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Biologics Fill Finish Manufacturing Market CAGR to be Around 6.72% by 2035, Due to the Growing Demand For Biologic Drugs | Roots Analysis
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The presence of biologics fill finish contract manufacturing organizations has enabled drug developers, which lack the necessary expertise and elaborate resources, to successfully manufacture biologic drug products. Additionally, outsourcing of fill finish operations allows drug developers to focus and navigate their capital investments towards research and development activities within their organization. Further, the role of biologics fill finish manufacturing companies has grown substantially over the years as they continue to aid pharmaceutical companies in addressing the challenging aspects of aseptic filling of biologics under contamination-free sterile conditions. This can be attributed to the fact that CMOs offer specialized expertise, aseptic clean rooms, provision for terminal sterilization, automated filling lines, advanced visual inspection equipment and robotic packaging arms, serving as an integral partner in expediting the biologic manufacturing and fill finish process. Additionally, their role is set to expand, contributing to the industry's resilience, efficiency, and ability to streamline and accelerate the timelines to bring novel biologic therapies to market swiftly. Moreover, due to the sterility challenges faced during biologic product approvals; pharmaceutical drug developers are actively engaging biologics fill finish contract manufacturing organizations to navigate the dynamic drug development and manufacturing landscape of traditional as well as novel biologic drug products.
Biologics Fill Finish Manufacturing Market Segments
Based on the type of primary packaging container, the market is segmented into ampoules, cartridges, syringes and vials.
1. Vials segment led the biologics fill finish manufacturing market, capturing the largest revenue share of 69% in 2024.
2. Syringes segment is anticipated to witness the highest market growth rate of 8.7%, during the forecast period.
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Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics.
1. The antibodies segment led the biologics fill finish manufacturing market, capturing the largest revenue share of close to 40% in 2024.
2. The cell therapies segment is anticipated to witness the highest market growth rate of more than 8%, during the forecast period.
Based on the scale of operation, the market is segmented into preclinical / clinical and commercial.
1. The commercial scale segment led the biologics fill finish manufacturing market, capturing the largest revenue share of 90% in 2024.
2. The preclinical / clinical scale segment is anticipated to witness the highest market growth rate of 8.8%, during the forecast period.
Based on the therapeutic area, the market is segmented into autoimmune disorders, cardiovascular disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders.
1. The oncological disorders segment has led the biologics fill finish manufacturing market, capturing the largest revenue share of close to 30% in 2024.
2. Autoimmune disorders segment is anticipated to witness the highest market growth rate of 8.8%, during the forecast period.
Based on the end-users, the market is segmented into pharmaceutical / biopharmaceutical companies and contract manufacturing organizations / others.
1. The pharmaceutical / biopharmaceutical companies segment led the biologics fill finish manufacturing market, capturing the largest revenue share of more than 85% in 2024.
2. In fact, the pharmaceutical / biopharmaceutical companies segment is anticipated to witness the highest market growth rate of 7.6%, during the forecast period.
Based on the type of player, the market is segmented into industry players and non-industry players.
1. The industry players segment led the biologics fill finish manufacturing market, capturing the largest revenue share of more than 90% in 2024.
2. In fact, industry players segment is anticipated to witness the highest market growth rate of 7.6%, during the forecast period.
Based on the company size, the market is segmented into small companies, mid-sized companies, and large companies.
1. The large companies segment led the biologics fill finish manufacturing market, capturing the largest revenue share of close to 90% in 2024.
2. The small companies segment is anticipated to witness the highest market growth rate of more than 16.5%, during the forecast period.
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Biologics Fill Finish Manufacturing Market Regional Outlook
Based on the key geographical regions, the biologics fill finish manufacturing market can be segmented into four major regions, including North America, Europe, Asia Pacific and rest of the world. Led by the France, Europe is anticipated to capture the majority share of the biologics fill finish manufacturing market in 2024 and this trend is likely to remain unchanged during the forecast period. The biologics manufacturing industry in Asia Pacific is accounted to be the fastest-growing segment of the market. The growth of the biologic fill finish manufacturing market in this region is primarily driven by technical advancements, rise in skilled population, low labor costs and socio-economic regulatory reforms favoring the growth of the biologics fill finish manufacturing industry.
Key Report Takeaways
1. Presently, 240 service providers worldwide, are engaged in offering fill finish services for various biologic molecules; close to 35% of these stakeholders are headquartered in the US
2. 80% of the service providers operate at all scales of operation to cater to the diverse fill finish needs of customers; notably, vials have emerged as the most adopted primary packaging container format
3. The global, installed biologics fill finish capacity is spread across various geographies; interestingly, more than 90% of the total capacity is installed at the facilities owned by large and very large players
4. Given the growing complexity of manufacturing sterile drug products, the demand for filling biologics has upsurged; by 2035, it is anticipated to reach 28.5 million liters, across clinical and commercial scales
5. With the rapid increase in the demand for biologic drugs in the treatment of chronic conditions, the opportunity for companies offering biologics fill finish services is poised to grow at a CAGR of 7.4%
6. Close to 30% of the market is expected to be captured by revenues generated from fill finish of biologics intended for the treatment of oncological disorders; further, biologics fill finish manufacturing market in Japan is likely to grow at a faster pace
Biologics Fill Finish Manufacturing Market Key Players
Examples of key companies engaged in biologics fill finish manufacturing market (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, Element Materials Technology, Evonik, Fareva, Fresenius Kabi, GSK, Hetero, Lonza, Patheon pharma services, Pierre Fabre, Recipharm, Sandoz, Syngene, WACKER and WuXi Biologics
Gaurav Chaudhary
Email: Gaurav.chaudhary@rootsanalysis.com or sales@rootsanalysis.com
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.
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