Fill-finish Manufacturing Market Size & Forecast

The Fill-finish Manufacturing Market is projected to reach $19.14 billion by 2031, at a CAGR of 9.9% from 2024 to 2031. The growth of this market is driven by the growth of the biopharmaceutical industry, initiatives by pharmaceutical & biopharmaceutical companies to expand their production capacities, advancements in fill-finish manufacturing processes, and the increasing demand for pre-filled syringes.

Moreover, initiatives aimed at increasing vaccination rates, increasing focus on biosimilar development, and rising investments in the development of new biologics are expected to create market growth opportunities.

Fill-finish Manufacturing Market Growth Drivers

Growth of the Biopharmaceutical Industry

The global biopharmaceutical market is witnessing significant growth, driven by the increase in biologics approvals, rising investments by vendors in expanding biomanufacturing capacities, and government initiatives aimed at boosting bioproduction. In 2021, the number of new planned clinical trials reached 5,500, an increase of 14% and 19% from 2020 and 2019, respectively. This increase in clinical trials and R&D activities is driving the growth of the fill-finish manufacturing market.

Governments worldwide are launching initiatives to support the biopharmaceutical market's growth. For instance, the government of China has implemented various measures to promote the development and commercialization of biosimilars. Similarly, countries such as Malaysia, Indonesia, Thailand, and Taiwan have established regulatory pathways for biosimilars, thereby enhancing access to biosimilar technologies. The production of biosimilars is expected to drive the demand for fill-finish manufacturing, thereby driving market growth.

Advancements in Fill-finish Manufacturing Processes

There is an increased demand for fill-finish manufacturing services in the pharmaceutical industry, driven by increased drug approvals and growth in the biopharmaceutical sector. Recent advancements in fill-finish technology have improved bioprocessing capabilities, enhancing product quality & efficiency and reducing contamination risks. Key advancements include the adoption of single-use systems, advanced barrier technologies, and robotics, among others.

A significant innovation in aseptic fill-finish technologies involves the integration of data analytics and sensor technology for real-time process control and monitoring. Continuous monitoring of critical parameters such as airflow, temperature, and pressure enables swift detection of process deviations, thereby minimizing contamination risks and optimizing process efficiency.

Fill-finish Manufacturing Market Trends

Integration of Automation & Robotics in Fill-finish Manufacturing

Automation has revolutionized several aspects of the pharmaceutical industry, including fill-finish manufacturing. Robotic systems are now being used to perform tasks like inspection, container loading, capping, and filling. These robots are extremely precise and can work in a sterile environment without posing contamination risks. By integrating automation and robotics, pharmaceutical companies are improving the speed and consistency of fill-finish operations, resulting in reduced labor costs and higher production yields.

Robotic systems can operate around the clock without needing breaks or rest. This continuous operation capability enhances productivity & efficiency in manufacturing processes. Leading market players are increasingly launching robotic systems for fill-finish operations. For instance, in March 2023, 3P Innovation (U.K.) launched a Robotic Fill-Finish Cell at the ISPE Aseptic Conference in North Bethesda, Maryland, U.S. This robotic cell provides a compliant and autonomous solution for filling and finishing cartridges, ready-to-use (RTU) vials, and syringes.

Fill-finish Manufacturing Market Opportunity

Rising Investments in the Development of New Biologics

The demand for biopharmaceuticals is rising, driven by their benefits, including their ability to target specific molecules, minimal side effects, and high activity & specificity. Biopharmaceuticals are increasingly being used for treating Immune-mediated Inflammatory Diseases (IMIDs), including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD), and cancer. According to the U.S. FDA, out of the total drugs approved in 2022, 15 were biologics, an increase from 13 in 2020.

Furthermore, governments worldwide are providing funding for the R&D of biologics. For instance, in October 2022, the U.S. FDA provided funding of USD 1.3 million to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) to advance biologics research. The increased share of biologics in total drug approval and investments by government bodies in the R&D of biologics is driving the demand for fill-finish manufacturing services.

Initiatives Aimed at Increasing Vaccination Rates

Vaccination is recognized as an effective, simple, and safe method to protect against harmful diseases. In recent years, both private and government agencies have intensified their focus on vaccinations due to their role in preventing serious illnesses and reducing mortality rates. According to the WHO, vaccination and immunization prevent 3.5 to 5 million deaths annually from diseases such as measles, diphtheria, influenza, tetanus, and pertussis.

Governments worldwide are increasingly prioritizing vaccination efforts. For instance, the Canadian government has ramped up its vaccination initiatives, leading to heightened demand for fill and finish instruments. In June 2022, in alignment with global vaccination efforts, Canada launched the Global Initiative for Vaccine Equity (CanGIVE) with an investment of USD 317 million. This initiative aims to bolster COVID-19 vaccine distribution, strengthen healthcare systems, and enhance domestic vaccine manufacturing capacity. Such initiatives are expected to create opportunities for the growth of the fill-finish manufacturing market.

Fill-finish Manufacturing Market Analysis: Key Findings

By Offering: In 2024, the Packaging Type Segment to Dominate the Fill-finish Manufacturing Market

Based on offering, the fill-finish manufacturing market is segmented into packaging type, packaging instruments, and packaging services. In 2024, the packaging type segment is expected to account for the largest share of the fill-finish manufacturing market. This segment encompasses consumables like vials, pre-filled syringes, ampoules, and other containers used for drug filling. This segment's large market share can be attributed to the increasing utilization of vials and ampoules in vaccine packaging, the growing adoption of pre-fillable syringes and ampoules for single-dose packaging, and advancements in fill-finish technology.

Technological advancements, such as the integration of automation & robotics in filling instruments, are crucial in reducing drug wastage, optimizing production speed, and minimizing human interventions, thereby lowering the risk of contamination. The integration of these technologies in fill-finish packaging solutions is anticipated to drive the growth of this segment during the forecast period.

By Formulation: In 2024, the Parenteral Segment to Dominate the Fill-finish Manufacturing Market

Based on formulation, the fill-finish manufacturing market is segmented into oral, parenteral, topical, and other formulations. In 2024, the parenteral segment is expected to account for the largest share of the fill-finish manufacturing market. Parenteral administration is the second most prevalent drug delivery method after oral solids and liquids. In recent years, parenteral drugs have constituted approximately 40% of new molecular entities approved annually by the U.S. Food and Drug Administration. The rising development of parenteral drugs is driving the demand for advanced drug delivery devices such as pre-filled syringes, thereby boosting the adoption of fill-finish manufacturing services.

By Sterilization Process: In 2024, the Aseptic Processing Segment to Dominate the Fill-finish Manufacturing Market

Based on sterilization process, the fill-finish manufacturing market is segmented into aseptic processing and terminal sterilization. In 2024, the aseptic processing segment is expected to account for the larger share of 60.8% of the fill-finish manufacturing market. Aseptic processing ensures the sterility of pharmaceutical products. This method employs techniques such as dry heat, fumigation, gamma radiation, and others without subjecting the materials to high temperatures.

The increasing demand for aseptic processing is driven by the need to sterilize heat-sensitive drugs such as biologics, vaccines, and other parenteral medications. Additionally, the rising approvals and growing demand for vaccines and biologics are contributing to the increased demand for aseptic processing. According to data from the World Health Organization (WHO), global vaccine doses supplied increased from approximately 5.8 billion in 2019 to 16 billion in 2021.

By Application: In 2024, the Small Molecules Segment to Dominate the Fill-finish Manufacturing Market

Based on application, the fill-finish manufacturing market is segmented into biologics and small molecules. In 2024, the small molecules segment is expected to account for the larger share of 55.3% of the fill-finish manufacturing market. This segment’s large market share can be attributed to factors such as the cost-effectiveness of small molecules and their increasing efficacy in treating various diseases, the rising prevalence of conditions like cancer & diabetes, and the increasing number of small molecules in clinical development. According to Lonza Group (Switzerland), small molecules account for 52% of all molecules in clinical development. Furthermore, the increasing complexities associated with manufacturing small molecules have increased the reliance on fill-finish manufacturing services, thereby contributing to the segment's large market share.

However, the biologics segment is projected to register a higher CAGR of 11.1% during the forecast period. This growth is driven by increased funding for biologics development, rising approvals of biologic products, and investments by market players in expanding production capacities for biologics. Over the past five years, biologics manufacturing has grown significantly, with further growth anticipated with the advent of technologies like Bioprocessing 4.0. This approach harnesses the Internet of Things (IoT) for enhanced process control & efficiency.

By End User: In 2024, the CROs & CDMOs Segment to Dominate the Fill-finish Manufacturing Market

Based on end user, the fill-finish manufacturing market is segmented into pharmaceutical & biopharmaceutical companies, CROs & CDMOs, and compounding pharmacies. In 2024, the CROs & CDMOs segment is expected to account for the largest share of the fill-finish manufacturing market. This segment’s large market share can be attributed to the increasing outsourcing of drug fill-finish operations to contract companies, driven by rising product development costs and limited in-house R&D infrastructure, particularly among small and medium-sized enterprises. The surge in clinical trials and rapid growth in the healthcare and life sciences sectors are accelerating the outsourcing trend to ensure efficient and cost-effective drug filling. According to a report published by the Association for Packaging and Processing Technologies (U.S.) in 2022, 60% of pharmaceutical manufacturers currently outsource at least a portion of their operations to third-party contractors.

Geographical Analysis

North America to Dominate the Market in 2024

In 2024, North America is expected to account for the largest share of 35.1% of the fill-finish manufacturing market. North America’s significant market share can be attributed to the presence of leading fill-finish manufacturers and major biopharmaceutical companies, substantial R&D investments, government & regulatory support promoting biopharmaceutical usage, and expansions of manufacturing capacities by pharmaceutical companies. For instance, in 2022, the U.S. accounted for approximately 45% of the global pharmaceutical market and 22% of global production. According to the International Trade Administration (ITA), the U.S. holds the largest share of the biopharmaceutical market globally, comprising about one-third of the market, and leads in biopharmaceutical manufacturing and R&D activities. The large biopharmaceutical market in North America is driving the demand for fill-finish manufacturing services, particularly for aseptic drug filling.

However, the market in Asia-Pacific is projected to register the highest growth rate of 11.3% during the forecast period. Countries such as China, India, and South Korea are expected to present significant growth opportunities for vendors in the fill-finish manufacturing market. The market growth in Asia-Pacific can be attributed to several factors, including the proliferation of pharmaceutical and biopharmaceutical companies, expanding patient populations, rising disposable incomes, and growing foreign direct investments (FDIs) in the pharmaceutical and biopharmaceutical sectors.

In 2015, the Government of China launched the Made in China (MIC) 2025 plan to strengthen domestic manufacturing capabilities, resulting in a significant increase in the emergence of new Chinese biopharmaceutical firms. Additionally, China has become an attractive destination for international pharmaceutical companies seeking to streamline product timelines and minimize production costs. These factors are driving the demand for fill-finish manufacturing across Asia-Pacific, thereby fueling the market’s growth.

Fill-finish Manufacturing Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years. The key players operating in the Fill-finish manufacturing market are Syntegon Technology GmbH (Germany), Becton, Dickinson and Company (U.S.), Industria Macchine Automatiche S.p.A. (Italy), West Pharmaceutical Services, Inc. (U.S.), Catalent, Inc. (U.S.), AbbVie Inc. (U.S.), Gerresheimer AG (Germany), AptarGroup, Inc. (U.S.), OPTIMA packaging group GmbH (Germany), Baxter International Inc. (U.S.), C.H. Boehringer Sohn AG & Co. KG (Germany), Schott Pharma AG & Co. KGaA (Germany), SGD Pharma (France), and Stevanato Group (Italy).

Fill-finish Manufacturing Market Overview: Latest Developments from Key Industry Players

• In February 2024, Catalent, Inc. (U.S.) upgraded its capsule filling facility for Dry Powders for Inhalation and capsule blistering suites in Massachusetts, U.S., to accommodate potent drugs.
• In November 2023, Gerresheimer AG (Germany) expanded its manufacturing plant for ready-to-fill (RTF) syringes in Querétaro, Mexico, with an investment of approximately USD 108 million (EUR 100 million). This expansion aims to increase the manufacturing capacity by several hundred million RTF syringes annually.
• In June 2023, Corning, Inc. (U.S.) collaborated with SGD Pharma (U.S.) to establish a new glass tubing facility in Vemula, India. This collaboration enables SGD Pharma to adopt Corning's velocity vials technology, enhancing vial quality, filling-line productivity, and global delivery of injectable treatments. Manufacturing operations are expected to commence in 2025.
• In May 2023, Schott Pharma (Germany) launched prefillable syringes (PFS) designed for deep-cold drugs, capable of storage and transport on dry ice at temperatures down to -100°C. These syringes are made from pharmaceutical-grade polymer.
• In September 2022, Becton, Dickinson and Company (U.S.) launched the next-generation BD Effivax Glass Prefillable Syringe, setting new standards in performance for vaccine PFS. These syringes are developed in collaboration with leading pharmaceutical firms to meet the complex and evolving requirements of vaccine manufacturing.

Fill-finish Manufacturing Market Research Summary

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