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시장보고서
상품코드
2082891
당뇨병성 신증 : 시장 인사이트, 역학 및 시장 예측(2036년)Diabetic Nephropathy - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
본 '당뇨병성 신증/당뇨병성 신질환(DKD)' 시장 보고서는 표준 치료, 임상 실무, 그리고 진화하는 치료 알고리즘을 포함하여 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 당뇨병성 신증/ 당뇨병성 신질환(DKD)의 환자 부담 동향, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제공합니다. 본 보고서는 당뇨병성 신증/당뇨병성 신질환(DKD) 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
당뇨병성 신증/당뇨병성 신질환(DKD)의 유병률 증가
특히 60세 이상 연령층에서 DKD 유병률이 증가하는 것은 시장 성장의 주요 촉진요인으로 작용하고 있습니다.
당뇨병성 신증/당뇨병성 신질환(DKD) 치료 기회의 확대
SGLT2 억제제나 비스테로이드성 MRA 등 신약의 유효성 및 신장 보호 효과를 입증하는 새로운 임상적 근거가 밝혀짐에 따라, 제약 기업 입장에서는 DKD에서 발생하는 염증, 섬유화, 대사 이상에 관여하는 주요 경로를 표적으로 한 치료법에 주력할 기회가 확대되고 있음이 부각되고 있습니다.
당뇨병성 신증/당뇨병성 신질환(DKD)의 개요와 진단
DKD(당뇨병성 신증)는 당뇨병성 신증(DN)이라고도 불리며, 지속적인 알부민뇨와 신기능의 진행성 저하를 특징으로 하는 임상 증후군으로, 이 용어는 전형적인 사구체 질환 양상이 존재함을 시사합니다. DKD는 일반적으로 고혈압 및 심혈관계 질환의 발병률과 사망률 증가와 관련이 있습니다. DKD의 원인은 복잡하며, 여러 요인이 관여하는 것으로 보이지만, 주요 원인은 고혈당입니다. 초기 단계에서는 증상이 나타나지 않는 경우도 있습니다. 그러나 신장 기능이 더 악화되면 노폐물이 체내에 쌓이게 됩니다. 그 결과, 환자는 메스꺼움이나 구토를 느끼거나, 식욕 부진이나 딸꾹질이 생기거나, 체액 저류로 인한 체중 증가가 나타나는 경우가 종종 있습니다. 치료를 하지 않고 방치할 경우, 심부전이나 폐부종을 동반할 가능성이 있습니다.
당뇨병성 신병증(DKD)의 진단
DKD의 검출과 진단에는 어려움이 있습니다. 선별 검사와 신장 생검은 환자의 DKD를 확인하기 위해 시행되는 두 가지 주요 진단 검사입니다. 비알부민뇨성 DKD에서 고려해야 할 기타 진단으로는 허혈성 신증, 단백 이상증, 그리고 세뇨관-간질성 신염(TIN)이 있습니다. 미국당뇨병학회(ADA) 및 신장질환 세계 결과 개선 기구(KDIGO)의 지침에 따르면, 2형 당뇨병(T2DM) 환자 모두에게 매년 신장 기능과 알부민뇨 검사를 실시할 것을 권장하고 있습니다. 1형 당뇨병(T1DM)의 경우, 초기 진단 시점부터 측정을 시작할 수도 있고, 진단 후 5년이 경과한 시점부터 시작할 수도 있습니다.
당뇨병성 신증/당뇨병성 신질환(DKD)의 치료
현재의 약물 치료에는 혈당 조절 외에도 레닌-안지오텐신-알도스테론계(RAS) 억제제, SGLT2 억제제, 비구아나이드계 약물, 메글리티니드계 약물, DPP-4 억제제, 설포닐우레아 계열 약물을 이용한 혈압 및 지질 조절이 포함됩니다. DKD 환자의 경우, 혈압을 130/80 mmHg 미만으로 낮추는 것이 권장됩니다. 대부분의 DKD 환자에게는 항고혈압제의 병용 요법이 필요합니다. 이러한 경우, ACE 억제제 또는 ARB와 디하이드로피리딘계 칼슘 채널 차단제의 병용이 종종 권장되지만, 알부민뇨가 현저히 증가한 환자의 경우, 디하이드로피리딘계 칼슘채널 차단제 대신 비디하이드로피리딘계 칼슘채널 차단제나 이뇨제가 권장될 수 있습니다. 적절한 체중 관리와 식이 지도, 금연 지도와 같은 비약물적 치료도 매우 중요합니다.
당뇨병성 신증/당뇨병성 신질환(DKD)의 역학적 분석 및 예측에 관한 주요 조사 결과
당뇨병과 관련된 만성 신장 질환(CKD)의 일종인 DKD는 말기 신장 질환의 가장 흔한 원인이 되고 있습니다. DKD의 진행은 혈당 조절이 제대로 이루어지지 않는 것과 상관관계가 있습니다. 혈당 수치를 효과적으로 관리하면서 동시에 만성 신장 질환(CKD)의 진행을 억제하는 것은 당뇨병성 신장병(DKD) 환자의 치료에서 오랫동안 추구해 온 목표입니다. 그러나 많은 혈당강하제(GLD)는 DKD 환자에게 금기이거나, 세심한 용량 조정이 필요하기 때문에 문제가 되고 있습니다. CKD 환자의 혈당 조절은 더욱 복잡해집니다. 어떤 약물을 안전하게 사용할 수 있는지, 또한 신장 질환이 이러한 약물의 대사에 어떤 영향을 미치는지에 대해 상세한 지식이 필요합니다. 처음에는 치료 옵션으로 ACE 억제제(ACEi)와 안지오텐신 II 수용체 길항제(ARB)밖에 없었습니다. SGLT2 억제제의 등장으로 치료 패러다임에 긍정적인 변화가 가져왔습니다. 이러한 약물은 당뇨병이 없는 환자나 소변에서 알부민이 검출되는 초기 신장 질환 환자들에게서도 신장 기능을 보호하는 데 유망한 것으로 평가받고 있습니다. 현재 DKD 치료에 사용되는 FDA 승인을 받은 SGLT2 억제제에는 INVOKANA, FARXIGA, JARDIANCE 등이 있습니다. DKD 치료에 일반적으로 사용되는 다른 약물군으로는 비스테로이드성 미네랄코르티코이드 길항제(MRA)와 GLP-1 RA(글루카곤 유사 펩티드-1 수용체 작용제) 등이 있습니다. '케렌디아(KERENDIA)'는 2형 당뇨병 관련 신장 질환 환자를 대상으로 FDA 승인을 획득했습니다. GLP-1 RA의 사용은 특히 신장 질환에 더해 심근경색, 관상동맥 스텐트 삽입, 우회술 등의 병세를 동반한 관상동맥 질환을 앓고 있는 환자에게 권장됩니다.
DKD의 치료 패러다임에는 당뇨병 관리, 혈압 조절, 그리고 신장 손상 진행 억제를 목표로 하는 다각적인 접근법이 포함됩니다. 이는 매우 역동적인 분야이며, 에사크셀레논(MINNEBRO), SER150, 브레멜라노티드(VYLEESI) 등 유망한 치료법의 등장은 DKD 치료 상황에 긍정적인 변화를 가져올 가능성이 있습니다. 따라서 주요 의약품의 출시와 더불어 DKD 유병률 증가가 맞물려, 예측 기간 동안 시장이 더욱 성장할 것으로 전망됩니다.
표적 지향형 저분자 화합물과 MRA는 DKD 분야의 혁신을 주도하고 있으며, 확립된 치료법이 현재의 임상 실무를 이끌고, 차세대 약물이 미래 시장 성장을 뒷받침하고 있습니다.
DelveInsight's 'Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) - Market Insights, Epidemiology and Market Forecast - 2036' 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, Spain, Italy, and France), the United Kingdom, and Japan.
The Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) 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 Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) 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 Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Market
Rising Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Incidence
The rising prevalence of DKD, particularly among individuals aged >=60 years, is a key driver of market growth.
Rising Opportunities in Diabetic Nephropathy/ Diabetes Kidney Disease (DKD)-Targeted Therapies
Emerging clinical evidence demonstrating the efficacy and renal-protective benefits of novel agents such as SGLT2 inhibitors and non-steroidal MRAs highlights a growing opportunity for drug developers to focus on therapies targeting key pathways involved in inflammation, fibrosis, and metabolic dysregulation in DKD.
Emerging Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Competitive Landscape
The DKD market is being propelled by a robust and evolving pipeline, with emerging therapies such as Esaxerenone from Daiichi Sankyo, SER150 from Serodus, Bremelanotide from Palatin Technologies, and INV-202 from Novo Nordisk/Inversago Pharma, supporting continued innovation and expanding future treatment options.
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Overview and Diagnosis
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 Nephropathy/ Diabetes Kidney Disease (DKD) Diagnosis
The detection and diagnosis of DKD can be challenging. Screening and renal biopsy are the two primary diagnostic tests that are conducted to detect DKD in patients. Other diagnoses considered in non-albumin uric DKD are ischemic nephropathy, dysproteinemia, and tubule-interstitial 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 Nephropathy/ Diabetes Kidney Disease (DKD) 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 non-dihydropyridine calcium channel blocker or a diuretic may be preferred rather than a dihydropyridine calcium channel blocker in patients with severely increased albuminuria. Non-pharmacological approaches with appropriate weight management and guidance for diet and smoking cessation are also crucial.
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Unmet Needs
The section "unmet needs of Diabetic Nephropathy/ Diabetes Kidney Disease (DKD)" 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.
Comprehensive unmet needs insights in DKD and their strategic implications are provided in the full report.
Key Findings from Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Epidemiological Analysis and Forecast
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Drug Chapters & Competitive Analysis
The DKD drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III 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 DKD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the DKD therapeutics market.
Approved Therapies for Diabetic Nephropathy/ Diabetes Kidney Disease (DKD)
Empagliflozin (JARDIANCE): Boehringer Ingelheim/Eli Lilly
JARDIANCE is an oral, once-daily, highly selective SGLT2 inhibitor. Inhibition of SGLT2 with JARDIANCE in people with type 2 diabetes (T2D) and high blood sugar levels prevents sugar from being reabsorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, the initiation of JARDIANCE also prevents salt from being reabsorbed, 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).
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Pipeline Analysis
Esaxerenone (MINNEBRO): 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.
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Key Players, Market Leaders, and Emerging Companies
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Drug Updates
Drug Class Insights
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, FARXIGA, and JARDIANCE. The other class of drugs commonly used to treat DKD includes nonsteroidal mineralocorticoid antagonists (MRA) and GLP-1 RA (Glucagon-like peptide-1 receptor agonists). KERENDIA 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 esaxerenone (MINNEBRO), SER150, bremelanotide (VYLEESI), 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.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) (2022-2036 Forecast)
The DKD market comprises targeted small molecules and supportive therapies alongside standard-of-care treatments, each addressing distinct metabolic, hemodynamic, and fibrotic pathways underlying disease progression.
Targeted small molecules and MRAs together define the core innovation landscape in DKD, with established therapies driving current clinical practice and next-generation agents supporting future market growth.
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) 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 DKD market's uptake by drugs, patient uptake by therapy, and sales of each drug.
The uptake of therapies in DKD is expected to vary across SGLT2 inhibitors, non-steroidal mineralocorticoid receptor antagonists (MRAs), and conventional standard-of-care treatments such as RAAS inhibitors. Recently approved and emerging targeted therapies such as dapagliflozin (FARXIGA/FORXIGA), empagliflozin (JARDIANCE), and finerenone (KERENDIA) are demonstrating moderate to high uptake, supported by strong clinical evidence in slowing disease progression, reducing cardiovascular risk, and increasing physician confidence in early intervention. Their adoption is largely driven by the limitations of conventional therapies in halting renal decline and the growing need for cardio-renal protective strategies.
In comparison, other emerging therapies such as esaxerenone and pipeline agents are expected to show gradual but steady uptake as further clinical data become available and treatment guidelines increasingly incorporate these agents into DKD management pathways.
Diabetic Nephropathy/ Diabetes Kidney Disease (DKD) Therapies Price Scenario & Trends
Pricing and analogue assessment of DKD therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Bayer's once-daily KERENDIA carries a list price of USD 19 per day before discounts and patient assistance, equating to an annual therapy cost of approximately USD 6,935.
Further details are provided in the final report....
Industry Experts and Physician Views for Diabetic Nephropathy/ Diabetes Kidney Disease (DKD)
To keep up with DKD 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 the DKD 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 DKD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, the Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging DKD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in DKD.
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 Diabetic Nephropathy/ Diabetes Kidney Disease (DKD), 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 the acceptability, tolerability, and adverse events are mainly 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.
Market Insights