The global microneedle drug delivery system market was valued at USD 3,253.34 Million in 2022 and is projected to reach USD 5,842.64 Million by 2030, registering a CAGR of 7.6% for the forecast period 2023-2030.
The microneedle drug delivery system market was a growing segment within the broader pharmaceutical and medical device industries. Microneedle technology had garnered attention for its potential to revolutionize drug delivery, offering benefits such as painless administration, improved drug absorption, and targeted delivery. Fear of needles and injection-related pain were barriers to patient compliance and acceptance of treatments. Microneedles addressed these concerns by minimizing pain and discomfort during administration. The trend toward patient-centric care and self-administration of medications was on the rise. Microneedle systems designed for convenient at-home use aligned with this trend.
- 2022: USD 3,253.34 Million
- 2030: USD 5,842.64 Million
- CAGR (2023-2030): 7.6%
Growing number of minimally invasive procedures is surging the growth of the microneedle drug delivery system market:
The growth of the market is primarily driven by growing number of minimally invasive procedures. The microneedle delivery system is considered as the most suitable option for non-invasive delivery of medications through the skin surface and has attracted interest from many research institutes, healthcare professionals and healthcare companies. Microneedles offer a less painful and minimally invasive alternative to traditional needle-based injections. This factor has been a significant driver, as patients prefer a comfortable experience during drug administration. In recent years, researchers have been increasingly looking at the use of small microneedle patches as an alternative for vaccine delivery. Along with this, drug delivery research has tremendously gained popularity from therapists towards the transdermal route. Delivery of drugs through transdermal route has proved to be the convenient route for various medical implications. This has led to the increased demand for microneedle drug delivery systems to treat various diseases.
Developed vaccines face many challenges with regard to their safety and stability. In this context, microneedles (MNs) could potentially present a solution to address these challenges. Microneedles represent single dose administration systems that do not need reconstitution or cold-chain storage. Being self-administered, pain-free, and capable of producing superior immunogenicity makes them a more attractive alternative. All these factors could increase the demand for the microneedles drug delivery systems.
Rise in incidences of chronic diseases is accelerating the market growth of microneedle drug delivery system:
Rise in incidences of chronic diseases is driving factor for the growth of the market. The rise in the incidence of chronic diseases presents a significant healthcare challenge worldwide. Chronic diseases such as diabetes, cardiovascular diseases, and autoimmune disorders require ongoing management and treatment. Along with this, with the development of materials science and fabrication technology, the microneedles drug delivery technology has been applied and promoted in different clinical applications, including chronic illnesses such as arthritis or diabetes, cancer, dermato-cosmetology, family planning, and epidemic disease prevention, and has made great achievements. For example, according to the World Health Organization (WHO), cardiovascular disease is the cause of most non communicable diseases deaths, around 17.9 million per year, followed by cancer (9.3 million), chronic respiratory disease (4.1 million) and diabetes (2.0 million, including deaths from diabetic kidney disease). In recent years, the prevalence of diabetes has inclined to affect low- and middle-income countries more than high-income countries. According to the reports published by WHO, about 422 million people worldwide have diabetes, the majority living in low-and middle-income countries, and nearly 1.5 million deaths are directly attributed to diabetes each year. Diabetes is a metabolic syndrome that leads to many associated complications and is a leading cause of premature death. Microneedles drug delivery research has found tremendous potential in combining both the diagnostic and therapeutic elements, thus treating diabetes in a better way.
Chronic diseases require precise and controlled dosing. In such cases, microneedles can be widely adopted to deliver specific doses of medication, which is particularly important for drugs with narrow therapeutic areas. This precise dosing can help optimize treatment outcomes and minimize side effects. Some chronic disease medications need to be administered regularly, which can be difficult for patients. Thus, microneedles could enable continual drug release or deliver larger doses with less frequency, reducing the need for frequent injections. All these aforementioned factors are influencing the growth of the microneedle drug delivery system market.
In November 2021, NanoPass Technologies and Aesthetic Management Partners (AMP) have recently signed an agreement to begin commercializing NanoPass’s MicronJet® 600 intradermal delivery device in the USA. The goal of this partnership is to provide dermatologist and aesthetic physician with a safe, practically painless, shallow and consistent intradermal device to local anesthesia and treatment for the skin, fine wrinkles and other sensitive solutions.
In December 2020, Micron array technology has been reached between LTS and Micron. In accordance with the condition of the contract, LTS will invest in necessary manufacturing facility to produce Micron MAP technology in the future also this investment support LTS MAP program which will continue in parallel as product line LTS.
Costly infrastructure and equipment expenses may hamper the growth of the microneedle drug delivery system market:
The manufacturing process for microneedles that are designed to deliver drugs can be complex due to the precise engineering, materials science, drug formulation, and integration of various minor components. This might create hurdles in the adoption of microneedle drug delivery systems in near future. The ongoing challenges are the materials and fabrication methods of the microneedles in order to obtain a specific shape, configuration and function of the microneedles to achieve a noble biomedical application.
Depending on the desired drug delivery mechanism, microneedles may need to be drug-loaded, coated with a drug formulation, or designed to encase the drug in a microneedle matrix. Partnership with experts in various fields, including engineering, pharmaceuticals, and regulatory businesses, is extremely essential to effectively develop and production of these advanced drug delivery systems. Besides, the application of microneedles can cause skin irritation, bleeding, redness, or itching at the insertion site. Some individuals might also experience allergic reactions to the materials used in the microneedle fabrication or the drug formulation. All these factors could impact the growth of this market over the forecast period.
Lack of skilled professionals
One of the major barriers to the growth of the worldwide in this market is a lack of educated individuals who can operate technologically advanced diagnostic machines. Researchers must understand the science involved in order to conduct good research experiments. As a result, microneedle drug delivery systems must be performed by highly competent professionals. Adoption of critical experiments is still relatively new in developing Asia, Africa, and South America. Most laboratory personnel have not received appropriate training in the latest laboratory equipment technology and its benefits. The lack of experience raises the likelihood of incorrect diagnoses, which may have an impact on the Metal process. This will restrain market expansion over the forecast period.
Limitations associated with microneedle drug delivery systems
Microneedle drug delivery systems are innovative technologies that offer a minimally invasive way to deliver medications and therapeutics through the skin. While these systems hold great promise, they also come with certain challenges that need to be addressed for their successful implementation. Developing effective microneedle arrays requires intricate design to ensure proper drug loading, needle fabrication, and controlled release. The design must consider factors like needle length, density, material, and geometry to optimize drug delivery efficiency. The materials used for microneedles must be biocompatible and safe for use on human skin. The needles should not cause adverse skin reactions, infections, or tissue damage. Achieving consistent and controlled dosing with microneedles can be challenging. Variability in skin properties, insertion depth, and drug release rates can impact the actual dose delivered.
Furthermore, patient acceptance of microneedle technology can impact its adoption. Educating patients about the benefits and safety of microneedles is essential for their willingness to use the technology. Long-term effects of repeated microneedle use on the skin, especially for chronic conditions that require continuous treatment, need to be thoroughly studied to ensure safety. Like any medical device or drug delivery system, microneedles must undergo rigorous regulatory assessment for safety and efficacy before they can be approved for use in medical practice. Therefore, aforementioned factors can be challenges for the microneedle drug delivery system market growth.
Technological advancement in microneedles
Technological advancement led to development of dissolvable microneedles to deliver drugs at a higher dose and to engineer drug release. This will provide new avenues for the market expansion during the forecast period. Dissolving microneedles have superior drug loading along with other positive properties that make them an ideal delivery system, including fabrication and disposal, and abundantly available materials. These features will make the microneedle drug delivery system popular among healthcare providers. Dissolvable microneedles are small in size and designed to be painless on medical application. They don't reach the nerves that cause pain in the skin, will make them the most widespread choice as a patient friendly alternative to traditional injections.
In recent years, approaches in the pharmaceutical and biomedical fields, its applications are constantly evolving due to its ability to provide large molecules with ionic and hydrophilic properties. The recent advances in microneedling, focusing on the different types, manufacturing techniques, raw materials, and biomedical and pharmaceutical applications of microneedling as well as some approved microneedle products on the market.
Microneedles have shown promise in enhancing vaccine delivery. They can target immune cells within the skin, potentially leading to stronger immune responses. Additionally, microneedles can simplify vaccine administration, which is especially valuable for large-scale vaccination campaigns. Dissolvable microarray patches or dissolving microneedles (DMN) have been proposed as an innovative vaccine delivery platform that could potentially revolutionize vaccine delivery and circumvent many of the challenges faced with current vaccine strategies. In addition, advances have been made in developing biodegradable microneedles that dissolve after drug delivery. This eliminates the need for needle disposal and reduces the risk of infection from reused needles.
|Market Size in 2022
|USD 3,253.34 Million
|Market Forecast in 2030
|USD 5,842.64 Millio
|Compound Annual Growth Rate (CAGR)
|Revenue (USD Million) and Volume (Kilo Tons)
|By Type, By Material, By Application and By Geography
Segment Analysis of the Microneedle Drug Delivery System Market
The Microneedle Drug Delivery System market is segmented by type, material, application, and region.
The Hollow segment gained largest market share, in 2022:
Hollow segment anticipated to covered more than 28% of the market by the end of 2030. The hollow microneedle consists of a design with a hollow or empty core in which drug fluid is injected. Hollow microneedles can hold higher amounts of medication and act as drug reservoirs. They can thereby deliver a wider variety of medications, including those containing bigger molecules like proteins and peptides. The medicine is deposited in the dermis by hollow microneedles that are filled with the drug solution. For high molecular weight chemicals, a hollow microneedle also has the capacity to deliver the medication into the viable epidermis or dermis. It also regulates the drug release over time, making it appropriate for use with liquid vaccine formulations. Hollow microneedles are an active drug delivery system forming a tube for drug diffusion into the dermis based on a non-pressurized drug reservoir. These microneedles have a hollow lumen and may administer different pharmaceutical dosages. This adaptability is important for customized treatment and modifying drug administration based on the requirements of each patient. These characteristics of hollow microneedle led to increase the growth of the global market.
The Metal segment was the leading segment in 2022:
In 2022, Metal held top position as material, accounting for 35.34% of the globe market. Stainless steel, titanium, palladium, nickel, and palladium-cobalt alloys are the primary metals that are utilized for producing solid microneedle, coated microneedle, and hollow microneedle production. Metals have excellent hardness and mechanical strength for transdermal medication delivery. Due of their durability, metals are utilized for the production of microneedles. Stainless steel is one metal that has good heat conductivity. When utilizing microneedles for procedures requiring for heating or cooling, such as localized thermotherapy or temperature-sensitive medication formulations, this characteristic can be helpful. Moreover, metals can be used for microneedles with electrical or sensing functions. For instance, microneedles made of metal can be integrated into electrical circuits for drug release control or biosensing applications. As a result, the demand for metal type segment is increasing in the microneedle drug delivery system market.
In 2022, the Drug Delivery segment dominated the global market:
Drug delivery segment is anticipated to expand quickly share of more than 31% up to 2030. The increasing prevalence of chronic diseases such as cancer and cardiovascular diseases is the major factor that drives the demand for the drug delivery application segment. As the global burden of these diseases continues to rise, there is a growing need for effective drug delivery methods that can deliver treatments with greater precision and efficacy. For instance, 6.4 million people in England had cardiovascular disorders in 2021, according to the BHF England Factsheet, which was published in January 2022. Additionally, 7.4 million people in the UK will have heart and circulatory disorders in 2021, according to BHF figures for 2022. Therefore, the demand for regulated or slow drug release is increasing due to the growing prevalence of cardiovascular illnesses, which is anticipated to fuel market expansion over the next years.
Additionally, according to 2022 statistics published by the IDF, about 537 million people worldwide were suffering from diabetes in 2021, and this number is projected to reach 643 million and 784 million by 2030 and 2045, respectively. Thus, the expected increase in the diabetic population increases the demand for microneedle technology to deliver insulin through the stratum corneum of the skin in a minimally invasive and painless way. This is anticipated to augment market growth over the forecast period.
North America occupies the largest market share in 2022:
In 2022, North America held a top position as region accounted for 42.10% in the globe market. North America, particularly the United States, has a robust and advanced pharmaceutical industry that plays a significant role in driving the demand for microneedle drug delivery systems. This region is home to numerous pharmaceutical companies such as Abbott Laboratories, 3M, Becton, Dickinson and Company, and others that are at the forefront of drug discovery and development. These companies focus on drug discovery often involves drug delivery techniques including microneedle drug delivery systems. In addition, the regulatory environment is also supportive of the creation and commercialization of microneedle-based medication delivery devices. The development of microneedle technology is encouraged by the U.S. FDA and Health Canada, which has stimulated market investment and innovation.
Furthermore, North America faces a significant burden of chronic diseases such as diabetes, cardiovascular diseases, skin diseases, and others. For instance, one person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease in 2021 that's 1 in every 5 deaths. Thus, the increasing prevalence of heart disease across the United States boosts the demand for the microneedle drug delivery system and expected significant growth over the forecast period.
- Raphas Co Ltd.
- Dickinson and Company
- Nitto Denko Corporation
- Microdermic Inc.
- TheraJect Inc.
- Quad Medicine
- Snvia Co ltd.
- Endoderma Co Ltd.
- Nanopass Technology
- Vaxess Technology
- CosMed Pharmaceuticals
- Lohmann Therapy System Ag
- Micron Biomedical
Segmentation Analysis of the Microneedle Drug Delivery System Market
- Drug Delivery
- Pain Management
- Cancer Therapy
- Vaccine Delivery
Impact of the COVID-19 Pandemic on the Microneedle Drug Delivery System Market:
The COVID-19 pandemic has had a negative impact on the world economy as countries have been obliged to enact lockdown measures to prevent the virus from spreading. The reduction in demand for cross-border trades due to lockdown across the globe has impacted the global market severely. The halt in the manufacturing and transportation industry due to COVID-19 lockdown has further impacted the global market. However, with lockdowns and reduced access to healthcare facilities, there was an increased emphasis on remote healthcare and self-administration of medications. This could have increased interest in technologies like microneedle drug delivery systems that enable patients to administer treatments at home.
The rapid development of COVID-19 vaccines and the need for efficient mass vaccination strategies might have indirectly influenced discussions about various drug delivery methods, including microneedles, for vaccine administration.