Port Delivery System (PDS) Market (Disease Indication: Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema, Other Retinal Diseases; Type of Drug Delivered: Ranibizumab, Other Anti-VEGF Agents (in Clinical Trials); End-user: Hospitals, Specialty Clinics, Ambulatory Surgical Centers) – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2024-2032.
The Port Delivery System (PDS) market, specifically in ocular drug delivery, is witnessing significant growth and innovation. The market is projected to expand from USD 231.84 million in 2024 to USD 511.67 million by 2032, at a CAGR of 3.1% during the forecast period. Port Delivery Systems (PDS) constitute an emerging market on account of the rapid developments in the generation of ophthalmic drug delivery systems. Susvimo, as it is commercially known, is a refilling ocular implant that continuously delivers medication (including ranibizumab) to the vitreous cavity. Such an innovation overcomes the challenges associated with the frequent intravitreal injection needed in cases such as neovascular age-related macular degeneration (nAMD).
The FDA on October 2021 granted approval of Susvimo for use in wet age-related macular degeneration, a watershed event in ocular therapeutics. In October 2022, Genentech issued a recall of the device following reported cases of septum dislodgement, halting new implantations. Improved designs subsequently were granted approval for updates to Susvimo on July 2024 by the FDA, permitting reentry into the U.S. market. Additionally, on February 2025, approval to treat diabetic macular edema (DME) was expanded by the FDA, offering a less burdensome therapeutic option for patients.
The positive industry movement towards sustained releases ocular therapies through the PDS is perceived when looking at the developments involved in the PDS. The ability of the PDS to maintain therapeutic drug levels for long periods reduces the frequency of treatments, leading to more effective patient compliance. As demands for longer-lasting ophthalmic solutions increase, the market is indeed set for continued growth in the PDS and consolidated further into its transformative role in ocular drug delivery and delivery devices.
Increasing Prevalence of Retinal Diseases
Growth in the Port Delivery System (PDS) market is being driven primarily by the increasing incidence of chronic retinal diseases including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The advantage provided by PDS is continuous drug delivery, which leads to decreased frequency of intravitreal injections and thus improves patient compliance and reduces health care costs. The most recent of these include Genentech’s recall of the Susvimo PDS implant in October 2022, owing to a safety issue, indicating the company’s commitment to enhancing patient outcomes. In addition, the Archway Phase III clinical trial established that the PDS met its primary endpoint, demonstrating noninferior efficacy compared to monthly ranibizumab injections over two years, warranting further consideration for long-term management of retinal disease. The future of this market looks bright, considering that, especially in North America and Europe, the older population is expected to grow, and thus a higher demand for advanced ocular drug delivery systems like PDS is anticipated.
Technological Advancements
The ophthalmic pharmaceutical industry is undergoing a significant transformation due to innovations in drug delivery systems. Notably, the integration of biodegradable materials and controlled drug release mechanisms has led to the development of patient-friendly, sustained-release implants. These advancements enhance treatment efficacy and reduce the frequency of administrations, aligning with current trends toward minimally invasive procedures. For instance, the FDA’s recent review of Teva and Alvotech’s AVTO6 treatment positions it as a potential competitor to Regeneron’s Eylea, a leading therapy for various retinal disorders. Such developments are expected to drive market growth, with the global ophthalmic drug delivery systems market projected to expand at a CAGR of 6.6% from 2025 to 2030. Companies investing in bioengineering and personalized medicine are poised to capture increased market share by offering tailored solutions for diverse retinal diseases.
Restraints
The implantable drug delivery systems (IDDS) industry runs the risk of facing market challenges due to serious regulatory encumbrances, as demonstrated by stringent approval processes. Authorities like the U.S. FDA and EMA impose extensive preclinical and clinical trials, resulting in tremendous costs and delayed drug development milestones for entering the market. In such cases, the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. has been criticized for its limited capacities, scaring investors away from putting money in domestic manufacturing and clinical trials. Thus, regulatory hurdles can suppress market growth and profitability.
On the brighter side, emerging markets present favorable growth prospects for IDDS manufacturers. Such regions as Asia-Pacific, Latin America, and the Middle East are developing their healthcare infrastructures, creating a higher demand for advanced implantable drug-delivery devices. Companies that pursue opportunities in local partnerships and manufacturing, as well as educational initiatives, may gain a competitive edge within these expanding markets and realize increased market share.
Development of Multi-Drug Delivery Systems
The Ocular Drug Delivery Systems industry is emerging and is going to witness a significant journey that is driven by advancement in Port Delivery Systems. While historically focused on single-drug formulations, the industry is currently exploring multi-drug PDS that combine anti-VEGF agents with steroids, anti-inflammatories, or neuroprotective agents in order to offer more comprehensive treatment. Improved efficacy of treatment, reduced disease progression, and infrequent need for intervention are the benefits these innovations promise to provide to providers and patients alike. The addition of smart technology to monitor real-time drug release and disease progression adds to the appeal. However, the need to improve continuously PDS technologies is owing to some recent innovations, such as the recall of the Susvimo device by Genentech due to septum dislodgement. Yet, the future of PDS remains bright for continuous growth as its market can benefit from discovery and emerging patient needs in innovation and adoption of ocular drug delivery-the solution.
Types of Port Delivery Systems
These systems are known for their specific eye treatments such as PDS with ranibizumab wherein it provides anti-VEGF treatment to retinal diseases such as neovascular age-related macular degeneration (nAMD). Such items are originally intended for ocular uses but have possibly other applications in oncology or chronic disease treatment where consistent drug delivery can be advantageous.
Port delivery system (PDS) is a boon in drug delivery, especially in ocular therapy. It is an innovative design to provide drug substances into the eye over a prolonged time interval; hence, reduces the number of injections and improves patient compliance and outcomes in treatment of chronic retinal diseases.
Shift Toward Long-Acting Treatments
There is a growing trend in the industry towards long-acting delivery systems, thereby reducing the treatment burden on the patients. This trend has been effectively supported by the Port Delivery System (PDS) with respect to lengthy under-the-conjunctivan drug delivery and infrequent refill intervals in comparison with intravitreal injections. Fostering patient adherence and comfort creates future horizons in ophthalmology for sustained-release therapies.
Advancements in Technology and Device Design
Improving the materials and engineering of the devices, artificial implantation techniques, can lead to a lot of promising improvements in terms of safety, efficacy, and user experience. Besides that, much improvement in respect to designs of PDS, best illustrated by Susvimo, is already taking place with optimization efforts towards the delivery of drugs for finalizing some previous issues, including long-term reliability. Such technologies are going to move great progress into the business through the improved outcome of patients and enhanced usage among healthcare providers.
Regulatory Oversight and Product Adaptation
The withdrawal of Susvimo from the market and the design change thereafter present great weight on medical devices subject to regulatory scrutiny. Manufacturers appear to give primary consideration to compliance with safety requirements and risk reduction through design refinement prior to release for maximized performance. In parallel, regulatory agencies have been evolving in synchronization with these technologies to ensure that drug delivery innovations for sustained use meet safety requirements across the globe.
Key Industry Events
Reintroduction of Susvimo
Genentech’s Susvimo was initially recalled in October 2022 due to septum dislodgement issues affecting 5% of patients. Following an extensive redesign, the FDA approved the modified version, which was reintroduced to the market in January 2025. The updated Susvimo device features enhanced septum geometry and a silicone lubricant on the refill needle, reducing insertion force and addressing previous concerns.
Clinical Trials Validating Efficacy
The Archway trial demonstrated that PDS treatment provides comparable vision outcomes to monthly ranibizumab injections, while extending refill intervals to six months. These findings reinforce PDS as a viable long-term treatment option for retinal diseases, minimizing patient burden without compromising efficacy.
Market Expansion and Global Reach
With its successful reintroduction, Genentech has announced plans to expand Susvimo’s availability into European markets in 2025. This move highlights growing demand for long-acting ocular therapies and underscores the increasing acceptance of innovative drug delivery solutions worldwide.
Key Players in the Port Delivery System Market
Genentech, Inc. – The leading developer of Susvimo, specializing in long-acting treatments for retinal diseases.
ForSight VISION4 Inc. – A key contributor to early prototypes and foundational technology for ocular drug delivery systems.
Emerging Competitors – While Genentech remains the market leader, other companies are exploring similar innovations, though specific names are not widely reported in recent industry insights.
Market Segmentation for Port Delivery Systems
- By Disease Indication
- Neovascular age-related macular degeneration (nAMD)
- Diabetic macular edema
- Other retinal diseases
- By Type of Drug Delivered
- Ranibizumab
- Other anti-VEGF agents (in clinical trials)
- By End-User
- Hospitals
- Specialty Clinics
- Ambulatory surgical centers
Companies Manufacturing Port Delivery Systems
- Genentech, Inc. (Susvimo)
- ForSight VISION4 Inc.
- Regeneron Pharmaceuticals, Inc.
- Novartis AG
- Allergan (AbbVie Inc.)
- Bausch + Lomb
- Santen Pharmaceutical Co., Ltd.
- Acucela Inc.
- EyePoint Pharmaceuticals, Inc.
- Ocular Therapeutix, Inc.
What is the Port Delivery System (PDS)?
The PDS is a refillable implant that delivers sustained-release medication for chronic retinal diseases, reducing the need for frequent intravitreal injections.
What is driving the growth of the PDS market?
Increasing prevalence of retinal diseases, technological advancements, regulatory approvals, and demand for long-acting drug delivery solutions.
Which conditions are treated using PDS?
Primarily neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).
What are the key benefits of PDS?
Sustained drug release, reduced injection frequency, improved patient compliance, and better long-term treatment outcomes.
What challenges does the PDS market face?
Stringent regulatory approvals, high development costs, safety concerns, and global commercialization complexities.
Who are the major players in the PDS market?
Genentech, ForSight VISION4, Regeneron, Novartis, Allergan (AbbVie), Bausch + Lomb, and others.
How does PDS compare to conventional intravitreal injections?
PDS provides continuous drug release for up to six months, reducing the need for monthly injections.
What role does technology play in PDS advancements?
Innovations in biodegradable materials, bioengineering, and smart drug delivery systems enhance safety, efficacy, and patient experience.
What are the emerging trends in the PDS market?
Multi-drug delivery systems, expansion into emerging markets, and integration of smart technologies for real-time drug monitoring.
What is the market outlook for PDS?
The market is projected to grow from USD 231.84 million in 2024 to USD 511.67 million by 2032, at a CAGR of 3.1%.
Table Of Content
| 1. Executive Summary |
| 1.1. Definition |
| 1.2. Research Scope |
| 1.3. Key Findings by Major Segments |
| 2. Global Port Delivery System Market Overview |
| 2.1. Port Delivery System Market Dynamics |
| 2.1.1. Drivers |
| 2.1.2. Opportunities |
| 2.1.3. Restraints |
| 2.1.4. Challenges |
| 2.2. Product and Pricing Analysis |
| 2.3. Technological Advancements |
| 2.4. Key Industry Updates |
| 2.5. Regulatory Scenario by Region/ Countries |
| 2.6. Porters Five Forces Analysis |
| 3. Global Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 3.1. Global Port Delivery System Market Analysis, 2021-2023 |
| 3.2. Global Port Delivery System Market Opportunity and Forecast, 2025-2032 |
| 3.3. Global Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 3.3.1. Global Port Delivery System Market Analysis by Disease Indication: Introduction |
| 3.3.2. Market Trend, Analysis and Forecast, By Disease Indication, 2021-2032 |
| 3.3.2.1. Neovascular age-related macular degeneration (nAMD) |
| 3.3.2.2. Diabetic Macular Edema |
| 3.3.2.3. Others |
| 3.4. Global Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 3.4.1. Global Port Delivery System Market Analysis by Type of Drug Delivered: Introduction |
| 3.4.2. Market Trend, Analysis and Forecast, By Type of Drug Delivered, 2021-2032 |
| 3.4.2.1. Ranibizumab |
| 3.4.2.2. Others |
| 3.5. Global Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 3.5.1. Global Port Delivery System Market Analysis by End-User: Introduction |
| 3.5.2. Market Trend, Analysis and Forecast, By End-User, 2021-2032 |
| 3.5.2.1. Hospitals |
| 3.5.2.2. Specialty Clinics |
| 3.5.2.3. Ambulatory Surgical Centers |
| 3.6. Global Port Delivery System Market Analysis, Opportunity and Forecast, By Region, 2021-2032 |
| 3.6.1. Global Port Delivery System Market Analysis by Region : Introduction |
| 3.6.2. Market Trend, Analysis and Forecast, By Region , 2021-2032 |
| 3.6.2.1. North America |
| 3.6.2.2. Europe |
| 3.6.2.4. APAC |
| 3.6.2.5. Latin America |
| 3.6.2.6. Middle East & Africa |
| 4. North America Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 4.1. North America Port Delivery System Market Analysis, 2021-2023 |
| 4.2. North America Port Delivery System Market Opportunity and Forecast, 2025-2032 |
| 4.3. North America Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 4.3.1. Neovascular age-related macular degeneration (nAMD) |
| 4.3.2. Diabetic Macular Edema |
| 4.3.3. Others |
| 4.4. North America Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 4.4.1. Ranibizumab |
| 4.4.2. Others |
| 4.5. North America Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 4.5.1. Hospitals |
| 4.5.2. Specialty Clinics |
| 4.5.3. Ambulatory Surgical Centers |
| 4.6. North America Port Delivery System Market Analysis, Opportunity and Forecast, By Country, 2021-2032 |
| 4.6.1. U.S. |
| 4.6.2. Canada |
| 5. Europe Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 5.1. Europe Port Delivery System Market Analysis, 2021-2023 |
| 5.2. Europe Port Delivery System Market Opportunity and Forecast, 2025-2032 |
| 5.3. Europe Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 5.3.1. Neovascular age-related macular degeneration (nAMD) |
| 5.3.2. Diabetic Macular Edema |
| 5.3.3. Others |
| 5.4. Europe Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 5.4.1. Ranibizumab |
| 5.4.2. Others |
| 5.5. Europe Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 5.5.1. Hospitals |
| 5.5.2. Specialty Clinics |
| 5.5.3. Ambulatory Surgical Centers |
| 5.6. Europe Port Delivery System Market Analysis, Opportunity and Forecast, By Country, 2021-2032 |
| 5.6.1. Germany |
| 5.6.2. UK |
| 5.6.3. France |
| 5.6.4. Spain |
| 5.6.5. Italy |
| 5.6.6. Denmark |
| 5.6.7. Rest of Europe |
| 6. Asia Pacific Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 6.1. Asia Pacific Port Delivery System Market Analysis, 2021-2023 |
| 6.2. Asia Pacific Port Delivery System Market Opportunity and Forecast, 2026-2032 |
| 6.3. Asia Pacific Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 6.3.1. Neovascular age-related macular degeneration (nAMD) |
| 6.3.2. Diabetic Macular Edema |
| 6.3.3. Others |
| 6.4. Asia Pacific Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 6.4.1. Ranibizumab |
| 6.4.2. Others |
| 6.5. Asia Pacific Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 6.5.1. Hospitals |
| 6.5.2. Specialty Clinics |
| 6.5.3. Ambulatory Surgical Centers |
| 6.6. Asia Pacific Port Delivery System Market Analysis, Opportunity and Forecast, By Country, 2021-2032 |
| 6.6.1. China |
| 6.6.2. Japan |
| 6.6.3. India |
| 6.6.4. Australia & New Zealand |
| 6.6.5. South Korea |
| 6.6.6. Singapore |
| 6.6.7. Rest of Asia Pacific |
| 7. Latin America Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 7.1. Latin America Port Delivery System Market Analysis, 2021-2023 |
| 7.2. Latin America Port Delivery System Market Opportunity and Forecast, 2027-2032 |
| 7.3. Latin America Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 7.3.1. Neovascular age-related macular degeneration (nAMD) |
| 7.3.2. Diabetic Macular Edema |
| 7.3.3. Others |
| 7.4. Latin America Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 7.4.1. Ranibizumab |
| 7.4.2. Others |
| 7.5. Latin America Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 7.5.1. Hospitals |
| 7.5.2. Specialty Clinics |
| 7.5.3. Ambulatory Surgical Centers |
| 7.6. Latin America Port Delivery System Market Analysis, Opportunity and Forecast, By Country, 2021-2032 |
| 7.6.1. Brazil |
| 7.6.2. Mexico |
| 7.6.3. Colombia |
| 7.6.4. Rest of Latin America |
| 8. Middle East & Africa Port Delivery System Market Outlook and Future Prospects, 2021-2032 |
| 8.1. Middle East & Africa Port Delivery System Market Analysis, 2021-2023 |
| 8.2. Middle East & Africa Port Delivery System Market Opportunity and Forecast, 2028-2032 |
| 8.3. Middle East & Africa Port Delivery System Market Analysis, Opportunity and Forecast, By Disease Indication, 2021-2032 |
| 8.3.1. Neovascular age-related macular degeneration (nAMD) |
| 8.3.2. Diabetic Macular Edema |
| 8.3.3. Others |
| 8.4. Middle East & Africa Port Delivery System Market Analysis, Opportunity and Forecast, By Type of Drug Delivered, 2021-2032 |
| 8.4.1. Ranibizumab |
| 8.4.2. Others |
| 8.5. Middle East & Africa Port Delivery System Market Analysis, Opportunity and Forecast, By End-User, 2021-2032 |
| 8.5.1. Hospitals |
| 8.5.2. Specialty Clinics |
| 8.5.3. Ambulatory Surgical Centers |
| 8.6. Middle East & Africa Port Delivery System Market Analysis, Opportunity and Forecast, By Country, 2021-2032 |
| 8.6.1. GCC Countries |
| 8.6.2. South Africa |
| 8.6.3. Rest of Middle East & Africa |
| 9. Global Port Delivery System Market Competitive Landscape, Market Share Analysis, and Company Profiles |
| 9.1. Port Delivery System Market Share Analysis, By Company (2024) |
| 9.2. Company Profiles |
| 1. Genentech, Inc. (Susvimo) |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 2. ForSight VISION4 Inc. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 3. Regeneron Pharmaceuticals, Inc. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 4. Novartis AG |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 5. Allergan (AbbVie Inc.) |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 6. Bausch + Lomb |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 7. Santen Pharmaceutical Co., Ltd. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 8. Acucela Inc. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 9. EyePoint Pharmaceuticals, Inc. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 10. Ocular Therapeutix, Inc. |
| Company Overview |
| Financial Highlights |
| Product Portfolio |
| SWOT Analysis |
| Key Strategies and Developments |
| 9.3. Competitive Comparison Matrix |
| 10. Research Methodology |
| 11. Conclusion and Recommedations |
