Published Date : 16 May 2023
The global plasmid DNA manufacturing market value is expanding at USD 539.78 million in 2023 and is expected to touch around USD 2,156.58 million by 2032, growing at a noteworthy CAGR of 21.7% from 2023 to 2032.
The increased need for innovations in the biopharmaceutical sector is pushing the demand for novel manufacturing technologies for the commercial production of plasmid DNA.
Plasmid DNA (pDNA), which is utilized in vaccines and gene therapy, must fulfill strict purity and homogeneity standards, necessitating effective, repeatable, and scalable purification. Plasmid DNA is now becoming more and more significant for clinical research applications in genetic vaccination and gene therapy. Plasmid DNA that meets good manufacturing practice (GMP) standards are required for direct gene transfer into humans. The same is true if the drug material uses genetically modified cells, such as chimeric antigen receptor (CAR) T cells, which are employed in conjunction with the plasmids contained inside them. They must be produced under strict GMP, according to the regulatory bodies in charge.
There are several production steps that are included in the manufacturing process. A pilot run needs to be done first to make sure the plasmid is utilized under the proper circumstances. This stage involves performing a subsequent scaling with regard to impacts on product quality and repeatability. The changed production strain is then developed and given a cell bank, which is then characterized. The culturing method uses this cell bank. To get a pure plasmid product, multiple chromatography processes are carried out after cell collection and lysis. Based on the respective needed quality grade, the plasmid product is submitted to different quality controls. The product's formulation and filling make up the last phase.
Plasmid DNA Manufacturing Market Report Scope:
|Market Revenue in 2023||USD 539.78 Million|
|Projected Forecast Revenue in 2030||USD 2,156.58 Million|
|Growth Rate from 2023 to 2032||CAGR of 21.7%|
|Largest Market||North America|
|Forecast Period||2023 to 2032|
|Regions Covered||North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa|
In terms of revenue, North America led the world market for plasmid DNA production in 2022, and it is anticipated that it will continue to lead over the forecast period. The need for plasmid DNA is being significantly boosted by the presence of various biopharmaceutical sector companies in North America. The area is also noted for its high disposable income, rising consumer knowledge of gene treatments, enhanced healthcare infrastructure, and rising use of gene therapy to treat a range of illnesses.
In contrast, it is anticipated that Asia Pacific would be the most opportune market over the projection period. This may be attributed to the fact that the government has raised its funding in the healthcare sector, and business actors in the area are increasing their investments to support plasmid DNA research and development.
Market Drivers: Increase in capital expenditure
The establishment of a trustworthy and affordable supply of Critical Reagent Grade or GMP grade pDNA is crucial for firms engaged in cell and gene therapy (CGT) as well as businesses making mRNA vaccines and treatments. To support the expanding CGT and mRNA therapies business, there is a greater requirement for plasmid manufacturing in the CGT area due to a strong pipeline and rising capital expenditure.
CGT and mRNA biopharma firms with huge amounts of high-quality Critical Reagent Grade or GMP plasmid DNA. This service allows for plasmid DNA scaling up and promotes quick time to market since it is produced using a procedure that is optimized for a high yield of high-quality plasmid DNA.
Market Restraints: Challenge in monitoring, maintaining, and harvest
Due to its size, shear sensitivity, and resemblance to some contaminants, pDNA can be difficult to recover at large yields. High-density cell cultures are typically challenging to monitor, maintain, and harvest. Shear pressures have the potential to contaminate the plasmid extract by destroying pDNA and degrading precipitated genomic DNA. Plasmids larger than 6 kb are difficult to purify using conventional techniques like resins because they cannot effectively diffuse through the pores. It can be technically challenging to separate pDNA from impurities (such as undesirable plasmid isoforms) in order to produce a homogenous result; this frequently involves many chromatography processes.
Market Opportunities: Increasing number of partnerships or collaborations
The increasing number of partnerships or collaborations between the many entities participating in this sector emphasizes the rising interest in the synthesis of plasmid DNA. These collaborations are formed for a variety of objectives. Collaboration agreements have been made for a variety of reasons, such as the creation of vector promoters, the development of manufacturing facilities or their acquisition, and the sale and purchase of plasmid DNA synthesis technologies, among others.
According to product type, the viral vector market dominated the worldwide plasmid DNA manufacturing market in 2022 and is predicted to continue dominating throughout the course of the forecast period. Due to their widespread use in cell-based gene treatments, adeno-associated viral vectors are encouraging the expansion of this field. The capacity to integrate with big transgenes and the simplicity of production at high titers are two key factors that contribute to the viral vector holding a sizable part of the market for plasmid DNA synthesis.
The worldwide industry has been further divided into three categories based on ailments: cancer, genetic disorders, and infectious diseases. In 2022, the worldwide industry was led by the cancer illness sector, which brought in more than 40.23% of the total revenue.
Cancer has been treated with a variety of gene therapy techniques, including oncolytic virotherapy, immunological regulation based on gene therapy, and genetic modification of apoptosis. According to projections, the infectious illness market will expand significantly in the next years.
The global industry has been further divided based on applications into DNA vaccines, cell & gene therapy, immunotherapy, and others. The cell and gene therapy application segment led the worldwide industry market in 2022 and accounted for the greatest proportion of more than 58.00% of the entire revenue. The fact that gene therapy is widely used to treat a number of inherited and genetic diseases can be attributed to this high share. Furthermore, the segment's growth is being fueled by ongoing technological advancements in the search for a safe and effective treatment for a variety of disorders.
Major Key Players:
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