Published: February 2024
According to a recently published report by Roots Analysis, the growing pipeline of advanced therapeutic medicinal product and an increase in the demand for plasmid DNA is driving the plasmid DNA manufacturing market growth
The global plasmid DNA manufacturing market is anticipated to grow at a CAGR of 14.85% from 2023-2035, reaching USD 539 million by 2035.
Plasmid DNA, which is a circular, double-stranded molecule capable of autonomous replication separate from the chromosomal DNA, plays a crucial role in the development and manufacturing of cell and gene therapies as well as nucleic acid vaccines. Consequently, the demand for plasmid DNA is experiencing rapid growth, particularly driven by the expanding pipeline of cell and gene therapies. In addition, prominent pharmaceutical players, including Moderna and Pfizer-BioNTech have employed plasmid-based platforms for their mRNA vaccines, resulting in an increased demand. However, the production of plasmids encounters several obstacles, including limited yield, plasmid instability, and stringent regulatory oversight. Therefore, drug developers are increasingly relying on third-party service providers with specialized expertise in plasmid DNA manufacturing to overcome the aforementioned challenges. These service providers offer comprehensive support ranging from process development, optimization, plasmid construction, design, and engineering, to GMP-grade manufacturing. Additionally, they contribute to streamlining the manufacturing process, optimizing resource utilization, and ensuring the provision of plasmid DNA of superior quality that complies with regulatory and research standards.
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Various factors contribute to the plasmid DNA manufacturing market growth. These factors include growing demand for gene therapies, increased investment in nucleic acid-based vaccine development and advancements in gene editing technology. The recognition of gene therapies as a promising treatment approach for genetic and oncological disorders has increased the demand for reliable and efficient production of plasmid DNA, which serves as a vector for these therapies. Additionally, the rising adoption of nucleic acid vaccines has led to increased investment in vaccine research and development, driving the demand for plasmid DNA as a crucial component of RNA/DNA vaccines. Furthermore, advancements in gene editing technology, such as CRISPR-Cas9, are expected to enhance the efficiency and safety of plasmid production, contributing to the market's growth.
One of the primary restraints in this industry is the high cost of establishing facilities and installing sophisticated equipment required for plasmid DNA manufacturing. Additionally, the ongoing maintenance of such dedicated facilities and equipment requires substantial capital investment. These costs create significant barriers to entry for new entrants, limiting competition and potentially hindering overall industry growth. Furthermore, the evolving regulatory guidelines may reclassify plasmid manufacturers from starting material producers to drug substance suppliers, leading to stricter inspections and oversight. This increased scrutiny poses challenges for compliance and meeting regulatory requirements in a cost effective and timely manner.
Despite the challenges, several growth factors continue to drive the plasmid DNA manufacturing market forward. One notable factor is the emergence of new markets, specifically in China and India, which have a large patient population and a rising demand for biologics and gene therapies. As investments in these markets increase, it is expected that opportunities for plasmid DNA manufacturing service providers will also grow. Moreover, stakeholders in the industry can leverage strategic partnerships to enhance their existing service portfolios. Such collaborations not only facilitate market reach expansion but also enable manufacturers to broaden their customer base. In addition, the integration of novel technologies by CMOs and CDMOs can significantly enhance their manufacturing services. By incorporating unique features and characteristics, such organizations can differentiate themselves in the market, allowing them to vary the prices of their offerings.
The plasmid DNA manufacturing market report also includes detailed profiles of key players (listed below) that offer plasmid DNA manufacturing services:
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