Corneal Cross Linking Devices Market Analysis

Corneal Cross Linking Devices Market Overview

Corneal Cross Linking Devices Market Size was valued at USD 0.15 Billion in 2023. The Global Corneal Cross Linking Devices industry is projected to grow from USD 0.17 Billion in 2024 to USD 0.45 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.25% during the forecast period (2024 - 2032). Corneal Cross-linking (CXL) minimally invasive treatment for treating eye disorders such as keratoconus and post refractive surgery ectasia. In this treatment, a UV light source device and riboflavin eye drops are utilized. The resulting photochemical reaction results leads to bonding for the collagen molecules and proteoglycans.

The global CXL devices market is expected to be driven by the increasing incidence and prevalence of keratoconus disorders and improving healthcare infrastructure. However, the market growth is likely to be restrained by the lack of awareness and side effects associated with treatment. On the other hand, the increasing product development and launches are expected to create lucrative growth opportunities for players operating in the corneal cross linking devices market.

COVID-19 Analysis:

As a result of the pandemic, several countries had imposed import and export restrictions. This also affected the healthcare industry as many countries are dependent on other countries for raw material supply and technology. Raw materials required for manufacturing CXL devices faced a shortage during the first half of the pandemic. Additionally, COVID-19 significantly disrupted the eye care industry in 2020, as routine eye healthcare appointments were avoided to prevent patients from contracting the virus as well as due to fear among patients as eye was established as one of the major routes for virus transmission.

Additionally, the COVID-19 pandemic has moderately disrupted the production and revenue of many companies. Most key players have their manufacturing units in different regions which were highly affected by this pandemic due to restriction laid down by the authorities to curb virus transmission. Moreover, there has been an increase in online selling compared to retail shops for CXL devices and other eye care products, owing to changes in purchasing patterns due to the pandemic. Hence, the key players were required to strategize their marketing and sales accordingly to overcome challenges faced due to the pandemic. However, majority of the players saw a positive growth in the revenue of corneal cross-linking products by 2021 as supply chains got gradually restored and restrictions were reduced owing to the increasing percentage of vaccinated people and decline in infections rates globally.

Market Dynamics:

• Increasing incidence and prevalence of keratoconus disorders
  
  
  
  • There is an increasing incidence and prevalence of keratoconus disorders globally which is driving the market growth. According to a meta-analysis study published by Hashemi et al, funded by Noor Research Center for Ophthalmic Epidemiology, the prevalence of keratoconus in the whole population was 1.38 per 1000 population. In recent years there has been an increase in the number of cases reported for keratoconus disorders.
  
  
  • Moreover, it has also been reported in several studies that prevalence among Asian subjects is found to be higher than that of white Caucasians. Therefore, the increasing prevalence of keratoconus disorders is expected to continue driving market growth for the corneal cross linking devices market
  
  
  
  


• Improving healthcare infrastructure

• Lack of awareness regarding keratoconus disorders
  
  
  
  • The lack of awareness regarding keratoconus disorders stands as a restriction to market growth for the corneal cross linking devices market. Many of the cases of keratoconus go unnoticed and lead to serious issue owing to lack of awareness and misdiagnosis.
  
  
  • Furthermore, several developing nations in the Asia-Pacific region where a significant population, suffers from low awareness towards keratoconus disorders. Similar lack of awareness was seen in the African and Middle East nations as well. Therefore, lack of awareness regarding keratoconus disorders negatively impacts the growth for the corneal cross linking devices market.
  
  
  
  


• Side effects associated with treatment

• Increasing product development and launches
  
  
  
  • The high number of products in the pipeline signifies extensive R&D in the field and possible launches of more efficient products in the market in the future. The launch of new and improved products in the market supports in the market growth. There are several CXL devices in clinical trials that are expected to receive approval in the near future. For instance, in November 2021, CXL Ophthalmics, LLC (US), a clinical-stage company developing treatments for corneal ectasia, released results of its Phase 2 Trial in transepithelial (Epi-On) cross-linking.
  
  
  
  

Value Chain Analysis

The value chain analysis for the global corneal cross linking devices market comprises four major components that start with the research and product development (R&D), followed by the manufacturing of the products, distribution & sales, and ends with post-sales monitoring.

In the research and product development stage, new techniques and research are undertaken to develop new products, and to make the existing products better and unique. In manufacturing, the product strategies are ready, and the manufacturing process of the product starts. A few of the product development processes employed in the production of components are sometimes outsourced. In the global corneal cross linking devices market, the distribution includes intermediaries, direct selling, online channels, and other means of selling. For this, the company's marketing and sales strategies play a crucial role in understanding the characteristics of the industry in which one is competing. Post-sales monitoring plays a vital role in this market. As CXL devices are developed in accordance with a special purpose, post-sales monitoring is a must. The post-marketing monitoring stage begins with a periodic safety update report of the drug or device to be submitted to the FDA after the drug or device comes into the market.

Corneal Cross Linking Devices Market Segment Overview

The global corneal cross linking devices market has been divided based on type, method, and application, and end user.

Corneal Cross Linking Devices Market By Type

On the basis of type, the market is segmented into standard corneal cross-linking, corneal cross-linking plus, and accelerated cross-linking.

• Standard Corneal Cross-Linking

The standard cross-linking procedure is commonly known as the Dresden Protocol. The procedure involves anesthetizing eye, removing the central epithelium, and applying a riboflavin solution to the corneal surface. It is an effective technique for halting keratoconus progression.

• Corneal Cross-Linking Plus

Cross-linking Plus is a combination of cross-linking and a refractive procedure to flatten the cornea in order to overcome the optical inefficiency and improve functional visual outcomes in keratoconus. It has become popular among surgeons as it has the advantages of both halting KC progression and improving the visual outcome.

• Accelerated Cross-Linking

Accelerated cross-linking (CXL) is a safe and effective procedure in halting ectasia after corneal refractive surgery. However, the accelerated cross-linking (CXL) results are comparable to the standard cross-linking (CXL) with short-time exposure of the cornea to ultraviolet irradiation, which is leading to reduced operation time, ocular discomfort, and corneal haze.

Corneal Cross Linking Devices Market By Method

On the basis of method, the market is segmented into epithelium-off method and epithelium-on method.

• Epithelium-off Method

The epithelium-off method provides a barrier to the diffusion of riboflavin to the stroma, the epithelium is manually debrided to enable better penetration of the riboflavin eye drops. In addition, it helps to preserve the corneal thickness and improves visual acuity, by reducing postoperative ocular discomfort. Additionally, epithelium-off is the only cross-linking procedure approved by US Food and Drug Administration (FDA) when performed with Photrexa, Viscous, and the KXL System.

• Epithelium-on Method

Epithelium-on cross-linking is an investigational procedure where the epithelium is left intact. It helps to eradicate the risk of haze and has a significant improvement in postoperative pain. Additionally, it gives a less postoperative burning sensation to the eyes and reduces the risk of infection.

Corneal Cross Linking Devices Market By Application

Based on application, the global corneal cross linking devices market has been segmented into keratoconus, pellucid marginal degeneration, refractive surgery ectasia, and others.

• Keratoconus

Keratoconus is a progressive eye disease that causes thinning of the cornea and deforms the cornea into a cone or dome-like shape. It also distorts the vision that cannot be corrected with eyeglasses. The symptoms of keratoconus include blurred vision, nearsightedness, irregular astigmatism, and light sensitivity. In addition, overexposure to UV-rays and enzyme imbalance in the cornea increases the risk of eye disorders and also boosts market growth

• Pellucid Marginal Degeneration

Pellucid marginal corneal degeneration is a peripheral corneal thinning disorder with an adjoining area of ectasia. It causes due to the collagen abnormalities that occur in keratoconus. In addition, it is a rare ocular condition that occurs in men and women between 20 to 40 years of age. The condition results in high irregular astigmatism to develop acute hydrops or even perforation.

• Refractive Surgery Ectasia

Corneal refractive surgery encompasses multiple modalities, including photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), and small-incision lenticule extraction (SMILE). In addition, CXL for post-LASIK ectasia is proved to be beneficial for improving visual acuity and keratometric parameters

• Others

Other segments include bullous keratopathy and infectious keratitis. Bullous keratopathy is an eye disorder that involves swelling of the cornea resulting from corneal endothelial disease.

Corneal Cross Linking Devices Market By End User

Based on end user, the  global corneal cross linking devices market has been segmented into hospitals, eye clinics, and ambulatory surgical centers.

• Hospitals

Hospitals attributed to the increasing number of advanced treatment procedures, growing adoption of minimally invasive procedures, diagnostic and surgical procedures, and others. In addition, it also provides numerous types of eye surgical treatments, such as deep anterior lamellar keratoplasty, penetrating keratoplasty, and corneal collagen cross-linking.

• Eye Clinics

Eye clinics are a place where most of the developed eye procedures are conducted. The ophthalmologist suggests the right treatment consultation to the patients on the basis of the disease condition. In addition, eye clinics also provide an entry point for patients to receive glasses or contact lenses, screenings for asymptomatic eye disease, diagnosis and treatment for eye conditions, referral to specialists, and coordination with other aspects of medical care.

• Ambulatory Surgical Centers

Ambulatory surgery centers transformed the outpatient experience by providing an alternative to hospital-based outpatient procedures. Additionally, they provide enhanced surgeon productivity, improved convenience for patients and surgeons, decreased per-costs for insurers, and decreased out-of-pocket patient costs.

Corneal Cross Linking Devices Market Regional Analysis

The global corneal cross linking devices market, based on region, has been divided into the North America, Europe, Asia-Pacific, and Rest of the World.

• North America

Key factors attributed to the incidence and prevalence of keratoconus disorders are the rising geriatric population and the presence of a large number of market players in the region. For instance, according to 2020 statistics from the Cornea Research Foundation of America, keratoconus disorder affects 50–200 out of every 100,000 people. This indicates that the increase in the number of people suffering from keratoconus disorder will aid to boost the demand for corneal cross-linking procedures in the region.

• Europe

Owing to the growing cases of keratoconus in developed countries increase the demand for the CXL devices market in Europe. Increasing prevalence and subsequent increase in the prevalence of keratoconus, advancements in medical technology, and increasing demand for CXL devices are driving the market growth in Europe. Additionally, ongoing research by medical research laboratories and academic institutes is leading to new developments for an effective cure in this region.

• Asia-Pacific

Owing to the growing prevalence of cases of eye disorders is driving the market growth in the Asia-Pacific region. Companies are entering into strategic initiatives to develop and commercialize new treatment options for patients. This, in turn, is expected to boost the CXL device growth. For instance, in March 2022, Glaukos Corporation (US) announced that it has initiated the Phase 2 clinical program for third generation iLink therapy to treat keratoconus, which has presence in Asia as well. There are many start-ups coming up to deliver higher precision systems for CXL. This coupled with an increase in government spending on healthcare infrastructure are some of the major reasons that have boosted the growth of the corneal cross linking devices market in the Asia Pacific.

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  Rest of the World

  
  

The rest of the world accounted for the lowest market share in the corneal cross linking devices market. This is attributed to less availability of funds and limited medical facilities in the region. With the increasing strategic initiatives by private and public firms, the growth rate is expected to rise in the next few years. In addition, the number of corneal cross-linking performed for keratoconus patients has risen histrionically.

Competitive Landscape

The global CXL devices market is profitable, both for existing players as well as new entrants. There are several advantages to corneal cross-linking which benefits the key players, including highly effective anesthetic eye drops, a one-hour procedure that prevents further vision loss in almost all patients, and improved vision in three-fourths of patients. These advantages are propelling the corneal cross linking devices market forward.

Moreover, the major players have adopted strategies such as acquisitions, expansion, and collaborations to augment their position in the market. For instance, in November 2019, Glaukos Corporation (US) acquired Avedro, Inc. (US) to support its new corneal health franchise. This acquisition brought together two highly complementary hybrid pharmaceutical and device organizations. In addition, Avedro's innovative bio-activated pharmaceutical solutions and R&D capabilities combined with Glaukos' global commercial scale for corneal cross-linking products.

Key Players

• Glaukos Corporation (US)


• EMAGine AG (Switzerland)


• Peschke GmbH (Switzerland)


• IROMED GROUP Srl (Italy)


• iVIS Technologies (Italy)


• AJL Ophthalmic S.A. (Spain)

Recent Developments

• In November 2019, Glaukos Corporation acquired Avedro, Inc. (US) to support its new corneal health franchise. This acquisition brought together two highly complementary hybrid pharmaceutical and device organizations. In addition, Avedro's innovative bio-activated pharmaceutical solutions and R&D capabilities combined with Glaukos' global commercial scale for corneal cross-linking products.


• In October 2019, A partnership between SERVImed Industrial S.p.A. (Italy), distributor of IROMED GROUP Srl and TECHLens (Poland) aimed to develop a combination product to treat keratoconus. The final product will combine IROMED GROUP Srl transepithelial Ribocross riboflavin formulation with the CXLens cross-linking system for corneal remodelling from TECLens. The market for CXL devices is benefiting as a result.

Report Overview:

The study covers the existing short-term and long-term market effect, helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in the North America, Europe, Asia-Pacific, and Rest of the World. The report analyzes market drivers, restraints, opportunities, Porter's Five Forces, Value Chain, and impact of COVID-19 on the market.

Corneal Cross Linking Devices Market Segmentation

Global Corneal Cross-linking devices market, by Type

• Standard Corneal Cross-Linking


• Corneal Cross-Linking Plus


• Accelerated Cross-Linking

Global Corneal Cross-linking devices market, by Method

• Epithelium-off Method


• Epithelium-on Method

Global Corneal Cross-linking devices market, by Application

• Keratoconus


• Pellucid Marginal Degeneration


• Refractive Surgery Ectasia


• Others

Global Corneal Cross-linking devices market, by End User

• Hospitals


• Eye Clinics


• Ambulatory Surgical Centers

Global Corneal Cross-linking devices market, by Region

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America