Industry keenly focused on innovations
The glaucoma market seems to be in an expansion phase as evidence by the explosions in the numbers of new pharmaceutical and surgical options entering the marketplace. The introduction of new devices is possibly the single most influential factor currently driving the glaucoma market.
“The introduction of the microinvasive surgical devices [MIGS] especially has resulted in the opening up of the market to a new group of surgeons, with the cataract surgeons now performing combination procedures. The interest in MIGS has been increasing since this development,” according to Kristen Ingenito, MBA, vice president of Market Scope, St, Louis, who spoke at the Glaucoma 360 New Horizons Forum.
She continued, “The introduction of new devices is resulting in increases in both the numbers of doctors performing glaucoma procedures and in the numbers of patients that benefits from the procedures.”
Breakdown of the market shares
The current global glaucoma product market is estimated to reach $6.1 billion, with pharmaceuticals commanding 80% of the pie. Within that segment, fixed-combination drugs account for 29%; branded and generic prostaglandins 14% each; beta-blockers, carbonic anhydrase inhibitors, and alpha agonists 7% each; and miscellaneous drugs 5%.
Glaucoma devices represent 13%, of the market with the biggest share, 6%, held by MIGS; the remainder of that segment is comprised of canal surgery devices, tube shunts, and lasers, all at 2% each, and other devices at 1%.
These percentages divided up among a number of treatment options satisfy the surgeons’ desire for a variety of treatment options. “While the standard of care clearly remains the pharmaceutical option, surgeons want a variety of other options to facilitate treating different patients in the best way possible on an individual level. They all don’t respond well to the same treatment option,” she pointed out.
The surgical device segment is currently exhibiting a “very healthy” growth phase, a great deal of which is the result of new treatment options, i.e., rho kinase inhibitors and canal surgery devices, that are still relatively new.
“I am seeing a great deal of openness and willingness to accept new and novel technologies within the glaucoma space. This is very exciting considering all the new products on the horizon. The surgeons are willing to try new products to see if they can realize a benefit for their patients and integrate them into their practices,” Ms. Ingenito commented.
She views the expansion of MIGSas somewhat of a surprise. The MIGS segment of the market is currently enjoying an annual growth rate of 29%, thus far surpassing the other devices, fixed-combination drugs, and branded prostaglandins. And this growth was driven by both cataract and glaucoma specialists at all stages of their careers. In addition, the MIGs safety profile and less invasiveness of the devices also appeal to many surgeons.
As with most other elements in the economy, the growth of the glaucoma procedure volume was interrupted by the pandemic, which resulted in a 24% decrease from that which had been forecast for 2020 and a decrease of about 12% from 2019. The pharmaceuticals were not impacted in this way because patients continued to order and instill their anti-glaucoma drugs. This impact of the pandemic on the volume of glaucoma procedures performed is short term and already starting to rebound, she reported.
Growth of glaucoma disease population
The numbers of patients affected by glaucoma are increasing. In 2021, 145.9 million were estimated to be affected and by 2026 that number is projected to be 166.0 million, representing a combined annual growth rate of 2.6%. The bulk of patients have primary open-angle glaucoma and exfoliation glaucoma constitute 67% of the population; that percentage will increase to 77.1% by 2026, largely because of aging of the population,” she explained.
Another consideration is the substantial numbers of patients with glaucoma who are presently undiagnosed and untreated, there is substantial room for growth in disease screening and staging, gaining a better understanding of which patients to treat and when to treat, in the choice of the best individual treatments, and in maintaining patient compliance with pharmaceuticals.
The enthusiasm in the glaucoma pipeline lies in a few areas.
• Artificial intelligence (AI) has the potential to obtain a better understanding of the disease and improve the glaucoma diagnostic capabilities of physicians. This technology will produce home-based diagnostic and monitoring in the form of headsets for testing, objective testing, and AI-aided disease screening, staging, and monitoring of progression. “AI screening will expand patient access to care, which can then incorporate primary care or geriatric care doctors in the screening process to identify patients with undiagnosed glaucoma. AI also may become a tool to help doctors who may not have a firm background in glaucoma to determine when to refer patients and be more effective in doing so,” she explained.
• Many sustained release technologies are in the pipelines with the goals of improving efficacy and longevity of treatment. The impact on the market of durable drug options, she noted, will largely be determined by the technology that enters the market, that is, the safety, efficacy, and duration of effect.
• Expansion of treatments to severe disease while maintaining the safety profile of MIGS and stents is expected. These drugs in PreserFlo (Santen), MINIject (iStar), iStent Supra and Infinite (Glaukos), XEN (Allergan) ab externo and titratable procedure options that can be mixed and matched to address individual patient needs.
• Regulatory and reimbursement efforts are ongoing. Stand-alone procedures will allow more flexibility and address pseudophakic patients.
Sixty new companies have recently announced in 2021 their intention to enter the ophthalmic market and currently have no ophthalmic products. Ten of the 60 were specific to glaucoma and most were investigating pharmaceuticals or combination devices. There also is considerable interest in gene therapy as it affects glaucoma and diagnostics.
“I am very excited to see where all of these innovations are going,” she said.
The bottom line is that there is a great deal of interest by industry in glaucoma. The takeaways are that the specialty has a large and growing patient population, new market segments are being established, the market is accepting novel treatments, there is a continuing demand for flexible and varying treatment options, research into disease stages and diagnosis is ongoing, and reimbursement continues to be challenging, Ms. Ingenito concluded.