Plasmid DNA Manufacturing Market

Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2023-2030 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

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Industry: Pharmaceuticals & Biotechnology


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This study intends to unfurl the multiple facets of global plasmid DNA manufacturing market. The insights offered in the report aid in market growth examination during the forecast period.

Plasmid DNA Manufacturing Market Benefits from the Rise in Cell and Gene Therapy

In the healthcare sector, plasmid DNA is crucial. It is essential nowadays to create vaccines and cutting-edge cell and gene therapies. Now that new plasmid DNA vaccines are being created, manufacturing procedures will become more effective and hygienic. Plasmids are more desirable than recombinant viruses for generating vaccines, and gene treatments because they can deliver significant amounts of DNA with little risk of oncogenesis or immunogenicity. These elements are anticipated to fuel industrial expansion. To address the rising demand and solidify their place in the global plasmid DNA manufacturing market, emerging enterprises are entering the sector with cutting-edge technologies. For instance, Biotage introduced Biotage PhyPrep, a revolutionary automated plasmid DNA purification solution, in June 2021. Lab staff's time is saved by using a novel automated method for plasmid DNA purification instead of doing tedious manual work. The PhyTip columns' dual flow chromatography technology is used to create supercoiled, endotoxin-free, transfection-grade pDNA. In October 2021, ten pharmaceutical companies, five nonprofit groups, and the National Institutes of Health partnered to accelerate the discovery of gene therapy for the 30 million Americans who suffer from uncommon ailments. Growing public understanding of cell and gene therapy promotes industrial expansion. The availability of licensed gene therapy products, and the rise in cell and gene therapy products being accepted to treat various diseases internationally are the key causes of this. Plasmid DNA is in more demand due to the increased R&D efforts for improved medicines targeting the disease's genomic origins due to the rising demand for effective disease treatment therapies.

Plasmid DNA Manufacturing Market: COVID-19 Impact

The COVID-19 outbreak is anticipated to have a favorable effect on the industry for producing plasmid DNA Plasmid DNA vaccines are another type of COVID-19 vaccine candidate now undergoing clinical studies. These vaccinations are probably among the COVID-19 vaccines that have been given the go-ahead for usage everywhere. Many of them have also been approved or are close to being approved. Johnson & Johnson released positive efficacy and safety results from their Phase 3 ENSEMBLE clinical study, which used its AdVac vaccination technology for COVID-19, in January 2021. Its single-dose COVID-19 vaccine, which its Janssen Pharmaceutical Companies are currently developing, accomplished all prerequisites and objectives.

Plasmid DNA Manufacturing Market Largely Benefits from a Stable Pipeline

Around 400 embryonic cell and gene therapies are currently being created to treat a wide spectrum of illnesses. Cell and gene therapy fields interact with one another; both use DNA or RNA as their therapeutic targets, which can be found inside or outside the body. To either enhance function or treat the condition, every treatment focuses on changing genetic material in some way. To be more precise, gene therapy entails altering a patient's cells to treat an inherited or acquired ailment using genetic material, frequently referred to as DNA To treat an inherited or acquired illness, cell therapy can refer to either injecting whole cells or transplanting whole cells into a recipient.

Manufacturers’ Emphasis on Increasing Capabilities to Drive Plasmid DNA Manufacturing Market

There is an increasing need for practical, scalable production processes for plasmid DNA because cell and gene therapies have the potential to go quickly from clinical trials to commercialization. Brammer Bio, and Pall Biotech are constantly trying to develop and implement cutting-edge technologies that will quicken the process growth and scale-up necessary for the creation of plasmid DNA These remedies will hasten the procedure's expansion. Low molecular weight biological medicinal compounds are often produced through fermentation. Contrarily, bigger recombinant proteins and monoclonal antibodies (mAbs) are usually produced utilizing tried-and-true platform procedures. Most of the biologics now on the plasmid DNA manufacturing market are these two categories of biologics taken together. This led to the creation of manufacturing equipment for the production of mAbs, and equipment providers adequately stocked the area where it was located.

However, manufacturers of plasmid DNA who have products in phase III clinical trials or are working to create plasmid DNA for use in commercial applications face various challenges. One of these problems is the fact that many of the vector production techniques that are now in use do not meet requirements for things like productivity, efficiency, stability, and other criteria. Additionally, various research activities must be conducted by companies in the plasmid DNA manufacturing market that produce goods in large or small amounts. Both types of enterprises need this.

Cardiovascular Training Equipment Category Dominates Plasmid DNA Manufacturing Market Attributed to Gene Therapy Treatment Development for Orthopaedics

The cardiovascular training equipment category held the largest market share, and it is anticipated that it will continue to rule the plasmid DNA manufacturing market during the forecast period. The increase can be attributed to creation of more effective and efficient gene therapy treatments for orthopedic and ocular disorders. Over the projected period, the adoption rate will rise dramatically due to the recent sharp increases in AAV applications across numerous therapeutic domains. Their shown non-pathogenicity is one of the key factors supporting their use, and these factors drive the category expansion. Adenoviral vectors have also been deemed safe. They are therefore being used more frequently in a variety of study contexts. Because of their ability to strongly enhance humoral and T-cell immune responses, ADV vectors are routinely utilized as vaccines. In tests using an adenovirus vector as a CRISPR/Cas9 delivery mechanism, numerous human cell host genomes have successfully had genes disrupted.

Cancer Category Dominates Plasmid DNA Manufacturing Market in Line with Growing Use of DNA Plasmids in Cancer Treatment Medicines

The cancer category held the largest market share, and it is anticipated that it will continue to rule the market during the forecast period. The increased use of DNA plasmids for the creation of cancer treatment medicines is driving the expansion of plasmid DNA manufacturing market. Cancer is the primary focus of more than 60% of all active clinical gene therapy trials worldwide. Cancer has been treated using various gene therapy techniques, including genetic apoptosis manipulation, immunological modulation based on gene therapy, and oncolytic virotherapy. Besides, the infectious disease market will rise significantly in the next years. Trials are being conducted for gene treatments for hepatitis B, HPV, influenza, and HIV Infectious disease treatment is a goal of about 5–7 percent of gene therapy clinical trials. Furthermore, due to the high incidence of HIV and HPV infections and the existence of government-supported programs to prevent HPV infections, the segment share is anticipated to increase throughout the projected period.

North America to Dominate Plasmid DNA Manufacturing Market on Account of a Sizable Number of Centers

Over the forecast period, it is anticipated that the North American plasmid DNA manufacturing market will account for the largest revenue share. The existence of a sizable number of centers and institutes involved in the research and development of cutting-edge therapies is one of the key elements that has led to the big share of this region. The Recombinant DNA Advisory Committee, which the NIH established to track scientific, moral, and legal issues related to rDNA techniques, is also a major factor in the widespread acceptance of these methods. The body's main responsibility is to evaluate the research on human gene transfer.

Asia Pacific plasmid DNA manufacturing market is anticipated to experience stable revenue growth throughout the forecast period. This results from expanding private sector expenditures in the area and increased government spending on the healthcare sector to support plasmid DNA research and development. The development of cell culture systems, expression systems, and good manufacturing practices (G.M.P.) are just a few of the technologically sophisticated approaches that are expanding in popularity and are significantly boosting the market  in Asia Pacific. Due to these factors, this region has the quickest market growth rate.

Global Plasmid DNA Manufacturing Market: Competitive Landscape

In July 2021, Thermo Fisher built a current Good Manufacturing Practice (cGMP) facility in Carlsbad, California, to expand its commercial and clinical capabilities for producing pDNA for cells and gene-based therapies. Similarly, in January 2020, to make plasmid DNA under contract, Helixmith & Genopis opened a new facility.

A few of the prominent players in the plasmid DNA manufacturing market include Merck KgaA, Lonza, FUJIFILM Diosynth Biotechnologies U.S.A. Inc., Cobra Biologics Ltd., Brammer Bio, Waisman Biomanufacturing, Genezen, YPOSKESI, Advanced BioScience, Laboratories Inc. (A.B.L. Inc.), Novasep Holding S.A.S, ATVIO Biotech Ltd., and Wacker Biotech US Inc.

Global Plasmid DNA Manufacturing Market is Segmented as Below:

By Vector Type

  • Adenovirus
  • Retrovirus
  • Adeno-Associated Virus (AAV)
  • Lentivirus
  • Plasmids
  • Others

By Workflow

  • Upstream Manufacturing (Vector Amplification & Expansion and Vector Recovery/Harvesting)
  • Downstream Manufacturing (Purification and Fill Finish)

By Application

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

By End Use

  • Pharmaceutical and Biopharmaceutical Companies
  • Research Institutes

By Disease Type

  • Cancer
  • Genetic Disorders
  • Infectious Diseases
  • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • UK
    • France
    • Germany
    • Russia
    • Rest of Europe
  • Asia Pacific
    • Japan
    • South Korea
    • India
    • China
    • Rest of Asia-Pacific
  • LAMEA
    • Latin America
    • Middle East
    • Africa

Key Elements Included In The Study: Global Plasmid DNA Manufacturing Market

  • Plasmid DNA Manufacturing Market by Product/Technology/Grade, Application/End-user, and Region
  • Executive Summary (Opportunity Analysis and Key Trends)
  • Historical Market Size and Estimates, Value, 2019 - 2022
  • Market Value at Regional and Country Level, 2023 - 2030
  • Market Dynamics and Economic Overview
  • Market Size in Value, Growth Rates, and Forecast Figures, 2023 - 2030
  • Competitive Intelligence with Financials, Key Developments, and Portfolio of Leading Companies 
  • Regional and Product/Grade/Application/End-user Price Trends Analysis
  • Value Chain and Five Force’s Analysis
  • Regional/Sub-region/Country Market Size and Trend Analysis
  • Company Market Share Analysis and Key Player Profiles

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