Placing sterile drugs into prefilled syringes (and other primary drug containers) is considered to be one of the most crucial steps in the pharmaceutical production process. Proper fill / finish operations, carried out under aseptic conditions, is a necessity for not only maintaining pharmacological efficacy and quality, but also ensuring end user safety.
The prefilled syringe filling operation is considered complex as it requires close monitoring of both the syringe fill volume as well as the headspace between the liquid in the syringe and the bottom of the plunger.
Additionally, the rise in complexity of small molecule APIs and the increasing diversity of biologic drugs have also contributed towards the demand for advanced aseptic fill / finish operations. A number of small-sized companies and some large companies have outsourced their fill / finish operations to contract service providers.
According to the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, biomanufacturers have been shown to outsource over 30% of their fill / finish operations. With the increase in the demand for prefilled syringes, along with the growing complexity of fill / finish processes, the outsourcing of these operations is likely to increase further in the future. Currently, over 100 companies are actively providing fill / finish services for prefilled syringes.
A majority of these service providers (48%) are large companies (more than 500 employees), followed by 40% mid-sized companies (51-500 employees). Further, there are 12 small-sized companies (less than 50 employees) that offer fill / finish services for prefilled syringes. Examples of such companies include (in alphabetical order) Akron Biotech, Alanza, Bryllan, Hisun Pharmaceuticals USA, KP Pharmaceutical Technology, and VxP Biologics.
Further, the market landscape features the presence of well-established players in the domain, most of which claim to operate at various scales of operation and are located in different geographies. Among the players that were established before 2001, majority (51) of the players are capable of handling small molecules and within these players, 31 service providers are large companies followed by mid-sized (18) service providers.
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A majority (51%) of the service providers offer fill / finish services at both clinical and commercial scales of operation. It is worth highlighting that, most of the service providers are headquartered in Europe (34%) followed by North America (33%). Moreover, in order to acquire competencies across the supply chain and cater to the evolving needs of clients, companies offering services across different scales of operation have established a presence in various geographies by establishing fill / finish facilities at varied locations.
Around 40% of the service providers have fill / finish facilities in Europe with Germany and Italy being the key geographies. Further, 32% of the players have fill / finish facilities in North America. Examples of players that have more than one prefilled syringe fill / finish facilities include (in alphabetic order) AbbVie Contract Manufacturing, Ajinomoto Bio-Pharma Services, Boehringer Ingelheim BioXcellence, Catalent Biologics, LSNE Contract Manufacturing, and Vetter Pharma.
Given that multiple biologicals are about to go off-patent, a wave of biosimilars are soon
anticipated to enter the market. We believe that this is likely to create significant opportunities within the developing markets of the Asia Pacific region, specifically in China and India. Many companies are setting up facilities in these regions to serve the domestic and lesser-regulated international markets.
In addition, the scientific acumen, technical expertise and production capacity of companies based in the region have grown significantly over the past decade. It is also worth mentioning that a number of companies that are based in the developed regions in the west have built wholly / partially owned facilities in this region. Even the indigenous players, currently offer services and solutions that are considered to be at par with world-class biopharmaceutical CMOs and CDMOs.
Low production costs coupled to superior infrastructure and availability of skilled labor makes outsourcing to Asia-Pacific an attractive option. Currently, 30% of the prefilled syringe fill / finish service providers have fill / finish facilities in Asia-Pacific region. It is worth highlighting that within the Asia-Pacific region, a majority of the service providers have facilities located in India (18).
Read the complete report by Roots Analysis on Prefilled Syringe Fill / Finish Services Market, 2020-2030 here.