The global ophthalmic drug delivery devices market size was valued at USD 336.83 million in 2022. It is estimated to reach USD 577.33 million by 2031, growing at a CAGR of 6.17% during the forecast period (2023–2031).
The Royal College of Ophthalmologists (U.K.) defines ophthalmology as "the branch of medicine concerned with the diagnosis, treatment, and prevention of eye and visual system diseases." Drug delivery devices are a specialized medical device class that focuses on delivering therapeutic agents at the target sites. These are made of several materials, including glass, plastic, and polymers, which can be disposable or reusable.
Ophthalmic drug delivery devices are a specialized class of drug delivery devices focused on delivering ophthalmic therapeutic agents. These comprise conventional and advanced drug delivery systems such as pre-filled syringes, multidose eyedroppers, drug-coated contact lenses, mist sprayers, add-on devices, squeeze dispensers, tubes, and ocular inserts. Several approaches to ocular drug administration are considered, starting with basic formulation techniques to increase drug availability; mucoadhesives and viscosity enhancers aid in drug retention; and penetration enhancers encourage drug transport into the eye.
Development of Novel Drug Dispensers
Conventional eyedroppers have been the primary ophthalmic drug delivery device for patients with ocular conditions. However, the drug delivery device has various disadvantages, such as difficulty in usage, wastage of drugs, and minimal absorption. As a result, several market players have created either innovative dispensing methods or cutting-edge eyedroppers to address the inadequacies of conventional eyedroppers. For instance, businesses like AptarGroup, Inc. and Owen Mumford have created squeeze dispensers to deliver medications.
In addition, businesses like Nemera, Aero Pump GmbH, and Berry Healthcare have created sophisticated eyedroppers emphasizing user-friendliness and preservative-free formulation. Another breakthrough in novel drug dispensers is the development of sustainable drug delivery devices such as ocular inserts, implants, and drug-coated contact lenses. These are advanced drug dispensers focusing on targeted and prolonged drug delivery. Bausch Health Companies Inc. and EyePoint Pharmaceuticals, Inc. manufacture such devices, driving the market growth.
Integration of Digital Solutions in Ophthalmic Drug Delivery Devices
Conventionally, ophthalmic drug delivery devices are standalone without integrated software. However, ophthalmic drug delivery devices have incorporated digital solutions due to the growing digitalization of the global healthcare system, improvements in drug delivery systems, increased attention to medication adherence, and high costs associated with drug non-adherence.
Companies like Nemera have created digital devices for ensuring patient compliance with prescribed therapy and drug adherence. Moreover, Aptar Group, Inc. and Kali Care have created integrated solutions to guarantee eye care. Furthermore, owing to the increasing prevalence of ocular diseases, the focus on medication adherence is expected to rise. Therefore, digital solutions integration in ophthalmic drug delivery devices will increase during the forecast period.
Prolonged Regulatory Approval Process
The ophthalmic drug delivery devices pose a medium-high risk to the patient's health and must undergo an extensive regulatory process before commercialization. Similarly, novel ophthalmic drug delivery devices might have to undergo a prolonged regulatory process if they cannot be classified according to the pre-existing medical device classes.
The expense of the process rises due to the lengthy regulatory process and additional regulations, which further restricts the introduction of new products. Before launch, the product also goes through the regulatory process in each region. Therefore, the prolonged regulatory approval process hampers the advancements in the global ophthalmic drug delivery devices market and is a major restraint for the market's growth.
Inclusion of Nanotechnology in Ophthalmic Drugs Formulation
One of the key concerns in ophthalmology is drug wastage. For instance, as per the analysis published by National Center for Biotechnology Information (NCBI), titled 'Evaluating Eye Drop Instillation Technique and Its Determinants in Glaucoma Patients,' in 2018, only 11.7% of glaucoma patients had optimum drug delivery techniques. This has propelled the development of novel formulations focusing on target drug delivery.
Nanotechnology is a significant technology that can be used to create drug formulations. The technology's main benefits include targeted drug delivery, little wastage, continuous drug delivery, and cost-effectiveness. These formulations can also penetrate barriers like the cornea and replace invasive procedures like implants, opening up new market opportunities.
The global ophthalmic drug delivery devices market is bifurcated into the product, formulation, sales channel, and end-user.
Based on product, the global market is divided into pre-filled syringes, multidose eyedroppers, contact lenses, add-on devices, mist sprayers, squeeze dispensers, and others.
The pre-filled syringes segment accounts for the largest market share and is expected to exhibit a CAGR of 4.15% over the forecast period. Pre-filled syringes refer to syringes with medications already filled by the manufacturer. The key benefits of the device are contamination control, ease of use, and dosage management. In ophthalmology, pre-filled syringes offer various advantages, such as a low incidence rate of exogenous endophthalmitis, reduction in syringe preparation time, lowered downstream packaging cost, lowered drug volume usage, and reduced risk of intra-ocular inflammation.
Furthermore, the product held the largest market share owing to its various advantages, and the trend is projected to continue over the forecast period. Other drivers for product growth include the presence of key companies and emerging start-ups. For instance, various companies such as Congruence Medical Solutions LLC, Becton, Dickinson and Company, Schott AG, Gerresheimer AG, and Nipro Corporation operate in the segment. Similarly, emerging companies such as Congruence Medical Solutions LLC have also entered the segment with advancements in pre-filled syringes.
Based on formulation, the global market is bifurcated into eye drops, liquid sprays, gels, ointments, and others.
The eye drops segment dominates the global market and is expected to exhibit a CAGR of 4.92% over the forecast period. Eye drops are one of the conventional formulations in ophthalmic drug delivery. Various active pharmaceutical ingredients (APIs), namely, Dexamethasone sodium phosphate, Neomycin sulfate, Polymyxin B sulfate, Framycetine sulfate, Indomethacin, and Gentamicin sulfate, are delivered through this formulation. The key driving factors for adopting eye drops include ease of bulk manufacturing and handling and a higher degree of patient tolerance. However, factors such as technological advancements in other formulations manufacturing, the development of liquid sprays, and difficulty in usage, especially in geriatric patients, might limit the growth of eye drops in the global market.
Based on service, the global market is bifurcated into direct and indirect sales.
The direct sales segment owns the highest market share and is predicted to exhibit a CAGR of 6.15% over the forecast period. Direct sales refer to the sales of ophthalmic drug delivery devices to pharmaceutical companies. The sales are often conducted through partnerships or contracts, and the device manufacturers sell the bulk of the devices through these strategies. However, the sales are subject to compatibility and regulatory requirements between the device and drug before commercialization. For instance, according to the Food and Drug Administration (FDA), a pre-filled drug delivery system is considered a combination device and needs to be approved before commercialization. Furthermore, a device has to be approved distinctly for usage with multiple drugs of similar form. For instance, in February 2019, AptarGroup, Inc. Aptar Pharma received regulatory approval for using its preservative-free multidose Ophthalmic Squeeze Dispenser with Santen's prescription drug Taflotan/Saflutan in 26 countries of Europe.
Based on end-user, the global market is divided into hospitals, clinics, home care settings, and others.
The hospital segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 5.81% over the forecast period. Hospitals are primary medical facilities for performing surgical procedures. In the case of ophthalmology, surgeries are performed to treat glaucoma, cataract, vision correctness, and macular degeneration. Post-operative care for the procedures requires regular drug delivery to the patients, making hospitals the largest end user in the global market.
Furthermore, hospitals also play a pivotal role in the acceptance of advanced devices for drug delivery. For instance, a pre-clinical study conducted by Boston's Children's Hospital in 2019 highlighted the usage of drug-coated contact lenses as an alternative method for sustained drug delivery in the anterior and posterior segments of the eye. Consequently, such studies are projected to advance the acceptance of drug-coated contact lenses among patients and positively impact technological advancements in the global market.
Based on region, the global ophthalmic drug delivery devices market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global ophthalmic drug delivery devices market shareholder and is estimated to exhibit a CAGR of 5.07% during the forecast period. The growing prevalence of ocular disorders such as glaucoma, age-related macular degeneration (AMD), and cataract is the major growth driver for the North American global market. For instance, according to Global Health Data Exchange (GHDx), the prevalence of cataracts increased by 9.42% between 2016 and 2019 in the region. Likewise, the prevalence of glaucoma increased by 12.66% in North America during the same time frame. Consequently, the increasing prevalence of ocular diseases has increased the demand for ocular drugs and drug-delivery devices. Established and up-and-coming players are also driving the expansion of the North American market for ophthalmic medication delivery devices. Further, emerging companies in the region have propelled technological advancements and digital solutions integration with ophthalmic drug delivery devices.
Europe is anticipated to exhibit a CAGR of 6.59% over the forecast period. The growing prevalence of ocular disorders such as glaucoma, age-related macular degeneration (AMD), and cataract is the major growth driver for Europe's ophthalmic drug delivery devices market. For instance, according to Global Health Data Exchange (GHDx), the prevalence of cataracts increased by 4.62% between 2016 and 2019 in the region. Earlier in Europe, medical devices were regulated by the European Commission (EC) regulations. 90/385/EC, 98/99/EC, and 93/42/EC were the major medical device regulations under which the companies applied for the CE mark certification. However, owing to the demand for a change in the regulations, Medical Device Regulation (MDR) was introduced. The new regulations are anticipated to be more rigorous and stringent and are expected to increase the cost of regulatory procedures due to the requirement of extensive paperwork. In addition, various key companies operating in the market, namely, Schott AG, Aero Pump GmbH, Gaplast GmbH, Nemera, Owen Mumford, and Gerresheimer AG, are based in the region and hold a significant share in the global market.
In the Asia-Pacific region, Japan has one of the most advanced healthcare systems and holds the largest share of the regional market. The presence of various global players in the country and extensive distributor networks were the key growth factors for the market. However, China is projected to take over Japan as the largest market in the Asia-Pacific ophthalmic drug delivery devices market during the forecast period. The presence of various local manufacturers, expansion of global players in the region, inexpensive raw materials, and growing geriatric population in the country would be the driving factors for China's ophthalmic drug delivery devices market. Furthermore, the region has witnessed many patents filed between January 2016-July-21. Patents were filed in several countries: China, Japan, India, Australia, and New Zealand. The number of patents filed would ensure the exclusivity right and propel the advancement of the Asia-Pacific ophthalmic drug delivery devices market.
The growing prevalence of ocular disorders such as glaucoma, age-related macular degeneration (AMD), and cataract is the major growth driver for the Latin American ophthalmic drug delivery devices market. For instance, according to Global Health Data Exchange (GHDx), the prevalence of cataracts increased by 4.98% between 2016 and 2019 in the region. Furthermore, the prevalence of glaucoma increased by 6.02% in Latin America during the time frame. Therefore, the rising prevalence of ocular disorders makes Latin America one of the major sites for business expansion.
Technology integration in ocular drug formulations is one of the breakthroughs in the Middle East and Africa ophthalmic drug delivery devices market. Institutes in the Kingdom of Saudi Arabia (K.S.A.) and Israel are developing novel formulations using nanotechnology for sustained drug delivery. Consequently, advancement in formulations would speed up the technology integration in drug delivery devices. This would further expand business opportunities for key and emerging global ophthalmic drug delivery devices market players.
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