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고안압증 : 시장 인사이트, 역학 및 시장 예측(2036년)

Ocular Hypertension - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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고안압증에 대한 인사이트와 동향

  • Delveinsight사의 추산에 따르면, 주요 7개국(G7) 중 고안압증의 총 유병자 수는 미국이 가장 많았던 것으로 나타났습니다. 이 수치는 2036년까지 더욱 증가할 것으로 예측됩니다.
  • 안압 상승증은 초기 징후나 증상이 없기 때문에 녹내장으로 진행될 때까지 알아차리지 못하는 경우가 많습니다.
  • 평균 안압(IOP)은 나이가 들면서 서서히 상승합니다. 40세 이상인 것은 고안압증 및 원발성 개방각 녹내장(POAG)의 발병 위험 요인으로 간주됩니다.
  • 프랑스에서는 40세 이상 인구 중 녹내장 및 고안압증의 유병률이 4.1%, 즉 120만 명으로 추정됩니다.
  • 트라보프로스트 전방 내 임플란트(iDose TR), 오미데네파그·이소프로파일 점안액(OMLONTI), 비마토프로스트 임플란트(DURYSTA) 등 승인된 치료법은 지속형 약물 전달 시스템과 안압 저하 및 환자의 복약 순응도 향상을 목표로 하는 독자적인 프로스타글란딘 수용체 표적 기전을 통해 치료의 패러다임을 변화시키고 있습니다.
  • 안압 상승증이라는 새로운 치료 분야에 관여하고 있는 기업으로는 Nicox Ophthalmics, Sun Pharma Advanced Research Company, Visiox Pharma, 산텐, 오노제약 등이 있습니다.
  • 장시간 작용형 임플란트, 새로운 수용체 표적 치료법, 그리고 서방형 점안제의 등장으로 인해, 예측 기간 동안 고안압증 시장은 크게 변화할 것으로 예측됩니다.

본 고안압증 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, 고안압증 환자의 부담 추이, 매출액 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료 도입률 분석을 평가함과 동시에, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서는 안압 상승과 관련된 주요 미충족 요구 사항을 부각시키고, 경쟁 구도 및 임상 상황을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

안압 상승 시장을 주도하는 주요 요인

  • 안과 질환 유병률 증가

특히 고령층에서 안압 상승 및 녹내장 유병률 증가가 조기 진단과 장기 치료에 대한 수요를 이끌고 있습니다. 당뇨병, 고혈압, 장시간 화면 시청과 같은 위험 요인에 노출되는 경우가 늘어나고 있는 점도 질병 부담을 더욱 가중시키고 있습니다.

  • 치료법 개발 분야의 혁신

안압 상승증 시장에서는 서방형 치료제, 일산화질소 공급제, 차세대 프로스타글란딘 유사체의 개발을 통해 강력한 혁신이 진행되고 있습니다. 이 새로운 치료법은 안압(IOP) 조절을 개선하고, 투여 빈도를 줄이며, 환자의 복약 순응도를 높이는 것을 목표로 하고 있습니다. 각 제약사의 파이프라인 활동이 활발해짐에 따라 향후 시장 성장이 촉진될 것으로 예측됩니다.

  • 의식 고취와 헬스케어 접근성 확대

정기적인 안과 검진 및 예방적 안과 관리에 대한 인식이 높아짐에 따라 진단률이 향상되고 있습니다. 신흥 경제국에서의 의료 인프라 확충과 안과 의료 서비스에 대한 접근성 개선 또한 치료의 보급을 뒷받침하고 있습니다.

고안압증의 이해와 치료 알고리즘

고안압증의 개요와 진단

고안압증이란, 녹내장에 수반되는 감지 가능한 시신경 손상이나 시야 결손을 동반하지 않으면서 안압 상승을 특징으로 하는 상태를 말합니다. 이는 안구 내의 방수가 제대로 배출되지 않아 안압이 상승함으로써 발생합니다. 고안압증 자체는 초기에는 증상을 일으키지 않는 경우도 있지만, 치료하지 않고 방치할 경우 개방각 녹내장을 발병하게 하는 중요한 위험 요인으로 여겨집니다.

고안압증의 진단에는 주로 종합적인 안과 검사가 이루어집니다. 여기에는 안압을 측정하는 안압 측정, 각막 두께를 평가하는 각막 두께 측정, 배수각을 검사하는 각막경 검사, 그리고 안저 검사 및 광간섭 단층촬영(OCT)을 통한 시신경 평가가 포함됩니다. 또한, 초기 기능적 변화를 감지하거나 고안압증과 녹내장을 감별하기 위해 시야 검사가 시행되기도 합니다. 안압이 지속적으로 상승하고 있는 환자는 질환이 진행될 위험이 높으므로, 정기적인 경과 관찰이 필수적입니다.

안압 상승증의 현재 치료 현황

고안압증의 치료는 녹내장 발병 위험을 줄이기 위해 안압을 낮추는 데 중점을 두고 있습니다. 1차 치료법으로는 프로스타글란딘 유사제, β-차단제, α-작용제, 탄산탈수효소 억제제 등의 점안제가 일반적으로 사용됩니다. 약물 요법만으로는 충분한 조절이 어려운 환자의 경우, 선택적 레이저 섬유주대 성형술(SLT)이나 최소 침습 녹내장 수술(MIGS) 등의 레이저 치료를 고려할 수 있습니다. 또한, 장기적인 질환 관리와 환자의 복약 순응도를 개선하기 위해 서방형 임플란트나 일산화질소 방출제 등 새로운 치료법도 개발되고 있습니다.

고안압증의 역학

고안압증의 역학 분석 및 예측에 관한 주요 조사 결과

  • EU4 및 영국 중에서 2025년에는 독일의 확진자 수가 가장 많았고, 스페인이 가장 적었던 것으로 나타났습니다.
  • 안압 상승증은 남성보다 여성에게서 더 많이 나타납니다.
  • G7 국가들의 고안압증 유병 사례 중 일본이 약 20%를 차지하고 있습니다.

고안압증 시장 전망

안압 상승증의 치료 현황은 기존의 국소적인 안압 강하 요법에서 유효성, 지속성 및 환자의 복약 순응도 향상을 목적으로 하는 장시간 작용형 임플란트나 새로운 작용기전에 기반한 약제로 크게 진화하고 있습니다. 트라보프로스트 전방 내 임플란트(iDose TR), 오미데네파그·이소프로파일 점안액(OMLONTI), 비마토프로스트 임플란트 등 승인된 치료법은 지속적인 약물 전달 및 프로스타글란딘 수용체를 표적으로 하는 대체 요법 분야에서 중요한 진전을 보여줍니다. 이러한 치료법은 매일 점안약을 복용하는 순응도가 낮거나 안압 조절에 변동이 있는 등 주요 미충족 의료 수요를 해결하는 동시에, 녹내장 진행 위험이 있는 환자의 장기적인 질환 관리 개선에도 기여하고 있습니다.

NCX 470, PDP-716, 세페타프로스트(DE-126/ONO-9054/STN1012600) 등의 임상시험 후보 약물은 현재 이용 가능한 치료법과 비교하여 우수한 안압 강하 효과, 내약성 향상 및 작용 지속 시간 연장을 실현하기 위해 개발이 진행되고 있습니다. NCX 470은 일산화질소의 방출과 프로스타글란딘의 작용을 결합하여 방수의 유출을 촉진하는 반면, PDP-716은 서방형 브리모니딘 기술을 활용하여 하루 1회 투여가 가능하도록 합니다. 그러나 PDP-716의 규제 승인 절차에 지연이 발생하고 있습니다. 미국 식품의약국(FDA)은 2023년 7월, PDP-716에 대한 신약 승인 신청(NDA)에 대해 완전 답변서(CRL)를 발부했습니다. 이는 약제의 안전성이나 유효성에 대한 우려가 아니라, 제3자의 유효성분(API) 제조 시설에 대한 시설 점검과 관련된 지적 사항이 해결되지 않았기 때문입니다. 그 후, SPARC사와 Ocuvex Therapeutics사는 이러한 지적 사항을 해결하고 2025년 말에 NDA를 재제출했습니다. 그러나 FDA가 2026년 5월에 다시 CRL을 발부함에 따라, 승인 및 시판 개시까지의 일정이 연장될 가능성이 있습니다.

전반적으로, 주요 7개국의 고안압증 시장은 질환 유병률 증가, 고령화, 선별 검사율 향상, 그리고 안과 치료제의 지속적인 혁신에 힘입어 2026년부터 2036년에 걸쳐 꾸준한 성장이 예상됩니다. 서방형 임플란트, 저침습 치료법 및 차별화된 점안 요법의 도입이 확대됨에 따라 경쟁 구도가 새롭게 재편될 것으로 예측됩니다.

  • 서방형 치료법: 이 분류에는 매일 점안약을 투여해야 하는 부담을 최소화하고, 환자의 복약 순응도를 높이는 동시에 장기간에 걸쳐 안압(IOP)을 낮추도록 설계된 치료법이 포함됩니다. 트라보프로스트 전방 내 임플란트 및 비마토프로스트 임플란트는 장시간 작용형 프로스타글란딘 유사체를 안구 내부로 직접 전달하는 서방형 전방 내 임플란트인 반면, PDP-716은 서방형 기술을 활용하여 브리모니딘의 1일 1회 투여를 가능하게 합니다.
  • 프로스타글란딘 및 새로운 수용체 표적 치료법: 이 범주에는 방수의 유출을 개선하고 안압을 낮추기 위해 프로스타글란딘 관련 경로를 표적으로 하는 치료법이 포함됩니다. 오미데네파그·이소프로파일 점안액은 기존의 FP 수용체 작용제와는 다른 작용기전을 가진 선택적 EP2 수용체 작용제이며, NCX 470은 프로스타글란딘 유사체의 작용과 일산화질소의 방출을 결합함으로써, 이중의 방수 유출 촉진 효과를 발휘합니다. 세페타프로스트는 더 강력하고 지속적인 안압 강하를 목적으로 개발이 진행되고 있습니다. 이러한 치료법들은 고안압증 시장에서 라타노프로스트, 트라보프로스트, 비마토프로스트와 같은 기존의 프로스타글란딘 유사체들과 경쟁하며, 더 높은 효능, 독자적인 작용기전, 그리고 개선된 내약성 프로파일을 제공할 것으로 기대됩니다.

전반적으로, 고안압증 분야의 혁신은 안압 강하 효과 향상, 치료의 지속성, 그리고 환자의 복약 순응도 향상에 초점을 맞춘, 지속적으로 확대되고 있는 표적 치료제 파이프라인에 의해 주도되고 있습니다. 새로운 치료법은 일산화질소의 방출, 프로스타글란딘 수용체의 선택적 조절, 서방형 약물 전달 시스템과 같은 새로운 작용기전을 활용하여 방수의 유출을 촉진하고 있습니다. 이러한 개발 후보 약물의 연구가 진행됨에 따라, 기존의 점안제 범위를 넘어선 치료 선택지가 확대될 것이며, 고안압증 시장에서 작용 시간이 길고, 더 효과적이며, 내약성이 우수한 치료법으로의 전환이 촉진될 것으로 기대됩니다.

자주 묻는 질문

  • 고안압증의 유병률은 어떤가요?
  • 고안압증의 주요 위험 요인은 무엇인가요?
  • 고안압증의 치료법은 어떻게 변화하고 있나요?
  • 고안압증 시장의 성장 요인은 무엇인가요?
  • 고안압증의 진단 방법은 무엇인가요?
  • 고안압증 시장의 미래 전망은 어떻게 되나요?
  • 고안압증 치료에 참여하고 있는 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 고안압증 : 역학 및 시장 조사 방법

제6장 고안압증 : 시장 개요

제7장 고안압증 : 질환 배경과 개요

제8장 고안압증 : 역학 및 환자 인구

제9장 고안압증 : 환자 경과

제10장 시판 치료제

제11장 신흥 치료법

제12장 고안압증 : 주요 7개국 분석

제13장 고안압증 : 미충족 요구

제14장 고안압증 : SWOT 분석

제15장 고안압증 : KOL(Key Opinion Leader)의 견해

제16장 고안압증 : 시장 참여 및 보험 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH 26.07.27

Ocular Hypertension Insights and Trends

  • According to Delveinsight's estimates, the total prevalent cases of ocular hypertension were highest in the United States among the 7MM. The number are anticipated to increase further by 2036.
  • Since there are no early signs and symptoms for ocular hypertension, the disease often goes unnoticed until it progresses to glaucoma.
  • Mean Intraocular Pressure (IOP) slowly rises with increasing age. Age older than 40 years is considered a risk factor for the development of ocular hypertension and primary open-angle glaucoma (POAG).
  • In France, he prevalence of glaucoma and ocular hypertension in the population over 40 has been estimated at 4.1% or 1.2 million people.
  • Approved therapies such as travoprost intracameral implant (iDose TR), omidenepag isopropyl ophthalmic solution (OMLONTI), and bimatoprost implant (DURYSTA) are reshaping the treatment landscape through sustained drug delivery systems and differentiated prostaglandin receptor targeting mechanisms aimed at improving intraocular pressure reduction and patient adherence.
  • The companies involved in the emerging landscape of ocular hypertension are Nicox Ophthalmics, Sun Pharma Advanced Research Company, Visiox Pharma, Santen, Ono Pharmaceutical, and others.
  • The emergence of long-acting implants, novel receptor-targeting therapies, and sustained-release ophthalmic formulations is expected to significantly transform the ocular hypertension market during the forecast period.

DelveInsight's 'Ocular Hypertension - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the ocular hypertension, historical and forecasted epidemiology, as well as the ocular hypertension market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The ocular hypertension market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates ocular hypertension patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in ocular hypertension and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Ocular Hypertension Market

  • Rising Prevalence of Ocular Disorders

The increasing prevalence of ocular hypertension and glaucoma, particularly among the elderly population, is driving demand for early diagnosis and long-term treatment. Growing exposure to risk factors such as diabetes, hypertension, and prolonged screen time is further contributing to disease burden.

  • Innovation in Therapeutic Development

The ocular hypertension market is witnessing strong innovation with the development of sustained-release therapies, nitric oxide-donating agents, and next-generation prostaglandin analogs. Emerging therapies aim to improve intraocular pressure (IOP) control, reduce dosing frequency, and enhance patient adherence. Increasing pipeline activity from pharmaceutical companies is expected to strengthen future market growth.

  • Increasing Awareness and Healthcare Access

Rising awareness regarding routine eye examinations and preventive eye care is contributing to higher diagnosis rates. Expanding healthcare infrastructure and improved access to ophthalmic services in emerging economies are also supporting treatment uptake.

Ocular Hypertension Understanding and Treatment Algorithm

Ocular Hypertension Overview and Diagnosis

Ocular hypertension is a condition characterized by elevated IOP without detectable optic nerve damage or visual field loss associated with glaucoma. It occurs when the aqueous humor inside the eye does not drain properly, leading to increased pressure within the eye. Although ocular hypertension itself may not initially cause symptoms, it is considered a significant risk factor for the development of open-angle glaucoma if left untreated.

Diagnosis of ocular hypertension primarily involves comprehensive ophthalmic evaluation, including tonometry to measure intraocular pressure, pachymetry to assess corneal thickness, gonioscopy to examine the drainage angle, and optic nerve assessment through fundoscopy or optical coherence tomography (OCT). Visual field testing may also be conducted to detect early functional changes and differentiate ocular hypertension from glaucoma. Regular monitoring is essential, as patients with persistently elevated IOP are at increased risk of disease progression.

Current Ocular Hypertension Treatment Landscape

Treatment of ocular hypertension focuses on lowering IOP to reduce the risk of glaucoma development. First-line management commonly includes topical medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. In patients inadequately controlled with medications, laser procedures such as selective laser trabeculoplasty (SLT) or minimally invasive glaucoma surgeries (MIGS) may be considered. Emerging therapies, including sustained-release implants and nitric oxide-donating agents, are also being developed to improve long-term disease management and patient adherence.

Ocular Hypertension Unmet Needs

The section "unmet needs of ocular hypertension" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Poor long-term treatment adherence

2. Limited access to advanced ophthalmic care

3. Need for personalized treatment approaches

4. Challenges in monitoring disease progression, and others.....

Ocular Hypertension Epidemiology

Key Findings from Ocular Hypertension Epidemiological Analysis and Forecast

  • Among EU4 and the UK, Germany accounted for the highest number of cases whereas Spain accounted for the least number of cases in 2025.
  • Females are more affected than males with ocular hypertension.
  • Japan accounted for approximately 20% of prevalent cases of ocular hypertension among the 7MM.

Ocular Hypertension Drug Analysis & Competitive Landscape

The ocular hypertension drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase III-II clinical trials and preclinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the ocular hypertension treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the ocular hypertension therapeutics market.

Approved Therapies for Ocular Hypertension

Travoprost Intracameral Implant (iDose TR): Glaukos

iDose TR is a first-of-its-kind, long-duration, anchored intracameral procedural pharmaceutical therapy designed to continuously (24/7) deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is indicated for the reduction of IOP in patients with open-angle glaucoma (OAG) or ocular hypertension. iDose TR is composed of a biocompatible intracameral implant preloaded in a sterile, single-dose inserter.

Omidenepag Isopropyl Ophthalmic Solution (OMLONTI): Santen and UBE Corporation

OMLONTI is a novel ophthalmic therapy approved for the reduction of elevated IOP in patients with OAG and ocular hypertension. It contains omidenepag isopropyl, a selective prostaglandin E2 (EP2) receptor agonist that lowers IOP by enhancing both trabecular and uveoscleral aqueous humor outflow pathways. The FDA approval for OMLONTI was based on data from 12 clinical studies conducted in multiple global locations. Notably, a US Phase III study confirmed OMLONTI to be non-inferior to timolol, the standard of care. Two different Phase III studies conducted in Japan and Asia showed OMLONTI to be non-inferior to latanoprost, another standard of care. It is the first approved therapy with this unique EP2 receptor mechanism of action. OMLONTI is administered as a once-daily ophthalmic solution (0.002%), typically dosed in the evening.

Ocular Hypertension Pipeline Analysis

NCX 470: Nicox Ophthalmics

NCX 470 is considered a next-generation prostaglandin analog and represents Nicox's lead clinical asset. It is an investigational nitric oxide donating bimatoprost ophthalmic solution being developed for the treatment of OAG and ocular hypertension. The therapy combines bimatoprost with nitric oxide-mediated trabecular meshwork relaxation to enhance aqueous humor outflow and improve IOP reduction versus conventional prostaglandin analogs like latanoprost. In Phase III trials, including Mont Blanc and Denali, NCX 470 demonstrated non-inferior and numerically superior IOP lowering versus latanoprost at multiple timepoints while maintaining a favorable tolerability profile.

The drug successfully completed Phase III clinical trials, with topline results reported in August 2025. The company further anticipates submitting the NDA for NCX 470 in 2026.

PDP-716: Sun Pharma Advanced Research Company (SPARC)/Ocuvex Therapeutics

PDP-716 by Sun Pharma Advanced Research Company is an investigational once-daily ophthalmic suspension of brimonidine tartrate 0.35% being developed for the treatment OAG and ocular hypertension. Developed using SPARC's proprietary TearAct technology, PDP-716 is designed to provide sustained drug delivery and improved bioavailability, enabling once-daily dosing compared with currently marketed brimonidine formulations that require three-times-daily administration.

In a pivotal Phase III trial, PDP-716 met its primary endpoint by demonstrating intraocular pressure (IOP) reduction comparable to Alphagan P 0.1% dosed three times daily, with a similar safety profile. PDP-716 was licensed by SPARC to Visiox Pharmaceuticals in 2021 for global development and commercialization rights outside India and Greater China; in 2024, Visiox Pharmaceuticals merged with Ocuvex Therapeutics.

Ocular Hypertension Key Players, Market Leaders and Emerging Companies

  • Glaukos
  • Santen
  • UBE Corporation
  • Allergan
  • Nicox Ophthalmics
  • Sun Pharma Advanced Research Company
  • Visiox Pharma
  • Santen
  • Ono Pharmaceutical, and others

Ocular Hypertension Drug Updates

  • In May 2026, OcuVex Therapeutics, received a Complete Response Letter (CRL) from the US FDA. The CRL pertains to the New Drug Application (NDA) for PDP-716, a novel once-daily ophthalmic suspension intended for the treatment of glaucoma.
  • In February 2026, Nicox highlighted positive NCX 470 phase III data confirming therapeutic profile at the 2026 American Glaucoma Society Annual Meeting. The data demonstrated best-inclass IOP lowering efficacy of up to 10mmHg from baseline which has met the efficacy requirements for a New Drug Application (NDA) in the US. and China.
  • In February 2026, Nicox announced that it has received positive written feedback from its NCX 470 pre-NDA (New Drug Application) meeting with the US FDA.
  • In August 2025, Nicox announced that its partner, Kowa, has initiated a Phase III safety clinical trial of NCX 470 (also known as K-911) in Japan for the treatment of ocular hypertension.
  • In August 2025, Santen Pharmaceutical announced that it has obtained manufacturing and marketing approval in Japan for sepetaprost (SETANEO) ophthalmic solution 0.002% for the treatment of glaucoma and ocular hypertension.
  • In July 2025, Nicox announced a new agreement of NCX 470 with Kowa. The agreement grants Kowa exclusive rights to develop and commercialize NCX 470 in patients with glaucoma or ocular hypertension in the US and all other territories of the world excluding Japan, China, Korea and Southeast Asia.

Ocular Hypertension Market Outlook

The treatment landscape for ocular hypertension has evolved significantly from conventional topical IOP-lowering therapies toward long-acting implants and novel mechanism-based agents aimed at improving efficacy, durability, and patient adherence. Approved therapies such as travoprost intracameral implant (iDose TR), omidenepag isopropyl ophthalmic solution (OMLONTI), and bimatoprost implant represent important advancements in sustained drug delivery and alternative prostaglandin receptor targeting. These therapies are addressing major unmet needs associated with poor adherence to daily eye drops and fluctuations in IOP control, while also improving long-term disease management in patients at risk of glaucoma progression.

Investigational candidates such as NCX 470, PDP-716, and Sepetaprost (DE-126/ONO-9054/STN1012600) are being developed to provide superior IOP reduction, improved tolerability, and longer duration of action compared with currently available therapies. NCX 470 combines nitric oxide donation with prostaglandin activity to enhance aqueous humor outflow, while PDP-716 utilizes sustained-release brimonidine technology to enable once-daily dosing. However, the regulatory pathway for PDP-716 has encountered setbacks. The US FDA issued a Complete Response Letter (CRL) for the PDP-716 New Drug Application (NDA) in July 2023 due to unresolved facility inspection-related observations at a third-party Active Pharmaceutical Ingredient (API) manufacturing site, rather than concerns regarding the drug's safety or efficacy. SPARC and Ocuvex Therapeutics subsequently addressed the observations and resubmitted the NDA in late 2025. However, the FDA issued another CRL in May 2026, potentially extending timelines for approval and commercial launch.

Overall, the ocular hypertension market across the 7MM is expected to witness steady growth from 2026 to 2036, driven by increasing disease prevalence, aging populations, improved screening rates, and continued innovation in ophthalmic therapeutics. The growing adoption of sustained-release implants, minimally invasive treatment approaches, and differentiated topical therapies is anticipated to reshape the competitive landscape.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Ocular Hypertension (2022-2036 Forecast)

The ocular hypertension market is evolving toward mechanism-based therapies that target multiple aqueous humor outflow pathways to improve IOP reduction, enhance long-term disease control, and improve patient adherence while minimizing treatment burden and tolerability issues associated with conventional topical therapies.

  • Sustained-Release Therapies: This class includes therapies designed to provide prolonged IOP reduction while minimizing the burden of daily eye drop administration and improving patient adherence. Travoprost intracameral implant and bimatoprost implant are sustained-release intracameral implants delivering long-acting prostaglandin analogs directly into the eye, while PDP-716 utilizes sustained-release technology to enable once-daily dosing of brimonidine.
  • Prostaglandin and Novel Receptor-Targeting Therapies: This category includes therapies targeting prostaglandin-related pathways to improve aqueous humor outflow and reduce IOP. Omidenepag isopropyl ophthalmic solution is a selective EP2 receptor agonist offering a differentiated mechanism compared with conventional FP receptor agonists, while NCX 470 combines prostaglandin analog activity with nitric oxide donation for dual outflow enhancement. Sepetaprost is being developed for stronger and sustained IOP reduction. These therapies are expected to compete with established prostaglandin analogs such as latanoprost, travoprost, and bimatoprost by offering enhanced efficacy, differentiated mechanisms of action, and improved tolerability profiles in the ocular hypertension market.

Overall, innovation in ocular hypertension is being driven by a growing pipeline of targeted therapies focused on improving IOP reduction, treatment durability, and patient adherence. Emerging therapies are utilizing novel mechanisms such as nitric oxide donation, selective prostaglandin receptor modulation, and sustained-release drug delivery systems to enhance aqueous humor outflow. As these pipeline candidates advance, they are expected to expand the therapeutic landscape beyond conventional topical eye drops, supporting a shift toward longer-acting, more effective, and better-tolerated treatment options in the ocular hypertension market.

Ocular Hypertension Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the ocular hypertension drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

During the forecast period, approved therapies such as travoprost intracameral implant (iDose TR), and bimatoprost implant are expected to witness steady adoption due to their sustained-release delivery mechanisms, which reduce treatment burden and improve adherence compared with daily topical eye drops. Omidenepag isopropyl ophthalmic solution (OMLONTI) is also anticipated to maintain uptake through its differentiated EP2 receptor-targeting mechanism and competitive IOP lowering efficacy.

Among pipeline therapies, NCX 470 is expected to achieve significant uptake as a next-generation nitric oxide-donating prostaglandin analog with the potential for superior IOP reduction compared with existing prostaglandin therapies. PDP-716 may gain adoption through its once-daily sustained-release formulation designed to improve patient compliance. Overall uptake of emerging therapies will depend on long-term efficacy, safety, durability of IOP control, pricing, reimbursement, and competitive positioning against established glaucoma and ocular hypertension treatments.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved Therapies in Ocular Hypertension

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Ocular Hypertension Therapies Price Scenario & Trends

Pricing and analogue assessment of ocular hypertension therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Ocular Hypertension

To keep up with ocular hypertension market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the ocular hypertension emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in ocular hypertension, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as Bascom Palmer Eye Institute, Institut de la Vision, University Hospital Cologne Department of Ophthalmology, etc. were contacted. Their opinion helps understand and validate current and emerging ocular hypertension therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in ocular hypertension.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of ocular hypertension, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of ocular hypertension, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the ocular hypertension market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM ocular hypertension market.

Report Insights

  • Ocular Hypertension Patient Population Forecast
  • Ocular Hypertension Therapeutics Market Size
  • Ocular Hypertension Pipeline Analysis
  • Ocular Hypertension Market Size and Trends
  • Ocular Hypertension Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Ocular Hypertension Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Ocular Hypertension Treatment Addressable Market (TAM)
  • Ocular Hypertension Competitive Landscape
  • Ocular Hypertension Major Companies Insights
  • Ocular Hypertension Price Trends and Analogue Assessment
  • Ocular Hypertension Therapies Drug Adoption/Uptake
  • Ocular Hypertension Therapies Peak Patient Share Analysis

Report Assessment

  • Ocular Hypertension Current Treatment Practices
  • Ocular Hypertension Unmet Needs
  • Ocular Hypertension Clinical Development Analysis
  • Ocular Hypertension Emerging Drugs Product Profiles
  • Ocular Hypertension Market Attractiveness
  • Ocular Hypertension Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the ocular hypertension market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of ocular hypertension?
  • What are the disease risks, burdens, and unmet needs of ocular hypertension? What will be the growth opportunities across the 7MM concerning the patient population with ocular hypertension?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of ocular hypertension? What are the current guidelines for treating ocular hypertension in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the ocular hypertension market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Ocular Hypertension

6. Ocular Hypertension Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Ocular Hypertension By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Ocular Hypertension By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Ocular Hypertension

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm

8. Epidemiology and Patient Population of Ocular Hypertension

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Diagnosed Prevalent Cases of Ocular Hypertension in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Diagnosed Prevalent Cases of Ocular Hypertension in the United States
    • 8.4.2. Gender-specific Cases of Ocular Hypertension in the United States
    • 8.4.3. Age-specific Cases of Ocular Hypertension in the United States
    • 8.4.4. Treated Cases of Ocular Hypertension in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Diagnosed Prevalent Cases of Ocular Hypertension in EU4 and the UK
    • 8.5.2. Gender-specific Cases of Ocular Hypertension in EU4 and the UK
    • 8.5.3. Age-specific Cases of Ocular Hypertension in EU4 and the UK
    • 8.5.4. Treated Cases of Ocular Hypertension in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Diagnosed Prevalent Cases of Ocular Hypertension in Japan
    • 8.6.2. Gender-specific Cases of Ocular Hypertension in Japan
    • 8.6.3. Age-specific Cases of Ocular Hypertension in Japan
    • 8.6.4. Treated Cases of Ocular Hypertension in Japan

9. Patient Journey of Ocular Hypertension

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Ocular Hypertension
  • 10.2. Travoprost intracameral implant (iDose TR): Glaukos
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views
  • 10.3. Omidenepag Isopropyl Ophthalmic Solution (OMLONTI): Santen/UBE Corporation
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of Ocular Hypertension
  • 11.2. NCX 470: Nicox Ophthalmics
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. PDP-716: Sun Pharma Advanced Research Company (SPARC) and Ocuvex Therapeutics
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
    • 11.3.4. Safety and Efficacy
    • 11.3.5. Analyst Views

12. Ocular Hypertension: Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Ocular Hypertension
  • 12.3. Conjoint Analysis of Ocular Hypertension
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Ocular Hypertension in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of Ocular Hypertension in the United States
    • 12.6.2. Market Size of Ocular Hypertension by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of Ocular Hypertension in EU4 and the UK
    • 12.7.2. Market Size of Ocular Hypertension by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of Ocular Hypertension in Japan
    • 12.8.2. Market Size of Ocular Hypertension by Therapies in Japan

13. Unmet Needs of Ocular Hypertension

14. SWOT Analysis of Ocular Hypertension

15. KOL Views of Ocular Hypertension

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of Ocular Hypertension

  • 16.1. The United States
  • 16.2. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Ocular Hypertension Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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