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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Lyme disease occurs due to bacterium Borrelia burgdorferi (Bb) and is transmitted to humans through the bite of infected blacklegged ticks. Its general symptoms include fatigue, headache, fever and a skin rash called erythema migrans. The infection can spread to heart, nervous system and joints if left untreated. Centers for Disease Control and Prevention (CDC) recommends a two-step process to diagnose Lyme infection. The first step uses a testing procedure called enzyme immunoassay (EIA) or, an indirect immunofluorescence assay (IFA). If the first screening step is negative, no additional testing is required. However, if the first screening step is positive or not clear, the second screening step i.e. Western blot test is performed. Results of the screening tests are considered positive only if both the tests are positive. CDC does not recommend avoiding the first screening step as it will increase the rate of false positive results that can lead to misdiagnosis and inappropriate treatment. The ELISA and Western blot are the commonly used tests to diagnose the disease. Western blot is the most accurate antibody test, whereas ELISA tests are not sensitive enough for screening. Manufacturers could focus on developing new tests for the diagnosis of Lyme disease. However, these tests should have FDA approval and exhibit high performance.

Lyme Disease Diagnostics Market Dynamics

Lyme disease is a difficult medical condition to identify as it can be confused with increasing cases of tick-borne infectious diseases, emergence of new vector-borne diseases, and the complexity and variations of symptoms in each patient. Rising prevalence of Lyme disease and increasing focus of governments towards improvement of healthcare facilities is expected to drive growth of the Lyme disease diagnostics market during the forecast period. According to the National Institute of Allergy and Infectious Diseases (NIAID) 2016 report, there are over 300,000 reported cases of Lyme disease, annually in the U.S. alone. Various government organizations and institutes such as NIAID are working towards improving Lyme disease diagnostics. NIAID actively supports research on Lyme disease diagnostics. In collaboration with CDC, NIAID plays a key role in encouraging development of new methods to improve Lyme disease screening in people with co-infections such as the tick-borne infections. The institute is actively supporting research on Lyme disease diagnostics. NIAID grantees directly work in collaboration with CDC researchers to compare and evaluate the effectiveness of existing diagnostic methods.

Moreover, industry players are focusing on research and development of new tests for Lyme disease diagnosis and this is expected to aid in growth of the Lyme disease diagnostics market. For instance, in 2017, IGeneX Inc.—a Clinical Laboratory Improvement Amendments (CLIA) and New York-approved Reference Laboratory, specializing in testing for tick-borne diseases— launched three new tests that are more comprehensive and specific for assisting in diagnosis of tick-borne relapsing fever and Lyme disease. However, lack of awareness about the disease and inefficiency in Lyme disease testing significantly affects the market growth. Several individuals with Lyme-like symptoms are wrongly diagnosed, owing to existing serological tests that cannot identify antibodies of all the different strains of B. burgdorferi. Therefore, demand for better diagnostic tests for the disease is increasing. Since the symptoms of tick-borne relapsing fever and Lyme are similar, development of more accurate test is required for proper diagnosis.

Lyme Disease Diagnostics Market Regional Insights

Regional segmentation of lyme disease diagnostics market by Coherent Market Insights, includes North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America Lyme disease diagnostics market is expected to hold a dominant position over the forecast period. This is due to increasing government initiatives for diagnosing and treatment of various diseases. The Centers for Disease Control and Prevention (CDC) has increased their focus to develop novel strategies for the prevention of Lyme disease, in order to reduce the occurrence of disease in the target populations. Another factor aiding in growth of the market in the region is increasing pervasiveness of common tick disease, which has led to high demand for effective disease treatment. According to a research paper, Lyme disease is the most prevalent tick-borne infection in North America and Europe. It is the most commonly listed vector borne disease in the U.S. so far. According to CDC, in 2015, it was regarded as the sixth most common Nationally Notifiable disease in the country. Europe Lyme disease diagnostics market is expected to exhibit high growth, due to increasing number of infected patients. The incidence of Lyme disease has been increasing significantly in some European countries. According to Center for Health Protection, Lyme disease cases  in Europe are expanding with about 100 cases per 100,000 population every year.

Lyme Disease Diagnostics Market Competitive Analysis

Major players operating in the Lyme disease diagnostics market include Abbott Laboratories, Affymetrix Inc., Alere Inc., Baxter International Inc., Bio-Rad Laboratories, Boulder Diagnostics, Canon Life Sciences, Covance Inc., Fresenius Medical Care AG & Co., GlaxoSmithKline Pharmaceuticals Ltd., Roche Diagnostics International Ltd., Siemens AG, and T2 Biosystems, Immunetics Inc. Key players in the market are focusing on developing new diagnostic tools, in collaboration with government organizations or research institutes or by themselves.

Lyme Disease Diagnostics Market Taxonomy

On the basis of diagnostics test, the Lyme disease diagnostics market is segmented into:

  • Enzyme Linked Immunosorbent Assay (ELISA)
  • Western Blot
  • Others

On the basis of end user, the Lyme disease diagnostics market is segmented into:

  • Hospitals
  • Clinics
  • Diagnostic Laboratories

On the basis of region, the Lyme disease diagnostics market is segmented into:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users