Biopharmaceuticals represent the most rapidly growing and high-value segment of the pharmaceutical industry. Growing at an annualized rate of ~12%, the industry stands tall with more than 5,000 biologics in development and over 300 FDA approved biologics, since 2002. Biologic drug development is characterized by high quality standards and a rapidly growing demand for novel and effective treatment options. Even though it is a technically challenging field, outsourcing has grown into a promising and prominent segment, especially for manufacturing and fill / finish operations. In spite of the fact that fill / finish services are one of the crucial stages of product development, these operations represent one of the most heavily outsourced activities in the pharmaceutical industry. Currently, it is estimated that about one-third of the total fill / finish operations are outsourced to contract service providers.
What are the Opportunities for the Players Active in the Field?
Owing to the recent advances in the product development technologies and innovative drug products, there are multiple growth opportunities for companies providing fill / finish services to biopharmaceutical drug manufacturers. the demand for contract services continues to be driven by a variety of needs, including requirement of single use systems, rising adoption of RABS and isolator barriers, introduction of robotic solutions and automation, and carrying out fill / finish in diverse type of drug-delivery devices; these are some of the areas where developer companies claim to benefit from engaging the services of capable CMOs.
Who are the Leading Players in the Industry?
There are more than 115 service providers actively providing fill / finish services for various biologics. In addition to fill / finish, these provide an array of services for late stage product development, including lyophilization, quality control testing, labeling, storage and distribution services. Further, the service providers can be distinguished on the basis of their headquarters, year of establishment, company size, location of fill / finish facilities, type of packaging used for filling, services offered in addition to fill / finish, scale of operation, type of biologics handled and other details related to the fill / finish capabilities of service providers (such as number of units filled per batch).
How is the Industry Landscape Changing in Response to Increase in Demand?
Owing to the complexities related to the handling of biologics and the requirement of fully automated fill / finish equipment, several contract service providers have made significant investments for expanding their respective production capabilities and capacities. Certain players have also established new facilities to cater to the growing demand for both conventional biologics and novel biologics. Since 2013, the industry has witnessed about 70 such developments; of which more than 30% were associated with establishment of new facilities.
Further, since 2013 the industry has witnessed ~70 instances wherein players have joined hands to offer their combined services, including fill / finish of biologics. Several players have entered into mergers and acquisitions with other service providers in order to expand their service offerings.
Do the Contract Service Providers have Enough Capacity to Fulfill the Current and Future Demand for Biologic Drug Products?
The global installed fill / finish capacity of companies providing contract services for biologics is estimated to be about 17 million units, per day (or per batch). The current global installed capacity is primarily driven by players operating at commercial scale, which together account for 85% of the installed fill / finish capacity.
The demand for commercial biologics is driven by antibodies; this trend is likely to continue in future as well. Currently, vials are estimated to be the most prevalent format of packaging container. In addition, by 2030, majority of the demand is likely to come from biologics commercialized for oncological disorders.
How will the Market Evolve in the Foreseen Future?
Owing to the surge in efforts for development of various types of biologic drugs, the overall opportunity for contract fill / finish service providers is significant. Overall the market is likely to grow at an annualized rate of over 10% till 2030 and be worth more than USD 4 billion.
The current opportunity lies heavily with the service providers packaging biologic drug products in vials. Antibodies which represent the most prominent type of biologic are likely to continue to dominate this market in the future as well.
To get a detailed information on the key players across different geographies, key performance indicators for the service providers, role of robotic fill / finish systems and ready-to-use primary packaging, and other key industry trends impacting this domain, visit this link