The growth of the market is attributed to rising adoption of prefilled syringes for parenteral administration, and elevating demand for biologics.
According to our new research study on “Fill Finish Manufacturing Market to 2027 – Global Analysis and Forecast – by Product and End User,” the fill finish manufacturing market was valued at US$ 6,129.03 million in 2019 and is projected to reach US$ 12,547.23 million by 2027; it is expected to grow at a CAGR of 9.6% during 2020–2027. The growth of the market is attributed to rising adoption of prefilled syringes for parenteral administration, and elevating demand for biologics. However, the growing competition in biopharmaceutical contract manufacturing industry hinders the growth of the market.
Fill-finish is the final manufacturing step (and perhaps the most critical) in the overall drug manufacturing process. It comes after upstream bioprocessing and also takes place after downstream purification. Fill finish manufacturing involves aseptically filling of biological drugs or medicines in any form, such as sterile liquid, powder, and suspension, in vials, ampoules, bottles syringes, and cartridges.
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Fill Finish Manufacturing Market Competitive Landscape and Key Development
Becton, Dickson and Company, West Pharmaceutical Services, Gerresheimer AG, Robert Bosch GmbH, IMA Industria Macchine Automatiche S.p.A., OPTIMA, Bausch+Strobel, Groninger and Co. GmbH, Maquinaria Industrial Dara, NIPRO MEDICAL CORPORATION, SCHOTT AG, SGD Pharma, and Stevanato Group are among the key companies operating in the global fill finish manufacturing market. Leading players are focusing on the expansion and diversification of their market presence, and acquisition of new customer base, thus tapping prevailing business opportunities.
Rising Adoption of Prefilled Syringes for Parenteral Administration Fuels Fill Finish Manufacturing Market Growth
Parenteral administration is one of the most prominent routes chosen to stimulate immediate immune response and ensure 100% 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. Prefilled syringes segment is a rapidly growing segment of the fill-finish manufacturing market. The benefits of prefilled syringes over traditional delivery systems include easy administration, improved safety, accurate dosing, and reduced contamination risks, among others. Among drug delivery devices, prefilled syringes represent one of the fastest-growing primary packaging formats, which are also designed for dose administration. In the past 10 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 pre-filled syringes can be attributed to safety and easy-of-use of these products. Current 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 form across different regions, including North America, Europe, and Asia Pacific. Several drugs in clinical stages of drug development are being evaluated in combination with prefilled syringes.
The filling 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 syringe filling is a complex operation as it requires close monitoring of both the syringe fill volume as well as the headspace between liquid in the syringe and bottom of the plunger. Additionally, the rise in complexity of small molecule active pharmaceutical ingredient (APIs) and the increasing diversity of biologic drugs also contribute to the demand for advanced aseptic fill finish operations.
Companies, including small enterprises and large businesses, outsource their fill finish operations to contract service providers. According to the 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, manufacturers of biologicals have been observed to outsource more than 30% of their fill finish operations. With the increase in the demand for prefilled syringes and the growing complexity of fill finish processes, outsourcing these operations is likely to increase further in the future. Currently, more than 100 companies in the world are providing fill finish services for prefilled syringe manufacturers. To cope with the current and future market demand, service providers are actively investing in expanding their existing infrastructure and capabilities; they are also expanding their clientele through service agreements since 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 projected to grow in the coming years. Due to the recent COVID-19 pandemic, vaccine development initiatives have increased across the world. This is expected to significantly raise the demand for prefilled syringes, providing an additional motivation to the overall fill finish manufacturing market.
Fill Finish Manufacturing Market: Segmental Overview
In terms of product, the consumables segment is anticipated to register a higher CAGR in the fill finish manufacturing market during the forecast period. The greater sales of consumables is mainly attributed to higher replacement rate than instruments as the former has short shelf life and are required in large quantities. The consumables segment accounted for more than 58.66% share in the fill finish manufacturing market in 2019. In terms of end user, the market for the contract manufacturing organizations segment is expected to grow at the fastest CAGR during the forecast period.
In December 2020, BD invested US$ 1.2 billion in its pre-fillable syringe manufacturing capacity to fund capacity expansion, new product innovations, and manufacturing technology enhancements. As a result, the company’s new manufacturing facility in Europe is expected to be operational by the end of 2023.
In February 2019, West Pharmaceutical and Scission AG entered into a partnership for the development of integrated solution for clinical filling of SmartDose drug delivery platform cartridges. Swissfillon AG is a provider of aseptic fill and finish services; through this partnership, it is expected to offer fill-finish capabilities to customers using West’s SmartDose drug delivery platform for complex molecules.
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