全球莱姆病诊断市场 - 2023-2030

概述

全球莱姆病诊断市场在 2022 年达到 16 亿美元，预计到 2030 年将达到 22 亿美元，2023-2030 年预测期间复合年增长率为 4.3%。

莱姆病诊断测试在血液或脑脊液 (CSF) 样本中寻找感染迹象。脑脊液是一种透明液体，在大脑和脊髓内部及其周围流动。该测试检查样本中免疫系统产生的抗体，以对抗引起莱姆病的细菌。这些诊断测试可识别免疫系统响应感染而产生的抗体。莱姆病诊断可以预测患者是否接触受感染的黑腿蜱的可能性。

莱姆病诊断市场研究分析提供了包含定量和定性数据的市场深入展望。它根据市场细分对全球市场进行了展望和预测。它还提供全球莱姆病诊断市场规模和增长，以及到 2030 年的最新趋势、机会和预测。

在所有地区中，北美地区预计将在预测期内占据全球莱姆病诊断市场的最大份额。北美在全球莱姆病诊断市场中占据主导地位。血清学检测领域在市场份额中占有重要地位。

动力学

技术进步的不断进步和新产品的推出预计将推动市场增长

全球莱姆病诊断市场的增长是由多种因素推动的，例如市场上发布的各种新创新和产品。据莱姆病协会称，莱姆病是全球最常见的蜱传细菌感染。市场正在见证新的经过验证的诊断测试的推出和批准，以准确诊断莱姆病。

例如，2022 年 6 月 15 日，Adaptive Biotechnologies Corporation 是一家商业阶段的生物技术公司，旨在将适应性免疫系统的遗传学转化为诊断和治疗疾病的临床产品，宣布推出 T-Detect Lyme。这是该公司通过其不断壮大的 T-Detect 特许经营权提供的第二项测试。

新型产品的增加和莱姆病诊断各种产品的推出预计将促进市场增长。例如，2022 年 10 月 26 日，数字诊断公司 ixlayer 宣布将生产 CVS Health 品牌的家用样本采集套件。 Ixlayer 的试剂盒可以检测莱姆病、维生素 D 水平、甲状腺功能和性传播感染。因此，上述因素预计将推动市场增长。

不断增长的政府倡议和对即用型诊断试剂盒的日益关注推动了市场增长

政府为预防感染而采取的更多倡议预计将推动市场增长。例如，2023 年 7 月 22 日，哈德逊河谷立法者提出的增加对抗莱姆病和蜱传疾病资金的法案被签署成为法律。由州参议员皮特·哈卡姆（Pete Harckham）和苏·塞里诺（Sue Serino）以及议员迪迪·巴雷特（Didi Barrett）提出的两党立法旨在增加资金，以更有效地对抗传播并更好地保护纽约人免受蜱传疾病的侵害，该立法已由州长凯西·霍赫尔（Kathy Hochul）签署成为法律。

对推出即用型诊断试剂盒的日益关注正在推动市场增长。例如，2023年3月21日，江苏BioPerfectus科技有限公司发布了BioPerfectus自主研发的六款新型实时PCR试剂盒。 BioPerfectus 为我们的合作伙伴提供从样本预处理到 PCR 扩增分析的媒介传播疾病整体诊断解决方案，以快速应对全球卫生紧急情况。因此，政府采取的倡议可以促进市场增长。

缺乏与莱姆病诊断相关的意识预计将阻碍市场增长

对莱姆病诊断的不了解预计将阻碍预测期内市场的增长。有许多针对莱姆病的诊断测试和试剂盒，但欠发达地区无法获得这些测试和试剂盒。只有少数人可能知道这种疾病及其诊断。在农村地区，人们缺乏与疾病及其诊断相关的知识。

缺乏设备齐全的诊断中心无法帮助正确诊断该疾病，这可能会影响市场增长。欠发达地区的患者无法获得诊断测试，疾病的严重程度将会增加，从而影响市场增长。因此，预计市场在预测期内将下降。

目录

第 1 章：方法和范围

• 研究方法论
• 报告的研究目的和范围

第 2 章：定义和概述

第 3 章：执行摘要

• 按测试类型分類的片段
• 测试样本片段
• 最终用户的片段
• 按地区分類的片段

第 4 章：动力学

• 影响因素
  • 司机
• 不断进步的技术和新产品的推出
• 政府倡议不断增多，对即用型诊断试剂盒的关注度不断提高
• 限制
• 缺乏对莱姆病诊断的认识
  • 机会
  • 影响分析

第 5 章：行业分析

• 波特五力分析
• 供应链分析
• 定价分析
• 管道分析
• 监管分析
• 俄乌战争影响分析
• DMI 意见

第 6 章：COVID-19 分析

• COVID-19 分析
  • 新冠疫情爆发前的情景
  • 新冠疫情期间的情景
  • 新冠疫情后的情景
• COVID-19 期间的定价动态
• 供需谱
• 疫情期间政府与市场相关的倡议
• 製造商战略倡议
• 结论

第 7 章：按测试类型

• 血清学检测
• 尿抗原测试
• 淋巴细胞转化试验
• 免疫荧光染色
• 核酸检测
• 其他的

第 8 章：通过测试样本

• 血
• 脑脊液
• 尿
• 其他的

第 9 章：最终用户

• 医院
• 诊断中心
• 门诊手术中心
• 公共/私人实验室
• 医生办公室

第 10 章：按地区

• 北美
  • 我们
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 意大利
  • 西班牙
  • 欧洲其他地区
• 南美洲
  • 巴西
  • 阿根廷
  • 南美洲其他地区
• 亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
• 中东和非洲

第 11 章：竞争格局

• 竞争场景
• 市场定位/份额分析
• 併购分析

第 12 章：公司简介

• T2 Biosystems, Inc.
• 公司简介
• 产品组合和描述
• 财务概览
• 主要进展
• Bio-Rad Laboratories, Inc.
• Oxford Immunotec USA, Inc.
• Thermo Fisher Scientific Inc.
• Quidel Corporation
• Quest Diagnostics
• BioMerieux India Private Limited
• Diasorin SpA
• Meridian Bioscience Inc.
• Cortez Diagnostics Inc.

第 13 章：附录

Overview

Global Lyme Disease Diagnostics Market reached US$ 1.6 billion in 2022 and is expected to reach US$ 2.2 billion by 2030, growing with a CAGR of 4.3% during the forecast period 2023-2030.

Lyme disease diagnostics tests look for signs of infection in a sample of the blood or cerebrospinal fluid (CSF). CSF is a clear liquid that flows in and around the brain and spinal cord. The test checks samples for antibodies the immune system makes to fight the bacteria that cause Lyme disease. These diagnostic tests identify the antibodies produced by the immune system in response to the infection. Lyme disease diagnostics predict the likelihood of whether the patient is exposed to infected black-legged ticks.

Lyme Disease Diagnostics Market study analysis offers an in-depth outlook on the market containing quantitative and qualitative data. It gives an outlook and forecast of the global market based on market segmentation. It also provides global lyme disease diagnostics market size and growth, along with the latest trends, opportunities, and forecast till 2030.

Among all regions, the North America region is expected to hold the largest share of the global Lyme disease diagnostics market over the forecast period. North America shares a dominant position in the global Lyme disease diagnostics market. The serological test segment holds a significant position in the market share.

Dynamics

Increasing Technological Advancements and the Introduction of Novel Products are Expected to Drive Market Growth

The global Lyme disease diagnostics market growth is driven by several factors, such as various new innovations and products released in the market. According to the Lyme Disease Association, Lyme Disease is the most common tick-borne bacterial infection globally. The market is witnessing the launch and clearance of new validated diagnostic tests for accurate diagnosis of Lyme Disease.

For instance, on June 15, 2022, Adaptive Biotechnologies Corporation, a commercial-stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced the launch of T-Detect Lyme. This is the company's second test to be made available from its growing T-Detect franchise.

The increase in novel launches and the introduction of various products for lyme disease diagnosis are expected to elevate the market growth. For instance, on October 26, 2022, Digital diagnostics company ixlayer announced it would produce CVS Health's branded at-home sample collection kits. Ixlayer's kits can test for Lyme disease, Vitamin D levels, thyroid function, and sexually transmitted infections. Thus, the above factors are expected to drive the market growth.

Growing Government Initiatives and Increased Focus on Ready-to-Use diagnostic Kits Drive Market Growth

The increased government initiatives in order to prevent infection are expected to drive market growth. For instance, on July 22, 2023, Hudson Valley Lawmakers' bill to bolster funding to combat Lyme and tick-borne diseases was signed into law. Bipartisan legislation advanced by State Senators Pete Harckham and Sue Serino, along with Assemblymember Didi Barrett, that aims to bolster funding to more effectively combat the spread and better protect New Yorkers against tick-borne illness has been signed into law by Governor Kathy Hochul.

The increased focus in introducing ready-to-use diagnostic kits is driving the market growth. For instance, on March 21, 2023, Jiangsu Bioperfectus Technologies Co., Ltd. has released six new Real-Time PCR Kits independently developed by BioPerfectus. BioPerfectus provides Vector-Borne Diseases Total Diagnostic Solutions from sample pre-processing to PCR amplification analysis for our partners to rapid response to a global health emergency.Thus, the initiatives taken by the government can enhance the market growth.

Lack of Awareness Associated with Lyme Disease Diagnostics is Expected to Hamper the Market Growth

Unawareness of Lyme disease diagnosis is expected to hinder the market's growth over the forecast period. A number of diagnostic tests and kits are available for lyme disease, which are not accessible by the under-developed areas. Only a few people may know about the disease and its diagnosis. In rural areas, people lack knowledge related to disease and its diagnosis.

The lack of diagnostic centers with fully equipped equipment cannot aid in the proper diagnosis of the disease, which can impact the market growth. The availability of diagnostic tests will not reach the patients in underdeveloped areas, and the severity of the disease will increase, thus impacting the market growth. Hence, the market is expected to decline over the forecast period.

Segment Analysis

The global lyme disease diagnostic market is segmented based on test type, test sample, end-user, and region.

Serological Tests Segment is Expected to Hold the Largest Market Share in the Global Lyme Disease Diagnostics Market

The global Lyme disease diagnostics market is segmented based on test type such as serological tests, urine antigen tests, lymphocytic transformation tests, immunofluorescent staining, nucleic acid tests, and others. The serological tests segment holds a dominant share over the others segments because of the presence of the identifiable number of antibodies in the blood against the pathogen. Serologic tests indicates the presence of both IgG and IgM antibodies to Borrelia burgdorferi in the blood of the individual.

The increased number of lsunches of the tests holds the segment in the dominant postion. For instance, on August 1, 2023, Incite Health, Inc., a CLIA-certified, CAP-accredited, high-complexity clinical laboratory specializing in immune system testing, announces the launch of a new paradigm in Lyme Disease testing, the ZEUS Scientific MTTT-2 ELISA system. Recently, the CDC updated its recommendation to state that serologic assays using a second ELISA test are an acceptable alternative to assays that use an immunoblot as a second test. Thus, holding the segment in the dominant position in the market share.

Geographical Penetration

North America Region Holds the Largest Market Share in the Global Lyme Disease Diagnostics Market

North America region is the dominating force in the global Lyme disease diagnostics market for the year 2022 due to the high prevalence of Lyme Disease. For instance, according to the CDC, it is estimated that approximately 476,000 people suffer Lyme disease each year in the United States, and every year, approximately 30,000 cases of Lyme disease are reported to the CDC by state health departments and the District of Columbia.

There are rising government and private institutes initiatives to treat and diagnose Lyme diseases in countries in the region. There are a majority of the companies developing Lyme disease diagnostics. Several institutes have increased their focus on developing novel diagnostic tests. Thus, the above factors are expected to drive the market growth in the region.

The increase in the government fundings is expected to drive the market growth in the region. For instance, on July 21, 2023, NIH awards announced that it will fund Post-Treatment Lyme Disease Syndrome research. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded five projects for research to understand better Post-treatment Lyme Disease Syndrome (PTLDS), which is a collection of symptoms, such as pain, fatigue, and difficulty thinking or "brain fog," which linger following standard treatment for Lyme disease. Thus, the above factors are expected to raise the region's market share.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global Lyme disease diagnostics market. As countries grappled with lockdowns, the diagnostic and treatment procedures were significantly impacted, negatively impacting the whole market.

The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting the appointments and delaying the diagnosis. The hospitals and the diagnostic centers were closed for non-essential diagnosis of the diseases. The research and new developments have been halted due to COVID-19. Thus, it has negatively impacted the Lyme disease diagnostics market.

By Test Type

• Serological Test
• Urine Antigen Tests
• Lymphocytic Transformation Test
• Immunofluorescent Staining
• Nucleic Acid Test
• Others

By Test Sample

• Blood
• Cerebrospinal Fluid
• Urine
• Others

By End-User

• Hospitals
• Diagnostic Centers
• Ambulatory Surgical Centers
• Public/Private Laboratories
• Physician's Office

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• On April 21, 2023, Moderna released new treatments for Lyme disease. Moderna has unveiled two novel mRNA vaccine candidates for Lyme disease in its development pipeline: mRNA-1982 and mRNA-1975. Lyme disease is a bacterial infection spread to humans by infected ticks, which can cause various symptoms, including a rash and a fever.

Competitive Landscape

The global Lyme disease diagnostics market is fragmented, with the presence of many local and international players. T2 Biosystems, Inc., Bio-Rad Laboratories, Inc., Oxford Immunotec USA, Inc., Thermo Fisher Scientific Inc., Quidel Corporation, Quest Diagnostics, BioMerieux India Private Limited, Diasorin S.p.A, Meridian Bioscience Inc., and Cortez Diagnostics Inc. are the leading companies with a significant market share.

Why Purchase the Report?

• To visualize the global Lyme disease diagnostic market segmentation based on test type, test sample, end-user, and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of Lyme disease diagnostic market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global Lyme disease diagnostic market report would provide approximately 61 tables, 58 figures, and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Test Type
• 3.2. Snippet by Test Sample
• 3.3. Snippet by End-User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
• 4.2. Increasing technological advancements and the introduction of novel products
• 4.3. Growing Government Initiatives and Increased Focus on Ready-to-Use diagnostic Kits
• 4.4. Restraints
• 4.5. Lack of awareness associated with Lyme disease diagnostics
  • 4.5.1. Opportunity
  • 4.5.2. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Pipeline analysis
• 5.5. Regulatory Analysis
• 5.6. Russia-Ukraine War Impact Analysis
• 5.7. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Test Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 7.1.2. Market Attractiveness Index, By Test Type
• 7.2. Serological Test *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Urine Antigen Tests
• 7.4. Lymphocytic Transformation Test
• 7.5. Immunofluorescent Staining
• 7.6. Nucleic Acid Test
• 7.7. Others

8. By Test Sample

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 8.1.2. Market Attractiveness Index, By Test Sample
• 8.2. Blood *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Cerebrospinal Fluid
• 8.4. Urine
• 8.5. Others

9. By End-User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 9.1.2. Market Attractiveness Index, By End-User
• 9.2. Hospitals *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Diagnostic Centers
• 9.4. Ambulatory Surgical Centers
• 9.5. Public/Private Laboratories
• 9.6. Physician's Office

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Test Sample
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. T2 Biosystems, Inc.*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Bio-Rad Laboratories, Inc.
• 12.3. Oxford Immunotec USA, Inc.
• 12.4. Thermo Fisher Scientific Inc.
• 12.5. Quidel Corporation
• 12.6. Quest Diagnostics
• 12.7. BioMerieux India Private Limited
• 12.8. Diasorin S.p.A
• 12.9. Meridian Bioscience Inc.
• 12.10. Cortez Diagnostics Inc.

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us