“Delveinsight Business Research LLP”
As per DelveInsight, the Fabry Disease Market is anticipated to evolve immensely in the coming years owing to the rise in the number of cases of Fabry Disease and the launch of new therapies in the market.
DelveInsight’s “Fabry Disease Market Insights, Epidemiology, and Market Forecast 2032” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Fabry Disease market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
The report covers emerging Fabry Disease drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2019 to 2032. It also evaluates the current Fabry Disease treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Fabry Disease: An Overview
Fabry Disease is an inherited lysosomal storage disease caused by a nonfunctional or partially functional enzyme, alpha-galactosidase A (α-Gal A). Decreased activity of α-Gal A in lysosomes results in the accumulation of enzyme substrates (Gb3 and lyso-Gb3) which cause cellular damage in tissues throughout the body. Symptoms include pain that spreads through the body (called a Fabry crisis), gastrointestinal complications, headaches, impaired sweating, vertigo, and hearing impairment.
It was once thought that Fabry Disease only affected males; females were thought of as only “carriers.” However, it is now known that both men and women can get Fabry Disease, though it may manifest differently depending on gender. Despite being X-linked, heterozygous women may experience all the signs and symptoms of Fabry Disease that are seen in men; however, compared with hemizygous males, signs and symptoms of Fabry Disease in women typically emerge at an older age and with less severity.
Enzyme replacement therapy (ERT) with agalsidase alfa (Replagal) or agalsidase beta (Fabrazyme) has been the standard of care since 2001. Fabrazyme is the only enzyme replacement medication for Fabry Disease that has been approved by the US FDA and has long-term efficacy and safety data. It received accelerated approval from the FDA in 2003, and the federal agency converted its authorization to full, regular approval 18 years later.
Amicus Therapeutics’s Galafold approval in 2018 has been the most recent entrant in the Fabry Disease market in the last 15 years. The therapy gained significant market share from the existing treatments as it alleviated the current unmet needs. As per NICE, it represents better value for money and may also provide more clinical benefits. Galafold, however, is only eligible for patients with amenable mutations (35–50% of the overall Fabry Disease population); therefore, one-size-fits-all treatment does not hold for Fabry Disease.
Fabry Disease Market Key Facts
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The total Fabry Disease market size in the 7MM is approximately USD 1,306 million in 2022 and is projected to increase during the forecast period (2023-2032)
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Among EU countries, the UK and Italy account for the maximum market size of USD 158, and USD 150 million in 2022 while Spain occupies the bottom of the ladder in the same year with USD 44 million.
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Japan accounts for a market size of USD 125 million in 2022, but these dynamics are expected to change in the forecast period.
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There were 15,200+ diagnosed prevalent cases of Fabry Disease estimated to have occurred in the 7MM in 2022 of which 8,300+ of the accounted cases were estimated to be from the US alone and these cases are anticipated to increase during the forecast period.
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The diagnosed prevalent cases of Fabry Disease were further divided into Phenotype-specific cases. The Phenotype-specific diagnosed prevalent cases of Fabry Disease are categorized into Classic and Late-onset with 6,900+, and 8,300+ cases respectively in the 7MM in 2022 which will further increase in 2032.
Fabry Disease Market
The market outlook section of the report helps to build a detailed comprehension of the historical, current, and forecasted market size by analyzing the impact of current and emerging Fabry Disease pipeline therapies. It also thoroughly assesses the Fabry Disease market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.
The report gives complete details of the market trend for each marketed Fabry Disease drug and mid & late-stage pipeline therapies by evaluating their impact based on the annual cost of therapy, their Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competition with other therapies, brand value, and their impact on the market.
Fabry Disease Epidemiology Assessment
The epidemiology section provides insights into the historical, current, and forecasted Fabry Disease epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted Fabry Disease epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pools, future trends, and views of key opinion leaders.
The Report Covers the Fabry Disease Epidemiology, Segmented as –
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Prevalent Cases of Fabry Disease in the 7MM [2019–2032]
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Age-specific Cases of Fabry Disease in the 7MM [2019–2032]
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Gender-specific Cases of Fabry Disease in the 7MM [2019–2032]
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Diagnosed Cases of Fabry Disease in the 7MM [2019–2032]
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Phenotype-specific cases of Fabry Disease in the 7MM [2019–2032
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Treated Cases of Fabry Disease in the 7MM [2019–2032]
Fabry Disease Drugs Uptake and Pipeline Development Activities
The drug uptake section focuses on the uptake rate of potential drugs recently launched in the Fabry Disease market or expected to be launched during the study period. The analysis covers the Fabry Disease market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the market dynamics by drug sales, the most rapid drug uptake, and the reasons behind the maximal use of particular drugs. Additionally, it compares the Fabry Disease drugs based on their sale and market share.
The report also covers the Fabry Disease pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key Fabry Disease companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
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Fabry Disease Therapeutics Analysis
Treatment of Fabry Disease consists of enzyme replacement therapy (ERT), oral chaperone therapy, and adjunctive treatment, including ACE inhibitors or angiotensin receptor blockers, antiplatelet drugs, and analgesics. Studies have shown that ERT can delay, but not always prevent, some of the clinical complications of Fabry Disease. Currently, the effective management of Fabry Disease requires a multidisciplinary approach with comprehensive therapy of intravenously administered ERT or chaperone therapy and adjunct therapies, including lifestyle modifications and
prophylactic medications.
Currently, there are only two therapies approved for treating patients with Fabry Disease in the US: Galafold (Amicus Therapeutics) and Fabrazyme (Sanofi-Genzyme). In Europe and Japan, Replagal (Takeda/Shire), Fabrazyme (Sanofi-Genzyme), and Galafold (Amicus Therapeutics) are currently the only approved therapies for Fabry Disease patients.
To improve the treatment scenario, several companies are working aggressively to develop new therapies with a novel mechanisms of action. Emerging therapies such as pegunigalsidase alfa (Protalix Biotherapeutics), Venglustat (Sanofi Genzyme), lucerastat (Idorsia Pharmaceuticals), ST-920 (Sangamo Therapeutics), 4D-310 (4D Molecular Therapeutics), and FLT190 (Freeline Therapeutics) are expected to enter the Fabry Disease market by 2032.
Fabry Disease Companies Actively Working in the Therapeutics Market Include
Some of the key companies in the Fabry Disease Market include 4D Molecular Therapeutics, Amicus Therapeutics, AVROBIO, Canbridge, CellGenTech, Inc., Codexis, Eleva GmbH, Freeline Therapeutics, Idorsia Pharmaceuticals, MP6 Therapeutics, Ozmosis Research Inc., Protalix, Resverlogix Corp, Sangamo Therapeutics, Sanofi Genzyme, Sigilon Therapeutics, uniQure, and others.
Emerging and Marketed Fabry Disease Therapies Covered in the Report Include:
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4D 310: 4D Molecular Therapeutics
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ELFABRIO (PRX-102): Chiesi and Protalix Biotherapeutics
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FLT190: Freeline Therapeutics
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Lucerastat: Idorsia Pharmaceuticals
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Moss-aGal: GREENOVATION BIOTECH GMBH
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Pegunigalsidase Alfa: Protalix Biotherapeutics
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ST-920: Sangamo Therapeutics
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Venglustat: Sanofi Genzyme
And Many More
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Table of Content (TOC)
1. Key Insights
2. Executive Summary
3. Fabry Disease Competitive Intelligence Analysis
4. Fabry Disease Market Overview at a Glance
5. Fabry Disease Disease Background and Overview
6. Fabry Disease Patient Journey
7. Fabry Disease Patient Population and Epidemiology Trends (In the US, EU5, and Japan)
8. Fabry Disease Treatment Algorithm, Current Treatment, and Medical Practices
9. Fabry Disease Unmet Needs
10. Key Endpoints of Fabry Disease Treatment
11. Fabry Disease Marketed Therapies
12. Fabry Disease Emerging Drugs and Latest Therapeutic Advances
13. Fabry Disease Seven Major Market Analysis
14. Attribute Analysis
15. Fabry Disease Market Outlook (In US, EU5, and Japan)
16. Fabry Disease Companies Active in the Market
17. Fabry Disease Access and Reimbursement Overview
18. KOL Views on the Fabry Disease Market
19. Fabry Disease Market Drivers
20. Fabry Disease Market Barriers
21. Appendix
22. DelveInsight Capabilities
23. Disclaimer
*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research Firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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