[188 Pages Report] The Gene Therapy Market size was estimated at USD 5.67 billion in 2023 and expected to reach USD 7.05 billion in 2024, at a CAGR 27.15% to reach USD 30.48 billion by 2030.
Gene therapy is a medical procedure that introduces, alters, or corrects genetic material within an individual's cells to treat or prevent disease. The primary purpose of gene therapy is to address genetic disorders by replacing or repairing faulty genes, introducing therapeutic genes, or regulating the expression of genes. This field holds great promise for treating various genetic and acquired diseases at their root cause. Several factors are contributing to the growth of the gene therapy market, including an increase in the prevalence of chronic conditions, a rise in acceptance of gene therapy treatment, a surge in clinical trials, and escalated R&D expenditure in the pharmaceutical sector. However, the cost of these therapies is exceptionally high, accompanied by a complex and lengthy development process. Additionally, concerns regarding off-target effects, immunogenicity, and long-term safety may hamper its market demand. Moreover, advanced technology development has opened several previously inaccessible gene editing and therapy frontiers. The gene therapy market is anticipated to grow further due to regulatory authorities' rising approval of gene therapy products, which brought forth many potential opportunities with targeted disease treatments.
The Americas has a significant landscape in gene therapy owing to rising research and innovation with significant investments in this domain. The gene therapy market has witnessed exponential growth, mainly due to the improved prevalence of chronic diseases, availability of funding for genetic research, a strong presence of industry players, and FDA approvals that significantly impact gene therapy trends. The European region shows considerable growth in the gene therapy sector due to advanced research in gene therapy due to its well-established pharmaceutical companies. The European Union invests heavily in healthcare research, including gene therapy. Countries lead in therapeutic clinical trials, particularly in oncology, cardiovascular, and inherited diseases. The Asia-Pacific region is a rapidly emerging market in the arena of gene therapy. The surge in clinical trials spurred by its burgeoning biotech sector and substantial government funding, fast-track innovative gene therapy research is further fueled by expanded market demand. Overall, the APAC region's growth in gene therapy is driven by a combination of large patient populations, growing healthcare expenditure, and evolving regulatory environments.
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Market Dynamics
The market dynamics represent an ever-changing landscape of the Gene Therapy Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
- Market Drivers
- Increasing Prevalence of Chronic Diseases and Upsurge in Number of Gene Therapy Treatment Centers
- Government Support and Ethical Acceptance of Gene Therapy For Treatments
- Market Restraints
- High Costs Associated with Gene Therapies
- Market Opportunities
- Ongoing Research & Development in Orphan Diseases and Advancements in Gene Therapy
- Innovative Payment Models and Favorable Regulatory Approvals
- Market Challenges
- Potential Harmful Effects and Moral Concerns Regarding New Gene Therapy
Market Segmentation Analysis
Type: Prevalence of cancer gene therapy for cancer treatment
Antigen gene therapy introduces genes that encode specific antigens into a patient's cells. The goal is stimulating the immune system to recognize and mount an immune response against cells expressing these antigens. This approach is often explored in cancer immunotherapy, where the immune system is encouraged to target and eliminate cancer cells. Cancer gene therapy aims to treat or eliminate cancer by targeting specific aspects of cancer cells. This therapy uses gene editing technologies to modify or correct specific genetic mutations associated with cancer. Cytokine gene therapy involves introducing genes encoding specific cytokines into the patient's cells. This approach aims to enhance the immune system's capacity to identify and eliminate cancer cells by introducing genes that produce immune-stimulating cytokines. Suicide gene therapy, also known as gene-directed enzyme prodrug therapy (GDEPT), involves introducing a gene that encodes an enzyme into target cells. The enzyme produced by the gene activates a prodrug (a non-toxic substance), converting it into a toxic drug selectively in the target cells. This approach is often used in cancer therapy to cause apoptosis in cancer cells. Tumor suppressor gene therapy focuses on restoring or enhancing the function of tumor suppressor genes. Tumor suppressor gene therapy aims to either replace or activate these genes to control or inhibit the growth of cancer cells.
Vector Type: Significant utilization of viral vector providing higher efficiency in delivering genes into cells
Non-viral vectors in gene therapy are carriers or delivery systems that do not involve viruses. These vectors transport therapeutic genetic material, such as DNA or RNA, into target cells to treat or prevent diseases. Non-viral vectors are considered safer in terms of immunogenicity than viral vectors and have some advantages in terms of ease of production and reduced risk of integration into the host genome. Viral vectors are vehicles or carriers derived from viruses modified to deliver therapeutic genetic material into target cells as part of gene therapy. These vectors are engineered to be safe and effective, taking advantage of the natural ability of viruses to enter cells and deliver their genetic payload. Viral vectors are key to many gene therapy strategies because they efficiently deliver genes into cells.
Porter’s Five Forces Analysis
The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Gene Therapy Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.
Value Chain & Critical Path Analysis
The value chain of the Gene Therapy Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of theGene Therapy Market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.
Regulatory Framework Analysis
The regulatory framework analysis for the Gene Therapy Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Gene Therapy Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Gene Therapy Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Recent Developments
Charles River Unveils Lentivation Platform to Expedite LVV-based Gene Therapy Manufacturing
Charles River introduced the Lentivation Platform to expedite the development of lentiviral-based gene therapies. This innovative platform empowers scientists with enhanced control over transgene expression, ensuring better safety and efficacy for gene therapy products. With the Lentivation Platform, researchers can stress the importance of transgene regulation, leading to improved outcomes in gene therapy treatments. This technology represents a significant advancement in gene therapy, offering a promising solution for addressing various genetic disorders and diseases. [Published On: September 26, 2023]
Laurus to launch Gene Therapy Assets in India
Laurus Labs introduced gene therapy-based assets in India, offering treatment options for retinal and muscular dystrophy. This development signifies the entry of the genetic medicine market in India, with industry experts anticipating significant opportunities in the field of gene therapy. [Published On: June 20, 2023]
Bluebird bio Lays Gene Therapy Launch Groundwork As Sickle Cell Application Nears
Bluebird Bio launched Zynteglo, its dual gene therapy. Gene therapy is a rapidly expanding medical research and treatment field, with Zynteglo offering potential cures for previously untreatable genetic diseases. This groundbreaking therapy brings hope to patients and opens up new possibilities in the fight against genetic disorders. [Published On: March 29, 2023]
Key Company Profiles
The report delves into recent significant developments in the Gene Therapy Market, highlighting leading vendors and their innovative profiles. These include Cellectis, Inc., Novartis AG, Biogen Inc., AnGes, Inc., Orchard Therapeutics PLC, Poseida Therapeutics, Inc., Astellas Gene Therapies, Sarepta Therapeutics, Inc., Uniqure N.V., Applied Genetic Technologies Corporation, Mustang Bio, Abeona Therapeutics Inc., Adaptimmune Therapeutics PLC, Shenzhen SiBiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Ionis Pharmaceuticals, Inc., Amgen Inc., Sangamo Therapeutics, Inc., AGC Biologics., Merck & Co., Inc., American Gene Technologies Inc., Editas Medicine, Inc., Bluebird Bio, Inc., Alnylam Pharmaceuticals, Inc., and Human Stem Cells Institute.
Market Segmentation & Coverage
This research report categorizes the Gene Therapy Market to forecast the revenues and analyze trends in each of the following sub-markets:
- Type
- Antigen Gene Therapy
- Cancer Gene Therapy
- Cytokine Gene Therapy
- Suicide Gene Therapy
- Tumor Suppressor Gene Therapy
- Vector Type
- Non-viral Vectors
- Viral Vectors
- Application
- Cardiovascular Diseases
- Genetic Diseases
- Infectious Diseases
- Neurological Diseases
- Oncological Disorders
- Region
- Americas
- Argentina
- Brazil
- Canada
- Mexico
- United States
- California
- Florida
- Illinois
- New York
- Ohio
- Pennsylvania
- Texas
- Asia-Pacific
- Australia
- China
- India
- Indonesia
- Japan
- Malaysia
- Philippines
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam
- Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom
- Americas
This research report offers invaluable insights into various crucial aspects of the Gene Therapy Market:
- Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
- Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
- Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
- Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
- Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.
Additionally, the report addresses key questions to assist stakeholders in making informed decisions:
- What is the current market size and projected growth?
- Which products, segments, applications, and regions offer promising investment opportunities?
- What are the prevailing technology trends and regulatory frameworks?
- What is the market share and positioning of the leading vendors?
- What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?
- Preface
- Research Methodology
- Executive Summary
- Market Overview
- Market Insights
- Gene Therapy Market, by Type
- Gene Therapy Market, by Vector Type
- Gene Therapy Market, by Application
- Americas Gene Therapy Market
- Asia-Pacific Gene Therapy Market
- Europe, Middle East & Africa Gene Therapy Market
- Competitive Landscape
- List of Figures [Total: 21]
- List of Tables [Total: 293]
- List of Companies Mentioned [Total: 25]
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- What is the Gene Therapy Market growth?
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