Chronic Kidney Disease Market Poised for Rapid Growth Amid FDA Drug Approvals | DelveInsight
DelveInsight’s “Chronic Kidney Disease Market Insight, Epidemiology, and Market Forecast – 2034” report provides comprehensive insights into chronic kidney disease, including historical and forecasted epidemiology, current treatment paradigms, and emerging therapies across the 7MM (United States, EU4, United Kingdom, and Japan).
According to the report, the market size of chronic kidney disease across the 7MM was approximately USD 4.6 billion in 2023, and is projected to grow steadily through 2034. The United States emerged as the largest contributor, accounting for nearly USD 2.5 billion of the total market, significantly outpacing other key regions such as the EU4, the UK, and Japan. Within Europe, Germany held the leading position and is expected to maintain its dominance by 2034, followed closely by the UK. While Japan also captured a considerable share, the overall market landscape is being shaped by rising prevalence, better diagnostic rates, and the adoption of advanced treatment approaches across major geographies.
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According to DelveInsight’s epidemiological analysis, the estimated total number of chronic kidney disease prevalent cases diagnosed in the 7MM was nearly 82 million in 2023, and this number is expected to increase significantly over the next decade. The US accounted for the highest total diagnosed prevalent cases of chronic kidney disease in 2023, with approximately 4 million cases. Further, stage 3 CKD represents the largest patient population segment in the 7MM.
Gender disparities in CKD prevalence and progression are becoming increasingly apparent, with women showing higher prevalence in early stages. Furthermore, age-specific data shows the highest prevalence among individuals aged 65 and older. These differential progression patterns highlight the need for gender- and age-specific approaches to CKD management and intervention.
Diabetes and hypertension remain the leading causes of CKD, while the prevalence increases substantially with age, with individuals over 65 years showing markedly higher rates compared to younger populations. Additionally, the increasing recognition of non-traditional risk factors, including obesity, environmental exposures, and certain medications, is reshaping our understanding of CKD epidemiology.
The chronic renal failure therapeutics landscape has evolved substantially in recent years, moving beyond traditional approaches focused solely on slowing disease progression to novel therapies targeting specific pathways. SGLT2 inhibitors, including FARXIGA (dapagliflozin) and INVOKANA (canagliflozin), have revolutionized renal disease management by demonstrating significant renoprotective benefits beyond glycemic control, substantially reducing the risk of kidney failure and cardiovascular events in CKD patients. The approval of KERENDIA (finerenone), a non-steroidal mineralocorticoid receptor antagonist, has further expanded treatment options by addressing inflammation and fibrosis pathways in diabetic kidney disease.
For renal anemia, the market has witnessed significant advancements with the approval of hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors, such as VAFSEO (Akebia Therapeutics) and EVRENZO (Astellas), which provide alternatives to traditional erythropoiesis-stimulating agents. These therapies offer improved convenience with oral administration and potentially reduced cardiovascular risks compared to injectable options. Additionally, KORSUVA (Cara Therapeutics) has addressed the significant burden of Uremic Pruritus (CKD-aP), substantially improving the quality of life for affected patients on hemodialysis.
According to DelveInsight’s analysis, the renal treatment pipeline is robust, with several therapies in various development stages targeting different aspects of renal disease progression and complications. Notable candidates include Ocedurenone (KBP Biosciences), a nonsteroidal mineralocorticoid receptor antagonist being investigated for the treatment of resistant hypertension in patients with chronic kidney disease; Sparsentan (Travere Therapeutics), a dual endothelin and angiotensin receptor antagonist showing promise in IgA nephropathy and focal segmental glomerulosclerosis; and atrasentan (Chinook Therapeutics), an endothelin A receptor antagonist demonstrating potential in proteinuric kidney diseases.
Cell and gene therapies are also emerging as potential transformative approaches, with candidates like FCR001 (Talaris Therapeutics) being investigated for inducing immune tolerance in kidney transplant recipients. Additionally, several bispecific antibodies targeting inflammatory pathways involved in CKD progression are advancing through early clinical trials, potentially offering new mechanisms to address kidney inflammation and fibrosis.
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The chronic renal disease treatment landscape has seen significant advancements in early 2025, marked by key regulatory milestones and expanded therapeutic options.
In March 2025, the FDA expanded the approval of Furoscix (furosemide injection, scPharmaceuticals, Inc.) to include the treatment of edema in adult CKD patients, including those with nephrotic syndrome, with availability expected by April 2025.
Additionally, in January 2025, Semaglutide (Novo Nordisk) received FDA approval for a new indication to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and CKD, further enhancing patient care.
Unicycive Therapeutics announced in November 2024 that the FDA has accepted its New Drug Application for Oxylanthanum Carbonate (OLC), targeting hyperphosphatemia in CKD patients on dialysis, with a PDUFA action date set for June 28, 2025. These developments underscore a rapidly evolving CKD market, offering new hope and improved outcomes for patients.
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Despite these advancements, significant challenges persist in the CKD treatment landscape. Early diagnosis remains elusive, with many patients identified only after substantial kidney damage has occurred. Additionally, the complex, multifactorial nature of renal diseases often requires combination therapies, creating concerns about polypharmacy, drug interactions, and economic burden. DelveInsight’s analysis emphasizes the need for biomarker-driven, personalized treatment approaches and more effective strategies for early intervention to address these unmet needs.
Looking ahead, the chronic kidney disease market is poised for substantial transformation, with multiple late-stage therapies expected to gain approval in the coming years. Combination regimens leveraging complementary mechanisms of action are likely to become standard practice, offering more comprehensive kidney protection. Additionally, the integration of artificial intelligence in predictive modeling and treatment selection promises to enhance personalized care, potentially revolutionizing CKD management by enabling earlier intervention in high-risk populations and optimizing therapy selection based on individual patient characteristics and disease subtypes.
Table of Contents
1. Key Insights
2. Report Introduction
3. CKD Market Overview at a Glance
4. CKD Epidemiology and Market Forecast Methodology
5. Key Events
6. CKD Executive Summary
7. Disease Background and Overview of Chronic Kidney Disease (CKD)
8. CKDEpidemiology and Patient Population
9. CKD Patient Journey
10. CKD Marketed Drugs
11. CKD Emerging Drugs
12. CKD: Seven Major Market Analysis
13. Key Opinion Leaders’ Views
14. SWOT Analysis
15. CKD Unmet needs
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
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About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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