U.S. Viral Vector and Plasmid DNA Manufacturing Market Size | Companies
The U.S. viral vector and plasmid DNA manufacturing market size was valued at USD 2.24 billion in 2023 and is anticipated to reach around USD 13.92 billion by 2033, growing at a CAGR of 20.04% from 2024 to 2033. The U.S. viral vector and plasmid DNA manufacturing market has witnessed remarkable growth is driven by advancements in biotechnology, gene therapy, and genetic engineering.
The growth of the U.S. viral vector and plasmid DNA manufacturing market is fueled by an increased investments in biotechnology research and development, particularly in gene therapy and genetic medicine, are driving demand for these essential components. Secondly, technological advancements in bioprocessing techniques, including viral vector production systems and gene editing technologies, are enhancing manufacturing efficiency and product quality. Additionally, favorable regulatory frameworks, such as expedited approval pathways for gene therapy products, are facilitating market growth by streamlining the development and commercialization process.
In terms of vector type, the adeno-associated virus (AAV) segment emerged as the market leader, commanding the largest revenue share of 20% in 2023. The robust technologies employed in the recovery of vectors and clarification processes significantly contribute to revenue generation within this segment. The recovery of plasmid DNA (pDNA) from biomass is primarily accomplished through techniques such as centrifugation or Tangential-Flow Filtration (TFF), followed by alkaline or heat lysis methods. Additionally, filtration methods utilizing depth filters are utilized for the harvesting process in vector manufacturing.
The lentivirus segment is anticipated to exhibit the fastest CAGR of 20.13% during the forecast period. Lentiviral vectors are predominantly produced through transient transfection of adherent human-derived HEK293 cell lines in media containing bovine serum, utilizing Polyethylenimine (PEI) transfection reagent. While small-scale lentivirus manufacturing based on adherent systems is cost-effective, conducting high-throughput screening experiments poses challenges for companies.
The downstream processing segment emerged as the market leader, commanding the largest revenue share of 54% in 2023. Downstream processes encompass various purification methods, organized into three stages: capture, intermediate purification, and polishing. Chromatography and ultrafiltration techniques are utilized for intermediate purification and final polishing. Chromatography, employing ion exchange and affinity methods, is the industry's preferred technique. However, these methods present challenges, such as requiring additional purification methods, resulting in yield loss.
The upstream processing segment is projected to grow at a CAGR of 19.13% over the forecast period. Initial processing, termed upstream processing, involves cell introduction to the virus, cell cultivation, and subsequent virus extraction. The growth in innovative product development, such as the ambr 15 microbioreactor system for high-throughput upstream process development, is expected to drive this segment.
In terms of application, the vaccinology segment held the largest revenue share of 23% in 2023. The anticipated rise in vaccine demand across various health conditions and cancer is poised to propel market growth.
The cell therapy segment is projected to exhibit the fastest CAGR over the forecast period. The increasing adoption of cell therapy-based medicines, facilitated by next-generation transfer vectors known for their safety and efficacy, drives this growth. Patient samples are typically expanded, extracted, and further transduced using gene therapy vectors. The modified transduced cells are then reintroduced into patients for therapeutic purposes.
Among end-users, research institutes dominated the market with the largest revenue share of 59% in 2023, driven by the high demand for vectors in research endeavors and the growing engagement of scientific communities in gene and cell therapy research.
The pharmaceutical & biotechnology companies segment is expected to grow at a CAGR of 20.33% over the forecast period. With increased investments in cell and gene therapy, several biopharmaceutical companies are shifting focus toward these advanced therapies. Consequently, more research studies are being conducted to assess the potential of gene and cell therapies. Biotechnology and pharmaceutical firms are actively involved in developing advanced therapies for various life-threatening diseases. For instance, Abeona Therapeutics is evaluating AAV9-based gene therapies for CLN1 and CLN3 diseases, while U.S.-based company StrideBio offers AAV-mediated gene therapy solutions based on its research findings.
Regarding diseases, the cancer segment dominated the market with the largest revenue share of 39% in 2023. Increased vector adoption for cancer therapy development, numerous research programs, and recent gene therapy product approvals have driven market growth. Companies maintain robust pipelines of cancer gene therapy products, which are expected to sustain market growth throughout the forecast period.
The genetic disorders are expected to grow rapidly during the forecast period. Genetic diseases are most commonly congenital; however, some diseases can be acquired by random mutations. The most common genetic diseases include sickle cell anemia and hemophilia, which are characterized by the formation of blood clots and the production of hemoglobin, affecting the oxygen-carrying capacity of the blood.
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