[See Report #G125]
There are four opportunities for significant growth in the ophthalmic medical device arena – each focusing on improving therapeutic outcomes. These include (1) Refractive Surgery, (2) Glaucoma, (2) Cataract Surgery, and (4) Management of Retinal Disorders. The drivers for each of these segments overlap in certain areas – aging demographics, increased consumer awareness, improved access to healthcare services and increasing disposable incomes, but they diverge in others areas as indicated in the discussions that follow.
Note: Figures above represent manufacturer revenues, not total costs that would also include physicians fees and facility charges for surgical procedures.
Source: MedMarket Diligence, LLC, Report #G125, "Worldwide Ophthalmology."
Refractive surgery is performed using a number of surgical techniques. The term refractive surgery refers to any and all procedures that reduce refractive error, for example; myopia, hyperopia and astigmatism. Each of these procedures is designed to minimize the patient’s dependence on eyeglasses and contact lenses. Although there are many options to improve refractive error making it a complex field for the surgeon, while at the same time offering a broad range of options to treat each patient’s unique needs, some approaches will grow at a greater rate while other refractive surgery options will be cannibalized by these faster growing techniques or they will be relegated to serving the needs of niche populations. For those techniques that serve a particular niche population, manufacturers will struggle with how to maintain visibility for these sub-population therapies while ensuring that clinical competence will be maintained at a level to allow the surgeon to deliver the outcomes that are feasible.
Numerous factors will come into play as the market for refractive surgery evolves. Among these;
- Clinical Outcomes – documented clinical advantage will not only encourage physicians to embrace new approaches to refractive surgery, it will help clinicians to determine the subset of patients that are most likely to benefit by one technique over another.
- Physician Education – the speed with which surgeons can be trained on the new techniques
- Access – how rapidly will the market adopt the technology that is necessary to perform the procedure and how quickly will the market be penetrated
- Patient Education – the ability of physicians and marketing efforts by manufacturers to inform patients of various options
- Cost – Significant differences in price to the patient as well as cost associated with training and equipment by physicians and ambulatory care centers
- Reimbursement – insurers willingness to pay for such procedures will continue to be a factor in a patient’s decision to undergo refractive surgery
The various types of refractive procedures are indicated below.
- LASIK – Laser Assisted in Situ Keratomileusis – a laser or microkeratome is used to create a flap so that the cornea can be accessed to use an excimer laser to modify the shape of the cornea.
- Epi-LASIK – Epithelial LASIK – uses a keratome to remove the epithelial surface of the cornea rather than a microkeratome or femtosecond laser as in conventional LASIK. Once the flap is created and folded out of the way, an excimer laser is used to sculpt the underlying corneal tissue.
- LASEK – Laser Epithelial Keratomileusis – similar to LASIK, however, instead of creating a flap, alcohol is used to loosen the epithelium to create a flap and to give the surgeon access to the cornea. Once the cornea is re-shaped, the flap is replaced.
- Wavefront LASIK – sometimes referred to as Custom LASIK – uses a computerized device to correct for an individual’s specific visual aberrations. This not only corrects for lens power, but for subtle imperfections that lead to astigmatism as well as other higher order aberrations (hales, glare and blurry images).
- CK – Conductive Keratoplasty is a direct threat to laser vision correction in moderate hyperopes. The procedure uses radio frequency energy to shrink collagen in the periphery of the cornea, thus steepening the cornea. This technique may also be used to correct for under or over-correction following LASIK.
- PRK – Photorefractive Keratectomy – a laser is used to reshape the outside of the cornea to correct refractive errors. Unlike LASIK, it does not involve the creation of a corneal flap. It is appropriate for patients who are myopic, hyperopic or astigmatic.
- P-IOL – Phakic Intraocular Lens – a lens is placed in front of the natural lens to correct visual limitations.
- RK – Radial Keratotomy – a refractive surgery procedure for myopia which places radial incisions in the peripheral cornea to reshape its surface and improve visual acuity. It has largely been replaced by PRK, LASIK and Custom LASIK.
LASIK contintues to be the dominant choice for the performance of refractive surgery, although Custom LASIK seems to have the edge when it comes to clinical outcomes. The only factors holding Custom LASIK from overtaking LASIK are access, which is somewhat of a cost issue, and, perhaps more importantly – the significant cost differential to the patient.
P-IOLs are a promising technique for certain subsets of patients, however, they have neither the awareness among patients, nor the educated physician base to capitalize on their potential. This is, in some way due to the size of the companies that offer P-IOL technology and their investment in market development programs that include both physician and patient education. As larger players enter this segment, it is likely that the investment in marketing programs will create opportunity for each of the manufacturers in this segment.
Laser vision correction (LVC) continues to evolve giving the surgeon more choices in the management of each patient’s individual needs. Not only have lasers become more accurate, they allow for customization as in Custom LASIK. Further, the lines have begun to blur between LVC and corrective lens implants. These dynamic options to vision correction have created an unlimited pool of options from which the patient and surgeon can choose. But is it possible for industry to ensure that a patient’s choice is not constrained by the depth of his/her ECP’s awareness?
Although advances in LVC continue to offer improved vision to patients, the adoption of the technology continues to be affected by economic considerations. These procedures are expensive and not typically covered by insurance plans. The total dollars spent globally on refractive surgery — including manufacturers revenues (included in this report) and fees for physician/facility services are upwards of $4 billion annually. In international markets, this poses a particularly daunting set of challenges as most capital equipment manufacturers that provide laser vision correction systems have developed a market model in which they charge a per-procedure fee for the use of the laser.
[See Report #G125 for exhaustive procedure, incidence, product, market and geographic data.]