According to FutureWise analysis, the market for cell and gene therapy drug delivery devices in 2025 is US$ 1.12 billion, and is expected to reach US$ 2.6 billion by 2033 at a CAGR of 11.10%. The sector is experiencing growth due to the rising use of advanced therapies for genetic disorders, cancers, and rare diseases. There is a growing need for precise delivery systems as researchers develop innovative vectors and microinjection technologies that improve targeted delivery and outcomes. Ongoing R&D investments are also driving the development of next-generation devices optimized for safety and scalability in clinical applications.
Cell and gene therapies (CGTs) are an innovative class of medical treatments designed to address diseases by introducing, removing, or modifying genetic material within patient cells. Unlike conventional small-molecule drugs or biologics, CGTs operate as living therapeutics, which include autologous or allogeneic cells, viral vectors, or nucleic acids. These treatments necessitate precise, safe, and efficient delivery mechanisms to ensure that therapeutic agents reach the targeted tissues effectively. This need has led to the development of specialized drug delivery devices tailored for cell and gene therapies, which help ensure that therapeutic payloads achieve accurate anatomical location, adequate transduction or engraftment, and reduced off-target effects or immune reactions.
These delivery systems encompass various technologies, including minimally invasive catheters, microneedle arrays, implantable bioreactors, and microfluidic platforms. For instance, intramyocardial injection catheters equipped with deflectable tips facilitate the direct delivery of cardiosphere-derived cells or adeno-associated virus (AAV) vectors into ischemic heart tissue during minimally invasive procedures. In oncology, electroporation devices like the Cliniporator are used to administer controlled electrical pulses, enhancing the uptake of plasmid DNA in solid tumors. Ocular gene therapies utilize subretinal cannulas designed for micro-volume accuracy, enabling the precise delivery of AAV2 vectors beneath the retina while protecting sensitive areas such as the fovea. Additionally, ex vivo platforms like the Miltenyi CliniMACS Prodigy streamline the automation of CAR-T cell transduction, washing, and formulation within a closed, Good Manufacturing Practice (GMP)-compliant system, effectively merging device use with manufacturing processes.
Regulatory agencies such as the FDA and EMA categorize many of these tools as combination products, which necessitate dual oversight of both the biologic and device components in accordance with regulations like 21 CFR Part 820 and ISO 13485. Significant challenges in this field include scalability, ensuring lot-to-lot consistency, and minimizing shear stress during infusion, which can compromise cell viability. Recent advancements in biomaterials, such as heparin-coated tubing and biodegradable scaffolds, are being developed to mitigate the risks associated with immunogenicity and thrombosis.
FutureWise Market Research has instantiated a report that provides an intricate analysis of Cell and Gene Therapy Drug Delivery Devices Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.
According to the research study conducted by FutureWise research analysts, the Cell and Gene Therapy Drug Delivery Devices Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.