The ophthalmology therapeutics market for Dry Eye Syndrome (DES) and glaucoma in four Asia-Pacific (APAC) countries, India, Australia, China and Japan, was worth $2.4 billion in 2012 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% to reach $3.3 billion by 2019.
The Indian market is expected to show the fastest growth over the forecast period with a CAGR of 9.9%. The other three markets are expected to see similar but slightly lower CAGRs, with China at 5%, Australia at 4.4%, and Japan at 4.2%. In 2012, Japan had the largest market in APAC with a value of $1,065m, or 45% of the total APAC ophthalmology market. The next largest market was China at $767m or 33% of the total APAC market. In the same year, the Indian market was valued at $427m, a share of 18%. Australia had the lowest market share at 4% with a market value of $95m.
Moderate Pipeline with Promising Drugs in Late Stages of Development Could Drive Market Expectations
The global ophthalmology pipeline is becoming increasingly innovative with a cluster of novel molecules in the early stages of development. The drug approval processes in many APAC countries, including Japan and China, require clinical trials to be run domestically in order to account for differences in drug metabolism between populations of different ethnicities. This can delay new drug launches but in the long term secures greater confidence in safety and efficacy profiles. There are currently five molecules in the Pre-registration stage of development that are expected to be granted approval within the forecast period. Two of these are indicted for DES and three for glaucoma. Nearly 36% of the pipeline for glaucoma and DES are molecules in the late stages of development (Phases II and III), and of these, 21 molecules (43%) are indicated for DES and 28 (57%) for glaucoma.
Some of the major factors driving the growth of the market are growing awareness of the importance of detecting ophthalmic diseases early, the availability of effective diagnostic tools, and an increase in the prevalence of both diseases. The expiration of blockbuster drug patents and the subsequent pressure from cheaper off-label products will be a key market restraint. A sizeable section of glaucoma patients require combination therapy – the use of additional agents to the treatment regimen – to control elevated intraocular pressure. The demand for combination products over single-ingredient formulations has risen, and they often improve patient compliance as the two drugs can be administered simultaneously.
Diquas (diquafosol tetrasodium), by Santen Pharmaceutical and Mucosta (rebamipide), by Otsuka Holdings were recently launched in Japan. These manufacturers must now focus on increasing diagnosis rates and growing their product’s market share before looking at adding new therapies to the treatment scheme. The current DES pipeline in APAC is somewhat stagnant, as there are only three late-stage products expected to enter the market during the forecast period; Diquas will launch in China in 2013 and CF-101, in development by Can-Fite BioPharma, is expected to gain marketing approval in China by 2017 after approval in the US and Europe in 2014.