개요
세계의 신증후군 치료제 시장은 2023년에 4억 2,370만 달러에 달하며, 2024-2031년의 예측 기간 중 CAGR 5.4%로 성장하며, 2030년에는 6억 4,530만 달러에 달할 것으로 예측되고 있습니다.
신부전 증후군(NS)은 저알부민혈증(30g/L 미만)을 유발하는 다량의 단백뇨(시간당 40mg/m^2 이상)로 정의되는 임상 증후군으로, 결과적으로 고지혈증, 부종 및 다양한 합병증을 유발하는 임상 증후군입니다.
저알부민혈증은 사구체 기저막의 손상으로 인한 투과성 증가로 인해 발생합니다. 사구체 투과성 이상에 의해 발생하지만 신장 특이적 질환으로 인한 1차적 인 것과 선천성 감염, 당뇨병, 전신성 홍반성 루푸스, 신 생물, 특정 약물 사용 등으로 인한 이차적 인 것이 있습니다.
미세변화형(MCD)과 국소경화형(FSGS)의 두 가지 유형이 있으며, MCD는 소아에게 흔하고 치료에 반응할 가능성이 높으며, FSGS는 더 공격적인 질환으로 신장 손상을 일으킬 수 있으며, NS에 걸린 대부분의 소아는 젊은 성인기까지 치료할 수 있습니다.
촉진요인
신증후군의 유병률 상승
세계 신증후군 치료제 시장 수요는 여러 요인에 의해 주도되고 있습니다. 주요 요인 중 하나는 신증후군 유병률 증가입니다. 모든 연령대의 사람들이 신증후군을 앓고 있지만, 소아 및 50세 이상의 성인에서 더 높은 유병률이 관찰됩니다. 인구 고령화, 당뇨병과 고혈압(이차성 신증후군의 주요 원인) 증가, 진단 능력의 향상 등의 요인으로 인해 전 세계에서 신증후군 유병률이 증가하고 있습니다.
2023년 5월 NCBI에 따르면 신증후군(Nephrotic Syndrome)은 소아에서 중요한 만성질환입니다. 건강한 소아에서 신증후군의 연간 발병률은 18세 미만 소아 10만 명당 2-7명으로 추정됩니다. 저연령에서는 여아보다 남아에서 더 많이 발생하지만, 사춘기에 접어들면 남녀 간에는 큰 차이가 없습니다. 아프리카계 미국인과 히스패닉계 미국인에서 발병률과 중증도가 더 높습니다.
또한 시장의 주요 업체들은 신증후군 치료에 주력하고 있으며, 현재 진행 중인 임상시험의 연구개발은 이 시장의 성장을 가속할 것으로 보입니다.2024년 5월 뉴잉글랜드 저널 오브 메디신(New England Journal of Medicine)에 게재된 연구에 따르면 연구진은 "항-네프린 자가 항체"를 식별했습니다. 네프린 자가항체'를 질병 진행을 추적할 수 있는 신뢰할 수 있는 바이오마커로 확인하여 맞춤형 치료 접근법의 새로운 길을 열었습니다. 연구팀은 새로운 기술을 사용하여 신증후군과 관련된 신장 질환의 새로운 바이오마커를 검출했습니다.
또한 2022년 2월, Goldfinch Bio는 포도세포를 표적으로 하는 저분자 표준 채널 5(TRPC5) 억제제 GFB-887을 FSGS, 당뇨병성 신증(DN) 및 신증후군의 치료제로 평가하기 위해 진행 중인 임상 2상 시험의 양호한 예비 데이터를 발표했습니다.
억제요인
높은 치료비, 제한된 인식과 진단, 약물로 인한 부작용, 제한된 치료 옵션의 가용성 등의 요인이 시장을 저해할 것으로 예상됩니다.
Overview
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.
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).
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.
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.
The global nephrotic syndrome drugs market report would provide approximately 70 tables, 63 figures, and 183 Pages.
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