Alpha Mannosidosis Market: Bone Marrow Transplant Segment to Dominate Market
- According to Transparency Market Research’s latest report on 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
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
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- 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
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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.
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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
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Global Alpha mannosidosis Market: Key Developments
- CHIESI Farmaceutici S.p.A has adopted the business strategy of mergers and acquisitions. For instance, in 2013, CHIESI Farmaceutici S.p.A acquired the Zymenex A/S and entered into the treatment of rare disease market.
The report on the global alpha mannosidosis market discussed individual strategies, followed by company profile of manufacturer of alpha mannosidosis. The competitive landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the global alpha mannosidosis market.
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