Global Enzyme Replacement Therapy Market to grow with a CAGR of 7.80%
Increasing
healthcare infrastructure and a supportive regulatory environment are the major
drivers for the Global Enzyme Replacement Therapy Market.
According
to TechSci Research report, “Global Enzyme Replacement Therapy Market Industry
Size, Share, Trends, Competition, Opportunity and Forecast, 2018-2028”, Global Enzyme Replacement
Therapy Market has valued at USD 9.95 billion in 2022 and is anticipated to
witness an impressive growth in the forecast period with a CAGR of 7.80%
through 2028. This can be due to collaborations and partnerships among leading
companies with a diverse approach to merge the expertise of individual
companies and to strengthen their position in the market. Orphan drug
designation plays a significant role in driving the demand for enzyme
replacement therapy (ERT) in the global market. Orphan drug designation is
granted to therapies intended for the treatment of rare diseases, which
includes many of the conditions that ERTs target. This designation offers
significant incentives for pharmaceutical companies to invest in the
development of ERTs. These incentives may include extended market exclusivity,
tax credits, and grants, which make it financially viable for companies to
develop treatments for rare diseases with smaller patient populations. Orphan
drug designation typically provides market exclusivity for a specified period,
during which competing products are restricted. This exclusivity encourages
pharmaceutical companies to invest in research and development for ERTs as it
enables them to recoup their investment and generate revenue in a less
competitive environment. Rare diseases, by their very nature, have a limited
patient population. Orphan drug designation helps make ERTs economically viable
by providing financial incentives, despite the smaller potential market. This
makes it more attractive for companies to develop and market these therapies. The
orphan drug designation status attracts more investment in ERT research and
development. With the financial incentives in place, pharmaceutical companies
are more likely to allocate resources to discover and produce ERTs for rare
diseases.
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Enzyme replacement therapy (ERT) is a medical
approach employed to treat congenital enzyme deficiencies by introducing human,
animal-derived, or recombinant engineered enzymes into the patient's system.
The fundamental concept of ERT involves replacing the deficient natural enzyme
with a therapeutic one. ERT is administered through various routes, including
oral and intravenous methods. It is commonly employed in the treatment of
lysosomal storage diseases such as Pompe disease, Gaucher disease, and Hurler
syndrome, among others. In February
2023, Codexis, Inc., a prominent enzyme engineering firm, and Nestlé Health
Science, a leading authority in nutritional science, have jointly unveiled
interim findings from a Phase 1 clinical study aimed at assessing the safety,
tolerability, pharmacokinetics (PK), and pharmacodynamics of CDX-7108. CDX-7108
represents a specially engineered lipase variant designed to address the
limitations associated with current pancreatic enzyme replacement therapy
(PERT). PERT serves as the primary therapeutic approach for exocrine pancreatic
insufficiency (EPI), a debilitating gastrointestinal condition resulting from
disorders that compromise pancreatic function, such as pancreatitis, pancreatic
cancer, Crohn's disease, celiac disease, and cystic fibrosis. CDX-7108 has been
intricately designed to exhibit a high degree of stability under the stomach's
acidic conditions and resistance to proteases in the upper intestinal tract. Accessibility and affordability are
significant challenges in the global enzyme replacement therapy (ERT) market,
particularly for patients with rare genetic disorders. In many developing or
low-income regions, access to specialized healthcare and advanced therapies
like ERTs is limited. Patients in these areas may face difficulties in
accessing diagnosis, treatment, and ongoing care for their rare genetic
disorders. Even in developed countries, geographic disparities in access to
healthcare can exist. Patients in rural or remote areas may struggle to access
specialized medical facilities and ERT administration. ERTs are often expensive
due to the complex manufacturing process and limited patient populations. The
high cost of treatment can make it unaffordable for many patients, even in
developed countries. Insurance coverage may not always fully address the financial
burden. Patients with rare genetic disorders may face economic disparities,
making the affordability of ERTs a significant issue. The cost of treatment can
be prohibitive for individuals with limited financial resources.
Global Enzyme Replacement Therapy Market is
segmented based on Products, Disease, Route of Administration, End User, and by region. Based
on the Disease, Global Enzyme Replacement Therapy Market is segmented into
Exocrine Pancreatic Insufficiency
(EPI), Pompe Disease, Scheie Syndrome, Maroteaux-Lamy Syndrome, Global Enzyme Replacement
Therapy Market largest share was held by Gaucher Disease segment, Others.
Pompe disease, also known as glycogen storage disease type II or acid maltase
deficiency, is a rare and inherited metabolic disorder. This genetic disorder primarily
affects the muscles and results from a deficiency of the enzyme acid
alpha-glucosidase (GAA), which is responsible for breaking down glycogen, a
complex sugar, into glucose within lysosomes, which are cellular structures.
Pompe disease is an autosomal recessive genetic disorder, which means that it
is inherited when an individual inherits two mutated copies of the GAA gene,
one from each parent. Due to the deficiency of the GAA enzyme, glycogen
accumulates abnormally within the lysosomes in various tissues, particularly in
the muscles. This glycogen buildup impairs normal cellular function and leads
to progressive muscle weakness. Pompe disease exhibits a spectrum of severity,
ranging from infantile-onset to late-onset forms. The severity of the disease
depends on the degree of enzyme deficiency and the age at which symptoms first
appear.
Based on Region, North America held the largest share in the Global Enzyme
Replacement Therapy Market. Many patients in North America have access
to health insurance, which can help cover the high costs of ERTs. Insurance
coverage makes ERTs more affordable and accessible to patients in the region. North
American pharmaceutical companies and academic institutions have historically
invested significantly in research and development for rare disease treatments,
including ERTs. This has led to the development of innovative therapies. Strong
patient advocacy and support networks in North America have played a crucial
role in raising awareness about rare diseases and advocating for better access
to ERTs. These organizations often collaborate with pharmaceutical companies to
improve patient outcomes. North America is home to many experienced healthcare
professionals, researchers, and clinicians with expertise in rare diseases and
ERTs. This expertise is vital in diagnosis, treatment, and ongoing patient
care.
Some of the major companies
operating in the Global Enzyme
Replacement Therapy Market include:
- Takeda
Pharmaceutical Company Ltd.
- Leadiant
Biosciences Inc.
- Biomarin
Pharmaceuticals Inc.
- Genzyme
Corporation
- Pfizer
Inc.
- Shire
plc
- Sigma-Tau
Pharmaceuticals, Inc
- Essential Pharmaceuticals Limited
- Merck
KGa
- AbbVie
Inc
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“Certain areas, particularly in North
America, are projected to exert significant demand for Enzyme Replacement
Therapy. The growth in the competitive landscape and the presence of
well-established companies in the market, committed to enhance the overall
wellbeing of people each year, are expected to contribute to a remarkable
growth of the Global Enzyme Replacement Therapy Market in the forecast period,"
said Mr. Karan Chechi, Research Director with TechSci Research, a
research-based Global management consulting firm.
Enzyme
Replacement Therapy Market by Products (Galsulfase, Velaglucerase Alfa, Laronidase,
Asfotasealfa, Others), By Diseases (Exocrine Pancreatic Insufficiency (EPI), Pompe
Disease, Scheie Syndrome, Maroteaux-Lamy Syndrome, Global Enzyme Replacement
Therapy Market largest share was held by Gaucher Disease segment, Others), By Route of Administrations (Oral Parenteral, Other), By End User (Hospitals
& Clinics, Ambulatory Surgical Centers, others), By Region, By Competition Forecast &
Opportunities, 2018-2028F has evaluated the future growth potential
of Global Enzyme Replacement Therapy Market and provides statistics &
information on market size, structure, and future market growth. The report
intends to provide innovative market intelligence and help decision makers take
sound investment decisions. Besides, the report also identifies and analyzes
the emerging trends along with essential drivers, challenges, and opportunities
in Global Enzyme Replacement Therapy Market.
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