Cell & Gene Therapy drug Delivery Devices Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Type (Subretinal Injection Cannula, Extension Tube, Intravenous Catheter, Sterile Insulin Syringe, Prefilled Syringe, Infusion Bags), By Route of Administration (Oral, Intravenous, Ocular, Transdermal, Others), By Method (In Vitro, Ex Vivo), By Region, & Competition, 2020-2030F

Market Overview

The Cell & Gene Therapy drug Delivery Devices market was valued at USD 1.15 Billion in 2024 and is expected to reach USD 2.03 Billion by 2030 with a CAGR of 9.85%. The Global Cell & Gene Therapy (CGT) Drug Delivery Devices Market is becoming a cornerstone of modern therapeutic delivery, propelled by the commercialization of regenerative medicines, precision-based interventions, and high-value biologics. As CGTs transition from clinical trials to mainstream treatment protocols, there is a critical and growing need for specialized delivery systems engineered to handle the complexity, fragility, and patient-specific nature of these therapies. Traditional delivery tools are often inadequate, making purpose-built devices essential for ensuring targeted, sterile, and effective administration particularly in procedures involving autologous cell infusions, in vivo gene transfers, or subretinal injections.

This market now represents a high-growth, innovation-driven segment within the life sciences industry, marked by rising investment, evolving regulatory standards, and an expanding portfolio of FDA- and EMA-approved CGTs. As adoption accelerates, the spotlight is shifting to device manufacturers that can engineer scalable, precision-based platforms aligned with therapy-specific delivery requirements whether for hospital-based CAR-T procedures or outpatient administration of gene-modified biologics. In this context, the ability to deliver customized, compliant, and commercially viable delivery solutions is rapidly becoming a competitive differentiator and a critical enabler of success in the global CGT ecosystem.

Key Market Drivers

Rising Prevalence of Chronic and Genetic Diseases

The rising prevalence of chronic and genetic diseases is a critical driver accelerating the growth of the Global Cell & Gene Therapy (CGT) Drug Delivery Devices Market. In 2021, 18 million individuals worldwide died prematurely before the age of 70 due to noncommunicable diseases (NCDs). Notably, 82% of these early deaths occurred in low- and middle-income countries (LMICs), highlighting a disproportionate disease burden in economically constrained regions. Furthermore, LMICs accounted for 73% of all global deaths attributed to NCDs, underscoring the urgent need for targeted healthcare interventions and infrastructure investment in these markets. As conventional treatments often fail to deliver long-term or curative outcomes for many of these conditions, there is a growing global shift toward advanced therapies namely cell and gene therapies that offer targeted, durable, and often one-time solutions. This growing demand, in turn, is fueling the need for specialized, efficient, and safe drug delivery devices to administer these cutting-edge therapies. Chronic and genetic diseases such as cancer, hemophilia, spinal muscular atrophy (SMA), cystic fibrosis, sickle cell anemia, and inherited retinal disorders often lack effective or sustainable treatment options in traditional medicine. CGTs provide personalized and disease-modifying interventions, directly addressing the root causes of these conditions at the cellular or genetic level. Targeting affected tissues or cells (e.g., retina, bone marrow, CNS), Protecting fragile biologics from degradation during delivery, Ensuring patient safety through sterile, dose-controlled administration. As the patient base expands due to increasing disease prevalence, demand rises for high-performance delivery devices capable of meeting these unique clinical requirements.

Chronic diseases such as cancer, cardiovascular diseases, diabetes, and neurodegenerative disorders are on the rise due to aging populations, urban lifestyles, and environmental factors. Cardiovascular diseases (CVDs) were the top global cause of mortality in 2021, responsible for approximately 20.5 million deaths nearly one-third of all fatalities worldwide. Many of these diseases are now being studied and treated through CGT-based approaches, especially in oncology, where CAR-T cell therapies have shown remarkable success in treating certain leukemias and lymphomas. Driving the adoption of intravenous catheters, infusion pumps, and subretinal cannulas for precise delivery of cell-based therapies, Requiring customized devices that can deliver high-value therapies without degradation or immune response, Pushing for innovations in non-invasive or minimally invasive delivery systems for long-term disease management, The increasing burden of chronic illness globally ensures a sustained and expanding demand for CGTs and their associated delivery technologies.

Unlike traditional drugs that manage symptoms over time, many CGTs are designed to be curative or one-time treatments, particularly in the field of rare genetic diseases. This paradigm shift increases the value and importance of delivery precision, as even a single administration must be: Biologically effective, Sterile and contamination-free, Targeted to the correct location within the body. Thus, the need for advanced, patient-specific delivery devices becomes a fundamental requirement for clinical success and regulatory approval. As more patients are identified through genomic screening and early diagnosis, especially in pediatric and neonatal populations, the market for delivery tools grows alongside therapeutic expansion.

Government and Institutional Support

Government and institutional support play a pivotal role in driving the expansion of the Global Cell & Gene Therapy (CGT) Drug Delivery Devices Market. Over the past five years, the Department has funded more than 80 targeted and collaborative R&D projects focused on genome editing technologies for healthcare applications. These initiatives span both individual-led innovations and multi-institutional partnerships, reflecting a strategic push to advance precision medicine, genetic diagnostics, and therapeutic interventions through cutting-edge genome editing platforms. Leading health authorities such as the U.S. FDA, European Medicines Agency (EMA), and regulatory bodies in Asia-Pacific are providing accelerated pathways for CGT products and associated delivery technologies. Programs like: Regenerative Medicine Advanced Therapy (RMAT) designation, Orphan Drug Designation, Breakthrough Therapy designation, Priority Review and Fast Track mechanisms allow companies to bring therapies and their corresponding delivery devices to market faster. This regulatory support reduces time-to-market and de-risks early-stage innovation for developers of novel delivery devices. By streamlining the approval process, governments are encouraging greater investment in specialized catheters, injection systems, prefilled syringes, and infusion devices required to administer CGTs safely and effectively.

Governments and institutional investors are allocating significant funding to support research, development, and scale-up of CGT delivery infrastructure. This includes: Grants and subsidies to biotech and medtech companies for device prototyping and clinical validation, Public-private partnerships (PPPs) to develop biomanufacturing and delivery platforms, Investment in specialized manufacturing facilities for sterile, single-use, and cryogenic-compatible devices. Such funding lowers the barriers for emerging players and accelerates the development of high-precision, regulatory-compliant delivery solutions. In countries like the U.S., Germany, Japan, and China, national innovation policies are increasingly prioritizing CGTs, and the tools required for their effective administration. Institutional support extends beyond product development into clinical trial facilitation and patient access programs. Governments are helping sponsor: Large-scale multicenter clinical trials involving cell and gene therapies, Expanded access programs that require the use of certified delivery devices, Patient registry and genomic screening initiatives that identify suitable candidates for CGT. These initiatives create predictable demand for delivery devices used in clinical and post-approval settings. For instance, an increase in CAR-T therapy trials directly drives up the requirement for closed-loop infusion systems and intravenous catheters that meet trial protocols and sterility standards.

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Key Market Challenges

High Cost of Development and Commercialization

One of the most significant barriers to market growth is the extremely high cost associated with developing, validating, and scaling delivery devices tailored for cell and gene therapies. Key cost drivers include: Custom device engineering for highly specific therapies, Sterility and biocompatibility requirements for human use, Specialized manufacturing infrastructure, often requiring GMP-certified cleanrooms. Cold chain logistics and cryopreservation systems for temperature-sensitive CGT products.

These costs are particularly burdensome for smaller biotech firms and startups, which dominate early-stage CGT innovation. Without substantial funding or strategic partnerships, many companies struggle to move from R&D to full-scale commercialization, thereby slowing the broader adoption of advanced delivery solutions.

Limited Standardization and Scalability

Cell and gene therapies are highly individualized and complex, often requiring case-by-case customization of delivery devices. This creates a lack of uniformity across therapeutic platforms, making it difficult to: Develop scalable, off-the-shelf devices suitable for multiple therapies, Integrate devices into existing hospital and laboratory workflows, Achieve consistent dose accuracy, targeting, and safety profiles.

This lack of standardization also complicates supply chain management and increases operational risks for manufacturers. Until the industry can establish universal design frameworks or modular platforms for drug delivery in CGT, scalability and mass adoption will remain limited.

Key Market Trends

Technological Advancements in Precision Delivery Systems

As the complexity and specificity of CGTs grow, so does the demand for next-generation delivery devices capable of ensuring accurate dosing, cellular targeting, and minimal tissue damage. Recent technological innovations are enabling: Electroporation devices for safer and more efficient gene transfection in ex vivo environments, Microneedle patches for localized and minimally invasive delivery of genetic materials, Lipid nanoparticles (LNPs) and viral vectors that can deliver CRISPR-based gene-editing tools and other payloads with high precision.

These technologies are not only improving therapeutic efficacy but are also reducing systemic toxicity, which is critical in the administration of CGTs. As research moves toward treatments for more delicate tissues like the brain, retina, or lungs, specialized delivery technologies will continue to evolve and drive market growth.

Expansion of Commercialized Cell & Gene Therapies and Clinical Pipelines

The global market is witnessing an accelerated shift from clinical trials to commercial rollouts of cell and gene therapies, especially for oncology, rare genetic disorders, and autoimmune conditions. This expansion is creating consistent demand for advanced delivery devices that are compatible with: Autologous and allogeneic therapies, Cold chain logistics and cryopreservation, Sterile, pre-filled formats for rapid deployment.

Moreover, the increasing volume of CGT clinical trials, particularly in North America, Europe, and Asia Pacific, continues to generate demand for scalable and GMP-compliant delivery tools. With more than 2,000 CGT trials underway globally, the commercial pipeline is expected to significantly boost device sales over the next decade.

Segmental Insights

Type Insights

Based on the category of Type, the prefilled syringe segment emerged as the fastest growing in the market for Cell & Gene Therapy drug Delivery Devices in 2024. Cell and gene therapies often involve sensitive biological products that require precise dosing and sterile handling. Prefilled syringes offer a ready-to-use format, minimizing human error and contamination risks compared to traditional vials and manual preparation methods. This makes them particularly well-suited for the intravenous or intramuscular administration required in CGTs.

Prefilled syringes significantly reduce preparation time for healthcare providers, thereby improving workflow efficiency in clinical settings. Additionally, they are often pre-dosed for single-use, reducing the burden on pharmacists and minimizing wastage. For gene and cell therapy applications where the therapeutic agents can be extremely expensive this aspect is critical in reducing costs and ensuring safety. As cell and gene therapies evolve toward more personalized and targeted treatments, there is a growing trend toward home-based care and self-administration models under clinical guidance. Prefilled syringes are easier to handle, store, and transport, making them ideal for decentralized care models, thereby expanding their adoption. These factors contribute to the growth of this segment.

Type Insights

Based on the category of Method, the ex vivo segment emerged as the dominating in the market for Cell & Gene Therapy drug Delivery Devices in 2024. Ex vivo methods involve extracting cells from a patient’s body, modifying them genetically or cellularly outside the body, and then reintroducing them. This approach offers a highly controlled environment, significantly minimizing off-target effects and improving therapeutic precision. Such control is especially critical in complex treatments like CAR-T cell therapy, where T-cells are engineered to target specific cancer cells.

Several of the most successful and FDA-approved cell and gene therapies such as Kymriah (Novartis), Yescarta (Gilead), and Zynteglo (bluebird bio) rely on ex vivo gene modification methods. These therapies are not only leading the market in terms of revenue but also setting standards for safety and efficacy, reinforcing the preference for ex vivo delivery models.

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Regional Insights

North America emerged as the largest market in the global Cell & Gene Therapy drug Delivery Devices market in 2024, holding the largest market share in terms of value. North America, particularly the United States, is home to a highly developed biopharmaceutical industry. Major biotech and pharmaceutical companies such as Pfizer, Novartis, Gilead Sciences, and Bluebird Bio are actively investing in cell and gene therapy pipelines. These companies not only lead innovation in therapy development but also significantly influence the demand for efficient and precise drug delivery devices.

Substantial public and private investments in R&D initiatives, often backed by venture capital and government funding (e.g., NIH grants), contribute to the region’s leadership. This investment climate accelerates the commercialization of novel drug delivery technologies tailored to CGTs. The region benefits from world-class medical and research institutions, specialized hospitals, and state-of-the-art laboratories that support the clinical translation of CGTs. This infrastructure enables the rapid adoption of new drug delivery systems, including electroporation devices, viral and non-viral vectors, microneedles, and intratumoral delivery systems, ensuring safe and targeted administration of therapies.

Key Market Players

• Becton, Dickinson, and Company
• Novartis AG
• Amgen Inc.
• Kite Pharma, Inc.
• Pfizer, Inc.
• Bausch & Lomb Incorporated
• Bluebird bio, Inc.
• Castle Creek Biosciences, Inc (Fibrocell Technologies, Inc.)
• Dendreon Pharmaceuticals LLC.
• Helixmith Co., Ltd (ViroMed Co., Ltd)

Report Scope:

In this report, the Global Cell & Gene Therapy drug Delivery Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cell & Gene Therapy drug Delivery Devices Market, By Type:

o   Subretinal Injection Cannula

o   Extension Tube

o   Intravenous Catheter

o   Sterile Insulin Syringe

o   Prefilled Syringe

o   Infusion Bags

• Cell & Gene Therapy drug Delivery Devices Market, By Route of Administration:

o   Oral

o   Intravenous

o   Ocular

o   Transdermal

o   Others

• Cell & Gene Therapy drug Delivery Devices Market, By Method:

o   In Vitro

o   Ex Vivo

• Cell & Gene Therapy drug Delivery Devices Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell & Gene Therapy drug Delivery Devices Market.

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Global Cell & Gene Therapy drug Delivery Devices market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).