Plasmid DNA Manufacturing Market - Global Forecast to 2026, by Product Type (High Quality (HQ) Plasmid DNA, GMP Grade Plasmid DNA, and Non-GMP Grade Plasmid DNA), by Application (DNA Vaccines, Gene Therapy, Immunotherapy, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018- 2026
- Report code : CMI12593 |
- Industry :
Biotechnology
- Published On : Apr 2019 |
- Pages : 149 Pages |
- Format :
Plasmid DNA Manufacturing Market – Increasing Number of Patients Opting for Gene Therapy
Plasmid (pDNA) DNA plays a major role in modern healthcare, as it is used directly as a therapeutic agent in gene therapy or generation of vaccine antigens. Furthermore, pDNA is used as a master-template product to support production of new and emerging biopharmaceutical products and processes including RNA, in-vitro protein production, and cell therapies.
The global plasmid DNA manufacturing market size was valued at US$ 65.1 million in 2017 and is expected to exhibit a CAGR of 23.7% over the forecast period (2018 – 2026).
Figure 1. Global Plasmid DNA Manufacturing Market Value (US$ Mn), by Region, 2017
Source: Coherent Market Insights Analysis (2019)
Increasing number of patients opting for gene therapy is expected to propel growth of plasmid DNA manufacturing market
Increasing number of patients opting for gene therapy is a major factor driving growth of the plasmid DNA manufacturing market. Gene therapy is a leading field in medical science, which promises new treatment development for patients suffering from various diseases.
For instance, Adeno-associated AAV2 vectors carrying therapeutic gene (RPE65) intra-retinal injection leads to improved vision of individuals suffering from Leber’s Congenital Amaurosis.
Several clinical trials are being conducted on viral vectors and plasmid DNA manufacturing that are focused on the potential of gene therapy. Increasing investments in drug development and commercialization of these therapies in order to meet significant medical needs are factors driving the market growth. These genetic markers are associated with complex diseases, therefore it is important to study about the genetic information and its clinical application in designing clinical trials and gene therapy product manufacturing.
According to a data published by the Journal of Gene Medicine: March 2018, till November 2017, an estimated 2,600 gene therapy clinical trials were ongoing, have been completed, or have been approved in 36 countries. Countries where the trials were conducted include the U.S., the U.K., Australia, Canada, China, France, Germany, Japan, Switzerland, the Netherlands, and others. Moreover, diseases targeted by gene therapies include cardiovascular diseases, cancer, inflammatory and infectious diseases, Hemophilia A and B, Severe Combined Immunodeficiency (SCID), ocular diseases, neurological diseases, and others.
Figure 2. Global Plasmid DNA Manufacturing Market Share (%), by Application, 2018 and 2026
Source: Coherent Market Insights Analysis (2019)
Collaboration by market players is expected to bolster the plasmid DNA manufacturing market growth in Europe
Europe region is expected to witness significant growth in the plasmid DNA manufacturing market due to adoption of strategies such as collaboration by the market players. For instance, in May 2018, PlasmidFactory GmbH & Co. KG collaborated with Sirion-Biotech GmbH, Vibalogics GmbH, and PROGEN for adeno-associated virus (AAV) vector manufacturing. This collaboration was done to accelerate timeline and to create easy workflow from plasmid manufacturing to GMP production, and analytics of recombinant AAV to fulfil the customers' requirement of AAV vector.
Key Players
Major players operating in the global plasmid DNA manufacturing market include Cobra Biologics and Pharmaceutical Services, VGXI, Inc., Aldevron, Kaneka Corporation, Nature Technology Corporation, PlasmidFactory GmbH & Co. KG, Cell and Gene Therapy Catapult, and Waisman Biomanufacturing.
Plasmid DNA (pDNA) can be used directly as a therapeutic agent in gene therapy or generation of vaccine antigens, and indirectly in a range of research applications. These applications include its use as a critical starting material for transient transfection to produce both viral-vector constructs such as lentivirus or Adeno-associated virus (AAV) and transient proteins in development such as monoclonal antibody. pDNA is used as a master-template product to support production of new and emerging biopharmaceutical products and processes including RNA, in-vitro protein production, and cell therapies.
Plasmids used as therapeutic agents tend to be relatively small in size (4.5– 6.0 kb and even down to 2.5 kb), requiring relatively low quantities to support early phase clinical trials (1–5 g of purified pDNA). These advantages make plasmid DNA more suitable to carry out late phase clinical trials.
Increasing demand for plasmid DNA (pDNA) and increasing research and development activities are major factors driving the plasmid DNA manufacturing market growth. For instance, in April 2018, PlasmidFactory GmbH & Co. KG acquired new laboratory space to expand research and development activities and production of plasmid DNA.
Cobra Biologics, a U.K.-based contract development and manufacturing organization (CDMO) has been producing plasmid DNA for a number of clinical applications for over 15 years at an approved site in the U.K. under the European Union (EU) clinical trials directive.
The company developed its own manufacturing process for production and purification of pDNA with related proprietary technologies, which include an antibiotic-free plasmid maintenance system, operator repressor titration (ORT), and cell-lysis technologies (2–4). Moreover, company successfully executed over 240 DNA programs with process development, manufacturing, and stability studies for over 35 different customers, globally. Generated plasmids have been used in clinical trials for gene therapy and vaccines as well as in viral vector production.
Moreover, large scale companies are actively focusing on strategic partnerships for drug development activity, which is expected to drive the market growth over the forecast period.
Key features of the study:
- This report provides in-depth analysis of the plasmid DNA manufacturing market and provides market size (US$ Mn) and Compound Annual Growth Rate (CAGR %) for the forecast period (2018 – 2026), considering 2017 as the base year
- It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
- This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
- It profiles key players in the global plasmid DNA manufacturing market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
- Key companies covered as a part of this study include Cobra Biologics and Pharmaceutical Services, VGXI, Inc., Aldevron, Kaneka Corporation, Nature Application Corporation, PlasmidFactory GmbH & Co. KG, Cell and Gene Therapy Catapult, and Waisman Biomanufacturing
- Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, market expansion, and marketing tactics
- The global plasmid DNA manufacturing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
- Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the plasmid DNA manufacturing market
Detailed Segmentation:
- Global Plasmid DNA Manufacturing Market, By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- Global Plasmid DNA Manufacturing Market, By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- Global Plasmid DNA Manufacturing Market, By Region:
- North America
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country:
- U.S.
- Canada
- Latin America
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country:
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Europe
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country:
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country:
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country:
- GCC
- Israel
- Rest of Middle East
- Africa
- By Product Type:
- High Quality (HQ) Plasmid DNA
- GMP Grade Plasmid DNA
- Non-GMP Grade Plasmid DNA
- By Application:
- DNA Vaccines
- Gene Therapy
- Immunotherapy
- Others
- By Country/Region:
- South Africa
- Central Africa
- North Africa
- Company Profiles
- Cobra Biologics and Pharmaceutical Services *
- Company Overview
- Product Portfolio
- Financial Performance
- Key Highlights
- Market Strategies
- VGXI, Inc.
- Aldevron
- Kaneka Corporation
- Nature Application Corporation
- PlasmidFactory GmbH & Co. KG
- Cell and Gene Therapy Catapult
- Waisman Biomanufacturing.
“*” marked represents similar segmentation in other categories in the respective section.
Table of Contents
- Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
- Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Product Type
- Market Snippet, By Application
- Market Snippet, By Region
- Coherent Opportunity Map (COM)
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Market Trends
- Impact Analysis
- Key Highlights
- PEST Analysis
- PORTER’s Analysis
- Mergers and Acquisitions
- Epidemiology
- Global Plasmid DNA Manufacturing Market, By Product Type, 2018 – 2026, (US$ Mn)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017– 2026
- Segment Trends
- High Quality (HQ) Plasmid DNA
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- GMP Grade Plasmid DNA
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Non-GMP Grade Plasmid DNA
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Global Plasmid DNA Manufacturing Market, By Application, 2018 – 2026, (US$ Mn)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017– 2026
- Segment Trends
- DNA Vaccines
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Gene Therapy
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Immunotherapy
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Mn)
- Global Plasmid DNA Manufacturing Market, By Region, 2018 – 2026, (US$ Mn)
- Introduction
- Market Share Analysis, By Region, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, For Regions, 2017–2026
- North America
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- U.S.
- Canada
- Latin America
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Europe
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- Germany
- U.K.
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- GCC
- Israel
- Rest of Middle East
- Africa
- Market Size and Forecast, By Product Type, 2018 – 2026, (US$ Mn)
- Market Size and Forecast, By Application, 2018 – 2026, (US$ Mn)
- South Africa
- Central Africa
- North Africa
- Competitive Landscape
- Heat Map Analysis
- Market Share Analysis
- Company Profiles
- Cobra Biologics and Pharmaceutical Services *
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- VGXI, Inc.
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Aldevron
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Kaneka Corporation
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Nature Application Corporation
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- PlasmidFactory GmbH & Co. KG
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Cell and Gene Therapy Catapult
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Waisman Biomanufacturing
- Company Overview
- Product Type Portfolio
- Financial Overview
- Key Highlights
- Market Strategies
- Analyst Views
- Section
- References
- Research Methodology
- About us and Sales Contact
*Browse 36 market data tables and 32 figures on "Plasmid DNA Manufacturing Market - Global forecast to 2026”.
Research Methodology
Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:
- Primary Research (Trade Surveys and Experts Interviews)
- Desk Research
- Proprietor Data Analytics Model
In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.
Coherent Market Insights desk research is based on a principle set of research techniques:
- National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
- Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.
Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:
- Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
- Trade association, National and international media and trade press.
- Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
- Scientific journals, and other technical magazines and whitepapers.
Preliminary Data Mining
The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.
Data Standardization:
Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.
Coherent Statistical model
We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:
- Micro-economic indicators
- Macro-economic indicators
- Environmental indicators
- Socio-political indicators
- Technology indicators
Data Processing
Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.
Data Validation
This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:
- It provides first-hand information on the market dynamics, outlook, and growth parameters.
- Industry experts validates the estimates which helps the company to cement the on-going research study.
- Primary research includes online surveys, face-to face interviews, and telephonic interviews.
The primary research is conducted with the ecosystem players including, but not limited to:
- Raw Material Suppliers
- Manufacturers
- System Integrators
- Distributors
- End-users
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