充填仕上げ製造の市場規模・予測（2020年～2030年）、世界・地域シェア、動向、成長機会分析レポート対象範囲製品別（消耗品（プレフィルドシリンジ、ガラスバイアル/プラスチックバイアル、カートリッジ、その他）、器具）、モダリティ別（組換えタンパク質、モノクローナル抗体、ワクチン、細胞治療・生物学的治療、遺伝子治療、その他）、エンドユーザー別（受託製造機関、バイオ医薬品企業、その他）

Fill Finish Manufacturing Market Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Product [Consumables (Prefilled Syringes, Glass Vials/Plastic Vials, Cartridges, and Others), and Instruments], Modality (Recombinant Proteins, Monoclonal Antibodies, Vaccines, Cell Therapies and Biological Therapies, Gene Therapies, and Others), and End User (Contract Manufacturing Organizations, Biopharmaceutical Companies, and Others)

フィル・フィニッシュ製造市場は、2022年の87億500万米ドルから2030年には171億6,500万米ドルに成長すると予想され、2022年から2030年までの年平均成長率は8.9%を記録すると予測されている。充填／仕上げ」とい... もっと見る

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フィル・フィニッシュ製造市場は、2022年の87億500万米ドルから2030年には171億6,500万米ドルに成長すると予想され、2022年から2030年までの年平均成長率は8.9%を記録すると予測されている。
充填／仕上げ」という用語は、製造工程の最終段階である充填と仕上げを表している。医薬品業界における充填とは、薬剤を容器に入れて閉じることを意味し、仕上げとは、医療用品や容器の滅菌や標準化を意味する。
非経口投与用プレフィルドシリンジの採用拡大が、充填仕上げ製造市場の成長を牽引する。

非経口投与は、即時の免疫反応を刺激し、医薬品の完全なバイオアベイラビリティを確保するために選択される最も顕著な経路の1つである。非経口医薬品の開発と市場での入手可能性の着実な上昇が、投与の容易さを約束する高度で費用対効果の高い薬物送達デバイスへの需要を後押ししている。従来の送達システムに対するプレフィルドシリンジの利点には、容易な投与、安全性の向上、正確な投与、汚染リスクの低減などがある。薬物送達デバイスの中でも、プレフィルドシリンジは最も急速に成長している一次包装形態の一つであり、投与用に設計されている。過去10年間で、非経口薬の開発（特にいくつかの生物製剤クラスの導入）が明らかに増加し、その結果プレフィルドシリンジの消費量が約3倍に増加した。プレフィルドシリンジに対する持続的な嗜好は、これらの製品の安全性と使いやすさに起因している。最近の製品は、投与ミス、閉塞、液漏れ（すなわち血管外漏出）、静脈の炎症（静脈炎）を減らすように設計されている。上記のような利点から、いくつかの注射剤-ヒュミラ、エンブレル、アバスチン、プレブナール13、アルプロリックス、ベネフィクスなど-、希釈剤、および非経口投与を必要とするその他の製品は、プレフィルドシリンジに包装されている。

過去7年間で、北米、欧州、アジア太平洋を含むさまざまな地域で、プレフィルドシリンジ包装の医薬品が90品目承認された。薬剤開発の臨床段階にあるいくつかの薬剤は、プレフィルドシリンジとの組み合わせで評価されている。
プレフィルドシリンジへの無菌薬剤の充填は、医薬品製造プロセスにおいて最も重要なステップのひとつと考えられています。薬理学的有効性と品質を維持し、エンドユーザーの安全性を確保するために、適切な充填-仕上げ作業は必然的に無菌条件下で実施される。プレフィルドシリンジ充填は、シリンジ充填量とシリンジに充填された液体とプランジャー底部との間のヘッドスペースの両方を極めて厳密に監視する必要があるため、複雑な作業となります。加えて、低分子原薬の複雑化と生物学的製剤の多様化が、高度な無菌充填仕上げ作業への需要を高めている。

中小企業や大企業を含む企業は、それぞれの充填仕上げ作業を受託サービス業者に委託している。第10回バイオ医薬品製造能力と生産に関する年次報告書および調査」によると、生物学的製剤メーカーは、充填仕上げ作業の30％以上を外注していることが確認されている。プレフィルドシリンジ需要の増加と充填仕上げ工程の複雑化に伴い、これらの業務のアウトソーシングは今後増加する可能性が高い。世界中で100社以上がプレフィルドシリンジメーカー向けに充填仕上げサービスを提供しています。医薬品需要の拡大に対応するため、サービスプロバイダーは既存のインフラと能力の拡大に積極的に投資しており、過去数年間はサービス契約を通じて顧客層も拡大しています。世界の研究開発パイプラインにある医薬品候補の約55％が注射剤であるため、プレフィルドシリンジメーカーや関連サービスプロバイダーの事業も成長している。COVID-19危機の出現により、ワクチン開発イニシアティブが世界中で増加し、プレフィルドシリンジの需要を大幅に押し上げた。このように、非経口投与用のプレフィルドシリンジの採用が増加していることが、充填仕上げ製造市場を牽引している。

充填仕上げ製造市場は、製品、モダリティ、エンドユーザーに基づいて分割されます。製品に基づき、充填仕上げ製造市場は消耗品と器具に区分される。消耗品セグメントはさらに、プレフィルドシリンジ、ガラスバイアル/プラスチックバイアル、カートリッジ、その他に分けられます。モダリティ別では、充填仕上げ製造市場は組換えタンパク質、モノクローナル抗体、ワクチン、細胞療法および生物学的療法、遺伝子療法、その他に区分される。エンドユーザー別では、充填仕上げ製造市場は受託製造機関、バイオ製薬会社、その他に分類されます。

地域別では、充填仕上げ製造市場は北米、欧州、アジア太平洋、中東・アフリカ、南米・中米に分けられる。北米は、充填仕上げ製造市場の成長に最も大きく寄与しています。カナダはバイオ医薬品産業が最も急速に発展している国のひとつである。様々な国際企業がカナダのバイオ医薬品産業に投資している。カナダでは、バイオ医薬品企業の数が大幅に増加している。例えば、ブリティッシュコロンビア州バンクーバーにはバイオ医薬品企業の大半があり、年間9,030万米ドル（1億2,000万カナダドル）の収益を上げている。国内のバイオ製薬会社は全国に35〜40社ある。カナダのバイオ医薬品企業には、Inex Pharmaceuticals、Quest Vitamins、StressGen Biotechnologies、Stanley Pharmaceuticals、QLT Phototherapeutics、Stemcell Technologiesなどがある。また、分子医学・治療学センター（Center for Molecular Medicine and Therapeutics）、ブリティッシュ・コロンビア大学バイオテクノロジー研究所（BC Biotechnology Laboratory）、BCがん研究センター（BC Cancer Research Center）、カナダHIV試験ネットワーク（Canadian HIV Trials Network）、ワクチン評価センター（Vaccine Evaluation Center）など、さまざまな公的・民間研究機関もある。このように、同国におけるバイオ医薬品産業の発展は、予測期間中の市場成長を後押しするだろう。
アジア太平洋地域は、今後数年間で最も急成長する市場になると予想される。アジア太平洋地域では、中国が充填仕上げ剤製造の最大市場である。同市場の成長は主に、中国における充填仕上げ製造プロセスの技術的進歩の高まり、市場参入企業による開発の増加、バイオ医薬品産業の拡大、慢性疾患の有病率の増加に起因しています。中国には500社以上の生物学的製剤／バイオ医薬品企業がある。研究開発に携わっている企業のほとんどは、海外からの帰国者や欧米の合弁企業によって設立された。見積もりは大きく異なるが、アナリストによれば、中国政府は資金援助イニシアティブを通じて、年間6億米ドル以上をバイオテクノロジー研究開発に費やしている。中国の国や地方政府も、IT企業に投資する準ベンチャー・キャピタル企業に投資している。市場プレーヤーは、有機的・無機的成長戦略を通じて事業を拡大している。例えば、WuXi Biologicsは2022年6月に中国の無錫に医薬品工場を開設し、プレフィルドシリンジ（PFS）の生産能力を年間1,700万ユニットに増やした。受託開発製造機関（CDMO）であるウーシー・バイオが運営する最新のD.P.施設はDP5と呼ばれ、信頼性の高い連続充填サービスのための高度なアイソレーター充填ラインを備えている。同社によると、これによりPFSは1.25mL、3mL、1mL、1mLなど様々な容量送達オプションを提供できる。
ClinicalTrails.com、疾病管理予防センター（CDC）、食品医薬品局（FDA）は、充填仕上げ剤製造市場に関する報告書を作成する際に参照したいくつかの主要な一次および二次情報源である。

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TABLE OF CONTENTS

1. Introduction
1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation
2. Executive Summary
2.1 Key Insights
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Fill Finish Manufacturing Market Landscape
4.1 Overview
4.2 PEST Analysis
5. Fill Finish Manufacturing Market - Key Industry Dynamics
5.1 Fill Finish Manufacturing Market - Key Industry Dynamics
5.2 Key Market Drivers
5.2.1 Growing Adoption of Prefilled Syringes for Parenteral Administration
5.2.2 Elevating Demand for Biologics
5.3 Key Market Restraints
5.3.1 Growing Competition in Biopharmaceutical Contract Manufacturing Industry
5.4 Key Market Opportunities
5.4.1 Low Business Costs in Emerging Markets
5.5 Key Future Trends
5.5.1 Single-Use Systems for Aseptic Fill Finish
5.6 Impact of Drivers and Restraints:
6. Fill Finish Manufacturing Market - Global Market Analysis
7. Fill Finish Manufacturing Market Analysis - Product
7.1 Consumables
7.1.1 Overview
7.1.2 Consumables Market, Revenue and Forecast to 2030 (US$ Million)
7.2 Instruments
7.2.1 Overview
7.2.2 Instruments Market, Revenue and Forecast to 2030 (US$ Million)
8. Fill Finish Manufacturing Market Analysis - Modality
8.1 Recombinant Proteins
8.1.1 Overview
8.1.2 Recombinant Proteins Market, Revenue and Forecast to 2030 (US$ Million)
8.2 Monoclonal Antibodies
8.2.1 Overview
8.2.2 Monoclonal Antibodies Market, Revenue and Forecast to 2030 (US$ Million)
8.3 Vaccines
8.3.1 Overview
8.3.2 Vaccines Market, Revenue and Forecast to 2030 (US$ Million)
8.4 Cell Therapies and Biological Therapies
8.4.1 Overview
8.4.2 Cell Therapies and Biological Therapies Market, Revenue and Forecast to 2030 (US$ Million)
8.5 Gene Therapies
8.5.1 Overview
8.5.2 Gene Therapies Market, Revenue and Forecast to 2030 (US$ Million)
8.6 Others
8.6.1 Overview
8.6.2 Others Market, Revenue and Forecast to 2030 (US$ Million)
9. Fill Finish Manufacturing Market Analysis - End User
9.1 Contract Manufacturing Organizations
9.1.1 Overview
9.1.2 Contract Manufacturing Organizations Market, Revenue and Forecast to 2030 (US$ Million)
9.2 Biopharmaceutical Companies
9.2.1 Overview
9.2.2 Biopharmaceutical Companies Market, Revenue and Forecast to 2030 (US$ Million)
9.3 Others
9.3.1 Overview
9.3.2 Others Market, Revenue and Forecast to 2030 (US$ Million)
10. Fill Finish Manufacturing Market - Geographical Analysis
10.1 Overview
10.2 North America
10.2.1 North America Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.2.1.1 North America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Product
10.2.1.1.1 North America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Consumables
10.2.1.2 North America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Modality
10.2.1.3 North America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By End User
10.2.2 North America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Country
10.2.2.1 US
10.2.2.2 US Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.2.2.2.1 United States Fill Finish Manufacturing Market Breakdown by Product
10.2.2.2.1.1 United States Fill Finish Manufacturing Market Breakdown by Consumables
10.2.2.2.2 United States Fill Finish Manufacturing Market Breakdown by Modality
10.2.2.2.3 United States Fill Finish Manufacturing Market Breakdown by End User
10.2.2.3 Canada
10.2.2.4 Canada Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.2.2.4.1 Canada Fill Finish Manufacturing Market Breakdown by Product
10.2.2.4.1.1 Canada Fill Finish Manufacturing Market Breakdown by Consumables
10.2.2.4.2 Canada Fill Finish Manufacturing Market Breakdown by Modality
10.2.2.4.3 Canada Fill Finish Manufacturing Market Breakdown by End User
10.2.2.5 Mexico
10.2.2.6 Mexico Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.2.2.6.1 Mexico Fill Finish Manufacturing Market Breakdown by Product
10.2.2.6.1.1 Mexico Fill Finish Manufacturing Market Breakdown by Consumables
10.2.2.6.2 Mexico Fill Finish Manufacturing Market Breakdown by Modality
10.2.2.6.3 Mexico Fill Finish Manufacturing Market Breakdown by End User
10.3 Europe
10.3.1 Europe Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.1.1 Europe Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Product
10.3.1.1.1 Europe Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Consumables
10.3.1.2 Europe Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Modality
10.3.2 Europe Fill Finish Manufacturing Market Breakdown by End User
10.3.2.1 Europe Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By End User
10.3.3 Europe Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Country
10.3.3.1 United Kingdom
10.3.3.2 United Kingdom Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.3.2.1 United Kingdom Fill Finish Manufacturing Market Breakdown by Product
10.3.3.2.1.1 United Kingdom Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.2.2 United Kingdom Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.2.3 United Kingdom Fill Finish Manufacturing Market Breakdown by End User
10.3.3.3 Germany
10.3.3.4 Germany Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.3.4.1 Germany Fill Finish Manufacturing Market Breakdown by Product
10.3.3.4.1.1 Germany Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.4.2 Germany Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.4.3 Germany Fill Finish Manufacturing Market Breakdown by End User
10.3.3.5 France
10.3.3.6 France Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.3.6.1 France Fill Finish Manufacturing Market Breakdown by Product
10.3.3.6.1.1 France Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.6.2 France Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.6.3 France Fill Finish Manufacturing Market Breakdown by End User
10.3.3.7 Italy
10.3.3.7.1 Italy Fill Finish Manufacturing Market Breakdown by Product
10.3.3.7.1.1 Italy Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.7.2 Italy Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.7.3 Italy Fill Finish Manufacturing Market Breakdown by End User
10.3.3.8 Spain
10.3.3.9 Spain Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.3.9.1 Spain Fill Finish Manufacturing Market Breakdown by Product
10.3.3.9.1.1 Spain Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.9.2 Spain Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.9.3 Spain Fill Finish Manufacturing Market Breakdown by End User
10.3.3.10 Rest of Europe
10.3.3.11 Rest of Europe Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.3.3.11.1 Rest of Europe Fill Finish Manufacturing Market Breakdown by Product
10.3.3.11.1.1 Rest of Europe Fill Finish Manufacturing Market Breakdown by Consumables
10.3.3.11.2 Rest of Europe Fill Finish Manufacturing Market Breakdown by Modality
10.3.3.11.3 Rest of Europe Fill Finish Manufacturing Market Breakdown by End User
10.4 Asia Pacific
10.4.1 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.1.1 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Product
10.4.1.1.1 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Consumables
10.4.1.2 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Modality
10.4.1.3 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By End User
10.4.2 Asia Pacific Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Country
10.4.2.1 China
10.4.2.2 China Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.2.2.1 China Fill Finish Manufacturing Market Breakdown by Product
10.4.2.2.1.1 China Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.2.2 China Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.2.3 China Fill Finish Manufacturing Market Breakdown by End User
10.4.2.3 Japan
10.4.2.3.1 Japan Fill Finish Manufacturing Market Breakdown by Product
10.4.2.3.1.1 Japan Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.3.2 Japan Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.3.3 Japan Fill Finish Manufacturing Market Breakdown by End User
10.4.2.4 India
10.4.2.5 India Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.2.5.1 India Fill Finish Manufacturing Market Breakdown by Product
10.4.2.5.1.1 India Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.5.2 India Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.5.3 India Fill Finish Manufacturing Market Breakdown by End User
10.4.2.6 Australia
10.4.2.7 Australia Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.2.7.1 Australia Fill Finish Manufacturing Market Breakdown by Product
10.4.2.7.1.1 Australia Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.7.2 Australia Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.7.3 Australia Fill Finish Manufacturing Market Breakdown by End User
10.4.2.8 South Korea
10.4.2.9 South Korea Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.2.9.1 South Korea Fill Finish Manufacturing Market Breakdown by Product
10.4.2.9.1.1 South Korea Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.9.2 South Korea Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.9.3 South Korea Fill Finish Manufacturing Market Breakdown by End User
10.4.2.10 Rest of APAC
10.4.2.11 Rest of APAC Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.4.2.11.1 Rest of APAC Fill Finish Manufacturing Market Breakdown by Product
10.4.2.11.1.1 Rest of APAC Fill Finish Manufacturing Market Breakdown by Consumables
10.4.2.11.2 Rest of APAC Fill Finish Manufacturing Market Breakdown by Modality
10.4.2.11.3 Rest of APAC Fill Finish Manufacturing Market Breakdown by End User
10.5 Middle East and Africa
10.5.1 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.5.1.1 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Product
10.5.1.1.1 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Consumables
10.5.1.2 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Modality
10.5.1.3 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By End User
10.5.2 Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Country
10.5.2.1 South Africa
10.5.2.2 South Africa Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.5.2.2.1 South Africa Fill Finish Manufacturing Market Breakdown by Product
10.5.2.2.1.1 South Africa Fill Finish Manufacturing Market Breakdown by Consumables
10.5.2.2.2 South Africa Fill Finish Manufacturing Market Breakdown by Modality
10.5.2.2.3 South Africa Fill Finish Manufacturing Market Breakdown by End User
10.5.2.3 Saudi Arabia
10.5.2.4 Saudi Arabia Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.5.2.4.1 Saudi Arabia Fill Finish Manufacturing Market Breakdown by Product
10.5.2.4.1.1 Saudi Arabia Fill Finish Manufacturing Market Breakdown by Consumables
10.5.2.4.2 Saudi Arabia Fill Finish Manufacturing Market Breakdown by Modality
10.5.2.4.3 Saudi Arabia Fill Finish Manufacturing Market Breakdown by End User
10.5.2.5 United Arab Emirates
10.5.2.6 United Arab Emirates Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.5.2.6.1 United Arab Emirates Fill Finish Manufacturing Market Breakdown by Product
10.5.2.6.1.1 United Arab Emirates Fill Finish Manufacturing Market Breakdown by Consumables
10.5.2.6.2 United Arab Emirates Fill Finish Manufacturing Market Breakdown by Modality
10.5.2.6.3 United Arab Emirates Fill Finish Manufacturing Market Breakdown by End User
10.5.2.7 Rest of Middle East and Africa
10.5.2.8 Rest of Middle East and Africa Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.5.2.8.1 Rest of Middle East and Africa Fill Finish Manufacturing Market Breakdown by Product
10.5.2.8.1.1 Rest of Middle East and Africa Fill Finish Manufacturing Market Breakdown by Consumables
10.5.2.8.2 Rest of Middle East and Africa Fill Finish Manufacturing Market Breakdown by Modality
10.5.2.8.3 Rest of Middle East and Africa Fill Finish Manufacturing Market Breakdown by End User
10.6 South and Central America
10.6.1 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.6.1.1 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Product
10.6.1.1.1 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Consumables
10.6.1.2 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Modality
10.6.1.3 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By End User
10.6.2 South and Central America Fill Finish Manufacturing Market Revenue and Forecasts and Analysis - By Country
10.6.2.1 Brazil
10.6.2.2 Brazil Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.6.2.2.1 Brazil Fill Finish Manufacturing Market Breakdown by Product
10.6.2.2.1.1 Brazil Fill Finish Manufacturing Market Breakdown by Consumables
10.6.2.2.2 Brazil Fill Finish Manufacturing Market Breakdown by Modality
10.6.2.2.3 Brazil Fill Finish Manufacturing Market Breakdown by End User
10.6.2.3 Argentina
10.6.2.4 Argentina Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.6.2.4.1 Argentina Fill Finish Manufacturing Market Breakdown by Product
10.6.2.4.1.1 Argentina Fill Finish Manufacturing Market Breakdown by Consumables
10.6.2.4.2 Argentina Fill Finish Manufacturing Market Breakdown by Modality
10.6.2.4.3 Argentina Fill Finish Manufacturing Market Breakdown by End User
10.6.2.5 Rest of South and Central America
10.6.2.6 Rest of South and Central America Fill Finish Manufacturing Market Revenue and Forecasts to 2030 (US$ Mn)
10.6.2.6.1 Rest of South and Central America Fill Finish Manufacturing Market Breakdown by Product
10.6.2.6.1.1 Rest of South and Central America Fill Finish Manufacturing Market Breakdown by Consumables
10.6.2.6.2 Rest of South and Central America Fill Finish Manufacturing Market Breakdown by Modality
10.6.2.6.3 Rest of South and Central America Fill Finish Manufacturing Market Breakdown by End User
11. Fill Finish Manufacturing Market – Impact of COVID-19 Pandemic
11.1 Pre & Post Covid-19 Impact
12. Industry Landscape
12.1 Overview
12.2 Growth Strategies in The Fill Finish Manufacturing Market, 2020-2023
12.3 Inorganic Growth Strategies
12.3.1 Overview
12.4 Organic Growth Strategies
12.4.1 Overview
13. Company Profiles
13.1 IMA Industria Macchine Automatiche SpA
13.1.1 Key Facts
13.1.2 Business Description
13.1.3 Products and Services
13.1.4 Financial Overview
13.1.5 SWOT Analysis
13.1.6 Key Developments
13.2 Nipro Medical Europe NV
13.2.1 Key Facts
13.2.2 Business Description
13.2.3 Products and Services
13.2.4 Key Developments
13.2.5 Financial Overview
13.2.6 SWOT Analysis
13.2.7 Key Developments
13.3 Maquinaria Industrial Dara SL
13.3.1 Key Facts
13.3.2 Business Description
13.3.3 Products and Services
13.3.4 Financial Overview
13.3.5 SWOT Analysis
13.3.6 Key Developments
13.4 Groninger and Co GmbH
13.4.1 Key Facts
13.4.2 Business Description
13.4.3 Products and Services
13.4.4 Financial Overview
13.4.5 SWOT Analysis
13.4.6 Key Developments
13.5 SGD SA
13.5.1 Key Facts
13.5.2 Business Description
13.5.3 Products and Services
13.5.4 Financial Overview
13.5.5 SWOT Analysis
13.5.6 Key Developments
13.6 Optima Packaging Group Gmbh
13.6.1 Key Facts
13.6.2 Business Description
13.6.3 Products and Services
13.6.4 Financial Overview
13.6.5 SWOT Analysis
13.6.6 Key Developments
13.7 NNE AS
13.7.1 Key Facts
13.7.2 Business Description
13.7.3 Product & Services
13.7.4 Financial Overview
13.7.5 SWOT Analysis
13.7.6 Key Developments
13.8 Stevanato Group SpA
13.8.1 Key Facts
13.8.2 Business Description
13.8.3 Products and Services
13.8.4 Financial Overview
13.8.5 SWOT Analysis
13.8.6 Key Developments
13.9 Syntegon Technology GmbH
13.9.1 Key Facts
13.9.2 Business Description
13.9.3 Products and Services
13.9.4 Financial Overview
13.9.5 SWOT Analysis
13.9.6 Key Developments
13.10 West Pharmaceutical Services Inc
13.10.1 Key Facts
13.10.2 Business Description
13.10.3 Products and Services
13.10.4 Financial Overview
13.10.5 SWOT Analysis
13.10.6 Key Developments
13.11 Gerresheimer AG
13.11.1 Key Facts
13.11.2 Business Description
13.11.3 Products and Services
13.11.4 Financial Overview
13.11.5 SWOT Analysis
13.11.6 Key Developments
13.12 Schott AG
13.12.1 Key Facts
13.12.2 Business Description
13.12.3 Products and Services
13.12.4 Financial Overview
13.12.5 SWOT Analysis
13.12.6 Key Developments
13.13 Becton Dickinson and Co
13.13.1 Key Facts
13.13.2 Business Description
13.13.3 Products and Services
13.13.4 Financial Overview
13.13.5 SWOT Analysis
13.13.6 Key Developments
14. Appendix
14.1 About Us
14.2 Glossary of Terms

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Table of Contents

Summary

The fill-finish manufacturing market is expected to grow from US$ 8.705 billion in 2022 to US$ 17.165 billion by 2030; it is anticipated to record a CAGR of 8.9% from 2022 to 2030.
The term "fill/finish" describes the final steps of the manufacturing process, which are filling and finishing. Filling in the pharmaceutical industry means putting medication into a container and closing it, whereas finishing refers to sterilizing and standardizing medical supplies and containers.
Growing Adoption of Prefilled Syringes for Parenteral Administration drives the growth of the 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 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.

The fill finish manufacturing market is divided on the basis of product, modality, and end user. Based on product, the fill finish manufacturing market is segmented into consumables and instruments. The consumables segment is further divided into prefilled syringes, glass vials/plastic vials, cartridges, and others. By modality, the fill finish manufacturing market is segmented into recombinant proteins, monoclonal antibodies, vaccines, cell therapies and biological therapies, gene therapies, and others. In terms of end users, the fill finish manufacturing market is classified as contract manufacturing organizations, biopharmaceutical companies, and others.

Based on geography, the fill finish manufacturing market is divided into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. North America is the most significant contributor to the growth of the fill finish manufacturing market. Canada is among the fastest-developing countries in terms of the biopharmaceutical industry. Various international companies are investing in the Canadian biopharmaceutical industry. In Canada, the number of biopharmaceutical companies is rising significantly. For instance, Vancouver, British Columbia, has the majority of biopharmaceutical companies, which generate US$ 90.3 million (CAD 120 million) revenue annually. There are ~35–40 domestic biopharmaceutical companies across the country. A few of the Canadian biopharmaceutical companies include Inex Pharmaceuticals, Quest Vitamins, StressGen Biotechnologies, Stanley Pharmaceuticals, QLT Phototherapeutics, and Stemcell Technologies. Various public and private research organizations include the Center for Molecular Medicine and Therapeutics, the Biotechnology Laboratory at the University of British Columbia, the BC Cancer Research Center, the Canadian HIV Trials Network, and the Vaccine Evaluation Center. Thus, the development of the biopharmaceutical industry in the country will bolster the market growth during the forecast period
Asia Pacific is expected to be the fastest-growing market in the coming years. In Asia Pacific, China is the largest market for fill finish manufacturing. The growth of the market is primarily attributed to the rising technological advancements in fill finish manufacturing processes in China, increasing developments by the market players, the biopharmaceutical industry’s expansion, and the growing prevalence of chronic diseases. There are more than 500 biological product/biopharmaceutical companies in China. Most of those involved in R&D were established by returnees from abroad or by Western/joint venture companies. Although estimates vary widely, analysts believe that the Chinese government spends more than US$ 600 million annually on biotech R&D through its funding initiatives. China’s national and local governments also invest in quasi-venture capital companies that invest in IT enterprises. The market players are expanding their business through organic and inorganic growth strategies. For instance, WuXi Biologics increased the capacity of prefilled syringes (PFS) to 17 million units yearly in June 2022 by opening its drug product factory in Wuxi, China. The most recent D.P. facility operated by WuXi Bio, a contract development manufacturing organization (CDMO), is called DP5, and it has an advanced isolator filling line for reliable, continuous filling services. According to the company, this provides PFS with a variety of volume delivery options, including 1.25 mL, 3 mL, 1 mL, and 1 mL.
ClinicalTrails.com, Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) are a few key primary and secondary sources referred to while preparing the report on the fill finish manufacturing market.

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