Prefilled Syringes Fill/Finish Services Market – Present Scenario and the Growing Future Potential
by Roots Analysis Roots Analysis provides market research and consulThe filling of 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.
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.
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 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 as the key geographies. Further, 32% 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 Asia-Pacific region, majority of
the service providers have facilities located in India (18).
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Created on Jun 3rd 2020 02:52. Viewed 468 times.