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시장보고서
상품코드
2117963
만성 신장 질환 : 시장 인사이트, 역학 및 시장 예측(2036년)Chronic Kidney Disease - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
주요 7개국 CKD 시장 규모 및 전망
본 CKD 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. CKD 환자의 부담 동향, 매출 및 시장 점유율 동향, 정점 시 환자 점유율 및 치료 도입 현황 분석을 평가함과 동시에, 전 세계 각 지역의 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서는 CKD 분야의 주요 미충족 의료 수요를 부각시키고, 경쟁 구도 및 임상 환경을 파악하여 고부가가치 기회를 밝혀냄으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시합니다.
고위험군, 특히 당뇨병, 고혈압, 심혈관질환 환자에 대한 선별 검사 확대와 더불어 정기적인 eGFR 및 UACR 검사 실시로 인해 CKD 진단 건수가 증가하고 있습니다. 조기 발견으로 인해, 특히 선진국 시장에서 질환의 초기 단계에 있는 치료 대상 환자층이 확대되고 있습니다. 이에 따라 장기 치료에 대한 수요가 직접적으로 증가하고 있습니다.
SGLT2 억제제, 비스테로이드성 MRA 및 신흥 알도스테론 합성 효소 억제제의 병용요법은 신장 및 심혈관 결과에서 탁월한 효과를 보여주기 때문에 단일 약물을 이용한 RAS 차단 요법을 대체하고 있습니다. 이러한 약물은 질환 진행의 상호 보완적인 경로에 작용하기 때문에 다제 병용요법은 예외적인 사례가 아니라 점점 더 표준 치료법으로 자리 잡고 있습니다. 이것이 시장의 주요 수익원이 되고 있습니다.
엔도세린 수용체 길항 작용, 알도스테론 합성 효소 억제, APOL1 억제, 세포 치료와 같은 새로운 작용기전을 통해 SGLT2i/MRA를 기반으로 한 치료 옵션의 범위를 넘어 치료의 폭이 넓어지고 있습니다. 각 기업은 차별화되고 정밀하며, 질병 수정 효과를 지닌 자산에 점점 더 집중하고 있습니다. 이에 따라 경쟁이 심화되고 시장이 확대되고 있습니다.
CKD의 개요와 진단
CKD는 신장 기능의 점진적인 저하를 특징으로 하는 진행성이며 이질성이 높은 질환으로, 일반적으로 사구체 여과율(GFR)의 저하 및/또는 신장 손상 마커에 의해 정의됩니다. 일반적으로 기저 질환인 당뇨병, 고혈압, 심혈관질환에 의해 유발되지만, APOL1 고위험 변이 및 사구체 질환과 같은 유전적 요인도 상당수의 사례에 기여하고 있습니다. 이 질환의 경과는 다양하며, 안정된 초기 단계부터 투석이나 이식이 필요한 신부전으로 급속히 진행되는 사례에 이르기까지 광범위합니다. 축적되는 신장의 구조적 손상 중 상당수는 되돌릴 수 없기 때문에 조기 진단이 매우 중요합니다.
CKD의 진단은 주로 추정 GFR과 소변 알부민-크레아티닌 비율(UACR)을 바탕으로 이루어지며, 중증도와 진행 위험을 평가하기 위해 이 두 지표를 결합한 KDIGO 기준에 따라 병기가 분류됩니다. 영상 검사, 혈청학적 검사, 그리고 특정 사례에서의 유전자 검사(예: APOL1 돌연변이)나 신장 생검 등의 추가 검사는 근본적인 병인을 규명하고, 신기능 장애의 다른 원인을 배제하는 데 도움이 됩니다. 초기 CKD는 많은 경우 무증상이기 때문에 진단은 증상에 기반한 내원보다는 고위험군에 대한 조기 선별 검사에 의존하는 경우가 빈번합니다.
현재 CKD 치료 현황
CKD 치료는 심혈관 위험을 줄이고, 빈혈 및 미네랄·골 질환 등의 합병증을 관리하면서 신부전으로의 진행을 지연시키는 것을 목표로 합니다. 관리는 일반적으로 단계적이고 점진적인 접근 방식을 따르며, RAS 차단제(ACE 억제제/ARB)와 생활 습관 개선으로 시작하여, 대부분의 CKD 원인에서 엠파글리플로진(JARDIANCE)이나 다파글리플로진(FARXIGA/FORXIGA) 등의 SGLT2 억제제를 기초적인 배경 요법으로 단계적으로 도입해 나갑니다. 2형 당뇨병에 동반된 만성 신장 질환(CKD) 환자 중 잔류 알부민뇨가 확인되는 경우, 심신장 위험을 더욱 낮추기 위해 SGLT2 억제제 외에도 비스테로이드성 MRA인 피넬레논(케렌디아)의 병용이 점점 더 늘어나고 있습니다. 엔도세린 수용체 길항제/SGLT2 억제제나 알도스테론 합성 효소 억제제/SGLT2 억제제 등의 새로운 병용요법이 이러한 기반 위에 추가로 적용되어 잔존 위험에 대처하고 있습니다. 한편, 특정 고위험 하위 집단을 대상으로 한 유전자 표적 치료나 세포 치료도 개발이 진행되고 있습니다.
CKD 역학 분석 및 예측을 통한 주요 인사이트
CKD 관리는 혈압 및 혈당 조절에만 국한되던 것에서 네프론 손실을 직접 표적으로 하는 치료로 전환되고 있습니다. 구체적으로는 혈역학적 스트레스, 알도스테론 과다, 엔도세린을 매개로 한 혈관 수축, 섬유화, 그리고 유전적 원인에 의한 포도세포 장애 등이 대상이 되고 있습니다. SGLT2 억제제인 엠파글리플로진(JARDIANCE) 및 다파글리플로진(FARXIGA/FORXIGA)은 각각 EMPA-KIDNEY 및 DAPA-CKD 임상시험을 통해 유효성이 입증되었으며, 현재는 보험사로부터 폭넓은 승인을 받아 표준 치료의 주축이 되고 있습니다. 한편, 피넬레논(KERENDIA)은 당뇨병성 만성 신장 질환(CKD)에서 잔존 알부민뇨를 다루는 보완적인 틈새 시장을 개척하고 있습니다. 이러한 다중 경로를 통한 병용요법은 주요 7개국 전체에서 사실상 표준 치료법으로 자리 잡고 있습니다.
엔도세린 수용체 길항제, 알도스테론 합성 효소 억제제(롤란드로스타트), APOL1 억제제(MZE829),세포 치료제(릴파렌셀)에 이르는 다양한 후기 개발 파이프라인은 SGLT2 억제제/MRA를 핵심으로 하는 치료 전략과 상호 보완적인 작용기전을 각각 표적으로 삼고 있어, 경쟁 구도를 완전히 바꿀 것으로 전망됩니다. 시장 성장은 진단 유병률의 상승, UACR/eGFR에 기반한 조기 선별 검사, 그리고 병용요법의 확대에 의해 견인될 전망입니다. 또한 패러다임이 다중 경로형 질환 수정 전략으로 전환되는 가운데, 지속적인 신장 예후 개선 효과, 안전성(체액 저류, 고칼륨혈증) 확보, 그리고 차별화된 포지셔닝을 입증할 수 있는 기업이 경쟁에서 우위를 점할 것입니다.
전반적으로 CKD 분야의 혁신은 SGLT2 억제제를 기반으로 한 병용 전략에 더해, 유전자 표적형 및 세포 기반 접근법에 점점 더 초점이 맞춰지고 있습니다. 현재 SGLT2 억제제와 비스테로이드성 MRA가 시장을 주도하고 있지만, 새롭게 등장하고 있는 알도스테론 합성 효소 억제제 병용요법 및 APOL1을 표적으로 하는 치료법은 치료 선택지의 다양화,잔존 위험 및 유전적 요인에 의한 위험에 대한 대응, 그리고 2036년까지 주요 7개국 시장에서 지속적 성장을 뒷받침할 것으로 기대됩니다.
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
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.
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.
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 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.
Key Findings from CKD Epidemiological Analysis and Forecast
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
CKD Drug Updates
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.
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.
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.
Market Insights