市場調查報告書
商品編碼
1533039
北美填充飾面製造市場預測至 2030 年 - 區域分析 - 按產品、方式和最終用戶North America Fill Finish Manufacturing Market Forecast to 2030 - Regional Analysis - by Product, Modality, and End User |
2022年北美填充飾面製造市值為34.3958億美元,預計2030年將達到65.0556億美元;預計2022年至2030年複合年成長率為8.3%。
擴大採用預充式注射,推動了北美填充劑製造市場的發展
腸胃外給藥是刺激即時免疫反應並確保藥品完全生物利用度的最重要途徑之一。腸外藥物的開發和市場供應的穩定成長推動了對先進、經濟高效且易於給藥的藥物輸送設備的需求。與傳統輸送系統相比,預充式注射器的優點包括易於管理、提高安全性、準確劑量和降低污染風險。在藥物傳輸裝置中,預充式注射器是成長最快的初級包裝形式之一,其設計用於劑量管理。在過去的十年中,腸外藥物的開發顯著增加(特別是隨著幾類生物製劑的引入),這導致預充式注射器的消耗量增加了約三倍。人們對預充式注射器的持續偏好歸因於這些產品的安全性和易用性。最近的變異體設計有減少劑量錯誤、閉塞風險、液體滲漏(即外滲)和靜脈發炎(靜脈炎)的規定。由於上述優點,幾種注射藥物(Humira、Enbrel、Avastin、PREVNAR 13、ALPROLIX 和 Benefix 等)稀釋劑和其他需要腸胃外給藥的產品被包裝在預充式注射器中。
在過去的七年裡,約 90 種藥物以預充式注射器包裝形式在不同地區獲得批准,包括北美、歐洲和亞太地區。幾種處於藥物開發臨床階段的藥物正在與預充式注射器結合進行評估。
將無菌藥物裝入預充式注射器被認為是藥品生產過程中最關鍵的步驟之一。適當的填充-完成操作必須在無菌條件下進行,以保持藥理學功效和品質並確保最終用戶的安全。預充式注射器填充是一項複雜的操作,因為它需要極其密切地監控注射器填充體積以及注射器中填充的液體與柱塞底部之間的頂部空間。此外,小分子原料藥複雜性的增加和生物藥物多樣性的增加增加了對先進無菌填充操作的需求。
公司,包括小型企業和大型企業,將各自的填充加工業務外包給合約服務提供者。根據第十次生物製藥產能和生產年度報告和調查,生物製藥製造商將超過 30% 的填充作業外包。隨著預充式注射器需求的增加以及填充完成製程的日益複雜,未來這些業務的外包可能會增加。全球有 100 多家公司正在為預灌封注射器製造商提供填充服務。為了滿足不斷成長的藥品需求,服務提供者正在積極投資擴大其現有的基礎設施和能力;過去幾年,他們也透過服務協議擴大了客戶群。由於注射劑佔全球研發管線中候選藥物的約55%,預充式注射器製造商和相關服務提供者的業務也在成長。由於COVID-19危機的出現,全球範圍內的疫苗開發措施有所增加,這大大增加了對預充式注射器的需求。因此,擴大採用預充式注射器進行腸外給藥,推動了填充劑製造市場的發展。
北美填充飾面製造市場概覽
美國的填充飾面製造市場預計將成為世界上最大且成長最快的市場。廣泛的研發活動以及創新生物製藥和醫藥產品的先進製造等多種因素導致了市場的成長。市場成長的另一個主導因素是全球生物製藥和醫藥產品的持續多樣性和大規模供應。
生物製藥業是該國最大的創收行業之一。 2023年,它為美國創造了超過130萬個就業機會。因此,生物製藥產業的成長極大地有助於維持該國的總體經濟平衡。它每年產生約 5.5 億美元的收入。因此,預計研究和產品開發的增加將增加美國對冷凍乾燥服務的需求。
北美填充飾面製造市場收入及 2030 年預測(百萬美元)
北美填充飾面製造市場細分
北美填充表面製造市場根據產品、模式、最終用戶和國家進行細分。根據產品,北美灌裝製造市場分為消耗品和儀器。到2022年,消耗品細分市場將佔據更大的市場佔有率。
就形式而言,北美填充劑製造市場分為重組蛋白、單株抗體、疫苗、細胞療法和生物療法、基因療法等。 2022 年,疫苗領域佔據最大的市場。
依最終用戶分類,北美填充劑製造市場分為合約製造組織、生物製藥公司等。 2022 年,合約製造組織細分市場佔據最大的市場佔有率。
根據國家/地區,北美填充飾面製造市場分為美國、加拿大和墨西哥。 2022 年,美國將主導北美填充飾面製造市場。
Becton Dickinson and Co、Gerresheimer AG、Groninger and Co GmbH、IMA Industria Macchine Automatiche SpA、Maquinaria Industrial Dara SL、Nipro Medical Europe NV、NNE AS、Optima Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SGD SA、Stevanato Technology SpA、Sma Packaging Group Gmbh、Schott AG、SG , 和West Pharmaceutical Services Inc 是北美填充劑製造市場的一些領先參與者。
The North America fill finish manufacturing market was valued at US$ 3,439.58 million in 2022 and is expected to reach US$ 6,505.56 million by 2030; it is estimated to grow at a CAGR of 8.3% from 2022 to 2030 .
Growing Adoption of Prefilled Syringes for Parenteral Administration Fuels North America Fill Finish Manufacturing Market
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 of 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.
North America Fill Finish Manufacturing Market Overview
The fill finish manufacturing market in the US is anticipated to be the largest and fastest-growing market in the world. Several factors such as extensive research and development activities and advanced manufacturing of innovative biopharmaceutical and pharmaceutical products lead to the growth of the market. The other leading factor for market growth is sustained diversity and large-scale supply of biopharmaceutical and pharmaceutical products across the globe.
The biopharmaceutical industry is among the largest revenue-generating sector in the country. In 2023, it generated more than 1.3 million jobs in the US. Thus, the growth in the biopharmaceutical industry has assisted in maintaining the total economic balance in the country substantially. It generates ~US$ 550 million in revenue annually. Therefore, it is expected that the rise in research and product development will increase the demand for lyophilization services in the US.
North America Fill Finish Manufacturing Market Revenue and Forecast to 2030 (US$ Million)
North America Fill Finish Manufacturing Market Segmentation
The North America fill finish manufacturing market is segmented based on product, modality, end user, and country. Based on product, the North America fill finish manufacturing market is bifurcated into consumables and instruments. The consumables segment held a larger market share in 2022. Furthermore, the consumables is sub segmented into prefilled syringes, glass vial/plastic vials, cartridges, and others.
In terms of modality, the North America fill finish manufacturing market is segmented into recombinant proteins, monoclonal antibodies, vaccines, cell therapies and biological therapies, gene therapies, and others. The vaccines segment held the largest market share in 2022.
By end user, the North America fill finish manufacturing market is segmented into contract manufacturing organizations, biopharmaceutical companies, and others. The contract manufacturing organizations segment held the largest market share in 2022.
Based on country, the North America fill finish manufacturing market is segmented into the US, Canada, and Mexico. The US dominated the North America fill finish manufacturing market share in 2022.
Becton Dickinson and Co, Gerresheimer AG, Groninger and Co GmbH, IMA Industria Macchine Automatiche SpA, Maquinaria Industrial Dara SL, Nipro Medical Europe NV, NNE AS, Optima Packaging Group Gmbh, Schott AG, SGD SA, Stevanato Group SpA, Syntegon Technology GmbH, and West Pharmaceutical Services Inc are some of the leading players operating in the North America fill finish manufacturing market.