diabetic nephropathy market insight

DelveInsight’s ‘Diabetic Nephropathy – Market Insights, Epidemiology, and Market Forecast – 2030’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of Diabetic Nephropathy in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Diabetic Nephropathy market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted Diabetic Nephropathy market Size from 2018 to 2030, segmented by seven major markets. The report also covers the current Diabetic Nephropathy treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Diabetic Nephropathy: Disease Understanding and Treatment Algorithm

Diabetic Nephropathy Overview

Diabetic nephropathy (DN), also known as diabetic kidney disease (DKD), 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. DN is usually associated with arterial hypertension and increased cardiovascular morbidity and mortality; outcomes for people with type 1 (T1DM) or type 2 (T2DM) diabetes who develop DN are significantly worse than those who do not.

Diabetic Nephropathy is classified into five stages: Stage 1, Stage 2, Stage 3, Stage 4, and Stage 5. These five stages are described as follows: Stage 1 or normoalbuminuria stage, showing normal kidney function or increased estimated glomerular filtration rate (eGFR), of more than 30 mL/min; Stage 2 or microalbuminuric stage, showing microalbuminuria with 30–299 mg/g Cr of urinary albumin excretion (UAE) and Egfr of 30 mL/min; Stage 3 or macroalbuminuric stage, showing macroalbuminuria >300 mg/g Cr of UAE and eGFR of >30 mL/min; Stage 4 or renal failure stage, showing a decline in renal function with eGFR <30 mL/min; and Stage 5 or kidney failure, which is the dialysis stage.

In many cases, diabetic nephropathy is a clinical diagnosis. A kidney biopsy is the gold standard test for diagnostic and prognostic information, but in most centers, it is usually only performed when an alternative renal pathology is suspected. Also, diabetic nephropathy usually does not cause symptoms, so guidelines from the ADA and KDIGO group recommend that all people with diabetes should have a renal function and albuminuria measured at diagnosis and annually thereafter in T2DM; in T1DM, this can start from 5 years after diagnosis. Albuminuria is best assessed using ACR measurements on spot urine samples (ideally early morning samples); timed or 24-h urine collections to measure albumin excretion are also appropriate, although less convenient and more prone to collection errors. Renal function should be assessed using a serum-creatinine-based eGFR calculation (CKD-EPI equation recommended due to its superior performance in the eGFR range 60–90 mL/min/1.73 m2).

Current management strategies employ aggressive glycemic and blood pressure control combined with renin–angiotensin–aldosterone system-blocking agents to slow the worsening of kidney disease. However, this approach nonetheless results in significant residual renal and cardiovascular risk. In addition, people with DKD are also more likely to experience retinopathy, neuropathy, and foot ulcers, so increased vigilance for these complications is important.

BP should be controlled with drugs that reduce cardiovascular events (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, thiazide-like diuretics, or calcium channel blockers). Mineralocorticoid receptor antagonists (MRA) are also considered in hypertensive management. The first oral MRA was spironolactone followed by Eplerenone; both are steroidal MRA. These drugs are often used off-label in type 2 DM patients with mild-to-moderate arterial hypertension and albuminuria.

Improving glycemic control has beneficial effects on the development and progression of DN. The recently introduced selective sodium-glucose cotransporter type 2 (SGLT2) inhibitors improve glycemic control in an insulin-independent manner by blocking glucose reabsorption in the renal-proximal tubule, thereby enhancing urinary glucose excretion. However, the use of SGLT2i is still limited by the high cost and regulatory contraindications for patients with eGFR <60 mL/min/1.73 m2. Some GLP-1RA, including liraglutide, semaglutide, and dulaglutide, have also shown renal benefits, and contrary to SGLT2i, can currently be administered up to an eGFR of 15 mL/min/1.73 m2. Besides, Sulfonylureas are also used for glycemic control. However, first-generation sulfonylureas are rarely prescribed. The second-generation sulfonylureas, which include glipizide, glimepiride, glyburide, and gliclazide (the latter is not available in the US), are commonly used. Nevertheless, sulfonylureas and their metabolites are renally cleared, leading to an increased risk of hypoglycemia as GFR declines. Other hypoglycemic agents with potential benefit in DKD are dipeptidyl peptidase 4 (DPP4) inhibitors, but further research needs to be conducted. The commonly used DPP4 inhibitors include sitagliptin, saxagliptin, linagliptin, and alogliptin.

To conclude, effective delivery of these interventions in combination reduces the risks of DKD progression and other microvascular complications, cardiovascular events, and mortality. However, the current management of DKD still leaves a substantial residual risk for kidney disease progression, morbidity, and mortality.

Diabetic Nephropathy Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnoses available in the Diabetic Nephropathy market to treat the condition. It also provides country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

The DelveInsight Diabetic Nephropathy market report thoroughly understands Diabetic Nephropathy by including disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for Diabetic Nephropathy in the US, Europe, and Japan.

Diabetic Nephropathy Epidemiology

The Diabetic Nephropathy epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool, trends, and assumptions.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted Diabetic Nephropathy epidemiology segmented as the Prevalence of Diabetic Nephropathy, Age-specific cases of Diabetic Nephropathy, Gender-specific cases of Diabetic Nephropathy, Stage-specific cases of Diabetic Nephropathy. The report includes the prevalent scenario of Diabetic Nephropathy in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country-wise Diabetic Nephropathy Epidemiology

The epidemiology segment also provides the Diabetic Nephropathy epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The prevalent population of Diabetic Nephropathy in the 7MM countries was estimated to be 27,634,000 cases in 2020.

Diabetic Nephropathy Drug Chapters

The drug chapter segment of the Diabetic Nephropathy report encloses the detailed analysis of Diabetic Nephropathy marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps understand the Diabetic Nephropathy 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.

Diabetic Nephropathy is strongly associated with CV events and has a major influence on survival. The cornerstone of therapy in patients with albuminuria is hypertensive control, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARB), which slow down the rate of kidney function decline. However, they do not reduce the number of cardiovascular events. In addition, glycemic control is essential to delay or possibly prevent nephropathy and the onset of complications from diabetes, which can be challenging for even the most experienced physician.

Products detail in the report…

Diabetic Nephropathy Emerging drugs

Esaxerenone (CS-3150) (Daiichi Sankyo) is an orally administered, nonsteroidal, selective inhibitor of the Mineralocorticoid Receptor (MR). The binding of aldosterone to the MR plays a central role in regulating plasma sodium (Na+), extracellular potassium (K+), and arterial blood pressure by acting on the collecting ducts in nephrons. As recently reported, aldosterone is regarded as a potent mediator of organ damage. CS-3150 may have a role in preventing these organ-damaging effects. Esaxerenone is a compound identified during the prior research collaboration between Exelixis and Daiichi Sankyo, which the companies entered into in March 2006 and has subsequently been developed by Daiichi Sankyo. In January 2019, Daiichi Sankyo announced marketing approval for esaxerenone under the brand name Minnebro to treat hypertension in Japan. The drug is currently in development for treating DN in Japan.

Bardoxolone methyl (RTA-402) (Kyowa Kirin) is a low-molecular compound that activates nuclear factor erythroid 2-related factor 2 (Nrf2), a transcription factor that has a key role in the body’s protective response to stress. A wide range of anti-oxidative stress and anti-inflammatory effects of this compound could improve renal function. In Phase II clinical study conducted in Japan (the TSUBAKI study), administration of bardoxolone methyl resulted in a clear improvement in glomerular filtration rate (kidney function) measured using the inulin clearance method. In March 2018, bardoxolone methyl was designated for the treatment of DKD under the Priority Review and Designation (SAKIGAKE Designation) system established by the Ministry of Health, Labour, and Welfare (MHLW). The drug is currently being evaluated in a Phase III clinical trial for the treatment of DKD.

Products detail in the report…

Diabetic Nephropathy Market Outlook

The Diabetic Nephropathy market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Diabetic Nephropathy market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Diabetic Nephropathy market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to view the market at first sight clearly.

According to DelveInsight, the Diabetic Nephropathy market in the 7MM is expected to change in the study period 2018–2030.

Despite all these treatment options, the current management of diabetic nephropathy still leaves a substantial residual risk for kidney disease progression, morbidity, and mortality. Therefore, novel treatments are being developed that target inflammation, fibrosis, oxidative stress, renal hemodynamics, glomerular hyperfiltration, the endothelin system, Janus kinase (JAK)-signal transducer, and activator of transcription (STAT) pathway, etc.

Among novel treatments, mineralocorticoid receptor antagonists (MRA) are considered extremely promising. The first oral MRA was spironolactone followed by Eplerenone; both are steroidal MRA. These drugs are often used off-label in T2DM patients with mild-to-moderate arterial hypertension and albuminuria. However, the risk of the development of hyperkalemia with their usage remains a pressing issue. Recently, the FDA has approved finerenone (Kerendia, Bayer) to treat adult patients with CKD associated with T2D. Finerenone is a first-in-class nonsteroidal MRA indicated to reduce the risk of sustained estimated glomerular filtration rate decline, kidney failure, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. It is also the first and only nonsteroidal MRA that has been approved for use in this patient population. The FDA approval was based on the Phase III FIDELIO-DKD trial results, which demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with T2D. The approval also follows the previously granted priority review designation by the FDA. The results demonstrated that rates of hyperkalemia as a serious adverse event or reason for discontinuation were not high with the usage of finerenone.

Key Findings

This section includes a glimpse of the Diabetic Nephropathy market in the 7MM. The market size of Diabetic Nephropathy in the seven major markets was found to be USD 8,546.5 million in 2020.

The United States: Market Outlook

This section provides Diabetic Nephropathy market size and market size by therapies of Diabetic Nephropathy in the United States.

The United States accounts for the largest market size of Diabetic Nephropathy compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

In the last few years, sodium/glucose co-transporter-2 (SGLT2) inhibitors made it to the forefront by lowering blood sugar, blood pressure, reducing kidney function decline, and improving cardiovascular outcomes. Since 2019, SGLT2 inhibitors have been part of the recommended treatment of DKD by the American Diabetes Association. Invokana (canagliflozin) was the first SGLT-2 inhibitor with a type 2 DN indication but has been unable to exploit much on it due to concerns about a possible increased risk of amputations. However, recently in August 2020, based on the US FDA review of new data from three clinical trials, FDA removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin. Invokana is currently marketed in the US and Europe. In addition, a newer formulation, Vokanamet (EU) (a fixed-dose combination of canagliflozin and metformin) and Invokamet (US), to treat T2DM patients with CKD are available. These drugs can also be used to replace canagliflozin and metformin given separately.

Another recently launched SGLT-2 inhibitor is Farxiga. It was approved for CKD in the US in April 2021 based on the results from a CKD trial that included both diabetics and nondiabetics. Jardiance, currently in a late-stage phase of clinical development, is also an SGLT-2 inhibitor. It is soon expected to compete in the United States market.

SGLT2 inhibitors should be avoided if the eGFR is <30 mL/min/1.73 m2 because of an increase in adverse events and reduced efficacy. Invokana and Farxiga are not approved for use if the eGFR is < 30 mL/min/1.73 m2 and < 25 mL/min/1.73 m2.

EU-5 Countries: Market Outlook

The total Diabetic Nephropathy market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total Diabetic Nephropathy market size and market size by therapies of Diabetic Nephropathy in Japan are also mentioned.

Diabetic Nephropathy Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Diabetic Nephropathy market uptake by drugs, patient uptake by therapies, and sales of each drug. 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Diabetic Nephropathy Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses Diabetic Nephropathy key players involved in developing targeted therapeutics.

Major players include Kyowa Kirin, Teijin America, Chinook Therapeutics/Abbvie, AstraZeneca, Boehringer Ingelheim, Gilead Sciences, and Novartis Pharmaceuticals whose key products are expected to get launched in the US market by 2030.

Pipeline Development Activities

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

KOL Views

To keep up with current market trends, we take KOLs and SME’s opinions working in the Diabetic Nephropathy domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or Diabetic Nephropathy market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform a Competitive and Market Intelligence analysis of the Diabetic Nephropathy market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Diabetic Nephropathy, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
• Comprehensive insight has been provided into the Diabetic Nephropathy epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Diabetic Nephropathy is provided, along with the assessment of new therapies, which will impact the current treatment landscape.
• A detailed review of the Diabetic Nephropathy market, historical and forecasted, is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Diabetic Nephropathy market.

Report Highlights

• In the coming years, the Diabetic Nephropathy market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Nephropathy R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Diabetic Nephropathy. The launch of emerging therapies will significantly impact the Diabetic Nephropathy market
• A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for Diabetic Nephropathy.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Diabetic Nephropathy Report Insights

• Patient Population
• Therapeutic Approaches
• Diabetic Nephropathy Pipeline Analysis
• Diabetic Nephropathy Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Diabetic Nephropathy Report Key Strengths

• 10-years Forecast
• 7MM Coverage
• Diabetic Nephropathy Epidemiology Segmentation
• Key Competitors
• Highly Analyzed Market
• Drugs Uptake

Diabetic Nephropathy Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Diabetic Nephropathy Market share (%) distribution in 2018, and how would it look like in 2030?
• What would be the Diabetic Nephropathy total market Size and market Size by therapies across the 7MM during the forecast period (2018–2030)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest Diabetic Nephropathy market Size during the forecast period (2018–2030)?
• At what CAGR, the Diabetic Nephropathy market is expected to grow in the 7MM during the forecast period (2018–2030)?
• What would be the Diabetic Nephropathy market outlook across the 7MM during the forecast period (2018–2030)?
• What would be the Diabetic Nephropathy market growth till 2030, and what will be the resultant market Size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Diabetic Nephropathy?
• What is the historical Diabetic Nephropathy patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Diabetic Nephropathy in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Diabetic Nephropathy?
• Out of all 7MM countries, which country would have the highest prevalence of Diabetic Nephropathy during the forecast period (2018–2030)?
• At what CAGR is the population expected to grow in the 7MM during the forecast period (2018–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Diabetic Nephropathy?
• What are the current treatment guidelines for treating Diabetic Nephropathy in the USA, Europe, and Japan?
• What are the Diabetic Nephropathy marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Diabetic Nephropathy?
• How many therapies are developed by each company for the treatment of Diabetic Nephropathy?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Diabetic Nephropathy?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Nephropathy therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Diabetic Nephropathy and their status?
• What are the key designations that have been granted for the emerging therapies for Diabetic Nephropathy?
• What are the global historical and forecasted markets for Diabetic Nephropathy?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Diabetic Nephropathy market
• To understand the future market competition in the Diabetic Nephropathy market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Diabetic Nephropathy in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help devise strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Diabetic Nephropathy market.
• To understand the future market competition in the Diabetic Nephropathy market.