Non-Viral Drug Delivery Systems Global Market Report 2025

The non-viral drug delivery systems market size has grown rapidly in recent years. It will grow from $8.6 billion in 2024 to $9.84 billion in 2025 at a compound annual growth rate (CAGR) of 14.4%. The growth during the historical period is due to various drivers such as the increasing demand for safer gene therapy options, advancements in nanotechnology, a higher prevalence of chronic diseases, a stronger focus on personalized medicine, and enhanced regulatory backing for non-viral platforms.

The non-viral drug delivery systems market size is expected to see rapid growth in the next few years. It will grow to $16.72 billion in 2029 at a compound annual growth rate (CAGR) of 14.2%. Growth in the forecast period will be driven by the increasing adoption of targeted therapies, greater investment in drug delivery innovation, rising interest in non-invasive treatment methods, enhanced integration of artificial intelligence, and the growing need for sustained-release drug formulations. Key trends anticipated during this period include progress in nanocarrier technologies, development of next-generation biomaterials, innovations in mRNA delivery systems, incorporation of smart drug delivery devices, and improvements in gene editing delivery techniques.

The rising demand for personalized medicines is anticipated to drive the growth of the non-viral drug delivery systems market. Personalized medicine is a treatment approach tailored to an individual’s genetic profile, lifestyle, and environmental factors. This growing demand is fueled by the potential for more effective treatments that address the root causes of disease in each patient. Non-viral systems support personalized medicine by delivering drugs or genes safely to cells, thereby minimizing risks and enhancing treatment accuracy. For example, in February 2024, the Personalized Medicine Coalition, a U.S.-based non-profit organization, reported that the FDA approved 16 new personalized therapies for patients with rare diseases in 2023, up from six approvals in 2022. As a result, the increasing preference for personalized medicines is contributing to the expansion of the non-viral drug delivery systems market.

Key companies in the non-viral drug delivery system market are emphasizing the use of advanced technologies, such as pre-optimized ionizable lipid mix systems, to facilitate the development and delivery of RNA-based therapies. This formulation technology allows RNA molecules to be efficiently encapsulated within lipid nanoparticles, ensuring stability, payload protection, and targeted gene delivery. For instance, in September 2024, Cytiva, a U.S.-based biotechnology firm, introduced an RNA delivery LNP kit that is compatible with its NanoAssemblr Ignite and Ignite+ platforms. The system features a ready-to-use ionizable lipid mix that enables swift RNA payload screening and validation for delivery, particularly useful in vaccine development for infectious diseases. It integrates with automated microfluidic platforms, supports scalable manufacturing using GMP-grade materials, and provides protocols and proof-of-concept data to guide users from discovery through clinical trials.

In September 2023, SOHM Inc., a U.S.-based pharmaceutical firm, acquired ABBIE from CGA 369 for $10 million to enhance its non-viral gene-editing capabilities. This acquisition bolsters SOHM’s ability to deliver large genetic payloads through integrase-based, non-viral platforms. ABBIE is being developed for off-the-shelf gene-editing kits, with plans for commercialization in 2024 and human trials expected by the end of 2025. CGA 369, also a U.S.-based biotechnology company, focuses on non-viral, integrase-driven gene-editing and genetic delivery solutions.

Major players in the non-viral drug delivery systems market are Evonik Industries AG, Cytiva, Arcturus Therapeutics Holdings Inc., CureVac N.V., PolyPid Ltd, Ethris GmbH, Entos Pharmaceuticals Inc., Liquidia Technologies Inc., ReCode Therapeutics Inc., Enable Injections Inc., GenEdit Inc., N4 Pharma Plc, Hopewell Therapeutics Inc., Tiba Biotech LLC, Vesigen Therapeutics Inc., Carmine Therapeutics Inc., Evox Therapeutics Ltd, InnoCore Pharmaceuticals BV, Nanomerics Ltd, DelSiTech Ltd, and Curapath Inc.

North America was the largest region in the non-viral drug delivery systems market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in non-viral drug delivery systems report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the non-viral drug delivery systems market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Non-viral drug delivery systems are methods used to administer therapeutic agents into the body without relying on viral vectors. These systems utilize various physical, chemical, or mechanical approaches - such as nanoparticles, liposomes, or polymer-based carriers - to effectively transport drugs to specific target areas. Their primary goal is to minimize the risks commonly associated with viral delivery methods, including immune responses and insertional mutagenesis. This strategy improves the overall efficacy of treatments while enhancing patient safety for a wide range of medical conditions.

Non-viral drug delivery systems are primarily used to deliver two main categories of molecules: biologics and small molecules. Biologics are therapeutic agents derived from living organisms and include proteins, peptides, monoclonal antibodies, as well as nucleic acid-based treatments like RNA and DNA. The biologics delivered using these systems include ribonucleic acid (RNA), deoxyribonucleic acid (DNA), proteins or peptides, and antibodies. The major end users of these systems are pharmaceutical and biotechnology companies, academic and research institutions, contract development and manufacturing organizations (CDMOs), and hospitals and clinics.

The non-viral drug delivery systems market research report is one of a series of new reports that provides non-viral drug delivery systems market statistics, including the non-viral drug delivery systems industry global market size, regional shares, competitors with the non-viral drug delivery systems market share, detailed non-viral drug delivery systems market segments, market trends, and opportunities, and any further data you may need to thrive in the non-viral drug delivery systems industry. This non-viral drug delivery systems market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The non-viral drug delivery systems market consists of sales of exosomes, cell-penetrating peptides, and nanocrystals. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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