The keratoconus market is estimated to be valued at USD 307.6 Mn in 2024 and is expected to reach USD 424.3 Mn by 2031, growing at a compound annual growth rate (CAGR) of 4.7% from 2024 to 2031. There is increasing prevalence of eye disorders such as keratoconus worldwide which is driving the need for effective treatment. Favorable medical reimbursement for keratoconus treatment in developed regions is also supporting the market growth.

Market Driver - Growing Awareness of Keratoconus and Earlier Diagnosi

With growing awareness about keratoconus, more people are getting themselves screened for the condition at an early stage. Previously, keratoconus diagnosis often happened quite late when significant vision deterioration had already set in.

However, advances in technologies like topography and tomography have made it possible for optometrists to pick up subtle signs of the disorder much before symptoms manifest. School health screenings and routine eye checkups are also catching mild cases which would have otherwise gone unnoticed for years.

Several outreach campaigns by eye hospitals and NGOs in the last decade have played a big role in educating general public as well as eye care professionals about keratoconus. People are recognizing that certain eye problems or vision issues in younger individuals may not just be due to high myopia but could be an early sign of keratoconus as well. This is encouraging more proactive consultation with specialists.

Availability of detailed information online has answered many queries that patients previously had about the complexities of this progressive corneal disorder.

Market Driver - Advancements in Technological Procedures

Technological upgrades have revolutionized the management of keratoconus. Cross-linking which arrests the worsening of the corneal shape by enhancing its biomechanical strength using riboflavin and UV light, is now an established standard of care worldwide.

Second generation protocols have improved the safety and efficacy profile of CXL. Adaptive laser assisted in-situ keratomileusis or Lasek using advanced lasers and wavefront guided ablation profiles has enabled remarkable visual rehabilitation even in moderate to advanced keratoconus cases previously considered untreatable.

Bravelle continuum contact lenses have opened up new possibilities for fitting problematic keratoconic eyes. Availability of scleral lenses provide superior visual outcomes for those not fitted by other modalities. Newer specialized intraocular lenses tailored for keratoconus are being explored. Tissue engineering approaches hold promise for developing bioengineered corneas.

Three-dimensional printing technologies may enable customized corneal implants or cross-linking patterns in future. Collectively, these technological strides have boosted confidence in managing sight threatening keratoconus and offer renewed vision related quality of life.

Market Challenge - High Costs Associated with Treatments, Limiting Accessibility

Keratoconus is a degenerative disease requiring lifelong management and prescriptions. Treatment options like corneal collagen cross-linking (CXL) and corneal transplant surgeries are highly specialized procedures carried out by corneal specialists. These treatments involve significant costs running into thousands of dollars.

For many patients with limited or no health insurance, affording such expensive care remains a major challenge. Even in countries with universal healthcare, long wait times for procedures limit timely access. This delay in receiving treatment can allow the disease to progress rapidly in severe cases. The high economic burden restricts access to care especially for low-income groups and in developing nations.

While new less invasive options are being researched, traditional therapies will continue to be cost-prohibitive for many keratoconus patients for the foreseeable future. Addressing affordability through subsidies, affordable generic drug options, and boosting healthcare coverage can help alleviate this barrier.

Market Opportunity - Development of Non-invasive Treatments like IVMED-80

The keratoconus market is poised for growth with ongoing R&D into novel therapeutic approaches. One promising innovation is IVMED-80, an investigational, non-invasive drug delivered through eye drops being developed for keratoconus. If approved, it can potentially transform treatment landscape. Keratoconus management relies heavily on hard contact lenses and rigid gas permeable lenses to improve vision.

However, many patients struggle with discomfort from these options. IVMED-80 claims to slow keratoconus progression by modifying protein expression through topical application only, avoiding surgery. With a good safety profile demonstrated so far in studies and ability to be self-administered at home long-term, it can drive higher compliance. Its non-invasive nature also reduces costs compared to existing options.

With a large patient base and no approved pharmacologic treatments currently available, IVMED-80, if successful, has potential to capture a sizable market share globally. It can expand patient reach and lead to superior outcomes.

Keratoconus is typically treated via a staged approach depending on the severity of the condition. In mild cases, over-the-counter lubricating eye drops may provide relief from discomfort. For moderate Keratoconus, rigid gas-permeable contact lenses are often prescribed to help correct vision and slow progression, such as brands like BostonSight and SynergEyes.

As the condition advances, many prescribers rely on collagen cross-linking as the first line treatment. This non-invasive procedure uses riboflavin eye drops and UVA light to strengthen the cornea, and has proven effective in halting further eye shape changes. Some of the most commonly used riboflavin solutions are Medicross and Ribocross. For severe Keratoconus, intracorneal ring segments may be implanted to improve the cornea's shape under anesthetic, such as brands like Intacs and Ferrara rings.

Finally, in advanced cases where vision is greatly impaired, prescription of a corneal transplant is not uncommon. Transplants carry risks but provide the best chance of restoring vision through replacement of the damaged cornea. Prescriber preference here depends on factors like graft rejection risks, availability of donor tissue, and the patient's overall health profile and lifestyle.

Keratoconus has been typically classified into four stages based on severity of the condition:

Stage 1 (Mild): Characterized by central or paracentral steepening with or without slight irregularity of corneal surface. Conservative options like spectacle correction or rigid gas permeable contact lenses are the preferred treatment.

Stage 2 (Moderate): In addition to above, there may be mild or moderate thinning and protrusion of the cornea. This stage often requires contact lenses like BostonSight or Rose K2 lenses for visual rehabilitation. Cross-linking with riboflavin and UV-A rays is also recommended to stop progression.

Stage 3 (Advanced): Severe distortions lead to pinhole vision or counting fingers visibility. Rigid gas permeable lenses may not be tolerated. Intracorneal ring segments (ICRS) using Intacs or Ferrara Rings can improve vision by altering the steepened cornea.

Stage 4 (Severe): Extreme steepening with corneal Hydrops or scarring render the cornea opaque. The last line of management involves penetrating keratoplasty (corneal transplant) using donor corneal button grafting.

Most mild to moderate stages respond well to nonsurgical methods like scleral lenses or CXL. Advanced to severe cases often require ICRS or corneal transplant for optimal visual outcomes.

Collagen cross-linking has emerged as a very effective strategy for treating mild to moderate Keratoconus. Players like Avedro have developed riboflavin ultraviolet light therapies that employ this technique. When Avedro launched its KXL system in 2013 to perform collagen cross-linking, it helped slow or stop progression in many keratoconus patients by increasing collagen resistance. Clinical studies showed KXL reduced the rate of progression by around 96%, cementing its adoption.

Development of specialty contact lenses is another strategy seen in leaders like CooperVision. Their TrueEye lens was tailored with a reverse geometry design to fit the irregular cornea and improve visual acuity. Launched in 2010, it achieved success with practitioners recognizing its ability to delay more invasive options for longer. Over 200,000 TrueEye lenses have been prescribed globally.

Players are also offering intracorneal ring segments (ICRS) to halt the disease's progression. For instance, in 2008 BostonSight launched the Ferrara ring, claiming it provided 3-5 lines of improved unaided vision in over 90% of patients at 5 years post-surgery. A prospective study of 157 eyes showed the Ferrara ring stabilized 90% of keratoconic corneas after 5 years, allowing it to capture a major segment of the ICRS market.

Insights, By Treatment: Corneal Cross-Linking: The Leading Treatment Option

Corneal cross-linking segment is expected to account for 45.6% share of the keratoconus market in 2024, due to its effectiveness in halting the progression of the eye disease. As the gold standard treatment, cross-linking utilizes riboflavin eye drops and ultraviolet A light to form molecular bonds within the corneal collagen, strengthening the tissue and preventing further thinning and steepening. This proven photochemical procedure gives patients hope that their vision will be preserved without needing a cornea transplant.

The non-invasive nature of cross-linking is a major advantage over other surgical therapies. By avoiding incisions or scraping of the cornea, it reduces risks of infection, rejection, and long-term complications. Patients also experience a faster recovery with less discomfort compared to keratoplasty. Cross-linking's ability to forestall the need for a corneal transplant helps drive uptake, as transplants are a more complex solution that may eventually fail, requiring re-transplantation.

Due to cross-linking demonstrating concrete evidence that it can stop keratoconus progression in up to 95% of cases, eye care professionals widely recommend it as the first line of defense, especially for moderate to severe keratoconus. Its effectiveness in stabilizing vision makes it appealing to both doctors and their keratoconus patients seeking to delay or avoid keratoplasty. This clinical validity and non-invasiveness sustain corneal cross-linking at the forefront of the treatment landscape.

Insights, By Therapeutics: Lenses: Optimizing Vision through Customized Correction

In 2024, the lenses segment is expected to account for 52.7% revenue share of the keratoconus market. Contact lenses play a crucial role in managing keratoconus by optimizing vision and minimizing disability from the condition. As keratoconus causes the cornea to thin and distort, customized gas-permeable rigid contact lenses are able to compensate for this irregular astigmatism and bring clear focus to the eye.

By design, these rigid lenses have the steep curvature needed to vault over protruding corneal regions caused by keratoconus. Their high oxygen permeability further enhances patient comfort by allowing sufficient oxygen to reach the cornea.

For mild to moderate keratoconus, lenses can regularly provide good to excellent visual acuity without other interventions like cross-linking. They also enable clear vision during the monitoring period prior to cross-linking or determination of whether keratoplasty is needed. Even after corneal transplant, lenses may still be required for fully optimized vision.

Additionally, advances in lens material technology and custom lens design aid in extending the time that contact lenses can be viable. As keratoconus progresses, repeat fittings allow lenses to be refabricated to continually match the altered corneal curvature.

This ability of specialty contact lenses to accommodate keratoconus progression and optimize vision at every stage largely attributes to their prominence within the disease's therapeutic landscape.

• The prevalence of Keratoconus is notably higher in younger demographics, especially in individuals between the ages of 16 and 30. Increased awareness among clinicians has led to earlier diagnosis and intervention in these groups.
• Technological advancements in treatment such as corneal cross-linking are expected to drive significant market growth during the forecast period.
• Patient Pool: In the US, EU5, and Japan, the diagnosed patient pool is increasing, attributed to improved awareness and diagnosis techniques. The report highlights an increasing prevalence in young adults due to enhanced screening.
• Regional Growth: The United States dominates the market, followed by EU5 and Japan, reflecting regional differences in diagnosis and treatment adoption.

The major players operating in the keratoconus market include Glaukos Corporation, Bausch & Lomb Incorporated, Alcon Laboratories, Inc., Carl Zeiss Meditec AG, Topcon Corporation, Oculus Optikgeräte GmbH, Nidek Co., Ltd., Healon Medical Inc., Mediphacos, and KeraMed, Inc.

• In August 2023, Iveena Delivery Systems advanced IVMED-80 eye drops into Phase II trials, offering a potential non-surgical option for early-stage keratoconus patients globally.
• In May 2023, Avedro introduced an updated cross-linking device with enhanced UV light control for safer procedures, impacting the US market positively by reducing corneal transplant events. Avedro, a subsidiary of Glaukos Corporation, is a known leader in corneal cross-linking treatments.
• In February 2023, iVeena Delivery Systems entered a collaboration with leading ophthalmologists to work on an innovative therapy aimed at reducing the need for corneal transplants in advanced cases of keratoconus. This development builds on their work with IVMED-80, a pharmacologic treatment designed to address the underlying causes of keratoconus through non-surgical means. This collaboration could significantly improve late-stage disease management, offering new hope to patients who would otherwise require corneal transplants.
• In January 2023, Glaukos Corporation announced advancements in corneal cross-linking technologies, which aim to enhance patient outcomes by minimizing the invasiveness of treatment. This development is expected to significantly impact treatment approaches in the Keratoconus market, leading to better patient satisfaction and treatment accessibility. These innovations are part of their ongoing work to develop next-generation solutions for eye conditions such as keratoconus. The aim is to make treatments more efficient and patient-friendly, contributing to better clinical results.

• By Treatment
  • Corneal Cross-Linking
    • Epithelium-off Cross-Linking
    • Epithelium-on Cross-Linking
  • Keratoplasty
  • Intracorneal Rings
• By Therapeutics
  • Lenses
  • Eye Drops