Diabetic Nephropathy Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Angiotensin Converting Enzyme (ACE) Inhibitors, Angiotensin Receptor Blockers, Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors, Mineralocorticoid Receptor Antagonists, and Others), By Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2021-2028

The global diabetic nephropathy market size was USD 2.38 billion in 2020 and is anticipated to increase from USD 2.49 billion in 2021 to USD 3.34 billion by 2028, at a CAGR of 4.3% during the 2021 to 2028 period. The global impact of COVID-19 has been unprecedented and staggering, with witnessing a negative impact on demand across all regions amid the pandemic. Based on our analysis, the global market exhibited a decline of 6.8% in 2020 as compared to the average year-on-year growth during 2017-2019. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Diabetic nephropathy is a type of kidney disease caused when the kidney is exposed to persistent hyperglycemia and is defined by the presence of proteinuria. Its risk is high in diabetic patients. The extent of kidney disease can be determined by assessing the glomerular filtration rate. The global market is expanding due to the increased prevalence of diabetes. For instance, as per IDF Diabetes Atlas, in 2021, in Europe, there were around 61.0 million people affected with diabetes whereas Western Pacific consists of 206.0 million affected with diabetes. Additionally, other factors, such as genetics, blood sugar control, and blood pressure, can help diabetic patients develop kidney disease. The increased risk of the condition has been propelling the growth of the global market.

COVID-19 IMPACT

Market to Witness Negative Impact Owing to Delays in Drug Development and Approval

The outbreak of COVID-19 had a negative impact on the diabetic nephropathy market. For instance, as per the Fierce Healthcare article, in 2020, the clinical trial in the drug development process slowed. Furthermore, the report from Optum suggests that clinical trials did slowdown during the pandemic, but they did not stop. The COVID-19 pandemic has caused substantial strain to the research studies for new drug development. Studies in other therapeutic areas also suffered due to the redirection of resources and temporary halting of in-person visits. This eventually impacted the investigation happening for potential drugs in diabetic nephropathy. Most of the key players have shown a decline in their revenue during the COVID-19 pandemic.

For instance, according to the Medidata COVID-19 report, in 2020, supply chain disruptions and travel limitations across the globe hampered the commencement and continuity of clinical trials. The number of patients enrolling for the clinical studies observed approximately 74.0% decline during May 2020 as compared to the enrollments in May 20219. This led to significant delays in the drug development process for many therapeutics along with delays in the launch of new drugs and therapeutics for diabetic nephropathy.

The pandemic has also affected the pharmaceutical supply chains across the world. Based on the FDA data published in 2019, around 40% of the registered manufacturing sites for the active pharmaceutical ingredients were present in China and India. This has severely impacted the supply chain reliability, and thus led to shortages of drugs for many different reasons, including workforce availability and transport distance. These factors have also declined the revenues for the global market.

LATEST TRENDS

Surge in R&D Activities to Boost Market Growth

Kidney is the major target organ of microvascular damage in diabetes. A significant proportion of patients with diabetes is expected to develop kidney disease due to diabetes and other comorbidities such as hypertension and aging-related nephron loss. The growing number of R&D activities for the treatment of this condition is boosting the diabetic nephropathy market.

For instance, based on recent data from ClinicalTrials.gov, in 2021, more than 50 ongoing studies would be related to the treatment for diabetic nephropathy. These drugs mainly consist of antiproteinuric and antihypertensive measures that arise from renin-angiotensin-aldosterone system inactivation. These studies are helping for the growth of the market in the long run. 

Also, there is a surge in awareness in terms of early diagnosis of chronic diabetic kidney, increasing the number of patient visits to the clinical laboratories, and thus would boost the demand for drugs during the forecast period. In addition, the scientific developments for Diabetic Kidney Disease (DKD) are being promoted by technological innovations worldwide.

For instance, based on a published article in BMC Nephrology in April 2021, high-throughput technology and multi-omics studies help researchers understand the pathogenesis and prognosis of diabetic kidney disease, which eventually are anticipated to escalate the research and development activities across the world.

DRIVING FACTORS

Rise in Prevalence of Diabetes and Obesity Boosts Market

Cases of obesity have been significantly increasing. For instance, according to A-Mansia Biotech article, the global prevalence of obesity has nearly tripled between 1975 and 2020. In 2020, more than 2 billion adults were overweight, which was 39% of the global adult population. In Europe, more than half of the population is overweight, and around 30% of them are obese. If the number of obese cases continues to increase at this pace, by 2030, half of the global adult population will be overweight or obese.

Furthermore, the WHO has called diabetes the 21st-century pandemic. As per the International Diabetes Federation 2019 report, around 463 million adults worldwide between the age of 18 and 79 suffer from type 2 diabetes. This number is expected to reach 700 million by 2045. Individuals suffering from obesity and diabetes are at a higher risk of being diagnosed with diabetic nephropathy. Therefore, the increasing prevalence of diabetes is leading to increasing number of patients suffering from this condition, thereby boosting the demand for its treatment.

Strong Pipeline of Drugs to Fuel Diabetic Nephropathy Market Growth

There is growing evidence suggesting that Glucagon-like peptide 1 (GLP-1) receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors are anticipated to control chronic kidney disease. There is a surge in the number of different drug discovery studies being assessed. The current therapeutic management of diabetic nephropathy includes glycemic control and blockade of the renin-angiotensin-aldosterone system. However, many patients eventually progress to end-stage renal disease.

Therefore, the key players are concentrating on developing new drugs or improving the treatment for diabetic nephropathy. Such R&D for the development and launch of the drugs are driving the market. For instance, based on ClinicalTrials.gov, Boehringer Ingelheim, in April 2021, registered for a phase 2 clinical trial to study the efficacy of BI 685509 against diabetic nephropathy. The aim is to study the efficacy of the medicine for kidney function improvement.

There is a robust pipeline of drugs, such as bardoxolone methyl TMX-049, in different clinical development stages. Recent drug approval paved the way for future therapies such as Farxiga, Invokana, and Kerendia. In April 2021, the FDA approved Farxiga (dapagliflozin) oral tablets from AstraZeneca to lower the risk of kidney function, kidney failure, cardiovascular mortality, and individuals with chronic kidney disease who are at risk of disease progression. The FDA granted clearance based on positive results from the landmark Phase III DAPA-HF trial, demonstrating Farxiga reduced CV death or hospitalization for heart failure (HF) with or without type-2 diabetes by a statistically significant and clinically driven study compared to placebo. All these factors are eventually fueling the industry growth.

RESTRAINING FACTORS

Stringent Regulatory Requirements Limit the Market Growth

There is a stringent regulatory policy for the approval of any medicine drugs by pharmaceutical companies. Thus, pharmaceutical organizations seeking FDA approval for selling new prescription drugs must complete the five-step process, discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring. In the U.S., it takes an average of 12 years for an experimental drug to reach from the laboratory to the medicine cabinet if it makes it. Around 5 in 5,000 drugs enter preclinical testing headway to human testing. One of these 5 drugs that are tested in people is approved.

Regulatory bodies decide these approvals of the treatment options and decisions on the basis of the result of clinical trial studies. Also, the requirement of different phases of drugs is very stringent. For instance, the aim of phase 3 trials of these drugs is to determine and confirm the preliminary evidence gathered in the previous trials that the drug is a safe, beneficial, and provides effective treatment. Many clinical trial studies are excluded from analysis if they show a low efficacy on the renal outcome. Based on the cross-sectional analysis of clinical trials on diabetes nephropathy by the National Center for Biotechnology Information in 2017, out of 49 completed phase 3 clinical trial studies, 15 studies were excluded as they did not include diabetic patients or any intervention of DKD.

Moreover, there is no cure for this condition, and the currently available drugs in the market can only control or slow down the progression of diabetic kidney diseases. All these factors are restricting the global diabetic nephropathy market growth.

SEGMENTATION

By Drug Class Analysis

Angiotensin Receptor Blockers Segment has the Highest Market Share

Based on drug class, the diabetic nephropathy market is segmented into Angiotensin Converting Enzyme (ACE) inhibitors, angiotensin receptor blockers, Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, mineralocorticoid receptor antagonists, and others (antioxidant inflammation modulator, diuretics, and calcium channel blockers).

The angiotensin receptor blockers segment accounted for the highest market share in 2020. The market growth is attributed to various advantages associated with the use of angiotensin receptor blocker. For instance, it prevents and delays the development of nephropathy among patients suffering from type 2 diabetes and microalbuminuria and helps diabetic patients prevent the development of any kind of complications.

The ACE inhibitors segment accounted for second-largest market in 2020. Various clinical studies have established the clinical efficiency of ACE inhibitors in delaying the progression of CKD to end-stage renal disorders by around 40.0%. Such clinical benefits are leading to the growing acceptance of ACE inhibitors for the treatment of diabetic nephropathy, eventually contributing to the market growth

The SGLT2 inhibitors segment is estimated to grow at the highest CAGR. This is attributed to the reduction of renal fibrosis albuminuria by improving and reducing various factors such as glomerular filtration and extracellular matrix production. Other clinical benefits, including reduced complications of comorbidities, such as cardiovascular diseases among patients suffering from diabetic type of nephropathy, are some of the factors that are fueling the application of SGLT inhibitors in the management of the disease.  

By Distribution Channel Analysis

Hospital Pharmacies to Witness Highest Market Share 

Based on distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.

Hospital pharmacies have the highest market share as chronic kidney disease has become common across the globe and people suffering from CKD have an increased risk of health complications. Based on one of the research articles from Plos Medicine, adults suffering from chronic kidney disease have a higher hospitalization rate than the general population getting hospitalized. This eventually increases the use of drugs for treatment from hospital pharmacies.

The drug store & retail pharmacies segment held the second-largest share in 2020. This is due to the procurement of prescription drugs and the refills of the prescribed medicines. Furthermore, the initial phase 3 symptoms related to diabetic nephropathies, such as inflammation, can also be treated with OTC drugs that can be easily procured from retail pharmacies.

REGIONAL INSIGHTS

On the basis of region, the diabetic nephropathy market is segmented into North America, Europe, Asia Pacific, and the Rest of the World.

The market in North America was valued at USD 1.06 billion in 2020 and is anticipated to continue to dominate the global market during the forecast period. This is attributed to the increasing incidence of diabetes. For instance, according to the National Diabetes Statistics Report by CDC, for 2020, 34.2 million Americans were suffering from diabetes. Due to rapid increase of diabetes and associated complications, a large patient pool suffers from diabetic nephropathy. Also, based on the CDC report, in 2021, around 15% of the U.S. adults were estimated to have Chronic Kidney Disease, making approximately 37 million people in the U.S. suffering from the disease. These factors are fueling the increasing demand for drugs in the U.S. and Canada.  

Europe is estimated to be the second-most dominant region in terms of market share. The growing prevalence of diabetes, obesity, and associated complications, among others, propel the market growth in the region. For instance, as per the AstraZeneca article in 2021, chronic kidney disease decreases kidney function and is also responsible for heart disease or stroke. The article states that CKD has affected around 840 million people worldwide and around 47 million in the European Union. This prevalence of CKD also indicates the surge in diabetic kidney disease. All these factors are fueling the demand for drugs in the Europe market.

The market in Asia Pacific is estimated to grow at the highest CAGR. The growing diabetic population and the sedentary lifestyle of the people in the region contribute majorly to the market growth. Various initiatives by regulatory bodies toward managing the disease in the region also boost the market growth. Based on the article published by the Asia Pacific Society of Nephrology in 2020, diabetic nephropathy is a significant healthcare burden in the region, with Malaysia and Singapore contributing the most. The Asian Pacific Society of Nephrology (APSN) commissioned a Working Group (WG), based on the difference in healthcare infrastructure and resources among others of various countries in the region, developed a set of clinical guidelines to manage patients suffering from the disease, and pay attention to modulations of healthcare across different countries in the region.

The Rest of the World is expected to account for a limited market revenue share during the forecast period. The market growth is attributed to the increasing prevalence of diabetic nephropathy and rising awareness regarding early diagnosis and treatment of diabetic kidney disease.

KEY INDUSTRY PLAYERS

Novartis, AstraZeneca, and Sanofi Dominated Global Market in 2020

Novartis accounted for around 28-30% of the major market shareholding in 2020. This is mainly attributed to more emphasis on R&D to improve its products offering. For instance, in April 2018, Novartis AG had strong product offerings such as Diovan and Entresto for diabetic nephropathy. AstraZeneca accounted for a significant market share of 20-22% in the global market in 2020. This is attributed to focus on mergers & acquisitions and getting approvals from the regulatory bodies to establish the company’s market position and enhance product portfolio. For instance, in April 2021, AstraZeneca announced the approval of its product Farxiga/Forxiga in the U.S. to treat chronic kidney disease (CKD) in adults with and without type-2 diabetes. This expanded the product portfolio of the company for one more disease. Other major players include Pfizer, Bayer AG, Mitsubishi Tanabe Pharma Corporation, Par Pharmaceuticals, and Sun Pharma. These players have a strong focus on R&D to expand their product offerings for the treatment of kidney disease and diabetes.

LIST OF KEY COMPANIES PROFILED:

• Janssen Pharmaceuticals, Inc (U.S.)


• AstraZeneca (U.K.)


• Aurobindo Pharma Limited (India)


• Teva Pharmaceutical Industries Ltd (Israel)


• Sanofi (France)


• Novartis AG (Switzerland)


• Sun Pharmaceutical Industries Ltd. (India)


• Bayer AG (Germany)


• Par Pharmaceuticals (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• July 2021 – FDA approved Bayer Ag’s Kerendia (finerenone) tablets to reduce the risk of decreasing kidney function, kidney failure, non-fatal heart attacks, cardiovascular death, and hospitalization due to heart failure in adults with chronic kidney disease associated with type 2 diabetes.


• September 2019 – Janssen Pharmaceuticals, Inc. announced that the company got approval for Invokana (canagliflozin) by the U.S. Food and Drug Administration (FDA) for reducing the progression of diabetic nephropathy heart failure chances in patients with type 2 diabetes and diabetic kidney disease.

REPORT COVERAGE

The global diabetic nephropathy market research report provides detailed market analysis and focuses on key aspects such as an overview of the market, penetration of outsourcing in R&D and key countries, and pricing analysis. Additionally, it includes key industry developments such as mergers, partnerships, & acquisitions, the impact of COVID-19 on the market, and brand analysis. Besides these, the report offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the market's growth in recent years. The report also covers regional analysis of different segments.

Report Scope & Segmentation