Global AI Powered Gene Therapy Market is expected to grow with a CAGR of 26.8% over the year 2024 to 2030. Intensification of technological advancements and prevalence of target diseases embracing the use of AI-Powered Gene Therapy market across the global healthcare system.
Gene therapy is an advanced technique that can modify or manipulate the expression of a gene, or it can be used to alter the biological properties of living cells for therapeutic use. This method can be used to cure a particular disease by modifying a human gene. It can also be used to modify a plant or microorganism gene, such as bacteria. As the name suggests, if artificial intelligence is applied along with gene therapy, it can be known as AI-powered gene therapy. Gene therapy can be performed by different mechanisms: Replacing a disease-causing gene with a healthy modified copy of that gene. Inactivating a disease-causing gene that is not functioning as required. Insertion of a new modified gene to treat a particular disease. Gene therapy has a variety of products, which include Plasmid DNA, viral vectors, bacterial vectors, human gene editing technology, and patient-derived cellular gene therapy products.
The AI-powered gene therapy market is affected by COVID-19 to a certain extent. Lockdowns and travel ban across the world have harmed each sector. Manufacturing and supply chain management were limited to essential items. Moreover, there was a hesitancy among people to visit hospitals and clinics, even when infection rates were minimal. People were preferring at-home consultations and tests to avoid the infection. Elective surgery and treatments such as gene therapy were delayed. According to a research article, in the U.S., elective cardiac and vascular surgeries were delayed in patients.
Global AI Powered Gene Therapy Market is segmented based on indication, type of vector, and region level. Based on indication, the Global AI Powered Gene Therapy Market is classified into Cancer, Metabolic Disorders, Eye Disorders, Spinal Muscular Atrophy, and others. Based on type of vector, the Global AI Powered Gene Therapy Market is classified into Adenovirus vector, Adeno-associated virus vector, Lentiviral vector, Retroviral vector, Herpes virus vector, and others.
The regions covered in this Global AI Powered Gene Therapy Market report are North America, Europe, Asia-Pacific, and Rest of the World. Based on country level, market of Global AI Powered Gene Therapy Market is sub divided into U.S., Mexico, Canada, UK, France, Germany, Italy, China, Japan, India, South-East Asia, GCC, Africa, etc.
Some of the key players for the Global AI Powered Gene Therapy Market are Novartis, Spark Therapeutics, Bluebird Bio, Editas Medicine, Intellia Therapeutics, CRISPR Therapeutics, Sangamo Therapeutics, RegenxBio, Orchard Therapeutics, Ultragenyx Pharmaceutical, Abeona Therapeutics, Homology Medicines, uniQure, Beam Therapeutics, Precision Biosciences, Moderna Therapeutics, Translate Bio, Alnylam Pharmaceuticals, Horizon Discovery, Thermo Fisher Scientific, Lonza Group, Charles River Laboratories, GeneCopoeia, 4D Molecular Therapeutics, REGENXBIO, GenScript, Cellectis, Inovio Pharmaceuticals, CRISPR, GEne Therapeutics, Bluebird Bio, and others.
On February 17th, 2022, BioMarin Pharmaceutical Inc. has provided updates on its ongoing gene therapy programs in clinical development. The company has recently received additional requests from the Food and Drug Administration (FDA) to furnish necessary information for the resolution of the clinical hold placed on the PHEARLESS Phase 1/2 study of BMN 307. This clinical hold was initially imposed in September 2021.
BMN 307 is an adeno-associated virus serotype 5 (AAV5) vector carrying the human phenylalanine hydroxylase (hPAH) gene, and it is under investigation for its potential in treating adults with phenylketonuria (PKU). To address the concerns raised by the FDA, the agency has sought additional data from non-clinical studies. This data will be crucial in assessing the theoretical oncogenic risk to participants in human studies. The process of obtaining and analyzing this data is expected to span several quarters.
FDA Approves First NGS-Based Companion Diagnostic to Aid in Selecting Non-Small Cell Lung Cancer Patients with HER2 (ERBB2) Activating Mutations (SNVs & Exon 20 Insertions) for Treatment with ENHERTU
On August 12th, 2022, The U.S. Food and Drug Administration (FDA) has officially granted premarket approval for Thermo Fisher Scientific's Oncomine Dx Target Test. This approval designates the test as a companion diagnostic (CDx) tool, primarily intended for the identification of patients with non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) activating mutations, which encompass both SNVs (Single Nucleotide Variants) and Exon 20 Insertions. The purpose of this CDx is to determine potential candidates who may benefit from treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki).
ENHERTU represents a specialized and precisely engineered antibody drug conjugate (ADC) that directly targets HER2. It is being developed and brought to the market through a collaborative effort by Daiichi Sankyo and AstraZeneca. This significant FDA approval signifies a milestone in the quest to provide tailored and effective treatment options for individuals with NSCLC harboring specific HER2 mutations.
The rise in technological advancements and the growing prevalence of target diseases such as cancer are the major factors driving the growth of the global AI-powered gene therapy market. The growth of cancer at an alarming rate for the last couple of years is a major concern in all regions globally. For instance, as per the American Cancer Society's Cancer Facts & Figures 2022, 1,918,030 new cancer cases and 609,360 deaths due to different types of cancer have been recorded in the United States in 2022.
For its treatment, several gene therapy strategies could be employed. These include anti-angiogenic gene therapy, pro-drug activating suicide gene therapy, gene therapy-based immune modulation, correction or compensation of gene defects, genetic manipulation of apoptotic pathways, and RNAi strategies, among others. Cancers such as liver, colorectal, prostate, bladder, brain, lung, breast, pancreatic, head and neck, skin, ovarian, and renal cancer have been the major targets of these gene therapies.
The main restraint in this market could be the lack of awareness about gene therapy. This market is still in its developing stage, and it would take time for it to be readily available in most healthcare facilities. Opportunities in the AI-powered gene therapy market include faster and more accurate disease diagnosis, precise gene editing, and personalized treatments. For example, In March 2022, the AI-powered gene therapy market saw significant opportunities with AI's potential to identify cancer subtypes, optimize therapies, enhance CRISPR precision, and tailor treatments to individual genetic profiles. The convergence of early cancer diagnosis and AI is driving innovation in healthcare, improving patient outcomes through more accurate and timely interventions.
North America is the prominent region that is contributing to the growth of the global AI Powered Gene Therapy Market. In which the United States continues to hold the largest market share for development and expansion of healthcare sector. For instance, in 2021, As per the Center for Disease Control and Prevention article on spinal muscular atrophy (SMA), it is a genetic disorder that affects every 1 person in 10,000 people. It is one of the rare diseases known to medical science. However, these numbers indicate the growing demand for gene therapy in the United States. These types of genetic disorders can be cured by timely screening and gene therapy.
After North America, Europe is the second leading region for the growth of global AI powered Gene Therapy Market. According to the guidelines for gene therapy by the European Union (EU), there has been immense research in the field which is in progress and the treatment through gene therapy is carried out all over Europe. This would ultimately boost the market in this region.
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