Gene Therapy Market Extensive Industry Analysis, Growth Rate, Segmentation, Investment Opportunities and Top Manufacturers 2035

The ongoing evolution in the field of genomics and biotechnology, has catalyzed innovations and advancements of gene therapies across a wide spectrum of disorders  – Genetic aberration / mutation is well known to cause several systemic and localized (organ system specific) clinical conditions resulting in severe and hard-to-treat inherited disorders. Such diseases are often treated by modifying the abnormal gene / allele responsible for coding a dysfunctional / non-functional protein.

The global gene therapy market is estimated to grow from $2.4 billion in 2024 to $16.5 billion by 2035, representing a CAGR of 19.25% during the forecast period till 2035.

This has essentially led to the foundation of novel class of therapeutics known as gene therapies. According to the USFDA, gene therapy is defined as a the method introducing genetic material in order to modify or manipulate the expression of either disease-causing or suppressor genes.  Till date, a variety of gene-focused corrective strategies have been developed for the treatment of a wide range of genetic conditions, such as adenosine deaminase severe combined immunodeficiency (ADA-SCID), β-thalassemia, biallelic RPE65 mutation-associated retinal dystrophy, critical limb ischemia, head and neck squamous cell carcinoma, melanoma, peripheral artery disease and spinal muscular atrophy. It is worth mentioning that as of now, around 20 gene therapies have received approval; examples of recently USFDA approved gene therapies include (arranged in alphabetical order) Casgevy™  (developed by Vertex Pharmaceuticals, approved in 2024), Lenmeldy™ (developed by Orchard Therapeutics, approved in 2024), Lyfgenia™ (developed by bluebird bio, approved in 2023), Elevidys® (developed by Sarepta Therapeutics, approved in 2023), Roctavian® (developed by BioMarin Pharmaceutical, approved in 2023) and Vyjuvek® (developed by Krystal Biotech, approved in 2023). Considering that such therapies are designed to address the root cause (at the genetic level) of a disease, a number of contemporary drug / therapy development initiatives are focused on gene correction and genome editing-based therapeutic interventions. Further, the growing need for treatment options that can cure a clinical condition, as opposed to those intended for treatment of disease-related symptoms, has created a demand for more effective gene manipulation approaches.

Types of gene therapies

Gene augmentation therapy: In this type of therapy, a DNA segment representing the functional copy of a gene is inserted into cells (or tissues) that either lack or have dysfunctional copies of the same gene. Such an alteration usually results in restoration of normal function of the target cell / cell population.

Gene inhibition therapy: In this type of therapy, a DNA segment that is capable of either inhibiting the expression of a gene, or interfering with the activity of another gene, is introduced into a target cell / cell population.

Gene replacement therapy: In this type of therapy, a defective gene within a cell is replaced with a therapeutic gene by using an appropriate delivery vehicle (vector).

The future of gene therapy market- In recent years, gene therapy has been demonstrated to be a promising solution for patients suffering from severe inherited disorders. These therapies have shown remarkable outcomes in enhancing the life expectancy of patients suffering from severe conditions, such as AIDS, cancer, cystic fibrosis and diabetes. Further, with the rise in the R&D activity in this domain along with advancements in gene editing technologies, an increasing number of novel gene therapies are likely to be commercialized in the coming years. It is worth highlighting that, according to Robert M. Califf, the former commissioner of the USFDA, more than ten gene therapies are anticipated to receive approval annually, by 2025.

Research Methodology

Our analysts have performed an accurate examination of the various aspects of the global market leveraging avant-garde primary and secondary sources of data collection. The report has gathered the necessary data and information from several reliable sources. Additionally, the report offers many strategic recommendations for companies involved in this ever-growing business sector to help them attain a competitive edge in the Gene Therapy Market.

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