Global Nephrotic Syndrome Drugs Market - 2024-2031

Global Nephrotic Syndrome Drugs Market - 2024-2031

The global nephrotic syndrome drugs market reached US$ 423.7 million in 2023 and is expected to reach US$ 645.3 million by 2030, growing with a CAGR of 5.4% during the forecast period 2024-2031.

Nephrotic syndrome (NS) is a clinical syndrome defined by massive proteinuria (greater than 40 mg/m^2 per hour) responsible for hypoalbuminemia (less than 30 g/L), with resulting hyperlipidemia, edema, and various complications.

It is caused by increased permeability through the damaged basement membrane in the renal glomerulus. It results from an abnormality of glomerular permeability that may be primary with a disease specific to the kidneys or secondary to congenital infections, diabetes, systemic lupus erythematosus, neoplasia, or certain drug use.

It has two types, minimal change disease (MCD) and focal sclerosis (FSGS). MCD is much more common in children, and likely to respond to therapy. FSGS is a more aggressive disease and may lead to kidney damage. Most children with NS outgrow it by young adulthood.

Market Dynamics: Drivers

Rising prevalence of nephrotic syndrome

The demand for the global nephrotic syndrome drugs market is driven by multiple factors. One of the primary factors is the rising prevalence of nephrotic syndrome. The nephrotic syndrome affects people of all ages, with higher incidence rates observed in children and adults over 50 years old. The prevalence of nephrotic syndrome is rising globally due to factors such as aging populations, increased rates of diabetes and hypertension (leading causes of secondary nephrotic syndrome), and improved diagnostic capabilities.

According to NCBI in May 2023, Nephrotic syndrome is an important chronic disease in children. The estimated annual incidence of nephrotic syndrome in healthy children is two to seven new cases per 100,000 children less than 18 years of age. It is more common in boys than girls at younger ages, but once adolescence is reached, there is no significant difference between genders. Increased incidence and more severe diseases are seen in African American and Hispanic populations.

Moreover, key players in the market are more focused on the treatment of nephrotic syndrome, and research & development in the ongoing clinical trials would propel this market growth. According to the study published in the New England Journal of Medicine in May 2024, the researchers identified 'anti-nephrin autoantibodies' as a reliable biomarker for tracking disease progression, opening new roads for personalized treatment approaches. Researchers have detected novel biomarkers for kidney diseases associated with nephrotic syndrome using a new technique.

Also, in February 2022, Goldfinch Bio, positive preliminary data from its ongoing Phase 2 clinical trial evaluating GFB-887, a podocyte-targeting small molecule inhibitor of Transient Receptor Potential Canonical Channel 5 (TRPC5), for the treatment of FSGS, diabetic nephropathy (DN) and nephrotic syndrome.

Restraints

Factors such as the high cost of the treatment, limited awareness & diagnosis, adverse effects of medication, and availability of limited treatment options, are expected to hamper the market.

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Segment Analysis

The global nephrotic syndrome drugs are segmented based on type, drug class, application, distribution channel, treatment, end-user, and region.

The angiotensin-converting enzyme (ACE) Inhibitors segment accounted for approximately 61.2% of the global nephrotic syndrome drugs market share

The angiotensin-converting enzyme inhibitors segment is expected to hold the largest market share over the forecast period inhibitors are a major drug class used in the treatment of nephrotic syndrome, as they can help reduce proteinuria and slow the progression of kidney disease. They are considered a first-line treatment medication for the disease.

ACE inhibitors provide effective treatment for PMN. Primary membranous nephropathy (PMN) is a rare autoantibody-mediated autoimmune kidney disease and a leading cause of nephrotic syndrome (NS) in adults worldwide. Disease onset and diagnosis typically occur between 40 and 50 years of age, with 80% of patients presenting with nephrotic syndrome (i.e., edema, >3.5 g/day proteinuria, hypoalbuminemia).

Moreover, key players' research and developments, product launches, and approvals would drive this segment's growth in this region. As per Scientific Reports research study in November 2023, Budesonide was well-tolerated, and treatment-emergent adverse events were mostly mild in severity and reversible. Budesonide was effective in the treatment of patients with IgAN at high risk of progression in terms of reducing proteinuria and preserving renal function over 36 months of therapy.

Also, in October 2023, Human Immunology Biosciences (announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for felzartamab in primary membranous nephropathy (PMN).

Geographical Analysis

North America accounted for approximately 42.6% of the global nephrotic syndrome drugs market share

North America region is expected to hold the largest market share over the forecast period owing to the incidences of nephrotic syndrome, especially among children and infants and the prevalence of chronic kidney disease is increasing globally, driving the growth of the nephrotic syndrome market. According to the National Kidney Foundation, approximately 30 million people in the United States have kidney disease, and it is estimated that 50% of these individuals are unaware they have the condition.

As per NIH publication in May 2023, Chronic kidney disease (CKD) affects more than 1 in 7 U.S. adults an estimated 37 million Americans. For Americans with diabetes or high blood pressure, the two most common causes of kidney disease the risk for CKD is even greater. Nearly 1 in 3 people with diabetes and 1 in 5 people with high blood pressure have kidney disease. All these factors help to drive this market growth in this region.

The rise in diabetes and associated diseases is driving this market’s growth. Diabetic nephropathy associated with nephrotic syndrome is most common, with an estimated rate of around 50 cases per million population. In the pediatric population, nephrotic syndrome could occur at a rate of 20 cases per million. In adults, approximately 30 percent of people with nephrotic syndrome have an underlying medical problem, such as diabetes. According to the CDC in May 2024, the percentage of Americans 65 and older remains high, at 29.2%, or 15.9 million seniors (diagnosed and undiagnosed). New 1.4 million Americans are diagnosed with diabetes every year.

Moreover, a major number of key player's presence, well-established healthcare infrastructure, and a rising number of clinical trials and FDA approvals would drive this market growth. For instance, in February 2023, Travere Therapeutics announced FDA accelerated approval of FILSPARI (sparsentan), the first and only non-immunosuppressive therapy for the reduction of Proteinuria in IgA nephropathy.

Market Segmentation

By Type
• Primary Nephrotic Syndrome
• Secondary Nephrotic Syndrome

By Drug Class
• Angiotensin-converting enzyme (ACE) Inhibitors
• Diuretics
• Statins
• Blood Coagulants
• Corticosteroids
• Others

By Application
• Proteinuria
• Hypoalbuminemia

By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
UK
France
Italy
Russia
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the nephrotic syndrome drugs market include Aldeyra Therapeutics, Inc., Asahi Kasei Pharma Corp., Manus Aktteva Biopharma LLP, Dr. Reddy’s Laboratories, Century Pharmaceuticals Limited, Viatris Mylan, Alembic Pharmaceuticals, Salvavidas Pharmaceutical Pvt. Ltd., Rosemont Pharmaceuticals, Hoffmann-La Roche among others.

Key Developments

 In February 2023, Aldeyra Therapeutics, Inc. announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome. Aldeyra also announced the expansion of the minimal change disease clinical trial to encompass idiopathic nephrotic syndrome, a broad group of rare immune-mediated kidney disorders that includes minimal change disease.

 In November 2022, Alembic Pharmaceuticals received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome drugs in pediatric patients.

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• To visualize the global nephrotic syndrome drugs market segmentation based on type, drug class, application, distribution channel, and region, as well as understand key commercial assets and players.
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The global nephrotic syndrome drugs market report would provide approximately 70 tables, 63 figures, and 183 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies