There are continuous development activities carried by major players in order to test plasmid DNA applicability. Usually plasmid DNA is prepared by cesium chloride density ultracentrifugation process and it has wide applications such as clones screening, sequencing, restriction digestion, cloning, and PCR.  Plasmid DNA can be purified by various technique but most it is purified by using bacteria technique. These techniques include various methods such as alkaline lysis and ammonium acetate precipitation, and ion-exchange columns such as Qiagen columns, cesium chloride gradient separation, or PEG precipitation methods. Aldevron, Cobra Biologics Limited, Delphi Genetics, and VGXI, Inc., are some of the major manufacturers involved in manufacturing of the plasmid DNA.

Market Dynamics

Increased cancer prevalence is expected to boost the production of plasmid DNA. In applying gene therapy to diagnose and treat diseases in patients, plasmid DNA is used. Increased awareness about gene therapy promotes the growth of market for the production of plasmid DNA during upcoming period. This is mainly due to increase in gene therapy products, accepted to treat rare diseases worldwide and availability of approved gene therapy products. Plasmid DNA (pDNA) is the base for DNA vaccines and gene therapies for many infectious, acquired, and genetic diseases, including HIV-AIDS, Ebola, Malaria, and various cancer types, enteric pathogens, and influenza. The advantages of DNA vaccines are high, not contaminating and focusing on immune response only to those anti-immunization-wishing antigens and long-term persistence of immunization protection compared to conventional vaccines. These are the factors leading to the growth of plasmid DNA manufacturing. Well-developed infrastructure in developed countries that is able to support the R&D activities, high investment by government and private players, coupled with introduction of new various protocols in order to support the manufacturing of various products are some other major factors expected to support the growth of the target market.

Gene therapy has various complications such as risk of mutagenesis, safety & efficacy issues and strict regulatory framework which is resulting in limited adoption thus hampering the growth of the market. Lack of developed infrastructure in order to conduct the R&D activities, limitations pertaining to investment for adoption of advanced technology, and low awareness of the treatment are among other major factors expected to hamper the growth of the target market. Developing nations have poor access to such sophisticated treatments and the costs of these are sky high making it out of reach to most of the population.

Technological progress to address traditional vector production challenges provides lucrative opportunities to the manufacturers. Development of an adaptive electroporation system for intratumoral plasmid DNA delivery where pro-inflammatory cytokine interleukin 12 encoded plasmid DNA intratumoral electroporation promotes innate and adaptive immune responses related to antitumor effects. Fixed parameters for pre-clinical tumors consisting of cells implanted into the skin are optimized in clinical electroporation conditions. These conditions can be limited to clinically important tumors, because implanted models cannot detect the heterogeneity found in genetically engineered mouse models or clinical tumors. Variables affecting the result of treatment include tumor size, vascularization degree, fibrosis and necrosis that can produce the transfers of suboptimal genes and the results of variable therapies. To address this, an electroporation generator controlled by feedback was developed that can measure the electrochemical properties of tissue in real time.

Segment Analysis, by Application

Gene therapy is a promising therapeutic treatment for various inherited as well as genetic disorder. Rapid technological advancements and introduction of novel products and techniques that are safe and reliable for treatment of various disorders is expected to support the segment growth.

 Segment Analysis, by Disease

DNA plasmid can be used to encourage a protective immune response by delivering genes encoding vaccine antigens. The DNA provided without any alteration or host evasion systems is able to cross the cell from outside into the nucleus which further helps for better improvement of the immune system in preventing infection by pathogens. Growing number of infectious diseases in the world recently is driving the infectious disease segment.

The cancer market is expected to witness significant growth over the forecast period, owing to high usage of vectors for development of cancer therapies is the primary growth stimulant for the segment. In addition, constant research endeavors taken up to target cancer and gain approvals in various classes of biopharmaceutical drugs are supplementing the growth of the segment.

Segment Analysis, by End Use

Growing interest of pharmaceutical companies in new areas of medicine, including gene therapies, is contributing to the growth of the segment. Vectors are used by these companies for development of advanced therapies to treat chronic conditions such as cancer and genetic disorders among others.

Segment Analysis by Region

The North America Plasmid DNA Manufacturing market size was over 26 million USD in 2018 and is expected to witness the growth at a CAGR of around 22% from 2019 to 2026. North America is expected to dominate in the global plasmid DNA manufacturing market. This can be attributed to the presence of several biopharmaceutical manufacturers in the U.S., coupled with a strong and effective regulatory structure for development of advanced therapies in the country. Besides this, recent approval of gene therapies by U.S. FDA is projected to augment the demand for Plasmid DNA manufacturing in the coming years.

The market in Europe is expected to contribute significant revenue share in the global market, owing to significant incentives offer through Orphan Medicinal Products Regulations (European Union) that has encouraged pharmaceutical and biotechnology companies to consider the development of rare disease medicines as a potentially profitable endeavor.

The market in Asia Pacific is expected to witness faster growth, owing to factors such as increasing government expenditure on healthcare sector in order to facilitate R&D activities. In addition, growing government initiatives and increased investments by private companies related to R&D activities are likely to fuel this regional market. To overcome the challenge of manufacturing, prominent quality vectors in terms of formulation, cost physical size and formulation, manufacturers are adopting various advanced techniques, such as the development of cell line culture, expression systems, cell culture system, and current good manufacturing practices. Additionally, grants provided by government and the involvement of prominent market players in research and development activities for product advancement is estimated to drive the region’s plasmid DNA manufacturing market over the estimated timeframe.

Competitive Landscape

Plasmid DNA is highly competitive market owing to the presence of huge number of competitors. A huge number of local and international players are operating in the market which has increased the competition. In addition, increasing expansion activities through strategic mergers and acquisitions in order to increase their presence, customer base, and enhance their product portfolio are expected to further increase the competition.

Report coverage

The market research study on “Plasmid DNA Manufacturing  (Application: Gene Therapy and Vaccinology; Disease: Infectious Disease, Genetic Disorder, and Cancer; End Use: Research Institute and Biotech Companies) – Global Industry Analysis, Market Size, Opportunities and Forecast, 2019 - 2025”, offers a detailed insights on the global plasmid DNA manufacturing market entailing insights on its different market segments. Market dynamics with drivers, restraints and opportunities with their impact are provided in the report. The report provides insights on global plasmid DNA manufacturing market, its application, disease, end use, and major geographic regions. The report covers basic development policies and layouts of technology development processes. Secondly, the report covers global plasmid DNA manufacturing market size and volume, and segment markets by type, application, and geography along with the information on companies operating in the market. The plasmid DNA manufacturing market analysis is provided for major regional markets including North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. For each region, the market size and volume for different segments has been covered under the scope of report. The players profiled in the report include Aldevron, Cobra Biologics Limited, Delphi Genetics, VGXI, Inc., PlasmidFactory GmbH & Co. KG, LakePharma, Inc., Akron Biotech, Waisman Biomanufacturing, Richter-Helm BioLogics, Eurogentec, Kaneka Corporation, Nature Technology Corporation, Cell and Gene Therapy Catapult and among others.

Market Segmentation

Market By Application

• Gene Therapy
• Vaccinology

Market By Disease

• Infectious Disease
• Cancer
• Genetic Disorder

Market By End use

• Research Institute
• Biotech Companies

Market By Region

• North America
  • US
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Spain
  • Italy
  • Rest of EU
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of LA
• Middle East & Africa
  • Saudi
  • UAE
  • Rest of MEA