Plasmid DNA Manufacturing Market by Scale of Operation, Application Area, Therapeutic Area, and Geography: Industry Trends and Global Forecasts, 2023-2035

List of Tables

INTRODUCTION

The global plasmid DNA manufacturing market is estimated to be worth over USD XX billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of ~15% during the forecast period.

The plasmid DNA manufacturing market is a dynamic and rapidly growing sector that plays a pivotal role in biotechnology and genetic research. Plasmid DNA is a circular, double-stranded DNA molecule that replicates independently of chromosomal DNA. With its ability to be genetically engineered, plasmid DNA serves as a crucial component in the development of advanced therapy medicinal products (ATMPs), such as cell and gene therapy, and nucleic acid vaccines. Having said that, it is important to highlight that the current demand for plasmid DNA is experiencing an exponential growth due to the expanding landscape of cell and gene therapies. This surge in demand got further amplified in the global COVID-19 pandemic, as plasmid-based delivery became an indispensable approach in the development of RNA/DNA vaccines and therapeutics. During this time, several big pharma players, including Moderna and Pfizer-BioNTech utilized plasmid-based platforms for their mRNA vaccines, which significantly contributed towards increased demand for plasmid DNA.

However, the process of plasmid production is fraught with various challenges, including low yield, plasmid instability, and regulatory concerns, which necessitate specialized facilities and adherence to good manufacturing practices (GMP). As a result, an increasing number of researchers and drug developers are relying on contract service providers with specialized expertise and advanced technologies for their GMP plasmid manufacturing requirements. These service providers offer comprehensive services, including process development and optimization, plasmid construction, plasmid design, and plasmid engineering. In addition, there are specialty service providers that help to streamline the pDNA manufacturing process, optimize resource utilization, and ensure the delivery of high quality of plasmid DNA to fulfil the rigorous requirements of regulatory authorities and research standards. With growing demand for ATMPs and the increasing trend of outsourcing pDNA manufacturing operations, the pDNA manufacturing market is expected to witness substantial growth during the forecast period.

SCOPE OF THE REPORT

The "Plasmid DNA Manufacturing Market: Distribution by Scale of Operation (Commercial, Clinical and Preclinical), Application Area (Cell Therapy Manufacturing, Gene Therapy Manufacturing, DNA / RNA Vaccine Development, Viral Vector Manufacturing, and Other Application Areas), Therapeutic Area (Metabolic Disorders, Neurological Disorders, Oncological Disorders, Rare Disorders, and Other Disorders), and Geography (North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2023-2035" report features an extensive study of the current market landscape, market size and future opportunities within the plasmid DNA manufacturing market during the forecast period. The market report highlights the efforts of various stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the plasmid DNA manufacturing market are briefly discussed below.

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. Further, there are several challenges in scaling up plasmid DNA production particularly in process development, maintaining construct consistency, and ensuring reproducibility. These technical and operational obstacles have prompted pharmaceutical industry to increasingly rely on plasmid manufacturer with capability to provide contract services related to plasmid manufacturing. Additionally, the COVID-19 pandemic has fueled a surge in outsourcing activities, because of the rising demand for nucleic acid-based COVID-19 vaccines. In response to this urgent global need, numerous vaccine developers have established strategic collaborations with contract service providers to effectively meet the demand.

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 and 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. It is worth mentioning that around 80% of the plasmid manufacturer offer GMP grade plasmid DNA for commercial scale applications; notable examples (which have also been captured in this market report) include AGC Biologics, Aldevron, Biomay, Catalent Pharma Solutions, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI.

Technology Trends: Doggybone DNATM is Likely to Revolutionize Gene Therapy

The plasmid DNA industry is on the verge of groundbreaking revolution, driven by the emergence of Doggybone DNA™ (dbDNA) technology developed by Touchlight. This pioneering linear plasmid technology, produced abiotically through rolling circle amplification, represents a seismic shift in this field. DbDNA™ 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, dbDNA™ stands as a highly promising solution. It is interesting to note that in February 2023, Touchlight received FDA clearance for the Investigational New Drug (IND) application utilizing doggybone DNA (dbDNA™) as an in vitro transcription template for mRNA production in the manufacturing of a cell-based therapy product. Adoption of such novel plasmid DNA technologies will support the efforts of the industry to meet the growing demand for this starting material for cell therapy and mRNA based therapy. Novel technologies will propel the plasmid DNA manufacturing market growth during the forecast period.

Leading Companies Engaged in Plasmid DNA Manufacturing Market

Examples of key plasmid manufacturer (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. It is interesting to note that in January 2023, Charles River expanded its portfolio by launching eXpDNA™ plasmid manufacturing platform, in order to offer efficient and accelerated GMP plasmid manufacturing and supply services to ATMP developers. Such portfolio additions are expected to drive plasmid DNA manufacturing market growth during the forecast period.

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. In January 2023, Catalent Pharma Solutions, a US-based CDMO, established a new commercial scale plasmid development and manufacturing facility to expand its end-to-end capabilities for the production of GMP grade plasmid DNA. Increase in the demand for plasmid DNA to support the production of cell and gene therapies is one of the reasons for the facility / capability expansion by the contract organizations.

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

Stakeholders in the plasmid manufacturing industry have forged several partnerships in order 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. Notably, majority of such deals are focused on manufacturing and supply of plasmid products, followed by product development and technology utilization agreements. In May 2023, Aldevron signed an agreement with Evanoa Bioscience to improve its fermentation process by using latter's novel strains of Escherichia Coli. In another similar deal inked between AcuraBio and Cytiva in February 2023, the former company adopted Cytiva's single-use bacterial plasmid purification technology to expand its cGMP pDNA manufacturing service.

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 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 our market report, substantiate the overall market trends that we have outlined in our analyses.

In June 2023, INADcure Foundation announced a manufacturing alliance with Charles River Laboratories, under which the latter will be responsible for manufacturing high quality pDNA for phase I/II clinical trials of a gene therapy against Infantile Neuroaxonal Dystrophy.

In February 2023, BioNTech, a leader in mRNA-based vaccine and therapy developer, announced the completion of its in-house clinical and commercial scale pDNA manufacturing facility at Marburg, Germany.

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different geographies. Amongst other elements, the market research report features:

A preface providing an introduction to the full report, Plasmid DNA Manufacturing Market, 2023-2035.
An outline of the systematic research methodology adopted to conduct the study on plasmid DNA manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
An overview of economic factors that impact the overall plasmid DNA manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
An executive summary of the key insights captured during our research, offering a high-level view on the current state of the plasmid DNA manufacturing market and its likely evolution in the short to mid and long term.
A general overview of plasmid DNA, highlighting details on different types of plasmids based on their function. It also features the various applications of plasmid DNA in the pharmaceutical industry. Further, it provides information on the challenges associated with pDNA manufacturing, as well as the growing need for outsourcing the production of such products.
An overview of the current market landscape of plasmid DNA service providers based on relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe, Asia, and rest of the world), type of company (CDMOs, CMOs, CROs/CMOs, CROs, suppliers and others), type of venture (private companies, acquired by public companies, public companies, acquired by private companies), type of service(s) offered (plasmid design, and plasmid construction, process development and optimization, and plasmid manufacturing), location of manufacturing facility (North America, Europe, Asia and rest of the world), key offerings (proprietary technology / platforms and plasmid DNA products), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (preclinical, clinical, and commercial) and application area(s) (cell and gene therapy manufacturing, DNA / RNA vaccine development, viral vector manufacturing, and other application areas).
An insightful analysis, highlighting the contemporary market trends in the plasmid DNA manufacturing market through different representations, based on relevant parameters, such as company size and location of headquarters; company size and type of venture; key offerings and location of headquarters; scale of operation and company size; grade of plasmid DNA and application area(s); scale of operation, application area(s) and location of manufacturing facility.
A detailed analysis of the partnerships inked between various stakeholders engaged in this market, since 2015, covering manufacturing and supply agreements, product development and manufacturing agreements, technology utilization agreements, service alliances, and product development agreements.
A detailed analysis of the acquisitions reported in plasmid manufacturing market, during the period 2015-2023. It is worth mentioning that the data captured during our research was analyzed based on multiple parameters, such as year of acquisition, type of acquisition, geographical location, company size and ownership of the companies involved, key value drivers, and acquisition deal multiples (based on revenues).
An estimate of the overall installed pDNA manufacturing capacity of industry players based on the information available in the public domain, and insights generated via both secondary and primary research. It also highlights the distribution of global capacity by company size (very small, small, mid-sized, large and very large), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (pre-commercial and commercial), and location of manufacturing facility (North America, Europe, Asia and rest of the world).
A detailed competitiveness analysis of pDNA manufacturing service providers based on supplier power (based on the experience), their respective capabilities (types of services offered, grade of plasmid DNA, scale of operation, application areas, total capacity, number of acquisitions) and partnership activity (in terms of number of partnerships and type of agreement).
Elaborate profiles of prominent players (shortlisted based on our proprietary company competitiveness) engaged in offering plasmid manufacturing services. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives), details related to its financial performance (if available), recent developments and an informed future outlook.
An in-depth analysis to estimate the current and future demand for plasmid DNA, based on several relevant parameters, such as scale of operation (commercial, clinical and preclinical), application area (cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, and viral vector manufacturing), and geography (North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World) for the period 2023-2035. Kindly note that input parameters considered for this analysis include target patient population, dosing frequency and dose strength.
An in-depth analysis of the factors that can impact the growth of plasmid DNA manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

The key objective of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for plasmid manufacturer over the next decade. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The report also features the likely distribution of the current and forecasted opportunity within the plasmid DNA manufacturing market across various segments, such as scale of operation (commercial, clinical, and preclinical), application area (cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, and viral vector manufacturing, and other application areas), therapeutic area (metabolic disorders, neurological disorders, oncological disorders, rare disorders, and other disorders), and geography (North America, Europe, Asia, Latin America, Middle East and North Africa and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

Frenk Smrekar (Chief Executive Officer and Co-Founder, JAFRAL Biosolutions)

Jeff Briganti (Senior Director of Global Strategic Marketing, Aldevron)

Francisco Manuel Reyes Sosa (Business Development Manager, 53Biologics)

Blaine Rathmann (Client Engagement Manager, Center for Breakthrough Medicines)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts' views

While the focus has been on forecasting the market over the coming 12 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

Question 1: What are the steps in plasmid DNA manufacturing?

Answer: The steps involved in plasmid DNA manufacturing include plasmid design and plasmid construction, host cell transformation, culture expansion, plasmid isolation and purification, and quality control testing.

Question 2: What is GMP plasmid manufacturing?

Answer: GMP plasmid manufacturing involves compliance with comprehensive quality control and assurance standards, including facility design, equipment qualification, raw material selection, process controls, documentation, quality control testing, and personnel training, in order to ensure the production of high-quality plasmid DNA.

Question 3: Who manufactures plasmid DNA?

Answer: Plasmid DNA is manufactured by various organizations, including biotechnology companies, contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), academic institutions, and research laboratories with the necessary capabilities and expertise in molecular biology and bioprocessing.

Question 4: Who are the key players in the plasmid DNA manufacturing market?

Answer: Examples of key players engaged in the plasmid manufacturing market (which have also been captured in this report) include AGC Biologics, Aldevron, Biomay, Catalent Pharma Solutions, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI.

Question 5: What is the size of the plasmid manufacturing market?

Answer: The global plasmid DNA manufacturing market is expected to be worth around USD XX billion by 2035.

Question 6: What are the leading market segments in the plasmid DNA manufacturing market?

Answer: Currently, in terms of scale of operation, commercial scale manufacturing of plasmid DNA captures the largest market share. Further, in terms of therapeutic area, metabolic disorders and oncology are expected to capture a prominent share of the current and future market.

Question 7: Which region has the highest market share in plasmid DNA manufacturing market?

Answer: Currently, North America and Europe collectively hold around 70% of the market share. However, in the long run, the pDNA manufacturing market in Asia is expected to grow at a relatively faster pace.

Question 8: What is the plasmid DNA manufacturing market growth?

Answer: The global plasmid manufacturing market revenue is anticipated to grow at a compound annual growth rate (CAGR) of ~15%, during the forecast period, 2023-2035.

Question 9: What are the factors driving the plasmid DNA manufacturing market?

Answer: Advancements in genetic engineering, coupled with the increasing demand for genetically modified therapies and nucleic acid vaccines will lead to a significant growth in the plasmid DNA manufacturing market, over the forecast period.

Question 10: What are the upcoming trends in the plasmid DNA manufacturing market?

Answer: The plasmid DNA manufacturing market is witnessing a shift towards automation, with the implementation of robotic systems and automated technologies across various manufacturing stages. This has led to enhanced efficiency, scalability, and productivity; for instance, the use of robotic systems for high-throughput screening of transformed cells enabled rapid identification and selection of desired plasmid constructs with improved efficiency and accuracy.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Plasmid DNA Manufacturing Market, 2023-2035.

Chapter 2 is an outline of the systematic research methodology adopted to conduct the study on plasmid DNA manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of findings.

Chapter 3 provides an overview of economic factors that impact the overall plasmid DNA manufacturing market, which include historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.

Chapter 4 is an executive summary of the key insights captured during our research. It offers a high-level view on the current state of the plasmid DNA manufacturing market and its likely evolution in the short to mid and long term.

Chapter 5 provides a general overview of the plasmid DNA, highlighting the different types of plasmid DNA based on their function. It also features the various applications of plasmid DNA in the pharmaceutical industry. Further, provides information on the challenges associated with plasmid DNA manufacturing, as well as the growing need for outsourcing the production of such products.

Chapter 6 is an overview of the current market landscape of plasmid DNA service providers based on relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe, Asia, and rest of the world), type of company (CDMOs, CMOs, CROs/CMOs, CROs, suppliers and others), type of venture (private companies, acquired by public companies, public companies, acquired by private companies), type of service(s) offered (plasmid design, engineering and construct, process development and optimization, and plasmid manufacturing), location of manufacturing facility (North America, Europe, Asia and rest of the world), key offerings (proprietary technology / platform and plasmid DNA products), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (preclinical, clinical, and commercial), and application area(s) (cell and gene therapy manufacturing, DNA / RNA vaccine development, viral vector manufacturing, and other application areas).

Chapter 7 presents an insightful analysis, highlighting the contemporary market trends in the plasmid DNA manufacturing market through different representations, based on relevant parameters, such as company size and location of headquarters; company size and type of venture; key offerings and location of headquarters; scale of operation and company size; grade of plasmid DNA and application area(s); scale of operation, application area(s) and location of manufacturing facility.

Chapter 8 includes detailed analysis of the partnerships inked between stakeholders engaged in this market, since 2015, covering manufacturing and supply agreements, product development and manufacturing agreements, technology utilization agreements, service alliances, and product development agreements.

Chapter 9 presents insights from a detailed analysis of the acquisitions reported in plasmid DNA manufacturing market, during the period 2015-2023. It is worth mentioning that the data captured during our research was analyzed based on multiple parameters, such as year of acquisition, type of acquisition, geographical location, company size and ownership of the companies involved, key value drivers, and acquisition deal multiples (based on revenues).

Chapter 10 provides an estimate of the overall installed plasmid DNA manufacturing capacity of industry players based on the information available in the public domain, and insights generated via both secondary and primary research. The analysis also highlights the distribution of the global capacity by company size (very small, small, mid-sized, large and very large), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (pre-commercial and commercial), and location of manufacturing facility (North America, Europe, Asia and rest of the world).

Chapter 11 provides a detailed competitiveness analysis of plasmid DNA manufacturing service providers based on supplier power (based on the experience), their respective capabilities (types of services offered, grade of plasmid DNA, scale of operation, application areas, total capacity, number of acquisitions) and partnership activity (in terms of number of partnerships and type of agreement).

Chapter 12 includes detailed profiles of various prominent players (shortlisted based on our proprietary company competitiveness) engaged in offering plasmid DNA manufacturing services. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives), details related to its financial performance (if available), recent developments and an informed future outlook.

Chapter 13 includes an elaborate analysis in order to estimate the current and future demand for plasmid DNA, based on several relevant parameters, scale of operation (commercial, clinical and preclinical), application area (cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, and viral vector manufacturing), and geography (North America, Europe, Asia, Latin America, Middle East and North Africa and Rest of the World) for the period 2023-2035. Kindly note that input parameters considered for this analysis include target patient population, dosing frequency and dose strength.

Chapter 14 present an in-depth analysis of the factors that can impact the growth of plasmid DNA manufacturing market. In addition, it includes identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

Chapter 15 a detailed market forecast analysis in order to estimate the existing market size and future opportunity for plasmid DNA manufacturers over the next decade. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The report also features the likely distribution of the current and forecasted opportunity within the plasmid DNA manufacturing market. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

Chapter 16 provides detailed projections of the current and future plasmid DNA manufacturing market across different scales of operation, such as commercial, clinical and preclinical.

Chapter 17 provides detailed projections of the current and future plasmid DNA manufacturing market across various application areas, such as cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, viral vector manufacturing, other application areas.

Chapter 18 provides detailed projections of the current and future plasmid DNA manufacturing market across therapeutic areas, such as metabolic disorders, neurological disorders, oncological disorders, rare disorders, and other disorders.

Chapter 19 provides detailed projections of the current and future plasmid DNA manufacturing market across various geographies, such as North America, Europe, Asia, Latin America, Middle East and North Africa and rest of the world.

Chapter 20 summarizes the entire report, highlighting various facts related to contemporary market trends and the likely evolution of the plasmid DNA manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 21 is a collection of interview transcripts of discussions held with various key stakeholders in this market. It provides a brief overview of the companies and details of interviews held with Frenk Smrekar (Chief Executive Officer and Co-Founder, JAFRAL Biosolutions), Jeff Briganti (Senior Director of Global Strategic Marketing, Aldevron), Francisco Manuel Reyes Sosa (Business Development Manager, 53Biologics), and Blaine Rathmann (Client Engagement Manager, Center for Breakthrough Medicines).

Chapter 22 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 23 is an appendix, which contains a list of companies and organizations mentioned in this report.

Product Code: RA100448

1. PREFACE

1.1. Introduction
1.2. Project Objectives
1.3. Scope of the Report
1.4. Inclusions and Exclusions
1.5. Key Questions Answered
1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

2.1. Chapter Overview
2.2. Research Assumptions
2.3. Project Methodology
2.4. Forecast Methodology
2.5. Robust Quality Control
2.6. Key Market Segmentations
2.7. Key Considerations
- 2.7.1. Demographics
- 2.7.2. Economic Factors
- 2.7.3. Government Regulations
- 2.7.4. Supply Chain
- 2.7.5. COVID Impact / Related Factors
- 2.7.6. Market Access
- 2.7.7. Healthcare Policies
- 2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

3.1. Chapter Overview
3.2. Market Dynamics
- 3.2.1. Time Period
  - 3.2.1.1. Historical Trends
  - 3.2.1.2. Current and Forecasted Estimates
- 3.2.2. Currency Coverage
  - 3.2.2.1. Overview of Major Currencies Affecting the Market
  - 3.2.2.2. Impact of Currency Fluctuations on the Industry
- 3.2.3. Foreign Exchange Impact
  - 3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
  - 3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
- 3.2.4. Recession
  - 3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
  - 3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
- 3.2.5. Inflation
  - 3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
  - 3.2.5.2. Potential Impact of Inflation on the Market Evolution

4. EXECUTIVE SUMMARY

5. INTRODUCTION

5.1. Chapter Overview
5.2. Overview of Plasmids
- 5.2.1. Structure of a Plasmid DNA
5.3. Types of Plasmids (By Function)
- 5.3.1. Fertility Plasmids
- 5.3.2. Resistance Plasmids
- 5.3.3. Virulence Plasmids
- 5.3.4. Degradative Plasmids
- 5.3.5. Col Plasmids
5.4. Plasmid DNA Manufacturing
- 5.4.1. Steps Involved in Plasmid DNA Manufacturing
5.5. Applications of Plasmid DNA in Pharmaceutical Industry
- 5.5.1. Cell and Gene Therapy Manufacturing
- 5.5.2. Viral Vector Manufacturing
- 5.5.3. Vaccine Development
- 5.5.4. Other Research Applications
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
- 6.8.1. Analysis by Location of Manufacturing Facility

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

7.2.1 Analysis by Company Size and Location of Headquarters

7.2.2. Analysis by Company Size and Type of Venture

7.2.3. Analysis by Key Offerings and Location of Headquarters

7.2.4. Analysis by Scale of Operation and Company Size

7.2.5. Analysis by Grade of Plasmid DNA and Application Area(s)

7.2.6. Analysis by Scale of Operation, Application Area(s) and Location of Manufacturing Facility

8. PARTNERSHIPS AND COLLABORATIONS

8.1. Chapter Overview
8.2. Partnership Models
8.3. Plasmid DNA Services: Partnerships and Collaborations
- 8.3.1. Analysis by Year of Partnership
- 8.3.2. Analysis by Type of Partnership
- 8.3.3. Analysis by Year and Type of Partnership
- 8.3.4. Analysis by Type of Partner
- 8.3.5. Analysis by Type of Partnership and Type of Partner
- 8.3.6. Analysis by Grade of Plasmid DNA
- 8.3.7. Analysis by Scale of Operation
- 8.3.8 Analysis by Geography
  - 8.3.8.1. Local and International Agreements
  - 8.3.8.2. Intercontinental and Intracontinental Agreements
- 8.3.9. Most Active Players: Analysis by Number of Partnerships

9. ACQUISITIONS

9.1. Chapter Overview
9.2. Acquisitions Models
9.3. Plasmid DNA Services Providers: Acquisitions
- 9.3.1. Analysis by Year of Acquisition
- 9.3.2. Analysis by Type of Acquisition
- 9.3.3. Analysis by Geography
  - 9.3.3.1. Local and International Acquisitions
  - 9.3.3.2. Intercontinental and Intracontinental Acquisitions

9.3.4. Ownership Change Matrix

9.3.5. Analysis by Company Size

9.3.6. Analysis by Key Value Drivers

9.3.7. Valuation Analysis: Acquisition Deal Multiples

9.3.8. Most Active Players: Analysis by Number of Acquisitions

10. CAPACITY ANALYSIS

10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Plasmid DNA Manufacturing: Global Installed Capacity
- 10.3.1. Analysis by Company Size
- 10.3.2. Analysis by Scale of Operation
- 10.3.3. Analysis by Location of Manufacturing Facility
10.4. Concluding Remarks

11. COMPANY COMPETITIVENSS ANALYSIS

11.1. Chapter Overview
11.2. Assumptions and Key Parameters
11.3. Methodology
11.4. Plasmid DNA Manufacturing Service Providers: Company Competitiveness Analysis
- 11.4.1. Benchmarking of Service Strength
- 11.3.2. Benchmarking of Partnership Activity
- 11.3.3. Very Small Companies Offering Plasmid DNA Manufacturing
- 11.3.4. Small Companies Offering Plasmid DNA Manufacturing
- 11.3.5. Mid-Sized Companies Offering Plasmid DNA Manufacturing
- 11.3.6. Large Companies Offering Plasmid DNA Manufacturing
- 11.3.7. Very Large Companies Offering Plasmid DNA Manufacturing

12. COMPANY PROFILES

12.1. Chapter Overview
12.2. AGC Biologics
- 12.2.1. Company Overview
- 12.2.2. Service Portfolio
- 12.2.3. Recent Developments and Future Outlook
12.3. Aldevron (Acquired by Danaher)
- 12.3.1. Company Overview
- 12.3.2. Service Portfolio
- 12.3.3. Financial Information
- 12.3.4. Recent Developments and Future Outlook
12.4. Biomay
- 12.4.1. Company Overview
- 12.4.2. Service Portfolio
- 12.4.3. Recent Developments and Future Outlook
12.5. Catalent Pharma Solutions
- 12.5.1. Company Overview
- 12.5.2. Service Portfolio
- 12.5.3. Financial Information
- 12.5.4. Recent Developments and Future Outlook
12.6. Charles River
- 12.6.1. Company Overview
- 12.6.2. Service Portfolio
- 12.6.3. Financial Information
- 12.6.4. Recent Developments and Future Outlook
12.7. Cytovance Biologics
- 12.7.1. Company Overview
- 12.7.2. Service Portfolio
- 12.7.3. Recent Developments and Future Outlook
12.8. Forge Biologics
- 12.8.1. Company Overview
- 12.8.2. Service Portfolio
- 12.8.3. Recent Developments and Future Outlook
12.9. GenScript ProBio (a Subsidiary of GenScript)
- 12.9.1. Company Overview
- 12.9.2. Service Portfolio
- 12.9.3. Financial Information
- 12.9.4. Recent Developments and Future Outlook
12.10. Patheon pharma services (Acquired by Thermo Fisher Scientific)
- 12.10.1. Company Overview
- 12.10.2. Service Portfolio
- 12.10.3. Financial Information
- 12.10.4. Recent Developments and Future Outlook
12.11. VGXI
- 12.11.1. Company Overview
- 12.11.2. Service Portfolio
- 12.11.3. Recent Developments and Future Outlook

12.12. 53Biologics
- 12.12.1. Company Overview
- 12.11.2. Service Portfolio
12.13. Boehringer Ingelheim
- 12.13.1. Company Overview
- 12.13.2. Service Portfolio
12.14. Centre for Breakthrough Medicine (CBM)
- 12.14.1. Company Overview
- 12.14.2. Service Portfolio

12.15. JAFRAL Biosolutions
- 12.15.1. Company Overview
- 12.15.2. Service Portfolio

12.16. PackGene
- 12.16.1. Company Overview
- 12.16.2. Service Portfolio
12.17. Acural Bio
- 12.17.1. Company Overview
- 12.17.2. Service Portfolio
12.18. Hanmi BioPlant
- 12.18.1. Company Overview
- 12.18.2. Service Portfolio
12.19. BioCina
- 12.19.1. Company Overview
- 12.19.2. Service Portfolio
12.20. NorthXBiologics
- 12.21.1. Company Overview
- 12.22.2. Service Portfolio
12.21. Xpress Biologics
- 12.21.1. Company Overview
- 12.21.2. Service Portfolio
12.22. Eurogentec
- 12.22.1. Company Overview
- 12.22.2. Service Portfolio
12.23. ESCO Aster
- 12.23.1. Company Overview
- 12.23.2. Service Portfolio
12.24. Southern RNA
- 12.24.1. Company Overview
- 12.24.2. Service Portfolio
12.25. Richter-Helm
- 12.25.1. Company Overview
- 12.25.2. Service Portfolio

12.26. Aurigene Pharmaceutical Services
- 12.26.1. Company Overview
- 12.26.2. Service Portfolio
12.27. Wuxi AppTech
- 12.27.1. Company Overview
- 12.27.2. Service Portfolio

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)
- 13.3.1. Analysis by Scale of Operation
  - 13.3.1.1. Commercial Demand for Plasmid DNA, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.1.2. Clinical Demand for Plasmid DNA, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.1.3. Preclinical Demand for Plasmid DNA, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
- 13.3.2. Analysis by Application Area
  - 13.3.2.1. Plasmid DNA Demand for Cell Therapy Manufacturing, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.2.2. Plasmid DNA Demand for Gene Therapy Manufacturing, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.2.3. Plasmid DNA Demand for DNA / RNA Vaccine Development, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.2.4. Plasmid DNA Demand for Viral Vector Manufacturing, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.2.5. Plasmid DNA Demand for Other Application Areas, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
- 13.3.3. Analysis by Geography
  - 13.3.3.1. Demand for Plasmid DNA in North America, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.3.2. Demand for Plasmid DNA in Europe, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.3.3. Demand for Plasmid DNA in Asia, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.3.4. Demand for Plasmid DNA in Latin America, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.3.5. Demand for Plasmid DNA in Middle East and North Africa, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
  - 13.3.3.6. Demand for Plasmid DNA in Rest of the World, 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

15.1. Chapter Overview
15.2. Assumptions and Methodology
15.3. Global Plasmid DNA Manufacturing Market, Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
- 15.3.1. Scenario Analysis
15.4. Key Market Segmentations
15.5. Dynamic Dashboard

16. PLASMID DNA MANUFACTURING MARKET, BY SCALE OF OPERATION

16.1. Chapter Overview
16.2. Key Assumptions and Methodology
16.3. Commercial Products: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
16.4. Clinical Products: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
16.5. Preclinical Products: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
16.6. Data Triangulation
- 16.6.1. Insights from Primary Research
- 16.6.2. Insights from Secondary Research
- 16.6.3. Insights from In-house Repository

17. PLASMID DNA MANUFACTURING MARKET, BY APPLICATION AREA

17.1. Chapter Overview
17.2. Key Assumptions and Methodology
17.3. Cell Therapy Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
17.4. DNA / RNA Vaccine Development: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
17.5. Viral Vector Manufacturing: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
17.6. Other Application Areas: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
17.8. Data Triangulation
- 17.8.1. Insights based on Primary Research
- 17.8.2. Insights based on Secondary Research
- 17.8.3. Insights from In-house Repository

18. PLASMID DNA MANUFACTURING MARKET, BY THERAAPEUTIC AREA

18.1. Chapter Overview
18.2. Key Assumptions and Methodology
18.3. Metabolic Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.4. Neurological Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.5. Oncological Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.6. Rare Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.7. Other Disorders: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
18.8. Data Triangulation
- 18.8.1. Insights based on Primary Research
- 18.7.2. Insights based on Secondary Research
- 18.7.3. Insights from In-house Repository

19. PLASMID DNA MANUFACTURING MARKET, BY GEOGRAPHY

19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. North America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.4. Europe: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.5. Asia: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.6. Latin America: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.7. Middle East and North Africa: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.8. Rest of the World: Historical Trends (2018-2022) and Forecasted Estimates (2023-2035)
19.9. Data Triangulation
- 19.9.1. Insights based on Primary Research
- 19.9.2. Insights based on Secondary Research
- 19.9.3. Insights from In-house Repository

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