表紙:肝毒性・薬物性肝障害(DILI)検査の世界市場 - 予測(2024年~2031年)
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1403879

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)

出版日: | 発行: IndustryARC | ページ情報: 英文 112 Pages | 納期: 2~3営業日

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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
  • 全表示
  • 概要
  • 目次
概要

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。

要点

  • 規制要件の厳格化が市場を牽引しています。欧州医薬品庁(EMA)や米国食品医薬品局(FDA)のような規制機関は、新薬の承認に厳格なガイドラインを設けています。全体的な安全性、有効性、品質に関する審査は、規制手続きの一部です。厳格な法律により、安全で効率的な医薬品のみの上市が保証されています。
  • QSARとトキシコゲノミクスを薬物誘発性肝毒性の予測に用いることで、より多くの機会が生まれることが期待されます。これらのアルゴリズムは、さまざまな毒性データ(例えば米国FDAのHuman Liver Adverse Effects Database(HLAED)など)を用いてトレーニングすることにより、時間をかけて強化されてきました。現実に、QSARベースのモデルは、39~89%の感度、65~94%の特異度、59~84%の精度でiDILIを予測することができます。
  • 米国は、肝毒性・薬物性肝障害(DILI)検査市場において支配的な国です。米国で毎年発生する2,000件の急性肝不全の50%以上が薬物関連です(39%がアセトアミノフェン関連、13%がその他の薬物による特異的反応)。急性肝炎の全症例の約10%、黄疸による入院の2~5%が薬物に関連しています。

促進要因 - 肝毒性・薬物性肝障害(DILI)検査市場

漢方薬と補完療法への需要の増加

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。

処方薬の入手性の高まり

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。

目次

第1章 肝毒性・薬物性肝障害(DILI)検査市場 - 市場の概要

  • 定義と範囲

第2章 肝毒性・薬物性肝障害(DILI)検査市場 - エグゼクティブサマリー

第3章 肝毒性・薬物性肝障害(DILI)検査市場 - 情勢

    • 市場シェア分析 - 主要企業
    • 製品ベンチマーク - 主要企業
    • 5大財務分析
    • 特許分析 - 主要企業
    • 価格分析

第4章 肝毒性・薬物性肝障害(DILI)検査市場 - スタートアップ企業シナリオ(プレミアム)

  • 主要スタートアップ企業の分析
    • 投資
    • 収益
    • 製品ポートフォリオ
    • ベンチャーキャピタルと資金調達のシナリオ

第5章 肝毒性・薬物性肝障害(DILI)検査市場 - 業界の市場参入シナリオ(プレミアム)

  • 規制枠組みの概要
  • 新しいビジネスとビジネスのしやすさに関する指標
  • 成功したベンチャーのプロファイル
  • 顧客分析 - 主要企業

第6章 肝毒性・薬物性肝障害(DILI)検査市場 - 市場要因

  • 市場促進要因
  • 市場抑制要因
  • ポーターのファイブフォース分析モデル

第7章 肝毒性・薬物性肝障害(DILI)検査市場 - 戦略的分析

  • バリューチェーン分析
  • 機会の分析
  • サプライヤーと販売業者の分析

第8章 肝毒性・薬物性肝障害(DILI)検査市場 - 生体異物タイプ別

  • 薬物
  • アルコール
  • 食品添加物
  • 塩素系溶剤
  • 真菌毒素
  • 放射性同位体
  • 環境毒素
  • その他

第9章 肝毒性・薬物性肝障害(DILI)検査市場 - 技術タイプ別

  • ELISA
  • 迅速診断検査
  • PCR検査
  • INAAT検査
  • 画像検査(CT、MRI、超音波など)
  • その他

第10章 肝毒性・薬物性肝障害(DILI)検査市場 - 検査製品別

  • 検査装置
  • アッセイキット
  • 消耗品
  • ソフトウェア
  • サービス
  • その他

第11章 肝毒性・薬物性肝障害(DILI)検査市場 - エンドユーザー別

  • 病院
  • 診断研究所
  • 血液銀行
  • 医学研究所
  • 製薬企業
  • その他

第12章 肝毒性・薬物性肝障害(DILI)検査市場 - 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 南米
    • ブラジル
    • アルゼンチン
    • その他の南米
  • 欧州
    • 英国
    • ドイツ
    • フランス
    • イタリア
    • オランダ
    • スペイン
    • ロシア
    • デンマーク
    • その他の欧州
  • アジア太平洋
    • 中国
    • オーストラリア
    • 日本
    • 韓国
    • インド
    • 台湾
    • その他のアジア太平洋

第13章 肝毒性・薬物性肝障害(DILI)検査市場 - エントロピー

  • 新製品の発売
  • M&A、提携、JV、パートナーシップ

第14章 肝毒性・薬物性肝障害(DILI)検査市場 - 業界/セグメントの競合情勢(プレミアム)

  • 企業ベンチマークマトリクス - 主要企業
  • 世界レベルの市場シェア - 主要企業
  • 市場シェア - 主要企業:主要地域別
  • 市場シェア - 主要企業:主要国別
  • 市場シェア - 主要企業:主要製品タイプ別

第15章 肝毒性・薬物性肝障害(DILI)検査市場 - 主要企業リスト:国別(プレミアム)

第16章 肝毒性・薬物性肝障害(DILI)検査市場の企業プロファイル - 製品ポートフォリオ、財務、M&A、発展

  • Eurofins
  • Sigma Aldrich
  • Mayo ClinicH
  • Syngene International Ltd
  • Visikol Inc (BICO)
  • Cyprotex
  • BioIVT
  • XenoTech
  • Hemogenix Inc
  • Hamilton Company
目次
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"