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% from 2020 to 2027. The growth of the fill finish manufacturing market is mainly attributed to factors such as rising adoption of prefilled syringes for parenteral administration and elevated demand for biologics. However, the market is negatively impacted by the growing competition in biopharmaceutical contract manufacturing industry.
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. 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.
The prefilled syringes segment is witnessing a significant growth in 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 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. Biologics constitute a majority of the top-selling drugs, and they presently represent one of the fastest-growing pharmaceutical industry segments.Since the launch of recombinant protein-based therapies, ~30 years back, the overall biologics market has grown at an annual rate of more than 12%.
Fill finish is the final step in the production process, and it is one of the most crucial stages of drug manufacturing.Biologics require special procedures and equipment for fill finish operations to ensure product integrity and safety.
Thus, the rise in demand for biologics has resulted in an equivalent need for flexible aseptic fill finish technologies. COVID-19 pandemic has become the most significant challenge across the world.However, the pandemic has brought several growth opportunities to the pharmaceutical and biopharmaceutical companies to strengthen their R&D for vaccine formulation against the coronavirus.
Moderna, Inc. and Catalent, Inc. announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington. On December 9, 2020, CureVac N.V, a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Fareva announced an agreement regarding the fill & finish manufacturing of CureVac´s COVID-19 vaccine candidate, CVnCoV, at Fareva’s Pau and Val-de-Reuil-sites in France. Wockhardt Ltd has entered into an agreement with the UK government to fill and finish COVID-19 vaccine vials at its subsidiary CP Pharmaceuticals’ facility based in Wrexham, North Wales. Thus, such collaborations are expected to show a positive impact on the fill-finish manufacturing market in the coming few years. The fill finish manufacturing market, based on product, is segmented into consumables and instruments.The consumables is further segmented into prefilled syringes, vials, cartridges, and other consumables.
In 2019, the consumables segment accounted for a larger share of the market and is expected to register a higher CAGR during the forecast period. Growth of this segment is attributed to high replacement rate compared with that of instruments, rising adoption of prefilled syringes, wide applications of vials in lyophilization, and increasing fill-finish outsourcing. Based on end user, the fill finish manufacturing market is segmented into contract manufacturing organizations, biopharmaceutical companies, and other end users. The contract manufacturing organizations segment held the largest share of the market in 2019 and is anticipated to register the highest CAGR in the market during the forecast period. The Centers for Disease Control and Prevention, European Federation of Pharmaceutical Industry Associations, National Health Service, The Food and Drug Administration, World Health Organization, Good Manufacturing Practices, and Korea Biomedicine Industry Association are among the major primary and secondary sources referred to while preparing this report.
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