性肝损伤 (DILI) 测试市场 - 执行摘要

第三章肝毒性/药物性肝损伤（DILI）检测市场-现状

第四章肝毒性/药物性肝损伤（DILI）测试市场-新创公司场景（高级）

第五章肝毒性/药物性肝损伤（DILI）检测市场-产业市场进入情境（进阶）

第六章肝毒性/药物性肝损伤（DILI）检测市场－市场因素

第七章肝毒性/药物性肝损伤（DILI）检测市场-策略分析

第 8 章肝毒性/药物性肝损伤 (DILI) 测试市场 – 依异生素类型

第 9 章肝毒性/药物性肝损伤 (DILI) 测试市场 - 依技术类型

第10章肝毒性/药物性肝损伤（DILI）测试市场－按测试产品

第 11 章 肝毒性/药物性肝损伤 (DILI) 测试市场 – 依最终用户

第十二章肝毒性/药物性肝损伤（DILI）测试市场－按地区

第十三章肝毒性/药物性肝损伤（DILI）测试市场-熵

第十四章肝毒性/药物性肝损伤（DILI）测试市场-产业/细分市场竞争格局（进阶）

第十五章肝毒性/药物性肝损伤（DILI）测试市场 - 主要公司清单：按国家/地区（高级）

第十六章肝毒性/药物性肝损伤（DILI）检测市场公司概况 - 产品组合、财务、併购、发展