Chronic Kidney Disease Market to Surpass USD 5 Billion by 2036 Across 7MM, Driven by 40M+ US Cases and Robust Pipeline of 15+ Key Companies | DelveInsight

Key Chronic Kidney Disease Companies are ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc., Lexicon Pharmaceuticals, Sanofi, and others.
Chronic Kidney Disease market across the 7 major markets was valued at around USD 5 billion in 2025 and is projected to grow further by 2036. The United States holds the largest share at approximately USD 2.9 billion. Within Europe, Germany leads with about USD 480 million, followed by the UK at around USD 335 million. Japan accounts for nearly USD 665 million, representing roughly 13% of the total market in 2025, with expected changes over the forecast period.

Overall CKD management also involves controlling underlying conditions like hypertension, diabetes, and high cholesterol, along with regular monitoring to improve patient outcomes and quality of life..

A key development includes Boehringer Ingelheim's BI-690517, a selective aldosterone synthase inhibitor, which demonstrated a 39.5% reduction in albuminuria over 14 weeks when combined with empagliflozin in a Phase II study - marking the first trial of its class alongside standard care. These results, showcased at ASN Kidney Week 2023, highlight the shifting treatment landscape for CKD.

Additionally, Japan's Chronic Kidney Disease therapeutics market, valued at USD 1,402 million in 2023, is also expected to experience notable growth by 2036.

DelveInsight's "Chronic Kidney Disease Market Insights, Epidemiology, and Forecast-2036" report offers an in-depth evaluation of CKD, covering past and future epidemiology and market dynamics across the US, EU5, and Japan. The CKD market is projected to grow significantly due to increasing disease prevalence and heightened awareness. Moreover, the anticipated introduction of several emerging therapies across different development stages is expected to transform the competitive landscape and future treatment approaches.

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Some of the key facts of the Chronic Kidney Disease Market Report:

* In January 2026, Mineralys Therapeutics reported a corporate update that highlighted recent and upcoming clinical and regulatory milestones for Lorundrostat in CKD and related conditions.
* In Sept 2025, eGenesis received FDA clearance for its Investigational New Drug (IND) application to start clinical trials of EGEN-2784, a genetically engineered porcine kidney, for treating end-stage kidney disease (ESKD). The Phase 1/2/3 study will evaluate safety and efficacy in dialysis-dependent patients aged 50 and older on the transplant waitlist.
* In August 2025, Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat Chronic Kidney Disease (CKD). This patent follows the issuance of an earlier method of use patent for the treatment of Acute Kidney Injury with UNI-494.
* In July 2025, ProKidney Corp. (Nasdaq: PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced confirmation of alignment with the U.S. Food and Drug Administration (FDA) on the accelerated approval pathway for rilparencel. Rilparencel is an autologous cellular therapy that received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and currently is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes.
* In March 2025, the FDA broadened the approval of Furoscix (furosemide injection) to include the treatment of edema in adults with chronic kidney disease (CKD), including those with nephrotic syndrome. The expanded indication, developed by scPharmaceuticals, Inc., is expected to become available by April 2025, following the agency's acceptance of the supplemental new drug application in July 2024.
* In January 2025, the FDA approved a new indication for semaglutide, allowing its use to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and CKD, as announced by Novo Nordisk.
* The Chronic Kidney Disease therapeutics market size in the US was approximately USD 2,824 million in 2023 and is expected to grow further during the forecast period.
* In 2023, the United Kingdom had the largest Chronic Kidney Disease market size among the EU countries, with nearly USD 421 million, while Italy recorded the smallest market size at approximately USD 132 million.
* The Chronic Kidney Disease therapeutics market size in Japan was estimated at around USD 1,402 million in 2023.
* According to DelveInsight's analysis, the total diagnosed prevalent cases of Chronic Kidney Disease in the 7MM were approximately 16 million in 2023.
* In 2023, the United States held the largest Chronic Kidney Disease market size among the 7MM, valued at around USD 2,824 million, with projections indicating further growth by 2034.
* In 2023, the United States reported the highest prevalence of Chronic Kidney Disease among the 7MM, with approximately 40 million cases, and this number is projected to grow by 2034.
* The Chronic Kidney Disease market in 2023, valued at USD 5,479 million across the 7MM, primarily consists of erythropoietin-stimulating agents (ESAs), ACE inhibitors, angiotensin receptor blockers (ARBs), antidiabetic medications, treatments for secondary hyperparathyroidism (SHPT), and urate-lowering therapies. The market is anticipated to expand further with the introduction of emerging therapies during the forecast period.
* In 2023, Japan's Chronic Kidney Disease market size was valued at USD 1,402 million, with projections indicating substantial growth at a notable CAGR by 2036.
* In 2023, the United Kingdom had the highest number of diagnosed prevalent cases of Chronic Kidney Disease among European countries, with around 2 million cases, followed by Germany with approximately 1 million cases. Italy, on the other hand, had the lowest prevalent population, totaling 731 thousand cases.
* In 2023, Japan reported nearly 3 million total diagnosed prevalent cases of Chronic Kidney Disease, representing about 22% of the total cases across the 7MM.
* DelveInsight's analysis shows that in the EU4 and the UK, more females are impacted than males, with approximately 3.55 million female cases and 3.4 million male cases in 2023.
* Key Chronic Kidney Disease Companies: ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc., Lexicon Pharmaceuticals, Sanofi, and others
* Chronic Kidney Disease Therapies: Ocedurenone (KBP-5074), BI 690517 + Empagliflozin, and others.
* The Chronic Kidney Disease epidemiology based on gender analyzed that Chronic Kidney Disease is slightly more common in women (14%) than men (12%)

Chronic Kidney Disease Overview

Chronic Kidney Disease (CKD) is a progressive condition characterized by the gradual loss of kidney function over time, impairing the body's ability to filter waste, regulate fluids, and maintain electrolyte balance. It is commonly caused by diabetes, hypertension, and cardiovascular disorders, though genetic factors and autoimmune diseases also contribute. Chronic Kidney Disease often progresses silently, with symptoms emerging in advanced stages, such as fatigue, swelling, anemia, and metabolic complications. Diagnosis involves blood tests, urine tests, and imaging to assess kidney function and structural damage. Without timely intervention, Chronic Kidney Disease can advance to end-stage renal disease, requiring dialysis or kidney transplantation.

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Chronic Kidney Disease Epidemiology

DelveInsight's assessment indicates that the total diagnosed prevalent population of Chronic Kidney Disease (CKD) across the 7MM reached approximately 16 million individuals in 2023. The United States reported the highest burden, with an estimated 5 million diagnosed cases, a figure projected to rise over the forecast period. Among the EU5, the United Kingdom exhibited the greatest prevalence (~2 million), followed by Germany (~1 million), while Italy recorded the lowest at 731,000 cases. Japan accounted for roughly 3 million diagnosed cases, representing about 22% of the 7MM total. In terms of disease severity, Stage 3 CKD constituted the largest segment in the US (~2.94 million cases in 2023). Furthermore, across the EU4 and the UK, females exhibited a marginally higher diagnosed prevalence than males, with 3.55 million female cases compared to 3.4 million male cases.

Chronic Kidney Disease Epidemiology Segmentation:

The Chronic Kidney Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Total Prevalence of Chronic Kidney Disease
* Prevalent Cases of Chronic Kidney Disease by severity
* Gender-specific Prevalence of Chronic Kidney Disease
* Diagnosed Cases of Episodic and Chronic Chronic Kidney Disease

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Chronic Kidney Disease Market Outlook

Chronic kidney disease (CKD) management primarily aims to delay disease progression, control symptoms, and minimize complications. Lifestyle interventions play a key role, including dietary adjustments, physical activity, and quitting smoking. Patients are typically advised to reduce intake of salt, potassium, and protein to lessen the burden on the kidneys.

Medications are central to Chronic Kidney Disease treatment. ACE inhibitors and ARBs are widely used to manage blood pressure and reduce protein loss in urine, helping slow disease progression. Statins are prescribed to control cholesterol levels and lower the increased cardiovascular risk associated with Chronic Kidney Disease. For patients with diabetes, maintaining blood glucose levels is critical, often involving drugs such as metformin and SGLT2 inhibitors, which also provide renal protection.

Supportive therapies address complications such as anemia, where erythropoiesis-stimulating agents and iron supplements are commonly used. In advanced stages, renal replacement therapies like hemodialysis and peritoneal dialysis are required to perform kidney functions. For patients with end-stage renal disease, kidney transplantation offers the most effective long-term solution, although it requires ongoing immunosuppressive treatment.

Overall Chronic Kidney Disease management also involves controlling underlying conditions like hypertension, diabetes, and high cholesterol, along with regular monitoring to improve patient outcomes and quality of life.

From a market perspective, the Chronic Kidney Disease market across the 7 major markets was valued at around USD 5 billion in 2025 and is projected to grow further by 2036. The United States holds the largest share at approximately USD 2.9 billion. Within Europe, Germany leads with about USD 480 million, followed by the UK at around USD 335 million. Japan accounts for nearly USD 665 million, representing roughly 13% of the total Chronic Kidney Disease market in 2025, with expected changes over the forecast period.

Chronic Kidney Disease Drugs Analysis

Zibotentan/Dapagliflozin: AstraZeneca

Zibotentan/Dapagliflozin, being developed by AstraZeneca, is an investigational oral combination treatment currently under evaluation for adults with chronic kidney disease (CKD). This therapy integrates zibotentan, an endothelin receptor blocker, with dapagliflozin, an SGLT2 inhibitor, with the goal of enhancing renal outcomes by addressing multiple pathways that contribute to CKD progression.

Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim

Vicadrostat (BI 690517) combined with Empagliflozin, developed by Boehringer Ingelheim, is an investigational therapy being studied for adult CKD patients. It pairs vicadrostat, an aldosterone synthase inhibitor, with empagliflozin, an SGLT2 inhibitor, to act on complementary biological mechanisms involved in the progression of CKD.

Lorundrostat: Mineralys Therapeutics

Lorundrostat, developed by Mineralys Therapeutics, is an investigational oral therapy designed for adults with CKD. As an aldosterone synthase inhibitor, it works by selectively blocking aldosterone production, thereby targeting key hormonal drivers associated with disease progression.

Chronic Kidney Disease Therapies and Key Companies

* TRC101 (Veverimer): Tricida
* Tolvaptan: Otsuka Pharmaceuticals
* AZD5718: AstraZeneca
* KERENDIA (finerenone): Bayer HealthCare Pharmaceuticals Inc.
* INVOKANA (canagliflozin): Janssen Research & Development, LLC
* Ocedurenone (KBP-5074): KBP Biosciences
* BI 690517 + Empagliflozin: Novo Nordisk A/S
* And many others

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Chronic Kidney Disease Market Drivers

1. Rising Disease Prevalence

Increasing CKD cases across the US, Europe, and Japan-driven by aging populations and higher rates of diabetes and hypertension-are significantly boosting market growth.

2. Advancements in Diagnostic Techniques

Improved screening tools, biomarkers, and routine renal function testing are enabling earlier detection, expanding the diagnosed patient pool.

3. Growing Adoption of Novel Therapeutics

Emerging drug classes such as SGLT2 inhibitors, non-steroidal MRAs, and aldosterone synthase inhibitors (e.g., BI-690517) are transforming treatment standards and fueling market expansion.

4. Increased Awareness and Clinical Guidelines

Greater physician and patient awareness, coupled with updated global CKD management guidelines, is driving higher diagnosis and treatment rates.

5. Strong R&D Pipeline

Robust clinical development efforts targeting renal protection, inflammation, and fibrosis are expected to introduce multiple innovative therapies by 2034.

Chronic Kidney Disease Market Barriers

1. Limited Treatment Options for Early Stages

Therapies primarily slow progression rather than reverse kidney damage, reflecting a major unmet medical need.

2. High Treatment Costs

Advanced therapies, dialysis, and transplantation are expensive, restricting market accessibility in some regions.

3. Adverse Effects of Long-Term Treatments

Long-term use of ACE inhibitors, ARBs, and ESAs can lead to safety concerns, limiting patient adherence.

4. Late Diagnosis

CKD often remains asymptomatic in early stages, resulting in delayed diagnosis and reduced therapeutic effectiveness.

5. Regulatory and Clinical Trial Challenges

Renal therapeutics require long, complex clinical trials and face stringent regulatory pathways, slowing product approvals.

Scope of the Chronic Kidney Disease Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
* Key Chronic Kidney Disease Companies: Tricida, Otsuka Pharmaceuticals, AstraZeneca, and others
* Key Chronic Kidney Disease Therapies: TRC101 (Veverimer), Tolvaptan, AZD5718, and others
* Chronic Kidney Disease Therapeutic Assessment: Chronic Kidney Disease current marketed and Chronic Kidney Disease emerging therapies
* Chronic Kidney Disease Market Dynamics: Chronic Kidney Disease market drivers and Chronic Kidney Disease market barriers
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
* Chronic Kidney Disease Unmet Needs, KOL's views, Analyst's views, Chronic Kidney Disease Market Access and Reimbursement

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Table of Contents

1. Chronic Kidney Disease Market Report Introduction

2. Executive Summary for Chronic Kidney Disease

3. SWOT analysis of Chronic Kidney Disease

4. Chronic Kidney Disease Patient Share (%) Overview at a Glance

5. Chronic Kidney Disease Market Overview at a Glance

6. Chronic Kidney Disease Disease Background and Overview

7. Chronic Kidney Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Chronic Kidney Disease

9. Chronic Kidney Disease Current Treatment and Medical Practices

10. Chronic Kidney Disease Unmet Needs

11. Chronic Kidney Disease Emerging Therapies

12. Chronic Kidney Disease Market Outlook

13. Country-Wise Chronic Kidney Disease Market Analysis (2020-2034)

14. Chronic Kidney Disease Market Access and Reimbursement of Therapies

15. Chronic Kidney Disease Market Drivers

16. Chronic Kidney Disease Market Barriers

17. Chronic Kidney Disease Appendix

18. Chronic Kidney Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

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