Non-Alcoholic Steatohepatitis Biomarkers Market Outlook 2027: Rapid Growth at 21% CAGR to Reach ~US$2 Billion | TMR Insights

The global non-alcoholic steatohepatitis (NASH) biomarkers market is on track for explosive growth, expected to reach a valuation of approximately US$2 billion by the end of 2027. Starting from an estimated value of US$300 million in 2018, the market is anticipated to expand at a staggering compound annual growth rate (CAGR) of 21% from 2019 to 2027. This rapid rise reflects the urgent need for non-invasive diagnostic tools to address NASH, a progressive liver disease linked to rising global rates of obesity and diabetes. As healthcare systems prioritize early detection and management of this silent epidemic, the NASH biomarkers market is poised to play a pivotal role in transforming liver disease diagnostics through 2027.

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Understanding the NASH Biomarkers Market

Non-alcoholic steatohepatitis, an advanced stage of non-alcoholic fatty liver disease (NAFLD), involves fat accumulation, inflammation, and liver damage that can progress to cirrhosis or liver cancer if untreated. NASH biomarkers-non-invasive tools like serum markers, fibrosis panels, and imaging techniques-offer a safer alternative to liver biopsies for diagnosis and monitoring. The market's 2018 valuation of ~US$300 million highlights its nascent yet critical status, with the projected climb to ~US$2 billion by 2027 underscoring its response to a growing health crisis.

The 21% CAGR signals an extraordinary growth phase, driven by demand for reliable diagnostics and a robust pipeline. NASH's asymptomatic nature amplifies the need for biomarkers, ensuring sustained market momentum.

Key Drivers of Market Growth

Several factors are fueling the NASH biomarkers market's trajectory toward ~US$2 billion by 2027. First, the escalating prevalence of NAFLD and NASH is a major driver. With obesity and type 2 diabetes surging globally-conditions affecting up to 75% and 66% of patients with NAFLD, respectively-the NASH patient pool is expanding rapidly. This aligns with the market's 21% CAGR, as non-invasive diagnostics become essential for early intervention.

Second, the shift toward non-invasive diagnostics is accelerating growth. Liver biopsies, the traditional gold standard, are invasive, costly, and carry risks like bleeding, with a mortality rate of 1 in 10,000. Biomarkers-such as serum tests (e.g., ELF score) and imaging (e.g., FibroScan)-offer safer, scalable alternatives, driving the market toward US$2 billion as patients and providers embrace these tools.

Third, increased R&D and regulatory support are propelling the market. Pharmaceutical and biotech firms are investing heavily in biomarker development, backed by government initiatives to curb NAFLD's impact. The FDA's encouragement of biomarker use in clinical trials further supports innovation, reinforcing the market's path through 2027.

Leading Players:

Biopredictive
Quest Diagnostics
Exalenz Bioscience Ltd
GENFIT
Siemens Healthineers
ONE WAY LIVER
S.L
Prometheus Laboratories Inc
Gilead Sciences Ltd.

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Market Segmentation and Regional Insights

The market segments by biomarker type, end-user, and geography. Serum biomarkers lead due to their accessibility, followed by fibrosis and imaging biomarkers for staging disease progression. End-users include hospitals, diagnostic centers, and research institutes, with diagnostics driving adoption. Distribution spans healthcare facilities and labs, with growing online integration.

Regionally, North America held a significant share of the ~US$300 million valuation in 2018, driven by high NASH prevalence, advanced healthcare, and key players in the United States. Europe followed, with strong markets in Germany and France, supported by research focus. Latin America and the Middle East & Africa, however, were poised for the fastest growth through 2027, fueled by rising NASH cases-e.g., 35% prevalence in Brazil-and improving healthcare access.

Challenges and Opportunities

The market faced challenges during this period. Limited accuracy of some biomarkers in distinguishing NASH from simple steatosis restrained adoption, while high development costs and regulatory hurdles slowed progress. Low awareness in developing regions and reliance on biopsies in some settings also curbed growth. The 21% CAGR reflects a market overcoming these hurdles with innovation.

These challenges, however, present opportunities. Companies refining biomarker specificity or launching affordable tests could accelerate uptake, supporting the climb to ~US$2 billion. Collaborations-like GENFIT's NASHnext launch with Labcorp in 2021-offer growth potential, while expanding screening in high-prevalence regions could exceed projections.

The Road to 2027

By 2027, the global NASH biomarkers market reached its projected ~US$2 billion, reflecting nine years of exceptional growth at a 21% CAGR from ~US$300 million in 2018. This milestone was driven by disease burden, diagnostic innovation, and global health efforts. As the forecast concluded, the market's trajectory suggested continued expansion, with potential for multi-omics integration to shape future diagnostics.

In conclusion, the NASH biomarkers market showcased remarkable growth from 2019 to 2027. Rising from ~US$300 million to ~US$2 billion, it addressed a pressing liver health challenge with transformative impact. Stakeholders-from biotech firms to clinicians-played a vital role in this success, ensuring non-invasive solutions met global needs through 2027 and beyond.

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