Nontuberculous Mycobacterial (NTM) Diagnostic Market to Reach USD 3,261.1 million By 2032, Growing At An 6.64% CAGR - Credence Research

PR Newswire · 06/09 18:15

PUNE, India, June 9, 2025 /PRNewswire/ -- According to the latest research by Credence Research, the global Nontuberculous Mycobacterial (NTM) Diagnostic Market was valued at USD 1,814.8 million in 2023 and is projected to reach USD 3,261.1 million by 2032, growing at a compound annual growth rate (CAGR) of 6.64% during the forecast period. The rising incidence of NTM infections, especially among immunocompromised patients and individuals with chronic pulmonary conditions, is a primary factor driving market demand. Technological advancements in molecular diagnostics and imaging techniques are significantly enhancing detection accuracy and speed, leading to faster diagnosis and improved clinical outcomes.

Healthcare providers are increasingly adopting advanced diagnostic platforms to address the complexities of identifying NTM species, which often mimic other pulmonary disorders. This shift is further supported by growing awareness of NTM-related diseases and stronger clinical guidelines for early screening and diagnosis. Expanding healthcare infrastructure across emerging markets, coupled with increased investments in R&D by diagnostics companies, is expected to accelerate market expansion over the coming years.

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Key Growth Determinants: Nontuberculous Mycobacterial (NTM) Diagnostic Market

The growth of the NTM Diagnostic Market is primarily driven by the rising global prevalence of NTM infections, particularly among the aging population and individuals with underlying lung conditions such as COPD, bronchiectasis, and cystic fibrosis. As awareness of these infections increases among healthcare professionals, the demand for timely and accurate diagnostic solutions is expanding. This trend is supported by an uptick in hospital admissions and outpatient consultations related to unexplained pulmonary symptoms, where NTM is an emerging differential diagnosis.

Another key growth determinant is the rapid advancement in diagnostic technologies. Innovations in molecular diagnostics, PCR-based assays, and next-generation sequencing (NGS) are enabling faster, more precise identification of various NTM species, overcoming the limitations of traditional culture methods. Furthermore, increased funding for infectious disease research and growing collaborations between public health organizations and diagnostic manufacturers are creating favorable conditions for product development and market penetration. The rising implementation of clinical guidelines recommending early testing for at-risk populations is also bolstering the adoption of advanced NTM diagnostics globally.

Key Growth Barriers: Nontuberculous Mycobacterial (NTM) Diagnostic Market

Limited Awareness and Misdiagnosis

Many clinicians and patients remain unaware of NTM infections, which often mimic tuberculosis or other chronic pulmonary conditions. This lack of awareness leads to frequent misdiagnosis or delayed testing, particularly in settings with limited diagnostic infrastructure.

Diagnostic Complexity and Inaccessibility

Accurate identification of NTM species is essential for effective treatment, but traditional culture methods are time-consuming and may lack sensitivity. Advanced molecular diagnostic tools, though more effective, are not widely accessible in many regions, especially in developing markets.

Resource Constraints in Healthcare Facilities

Comprehensive NTM diagnostics require specialized laboratory equipment, trained personnel, and standardized testing protocols. Many healthcare systems, especially in low- and middle-income countries, face limitations in implementing such advanced diagnostics.

Regulatory and Reimbursement Challenges

Navigating regulatory approval for new diagnostic tools can be time-consuming and costly. In addition, limited reimbursement policies for advanced NTM diagnostic tests discourage healthcare providers from adopting innovative solutions.

Segmentation

Based on Diagnostic Method:

  • Nucleic Acid Amplification Tests (NAAT)
  • Microscopy
  • Culture-based Methods
  • Biochemical Tests
  • Immunological Tests
  • PCR
  • Others

Based on Infection Type:

  • Pulmonary
  • Cutaneous
  • Disseminated
  • Gastrointestinal
  • Others

Based on End-User:

  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Others

 Based on region

  • North America
    • The U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • UK.
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • South-east Asia
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Argentina
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • The Rest of the Middle East and Africa

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Regional Analysis: Nontuberculous Mycobacterial (NTM) Diagnostic Market

North America holds the largest share of the global NTM Diagnostic Market, accounting for approximately 39% of total revenue in 2023. This dominance is driven by advanced healthcare infrastructure, widespread use of molecular diagnostic technologies, and high awareness of NTM-related diseases. The presence of major diagnostic companies and strong R&D funding further support market growth in the United States and Canada.

Europe follows with around 27% of the market share. Countries like Germany, the UK, and France are key contributors, supported by growing recognition of NTM infections, aging populations, and well-established public health systems. Increased focus on early diagnosis and the adoption of advanced testing tools continue to fuel regional demand.

Asia-Pacific accounts for roughly 23% of the global market. Rapid improvements in healthcare infrastructure, growing patient awareness, and increased investments in diagnostic technologies are propelling growth in China, Japan, South Korea, and India. Partnerships between international diagnostic firms and regional players are expanding access to accurate NTM testing.

Latin America represents about 6% of the market, led by Brazil, Mexico, and Argentina. Market growth is supported by public health campaigns and improved diagnostic capabilities, though infrastructure disparities in remote areas remain a challenge.

Middle East & Africa comprise the smallest share, approximately 5% in 2023. While diagnostic capacity remains limited in many parts of the region, targeted investments in laboratory services and healthcare modernization—especially in the GCC and South Africa—are gradually improving market potential.

Credence Research's Competitive Landscape Analysis

Credence Research's Competitive Landscape Analysis presents a clear and focused view of key industry players in the NTM diagnostic segment with a spotlight on strategic strengths and market positioning:

Credence Research identifies a handful of dominant multinational diagnostics firms—Thermo Fisher Scientific Inc., F. Hoffmann‑La Roche Ltd, Becton, Dickinson & Company (BD), and bioMérieux SA—as frontrunners in the global NTM diagnostic market. These companies differentiate themselves via wide-ranging product portfolios that encompass both molecular and immunological diagnostic tools. They cater to centralized laboratory settings and decentralized testing environments, ensuring flexibility across different healthcare infrastructures. Their strong investment in R&D, global distribution networks, and robust service support contribute to their sustained competitive edge and rapid product adoption. https://www.credenceresearch.com/report/ntm-diagnostic-market?utm_source=chatgpt.com

Through its analysis, Credence Research highlights how these industry leaders are not only maintaining market dominance but also expanding access to advanced NTM diagnostic solutions via collaborations, innovative product development, and targeted regional strategies—positioning themselves to capitalise on the projected market growth.

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Key Player Analysis

  • Thermo Fisher Scientific Inc
  • Hoffmann-La Roche Ltd
  • Becton, Dickinson and Company (BD)
  • bioMérieux SA
  • Bruker Corporation
  • SD Biosensor
  • Bioneer
  • Seegene Inc.

 Recent Industry Developments

  • June 2025 – Thermo Fisher Scientific introduced two advanced mass spectrometry instruments—the Orbitrap Astral Zoom and Orbitrap Excedion Pro—during the ASMS conference. Designed primarily for proteomics and biopharma applications, these systems deliver enhanced speed and sensitivity, significantly advancing the analysis of complex biological samples. Their improved resolution and throughput have potential applications in infectious disease diagnostics, including NTM-related testing.
  • December 2024 – Shanghai MicuRx Pharmaceutical (688373.SH) announced that the U.S. FDA granted Orphan Drug Designation (ODD) to its investigational anti-infective drug MRX-5 for the treatment of NTM infections, representing a significant step in developing targeted therapies for this condition.
  • September 2023 – QIAGEN entered a strategic partnership with a major South Asian healthcare provider to integrate its proprietary diagnostics into regional laboratories, enhancing capabilities for detecting and managing NTM infections.
  • August 2023 – bioMérieux expanded its infectious disease portfolio through the acquisition of a biotech company specializing in NTM diagnostics.
  • July 2023 – Hologic, Inc. secured regulatory approval for a new diagnostic test specifically developed to identify NTM infections, reinforcing its commitment to infectious disease diagnostics.
  • January 2022 – Gaelan Medical Trade LLC partnered with RedHill Biopharma Ltd. to distribute Talicia (omeprazole magnesium, amoxicillin, and rifabutin) in the United Arab Emirates. Though primarily approved for H. pylori, its components hold relevance in mycobacterial infection strategies.
  • February 2021 – Koninklijke Philips N.V. completed the acquisition of BioTelemetry, Inc., a leader in remote monitoring and diagnostics, potentially expanding future integration of infectious disease tracking technologies.

Reasons to Purchase this Report:

  • Gain a comprehensive understanding of the market through qualitative and quantitative analyses, considering both economic and non-economic factors, with segmentation and sub-segmentation details provided in terms of market value (USD Billion).
  • Identify regions and segments expected to experience the fastest growth or dominate the market, with a detailed analysis of geographic consumption patterns and the factors driving or hindering market performance in each region.
  • Stay informed about the competitive environment, with rankings of major players, recent product and service launches, partnerships, business expansions, and acquisitions from the past five years.
  • Access detailed profiles of major market players, including company overviews, insights, product benchmarking, and SWOT analysis, to understand competitive advantages and market positioning.
  • Explore the present and forecasted market landscape, with insights into growth opportunities, market drivers, challenges, and constraints for both developed and emerging regions.
  • Benefit from Porter's Five Forces analysis and Value Chain insights to evaluate various market perspectives and competitive dynamics.
  • Understand the evolving market scenario, including potential growth opportunities and trends expected in the coming years.

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