Global Lyme Disease Diagnostics Market - 2022-2029

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.