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全球肝毒性/藥物性肝損傷 (DILI) 檢測市場 - 預測（2024-2031 年）
市場調查報告書
商品編碼
1403879

全球肝毒性/藥物性肝損傷 (DILI) 檢測市場 - 預測（2024-2031 年）

Hepatotoxicity and Drug-Induced Liver Injury Testing Market - Forecast(2024 - 2031)
出版日期: | 出版商: IndustryARC | 英文 112 Pages | 商品交期: 2-3個工作天內

價格
簡介目錄

預計2028年，全球肝毒性/藥物性肝損傷（DILI）檢測市場規模將達3.348億美元，2023年至2028年複合年增長率為6.34%。

該市場受到多種因素的推動，包括藥物審批的增加和確保藥物安全的需要、藥物性肝損傷（DILI）發生率的增加以及對個人化醫療的重視。

除製藥業外，該市場還服務於涉及藥物開發和毒理學的學術研究機構、臨床實驗室和合約研究組織（CRO）。由於藥物開發活動的增加、藥物安全意識的提高以及對更準確和可靠的測試方法的需求以確保患者安全，預計該市場在未來幾年將顯著增長。

重點

  • 更嚴格的監管要求正在推動市場發展。歐洲藥品管理局 (EMA) 和美國食品藥物管理局 (FDA) 等監管機構對於批准新藥有嚴格的指導方針。整體安全性、有效性和品質審查是監管過程的一部分。嚴格的法律確保只有安全有效的藥物才能進入市場。
  • 使用 QSAR 和毒理基因組學來預測藥物引起的肝毒性有望創造更多機會。隨著時間的推移，透過使用各種毒性數據（例如美國 FDA 的人類肝臟不良反應資料庫 (HLAED)）進行訓練，這些演算法得到了增強。事實上，基於 QSAR 的模型可以預測 iDILI，其靈敏度為 39-89%，特異性為 65-94%，準確度為 59-84%。
  • 美國是肝毒性/藥物性肝損傷（DILI）檢測市場的主導國家。美國每年發生的 2,000 例急性肝衰竭病例中，超過 50% 與藥物相關（39% 與對乙醯氨基酚相關，13% 與其他藥物相關的特異性反應）。大約 10% 的急性肝炎病例和 2% 至 5% 的黃疸住院病例與藥物有關。

驅動因素 - 肝毒性/藥物性肝損傷 (DILI) 測試市場

對草藥和補充療法的需求不斷增加

藥物性肝損傷 (DILI) 是一種罕見但可能致命的肝病，它與非處方藥、處方藥、草藥和補充劑 (HDS) 有關。越來越多的人開始意識到補充療法（包括草藥和補充劑 (HDS)）可能導致肝損傷。

根據 2019 年Journal of Hepatology發表的文章，目前很少有與 HDS 產品相關的 DILI 的流行病學研究。在 2005 年西班牙 DILI 登記中，草藥療法與異煙□一起在 DILI 發生率中排名第九。根據美國Drug-Induced Liver Injury Network（DILIN）的數據，HDS 產品被認為涉及所有 DILI 病例的 16%。這一比例從2004-2005年的7%增加到2013-2014年的20%。這一估計值與冰島一項前瞻性研究中發現的 HDS 相關肝毒性 16% 的盛行率相當。

增加處方藥的供應

由於保險政策的變化，HDS 市場的擴大和處方藥的供應可能會導致 DILI 的增加。DILI 的實際發生率很難確定。儘管人們對肝毒性的認識不斷增加，並且出現了毒性較小的替代藥物，但肝臟藥物反應的絕對頻率並未降低。當按處方使用藥物時，會發生一種獨特的事件，即意外地發生大量藥物引起的肝毒性。

該報告調查了全球肝毒性和藥物性肝損傷 (DILI) 檢測市場，並提供了市場份額、驅動因素、細分市場、地區和主要參與者的分析。

目錄

第一章肝毒性/藥物性肝損傷（DILI）檢測市場—市場概述

  • 定義和範圍

第二章肝毒性/藥物性肝損傷 (DILI) 測試市場 - 執行摘要

第三章肝毒性/藥物性肝損傷（DILI）檢測市場-現狀

    • 市佔率分析 - 主要公司
    • 產品基準 - 主要公司
    • 5大財務分析
    • 專利分析-主要公司
    • 價格分析

第四章肝毒性/藥物性肝損傷（DILI）測試市場-新創公司場景（高級）

  • 主要新創公司分析
    • 投資
    • 收入
    • 產品介紹
    • 創投和融資場景

第五章肝毒性/藥物性肝損傷（DILI）檢測市場-產業市場進入情境（進階）

  • 監理框架概述
  • 新業務及營商便利度指標
  • 成功企業簡介
  • 客戶分析－各大公司

第六章肝毒性/藥物性肝損傷（DILI）檢測市場－市場因素

  • 市場驅動力
  • 市場制約因素
  • 波特五力分析模型

第七章肝毒性/藥物性肝損傷（DILI）檢測市場-策略分析

  • 價值鏈分析
  • 機會分析
  • 供應商和經銷商分析

第 8 章肝毒性/藥物性肝損傷 (DILI) 測試市場 – 依異生素類型

  • 藥物
  • 酒精
  • 食品添加劑
  • 氯化溶劑
  • 真菌毒素
  • 放射性同位素
  • 環境毒素
  • 其他

第 9 章肝毒性/藥物性肝損傷 (DILI) 測試市場 - 依技術類型

  • □聯免疫吸附試驗
  • 快速診斷測試
  • 聚合□鏈反應測試
  • INAAT測試
  • 影像學檢查（CT、MRI、超音波等）
  • 其他

第10章肝毒性/藥物性肝損傷（DILI）測試市場－按測試產品

  • 檢驗設備
  • 檢測試劑盒
  • 消耗品
  • 軟件
  • 服務
  • 其他

第 11 章 肝毒性/藥物性肝損傷 (DILI) 測試市場 – 依最終用戶

  • 醫院
  • 診斷實驗室
  • 血庫
  • 醫療機構
  • 製藥公司
  • 其他

第十二章肝毒性/藥物性肝損傷（DILI）測試市場－按地區

  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美洲其他地區
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 義大利
    • 荷蘭
    • 西班牙
    • 俄羅斯
    • 丹麥
    • 歐洲其他地區
  • 亞太地區
    • 中國
    • 澳大利亞
    • 日本
    • 韓國
    • 印度
    • 台灣
    • 亞太其他地區

第十三章肝毒性/藥物性肝損傷（DILI）測試市場-熵

  • 新產品發布
  • 併購、聯盟、合資、合夥

第十四章肝毒性/藥物性肝損傷（DILI）測試市場-產業/細分市場競爭格局（進階）

  • 公司基準矩陣 - 主要公司
  • 全球市場佔有率 - 主要參與者
  • 市場佔有率 - 主要參與者：按主要地區
  • 市場佔有率 - 主要公司：依主要國家分類
  • 市場佔有率 - 主要參與者：依主要產品類型

第十五章肝毒性/藥物性肝損傷（DILI）測試市場 - 主要公司清單：按國家/地區（高級）

第十六章肝毒性/藥物性肝損傷（DILI）檢測市場公司概況 - 產品組合、財務、併購、發展

  • Eurofins
  • Sigma Aldrich
  • Mayo ClinicH
  • Syngene International Ltd
  • Visikol Inc (BICO)
  • Cyprotex
  • BioIVT
  • XenoTech
  • Hemogenix Inc
  • Hamilton Company
簡介目錄
Product Code: HCR 1559

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.

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.

Table of Contents

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"