The global gene therapy market was valued at USD 1.46 billion in 2020 and is expected to grow at a CAGR of 17.0% during the forecast period. Gene therapy is a medical science field, which deals with the therapeutic restructuring of nucleic acids (DNA and RNA) to cure disease or underlying disorder.
There are two types of therapies, namely, somatic and germline therapies. Under gene therapy, a faulty product is replaced with the functional one, for instance, a brain tumor is getting enlarged with the rapidly dividing cancerous cells, the reason for this might be faulty or mutated gene therapy.
Prominent factors responsible for the therapy market growth include the high prevalence of cancer, hereditary diseases, strong product pipeline, advancements in the field of gene therapy and allied sectors, and the developments in CAR-T cell-based therapies. Moreover, according to the data released by the Alliance for Regenerative Medicine (ARM), showed growth in the clinical trials numbers concerned with therapy. As of the first quarter of 2019, there were around 372 concerning clinical trials in progress, with the majority being in Phase II (58%), followed by Phase I (33%), and Phase III (9%) and year-on-year growth of 17%.
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The rapid advancements in molecular and cell biology driven by technological advancements in the field of editing and genomics research in the past few years has contributed significantly to the booming therapies market. Researchers, academicians, and competent in-house research entities of key players in the marketplace with significant funding have also played a pivotal role.
For instance, UK-based Ori Biotech Ltd, in October 2020, successfully closed Series A funding of USD 30 million to automate cell and gene therapy manufacturing. The company’s platform increases throughput and decreases costs to cater to more patients with a life-threatening disease.
Moreover, recent product approvals and sound industry events also propelled the market growth. In the year 2019, Catalent announced to expand its therapy portfolio with the acquisition of the U.S.-based Paragon Bioservices, for an estimated deal of USD 1.2 billion. In the second quarter of the year, Thermo Fisher Scientific expanded its manufacturing capability with the purchase of CDMO, Brammer Bio, for USD1.7 billion.
Similarly, Roche announced to acquire, the U.S.-based gene therapy company, Spark Therapeutics for USD 4.8 billion. The latter is the first company to have approved a product of gene therapy to treat rare retinal disorders. The clinical trials for the product have already shown promising results and are approved by the U.S. FDA. With this acquisition, Roche is finding its ways to garner more market share in the promising market.
The market is primarily segmented on the basis of therapeutic area, vector type, approach, route of administration, region.
By Therapeutic Area
By Vector Type
By Route of Administration
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In 2020, the genetic disorders market segment is estimated to account for the largest share. The increasing incidences of these disorders and the rise in concerning clinical trials are few segment drivers favoring its market growth.
Moreover, a strong pipeline of drugs currently being under clinical trials also making the market segment’s growth prospects bright. For instance, pharma giant, Novartis is focusing to extend the approval of its drug, Kymriah, designed to treat people suffering from hematological cancer, in Europe and other middle-income countries.
Based on the vector type, the market is classified into viral and non-viral vectors. In 2020, the viral vectors segment is estimated to account for the largest share and is expected to maintain its dominance over the study timeframe. This high share is attributed to the accuracy of viral vectors in gene delivery, particularly, adeno-associated viruses (AAV).
AAV as a platform within the clinical settings is preferred among key market players such as Spark Therapeutics, Sangamo Biosciences, AGTC, and AveXis. For instance, voretigene neparvovec, commonly known by the brand name, “Luxturna” is an AAV-based therapy medication for the treatment of Leber congenital amaurosis, developed by Spark Therapeutics. This was the first in-vivo therapy approved by the FDA.
North America gene therapy market is estimated to hold the maximum share in the global market. The region’s growth was primarily due to increased funding and financing in cell therapy. The companies based in the region are mostly engaged in enhancing their product offerings, after seeking approval from concerned regulatory authorities.
In August 2020, the UK-based University of London (UCL) and AlbionVC, a UK-based technology investment arm of Albion Capital Group LLP, have announced the closure of EUR 100 million funding to invest in UCL’s cell therapy research and spinouts. Earlier, in July 2020, UK-based biotechnology start-up, “Freeline” engaged in the curative genomic therapy for chronic diseases has announced the closure of approximately EUR 106 million funding.
Asia Pacific gene therapy market is anticipated to register the highest market growth rate over the forecast period. In Asia Pacific, China is considered as a focal point in therapy development, as the number of trials surpassed the U.S. Moreover, government-sponsored funding in the concerned area is also expected to spur the demand for genomic therapy in the region.
For instance, in May 2019, a Japanese regulatory panel has approved the sale of Kymriah, manufactured by Novartis. All such factors coupled with a huge pool of patients suffering from chronic disorders will drive the market.
Some of the major players operating in the market include Dimension Therapeutics; Novartis AG; Bluebird Bio; Gilead Sciences Inc.; Human Stem Cell Institute; Spark Therapeutics LLC, Celgene Corporation; Sangamo Biosciences; Shire Plc; GlaxoSmithKline; Voyager Therapeutics; Bristol Myer’s Squibb; UniQure NV; and Celgene Corporation.