Diabetic Kidney Disease (DKD) - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In the 7MM, the United States accounted for the largest market size in 2023, with approximately USD 6.50 billion.
• The disease is reported to occur in 20-50% of those living with diabetes and is the single most common cause of end-stage kidney disease (ESKD) in many populations.
• Current management strategies employ aggressive glycemic and blood pressure control combined with renin-angiotensin-aldosterone system-blocking agents to slow the worsening of kidney disease.
• For a long time, there were no drugs specific to DKD other than RAS inhibitors. In 2019, a CREDENCE trial proved the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors for DKD, adding a new treatment option, and improving glycemic control in an insulin-independent manner; however, the use of SGLT2i is still limited by the high cost and regulatory contraindications for patients with eGFR < 60 mL/min/1.73 m2
• INVOKANA and FARXIGA are two of the approved SGLT2 inhibitors available in the US, Europe, and Japan for treating DKD. Moreover, recently, JARDIANCE has also gained approval in the US and Europe in 2023 for treating CKD patients with and without type-2 diabetes.
• Among novel treatments, mineralocorticoid receptor antagonists (MRA) are considered extremely promising. In addition, Bayer’s KERENDIA has been approved in the US in 2021 and in Europe and Japan in 2022 to treat adult patients with CKD associated with type 2 diabetes.
• Off-label therapies and generics occupy the major share of the current DKD market as they are cheaper and more easily accessible to patients, being a major barrier to newly developed drugs.
• A few therapies are also being investigated for the treatment of DKD. Some key players involved in the development are Daiichi Sankyo (esaxerenone), ProKidney (REACT), Inversago Pharma (INV-202), AstraZeneca (zibotentan + dapagliflozin), and others.
• In May 2023, Reata Pharmaceuticals terminated the FALCON and EAGLE clinical trials of bardoxolone methyl as no safety issues were identified by the Data Monitoring Committee (DMC).
• Daiichi Sankyo’s esaxerenone is poised to gain a competitive edge over other emerging assets, as the drug is expected to have an early launch, securing a first-mover advantage in the DKD market compared to other upcoming therapies.
• ProKidney’s lead product, REACT (Renal Autologous Cell Therapy), is a first-of-its-kind, patented, proprietary autologous cellular therapy being evaluated to potentially preserve kidney function in diabetic patients at high risk of kidney failure.
• A deeper understanding of the molecular mechanisms of DKD onset and progression is necessary for the development of new and innovative treatments for DKD. Furthermore, as DDK often goes undiagnosed due to its initial lack of symptoms, the use of advanced predictive tests for early detection can augment physicians’ capacity to make well-informed treatment decisions. This, in turn, can result in improved clinical outcomes and streamline more effective therapeutic interventions.

This report delivers an in-depth understanding of the DKD, historical and forecasted epidemiology as well as the DKD market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The DKD market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM DKD market size from 2020 to 2034. The report also covers current DKD treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Diabetic Kidney Disease Understanding and Treatment Algorithm

Diabetic Kidney Disease Overview

Diabetic kidney disease (DKD), also known as diabetic nephropathy (DN), is a clinical syndrome characterized by persistent albuminuria and a progressive decline in renal function, and the term infers the presence of a typical pattern of glomerular disease. DKD is usually associated with arterial hypertension and increased cardiovascular morbidity and mortality. The causes of DKD are complex and most likely related to many factors, but the major factor is hyperglycemia. In the early stages, there may not be any symptoms. However, as kidney function decreases further, toxic wastes build up. Consequently, patients often feel sick to their stomachs and throw up, lose their appetites, have hiccups, and gain weight due to fluid retention. If left untreated, patients can develop heart failure and fluid in their lungs.

Diabetic Kidney Disease Diagnosis

The detection and diagnosis of DKD can be challenging. Screening and renal biopsy are the two primary diagnoses that are conducted to detect DKD in patients. Other diagnoses considered in nonalbuminuric DKD are ischemic nephropathy, dysproteinemia, and tubulointerstitial nephritis (TIN). Guidelines from the American Diabetes Association (ADA) and Kidney Disease Improving Global Outcomes (KDIGO) recommend that all people with T2DM should have their renal function and albuminuria measured annually, starting from initial diagnosis in T1DM; this can start from 5 years after diagnosis.

Diabetic Kidney Disease Treatment

The current pharmacological treatments include blood glucose control and blood pressure and lipid control with renin-angiotensin-aldosterone system (RAS) inhibitors, SGLT2 inhibitors, biguanides, meglitinides, DPP-4 inhibitors, and sulfonylureas. Blood pressure lowering in patients with DKD to levels below 130/80 mmHg is recommended. Combination antihypertensive therapy is required for most individuals with DKD. In such cases, the combination of an ACE inhibitor or ARB plus a dihydropyridine calcium channel blocker is often preferred; however, a nondihydropyridine calcium channel blocker or a diuretic may be preferred rather than a dihydropyridine calcium channel blocker in patients with severely increased albuminuria. Nonpharmacological approaches with appropriate weight management and guidance for diet and smoking cessation are also crucial.

Diabetic Kidney Disease Epidemiology

As the market is derived using a patient-based model, the DKD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of diabetes, total prevalent cases of DKD, total diagnosed prevalent cases of DKD, age-specific cases of DKD, and stage-specific cases of DKD in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• The prevalent cases of diabetes in the 7MM comprised approximately 82,858,700 cases in 2023 and are projected to increase during the forecast period.
• The total prevalent cases of DKD in the 7MM were approximately 33,152,000 in 2023. These cases are expected to increase by 2034.
• Among the 7MM, the United States accounted for the highest number of diagnosed prevalent cases of DKD, i.e., over ~45% of the total cases in the 7MM in 2023.

Among EU4 and the UK, Germany accounted for the largest number of DKD cases, whereas France accounted for the lowest number of cases in 2023.

Diabetic Kidney Disease Drug Chapters

The drug chapter segment of the DKD report encloses a detailed analysis of DKD-marketed drugs and emerging pipeline drugs. It also helps understand the DKD pivotal clinical trial details, recent and expected market approvals, patent details, each drug’s advantages and disadvantages, the latest news, and recent deals and collaborations.

Marketed Drug

JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly

JARDIANCE (empagliflozin) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar from being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, the initiation of empagliflozin also prevents salt from being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e., intravascular volume). The drug was approved in Europe in July 2023 and later in the US in September 2023 for the treatment of CKD with or without type 2 diabetes.

KERENDIA (Finerenone): Bayer

KERENDIA (finerenone/BAY 94-8862) is a novel, first-in-class nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block harmful effects of mineralocorticoid receptor (MR) overactivation. In type 2 diabetes (T2D), MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage, which metabolic, hemodynamic, or inflammation and fibrosis factors can drive. The drug was approved in the US in 2021 and in Europe and Japan in 2022 for the treatment of adult patients with CKD associated with T2D.

Emerging Drug

MINNEBRO (esaxerenone/CS-3150): Daiichi Sankyo

Esaxerenone is an orally administered, nonsteroidal, selective inhibitor of the mineralocorticoid receptor (MR). The binding of aldosterone to the MR plays a central role in the regulation of plasma sodium (Na+), extracellular potassium (K+), and arterial blood pressure by acting on the collecting ducts in nephrons. In January 2019, Daiichi Sankyo announced the receipt of marketing approval for esaxerenone under the brand name MINNEBRO to treat hypertension in Japan. The drug is currently in development for treating DKD in Japan. In July 2019, the top-line results for the Phase III (JapicCTI-173695) study in Japan for diabetic nephropathy were announced.

REACT (Renal Autologous Cell Therapy): ProKidney

REACT is designed to preserve kidney function in a CKD patient’s diseased kidneys. REACT is a product that includes selected renal cells (SRC) prepared from a patient’s autologous renal cells. Because REACT is a personalized treatment composed of cells prepared from a patient’s kidney, there is no need for treatment with immunosuppressive therapies, which are required during a patient’s lifetime when a patient receives a kidney transplant from another allogeneic donor. In October 2021, the US FDA granted ProKidney’s REACT Regenerative Medicine Advanced Therapy (RMAT) designation after reviewing more than 7 years of data collected from over 100 REACT-treated patients with stages 3/4 diabetic CKD and moderate-to-severe albuminuria. The company is currently conducting a Phase III development program and multiple Phase II clinical trials for REACT in subjects with moderate to severe diabetic kidney disease.

Drug Class Insights

The treatment landscape of DKD includes angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), SGLT2 inhibitors, mineralocorticoid antagonist (MRA), GLP-1 RA (glucagon-like peptide-1 receptor agonists), antihypertensive medications, statins, and others.

ACE inhibitors and ARBs lower blood pressure and are often used to protect the kidneys and slow the progression of DKD. In addition to ACE inhibitors, other classes of antihypertensive drugs may be used to control blood pressure, as hypertension can contribute to the progression of kidney disease. Selective sodium-glucose cotransporter type 2 (SGLT2) inhibitors improve glycemic control in an insulin-independent manner by blocking glucose reabsorption in the renal proximal tubule, thereby enhancing urinary glucose excretion. Stains like atorvastatin or simvastatin, are commonly used to lower cholesterol levels, which may help in managing cardiovascular risk factors associated with diabetic kidney disease.

SGLT2 inhibitors have emerged as a key therapy to prevent the progression of CKD in patients with albuminuria with or without diabetes including patients with IgA nephropathy, FSGS, and heart failure. Although the indications for SGLT2 inhibitors have expanded rapidly, data remain scarce in transplant recipients or patients with ESKD and future studies should evaluate their safety and effectiveness in these populations.

Diabetic Kidney Disease Market Outlook

DKD, a form of CKD linked to diabetes, represents the most prevalent cause of end-stage renal disease. The progression of DKD has been correlated with inadequate glycemic control. Effectively managing glucose levels while concurrently impeding the advancement of CKD has been a longstanding objective in treating individuals with DKD. However, numerous glucose-lowering drugs (GLDs) pose challenges, either being contraindicated or demanding meticulous dose adjustments for DKD patients. Blood sugar control in those with CKD adds another level of complexity. It requires detailed knowledge of which medications can be safely used and how kidney disease affects the metabolism of these medications. Initially, the treatment scenario included only ACE inhibitors (ACEi) and angiotensin II receptor blockers (ARBs). The advent of SGLT2 inhibitors has led to a positive shift in the treatment paradigm. They also show promise in safeguarding kidney function for non-diabetic individuals with early kidney disease but detectable albumin in their urine. There are various FDA-approved SGLT2 inhibitors currently being used to treat DKD, including INVOKANA (canagliflozin), FARXIGA (dapagliflozin), and JARDIANCE (empagliflozin). The other class of drugs commonly used to treat DKD include nonsteroidal mineralocorticoid antagonists (MRA) and GLP-1 RA (Glucagon-like peptide-1 receptor agonists). KERENDIA (finerenone) has been granted FDA approval for individuals with type 2 diabetes-related kidney disease. The utilization of GLP-1 RAs is particularly recommended for individuals contending with kidney disease and coronary artery issues, encompassing conditions like heart attacks, coronary stents, or bypass surgeries.

The treatment paradigm for DKD involves a multifaceted approach aimed at managing diabetes, controlling blood pressure, and mitigating the progression of kidney damage. It is highly dynamic, and the emergence of promising therapies such as REACT and zibotentan in combination with dapagliflozin, esaxerenone, and others might lead to a positive shift as far as the treatment landscape of DKD is concerned. Thus, the launch of key assets, along with an increase in the DKD prevalence will further boost the market during the forecasted period.

Key Findings

As per the analyst's estimates, the potential drugs that can mark a significant change in the forecast period include Esaxerenone (CS-3150), REACT (cell therapy), atrasentan, zibotentan with dapagliflozin, and others.

• The total market size of DKD in the 7MM is approximately USD ~7,200 million in 2023 and is projected to increase during the forecast period (2024-2034).
• Among EU4 and the UK, Germany accounted for the maximum market size in 2023, while France occupies the bottom of the ladder.
• Among the therapies, antidiabetic drugs are expected to generate the highest revenue in the 7MM by 2032.

DKD Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. ASIs are beginning to show a profile that's very robust at this stage on blood pressure reduction and potentially on proteinuria. Boehringer presented new data from the combination of its Eli Lilly-partnered SGLT2 drug empagliflozin with experimental aldosterone synthase inhibitor BI 690517 at ASN. 14-week data from a Phase II trial found that at the highest dose tested, BI 690517 plus empagliflozin achieved a 39.5% reduction in albuminuria compared to empagliflozin plus placebo, which the company said suggests “additive” and “clinically relevant” efficacy. Up to 70% of patients on the combination achieved the threshold of a 30% or better reduction in UACR, which was a secondary endpoint in the study. Using BI 690517 along with SGLT2 inhibition may offer the potential for additive kidney benefits while possibly mitigating hyperkalemia risk. We expect BI 690517 plus empagliflozin combination to have a medium fast uptake with its launch expected by 2027 in the US.

Diabetic Kidney Disease Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for DKD emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on DKD's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers, nephrologists, Professors, and others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the European Kidney Patients Federation, Steno Diabetes Center, Kidney Research Institute, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or DKD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint analysis. In the SWOT analysis, 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. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple 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, such as reduction in eGFR and UACR values, are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug’s market access. 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, payers and other industry insiders are considering many payment models. One of the drugs likely to be targeted by CMS for price negotiation, JARDIANCE, has a rebate of approximately 60% off of the WAC. Its minimum discount required by the IRA, on the other hand, is 25% of the non-FAMP. This translates to about 38% off of the WAC. It’s an empirical question whether CMS can get a better deal during its negotiation with the manufacturer. In addition to JARDIANCE, another five of the 10 drugs to be selected have rebates ranging from 38% to 68% off of the WAC.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of DKD, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the DKD market, historical and forecasted market size, market share by therapies, detailed assumptions, and 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 shape and drive the 7MM DKD market.

Diabetic Kidney Disease Report Insights

• Patient Population
• Therapeutic Approaches
• Diabetic Kidney Disease Pipeline Analysis
• Diabetic Kidney Disease Market Size and Trends
• Existing and future Market Opportunity

Diabetic Kidney Disease Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Diabetic Kidney Disease Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Diabetic Kidney Disease Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the DKD total market size, the market size by therapies, and market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• Which class is going to be the largest contributor in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the disease risks, burdens, and unmet needs of DKD? What will be the growth opportunities across the 7MM concerning the patient population of DKD?
• What is the historical and forecasted DKD patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What are the current options for the treatment of DKD? What are the current guidelines for treating DKD in the US and Europe?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for DKD?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the DKD market.
• 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.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• 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 current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around 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.