The COVID-19 pandemic is expected to have a positive effect on the gene therapy market. Gene and cell therapy technology is expected to be used extensively 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 which is being developed is likely to be far more convenient than the ones being sold in the market currently, as it has single-dose and can be stored at room temperature. Different approaches are being used by other researchers, like those from the University of Pennsylvania. In collaboration with Regeneron, the researchers are using adeno-associated viral vectors to transport lab-made antibodies into the body. These developments are expected to affect market growth in a positive manner.

The factors that drive market growth include technological advancements, rising investments in R&D, and the growing prevalence of target diseases.

Gene therapies are developed for the treatment of diseases by modifying genetic information, which includes inactivating genes that function improperly or replacing a gene, which causes disease with a healthy copy of the gene. Gene therapy is being used to treat several diseases and has shown promising results. Diseases such as Cystic Fibrosis, Cancer, Heart diseases, Diabetes, AIDS, Hemophilia can be cured by this method of treatment. Gene therapy is usually used to correct the defective gene to cure a specific disease or helps the body better fight against the diseases.

There has been an increasing prevalence of many target diseases, such as cancer, rheumatoid arthritis, diabetes, Parkinson's disease, Alzheimer’s disease, etc. that have been cured by several gene therapies present already in the market. There has also been an increase in several genetic and numerous life-threatening disorders, especially heart diseases, AIDS, cystic fibrosis, and age-related disorders. Although gene therapy was initially targeted for inherited diseases, it is now used in the treatment of a variety of acquired problems including cancer and HIV. Initially delivered through viruses, now there are safer direct or biochemical vectors, while in the future nano-particles might deliver the drug of choice directly to the nucleus of affected cells.

For instance, according to the World Health Organization, an estimated 17.9 million people die due to cardiovascular diseases worldwide, each year. This represents 35% of global deaths. As gene therapy provides a complete cure to patients affected with genetic and other life-threatening disorders, rather than ease symptoms that happen with other treatments, it is becoming more popular.

Investment in research and development activities is also expected to have a significant effect on the market. Companies such as Pfizer Inc., 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 and M&A activities. For instance, Pfizer announced in August 2019 that it was investing USD 500 million to expand a manufacturing facility in North Carolina which plays a central role in its efforts to become a major player in the gene therapy industry.

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Key Market Trends

Cancer is Expected to Hold Significant Market Share in the Indication Segment

The ever-rising prevalence of cancer all across the globe is a major factor driving the growth of this segment. According to Globocan 2020, an estimated 19,292,789 new cancer cases and 9,958,133 deaths due to cancers were reported in 2020 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 for these therapies.

Transferring genes into cancer cells have been one of the most difficult aspects of present-day gene therapy. Researchers are studying ways to alleviate the problems in this technique. Genes are taken into cancer cells with the help of a carrier known as a vector. The most common types of carriers that are used in gene therapy are viruses as they can enter cells and then deliver genetic material. Viruses are then changed in such a way so that they cannot result in any serious disorders.

Many key players in the market are focused on adopting strategies, such as mergers and acquisitions, to enhance their product portfolio, which in turn, is expected to propel the market growth over the forecast period. For instance, in December 2018, Kineta Inc. entered into a strategic research collaboration with Pfizer Inc. to develop RIG-I agonist immunotherapies for the treatment of cancer. In 2019, Amgen finalized a strategic collaboration with the Chinese company BeiGene, investing around USD 2.8 billion to gain a presence in China. The investment provided Amgen with an R&D pact and ownership of about one-fifth of BeiGene. 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 Forecasted Period

For gene therapy, in the United States, the DHHS (Department of Health and Human Services) has been appointed to oversee clinical trials. Two other separate organizations within DHHS, the U.S. FDA (Food and Drug Administration) and the OHRP (Office for Human Research Protections) have authority that is described in the CFR (Code of Federal Regulations).

Gene therap technologies are being given increasing approval by the afore-mentioned organizations, which is expected to drive market growth. For example, in May 2019, AveXis, a Novartis company, had announced that it had received US FDA approval for Zolgensma (onasemnogene abeparvovec-xioi) to treat pediatric patients younger than 2 years of age having spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.

Companies are also engaging in collaborations to increase their market share.In February 2020, Biogen partnered with Sangamo Therapeutics in a USD 2.7 billion deal. The partnership is expected to focus initially on two preclinical Sangamo gene therapy candidates – ST-501 for Alzheimer’s and ST-502 for Parkinson’s disease, plus an undisclosed neuromuscular target. The partnership also includes exclusive rights for up to nine other undisclosed neurological targets. Such developments are expected to have a positive effect on market development.

Competitive Landscape

The global 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 N.V., among others, hold the substantial market share in the Gene Therapy market.

There have various strategic alliances such as collaborations, acquisitions along with launch of advanced products to secure the position in the global market. In December 2019, Roche Group announced that it had acquired Spark Therapeutics in a deal valued at USD 4.8 billion. This is expected to strengthen the position of Roche in the gene therapy market.

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