ライム病診断の世界市場-2022-2029

市場力学

市場の成長は、ライム病の有病率の上昇と診断技術の進歩によるライム病診断の需要増に牽引されています。

技術的進歩や新製品の投入の増加は、市場成長の原動力になると予想されます。

ライム病診断の世界市場の成長は、様々な新しい技術革新や製品のリリース、ライム病の有病率の上昇など、いくつかの要因によって牽引されています。ライム病協会によると、ライム病はダニが媒介する細菌感染症の中で、世界で最も一般的な病気です。

市場では、ライム病の正確な診断のための新しい有効な診断テストの発売とクリアランスが示されています。例えば、2019年7月、Zeus Scientificは、Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM, Borrelia burgdorferi IgG/IgM, Borrelia burgdorferi IgM and Borrelia burgdorferi IgG Test Systems for Lyme diseaseといった診断テストについて、食品医薬品局（US FDA）から拡大市場許可を取得していました。これらの診断検査は、従来のEIA検査とウェスタンブロット検査という2段階のプロセスを必要とせず、2種類の酵素免疫測定法（EIA）を同時に使用するものです。

2020年2月、DiaSorinは、リエゾン・ライムトータル・アンティボディ・プラス・アッセイとリエゾン・ライムトータル・アンティボディ・プラス・コントロールセットの米国FDA（食品医薬品局）の認可を取得しました。このアッセイは、化学発光を利用して、ヒト血清および血漿試料中のボレリア・ブルグドルフェリに対するlgGおよびIgM抗体を検出するものです。

さらに、各機関はライム病診断検査薬の開発に対して助成金を提供しています。例えば、2019年7月、Enable Biosciences社は、改良型ライム病検査の開発のために、国立衛生研究所（NIH）の一部である国立アレルギー感染症研究所（NIAID）から1年間のフェーズI小規模企業革新研究（SBIR）助成金の22万5000米ドルの授与を受けていました。

ライム病診断に関する認知度の低さが、市場成長の妨げになると予想されます。

ライム病診断に関する認知度の低さが、予測期間中の市場成長の妨げになると予想されます。ライム病とその診断について知っている人はほとんどいないためです。農村部では、病気とその診断に関する知識が不足しているため、市場の成長を抑制しています。

産業分析

ライム病診断の世界市場は、ポーターのファイブフォース、規制分析、サプライチェーン分析、価格分析、製品イノベーション、アンメットニーズなど、様々な業界要因に基づいた市場の詳細な分析を提供しています。

ライム病診断の世界市場レポートでは、約45+市場データ表、40+図、180ページへのアクセスを提供します。

目次

第1章 調査手法と調査範囲

• 調査手法
• 調査目的および調査範囲

第2章 市場の定義と概要

第3章 エグゼクティブサマリー

第4章 市場の力学

• 市場影響要因
  • 促進要因
    • ライム病に関する有病率の上昇
    • 成長する技術的進歩
  • 抑制要因
    • ライム病に対する認知度の低さ
  • ビジネスチャンス
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• 規制分析
• サプライチェーン分析
• プライシング分析
• 製品イノベーション
• アンメットニーズ

第6章 診断技術別

• 血清学的検査
• 尿中抗原検査
• リンパ球形質転換検査
• 免疫蛍光染色
• 核酸検査
• その他

第7章 アプリケーション別

• 病院
• 公的/私的検査機関
• 医務室

第8章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ地域

第9章 競合情勢

• 主な展開と戦略
• 企業シェア分析
• 製品タイプ別ベンチマーク
• 注目の主要企業リスト

第10章 企業プロファイル

• Abbott Laboratories
  • 企業概要
  • 製品タイプ別ポートフォリオと内容
  • 主なハイライト
  • 財務概要
• T2 Biosystems, Inc.
• Bio-Rad Laboratories, Inc.
• Alere Inc.
• Roche Diagnostics International Ltd.
• Graphene Frontiers, LLC
• Covance Inc.
• Immunetics Inc.
• GlaxoSmithKline Pharmaceuticals Ltd.
• Boulder Diagnostics Inc.

第11章 ライム病診断の世界市場-DataM

Market Overview

Lyme Disease Diagnostics Market size was valued US$ 2.53 billion in 2021 and is estimated to reach US$ 4.27 billion by 2029, growing at a CAGR of 8.9% during the forecast period (2022-2029).

Lyme disease diagnostics are the diagnostic tests used for diagnosing the signs & symptoms, and other diseases such as neurologic, cardiac symptoms associated with Lyme disease. These diagnostic tests identify the antibodies produced by the immune system in response to the infection. Lyme disease diagnostics predicts the likelihood of whether the patient is exposed to infected blacklegged ticks.

Market Dynamics

The market growth is driven by the rising demand for Lyme disease diagnosis due to the rising prevalence of Lyme disease as well as technological advancements in diagnostics.

Increasing advancements in technology and 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 release in market and rising prevalence of Lyme disease. According to the Lyme Disease Association, Lyme Disease is the most common tick-borne bacterial infection in the world.

The market is witnessing the launch and clearance of new validated diagnostic tests for accurate diagnosis of Lyme Disease. For instance, in July 2019, Zeus Scientific had received the expanded market clearance from Food and Drug Administration (US FDA) for its diagnostic tests such as Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM, Borrelia burgdorferi IgG/IgM, Borrelia burgdorferi IgM and Borrelia burgdorferi IgG Test Systems for Lyme disease. These diagnostic tests include the concurrent use of two enzyme immunoassays (EIA), instead of the existing two-step process requiring an initial EIA test followed by a Western Blot protein test.

In February 2020, DiaSorin had received clearance from the Food and Drug Administration (US FDA) for Liaison Lyme Total Antibody Plus assay and Liaison Lyme Total Antibody Plus Control Set. This assay uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi in human serum and plasma samples.

Moreover, the organizations are providing grants for the development of Lyme disease diagnostic tests. For instance, in July 2019, Enable Biosciences had received the award of one-year Phase I Small Business Innovative Research (SBIR) grant for USD 225,000 from the National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) for the development of an improved Lyme disease test.

Scarcity of awareness associated with Lyme disease diagnostics is expected to hamper the market growth.

Unawareness about the Lyme disease diagnostic is expected to hinder the market's growth over the forecast period. As few people know about the disease and its diagnosis. In rural areas people lack knowledge related to disease and its diagnosis hence restrains the growth of market.

Industry Analysis

The global Lyme disease diagnostics market provides in-depth analysis of the market based on various industry factors such as Porter's Five Forces, Regulatory Analysis, Supply Chain Analysis, Pricing Analysis, Product Innovation, Unmet Needs.

Segment Analysis

Diagnostic technology segment is expected to hold the largest market share in global lyme disease diagnostics market

The global Lyme disease diagnostics market is segmented based on diagnostic technology as a serological test, urine antigen tests, lymphocytic transformation test, immunofluorescent staining, nucleic acid test, and others. The serological test segment accounts for the highest market share due to the high usage of Serological tests for diagnosing Lyme disease. This test involves the initial screening assay for the detection of antibodies leading to the development of Lyme Disease. Enzyme-Linked Immunosorbent Assay (ELISA) and Western Blot are the commonly used serological tests for Lyme Disease diagnosis.

The urine antigen tests segment is expected to have positive market growth due to growing research and development activities for urine antigen tests for the diagnosis of Lyme Disease. Ceres Nanosciences had developed the urine-based Nanotrap Lyme Antigen test for detecting Lyme disease. The urine antigen tests segment is dominated by the presence of the development of urine antigen tests products that have received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). For instance, In Jun 2022, Adaptive Biotechnologies decided to interpret adaptive immune structure genetics to clinical device for the diagnosis of disease using T-Detect Lyme.

Further, the market is also classified based on application into hospitals, public/private laboratories, and physician's offices. The hospital segment is expected to witness the highest market growth due to Lyme Disease diagnostic tests' high usages with the rising hospitalization cases.

The public/private laboratories segment is expected to have positive market growth due to the increase in the number of public/private laboratories for diagnosing Lyme Disease. The majority of the public/private laboratories are providing Lyme disease testing using urine or other body fluids and serological tests.

Geographical Analysis

North America region holds the largest market share in the global Lyme disease diagnostics market

By region, the global Lyme disease diagnostics market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, the North American region dominated the global Lyme disease diagnostics market due to the high prevalence of Lyme Disease. According to the Centres for Disease Control and Prevention (CDC), approximately 300,000 people are suffering from Lyme Disease in the United States every year. 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 Diseases diagnostics. Several institutes have increased their focus on developing novel diagnostic tests. For instance, in November 2019, the National Institutes of Health (NIH) had planned a five-year strategic plan to accelerate research initiatives leading to better prevention, diagnosis, and treatment of tick-borne diseases. In March 2020, a leading sponsor of Lyme disease research in the United States, Bay Area Lyme Foundation had opened the San Diego collection site of the Bay Area Lyme Foundation's Lyme Disease Biobank to provide researchers with blood and urine samples from people with early Lyme Disease from multiple endemic regions across the country.

Europe is expected to witness positive market growth due to the drastic increase in Lyme Disease cases. Over the last decade, the incidence of cases of Lyme Disease has increased by three times in Europe. The market is witnessing the development of novel diagnostic tests with technological advancement. These emerging diagnostic tests would help in the accurate diagnosis of Lyme Disease.

Competitive Landscape

The global Lyme disease diagnostics market is fragmented with the presence of many local and international players. Abbott Laboratories, Bio-Rad Laboratories, Affymetrix, Inc., Roche Diagnostics, T2 Biosystems, and GlaxoSmithKline Pharmaceuticals are the leading companies with a significant market share.

Technology advancement, product diversification, market expansion, and new product launches intensify the market competition. For instance, T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.

Ceres Nanosciences had developed the urine-based Nanotrap Lyme Antigen test for detecting Lyme disease. This Nanotrap enrichment technology would detect Lyme antigens in patient urine at the early stages of the disease. This technology would use Nanotrapto uses hydrogel particles to capture, preserve, and enrich target analytes and allow the more sensitive detection of low abundance molecules.

The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to increase the demand for Lyme Disease Diagnostics and their expansion across the globe. For instance, in June 2019, Qiagen and DiaSorin entered into the collaboration to develop an ultra-sensitive QuantiFERON-based diagnostic test to detect Lyme disease early. QuantiFERON technology comprises a sample collection component with its assay stimulus/initiation and a read-out component to measure the stimulus's signals. This component would be run on DiaSorin's LIAISON family of fully-automated analyzers.

In July 2019, PerkinElmer had entered into the collaboration with and EverlyWell for accelerating the innovation in and accessibility of consumer-initiated health testing, by adding PerkinElmer's CLIA-certified and CAP-accredited lab facilities to EverlyWell's network of laboratory providers. The first offerings resulting from this collaboration include the Lyme disease and food sensitivity tests for which PerkinElmer would provide the expertise behind EverlyWell's panels.

Key Companies to Watch

Abbott Laboratories:

Overview: Abbott is American multinational company that develops medical devices and healthcare products. It was founded in 1888 and is headquartered in Illinois, United States. Their products and services include medical devices, diagnostics, nutritional products and branded generic medicines.

Product Portfolio:

PLEX-ID: It is molecular diagnostic technology based which integrates mass spectrometry and PCR technology and identifies and characterises wide range of micro-organisms.

Key Developments: In Oct 2020, Abbott got emergency use authorization for their COVID-19 IgM antibody blood test from the FDA.

The global Lyme disease diagnostics market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.

Table of Contents

1. Methodology and Scope

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

2. Market Definition and Overview

3. Executive Summary

4. Market Dynamics

• 4.1. Market Impacting Factors
  • 4.1.1. Drivers:
    • 4.1.1.1. Rising prevalence concerning Lyme disease
    • 4.1.1.2. Growing Technological Advancement
  • 4.1.2. Restraints:
    • 4.1.2.1. Scarcity of awareness about Lyme disease
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Forces Analysis
• 5.2. Regulatory Analysis
• 5.3. Supply Chain Analysis
• 5.4. Pricing Analysis
• 5.5. Product Innovations
• 5.6. Unmet Needs

6. By Diagnostic Technology

• 6.1. Introduction
  • 6.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology Segment
  • 6.1.2. Market Attractiveness Index, By Diagnostic Technology Segment
• 6.2. Serological Test
  • 6.2.1.1. Introduction
  • 6.2.1.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 6.3. Urine Antigen Tests
• 6.4. Lymphocytic Transformation Test
• 6.5. Immunofluorescent Staining
• 6.6. Nucleic Acid Test
• 6.7. Others

7. By Application

• 7.1. Introduction
  • 7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application Segment
  • 7.1.2. Market Attractiveness Index, By Application Segment
• 7.2. Hospitals
  • 7.2.1.1. Introduction
  • 7.2.1.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
• 7.3. Public/Private Laboratories
• 7.4. Physician's Office

8. By Region

• 8.1. Introduction
  • 8.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology
  • 8.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 8.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.2.5.1. U.S.
    • 8.2.5.2. Canada
    • 8.2.5.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology
  • 8.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 8.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.3.5.1. Germany
    • 8.3.5.2. U.K.
    • 8.3.5.3. France
    • 8.3.5.4. Italy
    • 8.3.5.5. Spain
    • 8.3.5.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology
  • 8.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 8.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.4.5.1. Brazil
    • 8.4.5.2. Argentina
    • 8.4.5.3. Rest of South America
• 8.5. Asia Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology
  • 8.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
  • 8.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
    • 8.5.5.1. China
    • 8.5.5.2. India
    • 8.5.5.3. Japan
    • 8.5.5.4. Australia
    • 8.5.5.5. Rest of Asia Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Diagnostic Technology
  • 8.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application

9. Competitive Landscape

• 9.1. Key Developments and Strategies
• 9.2. Company Share Analysis
• 9.3. Product Types Benchmarking
• 9.4. List of Key Companies to Watch

10. Company Profiles

• 10.1. Abbott Laboratories
  • 10.1.1. Company Overview
  • 10.1.2. Product Type Portfolio and Description
  • 10.1.3. Key Highlights
  • 10.1.4. Financial Overview
• 10.2. T2 Biosystems, Inc.
• 10.3. Bio-Rad Laboratories, Inc.
• 10.4. Alere Inc.
• 10.5. Roche Diagnostics International Ltd.
• 10.6. Graphene Frontiers, LLC
• 10.7. Covance Inc.
• 10.8. Immunetics Inc.
• 10.9. GlaxoSmithKline Pharmaceuticals Ltd.
• 10.10. Boulder Diagnostics Inc.

LIST NOT EXHAUSTIVE

11. Global Lyme Disease Diagnostics Market - DataM

• 11.1. Appendix
• 11.2. About Us and End User
• 11.3. Contact Us