Fill-finish Pharmaceutical Contract Manufacturing Market Size, Share & Trends Analysis Report By Product Type (Prefilled Syringes, Vials, Cartridges), By Molecule Type, By End-user, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global fill-finish pharmaceutical contract manufacturing market size was valued at USD 8.7 billion in 2022 and is anticipated to grow a compound annual growth rate (CAGR) of 6.0% from 2023 to 2030. The need to reduce overall investment for developing drugs, rising technological advancements in fill-finish manufacturing processes and increasing demand for fill-finish outsourcing are the key factors driving the growth of the market. Pharmaceutical companies are increasingly focusing on their core competencies, such as drug discovery and development, and outsourcing other functions such as fill-finish operations to specialized contract manufacturers. This allows them to focus on what they do best while still ensuring high-quality manufacturing and efficient production.

The traditional process of fill-finish involved the usage of stainless-steel equipment connected through reusable tubing, valves, and piping. However, with the rising importance of product safety, expertise, specialized equipment, and care, much of this work has been outsourced to contract manufacturers. Moreover, biosimilar are increasingly influencing the demand for more fill-finish CMOs. Overall, CMOs reveals a yearly 10% -15% rise in development due to biological drugs, particularly those currently in development for the US market in the coming years. However, there is a positive impact of covid-19 on the market for fill-finish pharmaceutical contract manufacturing.

Recent pandemics and epidemics, such as COVID-19, Ebola, and Lassa fever, have highlighted the critical need for vaccines and therapeutics to combat emerging and re-emerging infectious diseases. As a result, the fill-finish services are urgently needed to handle vaccine production. Since fill-finish operations are typically outsourced to CDMOs/CMOs, these organizations are well-positioned to handle fill-finish of COVID-19 vaccines as they start to hit the market. Catalent is an example of a manufacturing partner and is well to deliver on both scale-up and demand fulfillment. Moreover, in May 2021, Moderna and Samsung Biologics announced a supply and manufacturing services agreement, where Samsung Biologics will offer large-scale, commercial fill-finish manufacturing of Moderna's COVID-19 mRNA-1273 vaccine. The sudden outbreak of the COVID-19 pandemic has resulted in greater demand for the contract fill-finish and manufacturing services of various biologics intended to treat the COVID-19 infection, thus supporting a significant growth across the market, specifically across the year 2021.

Another factor driving the demand for injectable drugs is their efficacy and convenience. Injectable drugs can be absorbed more quickly and effectively than oral medications, and they also offer greater flexibility in dosing and administration. For instance, some injectable drugs can be self-administered by patients using devices such as pre-filled syringes or auto-injectors, which can improve patient compliance and convenience.

Several Fill-Finish innovations involve mechanical engineering, such as pushing machinery to go faster with higher processing capacity. As a result, manufacturers of fill-finish equipment are constantly striving to make their equipment more efficient, credible (lower failure rates), and cost-effective. This frequently involves scaling up (and sometimes scaling down) machinery and operations to meet the needs of specific products. Since CMOs handle the vast majority of biopharma fill-finish, they are among the frontrunners in terms of actively developing, analyzing, and having adopted technologies and equipment that boost productivity while lowering the risk of contamination and process failure.

Product Type Insights

The prefilled syringes segment is expected to witness the fastest CAGR of 6.6% in the market over the forecast period. Prefilled syringes are a well-established technique of drug delivery for both new complex biologic drugs as well as traditional small molecule drugs. It offers convenience to both healthcare providers and patients, as they eliminate the need for manual filling of syringes, reducing the risk of dosing errors and contamination

The vials segment on the other hand is anticipated to hold the highest market of 52.9% across the forecast period. High shares of the segment are majorly due to increasing technological advancements in vial filling equipment. Moreover, it is evident that the majority of biologics and vaccines are filled in vials for extreme safety and to avoid leakage. Thus, the segment has held the highest share across the analysis timeframe. Additionally, several CMOs are focusing on the development of novel vial filling technologies for an efficient and safe fill-finish process. For instance, in February 2022, Recro Pharma, Inc. a CDMO, announced the addition of new lyophilization capabilities to its wide range of contract manufacturing offerings. The company’s fill-finish aseptic suite will feature an automated, sterile, vial filling platform with the capacity of filling 2,000 pre-sterilized vials per hour.

Molecule Type Insights

The large molecules segment dominated the market for fill-finish pharmaceutical contract manufacturing and accounted for the maximum revenue share of 67.2% in 2022. The large-molecule sector is evolving as the next era of therapeutics in biopharma, putting it at the frontline of drug development due to the potential for biologics have potential to treat unmet medical needs. The rising popularity and importance of biologics can be seen in the increasing number of biologics approvals: in 2020, FDA Center for Drug Evaluation and Research approved 53 new molecular entities (NMEs), 13 of which were large molecules (25%). According to Evaluate Vantage, new FDA drug approvals are also expected to generate considerable value in 2021, with ten drugs expected to achieve prospective Broadway status by 2026, five of which are large molecules. Moreover, the fill-finish services are majorly done for biologics or large molecules, which are mostly commercialized in the form of injectables. Hence, the increasing demand for such drug products is simultaneously supporting the demand for its fill-finish services, thus augmenting segmental growth.

The small molecules pharmaceutical industry is expected to witness the fastest CAGR over the forecast period. The increasing number of small molecules being developed across the past decade will strongly support the small molecules-based fill-finish segment’s growth. Moreover, several pharmaceutical companies have a robust pipeline of small molecules-based products that are in their late-stage clinical development phase, thus reflecting a lucrative growth for the segment.

End-user Insights

The biopharmaceutical companies segment dominated the market and accounted for the revenue share of 54.9% in 2022. An increase in the development of drugs and vaccines is the key factor for the growth of the market. There are several challenges during the fill-finish manufacturing such as special processes, and complex mechanical equipment (filling, dispensing, and sealing systems) to address this biopharma companies collaborate with CDMOs/ CMOs that specializes in high-volume injectable fill-finish development and manufacturing. This would drive the growth of the market.

Companies typically consider outsourcing biopharmaceutical fill-and-finish to a CMO to gain access to production capacity or specialized manufacturing capabilities. Pharmaceutical companies with intrinsic fill-and-finish capabilities outsource 40% of their necessities on average. Growing production of small molecule drugs has led to the surge in demand for third-party and contract manufacturing services of small molecules among the pharmaceutical companies as well. Sterile fill-finish is considered among the most vital steps in the pharmaceutical manufacturing process. Moreover, the complex development process of small molecule APIs has further boosted demand for suitable sterile fill-finish processes across the pharmaceutical companies, thus boosting demand for outsourcing services in the pharma industry.

Regional Insights

In the Asia Pacific, the fill-finish pharmaceutical contract manufacturing market is projected to witness a CAGR of 6.3% over the forecast period. The region also accounted for the largest market share of 35.3% in 2022 due to factors such as increasing investment by the companies in clinical research, improving healthcare infrastructure, the larger number of CMOs expanding, and the increasing number of fill-finish facilities being constructed in the region. For instance, In August 2021, Lonza is adding capacity at its biologics manufacturing facility in Guangzhou, China, by installing a new fill-finish line. Moreover, wages and material cost is cheaper in China and India which drives the market. The rapid expansion of the biopharmaceutical industry could be a major factor driving up demand for fill-finish manufacturing in the region.

However, with increasing demand for products to treat COVID-19 infection, biopharmaceutical and pharmaceutical companies in countries such as India and China, which are the largest exporters to western companies, have increased their production of APIs. For instance, in august 2020, Wockhardt Ltd under a deal announced with the U.K. government would supply millions of doses of numerous COVID-19 vaccines, as well as those being formed by AstraZeneca and Oxford University. As part of the deal, the company had also confined fill-and-finish capacity, which is the final production step of putting vaccines into syringes or vials and packaging them.

Key Companies & Market Share Insights

Market players are adopting a variety of strategic activities, such as the signing of a new partnership agreement, collaborations, mergers and acquisitions, and geographic expansion, to strengthen their services and gain a competitive advantage. For instance, In October 2021, Novartis announced a collaboration to broaden its support for the fill and finish of the Pfizer BioNTech covid-19 vaccine, leveraging its manufacturing capability and capacity to address the covid-19 pandemic. BioNTech's Also, in October 2021, Novartis would use its manufacturing expertise to help Pfizer and Covid-19 vaccine fill and finish. According to the agreement, Novartis intends to fill a minimal level of 24 million doses in the next year, utilizing sterile processing facilities at its technical operations plant in Ljubljana, Slovenia. Some of the prominent players in the global fill-finish pharmaceutical contract manufacturing market include:

• Boehringer Ingelheim

• Catalent Inc

• Recro Pharma, Inc.

• Baxter’s BioPharma Solutions

• Eurofins Scientific

• Symbiosis Pharmaceutical Service

• MabPlex International Co. Ltd.

• Recipharm AB

• Fresenius Kabi Contract Manufacturing

• Novartis

Fill-finish Pharmaceutical Contract Manufacturing Market Report Scope

Global Fill-finish Pharmaceutical Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global fill-finish pharmaceutical contract manufacturing market report based on product type, molecule type, end-user, and region:

• Product Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Prefilled Syringes

  • Vials

  • Cartridges

  • Others

• Molecule Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Large Molecules

  • Small Molecules

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical Companies

  • Pharmaceutical Companies

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Norway

    • Denmark

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait