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.
Over 240 companies claim to offer manufacturing services for a wide range of ophthalmic APIs and drug FDFs, at varying scales of operation
Since 2000, more than 75 new ophthalmology focused CMOs have been established. Amidst the tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry. This has caused many service providers to actively expand their respective service portfolios, either through strategic acquisitions or facility / capability expansions.
The market landscape is currently dominated by the presence of large firms (having more than 500 employees), which represent close to 60% of the total number of industry stakeholders. In addition, at present, close to 70% players claim to offer FDF manufacturing services for ophthalmic drugs. It is worth noting that nearly 80% contract FDF manufacturers formulate ophthalmic drug products in the form of liquid / suspension. Of these, more than 150 companies offer primary packaging services in glass / plastic bottles, specifically for products that are available in the form of eye drops. However, packaging of ophthalmic drug FDF in ampoules / vials is likely to gain significant momentum in the near future, owing to the growing demand for sterile injectables.
In order to acquire competencies across the supply chain and cater to evolving needs of sponsors, companies have established presence across different regions, having been certified by various regulatory authorities
Globalization, increased support from local governments and relatively low labor costs have driven innovator companies, even located in developed regions, to favor outsourcing opportunities within Asia-Pacific (primarily in India, China, Japan, Bangladesh and South Korea).
Most of the installed, global ophthalmic drug manufacturing capacity belongs to established CMOs, accounting for over 80% of available capacity across various geographies
The global, installed ophthalmic FDF manufacturing capacity of companies providing contract services is estimated to be more than 65 kiloliters. It is worth mentioning that companies in Asia-Pacific and Europe currently account for approximately 54% and 21% of the global installed FDF manufacturing capacity (in terms of volume), respectively.
On the other hand, the global, installed ophthalmic API manufacturing capacity of companies providing contract services, is estimated to be around 1,980 kiloliters (in terms of volume). It is worth mentioning that the available capacity is primarily driven by players operating at both clinical and commercial scale, which are known to possess 75% of the total installed capacity.
It is worth highlighting that very large companies contribute around 45% of the overall capacity for both ophthalmic APIs and FDFs. However, small sized companies contribute only 8% of the overall capacity for both domains. It is worth mentioning that the available capacity is primarily driven by players operating at both clinical and commercial scale, which are known to possess 75% of the total installed capacity.
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