The Gene Therapy Market was estimated to be USD 4,118.31 million in 2021, and it is poised to witness a CAGR of 25.71% by 2027 to reach USD 14,824.97 million.
The COVID-19 pandemic is expected to have a positive effect on the gene therapy market. Gene and cell therapy technology are expected to be extensively used in the development of vaccines used to treat COVID-19. For example, in January 2021, vaccine candidates developed by Mass General Brigham and made by utilizing gene-therapy technology elicited strong immune responses in animal models for the treatment of COVID-19. The vaccine candidate was named AAVCOVID, and the researchers received a USD 2.1 million grant to further develop the technology from the Bill & Melinda Gates Foundation. The vaccine that is being developed is likely to be far more convenient than the ones being sold in the market currently, as it has a single dose and can be stored at room temperature. Also, as per a January 2021 published article titled, Emerging Patent Landscape for Gene Therapy as a Potential Cure for COVID-19, the treatment of coronavirus from the perspective of RNA interference-based gene therapy offers a more direct approach to combating viral genes and is likely to have a promising future. Thus, the COVID-19 pandemic is leading to an increased demand for gene-based therapy for COVID-19.
The major factors propelling the market's growth include technological advancements, rising investments in research and development, and the growing prevalence of target diseases.
Investment in research and development (R&D) activities are also expected to have a significant effect on the market. Several companies are aiming to build a gene therapy platform with a strategy focused on establishing a transformational portfolio through in-house capabilities and enhancing those capabilities through strategic collaborations, expansion of R&D activities, as well as potential licensing, merger, and acquisition activities. For instance, in January 2022, the Cystic Fibrosis Foundation reported investing in SalioGen Therapeutics to support the company's preclinical research into novel gene therapy for cystic fibrosis. SalioGen's Gene Coding approach is designed to turn on, turn off, or modify the function of any gene in the genome. In March 2021, ElevateBio, one of the leading biotech companies focused on gene-based therapies, raised USD 525 million to advance its cell and gene therapy technologies.
However, the lack of standard regulations and the high price of products are the factors hindering the gene therapy market's growth.
By indication, the cancer segment is anticipated to hold a major share in the market. The factors bolstering the segment growth are the increasing burden of cancer disorder, the growing focus on research to develop an effective treatment for cancer, and rising investments pertaining to cancer research.
For instance, according to Globocan 2020, an estimated 19,292,789 new cancer cases and 9,958,133 deaths due to cancers were reported worldwide. In the treatment of cancer, various gene therapy strategies are currently employed. These include anti-angiogenic gene therapy, pro-drug activating suicide gene therapy, gene therapy-based immune modulation, oncolytic virotherapy, correction/compensation of gene defects, antisense, genetic manipulation of apoptotic and tumor invasion pathways, and RNAi strategies. The cancer types, such as brain, lung, breast, pancreatic, liver, colorectal, prostate, bladder, head and neck, skin, ovarian, and renal cancer, have been the target of these therapies.
A growing focus on developing effective therapies for cancer is also contributing to the market growth. For instance, in March 2021, the United States Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.
Many key players in the market are focused on adopting strategies, such as mergers and acquisitions, on enhancing their product portfolio, which in turn, is expected to propel the market growth over the forecast period. For instance, in June 2021, CyGenica secured funding from SOSV, a venture capital company, to accelerate cancer and rare genetic disease therapy.
Thus, developments such as these have led to the growth of the overall market.
Within North America, the United States has held a major share of the market. The major factors fueling the market growth are the increasing number of investments by the government, advancements in research and development pertaining to gene therapy, and the growing prevalence of target diseases.
For instance, as per the 2020 Spinal Muscular Atrophy Foundation, spinal muscular atrophy (SMA) was generally believed to affect as many as 10,000-25,000 children and adults in the United States, and therefore it is one of the most common rare diseases. The same source also reports that 1 in 40 to 1 in 50 people (approximately 6 million Americans) are carriers of the SMA gene. Thus, the numbers indicate the growing demand for gene therapy in the United States.
Several initiatives are being launched pertaining to gene therapy. For instance, as per an October 2021 update by the National Institutes of Health, the National Institutes of Health, United States Food and Drug Administration, 10 pharmaceutical companies, and 5 non-profit organizations have partnered to accelerate the development of gene therapies for the 30 million Americans who suffer from a rare disease. Such initiatives are anticipated to increase the demand for gene therapy, thereby contributing to market growth.
Thus, due to the above-mentioned developments, the market is expected to witness significant growth over the forecast period.
The gene therapy market is highly competitive and consists of a few major players. Companies like Amgen Inc., Bluebird Bio, Gilead Sciences, Inc., Novartis AG, Orchard Therapeutics, Sibiono GeneTech Co. Ltd, Spark Therapeutics (Roche AG), and UniQure NV hold a substantial market share. They have various strategic alliances, such as collaborations and acquisitions, along with the launch of advanced products to secure their position in the global market.
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The COVID-19 pandemic is expected to have a positive effect on the gene therapy market. Gene and cell therapy technology are expected to be extensively used in the development of vaccines used to treat COVID-19. For example, in January 2021, vaccine candidates developed by Mass General Brigham and made by utilizing gene-therapy technology elicited strong immune responses in animal models for the treatment of COVID-19. The vaccine candidate was named AAVCOVID, and the researchers received a USD 2.1 million grant to further develop the technology from the Bill & Melinda Gates Foundation. The vaccine that is being developed is likely to be far more convenient than the ones being sold in the market currently, as it has a single dose and can be stored at room temperature. Also, as per a January 2021 published article titled, Emerging Patent Landscape for Gene Therapy as a Potential Cure for COVID-19, the treatment of coronavirus from the perspective of RNA interference-based gene therapy offers a more direct approach to combating viral genes and is likely to have a promising future. Thus, the COVID-19 pandemic is leading to an increased demand for gene-based therapy for COVID-19.
The major factors propelling the market's growth include technological advancements, rising investments in research and development, and the growing prevalence of target diseases.
Investment in research and development (R&D) activities are also expected to have a significant effect on the market. Several companies are aiming to build a gene therapy platform with a strategy focused on establishing a transformational portfolio through in-house capabilities and enhancing those capabilities through strategic collaborations, expansion of R&D activities, as well as potential licensing, merger, and acquisition activities. For instance, in January 2022, the Cystic Fibrosis Foundation reported investing in SalioGen Therapeutics to support the company's preclinical research into novel gene therapy for cystic fibrosis. SalioGen's Gene Coding approach is designed to turn on, turn off, or modify the function of any gene in the genome. In March 2021, ElevateBio, one of the leading biotech companies focused on gene-based therapies, raised USD 525 million to advance its cell and gene therapy technologies.
However, the lack of standard regulations and the high price of products are the factors hindering the gene therapy market's growth.
Key Market Trends
Cancer is Expected to Hold Significant Market Share in the Indication Segment
By indication, the cancer segment is anticipated to hold a major share in the market. The factors bolstering the segment growth are the increasing burden of cancer disorder, the growing focus on research to develop an effective treatment for cancer, and rising investments pertaining to cancer research.
For instance, according to Globocan 2020, an estimated 19,292,789 new cancer cases and 9,958,133 deaths due to cancers were reported worldwide. In the treatment of cancer, various gene therapy strategies are currently employed. These include anti-angiogenic gene therapy, pro-drug activating suicide gene therapy, gene therapy-based immune modulation, oncolytic virotherapy, correction/compensation of gene defects, antisense, genetic manipulation of apoptotic and tumor invasion pathways, and RNAi strategies. The cancer types, such as brain, lung, breast, pancreatic, liver, colorectal, prostate, bladder, head and neck, skin, ovarian, and renal cancer, have been the target of these therapies.
A growing focus on developing effective therapies for cancer is also contributing to the market growth. For instance, in March 2021, the United States Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma.
Many key players in the market are focused on adopting strategies, such as mergers and acquisitions, on enhancing their product portfolio, which in turn, is expected to propel the market growth over the forecast period. For instance, in June 2021, CyGenica secured funding from SOSV, a venture capital company, to accelerate cancer and rare genetic disease therapy.
Thus, developments such as these have led to the growth of the overall market.
North America Dominates the Market and Expected to do Same in the Forecast Period
Within North America, the United States has held a major share of the market. The major factors fueling the market growth are the increasing number of investments by the government, advancements in research and development pertaining to gene therapy, and the growing prevalence of target diseases.
For instance, as per the 2020 Spinal Muscular Atrophy Foundation, spinal muscular atrophy (SMA) was generally believed to affect as many as 10,000-25,000 children and adults in the United States, and therefore it is one of the most common rare diseases. The same source also reports that 1 in 40 to 1 in 50 people (approximately 6 million Americans) are carriers of the SMA gene. Thus, the numbers indicate the growing demand for gene therapy in the United States.
Several initiatives are being launched pertaining to gene therapy. For instance, as per an October 2021 update by the National Institutes of Health, the National Institutes of Health, United States Food and Drug Administration, 10 pharmaceutical companies, and 5 non-profit organizations have partnered to accelerate the development of gene therapies for the 30 million Americans who suffer from a rare disease. Such initiatives are anticipated to increase the demand for gene therapy, thereby contributing to market growth.
Thus, due to the above-mentioned developments, the market is expected to witness significant growth over the forecast period.
Competitive Landscape
The gene therapy market is highly competitive and consists of a few major players. Companies like Amgen Inc., Bluebird Bio, Gilead Sciences, Inc., Novartis AG, Orchard Therapeutics, Sibiono GeneTech Co. Ltd, Spark Therapeutics (Roche AG), and UniQure NV hold a substantial market share. They have various strategic alliances, such as collaborations and acquisitions, along with the launch of advanced products to secure their position in the global market.
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value- USD million)
6 COMPETITIVE LANDSCAPE
Samples
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Companies Mentioned
A selection of companies mentioned in this report includes:
- Amgen Inc.
- Biogen Inc.
- Bluebird Bio Inc.
- Gilead Sciences Inc. (Kite Pharma)
- Novartis AG
- Orchard Therapeutics
- Sibiono GeneTech Co. Ltd
- F. Hoffmann-La Roche Ltd (Spark Therapeutics)
- UniQure NV
- Abeona Therapeutics Inc.
- Generation Bio
- Poseida Therapeutics
- Astellas Pharma
- Voyager Therapeutics Inc.
- REGENXBIO Inc.
- Editas Medicine
Methodology
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