United States Renal Biomarkers Market is expected to reach US$ 1,207.75 million by 2033 | Top Companies - Abbott Laboratories, BioPorto Diagnostics AS, F. Hoffmann-La Roche AG.

Market Size and Growth:

The Global Renal Biomarkers Market Size reached US$ 1.5 billion in 2024 and is expected to reach US$ 2.7 billion by 2032, growing at a CAGR of 7.8% during the forecast period 2025-2032. The Market is growing due to the rising prevalence of kidney diseases and increasing demand for early and accurate diagnostic tools.

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The Renal Biomarkers Market involves the development, production, and commercialization of biological indicators used to detect, monitor, and manage kidney-related diseases. These biomarkers enable early diagnosis, assess kidney function, predict disease progression, and guide treatment strategies. The market encompasses diagnostic assays, kits, and advanced technologies used in clinical and research settings to improve patient outcomes.

Industry Recent Developments: United States

✅ September 2025: The Foundation for the National Institutes of Health and Critical Path Institute announced FDA acceptance of a qualification plan for a urine biomarker panel to monitor drug-induced kidney injury.

✅ October 2025: Rising prevalence of chronic kidney disease and increased focus on government agencies developing diagnostic tests led to significant growth in market activities including FDA approvals, clinical trials, new product launches, and partnerships.

✅ November 2025: Continued growth driven by advancements in laboratory automation, growing insurer willingness to reimburse novel renal biomarker tests, and Medicare's incentive system linking nephrology scores to albuminuria testing frequency.

Industry Recent Developments: Japan

✅ September 2025: Otsuka Pharmaceutical's Diagnostic Division inaugurated a new laboratory in Tokyo specialized in biomarker and diagnostic technology research.

✅ October 2025: The market is benefiting from advancements in genomic sequencing technologies and precision medicine, which are driving demand for renal biomarkers and companion diagnostics.

✅ November 2025: Increased focus on early detection of renal cancer through advanced imaging techniques and novel biomarkers has expanded patient pools and stimulated development of specialized renal cancer drugs.

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Regulatory / FDA Approvals & Progress in 2025:

FDA Qualification Plan Accepted for Urine Biomarker Panel:

✅ In January 2025, the FDA accepted a Qualification Plan for a urinary biomarker panel designed to detect drug-induced kidney injury in clinical trials.

✅ The panel is being developed by Critical Path Institute (C-Path) in collaboration with the FNIH Biomarkers Consortium, with major pharma partners (Amgen, AstraZeneca, Lilly, J&J, Merck, Pfizer).

✅ This is important: drug‐safety biomarker panels like this can help detect kidney injury earlier than traditional markers (like creatinine or BUN), which could improve safety monitoring in trials.

Renalytix - KidneyIntelX:

✅ Renalytix's KidneyIntelX.dkd prognostic test (which uses AI + blood biomarkers like sTNFR1, sTNFR2, KIM-1, plus EHR data) has previously received FDA De Novo marketing authorization (though that was earlier, in mid-2023).

✅ Also, Renalytix's KidneyIntelX has Breakthrough Device designation from FDA.

✅ According to Renalytix's 2024 annual report, their platform continues to be a flagship in kidney risk stratification.

Point‐of‐care Biomarker Launch: penKid

✅ In May 2025, Boditech Med and SphingoTec GmbH commercially launched the AFIAS penKid assay. This gives "real-time kidney function assessment in critically ill patients."

✅ penKid (proenkephalin) is a relatively newer "functional" biomarker, considered more sensitive than traditional markers under certain conditions.

Regulatory Implications on Biomarker Adoption:

✅ According to Grand View Research, the regulatory focus (especially in the U.S.) on clinical and analytical validation of biomarker assays (including lab‐developed tests) is strong - this has slowed some approvals but improved assay reliability.

✅ Reimbursement and regulatory clarity remain key constraints in the broader renal biomarker market.

Mergers, Acquisitions & Partnerships in 2025:

Novartis Acquires Regulus Therapeutics (~US$ 800 M)

✅ In April 2025, Novartis announced acquisition of Regulus Therapeutics, including its microRNA therapeutic farabursen (RGLS8429) for autosomal dominant polycystic kidney disease (ADPKD).

The acquisition is structured with potential for further milestone payments.

✅ While Regulus is primarily a therapeutic company, its microRNA-based therapy (targeted to kidney) underscores the overlap between biomarker biology (miRNA) and renal disease drug development.

Healthy.io Acquires Labrador Health

✅ In April 2025, Healthy.io acquired Labrador Health, a company specializing in lab‐grade quantitative urine testing via microfluidics + computer vision.

✅ The aim: to develop the first quantitative home-based albumin-to-creatinine ratio (ACR) test, with a target launch in 2026.

✅ This is a significant move in bringing renal biomarker testing (albuminuria) into home diagnostics.

Other Partnerships / Strategic Moves:

✅ According to ASN (Kidney News), in early 2025, Pfizer entered a partnership (via Flagship Pioneering and Quotient Therapeutics) to identify novel targets for cardiovascular and renal diseases.

✅ Also, Boditech Med and SphingoTec's launch (mentioned above) reflects a commercial partnership to scale up penKid testing.

✅ Other M&A / Licenses in Renal-Related Space (but not strictly biomarkers)

✅ Boston Scientific acquired SoniVie (renal denervation developer) for US$ 540 M in 2025.

Major Key Players:

1. Abbott Laboratories - A global healthcare leader, Abbott develops diagnostics, medical devices, and nutritional products, with a strong presence in clinical diagnostics.

2. BioPorto Diagnostics AS - A Danish biotech firm specializing in innovative biomarker assays, particularly for kidney injury and critical care diagnostics.

3. F. Hoffmann-La Roche AG - A Swiss multinational known for pharmaceuticals and diagnostics, Roche is a pioneer in cancer, virology, and personalized medicine testing.

4. Thermo Fisher Scientific Inc. - A US-based company offering analytical instruments, reagents, and diagnostic tools, serving research, clinical, and industrial laboratories.

5. BioMérieux - A French diagnostics company focusing on infectious disease testing, immunoassays, and molecular diagnostics for clinical and industrial applications.

6. Siemens Healthineers - German-based, providing advanced diagnostic imaging, laboratory diagnostics, and digital health solutions to improve patient care worldwide.

Segments Covered in the Renal Biomarkers Market:

By Assay Platform Type: Chemiluminescent Enzyme Immunoassay (CLIA), Colorimetric Assay, Enzymatic Assay, Enzyme-Linked Immunosorbent Assay (ELISA), Liquid Chromatography-Mass Spectrometry (LS-MS).

By Type: Functional Biomarker, Up-Regulated Proteins, Others.

By End Users: Diagnostic Labs, Hospitals, Outpatient Clinics, Research Centres.

Regional Analysis for Renal Biomarkers Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Renal Biomarkers market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Renal Biomarkers Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Renal Biomarkers market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Renal Biomarkers Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

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➠ What are the Renal Biomarkers market opportunities and threats faced by the vendors in the global Renal Biomarkers Industry?

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