全球诊断酶市场：预测（2024-2029）

2022年全球诊断酵素市场规模为46.46亿美元。

使用酵素来识别和分析生物异常的概念是基于内源性酵素的活性对健康敏感的事实。此外，基材浓度的波动也是生理异常的征兆，可以透过酵素来检测。例如，使用胆固醇氧化酶测量胆固醇可以识别可能的心血管问题或高血压。在生物技术中，酵素有时被用来开发分析和检测技术，例如酵素结合免疫吸附检测法(ELISA) 和偶联多酶反应测定。

老年人口增加

由于人口老化，诊断酶市场预计将成长得更快。据世界卫生组织 (WHO) 称，到 2030 年，六分之一的人口将超过 60 岁，其中新兴国家是罪魁祸首。 2020年至2050年间，80岁及以上的人口数量预计将增加两倍，达到4.26亿。老年人通常患有听力损失、白内障、屈光不正、背部和颈部疼痛、骨关节炎、糖尿病、忧郁症和失智症，这些都导致​​学名药的使用增加。随着年龄的增长，我们变得更容易同时感染多种疾病，这可能会刺激诊断酵素市场的成长。

用于糖尿病诊断的诊断酶

辨识糖尿病最快、最简单的方法是血糖值测试。参与葡萄糖代谢的酵素与葡萄糖反应，从而检测血液样本中葡萄糖的存在。 Creative Enzymes 提供不同供应商的各种与糖尿病相关的酵素。例如，葡萄糖-6-磷酸去氢酶的缺乏与糖尿病的风险增加有关。葡萄糖氧化酵素和葡萄糖去氢酵素最常用于临床血糖检测。为了开始使用葡萄糖，己糖激酶催化葡萄糖磷酸化产生葡萄糖 6-磷酸。

用于肝功能测试的诊断酶

肝功能障碍的治疗和肝病的早期发现取决于肝功能检查的结果。人们已经创建了各种酶促反应来识别与各种肝损伤相关的奇怪化合物的存在，从而推动了诊断酶行业的发展。例如，Creative Enzymes 是一种诊断酶产品，支持肝功能评估的临床和科学应用。该业务包括多种天然来源或生化合成的肝功能相关酶，以满足消费者的特殊需求。苹果酸去氢酶、D-乳酸去氢酶、乙醇去氢酶和碱性磷酸酶均可以天然或重组形式取得。

对核酸酶的需求不断增加

核酸酶将 DNA 和 RNA 的核苷酸链分解成更小的片段。 DNA 分子被核酸酶分解，核酸酶也会分解连接 DNA 链中核苷酸的磷酸二酯键。核酸外切酶和核酸内切酶是两种不同类型的核酸酶。此外，酵素专家 Biocatalysts Ltd 于 2023 年 3 月推出了 Nuclease 46L (N046L)，这是一种用于降解多种来源的多种核酸的新型酵素。这种酶主要是作为一种低成本方法而开发的，用于在各种生物技术应用中去除 DNA。这些发展对于诊断酵素产业的进步至关重要。

在北美，诊断酶市场预计将稳定成长。

由于对酶的需求不断增长以及感染疾病的流行，预计北美将占据主导地位。例如，FDA 已授权实验室开发的 COVID-19 诊断方法紧急使用，以应对持续的感染疾病爆发。为了检测 SARS-CoV-2，大多数紧急使用授权也采用基于 RT-PCR 的测试和酵素结合免疫吸附测试。由于 RT-PCR 使用多种酶，因此此类检测方法的开发预计将在北美诊断酶市场上获利。

政府关于诊断酶的倡议

• 根据国家卫生使命，各州和首府将按照计划实施计划（PIP）和总体资源框架中规定的要求，在公共卫生设施中免费提供基本药物，并获得财政援助。为了确保普遍获得基本药物，卫生部提案在公共机构中提供特定设施的基本药物清单（EDL）。
• 快速诊断测试（RDT）在快速且准确地识别传染性微生物并确定其对各种抗生素的敏感性方面具有巨大潜力。因此，预计它将在未来的抗菌药物管理（AMS）计划中发挥重要作用。在某些特定情况下部署 AMS 的国际标准已鼓励使用 RDT。

诊断酵素产品

• EKF Diagnostics：诊断酵素由 EKF Life Sciences 生产并用作临床诊断剂。这些包括水杨酸羟化酶、β-羟基丁酸去氢酶和芳基酰胺酶。这些诊断酶以“Stand Biochemistry”品牌在市场上销售，用于临床诊断试剂製造商和OEM试剂的试剂生产。
• 旭化成製药：为了预防糖尿病併发症，正确控制血糖值很重要。糖化白蛋白测量采血前 2 週的平均血糖值。糖化白蛋白使用2004年推出的LucicaTM GA-L液体试剂检测套组进行测量。糖化白蛋白于2009年被日本红十字会采纳为捐血的检测项目。

目录

第一章简介

• 市场概况
• 市场定义
• 调查范围
• 市场区隔
• 货币
• 先决条件
• 基准年和预测年时间表

第二章调查方法

• 调查资料
• 先决条件

第三章执行摘要

• 研究亮点

第四章市场动态

• 市场驱动因素
• 市场限制因素
• 波特五力分析
• 产业价值链分析

第五章诊断酵素市场：依类型

• 介绍
• Taq聚合酵素
• MMLV RT
• HIV RT
• NG
• 核糖核酸酶抑制剂
• 其他的

第六章诊断酵素市场：依产品类型

• 介绍
• 分子酵素
• 临床酵素

第七章诊断酵素市场：依应用分类

• 介绍
• 糖尿病
• 肿瘤学
• 心臟病学
• 感染疾病
• 其他的

第八章诊断酵素市场：按地区

• 介绍
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 南美洲
  • 巴西
  • 阿根廷
  • 其他的
• 欧洲
  • 英国
  • 德国
  • 法国
  • 西班牙
  • 其他的
• 中东/非洲
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 以色列
  • 其他的
• 亚太地区
  • 日本
  • 中国
  • 印度
  • 韩国
  • 印尼
  • 泰国
  • 其他的

第九章竞争环境及分析

• 主要企业及策略分析
• 市场占有率分析
• 併购/协议/合作
• 供应商竞争力矩阵

第十章 公司简介

• EKF Diagnostics
• Sekisui Diagnostics
• Negen Corporation
• Novozymes
• CustomBiotech
• TOYOBO
• Asahi Kasei
• Sekisui Medical Co. Ltd.
• NZYTech
• Megazyme

The diagnostic enzymes market was valued at US$4.646 billion in 2022.

The notion of employing enzymes to identify and analyze biological abnormalities is based on the fact that the activity of endogenous enzymes is sensitive to health. In addition, variations in the concentration of the substrate, which are also a sign of physiological abnormalities, can be detected by enzymes. For instance, measuring cholesterol using cholesterol oxidase might identify probable cardiovascular problems or high blood pressure. In biotechnologies, enzymes may be employed to create analysis and detection techniques like the enzyme-linked immunosorbent assay (ELISA) and coupled multi-enzyme reaction assays.

Increase in geriatric population

The diagnostic enzymes market is expected to expand more quickly as a result of the aging population. By 2030, 1 in 6 individuals will be 60 or older, with emerging countries being primarily responsible for this growth, according to the World Health Organisation. Between 2020 and 2050, the number of persons 80 or older is projected to treble, reaching 426 million. Elderly patients typically have hearing loss, cataracts and refractive errors, back and neck pain and osteoarthritis, diabetes, depression, and dementia, which contributes to the rising usage of generic medications. People are more prone to several diseases at once as they get older which can fuel the growth of the diagnostic enzymes market.

Diagnostic Enzymes for Diabetes Diagnosis

The quickest and easiest way to identify diabetes is with a blood sugar test. Enzymes involved in the metabolism of glucose are created to react with glucose and, as a result, to detect the presence of glucose in blood samples. Creative Enzymes carries a wide range of diabetes-related enzymes from various suppliers. For instance, a lack of glucose-6-phosphate dehydrogenase has been linked to an increased risk of developing diabetes. For clinical blood sugar tests, glucose oxidase and glucose dehydrogenase are most frequently utilized. To start using glucose, hexokinase catalyzes the phosphorylation of glucose to produce glucose 6-phosphate.

Diagnostic enzymes for liver function test

The therapy of individuals with hepatic dysfunction and early detection of liver illnesses depend on the results of liver function tests. To identify the presence of odd compounds linked to various forms of liver injury or disorders, a variety of enzymatic reactions are created which boosts the diagnostic enzymes industry. For instance, with their diagnostic enzyme products, Creative Enzymes has supported the clinical and scientific usage of liver function assessment. The business includes several liver function-related enzymes from various natural sources or biochemical syntheses to satisfy the unique requirements of the consumer. Malate dehydrogenase, D-lactate dehydrogenase, alcohol dehydrogenase, and alkaline phosphatase are all available in either natural or recombinant forms.

Rising demand for nuclease enzymes

An enzyme called nuclease divides the DNA and RNA nucleotide chain into smaller pieces. The DNA molecule is broken down by the nuclease enzyme, as well as the phosphodiester bonds connecting one nucleotide to another in the DNA strand. Exonucleases and endonucleases are the two distinct kinds of nucleases. Additionally, in March 2023, Nuclease 46L (N046L), a novel enzyme from enzyme experts Biocatalysts Ltd, is now available for the breakdown of various nucleic acids from a variety of sources. It was created primarily as a low-cost method to get rid of DNA in a variety of biotechnology applications. These developments are essential for the development of the diagnostic enzymes industry.

In North America, it is projected that the diagnostic enzymes market will grow steadily.

North American region is expected to take a leading position as a result of the expanding demand for enzymes and the prevalence of infectious illnesses there. For instance, the FDA has authorized COVID-19 laboratory-developed diagnostics for use in emergencies to tackle the ongoing outbreak. For the detection of SARS-CoV-2, the majority of these emergency usage authorizations also employ RT-PCR-based testing and enzyme-linked immunosorbent tests. Because RT-PCR uses a lot of enzymes, the development of such assays is projected to be profitable in the North American diagnostic enzymes market.

Government initiatives for diagnostic enzymes

• Following the National Health Mission, States and UTs get financial assistance to offer free basic medications in public health facilities following the demands stated in their Programme Implementation Plans (PIPs) and the overall resource envelope. To guarantee universal access to necessary medications, the ministry has proposed that a facility-specific Essential Drugs List (EDL) be made accessible at public healthcare institutions.
• Rapid diagnostic tests (RDTs) have a great deal of potential for quickly and accurately identifying infectious organisms and determining their susceptibility to various types of antibiotics. As a result, they are expected to play a bigger role in antimicrobial stewardship (AMS) programs in the future. RDT usage is already encouraged by international standards for the deployment of AMS in a few particular contexts.

Diagnostic enzymes Products

• EKF Diagnostics, Diagnostic enzymes are produced by EKF Life Sciences and utilised as clinical diagnostic reagents. Among these are salicylate hydroxylase, beta-hydroxybutyrate dehydrogenase, and arylacylamidase. These diagnostic enzymes are sold commercially for use in the manufacturing of third-party clinical diagnostic firms' reagents as well as OEM reagents under the Stanbio Chemistry brand.
• Asahi Kasei Pharma, Controlling blood sugar properly is crucial for avoiding diabetic complications. The glycated albumin measures the average glycemia throughout the two weeks before the blood sample. Glycated albumin is measured using the LucicaTM GA-L liquid reagent test kit, which was introduced in 2004. Glycated albumin was included as a laboratory test component for donated blood by the Japan Red Cross in 2009.

Market Key Developments

• In June 2023, scientists from the Indian Institute of Science created a fluorogenic probe to identify an enzyme associated with the early stages of the neurodegenerative illness Alzheimer's.
• In February 2023, a pioneer in the production and delivery of diagnostic enzymes, Creative Enzymes, and research diagnostics. The company recently included pancreatic and kidney enzymes.
• In December 2022, Ginkgo Enzyme Services was launched, according to Ginkgo Bioworks, which is developing the top platform for cell programming and biosecurity. Ginkgo Enzyme Services is supported by optimized, patented bacterial and fungal host strains, machine learning-guided protein design, and ultra-high throughput screening.

Segmentation:

By Type

• Taq Polymerase
• MMLV RT
• HIV RT
• UNG
• RNase Inhibitors
• Others

By Product Type

• Molecular Enzymes
• Clinical Enzymes

By Application

• Diabetes
• Oncology
• Cardiology
• Infectious Diseases
• Others

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• United Kingdom
• Germany
• France
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Israel
• Others
• Asia Pacific
• Japan
• China
• India
• South Korea
• Indonesia
• Thailand
• Others

TABLE OF CONTENTS

1. INTRODUCTION

• 1.1. Market Overview
• 1.2. Market Definition
• 1.3. Scope of the Study
• 1.4. Market Segmentation
• 1.5. Currency
• 1.6. Assumptions
• 1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

• 2.1. Research Data
• 2.2. Assumptions

3. EXECUTIVE SUMMARY

• 3.1. Research Highlights

4. MARKET DYNAMICS

• 4.1. Market Drivers
• 4.2. Market Restraints
• 4.3. Porter's Five Force Analysis
  • 4.3.1. Bargaining Power of Suppliers
  • 4.3.2. Bargaining Power of Buyers
  • 4.3.3. Threat of New Entrants
  • 4.3.4. Threat of Substitutes
  • 4.3.5. Competitive Rivalry in the Industry
• 4.4. Industry Value Chain Analysis

5. DIAGNOSTIC ENZYMES MARKET, BY TYPE

• 5.1. Introduction
• 5.2. Taq Polymerase
• 5.3. MMLV RT
• 5.4. HIV RT
• 5.5. UNG
• 5.6. RNase Inhibitors
• 5.7. Others

6. DIAGNOSTIC ENZYMES MARKET, BY PRODUCT TYPE

• 6.1. Introduction
• 6.2. Molecular Enzymes
• 6.3. Clinical Enzymes

7. DIAGNOSTIC ENZYMES MARKET, BY APPLICATION

• 7.1. Introduction
• 7.2. Diabetes
• 7.3. Oncology
• 7.4. Cardiology
• 7.5. Infectious Diseases
• 7.6. Others

8. DIAGNOSTIC ENZYMES MARKET, BY GEOGRAPHY

• 8.1. Introduction
• 8.2. North America
  • 8.2.1. United States
  • 8.2.2. Canada
  • 8.2.3. Mexico
• 8.3. South America
  • 8.3.1. Brazil
  • 8.3.2. Argentina
  • 8.3.3. Others
• 8.4. Europe
  • 8.4.1. United Kingdom
  • 8.4.2. Germany
  • 8.4.3. France
  • 8.4.4. Spain
  • 8.4.5. Others
• 8.5. The Middle East and Africa
  • 8.5.1. Saudi Arabia
  • 8.5.2. UAE
  • 8.5.3. Israel
  • 8.5.4. Others
• 8.6. Asia Pacific
  • 8.6.1. Japan
  • 8.6.2. China
  • 8.6.3. India
  • 8.6.4. South Korea
  • 8.6.5. Indonesia
  • 8.6.6. Thailand
  • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 9.1. Major Players and Strategy Analysis
• 9.2. Market Share Analysis
• 9.3. Mergers, Acquisitions, Agreements, and Collaborations
• 9.4. Vendor Competitiveness Matrix

10. COMPANY PROFILES

• 10.1. EKF Diagnostics
• 10.2. Sekisui Diagnostics
• 10.3. Negen Corporation
• 10.4. Novozymes
• 10.5. CustomBiotech
• 10.6. TOYOBO
• 10.7. Asahi Kasei
• 10.8. Sekisui Medical Co. Ltd.
• 10.9. NZYTech
• 10.10. Megazyme