持続性上皮欠損治療の世界市場 - 2023年～2030年

概要

世界の持続性上皮欠損治療市場は、そのダイナミクスに影響を与える様々な要因によって、長年にわたって大きな成長と変貌を遂げてきました。日常的な支持療法を用いても、角膜損傷後10～14日の間に速やかに再上皮化および閉鎖が行われない場合、持続性上皮欠損（PEDまたはPCED）が生じます。

このような症例はまれであるが、支持療法に抵抗することが多いため、管理上の課題となっています。感染、角膜瘢痕化、視力低下、融解、場合によっては穿孔などの潜在的な副作用を防ぐために、持続性上皮異常には早急かつ注意深い治療が必要です。

特に新興経済諸国における政府投資と研究開発は、神経栄養性角膜炎に対する先端技術の利用を引き続き促進し、世界の持続性上皮異常治療市場を押し上げると思われます。

市場力学：市場促進要因と市場抑制要因

共同研究やライセンス契約の増加

新興経済諸国は、高額の投資、所得水準、インフラ整備に牽引され、ヘルスケア分野の改善において急速な成長を遂げています。いくつかの国では、研究の高まりに起因する持続性上皮欠損治療に対する大きな需要が発生しています。様々な国間での共同研究、買収、技術進歩に伴うライセンス契約は、市場の成長を促進する重要な要因です。

2023年7月19日、参天製薬株式会社、本社：東京都千代田区、代表取締役社長：小林健、以下「参天製薬」。2023年7月19日、参天製薬株式会社はアメリカの2社と資産譲渡およびライセンス契約を締結しました。参天製薬とVisiox Pharmaceuticals, Inc.は、OMLONTIの生産、マーケティング、販売に関する権利についてライセンシング契約を締結しました。この契約により、参天製薬はNatacyn（結膜炎、真菌性眼瞼炎、角膜炎の点眼薬）、Flarex、ZERVIATE、TobraDex ST、FRESHKOTEをHarrow Health社に販売・譲渡し、Harrow Health社には米国とカナダにおける独占的製造・販売権を付与します。

さらに、2023年4月28日、カリフォルニア再生医療研究所（CIRM）は、Kalaの完全子会社であるCombangio, Inc.に、進行中の持続性角膜上皮欠損症（PCED）治療プログラムKPI-012の資金援助として1,500万米ドルの助成金を交付しました。カラ・ファーマシューティカルズ社は、臨床段階にあるバイオ医薬品会社で、眼の希少かつ重篤な疾患に対する革新的な治療法の発見、開発、市場開拓に取り組んでいます。

さらに、治療目的での新薬やソリューションの利用が増加しています。持続性上皮欠損治療市場の成長を促進する主な要因は、革新的な製品開発のための研究とともに、上皮欠損の増加と外科手術の増加です。

人工涙液や無菌眼軟膏に伴う合併症

治療のための従来の医療アプローチは、防腐剤を含まない人工涙液や無菌眼軟膏を用いた強制的な潤滑から始まる。これらは、上皮がその典型的な構造と機能を回復できるような状況を与えます。上皮の再形成を妨げたり、先延ばしにしたりする可能性のある薬剤の併用はすべて中止しなければならないです。

細菌や真菌の汚染を防ぐために、多くの市販人工涙液には防腐剤が含まれており、最も多いのは塩化ベンザルコニウムです。これらの防腐剤は目にしみるだけでなく、常用すると目の上皮を傷つけ、眼毒性を誘発することが示されています。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 共同研究やライセンス契約の増加
    • 技術的進歩と開発の高まり
  • 抑制要因
    • 人工涙液や無菌眼軟膏に伴う合併症
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• SWOT分析
• 特許分析
• ロシア・ウクライナ戦争の影響分析
• DMI意見

第6章 COVID-19分析

第7章 疾患タイプ別

• 四肢幹細胞欠損症
• 神経栄養性角膜炎
• 炎症性疾患
• 上皮接着不全
• その他

第8章 治療薬別

• 点眼剤
  • 遺伝子組換えヒトNGF点眼液
  • 血清由来点眼液
• 幹細胞治療
• 羊膜移植

第9章 エンドユーザー別

• 病院
• 外来手術センター
• 専門クリニック

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他の欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他の南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他のアジア太平洋
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• Dompe
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Santen Pharmaceutical Co., Ltd.
• Noveome Biotherapeutics, Inc.
• Recordati Rare Diseases
• Kala Pharmaceuticals
• Corza Ophthalmology
• Amber Ophthalmics
• Kiora Pharmaceuticals, Inc.
• MimeTech Srl
• Cordlife

第13章 付録

Overview

The global persistent epithelial defect treatment market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. The failure of fast re-epithelialization and closure between 10-14 days of a corneal injury, even when using routine supportive therapy, results in persistent epithelial defects (PEDs or PCEDs).

Although they are uncommon, they present a management challenge since they frequently resist supportive care. To prevent potential side effects like infection, corneal scarring, vision loss, melting, and possibly perforation, persistent epithelial abnormalities require immediate and watchful treatment.

Government investments and research, particularly in developing economies, will continue to drive utilization of advanced technology for neurotrophic keratitis and boost the global persistent epithelial defect treatment market.

Market Dynamics: Drivers & Restraints

Growing collaborations and license agreements

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high investments, income levels, and infrastructure development. Several countries have experienced substantial demand for persistent epithelial defect treatment owing to the rising research. Various collaborations, acquisitions and license agreement with technological advancements among different countries will be a crucial factor driving the growth of the market.

On July 19, 2023, Santen Pharmaceutical Co., Ltd. Had executed asset transfer and license agreements with two American businesses. Santen and Visiox Pharmaceuticals, Inc. have reached an out-licensing agreement regarding the rights to OMLONTI's production, marketing, and sales. In accordance with the terms of the contract, Santen is going to sell and transfer Natacyn (an eyedrop for conjunctivitis, fungal blepharitis, and keratitis), Flarex, ZERVIATE, TobraDex ST, and FRESHKOTE to Harrow Health while granting Harrow Health exclusive rights for the product's production and commercialization in the United States and Canada.

Additionally, on April 28, 2023, the California Institute for Regenerative Medicine (CIRM) granted Combangio, Inc., Kala's entirely owned subsidiary, a $15 million grant to help fund its in progress KPI-012 program to treat cases of persistent corneal epithelial defect (PCED). Kala Pharmaceuticals, Inc. is a biopharmaceutical company in the clinical stage dedicated to the discovery, development, and marketing of innovative treatments for rare and severe diseases of the eye.

Furthermore, the rising utilization of novel medicines and solutions for treatment purposes. Rising epithelial defects and increasing surgical procedures along with research for innovative product development will be a major factor driving the growth of the Persistent Epithelial Defect Treatment market.

Complications associated with the artificial tears or sterile ocular ointments

The conventional medical approach for therapy starts with forceful lubrication using artificial tears without preservatives and sterile eye ointments. They give the epithelium a context in which it can recover its typical structure and function. All concurrent drugs that can obstruct or postpone re-epithelialization must be stopped.

To guard against bacterial and fungal contamination, many commercialized artificial tears include preservatives, most frequently benzalkonium chloride. These preservatives have been shown to sting the eyes as well as if used regularly, can harm the eye's epithelium and induce ocular toxicity.

Segment Analysis

The global persistent epithelial defect treatment market is segmented based on disease type, treatment, end user and region.

Ophthalmic solutions treatment segment accounted for approximately 67% of market share

The use of eye drops made from serum to treat PED is growing in popularity. In addition to lubricating the ocular surface, tears contain high concentrations of growth factors and cytokines that are typically found in natural tears, such as vitamin E, vitamin A, EGF, PDGF, TGF-, FGF, substance P, fibronectin, IGF, or NGF. These factors help epithelial cells proliferate and migrate.

NGF has emerged as the model protein for the group of proteins known as neurotrophins, which are involved in the growth and protection of neurons. Following secretion, the proenzyme, pro-NGF, is latent until it is activated by cleavage, at which point it can connect to cell-surface receptors. Numerous studies have indicated the promise of NGF as a treatment for many ocular surface diseases.

On January 9, 2023, positive topline outcomes from the second phase of the double-masked, randomized, vehicle-controlled clinical study (EXPEDE) assessing two topically administered amounts of NEXAGON (lufepirsen ophthalmic gel) for the management of persistent corneal epithelial defect (PCED), supplementary to chemical and/or therapy, were released by the privately owned biopharmaceutical company in clinical-stage, Amber Ophthalmics, Inc.

Geographical Penetration

North America accounted for around 38% of market share in 2022

Due to the rising need for persistent epithelial defect treatment in healthcare, manufacturers in North America have chances of increasing their operations. There are many producers and suppliers in North America and owing to the quick economic growth of the region, industrial production has expanded, driving the demand for persistent epithelial defect treatment.

Increasing expenditure on healthcare, advancement of technologies and different types of products for treatment, along with increase in biopharmaceutical or biotechnology business establishment across the region are also contributing to the growth of persistent epithelial defect treatment market share of this region. The market in this area is growing as people become more aware of various novel innovative systems. The aforementioned elements attest to North America's hegemonic position in the world.

North America continues to be a key player in the global persistent epithelial defect treatment market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising advancements have fueled the demand for persistent epithelial defect treatment in the United States have been proactive in executing several initiatives or surgical procedures, stimulating persistent epithelial defect medications demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global persistent epithelial defect treatment market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the pharmaceutical sector, with a significant consumer of various treatments, was significantly impacted. The widespread lockdowns and restrictions imposed by the pandemic, which began in early 2020, had an effect on a number of initiatives all around the world.

Major medical and biotechnology industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for persistent epithelial defect treatment. Now several research studies have been initiated and companies have again started trial for their products efficiency. Overall, the impact of the pandemic on the global persistent epithelial defect treatment market is expected to be relatively moderate, with the market continuing to grow steadily due to the ongoing need and research for innovative products, like ophthalmic solutions.

Key Developments

• On April 12, 2023, the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation for KPI-012, human mesenchymal stem cell secretome (MSC-S) therapy by Kala for the management of persistent corneal epithelial defect (PCED), an uncommon and crippling ocular condition. Kala Pharmaceuticals, Inc., a biopharmaceutical company in the clinical stage, committed to the discovery, development, and marketing of novel therapies for rare and serious conditions of the eye.
• On January 3, 2023, the safety and effectiveness of RGN-259 eyedrops in a clinical study in phase 3 in patients having Neurotrophic Keratopathy (NK) are described in a new scientific publication released by RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug manufacturer with a focus on tissue repair, protection, and regeneration. ReGenTree, LLC, a United States-based joint venture between HLB Therapeutics and RegeneRx Biopharmaceuticals, is developing the product candidate. The effectiveness and safety of RGN-259 in accelerating the recovery of persistent epithelial defects among patients having Stage 2 and Stage 3 NK were determined by the study.
• On July 18, 2022, a worldwide ophthalmology contract research company (CRO) and HLB Therapeutics (HLBT), the U.S. joint venture (JV) partner and licensee of RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company specializing in tissue repair, protection, and regeneration, have signed an agreement of intent to execute two phase 3 clinical trials concurrently for patients having neurotrophic keratitis (NK) starting in the U.S. and Europe.

Competitive Landscape

The major global players in the market include: Dompe, Santen Pharmaceutical Co., Ltd., Noveome Biotherapeutics, Inc., Recordati Rare Diseases, Kala Pharmaceuticals, Corza Ophthalmology, Amber Ophthalmics, Kiora Pharmaceuticals, Inc., MimeTech Srl and Cordlife.

Why Purchase the Report?

• To visualize the global persistent epithelial defect treatment market segmentation based on disease type, treatment, end user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of persistent epithelial defect treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global persistent epithelial defect treatment market report would provide approximately 61 tables, 59 figures and 186 Pages.

Target Audience 2023

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

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Disease Type
• 3.2. Snippet by Treatment
• 3.3. Snippet by End User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Growing collaborations and license agreements
    • 4.1.1.2. Rising technological advancements and developments
  • 4.1.2. Restraints
    • 4.1.2.1. Complications associated with the artificial tears or sterile ocular ointments
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. SWOT Analysis
• 5.6. Patent Analysis
• 5.7. Russia-Ukraine War Impact Analysis
• 5.8. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Disease Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 7.1.2. Market Attractiveness Index, By Disease Type
• 7.2. Limbal Stem Cell Deficiency*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Neurotrophic Keratitis
• 7.4. Inflammatory Disease
• 7.5. Defective Epithelial Adhesion
• 7.6. Others

8. By Treatment

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 8.1.2. Market Attractiveness Index, By Treatment
• 8.2. Ophthalmic Solution*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.2.3. Recombinant Human NGF Eye Drops
  • 8.2.4. Serum-Derived Eye Drops
• 8.3. Stem Cell Therapy
• 8.4. Amniotic Membrane Transplant

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Ambulatory Surgical Centers
• 9.4. Specialty Clinics

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Dompe*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Santen Pharmaceutical Co., Ltd.
• 12.3. Noveome Biotherapeutics, Inc.
• 12.4. Recordati Rare Diseases
• 12.5. Kala Pharmaceuticals
• 12.6. Corza Ophthalmology
• 12.7. Amber Ophthalmics
• 12.8. Kiora Pharmaceuticals, Inc.
• 12.9. MimeTech Srl
• 12.10. Cordlife

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us