Publication Month: Jan 2021 | Report Code: TIPRE00018228 | No. of Pages: 172 | Category: Medical Device | Status: Published
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.
The scope of the fill finish manufacturing market includes the product, end user and region. The market for fill finish manufacturing is analyzed based on regions such as North America, Europe, Asia Pacific, Middle East & Africa, and South and Central America. The report offers insights and in-depth analysis of the fill finish manufacturing market emphasizing on various parameters such as market trends, technological advancements, market dynamics, and competitive landscape analysis of leading market players across the globe.
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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.
The fill finish manufacturing market, based on product, is segmented into consumables and instruments. The consumables segment 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 the instruments segment, rising adoption of prefilled syringes, wide applications of vials in lyophilization, and increasing fill-finish outsourcing.
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The fill finish manufacturing market, based on end user, 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 of 10.1% in the market during the forecast period.
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.
Product launches and other expansion strategies are commonly adopted by companies to expand their footprint worldwide and meet the growing demand. The market players operating in the
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