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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Proteinuria is defined as an increase in protein levels in the urine. The condition of proteinuria is often a sign of kidney disease. Kidneys are bean-shaped organs, whose main function is to filter blood. The kidney contains blood vessels called glomeruli, which remove waste from the urine and reabsorb protein from the blood. However, if the kidneys or glomeruli gets damaged, the proteins such as albumin may accidently enter the urine. Hence, this leads to high protein levels in urine that is proteinuria. A progressive decline in kidney function might eventually require dialysis or a kidney transplant. Diabetes and high blood pressure, both can harm the kidneys and are the leading causes of kidney disease.

Proteinuria is frequently caused by relatively benign (non-cancerous) or temporary medical conditions including dehydration, inflammation, and low blood pressure. Proteinuria might also occur due to intense exercise or activity, emotional stress, aspirin therapy, and exposure to cold temperatures.

Some common symptoms of proteinuria include frequent urination, shortness of breath, tiredness, nausea, and lack of appetite. Proteinuria can be diagnosed and detected by a 24 hour urine test, glomerular filtrate rate (GMR) blood test, ultrasound or computed tomography (CT) scan, and kidney biopsy.

The treatment is determined by the underlying condition that caused the proteinuria. Each condition requires different treatment plans. For example, if kidney disease is diagnosed, a treatment plan may consist of medication such as diuretics, dietary changes, weight loss, and exercise. Patients with diabetes and hypertension who have proteinuria may require blood pressure medication such as angiotensin-converting enzyme (ACE) inhibitors, and those with diabetes might need to control their blood sugar level.

Global Proteinuria Therapeutics Market – Dynamics

The increase in prevalence of chronic kidney disease, a major cause of proteinuria is expected to drive growth of the global proteinuria therapeutics market. For instance, according to the Centers for Disease Control and Prevention, in March 2021, over one in seven, accounting for 37 million people (15% of the adults), are estimated to have chronic kidney disease in the U.S. Moreover, according to the same source, Chronic kidney disease was found to be more prevalent in people aged 65 years or older (38%) compared to people aged 45–64 years (12%) or 18-44 years (6%).

The increasing clinical development of drugs for the treatment of chronic kidney disease and proteinuria is expected to boost global proteinuria therapeutics market growth. For instance, on June 06, 2021, Novartis, a global healthcare company, revealed their Phase II primary endpoint data demonstrating that investigational ‘iptacopan’ reduced protein in the urine (proteinuria), a key risk predictor associated  with progression of kidney failure. Iptocan is a first-in-class, oral, targeted factor B inhibitor, which also showed a stabilizing kidney function in patients with IgA nephropathy.

The rising mergers, agreements, and acquisitions by market players are expected to propel growth of the global proteinuria therapeutics market over the forecast period. For instance, on January 10, 2020, Chinook Therapeutics Inc., a biotechnology firm focused on developing precision medicines for kidney diseases, announced a license agreement with AbbVie, a research-based global biopharmaceutical company, for worldwide exclusive rights to ‘atrasentan’, an endothelin receptor antagonist. Atrasentan is being developed for the treatment of primary glomerular diseases, which are characterized by proteinuria. These factors are expected to support global proteinuria therapeutics market growth over the forecast period.

Global Proteinuria Therapeutics Market – Regional Insights

Among regions, North America is expected to account for the largest share in global proteinuria therapeutics market over the forecast period, owing to the submission of new drug applications for the treatment of proteinuria associated diseases such as nephropathy. For instance, on March 15, 2021, Calliditas Therapeutics AB officially confirmed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral formulation targeting IgA1 down regulation for the treatment of primary IgA Nephropathy (IgAN). Nefecon in the part A of phase III study met its primary endpoint of lowering proteinuria compared to placebo, as well as stabilizing estimated glomerular filtration rate (eGFR) at nine months. Calliditas Therapeutics is a specialty pharmaceutical company, which focuses on developing novel treatments for orphan indications, with an initial focus on renal and hepatic diseases.

Moreover, due to recent drug approvals by regulatory authorities for the treatment of proteinuria associated diseases such as lupus nephritis, Europe may witness a lucrative growth in global proteinuria therapeutics market over the forecast period. For instance, on May 05, 2021, GlaxoSmithKline plc. (GSK), a science-led global healthcare company announced that the European Commission approved the expanded use of intravenous BENLYSTA (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN) in Europe. Proteinuria is one of the manifestations of lupus nephritis. BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. These factors are expected to support global proteinuria therapeutics market growth over the forecast period.

Global Proteinuria Therapeutics Market–Taxonomy

By Drug Class:

  • Angiotensin-converting Enzyme (ACE) Inhibitors
  • Angiotensin II Receptor Antagonists (ARBs)
  • Diuretics
  • Others

By Route of Administration:

  • Oral
  • Intravenous

By Distribution Channels:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa

Global Proteinuria Therapeutics Market – Competitive landscape

Key players operating in the global proteinuria therapeutics market include GlaxoSmithKline plc, Chinook Therapeutics Inc., Novartis International AG, AbbVie Inc., Calliditas Therapeutics AB, Travere Therapeutics Inc., Walden Biosciences, Ligand Pharmaceuticals Inc., and Retrophin, Inc.

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