Chronic Kidney Disease - Market Insight, Epidemiology And Market Forecast - 2032

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.

This “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 report.

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 the publisher's 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. The publisher's market 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.

This analysts connected with 50+ KOLs to gather insights, however interviews were conducted with 15+ KOLs in the 7MM. Centers such as Université 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

The publisher performs 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 Answered

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