Rising prevalence of genetic diseases and malignancies, growing investments in gene therapy research, and developments in viral vector production technologies are driving fast expansion of the market. By stressing the need of viral vectors in vaccine development, the COVID-19 epidemic has sped up market development even further.
Market trend: toward next-generation vector technologies for better gene delivery and expression
Next-generation vector technologies are clearly driving a major trend toward development and acceptance in the industry for viral vector and plasmid DNA manufacture. Comparatively to conventional vectors, these new vectors provide better gene delivery efficiency, payload capacity, and safety profiles. To get beyond the constraints of traditional systems, researchers and biopharmaceutical companies are heavily funding fresh vector innovations including modified viral vectors, hybrid vectors, and non-viral vectors. The quest for more exact and efficient gene therapies as well as the expanding requirement for vectors able of targeting particular cell types or tissues drive this trend. Since CRISpen-Cas9 gene editing technology demands effective delivery mechanisms for therapeutic uses, its development has driven this tendency even more. To develop and commercialize these next-generation vector technologies, academic institutions and industrial companies are therefore seeing a boom in cooperation between them, hence fostering innovation and market expansion.
Market Driver: Rising frequency of genetic diseases and malignancies fueling need for gene therapies
The North America viral vector and plasmid DNA manufacturing market is much driven by the growing frequency of genetic diseases and malignancies. Growing attention is on creating focused gene treatments to treat these disorders as knowledge of genetic elements in disease progression advances. Millions of people in North America have genetic diseases such cystic fibrosis, hemophilia, and muscular dystrophy, so generating a significant patient pool for gene therapy therapies. Similar high frequency of some tumors has resulted in more research and development of oncolytic virus treatments and gene-based immunotherapies. Pharmaceutical companies and venture capitalists have made large investments in gene treatments because of their promise to provide long-lasting or even curative effects for once untreatable diseases. This flood of money has sped up the creation of gene therapy pipelines, hence increasing the demand for plasmid DNA synthesis capacity in the area and viral vectors.
Restrain:High prices and complicated legal environment impeding market expansion
High production costs and a complex regulatory environment provide major obstacles for the North America viral vector and plasmid DNA manufacturing sector. Viral vectors and plasmid DNA are produced in a complex manner needing certain facilities, tools, and knowledge. For smaller businesses and research labs, these elements can be prohibitively expensive upfront investments and continuous running expenses. Furthermore changing and complicated is the regulatory environment for gene therapies and associated manufacturing techniques, which now demand strict safety, quality, and efficacy. Managing this regulatory environment can be time-consuming and expensive, thereby postponing the launch of products into the market and maybe product development. The final pricing of gene treatments also reflects the great expenses involved in vector manufacture, therefore restricting patient access and reimbursement possibility. These elements together slow down the expansion of the market by imposing obstacles to entrance for new competitors and difficulties scaling production to satisfy increasing demand.
Thanks to its safety profile and adaptability, adeno-associated virus (AAV) vectors rule the market.
Leading section in North America viral vector and plasmid DNA production market is Adeno-associated virus (AAV) vectors. Among the various benefits AAV vectors provide include minimal immunogenicity, transducing both dividing and non-dividing cells, and long-term gene expression. From uncommon genetic diseases to more common problems including heart disease and neurological disorders, these features make AAV vectors especially appropriate for a broad spectrum of gene therapy uses. AAV-based gene treatments' success in clinical trials and subsequent FDA approvals has confirmed even more its preferred vector for many developers. Increased investment in AAV production capabilities and continuous research to create better AAV variants with enhanced tissue tropism and transduction efficiency follow from this supremacy.
Leading the market with excellent research facilities and a favorable regulatory environment is United States
With the highest market share, the United States rules the North America viral vector and plasmid DNA manufacturing market. A strong biotechnology and pharmaceutical industry, major governmental and private investment in gene therapy research, and a supportive regulatory environment help to explain this leadership role. The nation boasts top-notch research facilities and a significant concentration of biotech enterprises, so encouraging innovation and field-of- expertise in gene therapy. Initiatives by the FDA to hasten the approval and development of gene treatments, including the Regenerative Medicine Advanced Therapy (RMAT) classification, which has pushed investment and hastened clinical development schedules, Furthermore supporting the nation's manufacturing capacity are significant contract development and manufacturing companies (CDMOs) focused in viral vector production. A sizable patient population and a healthcare system progressively using new technologies help the US market as well, raising demand for viral vectors and plasmid DNA production technologies.
Strong rivalry and fast technical developments define the North America viral vector and plasmid DNA production market. Important participants in the industry are contract manufacturing companies (CMOs), specialized gene therapy developers, and big pharmaceutical companies with internal production capacity. To satisfy the rising demand for viral vectors and plasmid DNA, these businesses are heavily spending on increasing their manufacturing capacity and upgrading production methods. Common as businesses try to improve their competencies and market position are strategic alliances, mergers, and acquisitions. Emerging biotech businesses and academic institutes creating new vector technologies also bring more competition for the market. Companies are concentrating on streamlining manufacturing processes, cutting costs, and providing end-to-end services from early-stage development to commercial manufacture if they are to keep a competitive edge. The fight to protect intellectual property rights for original vector designs and manufacturing techniques shapes the competitive scene even further.
Thermo Fisher Scientific Inc.
Merck KGaA
Lonza Group AG
Charles River Laboratories
Catalent, Inc.
Takara Bio Inc.
Vigene Biosciences, Inc.
FUJIFILM Diosynth Biotechnologies
Bluebird Bio, Inc.
Spark Therapeutics, Inc.
Uniqure N.V.
Oxford Biomedica plc
1. INTRODUCTION
1.1. Market Definition
1.2. Study Scope
1.3. Currency Conversion
1.4. Study Period (2022- 2031)
1.5. Regional Coverage
2. RESEARCH METHODOLOGY
2.1. Primary Research
2.2. Secondary Research
2.3. Company Share Analysis
2.4. Data Triangulation
3. EXECUTIVE SUMMARY
3.1. Global North America Viral Vector And Plasmid DNA Manufacturing Market (2018 – 2022)
3.2. Global North America Viral Vector And Plasmid DNA Manufacturing Market (2023 – 2031)
3.2.1. Market Segment By Vector Type (2023 – 2031)
3.2.2. Market Segment By Application (2023 – 2031)
3.2.3. Market Segment By Disease (2023 – 2031)
3.2.4. Market Segment By End User (2023 – 2031)
4. MARKET DYNAMICS
4.1. Market Trends
4.1.1. Shift towards next-generation vector technologies for enhanced gene delivery and expression
4.1.2. Adoption of single-use technologies in vector manufacturing
4.1.3. Increasing focus on scalable and cost-effective production methods
4.2. Market Drivers
4.2.1. Increasing prevalence of genetic disorders and cancers driving demand for gene therapies
4.2.2. Growing investment in cell and gene therapy research
4.2.3. Advancements in vector design and manufacturing technologies
4.3. Market Restraints
4.3.1. High costs and complex regulatory landscape hindering market growth
4.3.2. Manufacturing capacity constraints and supply chain challenges
4.4. Porter's Five Forces Analysis
4.4.1. Threat of New Entrants
4.4.2. Bargaining Power of Buyers/Consumers
4.4.3. Bargaining Power of Suppliers
4.4.4. Threat of Substitute Products
4.4.5. Intensity of Competitive Rivalry
4.5. Supply Chain Analysis
4.6. Pricing Analysis
4.7. Regulatory Analysis
4.8. Pipeline Analysis
5. BY VECTOR TYPE (MARKET VALUE (US$ MILLION) – 2022-2031*)
5.1. Adenovirus
5.2. Lentivirus
5.3. Retrovirus
5.4. Adeno-associated virus
5.5. Others
6. BY APPLICATION
6.1. Gene Therapy
6.2. Vaccinology
6.3. Cell Therapy
7. BY DISEASE
7.1. Cancer
7.2. Genetic Disorders
7.3. Infectious Diseases
7.4. Others
8. BY END USER
8.1. Pharmaceutical and Biopharmaceutical Companies
8.2. Research Institutes
9. GEOGRAPHY
9.1. North America
9.1.1. United States
9.1.2. Canada
9.1.3. Mexico
10. COMPETITIVE LANDSCAPE
10.1. Key Developments
10.2. Company Market Share Analysis
10.3. Product Benchmarking
11. SWOT ANALYSIS
12. COMPANY PROFILES
12.1. Thermo Fisher Scientific Inc.
12.2. Merck KGaA
12.3. Lonza Group AG
12.4. Charles River Laboratories
12.5. Catalent, Inc.
12.6. Takara Bio Inc.
12.7. Vigene Biosciences, Inc.
12.8. FUJIFILM Diosynth Biotechnologies
12.9. Bluebird Bio, Inc.
12.10. Spark Therapeutics, Inc.
12.11. Uniqure N.V.
12.12. Oxford Biomedica plc (*LIST NOT EXHAUSTIVE)
13. MARKET OPPORTUNITIES
By Vector Type:
Adenovirus
Lentivirus
Retrovirus
Adeno-associated virus
Others
By Application:
Gene Therapy
Vaccinology
Cell Therapy
By Disease:
Cancer
Genetic Disorders
Infectious Diseases
Others
By End User:
Pharmaceutical and Biopharmaceutical Companies
Research Institutes
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