Plasmid DNA Contract Manufacturing Market Size (2024 - 2029)

Plasmid DNA Contract Manufacturing Market Analysis

The Plasmid DNA Contract Manufacturing Market size is estimated at USD 5.52 billion in 2024, and is expected to reach USD 12.44 billion by 2029, growing at a CAGR of 14.5% during the forecast period (2024-2029).

The growing disease prevalence, investment in research studies, and popularity of gene therapy are the key factors driving the growth of the market. The ever-increasing popularity of gene therapy drives the demand for plasmid DNA contract manufacturing due to the essential role of plasmids in the gene therapy process. Plasmids serve as carriers for introducing therapeutic genes into target cells. As more gene therapy treatments advance through clinical trials and into commercial production, there is an increasing need for large-scale, high-quality production of plasmid DNA. For instance, in August 2023, Charles River established a world-class HQ plasmid manufacturing center of excellence to combat supply scarcity and fulfill the escalating demands of the cell and gene therapy industry.

The increasing disease burden, characterized by diverse health challenges ranging from chronic diseases to infectious threats, increases the demand for plasmid DNA contract manufacturing services. According to the British Heart Foundation's January 2024 England Factsheet, approximately 7.6 million individuals in England had cardiovascular diseases in 2022. As per the same source, around 620 million people live with heart and circulatory diseases (cardiovascular diseases) across the world in 2022; this number has been rising since then due to changing lifestyles, aging, and the growing population. Thus, with the rise in the prevalence of chronic diseases, there is a corresponding increase in demand for novel therapeutics and treatments. Plasmid DNA contract manufacturing is poised to benefit from this by meeting the requirements of biotech and pharmaceutical companies that are developing advanced therapies for chronic conditions.

As per the report published by WHO in March 2023, approximately 39.0 million people were living with HIV by the end of 2022, including 1.5 million children. Moreover, 29.8 million people living with HIV were receiving antiretroviral therapy globally. Plasmid DNA is crucial in gene therapy and vaccine development, gaining traction in treating chronic diseases. Gene therapies often utilize plasmid DNA to deliver therapeutic genes into cells, targeting genetic disorders associated with chronic conditions. Hence, the growing burden of chronic diseases is expected to boost the market’s growth over the forecast period.

The players in this market are continuously expanding their operations to accommodate the growing demand for plasmid DNA. They are vigorously advancing their capabilities to serve as a fully integrated one-stop-shop by offering various plasmid services, including process development and optimization, plasmid design, plasmid engineering, plasmid construction, and GMP plasmid manufacturing.

For instance, in January 2023, Catalent inaugurated a novel commercial-grade plasmid DNA (pDNA) production facility within its European Center of Excellence for Cell Therapies in Gosselies, Belgium. The facility has 12,000 square feet (1,100 m2) of development and manufacturing space across multiple cleanrooms for CGMP-grade pDNA production for clinical and commercial-phase supply.

Thus, the growing demand for cell and gene therapy and strategic activities from the market players is expected to boost the market’s growth over the forecast period. However, the need for advanced infrastructure for manufacturing in particular developing countries and quality issues associated with contract manufacturing are anticipated to restrain the market growth over the forecast period.

Plasmid DNA Contract Manufacturing Industry Segmentation

As per the scope of the report, plasmid DNA contract manufacturing refers to the outsourcing of the production of plasmid DNA to specialized contract manufacturing organizations (CMOs). Plasmid DNA is a small, circular DNA molecule often used in genetic engineering and gene therapy to introduce therapeutic genes into target cells.

The plasmid DNA contract manufacturing market is segmented by application, therapeutic area, end user, and geography. By application, the market is segmented into cell & gene therapy, immunotherapy, and others. By therapeutic area, the market is segmented into cancer, infectious diseases, autoimmune diseases, cardiovascular diseases, and others. By end user, the market is segmented into pharmaceutical and biotechnology companies and research institutes. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. For each segment, the market sizing and forecasts were made on the basis of value (USD).