Global Plasmid DNA Manufacturing Research Analysis Report 2023-2035: Expansion of Facilities for Building GMP Plasmid Manufacturing Capabilities

DUBLIN, Oct. 13, 2023 /PRNewswire/ -- The "Plasmid DNA Manufacturing Market by Scale of Operation, Application Area, Therapeutic Area, and Geography: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.

The global plasmid DNA manufacturing market is expected to grow at compounded annual growth rate (CAGR) of ~15% during 2023-2035

This report presents an extensive examination of the current landscape, market size, and forthcoming opportunities within the plasmid DNA manufacturing sector throughout the projected period. It underscores the contributions of various stakeholders involved in this rapidly emerging segment of the pharmaceutical industry.

The primary objective of this market report is to deliver a comprehensive market forecast analysis, estimating the existing market size and future prospects for plasmid manufacturers in the coming decade. Drawing upon multiple parameters, likely adoption patterns, and primary validations, the publisher has furnished a well-informed projection of market evolution from 2023 to 2035.

The plasmid DNA manufacturing market is a dynamic and swiftly expanding sector with a crucial role in biotechnology and genetic research. Plasmid DNA, a circular, double-stranded DNA molecule capable of independent replication from chromosomal DNA, is genetically engineered and plays a pivotal role in the development of Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, as well as nucleic acid vaccines. It's worth noting that the current demand for plasmid DNA is experiencing exponential growth, driven by the expanding landscape of cell and gene therapies.

This demand surge was further amplified by the global COVID-19 pandemic, as plasmid-based delivery methods became indispensable for RNA/DNA vaccine and therapeutic development. During this period, major pharmaceutical players like Moderna and Pfizer-BioNTech employed plasmid-based platforms for their mRNA vaccines, significantly boosting the demand for plasmid DNA.

However, plasmid production presents various challenges, including low yields, plasmid stability issues, and regulatory considerations, necessitating specialized facilities and adherence to Good Manufacturing Practices (GMP). Consequently, an increasing number of researchers and drug developers are turning to contract service providers with specialized expertise and advanced technologies to meet their GMP plasmid manufacturing needs.

These service providers offer comprehensive solutions encompassing process development and optimization, plasmid construction, plasmid design, and plasmid engineering. Moreover, specialized service providers streamline the pDNA manufacturing process, optimize resource utilization, and ensure the delivery of high-quality plasmid DNA that meets the stringent requirements of regulatory bodies and research standards.

With the rising demand for ATMPs and the growing trend of outsourcing pDNA manufacturing operations, the plasmid DNA manufacturing market is poised for substantial growth in the forecast period.

Key Market Insights

Enhanced Reliability on pDNA Manufacturing Service Providers

The development and manufacturing of plasmid DNA requires significant investment in terms of time, expertise, and resources. While a few large pharmaceutical companies have established in-house manufacturing facilities, the need for substantial capital investment and complex infrastructure to produce plasmid DNA has led many other drug developers to outsource pDNA manufacturing operations to specialized service providers.

Consequently, there has been an increased emphasis on collaboration, aimed at outsourcing pDNA manufacturing operations to experienced partners. Outsourcing offers a viable solution to overcome challenges associated with plasmid stability, ensuring the integrity and functionality of the desired DNA constructs.

Plasmid Manufacturer Market Landscape

The current market landscape features the presence of over 70 companies offering a range of plasmid DNA services, including plasmid design, plasmid engineering, plasmid construction, process development and optimization, and plasmid manufacturing.

Overall, the market seems to be well-fragmented, featuring the presence of very small, small, mid-sized, large, and very large companies having the required expertise to offer pDNA manufacturing services across different scales of operations, such as preclinical, clinical, and commercial.

Technology Trends: Doggybone DNATM is Likely to Revolutionize Gene Therapy

The plasmid DNA industry is on the verge of a groundbreaking revolution, driven by the emergence of Doggybone DNAT (dbDNA) technology developed by Touchlight. This pioneering linear plasmid technology, produced abiotically through rolling circle amplification, represents a seismic shift in this field.

DbDNAT offers unparalleled advantages, including enhanced stability, simplified purification, and cost-effective scalability, challenging conventional plasmid production methods. With its remarkable versatility in genetic engineering, gene therapy, and mRNA production, dbDNAT stands as a highly promising solution.

Leading Companies Engaged in Plasmid DNA Manufacturing Market

Examples of key plasmid manufacturers (which have also been profiled in this report) offering pDNA manufacturing services include (in alphabetical order) AGC Biologics, Aldevron, Biomay, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI.

Expansion of Facilities for Building GMP Plasmid Manufacturing Capabilities

The players in this market are continuously expanding their facilities in order to accommodate the growing demand for plasmid DNA. They are vigorously advancing their capabilities to serve as a fully integrated one-stop-shop by offering a range of plasmid services, including process development and optimization, plasmid design, plasmid engineering and plasmid construct, and GMP plasmid manufacturing. 

Market Trends: Partnership and Collaboration on the Rise for Plasmid DNA Manufacturing

Stakeholders in the plasmid manufacturing industry have forged several partnerships to enhance their service portfolios and augment the reach of their proprietary plasmid DNA technology. It is worth highlighting that over 55% of these partnerships have been inked since 2021.

Plasmid DNA Manufacturing Market Size: Gene Therapy Market Segment to Hold the Largest Market Share

Driven by the increasing adoption of gene therapies and rising demand for nucleic acid vaccines, the plasmid DNA manufacturing market is anticipated to grow at an annualized rate (CAGR) of ~15% during the forecast period 2023-2035. It is worth highlighting that, in terms of application area, gene therapy manufacturing is expected to capture the majority of the market share in the plasmid DNA manufacturing market in 2023.

Recent Developments

Several recent developments have taken place in the field of plasmid manufacturing. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of the market report, substantiate the overall market trends that the publisher has outlined in the analyses.

Key Topics Covered:

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
3.1. Chapter Overview
3.2. Market Dynamics

4. EXECUTIVE SUMMARY

5. INTRODUCTION
5.1. Chapter Overview
5.2. Overview of Plasmids
5.3. Types of Plasmids (By Function)
5.4. Plasmid DNA Manufacturing
5.5. Applications of Plasmid DNA in Pharmaceutical Industry
5.6. Challenges Associated with Plasmid DNA Manufacturing
5.7 Need for Outsourcing Plasmid DNA Manufacturing
5.8 Future Perspectives

6. OVERALL MARKET LANDSCAPE
6.1. Chapter Overview
6.2. Plasmid DNA Service Providers: Overall Market Landscape
6.3. Analysis by Year of Establishment
6.4. Analysis by Company Size
6.5. Analysis by Location of Headquarters
6.6. Analysis by Type of Company
6.7. Analysis by Type of Venture
6.8. Analysis by Type of Service(s) Offered
6.9. Analysis by Key Offerings
6.10. Analysis by Grade of Plasmid DNA
6.11. Analysis by Scale of Operation
6.12. Analysis by Application Area(s)

7. KEY INSIGHTS
7.1. Chapter Overview
7.2. Plasmid DNA Service Providers: Key Insights

8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. Plasmid DNA Services: Partnerships and Collaborations

9. ACQUISITIONS
9.1. Chapter Overview
9.2. Acquisitions Models
9.3. Plasmid DNA Services Providers: Acquisitions

10. CAPACITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Plasmid DNA Manufacturing: Global Installed Capacity
10.4. Concluding Remarks

11. COMPANY COMPETITIVENESS ANALYSIS
11.1. Chapter Overview
11.2. Assumptions and Key Parameters
11.3. Methodology
11.4. Plasmid DNA Manufacturing Service Providers: Company Competitiveness Analysis

12. COMPANY PROFILES
12.1. Chapter Overview
12.2. AGC Biologics
12.3. Aldevron (Acquired by Danaher)
12.4. Biomay
12.5. Catalent Pharma Solutions
12.6. Charles River
12.7. Cytovance Biologics
12.8. Forge Biologics
12.9. GenScript ProBio (a Subsidiary of GenScript)
12.10. Patheon pharma services (Acquired by Thermo Fisher Scientific)
12.11. VGXI
12.12. 53Biologics
12.13. Boehringer Ingelheim
12.14. Centre for Breakthrough Medicine (CBM)
12.15. JAFRAL Biosolutions
12.16. PackGene
12.17. Acural Bio
12.18. Hanmi BioPlant
12.19. BioCina
12.20. NorthXBiologics
12.21. Xpress Biologics
12.22. Eurogentec
12.23. ESCO Aster
12.24. Southern RNA
12.25. Richter-Helm
12.26. Aurigene Pharmaceutical Services
12.27. Wuxi AppTech

13. DEMAND ANALYSIS
13.1. Chapter Overview
13.2. Key Assumptions and Methodology
13.3. Global Demand for Plasmid DNA, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)

14. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
14.1. Chapter Overview
14.2. Market Drivers
14.3. Market Restraints
14.4. Market Opportunities
14.5. Market Challenges
14.6. Conclusion

15. GLOBAL PLASMID DNA MANUFACTURING MARKET

16. PLASMID DNA MANUFACTURING MARKET, BY SCALE OF OPERATION

17. PLASMID DNA MANUFACTURING MARKET, BY APPLICATION AREA

18. PLASMID DNA MANUFACTURING MARKET, BY THERAAPEUTIC AREA

19. PLASMID DNA MANUFACTURING MARKET, BY GEOGRAPHY

20 CONCLUSION

21. EXECUTIVE INSIGHTS
21.1. Chapter Overview
21.2. JAFRAL Biosolutions
21.2.1. Company Snapshot
21.2.2. Interview Transcript: Frenk Smrekar, Chief Executive Officer and Co-Founder
21.3. Aldevron (Acquired by Danaher)
21.3.1. Company Snapshot
21.3.2. Interview Transcript: Jeff Briganti, Senior Director of Global Strategic Marketing
21.4. 53Biologics
21.4.1. Company Snapshot
21.4.2. Interview Transcript: Francisco Manuel Reyes Sosa, Business Development Manager
21.5. Center for Breakthrough Medicines (CBM)
21.5.1. Company Snapshot
21.5.2. Interview Transcript: Blaine Rathmann, Client Engagement Manager

22. APPENDIX 1: TABULATED DATA

23. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/p6maix

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