In the past two decades, advances in optometry, along with an increased understanding of human eye and vision care, have led scientists to develop innovative treatment methods in order to treat eye disorders and to overcome the limitations offered by conventional medical practices. The current ophthalmic diseases treatment landscape is characterized by a number of blockbuster small molecule-based therapies, namely ALPHAGAN®, COSOPT®, LUMIGAN®, PAZEO®, RESTASIS®, TRAVATAN Z®, and XALATAN®, and a robust pipeline of over 400 candidate drugs in various stages of clinical development, designed for the treatment of approximately 1,000 chronic eye disorders. This has led to increasing demand for ophthalmic drugs’ contract manufacturing
Clinical trials focused on ophthalmic drugs
Over the years, stakeholders engaged in the development and manufacturing of ophthalmology drugs have invested significant capital towards assessing the clinical viability of their proprietary product candidates. During our research, we came across more than 10,700 registered clinical trials focused on ophthalmic drugs till Q3 2019; the maximum number of trials were registered in 2018. North America (53%) and Europe (26%) were observed to be the current hubs of clinical research activity related to this field. The abovementioned studies were conducted on a total of more than 4.5 million patients, recruited across different trial sites across the world. Of these, over 1.9 million were recruited in the Asia-Pacific regions.
Likely Evolution of Supply Chain and Demand of Ophthalmic Drugs
Owing to various reasons, such as growing manufacturing demand, need for specialized facilities, equipment and operational expertise, and high costs of development associated with certain drugs / therapies, a number of innovator companies have demonstrated a preference to outsource certain aspects of ophthalmic drug development and production operations to contract service providers.
The current, annual manufacturing demand for commercialized ophthalmic drug FDFs is projected to grow at an annualized rate of 11.9%, till 2030. According to our estimates, close to 40% of the anticipated future demand is likely to be for ampoules / vials packaging, followed by glass / plastic bottles (28%). Further, a significant proportion of the FDF demand is likely to come from ophthalmic drugs commercialized for age-related macular degeneration.
It is worth highlighting that Asia-Pacific is likely to continue to lead (in terms of manufacturing demand) among other geographies. Within this region, the global commercial demand for ophthalmic FDF is estimated to grow at a CAGR of 12.7%, in the time period 2020-2030.
Several CMOs engaged in this domain, are expanding their businesses to offer end-to-end services to clients, thereby, operating as one-stop-shops. This business model is known to offer a number of advantages to both service providers and sponsors. In addition to cost benefits, it also helps minimize multiple technology transfers and thereby, expedites time to market for clients’ products. For a CMO, having a wider service portfolio, is known to increase business opportunity and guarantee long term relations with sponsor companies.
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