주요 7개국의 포도막염 시장 규모는 2022년 약 14억 6,866만 달러로, 예측 기간(2023-2034년) 동안 질환에 대한 인식 개선과 새로운 치료법 출시로 인해 확대될 것으로 예상됩니다.
7개 주요 국가 중 포도막염 시장 점유율이 가장 높은 국가는 미국으로 2022년 매출액이 7억 5,903만 달러, 일본, 독일, 기타 국가 순으로 나타났으며, EU 4개국과 영국 중에서는 독일이 2022년 약 1억 1,573만 달러로 가장 큰 시장 규모를 차지했고, 스페인이 약 9,049만 달러로 가장 낮았습니다. 일본은 2022년 약 1억 9,662만 달러로 주요 7개국 중 두 번째로 큰 시장 규모를 차지했으며, 예측 기간(2023-2034년) 동안 증가세를 보일 것으로 예상됩니다.
2022년 포도막염 시장 규모는 미국이 주요 7개국 중 가장 큰 시장으로 약 7억 5,903만 달러에 달하며, 2034년까지 확대될 것으로 예상됩니다.
포도막염은 시력을 위협하는 염증성 질환으로 안구 중간층인 포도막에 영향을 미치는 질환입니다. 이 염증은 일반적으로 홍채, 맥락막, 섬모체, 공막, 각막, 유리체, 망막, 시신경 머리 등 주변 구조물에 영향을 미치는 감염과 면역 체계의 싸움으로 인해 발생합니다.
포도막염의 흔한 증상으로는 충혈, 통증과 함께 흐릿한 눈, 빛에 대한 과민반응, 시야가 떠다니는 증상, 안구 하부의 백반증 등이 있습니다. 한쪽 눈 또는 양쪽 눈이 감염될 수 있습니다. 포도막염의 병태생리는 잘 알려져 있지 않지만, 안구의 외상이 세포의 손상과 사멸을 유발하고 염증성 사이토카인이 분비되어 외상 후 포도막염을 유발한다는 가설이 있습니다.
포도막염의 치료는 염증을 억제하여 눈의 통증과 불편함을 완화하고 영구적인 시력 저하 및 기타 합병증을 예방하는 것을 목표로 합니다. 포도막염 치료의 1차 목표는 가능한 한 빨리 염증을 없애는 것입니다. 현재 승인된 치료제로는 XIPERE, OZURDEX, HUMIRA, YUTIQ/ILUVIEN, RETISERT, DUREZOL 등이 있습니다.
이 보고서는 주요 7개국의 포도막염 시장을 조사하여 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 의료 미충족 수요 등을 제공합니다.
Key Highlights.
DelveInsight's "Uveitis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of uveitis, historical and forecasted epidemiology, as well as the uveitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The uveitis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM uveitis market size from 2020 to 2034. The report also covers current uveitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
Uveitis Overview
Uveitis is a sight-threatening inflammatory disease affecting the middle uveal layer of the eye. The inflammation usually happens when the immune system fights an infection affecting the uveal tract (composed of the iris, choroid, and ciliary body) and adjacent structures (including the sclera, cornea, vitreous humor, retina, and optic nerve head).
Some common symptoms associated with uveitis include blurry vision with redness and sensation of pain, developing sensitivity to light, floaters in vision, and the presence of a white spot on the lower part of the eye. An individual's one eye or both may be affected. The pathophysiology of uveitis is not well understood; groups have hypothesized that trauma to the eye can cause cell injury or death, leading to the release of inflammatory cytokines leading to post-traumatic uveitis.
Uveitis Diagnosis
Uveitis is diagnosed after a complete evaluation of the past medical, family, and ophthalmic history of the patient. A full review of systems may also help identify a systemic disease with ocular manifestations. A visual acuity test, an ocular pressure test, and a slit lamp exam are performed by an ophthalmologist. The diagnosis and management of uveitis can be tricky for multiple reasons.
Further details related to country-based variations are provided in the report...
Uveitis Treatment
Treatment for uveitis aims to help reduce inflammation and relieve pain and discomfort in the eye, which can prevent permanent loss of vision or other complications. The primary goal of treating uveitis is getting rid of inflammation as fast as possible. Currently approved options include XIPERE, OZURDEX, HUMIRA, YUTIQ/ILUVIEN, RETISERT, and DUREZOL.
As the market is derived using a patient-based model, the uveitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of uveitis, type-specific diagnosed prevalent cases of uveitis, diagnosed prevalent cases of uveitis by anatomical location, and etiology-specific diagnosed prevalent cases of uveitis, in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
According to DelveInsight estimates, in EU4 and the UK, based on anatomical location highest cases of uveitis were diagnosed in anterior uveitis, while intermediate uveitis has the least cases. In EU4 and the UK, anterior uveitis accounted for approximately 203,439, followed by 84,154 cases in posterior uveitis, 81,773 cases in pan uveitis, and 46,485 in intermediate uveitis in 2022, which are projected to increase during the forecast period.
The drug chapter segment of the uveitis report encloses a detailed analysis of uveitis-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the uveitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
XIPERE: Clearside Biomedical/Bausch+Lomb
XIPERE, a triamcinolone acetonide injectable suspension, is the first approved medicine delivery via injection for suprachoroidal use to treat macular edema associated with uveitis in the US. Delivering the medicine to the suprachoroidal space (SCS) allows targeted delivery of the therapy with low levels elsewhere in the eye.
In October 2021, the US FDA approved XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use to treat macular edema associated with uveitis, a form of eye inflammation.
The recommended dosage is 4 mg (0.1 mL), administered as a suprachoroidal injection. It is a 40 mg/mL suspension in a single-dose glass vial with the supplied SCS microinjector.
Furthermore, the American Medical Association has granted a new permanent Category 1 Current Procedural Terminology (CPT) code for Bausch & Lomb's XIPERE to help facilitate better access and adoption of the product.
Emerging Drugs
TRS01: Tarsier Pharma
TRS01, a lead product of Tarsier Pharmaceuticals, first in first-in-class topical immune modulator agent. Dazdotuftide (TRS) is a breakthrough platform technology for treating blinding ocular diseases. TRS was developed to 're-engineer' the immune system. The platform approaches inflammatory diseases from within the system. The technology can effectively treat various autoimmune and inflammatory ocular diseases. TRS01 is a polypeptide conjugate with a dual mechanism of action; the investigational agent induces anti-inflammatory macrophages and inhibits the nuclear factor-kB (Nf-kB) signaling pathway by toll-like receptor 4 (TLR4).
TRS01 has completed a Phase III trial, called TRS4Vision, in patients with active noninfectious anterior uveitis, including those with uveitis glaucoma. The trial met its secondary endpoint; however, it failed to meet the primary endpoint. Based on the safety and potency of the TRS01 and a positive Type C meeting with the US FDA, the company plans to initiate a second Phase III trial (Tarsier-04) for the treatment of noninfectious uveitis, including uveitic glaucoma with revised endpoints. Additionally, the company is developing TRS02 intravitreal injection for intermediate, posterior, or pan uveitis.
Drug Class Insights
A severe intraocular inflammatory condition of the uveal tract known as uveitis frequently results in vision loss, blindness, and reduced quality of life. With the disease having a variable presentation, diagnosis and management are difficult. Treatment aims at obtaining quiescence of the disease, either by treating the infectious agent or treating the immune condition.
The current promising pharmacological classes for uveitis treatment include corticosteroids, immunosuppressants, and biologics.
Topical steroids like prednisolone 1% or dexamethasone 0.1% for anterior uveitis, mydriatic and cycloplegic agents to prevent the formation of posterior synechiae and for relieving photophobia and pain secondary to ciliary spasm are recommended. Difluprednate is recommended when there is posterior inflammation or macular edema. Systemic corticosteroids are typically reserved for bilateral uveitis, systemic disease, or when topical/local therapies fail to control inflammation; oral prednisone is the most commonly used drug. When the inflammation is severe, involving all the uveal layers and eventually the optic nerve, IV corticosteroids are needed to achieve ocular remission. Several intravitreal steroid injections are utilized in the treatment of uveitis. The approved products include YUTIQ, OZURDEX, XIPERE, RETISERT, and TRIESENCE. However, long-term corticosteroid treatment can cause serious systemic and ocular side effects, such as hypertension, diabetes, cataracts, and glaucoma.
Alternatively, immunomodulatory drugs are given as steroid-sparing agents when quiescence is not obtained with corticosteroids or in case of reactivation or new complications onset. These have good clinical results for systemic and ocular inflammatory diseases. It includes the antimetabolites (methotrexate, azathioprine, and mycophenolate mofetil); the calcineurin inhibitors (cyclosporine, tacrolimus, and sirolimus); alkylating agents (cyclophosphamide and chlorambucil). Despite these promising clinical results, it is used off-label for treating NIU. Refractory and recurrent uveitis require a combination of IMT agents. IMT is continued for 2 years while the patient is in remission before considering tapering medication.
These biologic response modifiers represent the next medications in the stepladder approach to noninfectious uveitis. Biologic response modifiers that include the tumor necrosis factor (TNF)-a inhibitors infliximab, adalimumab, etanercept, golimumab, and certolizumab; lymphocyte inhibitors include daclizumab, rituximab, abatacept, and basiliximab; specific receptor antagonists includes anakinra, canakinumab, gevokizumab, tocilizumab, alemtuzumab, efalizumab, secukinumab, and ustekinumab; and interferon (INF) treatments. While anti-TNF-a is the most widely used for treating uveitis. These medications are chosen, by adding or switching, when other immunosuppressive agents are ineffective. TNF-a is an important cytokine involved in ocular inflammation and tissue damage. Anti-TNF-a is also recommended for children. Adalimumab is a fully human anti-TNF-a monoclonal antibody approved for treating several immune-mediated inflammatory diseases, including noninfectious intermediate, posterior, and panuveitis. The lone approved product in this category, enjoying a major market share of biologics, is AbbVie's HUMIRA.
Uveitis is a serious intraocular inflammatory disorder of the uveal tract, often associated with visual impairment, blindness, and decreased quality of life. It often affects patients in their most active and economically productive years. It is the leading cause of preventable blindness worldwide and is a critically underserved disease in terms of treatment.
With the disease having a variable presentation, diagnosis and management are difficult. A prompt diagnosis, with the correct diagnostic approach and assessment of appropriate treatment, is extremely important to reduce inflammation and attain complete remission, thereby mitigating or avoiding ocular complications, permanent cumulative damage, and long-term vision loss. Treatment aims at obtaining quiescence of the disease, either by treating the infectious agent or treating the immune condition.
The recommended treatment scenario starts with the least aggressive treatments to induce inflammation remission and progresses to more aggressive treatments and, eventually, inflammation remission. The choice of therapy (including the administration route) depends on the underlying diagnosis, the aggressiveness of the disease, laterality, and the presence of comorbid conditions. It is also essential to balance the ability of these drugs to induce disease remission against their potential side effects and toxicities. Corticosteroids, immunomodulators, and biologics are the various treatment options besides surgery.
The current market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. YUTIQ/ILUVIEN, HUMIRA, and XIPERE are the major drugs covered in the forecast model.
Key players including RG6179, TRS01, OCS-02, OCS-01, EYS606, and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of uveitis.
Continued in report...
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, vamikibart (RO720220/RG6179), a monoclonal antibody, is being developed for a target patient pool having uveitic macular edema and is projected to enter EU4 and the UK in, 2027, is predicted to have a slow-medium uptake during the forecast period.
Further detailed analysis of emerging therapies drug uptake in the report...
Uveitis Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for uveitis.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on uveitis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of California, University of Nebraska Medical Center Omaha, Johns Hopkins University School of Medicine, University Medical Center Schleswig Holstein, Sapienza University of Rome, and University of Tokyo School of Medicine were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or uveitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
According to our primary research analysis, several corticosteroids with different modes of action (topical, oral, or injections), some possessing more than one, are available in the market and prescribed as monotherapy or adjunctive therapy in different lines of treatment. Many cases can be successfully managed with prompt diagnosis and treatment, reducing vision loss and complications. However, some types of uveitis are chronic or recurrent, necessitating ongoing treatment and monitoring to preserve vision and avoid complications. As a result, each patient's treatment plan is tailored to their specific needs based on factors such as the type of uveitis, its frequency, etiology, and anatomical location, the person's age, and associated complications. For elderly patients, factors such as overall health, medication tolerance, and functional status are taken into account.
The current pipeline contains gene therapy, monoclonal antibodies, recombinant fusion proteins, and several small molecules that target different anti-inflammatory pathways in uveitis. The entry of these drugs will provide different options relating to patient-specific needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, 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. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple 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.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in uveitis trials, one of the most important primary outcome measures is the anterior chamber cell (ACC) grade.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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.
Market Access and Reimbursement
Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited impact on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.
In June 2022, the CMS issued a product-specific J-Code for XIPERE (triamcinolone acetonide) effective July 1, 2022. J-Codes are reimbursement codes used by commercial insurers and government payers to identify therapies administered by a healthcare professional incident to the office visit. Issuing the permanent J-Code helped facilitate access to XIPERE for Americans suffering from macular edema associated with uveitis and helped streamline the reimbursement process. It became commercially available in March 2022. The new J-Code is J3299.
Blue Cross and Blue Shield of Alabama provide coverage for XIPERE (triamcinolone acetonide injectable suspension). The coverage is provided for 12 weeks and may be renewed.
In October 2018, the US FDA approved YUTIQ (fluocinolone acetonide intravitreal implant) to treat chronic noninfectious uveitis affecting the posterior segment of the eye. In July 2019, the CMS had assigned a specific and permanent reimbursement J-code, J7314, through the Healthcare Common Procedure Coding System (HCPCS) for YUTIQ, 0.18 mg 3-year micro-insert for chronic, noninfectious uveitis affecting the posterior segment of the eye. Furthermore, the code J7314 became effective in October 2019.
Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low-income, uninsured, and underinsured people who meet specific guidelines. Eligibility requirements vary for each program.
The YUTIQ developing company EyePoint Pharmaceuticals, Inc. provides EyePoint Assist HCP Portal that allows patients to conduct a benefits investigation, confirm insurance eligibility, and gain access to financial and reimbursement support.
OZURDEX is an intravitreal implant of 0.7 mg dexamethasone approved in the US in September 2010 for treating noninfectious uveitis affecting the posterior segment of the eye. Recognizing that reimbursement is a significant patient consideration, Allergan EyeCueSM provides a convenient and efficient way to help manage OZURDEX reimbursement processes. Through the OZURDEX saving program, eligible commercially insured patients may pay as little as USD 0 for OZURDEX.
An intravitreal implant RETISERT, for treating chronic noninfectious uveitis affecting the posterior segment, has a Medicare payment rate of almost USD 20,000 when used in a hospital outpatient setting, according to a press release from Bausch + Lomb. RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg was launched in the US in June, following approval by the FDA in April. The Centers for Medicare & Medicaid Services has designated the single-indication orphan drug eligible for Medicare pass-through payment under the hospital outpatient prospective payment system.
The European Union (EU) is the most biosimilar-friendly market, along with the European Economic Area countries (Iceland, Liechtenstein, and Norway), with the US vamping up its policies to align itself with its Trans-Atlantic neighbor. Biosimilar competition in Europe has brought about discounts to AbbVie's blockbuster immunosuppressant drug HUMIRA upwards of 80% during tendering. Overall, biosimilar uptake has increased in Europe because biologic "copycats" are cheaper, but full faith in these products is still required from physicians and patients.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Further details will be provided in the report.
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies