Chronic Kidney Disease - Market Insight, Epidemiology, and Market Forecast - 2036

Chronic Kidney Disease Insights and Trends

• Chronic kidney disease (CKD) is a progressive, heterogeneous condition characterized by a gradual decline in kidney function, typically defined by reduced glomerular filtration rate (GFR) and/or markers of kidney damage.
• As per DelveInsight analysis, in 2025, there were approximately 82.5 million prevalent and nearly 14.5 million total diagnosed prevalent cases of CKD in the 7MM. These cases are projected to increase further during the forecast period (2026-2036), due to the increasing geriatric population.
• In the US, more than 1 in 7 adults (14%) aged 18 or older (37 million people) were estimated to have CKD.
• CKD prevalence increases substantially with age, with the highest burden in adults aged 65 and above.
• Type 2 Diabetes drives 40% of all US CKD cases, with 23 million americans suffering from comorbid hypertension and CKD.
• Improved diagnostic sensitivity in blood and urine tests, specifically through GFR measurement, cystatin C use, and albuminuria detection, has facilitated earlier and more accurate identification of CKD. This advancement enables timely interventions, effectively mitigating disease progression and associated complications.
• Treatment of CKD is aimed at slowing progression to kidney failure while reducing cardiovascular risk and managing complications such as anemia and mineral bone disease.
• SGLT2 inhibitors, non-steroidal MRAs, and emerging aldosterone synthase inhibitor combinations are replacing single-agent RAS blockade due to superior renal and cardiovascular outcomes.
• The approved therapies in the CKD market include empagliflozin (JARDIANCE) (Boehringer Ingelheim and Eli Lilly), finerenone (KERENDIA) (Bayer), dapagliflozin (FARXIGA/FORXIGA) (AstraZeneca), and others.
• The pharmaceutical companies active in the emerging pipeline include AstraZeneca (zibotentan/dapagliflozin), Boehringer Ingelheim (vicadrostat + empagliflozin), Mineralys Therapeutics (lorundrostat), ProKidney (rilparencel), and others.
• Despite approval of SGLT2 inhibitors, non-steroidal MRAs, and RAS blockade, a substantial proportion of CKD patients continue to progress to kidney failure, and the disease remains markedly underdiagnosed, underscoring the need for therapies that more effectively halt progression and for improved early detection and diagnosis strategies.

CKD Market Size and Forecast in the 7MM

DelveInsight's 'CKD - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of CKD, historical and forecasted epidemiology, as well as the CKD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The CKD market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates CKD patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in CKD and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the CKD Market

• Rising Disease Prevalence and Earlier Screening

CKD diagnosis is increasing due to greater screening in high-risk populations, particularly patients with diabetes, hypertension, and cardiovascular disease, alongside routine eGFR and UACR testing. Earlier detection expands the treated patient pool at earlier disease stages, especially in developed markets. This directly increases long-term therapy demand.

• Shift Toward Combination Cardiorenal Therapy

SGLT2 inhibitors, non-steroidal MRAs, and emerging aldosterone synthase inhibitor combinations are replacing single-agent RAS blockade due to superior renal and cardiovascular outcomes. These agents address complementary pathways of disease progression, making multi-drug regimens increasingly standard rather than exceptional. This is the main revenue driver of the market.

• Diversifying Late-Stage Pipeline

New mechanisms such as endothelin receptor antagonism, aldosterone synthase inhibition, APOL1 inhibition, and cell-based therapy are expanding treatment choices beyond the SGLT2i/MRA backbone. Companies are increasingly focusing on differentiated, precision, and disease-modifying assets. This increases competition and market expansion.

CKD Understanding and Treatment Algorithm

CKD Overview and Diagnosis

CKD is a progressive, heterogeneous condition characterized by a gradual decline in kidney function, typically defined by reduced glomerular filtration rate (GFR) and/or markers of kidney damage. It is commonly driven by underlying diabetes, hypertension, and cardiovascular disease, though genetic drivers such as APOL1 high-risk variants and glomerular diseases also contribute to a meaningful subset of cases. The disease follows a heterogeneous course, ranging from stable, early-stage disease to rapid progression toward kidney failure requiring dialysis or transplantation. Early diagnosis is critical because much of the structural kidney damage that accumulates is irreversible.

Diagnosis of CKD is primarily based on estimated GFR and UACR, staged according to KDIGO criteria that combine both measures to assess severity and progression risk. Additional workup, including imaging, serologic testing, and in select cases genetic testing (e.g., for APOL1 variants) or kidney biopsy, helps identify the underlying etiology and exclude other causes of kidney dysfunction. Because early-stage CKD is often asymptomatic, diagnosis frequently relies on early screening in at-risk populations rather than symptom-driven presentation.

Current CKD Treatment Landscape

Treatment of CKD aims to slow progression to kidney failure while reducing cardiovascular risk and managing complications such as anemia and mineral bone disease. Management typically follows a stepwise, additive approach, starting with RAS blockade (ACE inhibitors/ARBs) and lifestyle modification, and progressing to SGLT2 inhibitors such as empagliflozin (JARDIANCE) and dapagliflozin (FARXIGA/FORXIGA) as foundational background therapy across most CKD etiologies. In patients with CKD associated with type 2 diabetes and residual albuminuria, the non-steroidal MRA finerenone (KERENDIA) is increasingly added on top of SGLT2 inhibition to reduce cardiorenal risk further. Emerging combination approaches, including endothelin receptor antagonist/SGLT2 inhibitor and aldosterone synthase inhibitor/SGLT2 inhibitor regimens, are being layered onto this foundation to target residual risk, while genetically targeted and cell-based therapies are being developed for specific high-risk subpopulations.

CKD Unmet Needs

The section "unmet needs of CKD" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Current therapies only delay progression and cannot halt or reverse CKD.

2. The asymptomatic progression of CKD often results in late-stage diagnosis.

3. Persistent residual cardiorenal risk despite combination SGLT2 inhibitor and MRA therapy

4. Lack of accessible, precision therapies for genetically driven CKD subtypes such as APOL1-mediated kidney disease, and others....

CKD Epidemiology

Key Findings from CKD Epidemiological Analysis and Forecast

• As per DelveInsight analysis, in 2025, there were approximately 82.5 million prevalent and nearly 14.5 million total diagnosed prevalent cases of CKD in the 7MM. These cases are projected to increase further during the forecast period (2026-2036), due to the increasing geriatric population.
• In 2025, the US accounted for the highest number of diagnosed prevalent cases of CKD among the 7MM, representing approximately 26% of the total, with around 3.8 million cases. This figure is anticipated to rise by 2036.
• In 2025, Germany recorded the highest number of diagnosed prevalent CKD cases among EU4 and the UK, followed by the UK and in contrast, Italy reported the lowest.
• Among the US diagnosed prevalent population in 2025, Stage III accounted for the highest number of cases, at approximately 1.8 million, followed by Stage V, then Stage II and Stage IV in comparable numbers, with Stage I representing the smallest share.
• In the US, hyperparathyroidism was the most common, affecting nearly 1.4 million patients, followed by anemia, with metabolic acidosis the least prevalent of the three in 2025.
• As per DelveInsight analysis, the gender distribution of the disease in the US indicates a female predominance, with approximately 2.1 million cases among females and 1.7 million cases among males in 2025.

CKD Drug Analysis & Competitive Landscape

The CKD drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase III/II clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the CKD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the CKD therapeutics market.

Approved Therapies for CKD

Empagliflozin (JARDIANCE): Boehringer Ingelheim and Eli Lilly

JARDIANCE (empagliflozin), developed by Boehringer Ingelheim and Eli Lilly, is an oral sodium-glucose cotransporter 2 inhibitor approved by the US FDA for adults with CKD. It inhibits SGLT2 in the proximal renal tubules, reducing glucose and sodium reabsorption and improving renal hemodynamics. In July 2023, Boehringer Ingelheim reported that the European Commission approved empagliflozin, in September 2023, it was approved by the US FDA, and in February 2024, the Ministry of Health, Labour and Welfare (MHLW) reported the approval.

Finerenone (KERENDIA): Bayer

Finerenone (KERENDIA) is a nonsteroidal, mineralocorticoid receptor antagonist. It is labeled for the treatment of CKD in adults with type 2 diabetes mellitus to reduce the risk of sustained renal function decline, end-stage renal disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. It was approved for by the US FDA in July 2021, followed by the European Commission in February 2022, and Japan's MHLW in March 2022.

Emerging Therapies for CKD

Zibotentan/Dapagliflozin: AstraZeneca

Zibotentan/Dapagliflozin, developed by AstraZeneca, is an investigational oral combination therapy being evaluated for adults with CKD. It combines zibotentan, an endothelin receptor antagonist, with dapagliflozin, an SGLT2 inhibitor, aiming to improve kidney outcomes by targeting complementary pathways involved in CKD progression. Building on positive Phase IIb ZENITH-CKD results showing up to a 52.5% reduction in urine protein markers, patient recruitment for the Phase III ZENITH High Proteinuria trial wrapped up in late 2024, with final study results expected in 2027.

Vicadrostat + Empagliflozin: Boehringer Ingelheim

Vicadrostat + Empagliflozin, developed by Boehringer Ingelheim, is an investigational combination therapy being evaluated for adults with CKD. The combined use of vicadrostat with empagliflozin has already shown promising results in a Phase II trial in CKD in 2023, with full data results demonstrating a significant reduction of excessive levels of protein in the urine (albuminuria) by up to 39.5% vs placebo. The combination of vicadrostat and empagliflozin could offer new hope for people living with CKD.

CKD Key Players, Market Leaders and Emerging Companies

• Bristol Myers Squibb
• UBC
• AbbVie
• Johnson & Johnson
• Sun Pharmaceutical Industries
• Affibody Medical
• Takeda Pharmaceuticals
• AltruBio
• Merck Sharp & Dohme, and others

CKD Drug Updates

• In March 2026, Maze Therapeutics announced positive topline data from Phase II HORIZON trial of MZE829, demonstrating the first clinical Proof-of-concept in patients with broad APOL1-Mediated Kidney Disease (AMKD).
• 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 November 2025, Mineralys Therapeutics reported the presentation of data for Lorundrostat in CKD and hypertension at ASN Kidney Week 2025 organized by the American Society of Nephrology.

CKD Market Outlook

CKD management has shifted from blood-pressure and glycemic control alone toward therapies targeting nephron loss directly hemodynamic stress, aldosterone excess, endothelin-mediated vasoconstriction, fibrosis, and genetically driven podocyte injury. SGLT2 inhibitors empagliflozin (JARDIANCE) and dapagliflozin (FARXIGA/FORXIGA), validated by EMPA-KIDNEY and DAPA-CKD respectively, now anchor standard of care with broad payer acceptance, while finerenone (KERENDIA) has carved a complementary niche addressing residual albuminuria in diabetic CKD; this multi-pathway stacking is increasingly becoming the de facto standard across the 7MM.

A diversified late-stage pipeline spanning endothelin receptor antagonists, aldosterone synthase inhibitors (lorundrostat), APOL1 inhibitors (MZE829), and cell therapy (rilparencel) is set to reshape competition, each targeting mechanisms complementary to the SGLT2i/MRA backbone. The market growth will be driven by rising diagnosed prevalence, earlier UACR/eGFR-based screening, and expanding combination use, with competitive intensity favoring players that demonstrate durable renal-outcome benefit, clean safety (fluid retention, hyperkalemia), and differentiated positioning as the paradigm shifts toward multi-pathway, disease-modifying strategies.

• SGLT2 inhibitors (empagliflozin, dapagliflozin) and finerenone are expected to remain the volume backbone of the market, with continued uptake as combination standard of care.
• Endothelin and aldosterone-pathway combinations (zibotentan/dapagliflozin, vicadrostat/empagliflozin, lorundrostat) are expected to drive the next wave of add-on growth, contingent on outcomes-trial and fluid-retention/hyperkalemia safety data.
• Rilparencel and MZE829 represent potential disease-modifying and precision-genetic opportunities, respectively, that could command premium positioning in advanced and APOL1-driven CKD if pivotal data remain positive.
• DISC-0974 could open a new anemia-specific revenue segment within the broader CKD market, largely uncontested by current SGLT2i/MRA-focused competitors.

Drug Class/Insights into Leading Emerging and Marketed Therapies in CKD (2022-2036 Forecast)

The CKD market (2022-2036) forecast is increasingly shifting toward mechanistically complementary, combination-based regimens that target hemodynamic, hormonal, and genetic drivers of nephron loss, layered on top of a well-established SGLT2 inhibitor backbone.

• SGLT2 inhibitors: This class includes empagliflozin (JARDIANCE) and dapagliflozin (FARXIGA/FORXIGA), which reduce intraglomerular pressure and glucose/sodium reabsorption in the proximal tubule, thereby slowing eGFR decline and reducing cardiovascular risk regardless of diabetes status.
• Aldosterone synthase inhibitor/SGLT2 inhibitor: Vicadrostat + empagliflozin, selectively inhibit CYP11B2-mediated aldosterone production to address the residual cardiorenal risk driven by aldosterone excess that persists despite SGLT2 inhibition and RAS blockade. By combining aldosterone synthase inhibition with an SGLT2 inhibitor, these regimens aim to deliver additive reductions in albuminuria and blood pressure while managing the hyperkalemia risk historically associated with mineralocorticoid receptor pathway agents, positioning this class as a leading next-generation add-on to standard of care.
• APOL1 Inhibitors: MZE829 is designed to address APOL1-mediated kidney disease (AMKD), a genetically defined and historically underserved subset of CKD. It directly targets the underlying genetic driver of podocyte injury rather than downstream hemodynamic effects, with the potential for meaningful proteinuria reduction.

Overall, innovation in CKD is increasingly centered on combination strategies layered onto the SGLT2 inhibitor foundation, alongside genetically targeted and cell-based approaches. While SGLT2 inhibitors and non-steroidal MRAs currently dominate the marketed landscape, emerging aldosterone synthase inhibitor combinations and APOL1-targeted therapies are expected to diversify treatment options, address residual and genetically driven risk, and support sustained market growth across the 7MM through 2036.

CKD Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the CKD drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Detailed insights of emerging therapies' drug uptake are included in the report

Market Access and Reimbursement of Approved Therapies in CKD

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

CKD Therapies Price Scenario & Trends

Pricing and analogue assessment of CKD therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for CKD

To keep up with CKD market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on CKD emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in CKD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as Rochester, University Hospital Erlangen, Kings College Hospital, etc. were contacted. Their opinions help understand and validate current and emerging CKD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in CKD.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of CKD, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of CKD, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the CKD market, historical and forecasted market size, market share by therapies, detailed assumptions, and the rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM CKD market.

Report Insights

• CKD Patient Population Forecast
• CKD Therapeutics Market Size
• CKD Pipeline Analysis
• CKD Market Size and Trends
• CKD Market Opportunity (Current and forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-Enabled Market Research Report
• 11-Year Forecast
• CKD Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (By Geography)
• CKD Treatment Addressable Market (TAM)
• CKD Competitive Landscape
• CKD Major Companies Insights
• CKD Price Trends and Analogue Assessment
• CKD Therapies Drug Adoption/Uptake
• CKD Therapies Peak Patient Share Analysis

Report Assessment

• CKD Current Treatment Practices
• CKD Unmet Needs
• CKD Clinical Development Analysis
• CKD Emerging Drugs Product Profiles
• CKD Market attractiveness
• CKD Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

• What was the CKD market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of CKD?
• What are the disease risks, burdens, and unmet needs of CKD? What will be the growth opportunities across the 7MM concerning the patient population with CKD?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of CKD? What are the current guidelines for treating CKD in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the CKD market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.