Leber's Hereditary Optic Neuropathy Market

• Increase in Leber's Hereditary Optic Neuropathy (LHON) market size anticipated for the study period, 2023–2032
• Leading LHON Companies working in the market are GenSight, Stealth Biotherapeutics and others.
• Some late stage products are under development to cater the unmet needs in Leber's Hereditary Optic Neuropathy (LHON) treatment scenario. Among them, GS010 by GenSight anticipates commercial launch, follow approval by the end of 2023, according to the company.

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DelveInsight's "Leber's Hereditary Optic Neuropathy (LHON) Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Leber's Hereditary Optic Neuropathy (LHON), historical and forecasted epidemiology as well as the Leber's Hereditary Optic Neuropathy (LHON) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Leber's Hereditary Optic Neuropathy (LHON) market report provides current treatment practices, emerging drugs, Leber's Hereditary Optic Neuropathy (LHON) market share of the individual therapies, current and forecasted Leber's Hereditary Optic Neuropathy (LHON) market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current Leber's Hereditary Optic Neuropathy (LHON) treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the Leber's Hereditary Optic Neuropathy (LHON) market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Leber's Hereditary Optic Neuropathy (LHON) Disease Understanding and Treatment Algorithm

Leber’s hereditary optic neuropathy (LHON) is a specific form of "inherited optic atrophies" or "hereditary optic neuropathies." It is characterized by dysfunction of the optic nerve due to specific mutations in the mitochondrial DNA and is inherited in a non-Mendelian manner.

LHON typically presents as painless, gradual loss of central vision in young adults, affecting both eyes, with one eye being affected first followed by the other a few weeks later. In some extremely rare cases, there may be additional neurological issues such as peripheral neuropathy, postural tremor, nonspecific myopathy, and movement disorders. The condition is caused by mutations in mitochondrial DNA and is strictly passed down through maternal inheritance.

Diagnosis of LHON is based on ophthalmologic examinations, including specialized visual tests such as dilated fundus examination to detect characteristic changes in the optic disc and vascular alterations during the acute phase, visual fields assessment, electrophysiologic studies, and imaging, particularly OCT. Molecular genetic testing of mitochondrial genes associated with LHON can be used to confirm the diagnosis.

Treatment for LHON mainly involves supportive management and the use of visual aids, occupational rehabilitation, and local social services. Individuals affected by LHON should avoid smoking and excessive alcohol consumption, as these habits produce reactive oxygen species (ROS) that impair mitochondria function.

Currently, Raxone (idebenone) is the only authorized medicinal product for treating LHON within the European Union. Other potential treatment options include Brimonidine, nutritional supplements, and ubiquinone analogs. Additionally, alternative therapies such as steroids and immunosuppressants like cyclosporine A are being explored for LHON treatment. Gene therapy holds significant promise as a potential means of treating LHON.

The Leber’s hereditary optic neuropathy market is expected to witness changes in the near future due to the anticipated launch of emerging therapies between 2019 and 2032, including GS010 by GenSight and Elamipretide by Stealth Biotherapeutics. These advancements in treatment options may bring new hope for individuals affected by LHON.

Leber's Hereditary Optic Neuropathy (LHON) Diagnosis

This segment of the report covers the detailed diagnostic methods or tests for Leber's Hereditary Optic Neuropathy (LHON).

Leber's Hereditary Optic Neuropathy (LHON) Treatment

It covers the details of conventional and current medical therapies available in the Leber's Hereditary Optic Neuropathy (LHON) market for the treatment of the condition. It also provides Leber's Hereditary Optic Neuropathy (LHON) treatment algorithms and guidelines in the United States, Europe, and Japan.

Leber's Hereditary Optic Neuropathy (LHON) Epidemiology

The Leber's Hereditary Optic Neuropathy (LHON) epidemiology section provides insights about the historical and current Leber's Hereditary Optic Neuropathy (LHON) patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Leber's Hereditary Optic Neuropathy (LHON) market report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted Leber's Hereditary Optic Neuropathy (LHON) epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2019 to 2032.

• According to Shemesh et. al. (2022), Leber’s hereditary optic neuropathy (LHON) is estimated to be the most frequent mitochondrial disease with a prevalence ranging from 1 in 27,000 in North East England to 1 in 45,000 in a meta-analysis of reports in the European population. It has a strong male preponderance (80% to 90%), and the usual age at onset is between 15 to 35 years.
• As per the NORD (2019), the prevalence of visual loss from LHON is approximately 1:50,000 people. Many carriers never suffer significant visual loss; males are about four to five times more likely than females to lose vision and be affected.
• As per Man et. al. (2016), LHON is characterized by a marked gender bias, with males more likely to become affected than females.
• According to a national epidemiological survey on LHON conducted by Takano et. al. (2022) in Japan, the number of newly diagnosed patients with LHON in 2019 was estimated to be 69, and the total number of LHON patients in Japan was estimated to be 2400, with a prevalence similar to other countries.

Country Wise- Leber's Hereditary Optic Neuropathy (LHON) Epidemiology

The epidemiology segment also provides the Leber's Hereditary Optic Neuropathy (LHON) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Leber's Hereditary Optic Neuropathy (LHON) Drug Chapters

The drug chapter segment of the Leber's Hereditary Optic Neuropathy (LHON) report encloses the detailed analysis of Leber's Hereditary Optic Neuropathy (LHON) marketed drugs and late-stage (Phase-III and Phase-II) Leber's Hereditary Optic Neuropathy (LHON) pipeline drugs. It also helps to understand the Leber's Hereditary Optic Neuropathy (LHON) 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.

Leber's Hereditary Optic Neuropathy (LHON) Marketed Drugs

The report provides the details of the marketed products/off-label treatments available for Leber's Hereditary Optic Neuropathy (LHON) treatment.

Leber's Hereditary Optic Neuropathy (LHON) Emerging Drugs

The report provides the details of the emerging therapies under the late and mid-stage of development for Leber's Hereditary Optic Neuropathy (LHON) treatment.

GS010 (lenadogene nolparvovec): GenSight

GS010 is a gene therapy-based treatment administered through a single injection into the eye, specifically targeting LHON. This therapy utilizes GenSight's proprietary Mitochondrial Targeting Sequence (MTS) technology platform, which facilitates the transportation of missing mitochondrial proteins into the mitochondrion, ultimately leading to the restoration of mitochondrial function.

GenSight has conducted two phase III studies, known as RESCUE and REVERSE, in different regions of the United States and Europe for treating LHON. Additionally, they are currently conducting a long-term follow-up study called RESCUE/REVERSE. In May 2019, the company reported encouraging data from the 96-week assessment of the REVERSE Phase III clinical trial for GS010's efficacy in LHON treatment.

Furthermore, GS010 has been granted Orphan Drug Designation in both the United States and Europe, which recognizes its potential to address a rare medical condition. As of now, the European Marketing Authorization Application for GS010 is under review, and a final recommendation is not anticipated until the third quarter of 2023.

Elamipretide: Stealth Biotherapeutics

Elamipretide, developed by Stealth Biotherapeutics, is a peptide compound with the unique ability to easily enter cell membranes and specifically target the inner mitochondrial membrane. Once inside the mitochondria, it forms a reversible bond with cardiolipin. This association between elamipretide and cardiolipin has been demonstrated to restore the normal structure of the inner mitochondrial membrane, leading to an improvement in mitochondrial function.

Stealth Biotherapeutics has successfully completed phase II clinical trials for the use of elamipretide in treating Leber's hereditary optic neuropathy. Additionally, the company is actively conducting clinical trials to explore its potential in other medical conditions, including primary mitochondrial myopathy, Barth syndrome, and various other indications.

In recognition of its potential as an innovative treatment, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to elamipretide in 2018 specifically for the treatment of Leber's hereditary optic neuropathy. This designation highlights the drug's importance in addressing a rare medical condition and provides incentives to support its development and availability for patients in need.

Leber's Hereditary Optic Neuropathy (LHON) Market Outlook

The Leber's Hereditary Optic Neuropathy (LHON) market outlook of the report helps to build a detailed comprehension of the historic, current, and forecasted Leber's Hereditary Optic Neuropathy (LHON) market trends by analyzing the impact of current Leber's Hereditary Optic Neuropathy (LHON) therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Leber's Hereditary Optic Neuropathy (LHON) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Leber's Hereditary Optic Neuropathy (LHON) market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Leber's Hereditary Optic Neuropathy (LHON) market in 7MM is expected to witness a major change in the study period 2019-2032.

Key Findings

This section includes a glimpse of the Leber's Hereditary Optic Neuropathy (LHON) market in 7MM.

The United States: Leber’s hereditary optic neuropathy Market Outlook

This section provides the total Leber's Hereditary Optic Neuropathy (LHON) market size and market size by therapies in the United States.

EU-5 Countries: Leber’s hereditary optic neuropathy Market Outlook

The total Leber's Hereditary Optic Neuropathy (LHON) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom is provided in this section.

Japan: Leber’s hereditary optic neuropathy Market Outlook

The total Leber's Hereditary Optic Neuropathy (LHON) market size and market size by therapies in Japan is also mentioned.

Leber's Hereditary Optic Neuropathy (LHON) Drugs Uptake

This section focuses on the rate of uptake of the potential Leber's Hereditary Optic Neuropathy (LHON) drugs recently launched in the Leber's Hereditary Optic Neuropathy (LHON) market or expected to get launched in the market during the study period 2019-2032. The analysis covers Leber's Hereditary Optic Neuropathy (LHON) market uptake by drugs; patient uptake by therapies; and sales of each drug.

Leber's Hereditary Optic Neuropathy (LHON) Drugs Uptake helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of Leber's Hereditary Optic Neuropathy (LHON) market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Leber's Hereditary Optic Neuropathy (LHON) Pipeline Development Activities

The Leber's Hereditary Optic Neuropathy (LHON) report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Leber's Hereditary Optic Neuropathy (LHON) key players involved in developing targeted therapeutics.

Pipeline Development Activities

The Leber's Hereditary Optic Neuropathy (LHON) report covers the detailed information of collaborations, acquisition, and merger, licensing, patent details, and other information for Leber's Hereditary Optic Neuropathy (LHON) emerging therapies.

Reimbursement Scenario in Leber's Hereditary Optic Neuropathy (LHON)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current Leber's Hereditary Optic Neuropathy (LHON) market trends, we take KOLs and SMEs ' opinion working in the Leber's Hereditary Optic Neuropathy (LHON) domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Leber's Hereditary Optic Neuropathy (LHON) market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Leber's Hereditary Optic Neuropathy (LHON) Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Leber’s hereditary optic neuropathy Report

• The report covers the descriptive overview of Leber's Hereditary Optic Neuropathy (LHON), explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
• Comprehensive insight has been provided into the Leber's Hereditary Optic Neuropathy (LHON) epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Leber's Hereditary Optic Neuropathy (LHON) is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the Leber's Hereditary Optic Neuropathy (LHON) market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Leber's Hereditary Optic Neuropathy (LHON) market

Leber’s hereditary optic neuropathy Report Highlights

• In the coming years, the Leber's Hereditary Optic Neuropathy (LHON) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Leber's Hereditary Optic Neuropathy (LHON) R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing therapies for Leber's Hereditary Optic Neuropathy (LHON). The launch of emerging therapies will significantly impact the Leber's Hereditary Optic Neuropathy (LHON) market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Leber's Hereditary Optic Neuropathy (LHON)
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Leber's Hereditary Optic Neuropathy (LHON) Report Insights

• Leber's Hereditary Optic Neuropathy (LHON) Patient Population
• Therapeutic Approaches
• Leber's Hereditary Optic Neuropathy (LHON) Pipeline Analysis
• Leber's Hereditary Optic Neuropathy (LHON) Market Size and Trends
• Leber's Hereditary Optic Neuropathy (LHON) Market Opportunities
• Impact of upcoming Leber's Hereditary Optic Neuropathy (LHON) Therapies

Leber's Hereditary Optic Neuropathy (LHON) Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Leber's Hereditary Optic Neuropathy (LHON) Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Leber’s hereditary optic neuropathy Market
• Leber’s hereditary optic neuropathy Drugs Uptake

Leber's Hereditary Optic Neuropathy (LHON) Market Report Assessment

• Current Treatment Practices
• Leber’s hereditary optic neuropathy Unmet Needs
• Leber's Hereditary Optic Neuropathy (LHON) Pipeline Product Profiles
• Leber's Hereditary Optic Neuropathy (LHON) Market Attractiveness
• Leber’s hereditary optic neuropathy Market Drivers
• Leber’s hereditary optic neuropathy Market Barriers

Key Questions

Leber’s hereditary optic neuropathy Market Insights:

• What was the Leber's Hereditary Optic Neuropathy (LHON) drug class share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Leber's Hereditary Optic Neuropathy (LHON) total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings pertaining to the market across 7MM and which country will have the largest Leber's Hereditary Optic Neuropathy (LHON) market size during the forecast period (2019-2032)?
• At what CAGR, the Leber's Hereditary Optic Neuropathy (LHON) market is expected to grow by 7MM during the forecast period (2019-2032)?
• What would be the Leber's Hereditary Optic Neuropathy (LHON) market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the Leber's Hereditary Optic Neuropathy (LHON) market growth till 2032, and what will be the resultant market Size in the year 2032?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Leber’s hereditary optic neuropathy Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of the Leber's Hereditary Optic Neuropathy (LHON)?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What is the historical Leber's Hereditary Optic Neuropathy (LHON) patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of Leber's Hereditary Optic Neuropathy (LHON) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to Leber's Hereditary Optic Neuropathy (LHON)?
• Out of all 7MM countries, which country would have the highest prevalent population of Leber's Hereditary Optic Neuropathy (LHON) during the forecast period (2019-2032)?
• At what CAGR the patient population is expected to grow in 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the Leber's Hereditary Optic Neuropathy (LHON) treatment in addition to the approved therapies?
• What are the current treatment guidelines for the treatment of Leber's Hereditary Optic Neuropathy (LHON) in the USA, Europe, and Japan?
• What are the Leber's Hereditary Optic Neuropathy (LHON) marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Leber's Hereditary Optic Neuropathy (LHON)?
• How many therapies are in-development by each company for Leber's Hereditary Optic Neuropathy (LHON) treatment?
• How many are emerging therapies in mid-stage, and late stage of development for Leber's Hereditary Optic Neuropathy (LHON) treatment?
• What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Leber's Hereditary Optic Neuropathy (LHON) therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies being developed to overcome the limitation of existing Leber’s hereditary optic neuropathy therapies?
• What are the ongoing Leber’s hereditary optic neuropathy clinical trials for Leber's Hereditary Optic Neuropathy (LHON) and their status?
• What are the current challenges faced in Leber’s hereditary optic neuropathy drug development?
• What are the key designations that have been granted for the emerging therapies for Leber's Hereditary Optic Neuropathy (LHON)?
• What are the global historical and forecasted Leber’s hereditary optic neuropathy market ?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Leber's Hereditary Optic Neuropathy (LHON) market
• To understand the future market competition in the Leber's Hereditary Optic Neuropathy (LHON) market and Insightful review of the key market drivers and barriers
• Organize sales and marketing efforts by identifying the best opportunities for Leber's Hereditary Optic Neuropathy (LHON) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for Leber's Hereditary Optic Neuropathy (LHON) market
• To understand the future market competition in the Leber's Hereditary Optic Neuropathy (LHON) market