by The global alpha mannosidosis market for the historical period 2017–2018 and forecast period 2019–2027, market exclusivity for orphan drugs, increasing investment in rare disease treatment, and faster market access are projected to drive the global alpha mannosidosis market during the forecast period
According to the report, the global alpha mannosidosis market was valued at US$ 7.6 Mn in 2018 and is anticipated to expand at a CAGR of 9.9% from 2019 to 2027
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Market Exclusivity for Orphan Drugs and Increasing Investment in Rare Disease Treatment: Key Drivers
The most important financial incentive of orphan drug approval for pharmaceutical companies is the market exclusivity of several years for products that have been designated as orphan drugs.
This allows pharmaceutical companies to recover costs incurred in development, as during this period regulatory agencies cannot approve a generic equivalent of the drug for the same rare indication.
In the U.S., the period for market exclusivity for orphan drugs is 7 years and in the EU it is 10 years. Similar incentives exist in Japan and Australia, among other major regions
Smaller clinical trial size, shorter trial time, and commercial benefits such as fast track approval, and fee waivers attract multinational corporations to invest in the rare disease segment
The regulatory environment has been more advantageous for developers since the passage of the 1983 Orphan Drug Act. Moreover, venture capitalists see the legislative incentives as a major opportunity to create returns on their investments
Moreover, saturation of the markets for diseases with large patient populations, such as asthma, diabetes and hypertension, has led to the focus of pharmaceutical industry towards more specialist, niche diseases where the unmet need is more substantial and the barriers to entry are much lower.
Fee Reductions & Tax Credits Boost Market Growth
Orphan drug designation qualifies the orphan drug manufacturer to claim tax credits of up to 50% of R&D costs incurred during the clinical trial phase in the U.S.
According to a study conducted by the U.S. Congress, Office of Technology Assessment (OTA, 1993), overall the tax credit lowers the cost of the extra dollar of clinical orphan research by 24% compared to cost without tax credit
Similar incentives include FDA fee waivers that reduces transaction cost associated with the approval process
Therefore, fee reductions & tax credits is likely to increase demand for alpha mannosidosis globally
High Cost of Treatment to Hamper Market
The most important barrier in this market is high cost of producing an orphan drug. The number of patients eligible to receive an orphan drug confines a company’s ability to recover its R&D investment.
Manufactures require incentives to develop orphan drugs. This being a narrow market, profit is based on supply and demand. By order of magnitude, these orphan drugs are more expensive.
High investment involved in research and costs incurred for production of recombinant enzymes, increases cost of ERT. The per year treatment cost of a single lysosomal storage disorder patient is several hundred thousand dollars. Also, such high costs are acceptable in developed countries with established reimbursement structure however, in underdeveloped countries these are unaffordable and limits the access.
Global Alpha mannosidosis Market: Competitive Landscape
This report profiles major players in the global alpha mannosidosis market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
The global alpha mannosidosis market is highly consolidated, with the presence of very few players
The only player operating in the global alpha mannosidosis market is Zymenex A/S
Key Questions Answered in Global Alpha mannosidosis Market Report
- What is the scope of growth of product companies in the global alpha mannosidosis market?
- What will be the Y-o-Y growth of the global alpha mannosidosis market between 2019 and 2027?
- What is the influence of changing trends in technologies on the global alpha mannosidosis market?
- Will North America continue to be the most profitable market for alpha mannosidosis providers?
- Which factors are anticipated to hamper the growth of the global alpha mannosidosis market during the forecast period?
- Which are the leading companies in the global alpha mannosidosis market?
Global Alpha mannosidosis Market – Segmentation
Treatment Type
- Bone Marrow Transplant
- Enzyme Replacement Therapy
Indication
- Type I
- Type II
- Type III
End-user
- Hospitals
- Specialty Clinics
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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