PUBLISHER: DelveInsight | PRODUCT CODE: 1259779
PUBLISHER: DelveInsight | PRODUCT CODE: 1259779
Key Highlights:
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.
Study Period: 2019-2032
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.
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)
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.
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.
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.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs and Emerging Therapies: