Cystic Fibrosis Diagnostic Tests Market: Introduction

  • Cystic fibrosis is a severe genetic condition that damages the proteins involved in development of sweat, digestive enzymes, and mucous. The cystic fibrosis causes severe damage to the lungs, respiratory track, digestive system, pancreas, and liver.
  • People with cystic fibrosis have defective gene that produces thick and sticky secretions than that of normal people who have thin and slippery secretions. Thick and sticky secretions in people with cystic fibrosis form clots and block the airway passages and ducts in lungs and pancreas.
  • The clogged secretions can lead to life-threatening problems such as infections, respiratory failure, and malnutrition
  • Symptoms of cystic fibrosis do not appear in early stages of disease, but in later stages it shows wheezing, persistent cough that produces thick mucus, stuffy nose and sinuses, swollen abdomen, poor metabolism, and delayed growth in children
  • There are several tests available to diagnose the cystic fibrosis which includes genetic tests or blood tests, immunoreactive trypsinogen (IRT) test, sweat chloride tests, pulmonary function tests, and sputum test

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Cystic Fibrosis Diagnostic Tests Market: Key Drivers

  • The global cystic fibrosis diagnostic tests market is primarily driven by high prevalence and rise in incidence rates of cystic fibrosis across the globe. It is estimated that more than 30,000 people are affected by cystic fibrosis in the U.S. and every year around 900 to 1000 cases are diagnosed.
  • In Europe, it is estimated that around 38,985 people are affected by cystic fibrosis in 27 countries. In the U.K. alone, around 10,336 people are affected with cystic fibrosis.
  • Increase in awareness about cystic fibrosis across the globe, development and commercialization of cystic fibrosis diagnostic tests, and various regulations laid by the government organization for the pre natal testing of cystic fibrosis are likely to drive the market during the forecast period.

Genetic Test Segment to Offer Attractive Opportunities

  • Based on test type, the global cystic fibrosis diagnostic tests market can be divided into genetic tests, fecal test, immunoreactive trypsinogen (IRT) test, sweat chloride tests, and pulmonary function tests. The genetic test segment is anticipated to gain market share during the forecast period.  
  • In genetic testing, the cystic fibrosis gene mutation panels are used to detect common mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on chromosome 7.
  • The immunoreactive trypsinogen (IRT) test is projected to be the fastest growing segment during the forecast period.  The IRT is considered as a standard diagnostic test for newborn that checks for abnormal levels of the protein IRT in blood.
  • The sweat chloride diagnostics test is most commonly used cystic fibrosis test. This test checks the levels of salt in the sweat.

Diagnostic Laboratories Segment to Dominate Global Market

  • Based on end-user, the global cystic fibrosis diagnostic tests market can be divided into hospitals, diagnostics laboratories, and others. The diagnostic laboratories segment is anticipated to dominate the global market during the forecast period.
  • The diagnostic laboratories are first point of contact for the blood and sweat chloride tests for diagnosis of cystic fibrosis. Large number of diagnostic laboratories, easy availability of cystic fibrosis test, and comparatively low cost of test are estimated to contribute to dominant share of the segment during the forecast period.

Asia Pacific Cystic Fibrosis Diagnostic Tests Market to Expand Rapidly

  • In terms of region, the global cystic fibrosis diagnostic tests market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is projected to dominate the global market during the forecast period. However, the region is anticipated to lose market share by the end of 2027.
  • Increase in awareness about cystic fibrosis in the region, early diagnosis of cystic fibrosis, low cost of diagnostic test, and well-established health care infrastructure in the region are likely to contribute to dominant share of North America by 2027
  • The cystic fibrosis diagnostic tests market in Europe is projected to be second largest market by the end of 2027
  • The cystic fibrosis diagnostic tests market in Asia Pacific is projected to expand at a high CAGR during the forecast period, owing to rapid increase in number of patients with inflammatory bowel diseases in densely populated countries such as India, China, and South Korea, and rapidly improving health care infrastructure in the region

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Key Players Operating in Global Market

The global cystic fibrosis diagnostic tests market is highly fragmented with a large number of domestic players accounting for majority of the market share in respective regions. Key players operating in the global cystic fibrosis diagnostic tests market include:

  • Quidel Corporation
  • Quest Diagnostics
  • Creative Diagnostics
  • Invitae Corporation
  • Asper Biogene
  • GeneDx
  • Illumina, Inc.
  • Elucigene Diagnostics
  • BillionToOne Inc.
  • ELITechGroup

Global Cystic Fibrosis Diagnostic Tests Market: Research Scope

Global Cystic Fibrosis Diagnostic Tests Market, by Test Type

  • Genetic Tests
  • Fecal Test
  • Immunoreactive Trypsinogen (IRT) Test
  • Sweat Chloride Tests
  • Pulmonary Function Tests

Global Cystic Fibrosis Diagnostic Tests Market, by End-user

  • Hospitals
  • Diagnostic Laboratories
  • Others

Global Cystic Fibrosis Diagnostic Tests Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Rest of Middle East & Africa

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

The study is a source of reliable data on:

  • Market segments and sub-segments
  • Market trends and dynamics
  • Supply and demand
  • Market size
  • Current trends/opportunities/challenges
  • Competitive landscape
  • Technological breakthroughs
  • Value chain and stakeholder analysis

The report has been compiled through extensive primary research (through interviews, surveys, and observations of seasoned analysts) and secondary research (which entails reputable paid sources, trade journals, and industry body databases). The report also features a complete qualitative and quantitative assessment by analyzing data gathered from industry analysts and market participants across key points in the industry’s value chain.

A separate analysis of prevailing trends in the parent market, macro- and micro-economic indicators, and regulations and mandates is included under the purview of the study. By doing so, the report projects the attractiveness of each major segment over the forecast period.

Highlights of the report:

  • A complete backdrop analysis, which includes an assessment of the parent market
  • Important changes in market dynamics
  • Market segmentation up to the second or third level
  • Historical, current, and projected size of the market from the standpoint of both value and volume
  • Reporting and evaluation of recent industry developments
  • Market shares and strategies of key players
  • Emerging niche segments and regional markets
  • An objective assessment of the trajectory of the market
  • Recommendations to companies for strengthening their foothold in the market   

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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