According to a report, “ Enzyme Replacement Therapy Market Size, Share & Trends Analysis By Enzyme (Pancreatic Enzymes, Agalsidase Beta), By Therapeutic Condition (Gaucher, Fabry, Pompe, MPS), By Route of Administration, By End Use, And Segment Forecasts, 2019 – 2026 ”, published by Grand View Research, Inc.,The global enzyme replacement therapy market size is expected to reach USD 12.13 billion by 2026, expanding at a CAGR of 7.7% during the forecast period, according to a new report by Grand View Research, Inc. As per the Genetic and Rare Diseases Information Center or GARD, a rare disease is defined as a condition that affects lesser than 200,000 individuals. These disorders are also called orphan diseases due to the lack of support exhibited by pharmaceutical companies previously. Since the passing of the Orphan Drug Act of 1983 in the U.S., several large pharmaceutical and biopharmaceutical companies have invested heavily in the development of orphan drugs. Thus, rising awareness, increasing R&D investment, growth in the number of lysosomal storage and genetic disorders, and easy drug approval process are factors propelling the market growth during the forecast period.
According to data from the National Institutes of Health, it is estimated that over 25 million Americans suffer from rare diseases. These facts are indicative of the fact that although the number of these ailments is low, individuals suffering from these are large. Some of the most common lysosomal storage disorders that make use of enzyme replacement therapy are Gaucher, Fabry, Pompe, MPS, SCID, and Shwachman-Diamond Syndrome among others.
In the recent past, these disorders have been gaining significant attention, impacting growth positively. Various grants and acts are in place to accommodate drug makers to invest in the development of orphan drugs. Orphan Drug Designation Program, Rare Pediatric Disease Priority Review Voucher Program, Humanitarian Use Device (HUD) Program, and Orphan Products Clinical Trials Grants Program are programs that aid in the development of orphan drugs.
The rising use of enzyme replacement therapy in home care and infusion centers are gaining traction in the market. Specialized infusion centers such as these are anticipated to witness the highest CAGR during the forecast period. Hospitals held the largest segmental share owing to easy accessibility and ability to treat a wide range of ailments.
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Further Key Findings From the Report Suggest:
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The high prevalence of Gaucher disease is attributable to the Imiglucerase segment gaining the highest CAGR during the forecast period.
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MPS I is anticipated to gain the highest share in the near future owing to rising prevalence and increasing cognizance about lysosomal storage diseases.
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The North America region is leading the regional sector and expected to dominate the market during the forecast period owing to the existence of a large number of major players and a high incidence of lysosomal storage diseases.
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The Asia Pacific region is expected to grow at the highest growth rate during the forecast period. High population bases teamed with the rising incidence of genetically acquired diseases such as Gaucher and Fabry are major factors attributing to regional growth.
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Some of the major players include in the enzyme replacement therapy market are Shire plc; Sanofi; Biomarin Therapeutics; AbbVie; Alexion; Allergan; Horizon Therapeutics; Actelion; Recordati Rare Diseases; and Protalix Biotherapeutics among others.
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Regional Insights
North America dominated the market in 2018. Well-developed healthcare infrastructure and the presence of leading market players in North America have fueled growth of the regional segment. Moreover, adoption of advanced technologies and increased focus on drug development in this region is expected to drive the sector growth.
The European region accounted for the second highest revenue after North America and is expected to grow with a CAGR of 7.1%. The healthcare system in the European region is publicly funded and some countries have adopted universal health care systems. Presence of large number of patients suffering from MPS and SCID are factors propelling market growth in the European region.
According to statistics from Fabry Outcome Survey prepared by Shire Outcome Surveys, Germany, Japan, and the UK exhibit the highest incidence of Fabry’s disease. Data from FDA’s Novel Drug Approvals indicate that over 39% of novel drugs approved in the year 2017 were for orphan diseases. Factors such as these are anticipated to further propel regional market growth.
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Asia Pacific region consists of developed as well as developing countries such as China, India, and other Asia Pacific countries. Most of the countries in this region are economically developing and the disposable income is gradually increasing. Many multinational companies are heavily investing in this region. In addition, countries such as Japan are technologically advanced in terms of healthcare and medical research, which aids in market growth of this region.
Grand View Research has segmented the global enzyme replacement therapy market report on the basis of enzyme, therapeutic condition, route of administration, end use, and region:
Enzyme Replacement Therapy Enzyme Outlook (Revenue, USD Million; 2015 – 2026)
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Imiglucerase
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Agalsidase Beta
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Taliglucerase
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Velaglucerase Alfa
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Laronidase
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Alglucosidase Alfa
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Galsulfase
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Idursulfase
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Pancreatic Enzymes
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Pegademase
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Others
Enzyme Replacement Therapy Therapeutic Condition Outlook (Revenue, USD Million; 2015 – 2026)
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Gaucher Disease
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Fabry Disease
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Pompe Disease
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SCID
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MPS
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MPS I – Hurler, Hurler Scheie and Scheie
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MPS II – Hunter
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MPS III – Sanfilippo
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Others
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Others
Enzyme Replacement Therapy Route of Administration Outlook (Revenue, USD Million; 2015 – 2026)
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Oral
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Parenteral
Enzyme Replacement Therapy End Use Outlook (Revenue, USD Million; 2015 – 2026)
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Hospitals
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Infusion Centers
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Others
Enzyme Replacement Therapy Regional Outlook (Revenue, USD Million; 2015 – 2026)
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North America
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U.S.
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Canada
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Europe
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Germany
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UK
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France
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Italy
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Spain
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Russia
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Asia Pacific
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Japan
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China
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India
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Australia
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South Korea
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Latin America
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Brazil
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Mexico
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Argentina
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MEA
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South Africa
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Saudi Arabia
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UAE
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