A steadily growing demand for biologic fill / finish services has generated a range of new opportunities for contract service providers; stakeholders have invested heavily to ensure product integrity and safety
The current landscape of biologics fill / finish contract service providers features the presence of several established and emerging players, with a diverse set of production capabilities. The fill / finish services market is presently dominated by service providers (more than 95) based in North America and Europe.
It is worth highlighting that some of these players operate fill / finish facilities in emerging regions of Asia-Pacific as well. Examples of such companies include (in alphabetical order) Boehringer Ingelheim, Hisun Pharmaceuticals USA, Lonza, PCT and Recipharm. This can be primarily attributed to the fact that globalization and increased support from local governments have played a pivotal role in driving numerous changes in domestic policies, which favor outsourcing opportunities in such regions.
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Antibodies, proteins / peptides and vaccines represent the most common types of biologics fill / finish across different types of packaging formats. According to our analysis, vials emerge as the most popular type of primary container used for packaging various types of biologics. Vials are presently the most preferred form of primary packaging used by 110 companies, for packaging biologic drug products. This is followed by syringes and cartridges, which are used by 55 and 25 players, respectively.
It is worth highlighting the players that offer biologics fill finish in the all four main types of primary packaging (ampoules, cartridges, syringes and vials); these include Corden Pharma, Fresenius Kabi Contract Manufacturing, Pfizer CentreOne, Recipharm and Siegfried Holding. To meet some the abovementioned challenges, drug developers have not hesitated to outsource fill / finish operations to capable contract service providers. Currently, around 170 companies claim to be actively providing biologics fill and finish services.
The market landscape features a mix of small-sized companies (less than 50 employees, 24%), mid-sized companies (more than 51 employees, 42%) and large companies (more than 500 employees, 34%) offering contract fill / finish services. Further, the fill and finish services market is presently dominated by service providers (more than 95) based in North America and Europe. It is worth highlighting that some of these players operate fill / finish facilities in emerging regions of Asia-Pacific as well.
Further, recent advancements in automation and packaging have enabled the service providers to further strengthen their service offerings. Access to state-of-the-art fill / finish technologies is one of the key parameters taken into consideration while outsourcing drug product manufacturing. Fully-automated fill / finish equipment enable the service providers to ascertain quality of service by providing aseptic conditions for fill / finish of sensitive biologics.
Owing to the increasing number of personalized therapies, there is a demand for ready-to-use primary packaging, suitable for aseptic fill / finish operations. The service providers need to ensure quality of service and have to establish highest levels of performance across various parameters. These parameters play a critical role in selection a contract service provider, especially for biologic drug products. Some of the key performance indicators of a service provider include strength of service portfolio, location of facility, reliability, quality, on-time delivery, financial stability and service cost.
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Types of Primary Packaging Containers
- Ampoules
- Cartridges
- Syringes
- Vials
Types of Biologics
- Peptides / proteins
- Antibodies
- Vaccines
- Cell therapies
- Gene therapies
- Viral products
- Oligonucleotides
- Others
Company Size
- Small-sized
- Mid-sized
- Large / very large
Scale of Operation
- Preclinical
- Clinical
- Commercial
Key Therapeutic Areas
- Cancer
- Infectious diseases
- Autoimmune diseases
- Cardiovascular diseases
- Other indications
Key Geographical Regions
- North America (US, Canada)
- Europe (UK, France, Germany, Italy, Spain and rest of the Europe)
- Asia-Pacific (Japan, China, South Korea, India and Australia)
The report features inputs from a number of eminent industry stakeholders, according to whom, “Currently, majority of biologics are being filled in vials, however, the scenario is likely to change in the future due to the growing demand and preference for self-administration devices.” The report features detailed transcripts of discussions held with the following experts:
- Ales Sima, Business Development Manager, oncomed manufacturing
- Gregor Kawaletz, Chief Commercial Officer, IDT Biologika
- Jos Vergeest, International Business Developer, HALIX
- Purushottam Singnurkar, Research Director and Head of Formulation Development, Syngene International
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