慢性腎臓病市場 - 市場の洞察、疫学、市場予測：2032年

2022年の慢性腎臓病の市場規模は、主要7ヶ国の中で米国が最も大きく、約25億6,600万米ドルを占めており、イタリアが最小で1億1,500万米ドルとなっています。同市場は2032年までにさらに増加すると予測されています。

当レポートでは、主要7ヶ国における慢性腎臓病市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 主な洞察

第2章 レポートのイントロダクション

第3章 慢性腎臓病（CKD）市場の概要

• 市場シェア（%）CKDの分布、2019年
• 市場シェア（%）CKD分布、2032年

第4章 疫学と市場予測の調査手法

第5章 主な出来事

第6章 慢性腎臓病（CKD）のエグゼクティブサマリー

第7章 慢性腎臓病（CKD）の病態背景と概要

• イントロダクション
• 病因と危険因子
• CKDのKDIGO分類
• 病態生理学
• 臨床症状
• 診断
• 管理と治療

第8章 CKDの疫学と患者数

• 主な調査結果
• 仮定と理論的根拠：主要7ヶ国
• 主要7ヶ国におけるCKDの罹患総数
• 主要7ヶ国における診断済みCKDの罹患総数
• 米国
• 欧州4ヶ国と英国
• 日本

第9章 患者動向

第10章 上市済み薬剤

第11章 新薬

第12章 CKD：主要7ヶ国市場分析

• 主な調査結果
• 市場の見通し
• 主要な市場予測の前提条件
• 属性分析
• 主要7ヶ国におけるCKDの市場規模
• 主要7ヶ国におけるCKDの市場規模、治療法別
• 米国におけるCKDの市場規模
• 欧州4ヶ国と英国におけるCKDの市場規模
• 日本におけるCKDの市場規模

第13章 キーオピニオンリーダーの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場アクセスと償還

• 米国
• 欧州4ヶ国と英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

List of Tables

• Table 1: Key Events
• Table 2: Summary of CKD Market and Epidemiology (2019-2032)
• Table 3: Stages of Chronic Kidney Disease
• Table 4: Nomenclature and Description for Rating Guideline Recommendations
• Table 5: Key recommendations for Practice
• Table 6: Total Prevalent Cases of CKD in the 7MM in '000s (2019-2032)
• Table 7: Diagnosed Prevalent Cases of CKD in the 7MM in '000s (2019-2032)
• Table 8: Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 9: Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 10: Gender-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 11: Age-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 12: Complication-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 13: Stage-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Table 14: Etiology-specific Diagnosed Prevalent Cases of CKD in the Unite States in '000s (2019-2032)
• Table 15: Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Table 16: Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Table 17: Gender-specific Diagnosed prevalent Cases of CKD in EU4 and the UK, in '000' (2019-2032)
• Table 18: Age-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK, in '000' (2019-2032)
• Table 19: Complication-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK, in '000' (2019-2032)
• Table 20: Stage-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK, in '000' (2019-2032)
• Table 21: Etiology-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK, in '000' (2019-2032)
• Table 22: Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 23: Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 24: Gender-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 25: Age-specific Diagnosed Prevalent Cases of CKD in Japan In '000s (2019-2032)
• Table 26: Complication-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 27: Stage-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 28: Etiology-specific Diagnosed prevalent Cases of CKD in Japan in '000s (2019-2032)
• Table 29: KERENDIA (finerenone), Clinical Trial Description, 2023
• Table 30: Farxiga (Dapagliflozin), Clinical Trial Description, 2023
• Table 31: Canagliflozin, Clinical Trial Description, 2023
• Table 32: Tolvaptan, Clinical Trial Description, 2023
• Table 33: Comparison of Emerging Drugs for Treatment
• Table 34: Renal Autologous Cell Therapy (REACT), Clinical Trial Description, 2023
• Table 35: Bardoxolone methyl, Clinical Trial Description, 2023
• Table 36: Ziltivekimab, Clinical Trial Description, 2023
• Table 37: Semaglutide, Clinical Trial Description, 2023
• Table 38: Empagliflozin, Clinical Trial Description, 2023
• Table 39: KBP-5074, Clinical Trial Description, 2023
• Table 40: KT-301, Clinical Trial Description, 2023
• Table 41: CIN-107, Clinical Trial Description, 2023
• Table 42: Zibotentan, Clinical Trial Description, 2023
• Table 43: ALLN-346, Clinical Trial Description, 2023
• Table 44: DM199, Clinical Trial Description, 2023
• Table 45: Sotagliflozin, Clinical Trial Description, 2023
• Table 46: Key Market Forecast Assumptions for Empagliflozin (JARDIANCE)
• Table 47: Key Market Forecast Assumptions for Semaglutide
• Table 48: Key Market Forecast Assumptions for Ziltivekimab
• Table 49: Key Market Forecast Assumptions for KBP-5074
• Table 50: Key Market Forecast Assumptions for Bardoxolone methyl
• Table 51: Key Market Forecast Assumptions for REACT
• Table 52: Market Size of CKD in the 7MM, in USD million (2019-2032)
• Table 53: Market Size of CKD by Therapies in the 7MM, in USD million (2019-2032)
• Table 54: Market Size of CKD in the United States, in USD million (2019-2032)
• Table 55: Market Size of CKD by Therapies in the US, in USD million (2019-2032)
• Table 56: Market Size of CKD in EU4 and the UK, in USD million (2019-2032)
• Table 57: Market Size of CKD by Therapies in Germany, in USD million (2019-2032)
• Table 58: Market Size of CKD by Therapies in France, in USD million (2019-2032)
• Table 59: Market Size of CKD by Therapies in Italy, in USD million (2019-2032)
• Table 60: Market Size of CKD by Therapies in Spain, in USD million (2019-2032)
• Table 61: Market Size of CKD by Therapies in the UK, in USD million (2019-2032)
• Table 62: Market Size of CKD by Therapies in EU4 and the UK, in USD million (2019-2032)
• Table 63: Market Size of CKD in Japan, in USD million (2019-2032)
• Table 64: Market Size of CKD by Therapies in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: Prognosis of CKD by GFR and Albuminuria Category
• Figure 2: Pathogenesis of CKD
• Figure 3: Symptoms and Signs of CKD
• Figure 4: Considerations for Diagnosis, Staging, and Referral of Patients With CKD
• Figure 5: Management of CKD
• Figure 6: Total Prevalent Cases of CKD in the 7MM in '000s (2019-2032)
• Figure 7: Diagnosed Prevalent Cases of CKD in the 7MM in '000s (2019-2032)
• Figure 8: Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Figure 9: Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Figure 10: Gender-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Figure 11: Age-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Figure 12: Complication-specific Diagnosed Prevalent Cases of CKD in the United States in '000s (2019-2032)
• Figure 13: Stage-specific Diagnosed Prevalent Cases of CKD by Etiologies in the United States in '000s (2019-2032)
• Figure 14: Etiology-specific Diagnosed Prevalent Cases of CKD s in the United States in '000s (2019-2032)
• Figure 15: Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 16: Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 17: Gender-specific Diagnosed prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 18: Age-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 19: Complication-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 20: Stage-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 21: Etiology-specific Diagnosed Prevalent Cases of CKD in EU4 and the UK in '000s (2019-2032)
• Figure 22: Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 23: Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 24: Gender-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 25: Age-specific Diagnosed Prevalent Cases of CKD in Japan In '000s (2019-2032)
• Figure 26: Complication-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 27: Stage-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 28: Etiology-specific Diagnosed Prevalent Cases of CKD in Japan in '000s (2019-2032)
• Figure 29: Patient Journey
• Figure 34: Total Market Size of CKD in the 7MM, in USD million (2019-2032)
• Figure 35: Total Market Size of CKD by Therapies in the 7MM, in USD million (2019-2032)
• Figure 36: Market Size of CKD in the United States, in USD million (2019-2032)
• Figure 37: Market Size of CKD by Therapies in the US, in USD million (2019-2032)
• Figure 38: Market Size of CKD in EU4 and the UK, in USD million (2019-2032)
• Figure 39: Market Size of CKD by Therapies in EU4 and the UK, in USD million (2019-2032)
• Figure 40: Market Size of CKD in Japan, in USD million (2019-2032)
• Figure 41: Market Size of CKD by Therapies in Japan, in USD million (2019-2032)
• Figure 30: Unmet Needs
• Figure 31: Health Technology Assessment
• Figure 32: Reimbursement Process in Germany
• Figure 33: Reimbursement Process in France
• Figure 34: Reimbursement Process in Italy
• Figure 35: Reimbursement Process in Spain
• Figure 36: Reimbursement Process in the United Kingdom
• Figure 37: Reimbursement Process in Japan

Key Highlights:

• The majority of prevalent CKD patients were estimated in the US followed by EU4 and the UK, and Japan. The diagnosed patient of CKD in the US were estimated to be 5.5 million.
• In 2022, the market size of CKD was highest in the US among the 7MM accounting for approximately USD 2,566 million, and lowest in Italy with USD 115 million which is further expected to increase by 2032.
• The total market size of the CKD treatment market is anticipated to experience growth during the forecast period (2023-2032) due to emerging treatments that includes Renal Autologous Cell Therapy (REACT), empagliflozin, KBP-5074, ziltivekimab, bardoxolone methyl, and semaglutide.
• Gender-specific diagnosed prevalent cases of CKD were higher in females (around 8,320 thousand cases) as compared to males (around 7,790 thousand) in 2022 in the 7MM.

DelveInsight's "Chronic Kidney Disease (CKD)- Market Insights, Epidemiology and Market Forecast- 2032" report delivers an in-depth understanding of the 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.

CKD market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM CKD market size from 2019 to 2032. The report also covers current CKD treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

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

Study Period: 2019-2032

Chronic Kidney Disease (CKD) Understanding and Treatment Algorithm

Chronic Kidney Disease (CKD) Overview

Chronic kidney disease (CKD) is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2, persisting for 3 months or more, irrespective of the cause. It is a state of progressive loss of kidney function ultimately resulting in the need for renal replacement therapy (dialysis or transplantation).

There are usually no symptoms of kidney disease in the early stages. It may only be diagnosed if a blood or urine test is done for another reason and the results show a problem with the kidneys. At a more advanced stage, symptoms can include tiredness, swollen ankles, feet or hands, shortness of breath, feeling sick, and blood in the urine.

Chronic Kidney Disease (CKD) Diagnosis

CKD can be diagnosed using blood and urine tests. The eGFR blood test shows the efficiency with which the kidneys are working. Imaging tests such as an ultrasound, CT scan, X-ray, or MRI are also used.

Further details related to country-based based variations are provided in the reported

Chronic Kidney Disease (CKD) Treatment

There's no cure for CKD, but treatment can help relieve the symptoms and stop it from getting worse. The treatment plan includes lifestyle and dietary changes, and medicines to lower blood pressure, blood sugar, or cholesterol are used. Diuretics (water pills) are used to help the kidneys get rid of water and lower swelling. Dialysis maybe needed in some cases. A kidney transplant may be an option when the kidneys have failed as in advanced CKD.

Many molecules are in the pipeline to treat CKD patients across the 7MM to cater to their needs. Some major products are anticipated hit the market during the study period 2019-2032, including KBP-074, renal autologous cell therapy (REACT), semaglutide, bardoxolone methyl, empagliflozin, and ziltivekimab.

Chronic Kidney Disease (CKD) Epidemiology

As the market is derived using patient based model, the CKD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Prevalent Cases of CKD, Diagnosed Prevalent Cases of CKD, Gender-specific Diagnosed Prevalent Cases of CKD, Age-specific Diagnosed Prevalent cases of CKD, Complication-specific Diagnosed Prevalent cases of CKD, Stage-specific Diagnosed Prevalent Cases of CKD and Etiology-specific Diagnosed Prevalent Cases of CKD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the UK, and Japan from 2019 to 2032. The total diagnosed prevalent cases of CKD in the 7MM comprised of approximately 16 million cases in 2022 and are projected to increase during the forecasted period (2023-2032)

• According to DelveInsight estimates, the US accounted for approximately 5.6 million diagnosed cases whereas in the EU4 and the UK, there were around 6.9 million diagnosed CKD cases in 2022. Japan accounted for 3.5 million diagnosed cases of CKD in 2022. These cases are expected to increase in the US, EU4 and the UK, and expected to decrease in Japan by 2032
• Among the EU4 and the UK, the UK had the highest diagnosed prevalent population of CKD (approximately 2.3 million cases), followed by the Germany (approximately 1.5 million cases) in 2022. On the other hand, Italy (0.7 million cases) had the lowest diagnosed prevalent population in EU4 and the UK countries and the 7MM.
• CKD has been identified as a female-dominant disease; in our analysis, the number of females suffering was higher than males. In 2022, 52% cases of CKD were of females, while 48% cases were of males in the 7MM.

Chronic Kidney Disease (CKD) Drug Chapters

Drug chapter segment of the CKD report encloses the detailed analysis of CKD marketed drugs and late stage pipeline drugs. It also helps to understand the CKD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

Renal Autologous Cell Therapy (REACT): ProKidney

REACT is a cell therapy product produced from a patient's kidney cells; REACT comprises a proprietary mixture of progenitor cells that have been taken from a patient, selected and grown, and then returned to the patient's kidney.

REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, as well as EMA, MHRA, and Health Canada guidance.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

Accurate diagnosis, non-pharmacologic interventions, and pharmacologic treatments are all important aspects of managing CKD.

There are different types of medications available in market. Available medicines cannot reverse CKD; however, they are used to treat complications and slow further kidney damage. DelveInsight'smarket forecast focus on the market revenue generated by pharmacological therapies (including all the currently used off-label therapies) prescribed for the management of CKD and doesn't comprise the revenue generated by devices &/or surgical procedures including dialysis.

Chronic Kidney Disease (CKD) Market Outlook

For the purpose of study, the chronic kidney disease (CKD) drugs market is categorized on the basis of drug class such as Erythropoietin stimulating agents (ESA), Angiotensin-converting-enzyme inhibitors and Angiotensin receptor blockers (ACE-I and ARBs), Antidiabetics, Secondary Hyperparathyroidism Treatment (SHPT), and Urate Lowering Therapies.

FARXIGA (dapagliflozin) has been approved in the US, EU and Japan for the treatment of CKD in adults with and without T2D. In 2019, INVOKANA (canagliflozin) has been approved by FDA to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy). Both dapagliflozin and canagliflozin are inhibitors of SGLT2.

KERENDIA has been approved in the US in 2021, in EU in 2022 and in Japan in 2022 for CKD and type 2 DM. JYNARQUE (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing ADPKD. The medication has been approved as a treatment for adults with ADPKD in Japan, the EU, the US, Canada, South Korea, Switzerland, Hong Kong, Australia, Turkey and Taiwan.

In emerging scenario, several companies are creating medications including antidiabetics, uricosurics, antihypertensives and novel therapies such as cell therapy. These include renal autologous cell therapy/REACT (ProKidney), bardoxolone methyl (Reata Pharmaceuticals, Inc.), KBP-5074 (KBP Biosciences), semaglutide (Novo Nordisk A/S), ziltivekimab (Novo Nordisk A/S), and empagliflozin (Boehringer Ingelheim). They aim to investigate their products for the treatment of CKD.

• The total market size of CKD in the 7MM was approximately USD 4,934 million in 2022 and is projected to increase during the forecast period (2023-2032)
• The market size in the 7MM will increase at a CAGR of 8.7% due to increasing prevalent cases of the disease and launch of the emerging therapies.
• Among EU4 and the UK, the UK accounts for the maximum market size in 2022 while Italy occupies the bottom of the ladder in 2022.

Chronic Kidney Disease (CKD) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. For example, for REACT, we expect the drug uptake to be slow-medium with a peak share of 0.8%, years to peak is expected to be 7 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Chronic Kidney Disease (CKD) Pipeline Development Activities

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

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for CKD emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on CKD evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, include Medical/scientific writers, Medical Professors, University of Arizona College of Medicine, US, Researchers from Health Economics and Outcomes Research Ltd., Cardiff, the UK, and Others.

DelveInsight'sanalysts connected with 50+ KOLs to gather insights, however interviews were conducted with 15+ KOLs in the 7MM. Centers such as Universite Claude Bernard, France, Kings College Hospital, NHS Foundation Trust, the UK, National University in Niigata, Japan etc. were contacted. Their opinion helps to understand and validate current and emerging therapies treatment patterns or CKD market trend. This will support the clients in potential upcoming novel treatment 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 SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, and patient burden, and competitive landscape, cost-effectiveness and geographical accessibility of therapies are provided. These pointers are based on Analyst's discretion and assessment of the patient burden, cost analysis and existing and evolving treatment landscape.

Conjoint Analysis is done to analyze multiple approved and emerging therapies on the basis of relevant attributes such as safety, efficacy, and frequency of administration, route of administration and order of entry. Scoring is given based on these parameters to analyze the effectiveness of a therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated, for instance, in CKD trials, one of the most important primary outcome measure is the change in eGFR which provides the evaluation of the improvement in the kidney function.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability and the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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 Access and Reimbursement

Once a patient with Medicare commences dialysis, the Centers for Medicare & Medicaid Services (CMS) pays the treating nephrologist a monthly capitated payment (MCP) ranging from approximately USD 188 to USD 388 per month for overseeing outpatient dialysis care. In contrast, for patients with CKD not on dialysis, CMS and other insurers pay for office visits on a fee-for-service basis, with the most complex return office visit reimbursed at approximately USD 148 a visit. Thus, the MCP for dialysis is substantially higher than the payments for CKD office visits

The report further provides the 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, executive summary, descriptive overview of CKD, explaining its causes, signs and symptoms, pathogenesis and currently available therapies
• Comprehensive insight has been provided into the epidemiology segments and forecasts, future growth potential of diagnosis rate, disease progression along with treatment guidelines
• Additionally, an all-inclusive account of both the current and emerging therapies along with the elaborative profiles of late-stage and prominent therapies, which will have an impact on at the current treatment landscape
• A detailed review of CKD 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 preference that help in shaping and driving the 7MM CKD market

Chronic Kidney Disease (CKD) Report Insights

• Patient Population
• Therapeutic Approaches
• Chronic Kidney Disease (CKD) Pipeline Analysis
• Chronic Kidney Disease (CKD) Market Size and Trends
• Existing and future Market Opportunity

Chronic Kidney Disease (CKD) Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Chronic Kidney Disease (CKD) Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Chronic Kidney Disease (CKD) Report Assessment

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

Key Questions

Market Insights:

• What was the CKD total market size, market size by therapies, market share (%) distribution in 2019 and how it would all look like in 2032? What are the contributing factors for this growth?
• How are different therapies going to affect the treatment paradigm of CKD?
• What kind of uptake REACT, empagliflozin, KBP-5074, ziltivekimab, bardoxolone methyl, and semaglutide is going to witness in the coming 10 years?
• Which drug is going to be the largest contributor in 2032?
• 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?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of CKD?
• How will the prevalent population of the indication change during the forecast period?
• What is the historical and forecasted CKD patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What is the prevalence rate of CKD and what are the evidence from literature or primary market research related to this?
• What factors are affecting the increase in prevalent cases of CKD?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of CKD? What are the current treatment guidelines for the treatment of CKD in the US, Europe and Japan?
• How many companies are developing therapies for the treatment of CKD?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of CKD?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for CKD?
• What will be the impact of approved therapies expected patent expiry?
• What is the cost burden of approved therapies on patient?
• Patient acceptability in terms of preferred treatment options as per real world scenario?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of CKD?

Reasons to buy:

• The report will help in developing business strategies by understanding latest trends and changing treatment dynamics driving the CKD Market
• Insights on patient burden/disease prevalence, evolution in diagnosis and factors contributing to the change in epidemiology of the disease during the forecast years
• To understand the existing market opportunity 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.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under Conjoint analysis section to provide visibility around leading classes
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs
• To understand the perspective of Key Opinion Leaders' around the accessibility, acceptability and compliance related challenges of existing treatment to overcome barriers in future
• Detailed insights on the unmet need of existing market so that the upcoming players can strengthen their development and launch strategy

Table of Contents

1. Key Insights

2. Report Introduction

3. CKD Market Overview at a Glance

• 3.1. Market Share (%) Distribution of CKD in 2019
• 3.2. Market Share (%) Distribution of CKD in 2032

4. Epidemiology and Market Forecast Methodology

5. Key Events

6. Executive Summary of of CKD

7. Disease Background and Overview of Chronic Kidney Disease (CKD)

• 7.1. Introduction
• 7.2. Etiology and Risk Factors
• 7.3. The KDIGO Classification of CKD
• 7.4. Pathophysiology
• 7.5. Clinical Manifestations
• 7.6. Diagnosis
  • 7.6.1. Diagnostic Guidelines
• 7.7. Management and Treatment
  • 7.7.1. Treatment Guidelines

8. Epidemiology and Patient Population of CKD

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
  • 8.2.1. The United States
  • 8.2.2. EU4 and the United Kingdom
  • 8.2.3. Japan
• 8.3. Total Prevalent Cases of CKD in the 7MM
• 8.4. Diagnosed Prevalent Cases of CKD in the 7MM
• 8.5. The United States
  • 8.5.1. Prevalent cases of CKD in the US
  • 8.5.2. Diagnosed Prevalent Cases of CKD in the US
  • 8.5.3. Gender-specific diagnosed prevalent cases of CKD in the US
  • 8.5.4. Age-specific diagnosed prevalent cases of CKD in the US
  • 8.5.5. Complication-specific prevalent cases of CKD in the US
  • 8.5.6. Stage-specific prevalent cases of CKD in the US
  • 8.5.7. Etiology-specific diagnosed prevalent cases of CKD in the US
• 8.6. EU4 Countries and the UK
  • 8.6.1. Prevalent cases of CKD in EU4 and the UK
  • 8.6.2. Diagnosed prevalent cases of CKD in EU4 and the UK
  • 8.6.3. Gender-specific diagnosed prevalent cases of CKD in EU4 and the UK
  • 8.6.4. Age-specific diagnosed prevalent cases of CKD in EU4 and the UK
  • 8.6.5. Complication-specific diagnosed prevalent cases of CKD in EU4 and the UK
  • 8.6.6. Stage-specific diagnosed prevalent cases of CKD in EU4 and the UK
  • 8.6.7. Etiology-specific diagnosed cases of CKD in EU4 and the UK
• 8.7. Japan
  • 8.7.1. Prevalent cases of CKD in Japan
  • 8.7.2. Diagnosed prevalent cases of CKD in Japan
  • 8.7.3. Gender-specific diagnosed prevalent cases of CKD in Japan
  • 8.7.4. Age-specific diagnosed prevalent cases of CKD in Japan
  • 8.7.5. Complication-specific diagnosed prevalent cases of CKD in Japan
  • 8.7.6. Stage-specific diagnosed prevalent cases of CKD in Japan
  • 8.7.7. Etiology-specific diagnosed prevalent cases of CKD in Japan

9. Patient Journey

10. Marketed Drugs

• 10.1. KERENDIA (finerenone): Bayer HealthCare Pharmaceuticals Inc
  • 10.1.1. Product description
  • 10.1.2. Regulatory milestone
  • 10.1.3. Other development activities
  • 10.1.4. Clinical development
  • 10.1.5. Clinical trial information
  • 10.1.6. Safety and efficacy
  • 10.1.7. Product profile
• 10.2. FARXIGA (dapagliflozin): AstraZeneca
  • 10.2.1. Product description
  • 10.2.2. Regulatory milestones
  • 10.2.3. Other development activities
  • 10.2.4. Clinical development
  • 10.2.5. Clinical trial information
  • 10.2.6. Safety and efficacy
  • 10.2.7. Product profile
• 10.3. INVOKANA (canagliflozin): Janssen Research & Development, LLC
  • 10.3.1. Product description
  • 10.3.2. Regulatory milestone
  • 10.3.3. Other development activities
  • 10.3.4. Clinical development
  • 10.3.5. Clinical trial information
  • 10.3.6. Safety and efficacy
  • 10.3.7. Product profile
• 10.4. JYNARQUE (tolvaptan): Otsuka Pharmaceutical
  • 10.4.1. Product description
  • 10.4.2. Regulatory milestone
  • 10.4.3. Clinical development
  • 10.4.4. Clinical trial information
  • 10.4.5. Safety and efficacy
  • 10.4.6. Product profile

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. Renal Autologous Cell Therapy (REACT): ProKidney
  • 11.2.1. Product description
  • 11.2.2. Other developmental activities
  • 11.2.3. Clinical development
  • 11.2.4. Clinical trials information
  • 11.2.5. Safety and efficacy
  • 11.2.6. Product profile
  • 11.2.7. Analysts' views
• 11.3. Bardoxolone methyl: Reata Pharmaceuticals, Inc.
  • 11.3.1. Product description
  • 11.3.2. Other developmental activities
  • 11.3.3. Clinical development
  • 11.3.4. Clinical trials information
  • 11.3.5. Safety and efficacy
  • 11.3.6. Product profile
  • 11.3.7. Analysts' views
• 11.4. Ziltivekimab: Novo Nordisk A/S
  • 11.4.1. Product description
  • 11.4.2. Other developmental activities
  • 11.4.3. Clinical development
  • 11.4.4. Clinical trials information
  • 11.4.5. Safety and efficacy
  • 11.4.6. Product profile
  • 11.4.7. Analysts' views
• 11.5. Semaglutide: Novo Nordisk A/S
  • 11.5.1. Product description
  • 11.5.2. Clinical development
  • 11.5.3. Clinical trials information
  • 11.5.4. Safety and efficacy
  • 11.5.5. Product profile
  • 11.5.6. Analysts' views
• 11.6. JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly and Company
  • 11.6.1. Product description
  • 11.6.2. Other developmental activities
  • 11.6.3. Clinical development
  • 11.6.4. Clinical trials information
  • 11.6.5. Safety and efficacy
  • 11.6.6. Product profile
  • 11.6.7. Analysts' views
• 11.7. KBP-5074: KBP Biosciences
  • 11.7.1. Product description
  • 11.7.2. Other developmental activities
  • 11.7.3. Clinical development
  • 11.7.4. Clinical trials information
  • 11.7.5. Safety and efficacy
  • 11.7.6. Product profile
  • 11.7.7. Analysts' views
• 11.8. KT-301: Kibow pharma
  • 11.8.1. Product description
  • 11.8.2. Clinical development
  • 11.8.3. Clinical trials information
  • 11.8.4. Product profile
  • 11.8.5. Analysts' views
• 11.9. CIN-107 (Baxdrostat): Cincor Pharma
  • 11.9.1. Product description
  • 11.9.2. Other developmental activities
  • 11.9.3. Clinical development
  • 11.9.4. Clinical trials information
  • 11.9.5. Product profile
  • 11.9.6. Analysts' views
• 11.10. Zibotentan: AstraZeneca
  • 11.10.1. Product description
  • 11.10.2. Clinical development
  • 11.10.3. Clinical trials information
  • 11.10.4. Product profile
  • 11.10.5. Analysts' views
• 11.11. ALLN-346: Allena Pharmaceuticals
  • 11.11.1. Product description
  • 11.11.2. Other developmental activities
  • 11.11.3. Clinical development
  • 11.11.4. Clinical trials information
  • 11.11.5. Product profile
  • 11.11.6. Analysts' views
• 11.12. DM199: DiaMedica Therapeutics Inc
  • 11.12.1. Product description
  • 11.12.2. Other developmental activities
  • 11.12.3. Clinical development
  • 11.12.4. Clinical trials information
  • 11.12.5. Safety and efficacy
  • 11.12.6. Product profile
  • 11.12.7. Analysts' views
• 11.13. Sotagliflozin: Lexicon Pharmaceuticals/Sanofi
  • 11.13.1. Product description
  • 11.13.2. Other developmental activities
  • 11.13.3. Clinical development
  • 11.13.4. Clinical trials information
  • 11.13.5. Safety and efficacy
  • 11.13.6. Product profile
  • 11.13.7. Analysts' views

12. CKD: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Key Market Forecast Assumptions
• 12.4. Attribute Analysis
• 12.5. Market Size of CKD in the 7MM
• 12.6. Market Size of CKD by Therapies in the 7MM
• 12.7. Market Size of CKD in the United States
  • 12.7.1. Total market size of CKD
  • 12.7.2. Market size of CKD by therapies
• 12.8. Market Size of CKD in EU4 and the UK
  • 12.8.1. Total market size of CKD
  • 12.8.2. Market size of CKD by therapies
• 12.9. Market Size of CKD in Japan
  • 12.9.1. Total market size of CKD
  • 12.9.2. Market size of CKD by therapies

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Centers for Medicare & Medicaid Services (CMS)
• 16.2. In EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer