DRUG AND GENE DELIVERY DEVICES MARKET ANALYSIS

The global drug and gene delivery devices market was valued at US$ 152.2 Thousand in 2022 and is forecast to reach a value of US$ 364.9 Thousand by 2030 at a CAGR of 11.6% between 2023 and 2030. The global drug and gene delivery devices market is experiencing strong growth due to the rise in burden of chronic disease and high demand for drug and gene delivery devices. Moreover, increasing funding for cell and gene therapies and rise in approvals for gene therapies is expected to boost growth of the market. However, factors such as stringent rules and regulations and high risk of needlestick injuries are expected to hamper the market growth.

Global Drug and Gene Delivery Devices Market: Regional Insights

Based on geography, the global drug and gene delivery devices market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America is expected to gain highest share in the market during the forecast period due to the increasing prevalence of chronic diseases, such as cancer, development of gene therapies, increasing demand for drug and gene delivery devices, and introduction of novel devices in the region. For instance, according to the American Cancer Society (ACS), in 2023, more than 1,958,310 new cancer cases and 609,820 cancer deaths are projected to occur in the U.S. In 2022, more than 1.9 million new cancer cases and 609,360 cancer deaths were projected to occur in the U.S. This in turn is driving the growth of the market.

Europe and Asia Pacific are also expected to witness robust growth in the global drug and gene delivery devices market owing to the rise in burden of chronic diseases, such as infectious disease, cardiovascular disease, cancer, and diabetes, increasing demand for drug or gene delivery devices, and introduction of novel devices in these regions. For instance, according to the European Heart Network, each year, cardiovascular diseases (CVDs) cause more than 3.9 million deaths in Europe and around 1.8 million deaths in the European Union (EU). CVDs account for around 45% of all deaths in Europe and 37% of all deaths in the EU.

Figure 1. Global Drug and Gene Delivery Devices Market Share (%), by Region, 2023

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Global Drug and Gene Delivery Devices Market Drivers:

Rise in burden of chronic diseases to drive market growth

One of the key factors expected to augment the growth of the global drug and gene delivery devices market during the forecast period is the increasing prevalence of chronic disease around the world. For instance, with the rise in burden of chronic diseases, such as infectious disease, cardiovascular disease, cancer, and diabetes, the demand for drug/gene delivery devices is also increasing with a rapid pace. According to the World Health Organization (WHO), cardiovascular diseases account for most NCD (noncommunicable disease) deaths, or 17.9 million people every year, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million).

High demand for drug/gene delivery devices to propel market growth

Another factor which is driving the growth of the global drug and gene delivery devices market is the increasing demand for gene and drug delivery devices around the world. For instance, a drug and gene delivery device is a medical device that enables a drug and gene to reach its site of action without reaching non-target cells, organs, and tissues. In May 2022, Jabil Healthcare launched the Qfinity autoinjector platform, a simple, reusable, and modular solution for subcutaneous (SC) drug self-administration, at a lower cost than market alternatives, supporting the emerging prioritization of sustainable drug delivery within the pharmaceutical industry.

Global Drug and Gene Delivery Devices Market Opportunities:

Increasing funding for cell and gene therapies is expected to offer significant growth opportunities for players in the drug and gene delivery devices market. For instance, in May 2023, ElevateBio has raised US$ 401 million in a Series D financing round for advancing its technology platforms to expedite the design, production, and development of cell & gene therapies. Moreover, in March 2021, ElevateBio raised US$ 525 million to advance its cell and gene therapies. A funding will be used to help the company expand its R&D and manufacturing capabilities, as well as continue to spin out new companies and partnerships based on the research.

Rise in approvals for gene therapies is expected to offer lucrative growth opportunities for players in the global drug and gene delivery devices market. For instance, gene therapy is a medical field used to treat or prevent disease by correcting the underlying genetic problem. In August 2022, the U.S. Food and Drug Administration (FDA) approved Zynteglo (betibeglogene autotemcel), a first cell-based gene therapy to treat adults and pediatrics with beta-thalassemia. Each dose of Zynteglo is a customized treatment made using patient’s own cells that are genetically modified to produce functional beta-globin (a hemoglobin component).

Global Drug and Gene Delivery Devices Market Trends:

High demand for self-Administered drugs is a recent trend

Self-administered drugs are medicines a person can take at home, without assistance. The growing trend towards the self-administration of drugs has increased the demand for convenient and easy-to-use drug delivery systems. Moreover, with the development of novel drug delivery technologies and the continued focus on patient-centric healthcare, the demand for novel drug delivery devices is also increasing with a rapid pace, worldwide. This trend is expected to continue over the forecast period, driving the drug and gene delivery devices market growth.

Introduction of novel devices/therapies is another trend

With the increasing prevalence of chronic/targeted diseases across the globe, the demand for safe and effective drug and gene delivery devices as well as demand for novel cell and gene therapies is also increasing with a rapid pace. Thus, players in the market are focusing on developing and/or launching novel devices or therapies to meet growing demand. This trend is expected to continue over the forecast period, driving the growth of the market.

Global Drug and Gene Delivery Devices Market Restraints:

Stringent rules and regulations to hinder market growth

One of the key factors expected to hamper the growth of the global drug and gene delivery devices market is the stringent rules and regulations. Due to safety issues such as over and/or underuse of medication, missed or delayed therapy, and medication errors, strict product regulations to govern these systems are in place. A large number of people die every year due to unsafe practices. Thus, all medical devices in the United States are subject to the Premarket Approval Application (PMA) pathway and 510(k) pathways. Moreover, strict regulation for classification, distribution, and sale of OTC medicines is the need of the hour.

Risk of needlestick injuries to hamper market growth

Another factor which is hampering the growth of the global drug and gene delivery devices market is the high risk of needlestick injuries. Needlestick injuries (NSIs) are wounds caused by needles that accidentally puncture the skin. Needlestick injuries are one of the most important occupational hazards among healthcare workers (HCWs) worldwide. Needlestick injuries can lead to serious or fatal infections with blood-borne pathogens, such as hepatitis B virus, hepatitis C virus, and HIV. Thus, several regulatory authorities across the world are mandating the usage of safety syringes to help reduce the risk associated with needlestick injuries.

Figure 2. Global Drug and Gene Delivery Devices Market Share (%), by Product, 2023

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Global Drug and Gene Delivery Devices Market Segmentation:

The global drug and gene delivery devices market report is segmented into Product, Commercialized Drugs, and Region.

Based on Product, the market is segmented into Subretinal Injection Cannula, Extension Tube, Intravenous Catheter, Sterile Insulin Syringe, Pre-filled Syringe, and Infusion Bags. Out of which, Sub-retinal Injection Cannula Segment is expected to dominate the drug and gene delivery devices market over the forecast period and is attributed to the increasing demand for subretinal injection cannulas. Subretinal injection cannula is a more efficient and precise method of ocular drug delivery for cell and gene therapies.

Intravenous Catheter Segment is also expected to witness significant growth in the near future and this is due to the increasing prevalence of chronic disease. Intravenous catheter is used to give intravenous fluids, blood transfusions, chemotherapy, and other drugs.

Based on Commercialized Drugs, the market is segmented into Luxturna (Drug Delivery Devices), Yescarta (Drug Delivery Devices), Zolgensma (Drug Delivery Devices), Kymriah (Drug Delivery Devices), Provenge (Drug Delivery Devices), and Strimvelis (Drug Delivery Devices). Out of which, Luxturna (Drug Delivery Devices) Segment is expected to dominate the market over the forecast period and this is attributed to the rise in approvals for gene therapies. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

Yescarta (Drug Delivery Devices) Segment is also expected to witness significant growth in the near future and this is owing to increasing demand for safe and effective drugs. Yescarta is a type of advanced therapy medicine called a 'gene therapy product'.

Global Drug and Gene Delivery Devices Market: Key Developments

In November 2022, IMUNON, Inc. and Acuitas Therapeutics signed an agreement to evaluate the combination of IMUNON’s PLACCINE nucleic acid vaccine constructs formulated with Acuitas’ proprietary lipid delivery technology.

In August 2022, Versant Ventures launched Vector BioPharma AG, a biopharmaceutical company developing a precision gene delivery platform devoid of viral genes.

In June 2022, Gufic Biosciences Ltd. launched a new drug delivery system, Dual Chamber Bags, at affordable prices for the first time in India.

In February 2022, Takeda received the U.S. Food and Drug Administration (USFDA) approval for TAKHZYRO (lanadelumab-flyo) injection, a single-dose prefilled syringe (PFS), to prevent attack of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Global Drug and Gene Delivery Devices Market: Key Companies Insights

The global drug and gene delivery devices market is highly competitive. This is attributed to the increasing prevalence of chronic/targeted disease across the globe, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global drug and gene delivery devices market are Pfizer, Inc., Novartis AG, Kite Pharma, Inc., Bluebird bio, Inc., Vericel Corporation, uniQure N.V., Spark Therapeutics, Inc., Renova Therapeutics, Orchard Therapeutics plc, Kolon Tissue Gene, Inc., Human Stem Cell Institute, Amgen, Inc., Dendreon Pharmaceuticals, Helixmith Co., Bausch & Lomb Incorporated, Ltd (ViroMed Co., Ltd), Becton Dickinson and Company, and Castle Creek Biosciences, Inc (Fibrocell Technologies, Inc.), among others.

*Definition: The field of drug and gene delivery involves development and delivery of drugs, genes, and gene products that ultimately alter protein expression and function of the cells, tissues, and living organisms.