당뇨병성 신장병(DKD)은 당뇨병성 신증(DN)으로도 알려져 있으며, 지속적인 알부민뇨와 진행성 신장 기능 저하를 특징으로하는 임상 증후군으로, 이 용어는 사구체 질환의 전형적인 패턴의 존재를 추론하게합니다. DKD의 원인은 복잡하고 많은 요인이 관련되어있을 가능성이 높지만 주요 요인은 고혈당입니다. 초기에는 증상이 없을 수도 있습니다. 그러나 신장 기능이 더욱 저하되면 유해한 노폐물이 축적됩니다. 그 결과, 환자는 종종 속이 메스꺼워 토하고, 식욕이 없어지고, 딸꾹질을 하고, 체액 저류로 인해 체중이 증가합니다. 치료하지 않고 방치하면 심부전이나 폐에 물이 쌓일 수도 있습니다.
당뇨병성 신장 질환을 발견하고 진단하는 데는 어려움이 있습니다. 스크리닝과 신장 생검은 환자의 DKD를 감지하기 위해 수행되는 두 가지 주요 진단입니다. 비알부민뇨증 DKD의 경우 허혈성 신증, 이단백혈증, 세뇨관 간질성 신염(TIN) 등의 진단도 고려됩니다. 미국당뇨병학회(ADA)와 KDIGO(Kidney Disease Improving Global Outcomes)의 가이드라인에 따르면 모든 T2DM 환자는 T1DM을 처음 진단받은 후 매년 신장 기능과 알부민뇨를 측정할 것을 권장하고 있습니다.
주요 7개국 당뇨병 환자 수는 2023년 약 8,285만 8,700명으로 예측 기간 중 증가할 것으로 예상됩니다. 주요 7개국내 DKD 환자 수는 2023년 약 3,315만 2,000명입니다. 이 수치는 2034년까지 증가할 것으로 예상됩니다.
주요 7개국 중 DKD 진단을 받은 유병자 수가 가장 많은 국가는 미국으로 2023년 주요 7개국 전체 환자의 45% 이상을 차지했으며, EU 4개국과 영국에서는 독일이 2023년 DKD 환자 수가 가장 많았고, 프랑스가 가장 적었습니다.
주요 7개국에서 DKD의 총 시장 규모는 2023년 약 72억 달러에 달했습니다. 이 시장은 예측 기간(2024-2034년) 동안 확대될 것으로 예상됩니다. 주요 7개국 중 미국이 2023년 시장 규모가 약 65억 달러로 가장 크고, EU 4개국과 영국 중 2023년 시장 규모는 독일이 최대이고, 프랑스는 최하위입니다. 치료제 중 항당뇨병제는 2032년까지 주요 7개국에서 가장 높은 매출을 올릴 것으로 예상됩니다.
주요 7개국에서 당뇨병성 신장병(DKD) 시장에 대해 조사했으며, 시장의 개요와 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측 및 의료 미충족 요구 등을 제공하고 있습니다.
DelveInsight's "Diabetic Kidney Disease - Market Insights, Epidemiology and Market Forecast - 2034" 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.
Study Period: 2020-2034
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.
Further details related to diagnosis and treatment are provided in the report…
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.
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.
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.
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.
Detailed market assessment will be provided in the final report
Key Findings
As per DelveInsight'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.
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.
Further detailed analysis of therapy drug uptake will be provided in the final report …
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.
Delveinsight's 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.
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