Biologics Fill Finish Manufacturing: Rise in Outsourcing to Optimize Production Efficiency
Roots Analysis
Market research & consulting services in the pharma / biopharma, medical devices & contract manufacturing domains
Biologics represents one of the promising and fastest growing segments of the pharmaceutical industry. These complex molecules have demonstrated a remarkable success rate of more than 70% in the treatment of different therapeutic indications. As a result, the demand for biologics has surged significantly over time. Notably, in 2023, the FDA has approved around 22 biological license applications for biologics targeting different therapeutic areas, such as inflammatory diseases, infectious diseases and respiratory disorders.
Nevertheless, manufacturing of biologics, particularly fill finish operation is a complex and cost-intensive process that requires specialized facilities, automated filling lines, advanced visual inspection equipments, and operational expertise. Consequently, the lack of the aforementioned requirements along with the escalating demand for biologics, has prompted drug developers to increasingly rely on biologics fill finish contract manufacturing organizations. These CMOs are well-equipped with expertise and advanced technologies required to cater to the GMP-based aseptic fill finish requirements of pharmaceutical companies. Further, this strategic shift enables drug developers to leverage the resources of CMOs and optimize the overall cost associated with fill finish of biologic drug products. It is worth highlighting that with outsourcing becoming increasingly accepted as a viable and beneficial business model within this field, the global market for biologics fill finish manufacturing is expected to witness remarkable growth during the forecast period.
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Biologics Fill Finish Manufacturing Market
According to Roots Analysis, the Biologics Fill Finish Manufacturing Market is estimated to be USD 5.3 billion in 2023 and is anticipated to grow at a CAGR of around 7.4% till 2035. In terms of type of primary packaging container, vials are expected to capture the majority share in the biologics fill finish manufacturing market by 2035. Additionally, in terms of type of biologic manufactured, antibodies currently hold the largest share (38%) of the market. Further, amongst scale of operation, the market for commercial scale is anticipated to represent the highest share of the biologics fill finish manufacturing market.
Current Market Landscape of the Biologics Fill Finish Service Providers
The biologics fill finish market landscape features the presence of 240 very large, large, mid-sized and small contract manufacturing organizations involved in offering aseptic fill finish services for biologics across different scales of operations, such as preclinical, clinical, and commercial scale. Close to 60% of these fill finish manufacturing companies were established between 2001 and 2020, indicating a growing demand for the manufacturing of finished dosage forms for both novel and conventional biologic molecules. Additionally, close to 35% of the fill finish companies are based in North America and Europe, each. Further, within Europe, Germany emerged as the hub of biologics fill/finish CMOs. Further, 70% of the companies are engaged in manufacturing proteins / peptides; notable examples (arranged in alphabetical order) include 3P Biopharmaceuticals, Akron Bio, Creative Biolabs, HALIX and WuXi Biologics.
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Market Share Analysis: Vials are the Most Widely Adopted Primary Packaging Containers for Sterile Filling of Biologics
Pharmaceutical vials have become the most preferred primary packaging container for the sterile filling of biologics. This can be attributed to the fact that vials are made of strong and durable materials, such as borosilicate glass, that are capable of withstanding the extreme conditions during the handling, thereby reducing the risk of product loss. Notably, close to 95% of the fill finish contract manufacturing companies provide vial filling services for the biologics. Examples of large companies involved in offering only vial filling services (based in Europe, arranged in alphabetical order) include Bachem, BioNTech, BSP Pharmaceuticals, Miltenyi Biotec and Oxford BioMedica.
Demand Analysis: Estimates of the Annual Demand for Biologics Fill Finish
The demand for biologics fill finish manufacturing is projected to reach 28.5% in 2035, growing at a CAGR of 12.8%. In addition, the commercial and clinical demand for biologics fill finish manufacturing is projected to reach over 24.5 million liters and 3.5 million liters, respectively, in 2035. Further, in terms of the type of primary packaging container used, the current demand is driven by vials, and this trend is unlikely to change in the foreseen future.
Leading Companies in Biologics Fill Finish Manufacturing Market
Examples of key companies engaged in the biologics fill finish manufacturing domain (which have also been profiled in this market report; the complete list of companies is available in the full report) include AbbVie Contract Manufacturing, Asymchem, Boehringer Ingelheim BioXcellence, Catalent Biologics, Charles River, Elements Material Technology, Evonik, Fareva, Fresenius Kabi, GSK, Hetero, Lonza, Patheon pharma services, Pierre Fabre, Recipharm, Sandoz, Syngene, WACKER and WuXi Biologics. This market report includes an easily searchable excel database of all the fill finish companies offering aseptic fill finish services for biologic drugs.
All your Questions Related to Biologics Fill Finish Market Answered in this Report
The Biologics Fill Finish Manufacturing Market report features an extensive study of the current market landscape, market size and future opportunities for biologics fill finish manufacturing, during the given forecast period. Further, the report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. The report answers many key questions related to this market. Click on the below link to know more about this emerging area of research
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