Biologics Fill Finish Manufacturing Market Revenue to Cross $11.6 billion by 2035

Published: June 2024


According to a recently published report by Roots Analysis, the increase in demand for high-quality and sterile biologics, along with the complexities associated with the manufacturing and fill / finish of biologics is creating lucrative opportunities for biologic fill finish contract manufacturing organizations

Biologics Fill Finish Manufacturing Industry Overview

The global market for biologics fill finish manufacturing is anticipated to grow at a CAGR of 7.4% during the forecast period 2024-2035, reaching USD 11.6 billion by 2035.

Biopharmaceuticals, commonly referred to as biologics, are a class of therapeutic products that are highly specific and have fewer side effects as compared to the conventional pharmacological molecules. Currently, over 410 biologics are commercially available, and more than 16,500 candidates are being evaluated across various clinical trials. However, it is worth noting that, unlike small molecules, biologics are large therapeutic entities and production of these molecules is a complex and highly demanding process, as they tend to be highly sensitive to various environmental conditions, such as light, temperature, pH and oxygen levels. Additionally, the fill finish operation is one of the most critical steps in the production of biologics, as any error encountered at this stage of development can result in potential loss of drug substance along with increasing chances of microbial contamination. Consequently, outsourcing fill finish operations of biologics to fill finish manufacturing companies have gained popularity over time, occupying about one-third of the total outsourced biologics manufacturing activities. Further, the fill finish contract manufacturing organizations boast the required technical expertise while adhering to the sterility guidelines of the regulatory bodies and enables drug developers to accelerate the timelines involved in bench to bedside transition of biologic drug products.

Browse 190+ figures and 210+ market data tables spread across 470 pages and detailed Table of Content on “Biologics Fill Finish Manufacturing Market: Industry Trends and Global Forecasts, till 2035, by Type of Primary Packaging Container, Type of Biologic Manufactured, Scale of Operation, Therapeutic Area, End-users, Type of Player, Company Size and Key Geographical Regions” here: https://www.rootsanalysis.com/reports/biologics-fill-finish-services-market/256.html

Market Drivers 

Owing to the growing demand for biologics along with the rise in adoption of personalized medicines, drug developers are proactively outsourcing the fill finish operations of their biologic products to third-party service providers. Consequently, the market for biologics fill finish manufacturing is likely to witness significant growth in the future. In addition, the growing investments in the field of advanced aseptic fill finish technologies such as robotic automation filling lines, artificial intelligence and utilization of 3D vision cameras are enabling CMOs to streamline biologics fill finish processes while increasing production efficiency and minimizing the rate of drug product wastage. 

Market Restraints 

While the biologics fill finish manufacturing market is experiencing substantial growth, there are various restraints that can hinder the growth of the industry. One of the primary restraints in this domain is to maintain high-quality standards throughout the fill finish process involving rigorous testing and visual inspection to ensure sterility and consistency of the final drug product. Further, the unsustainable supply chain and inadequate global fill finish capacities hinder the clinical and commercial manufacturing of biologics. Moreover, companies lacking the required technological know-how may struggle to optimize the biologics fill finish process, thereby resulting in lower yield and wastage of resources.

Growth Factors

Despite the challenges and various market restraints, several growth factors continue to drive the biologics fill finish manufacturing market forward. Notably, biologics are widely used in the treatment of a myriad of chronic indications (including oncological disorders and infectious diseases), targeting larger patient populations, thereby increasing the demand for biologic-based therapies. Additionally, the growing market for biosimilars resulting from the patent expiry of some of the blockbuster biologic drugs, such as Keytruda® and Stelara® in the next five years, is likely to present lucrative opportunities for biologic fill finish manufacturing companies to support the biosimilar production of these high demand drugs. 

Biologics Fill Finish Manufacturing Market Segments

Based on the type of primary packaging container, the market is segmented into ampoules, cartridges, syringes and vials.

  • Vials led the biologics fill finish manufacturing market, capturing the largest revenue share of 69% in 2024.
  • Syringes are anticipated to witness the highest market growth rate of 8.7%, during the forecast period.

Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, gene therapies, oligonucleotides, recombinant proteins, vaccines and other biologics.

  • The antibodies segment led the biologics fill finish manufacturing market, capturing the largest revenue share of 39% in 2024.
  • Cell therapies is anticipated to be the fastest growing segment in biologics fill finish manufacturing market with a CAGR of 8.1%, during the forecast period.

Based on the scale of operation, the market is segmented into Preclinical / Clinical and Commercial.

  • The commercial scale of operation segment captures the largest revenue share of 90% in the biologics fill finish manufacturing market, in 2024.
  • The preclinical / clinical scale of operation segment is anticipated to witness a higher CAGR 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.

  • The oncological disorders segment captures the largest revenue share of close to 30% in the biologics fill finish manufacturing market, in 2024.
  • The 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.

  • The pharmaceutical / biopharmaceutical companies capture the largest revenue share of more than 85% in the biologics fill finish manufacturing market, in 2024.
  • In fact, the pharmaceutical / biopharmaceutical companies segment are anticipated to witness a higher  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.

  • The industry players capture the largest revenue share of more than 90% in the biologics fill finish manufacturing market, in 2024.
  • In fact, industry players segment is anticipated to witness a higher 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.

  • The large companies are anticipated to dominate the biologics fil finish manufacturing market in the forecast period and are expected to capture close to 90% of the overall market, in 2024.
  • The small companies have shown significant potential to drive the market in the future and is estimated to grow at a CAGR of 16.6% during 2024-2035.

Based on the key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World

  • Europe dominates the biologics fill finish manufacturing market and accounts for the largest revenue share of about 40% in 2024.
  • In Asia-Pacific, the biologics fill finish manufacturing market is anticipated to witness a higher growth rate of 8.6%, during the forecast period.

Biologics Fill Finish Manufacturing Market Key Companies Profiled 

The biologics fill finish manufacturing market report also includes profiles of key players (listed below) that offer biologics fill finish services:

  • 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
  • WuXi Biologics

You Can Download Free Sample PDF Copy of This Report At:
https://www.rootsanalysis.com/reports/biologics-fill-finish-services-market/request-sample.html

About Roots Analysis 

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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Gaurav Chaudhary
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Email: Gaurav.chaudhary@rootsanalysis.com or sales@rootsanalysis.com
 

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