Tuesday, 02 January 2024 12:17 GMT

Viral Vectors And Plasmid DNA Manufacturing Market To Reach US$ 20.30 Billion By 2033 Astute Analytica


(MENAFN- GlobeNewsWire - Nasdaq) The market stands on the precipice of unprecedented expansion. Driven by substantial investments, groundbreaking therapeutic pipelines, and advanced technological integration, the industry is poised for transformative growth. Strategic collaborations, a supportive regulatory environment, and dedicated talent development further fortify its foundation.

Chicago, Aug. 25, 2025 (GLOBE NEWSWIRE) -- The global viral vectors & plasmid DNA manufacturing market was valued at US$ 4.21 billion in 2024 and is expected to reach US$ 20.30 billion by 2033, growing at a CAGR of 19.1% during the forecast period 2025–2033.

The global viral vectors & plasmid DNA manufacturing market is witnessing aggressive capacity expansion. Leading CDMO A anticipates adding 150,000 square feet of new GMP manufacturing space by mid-2025 for viral vectors. Global CDMO B projects operationalizing 8 new commercial-scale bioreactors for plasmid DNA production by Q3 2024. Specialized CDMO C plans to increase its lentiviral vector production capacity by 200 liters by year-end 2024. Across the top 5 CDMOs, a collective 35 new manufacturing suites are expected to become cGMP operational for gene therapies by 2025. Emerging CDMO D forecasts a 5-fold increase in its plasmid DNA batch output by early 2025 to meet surging demand.

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Key players in the viral vectors & plasmid DNA manufacturing market are expected to invest over $750 million into facility upgrades and expansions through 2025. The number of operational single-use bioreactors for viral vector production is projected to grow by 40% across major CDMOs by 2024. These substantial investments underscore a proactive approach to meet escalating global requirements.

Key Findings in Viral Vectors & Plasmid DNA Manufacturing Market

Market Forecast (2033) US$ 20.30 billion
CAGR 19.1%
Largest Region (2024) North America (50%)
By Vector Type AAV (22%)
By Application Vaccinology (26%)
By Workflow Downstream Processing (55%)
By Disease Cancer (39%)
Top Drivers
  • Robust clinical pipeline for cell and gene therapies expands.
  • Rising prevalence of cancer and genetic disorders fuels demand.
  • Increased funding and investment in biopharmaceutical research and development.
Top Trends
  • Shift towards scalable manufacturing platforms and suspension cell cultures.
  • Growing adoption of in-vivo gene therapies reducing treatment complexity.
  • Development of next-generation capsids with enhanced targeting and safety.
Top Challenges
  • Complex downstream processing hurdles
  • Stringent and evolving regulatory requirements create development complexities.
  • Managing host immune responses to viral vectors limits applicability.

Strategic Capital Inflow Propelling Innovation in the Market

Significant financial commitment is flowing into the viral vectors & plasmid DNA manufacturing market. Venture capital funding for gene and cell therapy startups requiring viral vectors & plasmid DNA manufacturing is projected to exceed $15 billion in 2024. Large pharmaceutical companies are anticipated to allocate an additional $500 million towards partnerships with viral vectors & plasmid DNA manufacturing CDMOs in 2025. Private equity firms are forecast to close 12 significant acquisitions or growth equity deals in the viral vector and plasmid DNA space by Q4 2024. Government grants supporting advanced therapy manufacturing infrastructure are expected to reach $200 million globally in 2024. A top-tier viral vectors & plasmid DNA manufacturing company is planning a $100 million Series B funding round in Q1 2025 to scale operations.

Total R&D spending by biotech companies on gene therapies utilizing advanced vectors is projected to surpass $25 billion globally in 2025. Infrastructure bonds dedicated to life sciences parks featuring viral vectors & plasmid DNA manufacturing capabilities are expected to issue over $1 billion by 2025. Strong financial backing highlights the market's immense potential and investor confidence.

Burgeoning Therapeutic Pipelines Fueling Demand

The therapeutic pipeline for gene and cell therapies continues its remarkable expansion, directly fueling demand for the viral vectors & plasmid DNA manufacturing market. The number of gene therapy programs in Phase III clinical trials is projected to reach 120 globally by 2024, driving demand for viral vectors. Regulatory agencies are anticipated to approve 8-10 new gene therapy products that rely on viral vectors & plasmid DNA manufacturing in 2025. Orphan drug designations for gene therapies requiring specialized viral vectors are expected to climb by 15% in 2024.

Approximately 30 new IND (Investigational New Drug) applications for viral vector-based therapies are projected for submission in 2024. Cell therapy programs requiring feeder plasmids are forecast to double their pre-clinical stage volume by Q2 2025. The number of clinical trial sites for gene therapy studies is expected to expand by 25% by 2025, increasing manufacturing requirements. Oncology applications for viral vector therapies are projected to account for 60% of new clinical trial starts in 2024. The escalating number of clinical programs signals a robust future for gene and cell therapies.

Advanced Technologies Revolutionizing Biomanufacturing Processes

Technological innovation is profoundly transforming the viral vectors & plasmid DNA manufacturing market. Adoption of automated viral vector filling lines is expected to increase by 30% across major manufacturers by 2024. Implementation of AI/ML algorithms for process optimization in viral vectors & plasmid DNA manufacturing is projected in 20 new facilities by 2025. The yield of AAV vectors per batch is expected to improve by 10-15% on average across the industry due to process enhancements by 2024. Continuous manufacturing platforms for plasmid DNA are anticipated to be adopted by 5 additional major players by 2025.

Single-use technologies are forecast to comprise 80% of new bioreactor installations for viral vectors & plasmid DNA manufacturing in 2024. Companies are expected to reduce downstream processing time for viral vectors by 20% through novel purification methods by 2025. The number of companies utilizing analytical tools for real-time quality control of plasmid DNA is projected to increase by 40% in 2024. Advanced technologies are enhancing efficiency, scalability, and product quality significantly.

Global Footprint Expansion Addressing Regional Needs

The global viral vectors & plasmid DNA manufacturing market is expanding its geographical footprint to address localized demand. North America is expected to initiate 40% of all new gene therapy clinical trials globally in 2024, driving regional viral vectors demand. Asia-Pacific based CDMOs are projected to attract $300 million in new manufacturing contracts for viral vectors & plasmid DNA by 2025. Europe is expected to see the establishment of 7 new specialized viral vectors & plasmid DNA manufacturing sites by 2024. China's domestic gene therapy pipeline is projected to grow by 25% in 2025, increasing localized viral vectors & plasmid DNA manufacturing needs. The number of viral vectors & plasmid DNA manufacturing facilities with a global reach is expected to increase by 10% by 2024. Emerging markets are anticipated to launch 5 new clinical programs for gene therapies, necessitating regional manufacturing solutions by 2025. Latin America is projected to witness the opening of 2 new strategic partnerships for viral vectors & plasmid DNA manufacturing collaborations in 2024. Decentralized manufacturing capabilities are crucial for global accessibility and responsiveness.

Collaborative Synergies Strengthening Supply Ecosystems

Strategic collaborations are a cornerstone of growth in the viral vectors & plasmid DNA manufacturing market. Top 3 CDMOs in the market are expected to sign a combined 15 new long-term supply agreements by Q4 2024. Biotech companies are anticipated to establish 20 new co-development or manufacturing agreements with specialist viral vectors & plasmid DNA manufacturers in 2025. The number of strategic alliances between academic institutions and commercial manufacturers for viral vector research is projected to increase by 18% in 2024. Large pharmaceutical companies are forecast to initiate 10 new strategic outsourcing deals for viral vectors & plasmid DNA manufacturing by 2025.

Gene therapy developers are expected to form 8 new joint ventures focused on accelerating viral vector production capabilities in 2024. The average duration of new viral vectors & plasmid DNA manufacturing contracts is projected to extend to 5 years by 2025. Companies providing ancillary materials are expected to secure 25 new supply chain partnerships with viral vectors & plasmid DNA manufacturers in 2024. These partnerships foster innovation and ensure consistent supply.

Evolving Regulatory Frameworks Ensuring Quality and Safety

The regulatory landscape for the viral vectors & plasmid DNA manufacturing market is continuously evolving to support innovation while upholding safety. Global regulatory bodies are expected to release 5 new guidance documents impacting viral vectors & plasmid DNA manufacturing quality and safety by 2024. The number of regulatory audits for gene therapy manufacturing facilities is projected to increase by 15% in 2025. Companies are anticipated to invest over $50 million in compliance systems and personnel training for viral vectors & plasmid DNA manufacturing in 2024. Harmonization efforts for viral vectors & plasmid DNA manufacturing standards are expected to result in 2 key international agreements by 2025. The average time for regulatory approval of new viral vector-based therapies is projected to slightly decrease by 3 months by 2024 due to expedited pathways. Number of successful BLA (Biologics License Application) submissions for gene therapies is expected to reach 10 in 2025, signifying robust regulatory navigation. Regulatory bodies are anticipated to approve 3 new fast-track designations for novel viral vector technologies by 2024. A proactive regulatory environment is vital for market maturation.

Talent Development Cultivating Future Capabilities

The demand for specialized expertise within the viral vectors & plasmid DNA manufacturing market is driving significant workforce development initiatives. The demand for skilled bioprocess engineers in viral vectors & plasmid DNA manufacturing is projected to grow by 20% in 2024. Leading CDMOs are expected to collectively hire 1,000 new full-time employees for their viral vectors & plasmid DNA manufacturing operations by 2025. Academic institutions are anticipated to launch 10 new specialized training programs focusing on gene therapy manufacturing by 2024.

The number of internships offered by viral vectors & plasmid DNA manufacturing companies is projected to increase by 30% in 2025. Companies are expected to invest $20 million in upskilling their existing workforce in advanced viral vector purification techniques by 2024. The average salary for senior-level viral vectors & plasmid DNA manufacturing scientists is projected to increase by 8% by 2025. Collaborations between industry and vocational schools are expected to produce 500 new technicians ready for viral vectors & plasmid DNA manufacturing roles by 2024. Cultivating a robust talent pool is critical for sustained market growth.

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Resilient Supply Chains Meeting Surging Global Demand

Ensuring robust raw material supply chains is paramount for the expanding viral vectors & plasmid DNA manufacturing market. The number of qualified suppliers for critical raw materials like cell culture media and plasmids is expected to grow by 12% in 2024. Investments in in-house production of key raw materials by viral vectors & plasmid DNA manufacturing companies are projected to exceed $150 million by 2025. Implementation of advanced supply chain traceability systems is anticipated in 25 new facilities by 2024. The lead time for procuring specialized viral vector production components is projected to decrease by 2 weeks on average by 2025. Companies are expected to establish 5 new multi-year agreements with key raw material suppliers to ensure supply stability by 2024. The use of animal-free components in viral vectors & plasmid DNA manufacturing is projected to increase by 20% in 2025.

Reshoring initiatives for critical raw materials are expected to bring 3 new manufacturing sites online in North America and Europe Viral vectors & plasmid DNA manufacturing market by 2024. The total number of patients enrolled in viral vector-based gene therapy clinical trials is projected to surpass 15,000 globally by 2024. Pediatric gene therapy clinical trials are expected to increase by 10% in volume by 2025, requiring specialized viral vectors. Rare disease indications are projected to account for 70% of new gene therapy clinical trial starts in 2024. The average size of a gene therapy clinical trial cohort is expected to increase by 5 patients by 2025 to gather more robust data. The number of clinical trial sites for ex-vivo gene therapies, heavily reliant on viral vectors & plasmid DNA manufacturing, is projected to expand by 15% by 2024. Phase I/II gene therapy trials are anticipated to collectively enroll 5,000 new patients in 2025, driving early-stage viral vectors demand. Global gene therapy approvals are expected to treat over 1,000 patients annually by 2025, requiring consistent viral vectors & plasmid DNA manufacturing. These efforts ensure continuous production and broader patient access.

Viral Vectors and Plasmid DNA Manufacturing Market Major Players:

  • ABNOVA
  • BGI Genomics
  • Boehringer Ingelheim
  • Catalent Inc.
  • Cobra Biologics
  • FinVector
  • Fujifilm Diosynth Biotechnologies
  • GenScript
  • Lonza
  • Medigen Biotechnology Corp
  • Oxford Biomedica
  • Sarepta Therapeutics
  • Synthra
  • Takara Bio
  • Thermo Fisher Scientific
  • UniQure NV
  • Univercells
  • Viralgen
  • Wuxi AppTec
  • Other Prominent Players

Key Market Segmentation:

By Vector Type

  • AAV
  • Plasmid DNA
  • Lentivirus
  • Adenovirus
  • Retrovirus
  • Others

By Application

  • Vaccinology
  • Gene Therapy
  • Antisense &RNAi
  • Cell Therapy

By Disease

  • Cancer
  • Genetic Disorders
  • Infectious Diseases
  • Others

By Workflow

  • Upstream Processing
    • Vector Amplification & Expansion
    • Vector Recovery/Harvesting
  • Downstream Processing
    • Fill-finish
    • Purification

By End-User

  • Research Institutes
  • Biopharmaceutical and Pharmaceutical Companies

By Region

  • North America
  • Europe
  • Asia Pacific
  • Middle East & Africa
  • South America

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About Astute Analytica

Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.

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