According to our new research study on "Fill Finish Manufacturing Market Size and Forecast (2020-2030), Global and Regional Share, Trends, and Growth Opportunity Analysis," the fill finish manufacturing market size is expected to grow from US$ 8,705.58 million in 2022 and to reach a value of US$ 17,165.41 million by 2030; it is anticipated to record a CAGR of 8.9% from 2022 to 2030. Key factors driving the market growth are the growing adoption of prefilled syringes for parenteral administration and elevating demand for biologics. However, growing competition in the biopharmaceutical contract manufacturing industry hinders the fill finish manufacturing market growth.

Parenteral administration is one of the most prominent routes chosen to stimulate immediate immune response and ensure the complete bioavailability of pharmaceutical products. A steady rise in the development and market availability of parenteral drugs has propelled the demand for advanced, cost-effective drug delivery devices that promise ease of administration. The benefits of prefilled syringes over traditional delivery systems include easy administration, improved safety, accurate dosing, and reduced contamination risks. Among drug delivery devices, prefilled syringes represent one of the fastest-growing primary packaging formats, which are designed for dose administration. In the past ten years, there has been an evident increase in the development of parenteral drugs (especially with the introduction of several classes of biologics), which has resulted in approximately three-fold increase in the consumption of prefilled syringes. The sustained preference for the prefilled syringes is attributed to the safety and ease of use of these products. Recent variants are designed with provisions to reduce errors in dosing, risk of occlusions, leakage of fluids (i.e., extravasation), and inflammation of veins (phlebitis). Owing to the benefits mentioned above, several injectable drugs-Humira, Enbrel, Avastin, PREVNAR 13, ALPROLIX, and Benefix, among others-diluents and other products requiring parenteral administration are packaged in prefilled syringes.

Over the past seven years, ~90 drugs have been approved in the prefilled syringe packaging form across different geographies, including North America, Europe, and Asia Pacific. Several drugs in the clinical stages of drug development are being evaluated in combination with prefilled syringes.

The loading of sterile drugs into prefilled syringes is considered one of the most crucial steps in the pharmaceutical production process. Proper fill-finish operations are necessarily carried out under aseptic conditions to maintain pharmacological efficacy and quality and to ensure the safety of end users. The prefilled syringe filling is a complex operation as it requires extremely close monitoring of both the syringe fill volume and the headspace between the liquid filled in the syringe and the bottom of the plunger. In addition, the rise in complexity of small molecule APIs and the increasing diversity of biological drugs contribute to the demand for advanced aseptic fill finish operations.

Companies, including small enterprises and large businesses, outsource their respective fill finish operations to contract service providers. Per the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, manufacturers of biological have been observed to outsource more than 30% of their fill finish operations. With the rise in the demand for prefilled syringes and the growing complexity of fill finish processes, outsourcing these operations is likely to increase in the future. Over 100 companies across the globe are providing fill finish services for prefilled syringe manufacturers. To cater to the growing demand for pharmaceutical products, service providers are actively investing in expanding their existing infrastructure and capabilities; they have also expanded their clientele through service agreements over the past few years. As injectables account for ~55% of drug candidates in the global R&D pipeline, the businesses of prefilled syringe manufacturers and associated service providers are also growing. Due to the emergence of the COVID-19 crisis, vaccine development initiatives have increased across the globe, which significantly boosted the demand for prefilled syringes. Thus, the rising adoption of prefilled syringes for parenteral administration drives the fill finish manufacturing market.

Based on product, the fill finish manufacturing market is segmented into Consumables and Instruments. The Consumables segment is further bifurcated into prefilled syringes, glass vial/plastic vials, cartridges, and others. The increase in the number of biotechnology firms worldwide, advances in life science research and technology innovations with human genome mapping, and the emergence of proteomics have enabled industry growth, such as high-end research projects that require quality instruments with high throughput capacity are the key factors fueling the segment growth. However, the presence of alternative technologies and the high cost of instruments are a few factors hampering the growth of this segment in the fill finish manufacturing market.

Based on the modality, the fill finish manufacturing market is classified into recombinant proteins, monoclonal antibodies, vaccines, cell therapies and biological therapies, gene therapies, and others. Vaccine fill finish manufacturing is a critical stage in the production process. It involves filling vials with the prepared vaccine and ensuring precise quantities. This step demands stringent quality control to maintain efficacy and safety. Once filled, the vials undergo sealing and packaging. This meticulous process plays a pivotal role in delivering vaccines to the global population, safeguarding public health by meeting quality standards and regulatory requirements.

Furthermore, increasing key development related to vaccine fill finish manufacturing is driving the market growth. For instance, in May 2023, Novocol Pharma-a leading sterile injectable contract development and manufacturing organization (CDMO) in Ontario-and Moderna, Inc.-a biotechnology company that pioneered messenger RNA (mRNA) therapeutics and vaccines-announced a long-term agreement to perform aseptic fill finish, labeling, and packaging of mRNA respiratory vaccines expected to be produced in Canada. The last stage of the production cycle, known as fill-finish sterile manufacturing, entails putting the vaccine medication product into vials and preparing it for use. Furthermore, the arrangement with Novocol Pharma will increase the fill finish capacity of vaccines produced at Moderna's mRNA facility in Laval. Subject to planning and regulatory permissions, the facility is anticipated to open for business by the end of 2024

Based on the end user, the fill finish manufacturing market is classified into contract manufacturing organizations, biopharmaceutical companies, and others. Companies engaged in therapeutics development often address the challenge of product stability and cold-chain management. At commercial scale, many problems can occur that might affect the therapeutic capabilities of the product. These factors are driving the adoption of commercial manufacturing services. Also, many industrial players offer commercial manufacturing services to overcome these issues. For instance, Piramal Pharma Solutions manufactures, supplies, and distributes commercial formulations from its facilities in the UK and India. They offer scalability services for commercial-level manufacturing of a wide range of pharmaceutical products.

IMA Industria Macchine Automatiche SpA, Nipro Medical Europe NV, Maquinaria Industrial Dara SL, Groninger and Co GmbH, SGD SA, Optima Packaging Group Gmbh, NNE AS, Stevanato Group SpA, Syntegon Technology GmbH, West Pharmaceutical Services Inc, Gerresheimer AG, Schott AG, and Becton Dickinson and Co. are among the leading companies operating in the global fill finish manufacturing market.

Companies operating in fill finish manufacturing adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies in the fill finish manufacturing. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall fill finish manufacturing growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.

A few of the significant developments by key market players are listed below.