Rockville , July 10, 2023 (GLOBE NEWSWIRE) -- As per Fact.MR, a provider of market research and competitive intelligence, the global gene therapy market is expected to witness a CAGR of 18.5% during the forecast period due to a significant increase in the number of cases of rare diseases.
The prevalence of rare disorders has significantly increased, which has increased demand for cell and gene therapy. Ex-vivo gene therapy is gaining acceptance for neurological therapies, which is anticipated to fuel market expansion for gene therapy until 2032.
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Key Driving Forces Accelerating the Market Growth
- The rising prevalence of genetic disorders, such as inherited diseases and genetic cancers, has created a substantial demand for gene therapy. North America has a significant population affected by genetic disorders, and gene therapy offers potential treatments and cures for these conditions.
- Significant advancements in gene therapy technologies, including viral vectors, gene editing tools (such as CRISPR-Cas9), and gene delivery systems, have enhanced the effectiveness and safety of gene therapy. These technological breakthroughs have expanded the scope of gene therapy applications, attracted increased investments, and driven market growth.
- North America, particularly the United States, has established a supportive regulatory environment for gene therapy. The U.S. Food and Drug Administration (FDA) has implemented expedited approval pathways, such as the Breakthrough Therapy designation, to accelerate the development and commercialization of gene therapies. This favorable regulatory landscape has facilitated market growth by reducing barriers and timelines for product approvals.
- The gene therapy sector in various geographies including North America has attracted significant investments from venture capitalists, pharmaceutical companies, and government organizations. The availability of substantial funding has supported research and development activities, clinical trials, and the commercialization of gene therapies.
Vital Indicators Shaping Future Of The Industry
Regulatory agencies play a crucial role in shaping the future of the gene therapy market. Changes in regulatory frameworks, guidelines, and approval processes can have a profound impact on the speed of product development, market access, and adoption of gene therapies. Continued collaboration and dialogue between regulators, industry stakeholders, and researchers will be essential for ensuring a supportive and agile regulatory environment.
The field of gene editing, particularly tools like CRISPR-Cas9, continues to evolve rapidly. Ongoing research and advancements in gene editing technologies have the potential to revolutionize the gene therapy landscape. Further improvements in the precision, efficiency, and safety of gene editing techniques will expand the therapeutic applications and drive the future growth of the gene therapy market.
As gene therapies progress from clinical trials to commercialization, scalable manufacturing processes, and infrastructure become critical. The ability to produce gene therapies at a large scale and with consistent quality is vital for meeting the increasing demand and ensuring affordability. Advances in manufacturing technologies, process optimization, and supply chain logistics will shape the future scalability and accessibility of gene therapies.
The cost-effectiveness and reimbursement of gene therapies are significant considerations for their adoption and market growth. Developing sustainable reimbursement models that balance the high upfront costs of gene therapies with long-term clinical and economic benefits will be crucial.
Key Companies Profiled in This report
- Novartis AG
- Gilead Sciences Inc.
- Spark Therapeutics Inc.
- Sibiono GeneTech Co. Ltd.
- CELGENE CORPORATION
- Orchard Therapeutics Limited
- BioNTech
Challenges Hindering The Market Growth
Gene therapy development involves extensive research, preclinical studies, and rigorous clinical trials, which can be time-consuming and expensive. The high cost of development, including manufacturing, regulatory compliance, and infrastructure requirements, poses a significant challenge for smaller biotech companies and academic institutions in bringing gene therapies to market. The substantial upfront investment required can hinder the growth of the market.
Manufacturing gene therapies is a complex and challenging process. The production of viral vectors, gene delivery systems, and gene editing tools requires specialized facilities, expertise, and quality control measures. Scaling up manufacturing processes while maintaining product consistency and quality adds further complexity.
How competition influences the market
- Competition encourages companies to differentiate their gene therapies in terms of technology, therapeutic targets, delivery systems, and clinical applications.
- In October 2021, US FDA, pharmaceutical companies, and non-profit organizations collaborated to accelerate the growth of gene therapies for millions of Americans who had suffered from rare disease.
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Key Segments Covered in Gene Therapy Industry Research Report
- By Product :
- Yescarta-based
- Kymriah-based
- Luxturna-based
- Strimvelis-based
- Gendicine
- Others
- By Application :
- Ophthalmology
- Oncology
- Adenosine Deaminase/Deficient Severe Combined Immunodeficiency (ADA-SCID)
- By Region :
- North America
- Latin America
- Europe
- East Asia
- South Asia
- MEA
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Genetic Testing Services Market Outlook: Adoption of genetic testing services is forecasted to increase at a CAGR of 8% through 2033.
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