Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market

Madrigal Pharmaceuticals sold USD 431.3 million of Rezdiffra (resmetirom) in the third quarter of 2026, up 50% on a year earlier, with more than 55,850 patients on therapy, its results of 3 November 2026 show, while semaglutide became the second approved drug after its US accelerated approval on 15 August 2025. The non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market, now usually called metabolic dysfunction-associated steatohepatitis (MASH), covers prescription drugs used to treat the disease and the non-invasive tests, imaging and biopsies used to find and stage it, valued at net manufacturer and laboratory revenue. Douglas Insights sizes it at USD 1.65 billion in 2025, about 47,000 treated patient-years at an average USD 35,100 of market revenue each, and at USD 14.6 billion in 2035, a 24.4% compound annual growth rate (CAGR). The study sits in our pharmaceuticals coverage, beside the Pharmaceutical Drug Market, Compounding Pharmacies Market and Healthcare Contract Research Organization Market reports; every figure follows the Douglas Insights research methodology.

Which NASH therapeutics and diagnostics segment leads: resmetirom, GLP-1 drugs or tests?

Thyroid hormone receptor-beta (THR-beta) agonists, in practice resmetirom alone, lead NASH therapeutics and diagnostics with 58.1% of 2025 value, about USD 958 million, Douglas Insights estimates. New-mechanism therapies grow fastest, 55.5% a year to USD 4.10 billion by 2035.

Resmetirom leads because it was the first drug approved for the disease and had a full year of US sales in 2025: Rezdiffra net sales reached USD 958.4 million, with more than 36,250 patients on therapy at year-end, Madrigal’s results of 19 February 2026 show. The class grows 17.0% a year to USD 4.60 billion, slower than the market because competitors arrive. GLP-1 and incretin agonists, USD 120 million in 2025 on a Douglas Insights estimate of the share of semaglutide use attributable to MASH, grow 43.0% a year to USD 4.30 billion.

FGF21 analogues, pan-PPAR agonists and other therapies, USD 49.5 million in 2025 from off-label pioglitazone and vitamin E, grow fastest as efruxifermin, pegozafermin, efimosfermin and lanifibranor reach market. Non-invasive diagnostic tests, USD 401 million, cover vibration-controlled transient elastography (VCTE), sold as FibroScan, and blood panels such as Siemens Healthineers’ Enhanced Liver Fibrosis (ELF) test; they grow 12.0% a year to USD 1.25 billion. MRI proton density fat fraction (MRI-PDFF) imaging and liver biopsy, USD 120 million, grow 11.3%, mostly in clinical trials. Product-class values for 2035 sum to USD 14.6 billion, in line with the headline.

Diagnostic spending follows the drugs. Every prescription for resmetirom or semaglutide in MASH requires evidence of F2 to F3 fibrosis, so Douglas Insights estimates about 4 patients are staged for each 1 who starts therapy, which is why non-invasive tests already make up 24.3% of 2025 value. Laboratories bill a FIB-4 score from routine blood results at little extra cost, while an ELF panel and a VCTE scan carry the value. Liver biopsy, once the standard, is now used mainly in phase 3 trials such as NATiV3 and the FGF21 programmes, and MRI-PDFF serves as a trial endpoint for liver fat; together they grow more slowly than blood and elastography tests because guidelines steer routine care away from them.

What drives NASH therapeutics and diagnostics demand: new approvals, deals or diagnosis rates?

Treated NASH patient-years rise 34.3% a year in our base case, from about 47,000 in 2025 to about 900,000 in 2035. Four drivers add 37.0 points of gross volume growth; restraints remove 2.7 points.

A second approved drug and new countries: 14.0 points

Approvals are the largest driver, worth 14.0 points. The US Food and Drug Administration (FDA) granted Wegovy (semaglutide) accelerated approval for noncirrhotic MASH with moderate to advanced fibrosis (F2 to F3) on 15 August 2025, Novo Nordisk’s filing of that date states. The European Commission granted Rezdiffra conditional authorisation on 18 August 2025, the European Medicines Agency (EMA) product page shows, and authorised semaglutide for MASH under the brand Kayshild on 26 March 2026, the EMA Kayshild page shows. Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) authorised resmetirom on 3 June 2026, its announcement states.

Large-pharma acquisitions of the FGF21 class: 9.0 points

Acquisitions add 9.0 points by funding phase 3 programmes. Novo Nordisk agreed on 9 October 2025 to buy Akero Therapeutics and its efruxifermin for USD 54 a share in cash, about USD 4.7 billion, plus a USD 6 contingent value right tied to approval in compensated cirrhosis, its filing states. Roche agreed on 18 September 2025 to buy 89bio and its pegozafermin for about USD 2.4 billion upfront and up to about USD 3.5 billion in total, its release shows. GSK agreed on 14 May 2025 to buy efimosfermin from Boston Pharmaceuticals for USD 1.2 billion upfront and up to USD 800 million in milestones, and expects a first launch in 2029, its release states.

A large undiagnosed patient pool: 8.0 points

Diagnosis adds 8.0 points. Global prevalence of non-alcoholic fatty liver disease, now metabolic dysfunction-associated steatotic liver disease (MASLD), is 30.05% of adults and NASH prevalence about 5.27%, a pooled analysis by Younossi and colleagues in Hepatology in 2023 found. Madrigal counts about 315,000 diagnosed F2 to F3 patients under liver-specialist care in the US and about 245,000 with compensated cirrhosis, its February 2026 results state, and more than 530,000 addressable F2 to F3 patients by 30 June 2026, its November release adds. Douglas Insights estimates fewer than 1 in 10 eligible US patients was treated in 2025.

Stronger clinical evidence: 6.0 points

Evidence adds the last 6.0 points by giving doctors data to prescribe. In the ESSENCE trial of 800 patients, 62.9% on semaglutide had steatohepatitis resolution without worse fibrosis at week 72 against 34.3% on placebo, and 36.8% had fibrosis improvement against 22.4%, King’s College London reported of the results published in the New England Journal of Medicine on 30 April 2025. Inventiva announced the last patient visit in its 1,009-patient NATiV3 trial of lanifibranor on 2 September 2026 and guided topline results for the fourth quarter of 2026, its release states. Summed, 14.0 + 9.0 + 8.0 + 6.0 = 37.0 points, a Douglas Insights estimate.

What are the restraints on NASH therapeutics and diagnostics: diagnosis gaps or payer limits?

Two restraints remove 2.7 points a year from NASH patient growth: the need for fibrosis staging before treatment takes 1.5 points, and payer limits plus waiting for outcomes data take 1.2 points.

Staging is the heavier restraint. Both drugs are approved only for F2 to F3 fibrosis, so a patient needs a FIB-4 blood score and then elastography before a prescription, the stepwise path set out in the American Association for the Study of Liver Diseases (AASLD) practice guidance and the European EASL-EASD-EASO guideline of June 2024. Primary-care doctors see most patients but rarely own a FibroScan, so Douglas Insights estimates about 40% of referred patients are lost before staging.

Payers and evidence take 1.2 points. The FDA approvals are accelerated or conditional, so outcome trials must confirm benefit: Madrigal’s MAESTRO-NASH OUTCOMES data in compensated cirrhosis are due in late 2027, its November 2026 release states, and semaglutide’s ESSENCE outcomes part reads out in 2029, Novo Nordisk’s August 2025 filing shows. In Britain semaglutide for MASH is not yet available on the National Health Service while the National Institute for Health and Care Excellence (NICE) assesses it, the MHRA said on 3 July 2026.

Which region spends the most on NASH therapeutics and diagnostics, and where is growth fastest?

North America spends the most, USD 1.29 billion or 78.0% of 2025 value, because Rezdiffra launched there first. Asia Pacific grows fastest, 32.3% a year to USD 1.90 billion by 2035, Douglas Insights estimates.

North America leads on first-mover approvals and specialist capacity. Rezdiffra sales of USD 364.3 million in the second quarter of 2026, up 71%, came overwhelmingly from the US, Madrigal’s release of 30 July 2026 shows, and the region grows 21.5% a year to USD 9.00 billion in our model. Commercially insured US patients can pay as little as USD 25 for Wegovy under Novo Nordisk’s MASH savings offer.

Europe, USD 198 million, grows 31.2% to USD 3.00 billion after Madrigal launched in Germany in September 2025, its February 2026 release notes, and Kayshild won EU authorisation in March 2026. Asia Pacific, USD 116 million, grows fastest because China and India hold the largest MASLD populations and Novo Nordisk filed semaglutide for MASH in Japan in May 2025, its August 2025 filing states. Latin America, USD 33.0 million, grows 29.9% and the Middle East and Africa, USD 16.5 million, grow 31.2% from Gulf obesity programmes, Douglas Insights estimates. Regional values sum to USD 2.04 billion in 2026 and USD 14.6 billion in 2035, in line with the headline.

Which companies lead NASH therapeutics and diagnostics?

Madrigal Pharmaceuticals holds 58.1% of NASH therapeutics and diagnostics value in 2025, Douglas Insights estimates; Novo Nordisk, Roche, GSK and Inventiva lead the challengers, and Echosens and Siemens Healthineers lead testing.

Madrigal sets the pace. Year-to-date Rezdiffra sales reached USD 1.1 billion by 30 September 2026 and the company posted its first profitable quarter, with net income of USD 55.4 million, its third-quarter release shows. Its share falls to about 32% by 2035 in our model as GLP-1 and FGF21 drugs gain, a Douglas Insights estimate. Eli Lilly’s tirzepatide produced MASH resolution in 51.8% to 73.3% of patients against 13.2% on placebo in the 190-patient SYNERGY-NASH phase 2 trial, its release of 8 June 2024 shows, and Boehringer Ingelheim’s survodutide is in phase 3.

Testing is led by two firms. The FDA accepted a letter of intent on 28 August 2025 to qualify liver stiffness measured by VCTE, the FibroScan method from Echosens, as a reasonably likely surrogate endpoint in noncirrhotic F2 to F3 trials, its bulletin states. Siemens Healthineers’ ELF blood test holds an FDA De Novo grant, DEN190056, as a prognostic aid for advanced fibrosis. Douglas Insights estimates the two hold about half of non-invasive test value.

How much does NASH treatment cost per patient a year?

NASH treatment brings in an average USD 35,100 per treated patient-year in 2025, including about USD 11,100 of diagnostic spend, Douglas Insights estimates; drug revenue runs from about USD 4,200 a year for self-pay semaglutide to USD 33,000 for resmetirom.

Resmetirom sets the top of the range. Madrigal’s third-quarter 2026 sales of USD 431.3 million across an average of about 52,400 patients on therapy equal about USD 8,230 a quarter, or USD 32,900 a year of net revenue per patient, a Douglas Insights estimate from its filing. Semaglutide sits far lower: Novo Nordisk sells Wegovy to self-paying US patients at USD 349 a month for most doses, about USD 4,190 a year, with an introductory USD 199 a month for 2 months, its price guide shows.

The average price per treated patient-year falls 7.4% a year in our base case, to about USD 16,200 in 2035, because cheaper GLP-1 drugs take a growing share of patients and payers push net prices down. Diagnostic work is cheaper still: a VCTE scan is billed under US procedure code 91200, and Douglas Insights puts the realised value of a staging work-up, FIB-4 plus one elastography, at USD 80 to USD 150.

Doses also move the price. Novo Nordisk lists a 7.2 mg Wegovy pen at USD 399 a month for self-pay patients, above the USD 349 for other doses, its price guide shows, while commercially insured MASH patients can pay as little as USD 25 through the savings offer valid to 31 December 2026. FGF21 drugs, dosed weekly or monthly by injection, are likely to launch nearer to resmetirom’s net price than to semaglutide’s, a Douglas Insights estimate, which keeps the average from falling faster than 7.4% a year.

What if FGF21 drugs launch late or payers open up: what is the 2035 forecast?

The NASH therapeutics and diagnostics market ends 2035 between USD 6.75 billion and USD 23.1 billion across our three cases, around a base of USD 14.6 billion. Launch timing and diagnosis rates set the spread.

In the slower case NATiV3 or the FGF21 phase 3 trials disappoint, outcomes data arrive late and primary care keeps referring few patients, taking 9.3 points off patient growth. In the faster case FGF21 drugs launch from 2029 as GSK plans, FibroScan qualification makes staging routine and payers cover the disease widely, adding 5.7 points. One extra point of yearly revenue growth adds about USD 1.20 billion to 2035 value, a Douglas Insights estimate.

Live signals sit above the base case for 2026. Rezdiffra sales of USD 1.1 billion in nine months already put 2026 ahead of the smooth model path of USD 2.04 billion for the whole market, so our base case assumes growth slows after 2028 as price falls. The signal to watch is Inventiva’s NATiV3 topline, guided for the fourth quarter of 2026 in its September release.

Which rules govern NASH therapeutics and diagnostics, from FDA accelerated approval to EU conditional licences?

Three rule sets govern NASH therapeutics and diagnostics: accelerated or conditional approval based on liver biopsy endpoints, the FDA and EMA paths to accept non-invasive tests, and clinical guidelines that decide who is treated.

Approval rules decide what counts as proof. The FDA’s guidance for noncirrhotic NASH with liver fibrosis is still the December 2018 draft under docket FDA-2018-D-3632, its guidance page shows; it accepts biopsy-based resolution or fibrosis improvement as a surrogate for accelerated approval, which is how both resmetirom and semaglutide reached market. The EU uses conditional authorisation, granted to Rezdiffra on 18 August 2025 after a positive Committee for Medicinal Products for Human Use (CHMP) opinion on 19 June 2025, the EMA record shows.

Test rules are moving. The FDA’s acceptance of the VCTE letter of intent on 28 August 2025, its bulletin states, starts a qualification that could let trials replace some biopsies. Clinical guidance closes the loop: the European guideline recommends considering resmetirom for noncirrhotic MASH with fibrosis stage 2 or higher where it is approved, its summary states, and AASLD issued updates on resmetirom in October 2024 and semaglutide in November 2025, its guidance page lists.

Douglas Exclusive: the MASH Treatment Funnel model

The MASH Treatment Funnel is a Douglas Insights model built from 15 inputs: 7 company filings or releases, 5 regulator decisions and 3 peer-reviewed or guideline sources. It estimates how many eligible patients reach a prescription at each step.

The finding, a Douglas Insights estimate: of more than 530,000 addressable US patients with F2 to F3 disease, about 55,850, or 10.5%, were on resmetirom by 30 September 2026, and we estimate a further 25,000 to 35,000 are on semaglutide for the liver indication. Each step of the funnel loses patients: diagnosis, referral, staging and payer approval.

The funnel changes how to read the market. Growth to 2035 depends less on new molecules than on lifting the staging step, which is why diagnostic test value triples in our base case while drug prices fall. Douglas Insights therefore forecasts patients first and price second.

How does the methodology turn 47,000 patient-years into USD 1.65 billion?

Our methodology multiplies about 47,000 treated NASH patient-years in 2025 by an average USD 35,100 of market revenue each to reach USD 1.65 billion, then grows patient-years 34.3% a year while price per patient-year falls 7.4% a year.

The model covers 5 product classes and 5 regions, using 52 data points, 22 sourced and 30 modelled. Patient-years come from a product build: about 27,000 on resmetirom, a Douglas Insights estimate from Madrigal’s year-end count of 36,250 and its quarterly sales, and about 20,000 on semaglutide for MASH from August 2025. Price per patient-year includes diagnostic spend, which adds about USD 11,100 per treated patient-year because many more patients are tested than treated. Arithmetic: 47,000 x USD 35,100 = USD 1.65 billion; USD 1.65 billion x (1.343 x 0.926)^10 = USD 14.6 billion. Treated patient-years reach about 63,000 in 2026 and 900,000 in 2035.

Two cross-checks agree. First, Rezdiffra’s reported USD 958.4 million matches our THR-beta line exactly. Second, 900,000 treated patients in 2035 equal about 0.3% of the adults with NASH implied by the 5.27% prevalence in our 2023 Hepatology source, a modest share for a decade of launches, because only staged F2 to F3 patients with access to specialists qualify. AI tools help draft the text and automated checks test the arithmetic and links; the Douglas Insights research desk chooses the sources, builds the model and approves publication, as our editorial standards explain.

Sources

1. US SEC Madrigal Q4 and FY 2025 results (2026)
2. Madrigal Pharmaceuticals Madrigal Q2 2026 results (2026)
3. US SEC Madrigal Q3 2026 results (2026)
4. European Medicines Agency Rezdiffra EPAR (2025)
5. European Medicines Agency Kayshild EPAR (2026)
6. UK MHRA Resmetirom authorised to treat MASH (2026)
7. UK MHRA Semaglutide approved to treat form of liver disease (2026)
8. US SEC Wegovy FDA accelerated approval in MASH (6-K) (2025)
9. US SEC Novo Nordisk to acquire Akero (6-K) (2025)
10. Roche Roche to acquire 89bio (2025)
11. GSK GSK to acquire efimosfermin (2025)
12. Inventiva Inventiva NATiV3 last patient last visit (2026)
13. Eli Lilly SYNERGY-NASH results (2024)
14. King's College London Semaglutide treats liver disease in two-thirds of patients (ESSENCE) (2025)
15. Hepatology Global prevalence of NAFLD and NASH (Younossi et al.) (2023)
16. US FDA FDA accepts letter of intent for LSM by VCTE (2025)
17. US FDA ELF test De Novo DEN190056 (2021)
18. AASLD Clinical assessment and management of NAFLD guidance (2025)
19. EASL EASL-EASD-EASO MASLD guideline summary (2024)
20. US FDA Noncirrhotic NASH with liver fibrosis draft guidance (2018)
21. Novo Nordisk Wegovy MASH savings offer (2026)
22. Novo Nordisk Wegovy price guide (2026)

What counts in the NASH therapeutics and diagnostics study, and what is excluded?

The NASH therapeutics and diagnostics study counts prescription drugs used for MASH and the tests, imaging and biopsies used to diagnose and stage it. GLP-1 use for obesity or diabetes alone, transplants, alcohol-related liver disease and clinic fees are excluded.

The study splits value by 5 product classes and 5 regions: North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Wider drug spending appears in our Pharmaceutical Drug Market report, compounded copies of GLP-1 drugs in the Compounding Pharmacies Market study and outsourced liver trials in the Healthcare Contract Research Organization Market report.