Transparency Market Research
(TMR) has published a new report titled, “Gene Therapy Market - Global Industry
Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026”. According to
the report, the global gene
therapy market was valued at US$ 17.0 Mn in 2017 and is projected to expand
at a CAGR of 40.0% from 2018 to 2026. New product approvals, promising
therapeutic outcomes of gene therapy, and high prevalence of non-Hodgkin
Lymphoma are anticipated to drive the global market in the next few years.
Europe is projected to dominate the global gene therapy market, followed by
U.S., by the end of 2026. Potential unmet needs in the fields of oncology, rare
genetic disorders in the U.S. and Europe, new product approvals and
commercialization, and high clinical R&D budgets are likely to drive the
gene therapy market in these regions during the forecast period. The gene
therapy market in Rest of World is projected to expand at a significant CAGR
during the forecast period. The high growth rate is attributed to the
anticipated approval and commercialization of gene therapy products in
developed countries such as Japan, Australia & New Zealand, GCC countries,
and China, and high prevalence of non-Hodgkin Lymphoma and head and neck
cancers.
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New product approvals & commercialization drives market
2016, 2017, and 2018 were key
milestones in the history of the gene therapy market in the U.S. and Europe, as
around four gene therapy products have been approved and commercialized. These
products are currently in the infancy stage of commercialization, and have
exhibited highly positive therapeutic outcomes. For instance, in May 2016,
GlaxoSmithKline (GSK) gene therapy product, Strimvelis, received marketing
approval for the treatment of patients with a very rare disease called ADA-SCID
(Severe Combined Immunodeficiency, due to Adenosine Deaminase deficiency).
Strimvelis is the first ex-vivo stem cell gene therapy to be approved in Europe
for the treatment of ADA-SCID. Furthermore, in August 2017, the USFDA approved
Novartis AG’s flagship gene therapy product, Kymriah, for the treatment of
children and adults up to the age of 25 years affected with B-cell precursor
acute lymphoblastic leukemia (ALL). Thus, recent approvals of gene therapy
products in the U.S. and Europe for the treatment of various life threatening
disorders is projected to fuel the gene therapy market during the forecast
period.
Yescarta to be highest revenue generating gene therapy product
The report offers a detailed
segmentation of the global gene therapy market based on different gene therapy
products approved and commercialized. Based on product, the global gene therapy
market has been segmented into Yescarta, Kymriah, Luxturna, Strimvelis, and
Gendicine. Yescarta (Axicabtagene Ciloleucel) is a genetically modified
autologous Chimeric Antigen Receptor T (CAR T) cell immunotherapy developed by
Gilead Sciences, Inc. for the treatment of adult patients with relapsed or
refractory large B-cell lymphoma including diffuse large B-cell lymphoma
(DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). It is the first
CAR T therapy approved by the US FDA for the treatment of DLBCL. The Yescarta
segment is projected to dominate the global gene therapy market by the end of
2026. Anticipated commercialization of Yescarta in Europe and other developed
countries and increasing number of treatment centers are key factors that are
likely to lead to the dominant share held by Yescarta by the end of 2026.
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Oncology segment to account for high market share
In terms of application, the
global gene therapy market has been segmented into ophthalmology, oncology, and
adenosine deaminase ?deficient severe combined immunodeficiency (ADA-SCID). The
oncology segment is likely to account for a significant share of the market by
the end of 2026. Oncology is a highly studied medical field in the clinical
pipeline studies of gene therapy candidates. More than 60% of gene therapy
clinical research studies are focused on oncology. The large share held by the
oncology segment is attributed to the approval and commercialization of
Yescarta and Kymriah, in the last one to two years, for the treatment of
certain types of non-Hodgkin lymphoma in the U.S. and Europe. Furthermore,
increase in demand for Gendicine in China for the treatment of head and neck
cancers is projected to drive the segment during the forecast period.
Europe offers high incremental opportunity
The gene therapy market in Europe
is projected to expand at a significant CAGR of 30.6% during the forecast
period. Large number of patient population with refractory large B-cell
lymphoma, including diffuse large B-cell lymphoma (DLBCL) and primary
mediastinal large B-cell lymphoma (PMBCL), promising therapeutic outcomes,
rising demand for gene therapy treatment, and increasing number of gene therapy
treatment centers in Europe are key factors that are likely to fuel the gene
therapy market in Europe. Moreover, different pricing models are being
evaluated by payers and governments to enable access to high priced gene
therapy products. This is likely to drive the demand for gene therapy products
in Europe during the forecast period.
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Large number of clinical pipeline studies and significant investments
in gene therapy to gain the first mover advantage
The global gene therapy market is
highly consolidated, with very few global players accounting for a major share.
Currently, only five companies; Gilead life Sciences Inc. Spark Therapeutic
Inc., Novartis AG, Sibiono GeneTech Co. Ltd, and Orchard Therapeutics Limited
offer gene therapy products in the market. Most biopharmaceutical companies
have invested significantly in clinical R&D for the development of gene
therapy products for different chronic and genetic disorders. Large number of
gene therapy products are under different stages of clinical pipeline studies,
and the number of gene therapy candidates is projected to rise consistently
during the forecast period. For instance, according to the Journal of Gene
Medicine, there were around 2,597 gene therapy candidates under clinical
trials, as of 2017. Of the total clinical studies, around 65% of studies were
focused on oncology, 11% of studies were focused on monogenetic field, 7% on
infectious diseases and cardiovascular disease, each.
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