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The gene therapy market size is forecast to increase by USD 6.73 billion at a CAGR of 23.31% between 2023 and 2028. Gene therapy is an innovative medical field that holds great promise in the treatment of various chronic diseases. The U.S. Food and Drug Administration (FDA) has granted an increasing number of special drug designations to gene therapy products, underscoring their potential to address unmet medical needs. These designations include the Breakthrough Therapy Designation and the Accelerated Approval Program, which expedite the regulatory review process. Gene therapy offers several benefits over traditional treatments. It targets the root cause of diseases by introducing corrective genes into a patient's cells, potentially offering long-term solutions. Additionally, gene therapy may reduce the need for frequent dosing and offer more personalized treatment plans. The prevalence of chronic diseases continues to rise, creating a significant need for new and effective treatment options. Gene therapy holds promise in addressing various chronic conditions, including genetic disorders, cancer, and infectious diseases. As research and development in this field progress, we can expect to see more gene therapy products reach the market and transform the way we approach disease treatment.
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Clinical research initiatives in the genomics field have paved the way for advanced targeted therapies and the integration of traditional medicines. With a robust clinical pipeline, extensive preclinical testing and rigorous clinical trials, these therapies have gained regulatory approval for their efficacy in treating various neurology indications and other disease indications. The use of cell and gene therapies has revolutionized medical treatments, utilizing viral vectors for delivery and ensuring adequate shelf life and temperature control. Techniques such as gene silencing, cell replacement, and gene augmentation have proven effective in addressing conditions like metachromatic leukodystrophy through ex vivo gene therapy, gene replacement, and cutting-edge gene editing modalities. The development of molecular carriers and non-viral vectors has expanded the potential of these therapies beyond neurology and into other fields such as oncology. The commercial water heaters market, like clinical research, embraces innovation and continuous improvement to meet the diverse needs of customers. Our researchers analyzed the market research and growth data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The increase in special drug designations is one of the key drivers supporting the market growth. Most of the programs received designations such as orphan drug designation, fast track designation, and breakthrough designation from the US FDA, the EMA, and other regulatory bodies, for the treatment of certain disorders. These designations provide certain benefits to pharmaceutical companies.
For instance, orphan drug designation is given to the drugs that are being developed to treat rare diseases that affect less than 200,000 people in the US. When a drug receives orphan drug designation, the company receives market exclusivity for ten years instead of seven years. Orphan drug status also helps the company with tax benefits in the next research by the company. Such benefits of special drug designations will drive the market during the forecast period.
Growing research in gene therapy for CVDs and orphan diseases is one of the key market trends that is contributing to the market growth. Various research organizations and institutes play a significant role in the market. The market is witnessing continuous change owing to mergers and acquisitions (M&A). Small companies and research institutes have collaborations and partnerships with the giant leaders of the pharmaceutical industry. This further helps the market leaders to expand their area of research and product portfolio.
On the other hand, it proves to be a big financial support for small and new companies. Some of the major collaborations in the market are the collaboration between Celgene and Bluebird Bio and Adapt Immune and GlaxoSmithKline. Such growing research will boost the market during the forecast period.
High treatment costs is one of the factors hindering the market growth. The cost of gene therapies is in the range of USD 300,000- USD 1,200,000. It works differently on various individuals, and unlike other biological molecules and small molecules, it needs to be tailored for each individual separately.
Furthermore, the mutated gene in the cell is extracted from the patient and is modified in the laboratory. The modified stem cells are introduced into the patient using a viral vector administered through the intravenous route. This increases the cost of manufacturing, thus increasing the overall cost. Such increasing costs will be a challenging factor for the demand of the market during the forecast period.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.
Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Abeona Therapeutics Inc.: The company offers Phase 3 VIITAL Clinical Trial of EB 101. Also, under this segment, the company offers solutions to treat diseases including cancer, genetic diseases, and infectious diseases.
The research report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market share growth by the In Vivo will be significant during the forecast period. In this segment, owing to the high success rate of treatment, many companies are focusing on developing novel gene therapies. For instance, Novartis received approval from the US FDA to launch Kymriah (tisagenlecleucel) for the treatment of B-cell precursor acute lymphoblastic leukemia. Kymriah is a CAR T-cell-based gene therapy. It showed positive results in clinical trials in humans. The global market by oncology is expected to increase the demand during the forecast period owing to the entry of new therapies into the market globally.
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The In Vivo segment was valued at USD 1.30 billion in 2018. The global oncology drugs market has a huge unmet demand for the treatment of various indications. Also, the increasing prevalence of cancer indications led pharmaceutical companies and research organizations to conduct substantial research on the development of drugs for these indications. The lack of efficacy of the small molecules and biological molecules made the companies move toward effective treatment options. Several approaches were developed for the management of cancer, including anti-angiogenic gene therapy, suicide gene therapy, immunotherapy, siRNA therapy, pro-apoptotic gene therapy, oncolytic virotherapy, and gene-directed enzyme pro-drug therapy.
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North America is estimated to contribute 40% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional market growth and trends that shape the market during the forecast period.
The US has become a lucrative market for investments in the market in North America. This is because of the funding provided by government departments such as the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) to small-scale industries and companies that are focusing on developing novel products. The increasing funds from government and private organizations will foster the development of gene therapies during the forecast period. Due to the funding, about 18 clinical trials and 17 startup biotechnology companies are being set up in the country. Therefore, such funding is expected to contribute to the market demand during the forecast period.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
Genome Editing Market: Genome Editing Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, UK, Germany, China - Size and Forecast
Gene Panel Market: Gene Panel Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, UK, China, France - Size and Forecast
Gene Synthesis Services Market: Gene Synthesis Services Market Growth, Size, Trends, Analysis Report by Type, Application, Region and Segment Forecast
The market is rapidly advancing, driven by the potential of biological therapies in various therapeutic areas including hepatology. The integration of advanced technologies and diagnostics has paved the way for groundbreaking developments in this field. The market requires robust infrastructure and collaboration with hospitals for successful implementation. Non-viral vectors, such as nanoparticles and hybrid vector systems, are gaining traction due to their safety and effectiveness. With substantial capital investments and advancements in gene modification and genome sequencing, manipulation technologies and molecular switches are becoming more precise.
Furthermore, the delivery platforms and gene delivery methods are critical factors in ensuring successful treatment outcomes. Regulatory landscapes and reimbursements play a vital role in shaping commercialization strategies for marketed gene therapies and late-stage gene therapies. Mechanisms of action, patent portfolio strength, and emerging technologies are driving innovation in therapy development platforms. Clinical studies and pricing of gene therapies are essential considerations for both startup companies and big pharma players. Targeting specific therapeutic areas, the market holds significant promise for patients worldwide.
Industry Scope |
|
Report Coverage |
Details |
Page number |
177 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 23.31% |
Market growth 2024-2028 |
USD 6.73 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
18.59 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 40% |
Key countries |
US, UK, China, Canada, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Abeona Therapeutics Inc, Adaptimmune Therapeutics plc, Adverum Biotechnologies Inc, Amgen Inc., Astellas Pharma Inc., Biogen Inc., bluebird bio Inc., Editas Medicine Inc., ElevateBio, F. Hoffmann La Roche Ltd., Generation Bio Co., Gilead Sciences Inc., Novartis AG, Orchard Therapeutics Plc, Poseida Therapeutics Inc., Sangamo Therapeutics Inc, Sibiono GeneTech Co. Ltd., Syncona Ltd., uniQure NV, and Voyager Therapeutics Inc |
Market dynamics |
Parent market analysis, Market forecasting growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Delivery Mode
7 Market Segmentation by Therapy Area
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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