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1771299

脂質CMO市場:業界動向と世界の予測 - 脂質タイプ別、企業規模別、事業規模別、主要地域別

Lipid CMO Market: Industry Trends and Global Forecasts - Distribution by Type of Lipid, Company Size, Scale Of Operation and Key Geographical Regions


出版日
ページ情報
英文 230 Pages
納期
即日から翌営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=148.47円
脂質CMO市場:業界動向と世界の予測 - 脂質タイプ別、企業規模別、事業規模別、主要地域別
出版日: 2025年07月15日
発行: Roots Analysis
ページ情報: 英文 230 Pages
納期: 即日から翌営業日
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  • 概要
  • 図表
  • 目次
概要

世界の脂質CMO市場:概要

世界の脂質CMOの市場規模は、今年24億米ドルとなりました。同市場は、予測期間中に10.8%のCAGRで拡大すると予測されています。

市場セグメンテーションでは、市場規模と機会分析を以下のパラメータで区分しています。

脂質タイプ

  • リポソーム/脂質ナノ粒子
  • リン脂質
  • ペギル化脂質
  • イオン化可能脂質(カチオン性/アニオン性脂質)
  • トリグリセリド
  • スフィンゴ脂質
  • 中性脂質
  • その他

企業規模

  • 小規模
  • 中規模
  • 大手/超大手

事業規模

  • 前臨床
  • 臨床試験
  • 商業

主要地域

  • 北米
  • 欧州
  • アジア太平洋
  • 中東・北アフリカ
  • ラテンアメリカ
  • その他の地域

世界の脂質CMO市場:成長と動向

現在、開発段階にある医薬品候補の約90%、承認された医薬品の40%近くが、溶解性と浸透性に関する課題に直面しています。その結果、現代の規制基準の下では、多くの有望な治療薬がバイオアベイラビリティの低さのために臨床試験を通過できず、市場に到達できないでいます。このような問題に対処するため、バイオ医薬品業界の革新者たちは、医薬化合物の物理化学的特性と全体的な薬物様挙動を向上させる様々な戦略を考案してきました。これらのアプローチの中でも、生体膜を通過する透過性を向上させる脂質ナノ粒子やその他の脂質ベースの賦形剤は、医薬品開発者の大きな関心を集めています。実際、新規mRNAベースのCOVID-19ワクチンは、脂質ナノ粒子を利用して、ヒト体内の標的抗原提示細胞に有効成分を効果的に送達しました。

Lipid CMO Market-IMG1

さらに、多くの企業が脂質ベースのソリューションを活用して既存の医薬品候補を再製剤化し、バイオアベイラビリティを高めており、脂質医薬品キャリアと賦形剤の需要を大きく伸ばしています。しかし、特定の医療用脂質、特にリポソームや脂質ナノ粒子製剤に使用される脂質の製造は、依然として非常に複雑で、資本集約的であり、課題も多いです。そのため、脂質の製造を専門業者に委託する製薬会社が増えています。医療グレードの脂質について製造受託機関(CMO)と提携することで、先端技術へのアクセス、生産能力の拡大、業務の柔軟性向上など、いくつかの利点が得られます。さらに、高品質な脂質に対する需要の高まりが、予測期間中の特殊な受託製造セクターの市場成長を大きく促進すると予想されます。

世界の脂質CMO市場:主要インサイト

当レポートでは、世界の脂質CMO市場の現状を掘り下げ、業界内の潜在的な成長機会を特定しています。当レポートの主な調査結果は以下の通りです。

  • 現在、世界中で約60の企業が、治療開発用脂質やその他の関連製品の開発・製造を支援する受託製造サービスを提供していると主張しています。
  • この業界に従事するCMOの中には、さまざまなタイプの脂質ベースの製品に対応する幅広いサービスを提供するために必要な能力を備えているところもあり、多くのCMOはあらゆる規模に対応できる能力を有しています。
  • 脂質ベースのDDSの受託製造サービスを提供している企業の35%近くが、商業規模でリポソーム/LNPを製造するために必要な能力と専門知識を有していると主張しています。
Lipid CMO Market-IMG2
  • 2010年以降に設立された利害関係者の40%近くは、臨床スケールと商業スケールの両方で製造受託サービスを提供する能力を有しており、これらの参入企業の約60%は米国に拠点を置いています。
  • リポソーム/LNPを提供する超大手企業の代表例としては、AMRI、CordenPharma、Evonik、Fresenius Kabi、Fujifilm、Merck、TTY Biopharmなどが挙げられます(アルファベット順)。
  • サプライチェーン・コンピテンシーを獲得し、スポンサーの進化するニーズに対応するため、脂質CMO会社は主要な地域でプレゼンスを確立しています。
  • 競争上の優位性を追求するため、各社は既存のサービス・ポートフォリオや提携製品を増強するため、労力と資本の両面で投資を行っているか、その意向を示しています。
  • 最近、この業界では提携活動が急増していますが、その大半は、その他の企業の独自能力を獲得する目的で締結されたものです。
  • 脂質CMO業界では、mRNAベースのCOVID-19ワクチン候補の生産に向けた脂質ナノ粒子の需要が世界的に急増したため、取引件数が急増しました。
  • 締結されたパートナーシップの50%近くが製造契約でした。さらに、これらの契約の約65%は、脂質ベースのドラッグデリバリーシステムまたは賦形剤の製造のために締結されました。
  • 提携の75%近くは北米が中心となっています。北米を拠点とする企業と契約を結んだ例としては、ABITEC、AMRI、Catalent、Precision NanoSystemsなどがあります。
  • 脂質に対する需要の高まりに対応するため、CMO/CDMOはここ数年、数多くの事業拡大に取り組んでおり、米国を拠点とする施設がその最多を占めています。
  • 脂質をベースとした製剤は、ここ数年、医薬品のバイオアベイラビリティを向上させるための一般的なアプローチとして台頭してきており、55社近くがこの目的のために様々な脂質関連技術を開発しています。
  • この市場の供給サイドは、主に中規模から大規模のCMOが牽引しています。興味深いことに、現在利用可能な生産能力の65%近くが北米の生産工場に設置されています。
Lipid CMO Market-IMG3
  • 中長期的には、脂質ベースの製剤開発企業がCMO/CDMOへの製造業務のアウトソーシングを継続し、それ別このサービス市場がCAGR 10.8%以上で成長すると予想されます。

脂質CMO市場の参入企業例

  • Avanti Polar Lipids
  • Creative Biolabs
  • Exelead
  • FormuMax Scientific
  • T&T Scientific
  • Ardena
  • Corden Pharma
  • Evonik
  • Fresenius Kabi
  • Merck KGaA
  • Fujifilm
  • Nagase Medicals
  • Nippon Fine Chemical
  • TTY Biopharm
  • VCARE Bio Labs

当レポートでは、世界の脂質CMO市場について調査し、市場の概要とともに、脂質タイプ別、企業規模別、事業規模別動向、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 序文

第2章 エグゼクティブサマリー

第3章 イントロダクション

  • 章の概要
  • 脂質イントロダクション
  • 医薬品業界における脂質の応用
  • 脂質製造に伴う課題
  • 脂質製造のアウトソーシングの必要性
  • 結論

第4章 競合情勢

  • 章の概要
  • 脂質CMO業者:市場情勢

第5章 企業競争力分析

  • 章の概要
  • 前提と主要なパラメータ
  • 調査手法
  • 脂質CMO業者:企業競争力分析

第6章 企業プロファイル:北米の脂質CMO業者

  • 章の概要
  • Avanti Polar Lipids
  • Creative Biolabs
  • Exelead
  • FormuMax Scientific
  • T&T Scientific

第7章 企業プロファイル:欧州の脂質CMO業者

  • 章の概要
  • Ardena
  • CordenPharma
  • Evonik
  • Fresenius Kabi
  • Merck KGaA

第8章 企業プロファイル:アジア太平洋の脂質CMO業者

  • 章の概要
  • Fujifilm
  • Nagase Medicals
  • Nippon Fine Chemical
  • TTY Biopharm
  • VCARE Bio Labs

第9章 パートナーシップとコラボレーション

  • 章の概要
  • パートナーシップモデル
  • 脂質CMO市場:パートナーシップとコラボレーション

第10章 最近の拡張

第11章 容量分析

  • 章の概要
  • 主要な前提と調査手法
  • 脂質受託製造:世界全体の設備容量(100万リットル)
  • 結論

第12章 製造か購入かの意思意思決定の枠組み

  • 章の概要
  • 仮定とパラメータ定義
  • 脂質の受託製造:製造か購入かの意思決定
  • 結論

第13章 市場予測と機会分析

  • 章の概要
  • 予測調査手法と主要な前提条件
  • 2035年までの世界の脂質CMO市場
  • 脂質CMO市場(2035年まで):脂質タイプ別
  • 脂質CMO市場(2035年まで):企業規模別
  • 脂質CMO市場(2035年まで):事業規模別
  • 脂質CMO市場(2035年まで):地域別

第14章 ケーススタディ:脂質と脂質製剤技術の応用

  • 章の概要
  • バイオ医薬品分類システム
  • ドラッグデリバリーシステムとしての脂質ベースの製剤
  • 脂質ベースの製剤技術開発者

第15章 結論

第16章 エグゼクティブ洞察

第17章 付録1:表形式データ

第18章 付録2:企業・団体一覧

図表

List of Tables

  • Table 4.1 List of Lipid Contract Manufacturers
  • Table 4.2 Lipid Contract Manufacturers: Information on Number and Location of Manufacturing Facilities
  • Table 4.3 Lipid Contract Manufacturers: Information on Type of Product and Scale of Operation
  • Table 4.4 Lipid Contract Manufacturers: Information on Service(s) Offered
  • Table 4.5 Lipid Contract Manufacturers: Information on Types of Lipids Manufactured
  • Table 6.1 Lipid Contract Manufacturers: List of Profiled Companies (North America)
  • Table 6.2 Avanti Polar Lipids: Company Snapshot
  • Table 6.3 Avanti Polar Lipids: Lipid-related Service Offerings
  • Table 6.4 Avanti Polar Lipids: Information on Manufacturing Facility
  • Table 6.5 Avanti Polar Lipids: Recent Developments and Future Outlook
  • Table 6.6 Creative Biolabs: Company Snapshot
  • Table 6.7 Creative Biolabs: Lipid-related Service Offerings
  • Table 6.8 Creative Biolabs: Information on Manufacturing Facility
  • Table 6.9 Exelead: Company Snapshot
  • Table 6.10 Exelead: Lipid-related Service Offerings
  • Table 6.11 Exelead: Information on Manufacturing Facility
  • Table 6.12 Exelead: Recent Developments and Future Outlook
  • Table 6.13 FormuMax Scientific: Company Snapshot
  • Table 6.14 FormuMax Scientific: Lipid-related Service Offerings
  • Table 6.15 FormuMax Scientific: Information on Manufacturing Facility
  • Table 6.16 T&T Scientific: Company Snapshot
  • Table 6.17 T&T Scientific: Lipid-related Service Offerings
  • Table 6.18 T&T Scientific: Information on Manufacturing Facility
  • Table 6.19 T&T Scientific: Recent Developments and Future Outlook
  • Table 7.1 Lipid Contract Manufacturers: List of Profiled Companies (Europe)
  • Table 7.2 Ardena: Company Snapshot
  • Table 7.3 Ardena: Lipid-related Service Offerings
  • Table 7.4 Ardena: Information on Manufacturing Facility
  • Table 7.5 Ardena: Recent Developments and Future Outlook
  • Table 7.6 CordenPharma: Company Snapshot
  • Table 7.7 CordenPharma: Lipid-related Service Offerings
  • Table 7.8 CordenPharma: Information on Manufacturing Facility
  • Table 7.9 CordenPharma: Recent Developments and Future Outlook
  • Table 7.10 Evonik: Company Snapshot
  • Table 7.11 Evonik: Lipid-related Service Offerings
  • Table 7.12 Evonik: Information on Manufacturing Facility
  • Table 7.13 Evonik: Recent Developments and Future Outlook
  • Table 7.14 Fresenius Kabi: Company Snapshot
  • Table 7.15 Fresenius Kabi: Lipid-related Service Offerings
  • Table 7.16 Fresenius Kabi: Information on Manufacturing Facility
  • Table 7.17 Fresenius Kabi: Recent Developments and Future Outlook
  • Table 7.18 Merck KGaA: Company Snapshot
  • Table 7.19 Merck KGaA: Lipid-related Service Offerings
  • Table 7.20 Merck KGaA: Information on Manufacturing Facility
  • Table 7.21 Merck KGaA: Recent Developments and Future Outlook
  • Table 8.1 Lipid Contract Manufacturers: List of Profiled Companies (Asia-Pacific)
  • Table 8.2 Fujifilm: Company Snapshot
  • Table 8.3 Fujifilm: Lipid-related Service Offerings
  • Table 8.4 Fujifilm: Information on Manufacturing Facility
  • Table 8.5 Fujifilm: Recent Developments and Future Outlook
  • Table 8.6 Nagase Medicals: Company Snapshot
  • Table 8.7 Nagase Medicals: Lipid-related Service Offerings
  • Table 8.8 Nagase Medicals: Information on Manufacturing Facility
  • Table 8.9 Nagase Medicals: Recent Developments and Future Outlook
  • Table 8.10 Nippon Fine Chemical: Company Snapshot
  • Table 8.11 Nippon Fine Chemical: Lipid-related Service Offerings
  • Table 8.12 Nippon Fine Chemical: Information on Manufacturing Facility
  • Table 8.13 TTY Biopharm: Company Snapshot
  • Table 8.14 TTY Biopharm: Lipid-related Service Offerings
  • Table 8.15 TTY Biopharm: Information on Manufacturing Facility
  • Table 8.16 TTY Biopharm: Recent Developments and Future Outlook
  • Table 8.17 VCARE Bio Labs: Company Snapshot
  • Table 8.18 VCARE Bio Labs: Lipid-related Service Offerings
  • Table 9.1 Lipid Contract Manufacturers: List of Partnerships and Collaborations, Since 2016
  • Table 10.1 Lipid Contract Manufacturers: Recent Expansions, Since 2016
  • Table 14.1 Lipid Formulation Technologies: List of Developers
  • Table 14.2 List of Approved Lipid-based Drugs
  • Table 17.1 Lipid Contract Manufacturers: Distribution by Year of Establishment
  • Table 17.2 Lipid Contract Manufacturers: Distribution by Company Size
  • Table 17.3 Lipid Contract Manufacturers: Distribution by Scale of Operation
  • Table 17.4 Lipid Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
  • Table 17.5 Lipid Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
  • Table 17.6 Lipid Contract Manufacturers: Distribution by Company Size and Location of Headquarters
  • Table 17.7 Lipid Contract Manufacturers: Distribution by Location of Lipid Manufacturing Facilities (Region-wise)
  • Table 17.8 Lipid Contract Manufacturers: Distribution by Location of Lipid Manufacturing Facilities (Country-wise)
  • Table 17.9 Lipid Contract Manufacturers: Distribution by Type of Product
  • Table 17.10 Lipid Contract Manufacturers: Distribution by Service(s) Offered
  • Table 17.11 Lipid Contract Manufacturers: Distribution by Type of Product and Service(s) Offered
  • Table 17.12 Lipid Contract Manufacturers: Distribution by Service(s) Offered and Location of Headquarters
  • Table 17.13 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured
  • Table 17.14 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Company Size
  • Table 17.15 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Scale of Operation
  • Table 17.16 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Location of Headquarters
  • Table 17.17 Partnerships and Collaborations: Cumulative Year-wise Trend, Since 2016
  • Table 17.18 Partnerships and Collaborations: Distribution by Type of Partnership
  • Table 17.19 Partnerships and Collaborations: Year-wise Trend by Type of Partnership
  • Table 17.20 Partnerships and Collaborations: Distribution by Type of Product
  • Table 17.21 Partnerships and Collaborations: Year-wise Trend by Type of Product, Since 2016
  • Table 17.22 Partnerships and Collaborations: Distribution by Type of Focus Area
  • Table 17.23 Most Active Players: Distribution by Number of Partnerships
  • Table 17.24 Partnerships and Collaborations: Distribution by Region (Continent-wise)
  • Table 17.25 Partnerships and Collaborations: Distribution by Region (Country-wise)
  • Table 17.26 Recent Expansions: Cumulative Year-wise Trend, Since 2016
  • Table 17.27 Recent Expansions: Distribution by Type of Expansion
  • Table 17.28 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
  • Table 17.29 Recent Expansions: Distribution by Type of Product
  • Table 17.30 Recent Expansions: Distribution by Type of Expansion and Type of Product
  • Table 17.31 Recent Expansions: Distribution by Amount Invested (USD Million)
  • Table 17.32 Recent Expansions: Distribution by Company Size and Location of Headquarters
  • Table 17.33 Recent Expansions: Distribution by Location of Expanded Facility
  • Table 17.34 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
  • Table 17.35 Most Active Players: Distribution by Number of Recent Expansions
  • Table 17.36 Recent Expansions: Distribution by Year of Expansion and Region
  • Table 17.37 Recent Expansions: Distribution by Region (Country-wise)
  • Table 17.38 Lipid Contract Manufacturing Capacity: Distribution by Company Size
  • Table 17.39 Lipid Contract Manufacturing Capacity: Distribution by Scale of Operation
  • Table 17.40 Lipid Contract Manufacturing Capacity: Distribution by Location of Manufacturing Facility
  • Table 17.41 Global Lipid Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.42 Lipid Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, Till 2035: Distribution by Type of Product (USD Billion)
  • Table 17.43 Lipid Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, Till 2035: Distribution by Company Size (USD Billion)
  • Table 17.44 Lipid Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, Till 2035: Distribution by Scale of Operation (USD Billion)
  • Table 17.45 Lipid Contract Manufacturing Market in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.46 Lipid Contract Manufacturing Market in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.47 Lipid Contract Manufacturing Market in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.48 Lipid Contract Manufacturing Market in MENA, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.49 Lipid Contract Manufacturing Market in Latin America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
  • Table 17.50 Lipid Contract Manufacturing Market in Rest of the World, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)

List of Figures

  • Figure 3.1 Applications of Lipid-based Formulations
  • Figure 3.2 Classification of Lipids
  • Figure 4.1 Lipid Contract Manufacturers: Distribution by Year of Establishment
  • Figure 4.2 Lipid Contract Manufacturers: Distribution by Company Size
  • Figure 4.3 Lipid Contract Manufacturers: Distribution by Scale of Operation
  • Figure 4.4 Lipid Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
  • Figure 4.5 Lipid Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
  • Figure 4.6 Lipid Contract Manufacturers: Distribution by Company Size and Location of Headquarters
  • Figure 4.7 Lipid Contract Manufacturers: Distribution by Location of Lipid Manufacturing Facilities (Region-wise)
  • Figure 4.8 Lipid Contract Manufacturers: Distribution by Location of Lipid Manufacturing Facilities (Country-wise)
  • Figure 4.9 Lipid Contract Manufacturers: Distribution by Type of Product
  • Figure 4.10 Lipid Contract Manufacturers: Distribution by Service(s) Offered
  • Figure 4.11 Lipid Contract Manufacturers: Distribution by Type of Product and Service(s) Offered
  • Figure 4.12 Lipid Contract Manufacturers: Distribution by Service(s) Offered and Location of Headquarters
  • Figure 4.13 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured
  • Figure 4.14 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Company Size
  • Figure 4.15 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Scale of Operation
  • Figure 4.16 Lipid Contract Manufacturers: Distribution by Types of Lipids Manufactured and Location of Headquarters
  • Figure 5.1 Company Competitiveness Analysis: Lipid Contract Manufacturers in North America
  • Figure 5.2 Company Competitiveness Analysis: Lipid Contract Manufacturers in Europe
  • Figure 5.3 Company Competitiveness Analysis: Lipid Contract Manufacturers in Asia-Pacific
  • Figure 9.1 Partnerships and Collaborations: Cumulative Year-wise Trend, Since 2016
  • Figure 9.2 Partnerships and Collaborations: Distribution by Type of Partnership
  • Figure 9.3 Partnerships and Collaborations: Year-wise Trend by Type of Partnership
  • Figure 9.4 Partnerships and Collaborations: Distribution by Type of Product
  • Figure 9.5 Partnerships and Collaborations: Year-wise Trend by Type of Product, Since 2016
  • Figure 9.6 Partnerships and Collaborations: Distribution by Type of Focus Area
  • Figure 9.7 Most Active Players: Distribution by Number of Partnerships
  • Figure 9.8 Partnerships and Collaborations: Distribution by Region (Continent-wise)
  • Figure 9.9 Partnerships and Collaborations: Distribution by Region (Country-wise)
  • Figure 10.1 Recent Expansions: Cumulative Year-wise Trend, Since 2016
  • Figure 10.2 Recent Expansions: Distribution by Type of Expansion
  • Figure 10.3 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
  • Figure 10.4 Recent Expansions: Distribution by Type of Product
  • Figure 10.5 Recent Expansions: Distribution by Type of Expansion and Type of Product
  • Figure 10.6 Recent Expansions: Distribution by Amount Invested (USD Million)
  • Figure 10.7 Recent Expansions: Distribution by Company Size and Location of Headquarters
  • Figure 10.8 Recent Expansions: Distribution by Location of Expanded Facility
  • Figure 10.9 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
  • Figure 10.10 Most Active Players: Distribution by Number of Recent Expansions
  • Figure 10.11 Recent Expansions: Distribution by Year of Expansion and Region
  • Figure 10.12 Recent Expansions: Distribution by Region (Country-wise)
  • Figure 11.1. Lipid Contract Manufacturing Capacity: Distribution by Company Size
  • Figure 11.2. Lipid Contract Manufacturing Capacity: Distribution by Scale of Operation
  • Figure 11.3. Lipid Contract Manufacturing Capacity: Distribution by Location of Manufacturing Facility
  • Figure 12.1. Make versus Buy Decision Making Framework
  • Figure 12.2. Make versus Buy Decision Making: Description of Possible Scenarios
  • Figure 13.1 Global Lipid Contract Manufacturing Market, Till 2035 (USD Billion)
  • Figure 13.2 Lipid Contract Manufacturing Market, Till 2035: Distribution by Type of Product (USD Billion)
  • Figure 13.3 Lipid Contract Manufacturing Market, Till 2035: Distribution by Company Size (USD Billion)
  • Figure 13.4 Lipid Contract Manufacturing Market, Till 2035: Distribution by Scale of Operation (USD Billion)
  • Figure 13.5 Lipid Contract Manufacturing Market in North America, Till 2035 (USD Billion)
  • Figure 13.6 Lipid Contract Manufacturing Market in Europe, Till 2035 (USD Billion)
  • Figure 13.7 Lipid Contract Manufacturing Market in Asia-Pacific, Till 2035 (USD Billion)
  • Figure 13.8 Lipid Contract Manufacturing Market in MENA, Till 2035 (USD Billion)
  • Figure 13.9 Lipid Contract Manufacturing Market in Latin America, Till 2035 (USD Billion)
  • Figure 13.10 Lipid Contract Manufacturing Market in Rest of the World, Till 2035 (USD Billion)
  • Figure 14.1 Biopharmaceutics Classification System (BCS)
  • Figure 14.2 Types of Lipid-based Drug Delivery Systems
  • Figure 14.3 Lipid-based mRNA Vaccines: Mechanism of Action
  • Figure 15.1 Concluding Remarks: Overall Market Landscape
  • Figure 15.2 Concluding Remarks: Partnerships and Collaborations
  • Figure 15.3 Concluding Remarks: Recent Expansions
  • Figure 15.4 Concluding Remarks: Capacity Analysis
  • Figure 15.5 Concluding Remarks: Market Forecast
目次
Product Code: RA100277

GLOBAL LIPID CMO MARKET: OVERVIEW

As per Roots Analysis, the global lipid CMO market valued at USD 2.4 billion in the current year is expected to grow at a CAGR of 10.8% during the forecast period.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Lipid

  • Liposomes / Lipid Nanoparticles
  • Phospholipids
  • Pegylated Lipids
  • Ionizable Lipids (Cationic / Anionic Lipids)
  • Triglycerides
  • Sphingolipids
  • Neutral Lipids
  • Others

Company Size

  • Small
  • Mid-Sized
  • Large / Very Large

Scale Of Operation

  • Preclinical
  • Clinical
  • Commercial

Key Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • Middle East and North Africa
  • Latin America
  • Rest of the World

GLOBAL LIPID CMO MARKET: GROWTH AND TRENDS

Currently, ~ 90% of drug candidates in the development stage and nearly 40% of approved pharmaceutical products face challenges related to solubility and permeability. As a result, under modern regulatory standards, many promising therapeutic leads fail to progress through clinical trials and reach the market due to poor bioavailability. To address these issues, innovators in the biopharmaceutical industry have devised various strategies to enhance the physicochemical properties and overall drug-like behavior of pharmaceutical compounds. Among these approaches, lipid nanoparticles and other lipid-based excipients, which improve permeability across biological membranes have attracted significant interest from drug developers. In fact, the novel mRNA-based COVID-19 vaccines utilized lipid nanoparticles to effectively deliver their active ingredients to target antigen-presenting cells within the human body.

Lipid CMO Market - IMG1

Furthermore, numerous companies are leveraging lipid-based solutions to reformulate existing drug candidates and enhance their bioavailability, driving significant growth in the demand for lipid drug carriers and excipients. However, manufacturing certain medically relevant lipids, particularly those used in liposome and lipid nanoparticle formulations remains highly complex, capital-intensive, and challenging. Consequently, an increasing number of pharmaceutical companies are opting to outsource lipid manufacturing to specialized providers. Partnering with contract manufacturing organizations (CMOs) for medical-grade lipids offers several advantages, including access to advanced technologies, greater production capacity and enhanced operational flexibility. Moreover, we anticipate that the growing demand for high-quality lipids will significantly propel market growth in the specialty contract manufacturing sector over the forecast period.

GLOBAL LIPID CMO MARKET: KEY INSIGHTS

The report delves into the current state of global lipid CMO market and identifies potential growth opportunities within industry. Some key findings from the report include:

  • Presently, around 60 players, across the world, claim to provide contract manufacturing services to support the development and production of lipids for use in therapeutic development, as well as other associated products.
  • Several CMOs engaged in this industry have the required capabilities to offer a range of services for different types of lipid-based products; many CMOs have the capacity to operate across all scales.
  • Close to 35% of players offering contract manufacturing services for lipid-based DDS claim to have the required capabilities and expertise to manufacture liposomes / LNPs at the commercial scale.
Lipid CMO Market - IMG2
  • Nearly 40% of the stakeholders established post-2010 have the capability to offer contract manufacturing services at both clinical and commercial scales; around 60% of these players are based in the US.
  • Prominent examples of very large players offering liposomes / LNPs include (in alphabetical order) AMRI, CordenPharma, Evonik, Fresenius Kabi, Fujifilm, Merck and TTY Biopharm.
  • In order to acquire supply chain competencies and meet the evolving needs of sponsors, lipid contract manufacturers have established a presence in key geographical regions.
  • In pursuit of competitive edge, companies have made / revealed intentions to make investments, in terms of both effort and capital, to augment their existing service portfolios and affiliated offerings.
  • Recently, there has been a surge in partnership activity within this industry; most deals were inked for the purpose of acquiring the proprietary capabilities of other players
  • The lipid CMO industry witnessed a surge in the number of deals owing to the sudden increase in demand for lipid nanoparticles for the production of mRNA-based COVID-19 vaccine candidates, globally.
  • Close to 50% of the partnerships inked were manufacturing agreements. Further, around 65% of these agreements were signed for the production of either lipid-based drug delivery systems or excipients.
  • Nearly 75% of the partnership activity is centered in North America. Examples of firms that have signed deals within players based in North America, include ABITEC, AMRI, Catalent and Precision NanoSystems.
  • To keep pace with the growing demand for lipids, CMOs / CDMOs have undertaken a number of expansion initiatives in the recent past; the maximum number of such instances involved facilities based in the US.
  • Lipid-based formulations have emerged as a popular approach for improving drug bioavailability over the past years; close to 55 companies have developed various lipid-related technologies for this purpose.
  • The supply side of this market is primarily driven by mid-to-large sized CMOs; interestingly, close to 65% of the currently available capacity is installed in production plants located in North America.
Lipid CMO Market - IMG3
  • In the mid-long term, we expect lipid-based formulation developers to continue outsourcing their manufacturing operations to CMOs / CDMOs, thereby, enabling this services market to grow at a CAGR of more than 10.8%.

Example Players in the Lipid CMO Market

  • Avanti Polar Lipids
  • Creative Biolabs
  • Exelead
  • FormuMax Scientific
  • T&T Scientific
  • Ardena
  • Corden Pharma
  • Evonik
  • Fresenius Kabi
  • Merck KGaA
  • Fujifilm
  • Nagase Medicals
  • Nippon Fine Chemical
  • TTY Biopharm
  • VCARE Bio Labs

PRIMARY RESEARCH OVERVIEW

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews conducted with the following industry stakeholders:

  • Founder and Chief Executive Officer, Company A
  • Associate Director, Formulation Development, Company B
  • Acting Manager, Biotech Process Development and Director, Process Development - Chemistry, Company C

GLOBAL LIPID CMO MARKET

  • Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global lipid CMO market, focusing on key market segments, including [A] type of lipid, [B] company size, [C] scale of operation and [D] key geographical regions.
  • Market Landscape: A comprehensive evaluation of companies offering contract services for the manufacturing of lipids, considering various parameters, such as [A] year of establishment, [B] company size, [C] scale of operation, [D] location of headquarters, [E] location of manufacturing facilities, [F] type of product, [G] type of service(s) offered and [H] type of lipid manufactured.
  • Company Competitiveness Analysis: An insightful competitive analysis of the lipid manufacturers, examining factors, such as [A] supplier power and [B] service strength.
  • Company Profiles: In-depth profiles of companies that offer various lipid manufacturing services, across North America, Europe and Asia-Pacific, focusing on [A] company overview, [B] financial performance (if available), [C] service portfolio and [D] recent developments and an informed future outlook.
  • Partnerships and Collaborations: An in-depth analysis of the deals inked by stakeholders in this domain, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] type of focus area, [D] most active players (in terms of the number of partnerships signed) and [E] geographical distribution of partnership activity.
  • Recent Expansions: A detailed analysis of the recent expansions, based on several relevant parameters, including [A] year of expansion, [B] type of expansion, [C] scale of operation, [D] type of product, [E] amount invested, [F] company size, [G] location of headquarters, [H] geographical location of the expanded facility, [I] most active players and [J] geographical distribution of the expansion activity.
  • Capacity Analysis: A comprehensive analysis of global installed capacity for lipids, based on several relevant parameters, such as [A] company size, [B] scale of operation and [C] key geographical regions.
  • Make Versus Buy Decision Making Framework: A detailed analysis, highlighting the various factors that need to be taken into consideration by lipid developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
  • Case study: An elaborate discussion on the wide adoption of lipids as drug delivery systems in mRNA vaccines.

KEY QUESTIONS ANSWERED IN THIS REPORT

  • How many companies are currently engaged in this market?
  • Which are the leading companies in this market?
  • What factors are likely to influence the evolution of this market?
  • What is the current and future market size?
  • What is the CAGR of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

  • The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
  • Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
  • The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

  • 1.1. Scope of the Report
  • 1.2. Research Methodology
    • 1.2.1. Research Assumptions
    • 1.2.2. Project Methodology
    • 1.2.3. Forecast Methodology
    • 1.2.4. Robust Quality Control
    • 1.2.5. Key Considerations
      • 1.2.5.1. Demographics
      • 1.2.5.2. Economic Factors
      • 1.2.5.3. Government Regulations
      • 1.2.5.4. Supply Chain
      • 1.2.5.5. COVID Impact / Related Factors
      • 1.2.5.6. Market Access
      • 1.2.5.7. Healthcare Policies
      • 1.2.5.8. Industry Consolidation
  • 1.3 Key Questions Answered
  • 1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

  • 3.1. Chapter Overview
  • 3.2. Introduction to Lipids
    • 3.2.1. Types of Lipids
  • 3.3. Applications of Lipids in Pharmaceutical Industry
  • 3.4. Challenges Associated with Lipid Manufacturing
  • 3.5. Need for Outsourcing Lipid Manufacturing
  • 3.6. Concluding Remarks

4. COMPETITIVE LANDSCAPE

  • 4.1. Chapter Overview
  • 4.2. Lipid Contract Manufacturers: Overall Market Landscape
    • 4.2.1. Analysis by Year of Establishment
    • 4.2.2. Analysis by Company Size
    • 4.2.3. Analysis by Scale of Operation
    • 4.2.4. Analysis by Location of Headquarters
    • 4.2.5. Analysis by Location of Lipid Manufacturing Facilities
    • 4.2.6. Analysis by Type of Product
    • 4.2.7. Analysis by Service(s) Offered
    • 4.2.8. Analysis by Types of Lipids Manufactured
      • 4.2.8.1. Analysis by Types of Lipids Manufactured and Company Size
      • 4.2.8.2. Analysis by Types of Lipids Manufactured and Scale of Operation
      • 4.2.8.3. Analysis by Types of Lipids Manufactured and Location of Headquarters

5. COMPANY COMPETITIVENESS ANALYSIS

  • 5.1. Chapter Overview
  • 5.2. Assumptions and Key Parameters
  • 5.3. Methodology
  • 5.4. Lipid Contract Manufacturers: Company Competitiveness Analysis
    • 5.4.1. Company Competitiveness Analysis: Lipid Contract Manufacturers in North America
    • 5.4.2. Company Competitiveness Analysis: Lipid Contract Manufacturers in Europe
    • 5.4.3. Company Competitiveness Analysis: Lipid Contract Manufacturers in Asia-Pacific

6. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN NORTH AMERICA

  • 6.1. Chapter Overview
  • 6.2. Avanti Polar Lipids
    • 6.2.1. Company Overview
    • 6.2.2. Lipid Manufacturing Service Offerings
    • 6.2.3. Manufacturing Facilities
    • 6.2.4. Recent Developments and Future Outlook
  • 6.3. Creative Biolabs
    • 6.3.1. Company Overview
    • 6.3.2. Lipid Manufacturing Service Offerings
    • 6.3.3. Manufacturing Facilities
    • 6.3.4. Recent Developments and Future Outlook
  • 6.4. Exelead
    • 6.4.1. Company Overview
    • 6.4.2. Lipid Manufacturing Service Offerings
    • 6.4.3. Manufacturing Facilities
    • 6.4.4. Recent Developments and Future Outlook
  • 6.5. FormuMax Scientific
    • 6.5.1. Company Overview
    • 6.5.2. Lipid Manufacturing Service Offerings
    • 6.5.3. Manufacturing Facilities
    • 6.5.4. Recent Developments and Future Outlook
  • 6.6. T&T Scientific
    • 6.6.1. Company Overview
    • 6.6.2. Lipid Manufacturing Service Offerings
    • 6.6.3. Manufacturing Facilities
    • 6.6.4. Recent Developments and Future Outlook

7. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN EUROPE

  • 7.1. Chapter Overview
  • 7.2. Ardena
    • 7.2.1. Company Overview
    • 7.2.2. Lipid Manufacturing Service Offerings
    • 7.2.3. Manufacturing Facilities
    • 7.2.4. Recent Developments and Future Outlook
  • 7.3. CordenPharma
    • 7.3.1. Company Overview
    • 7.3.2. Lipid Manufacturing Service Offerings
    • 7.3.3. Manufacturing Facilities
    • 7.3.4. Recent Developments and Future Outlook
  • 7.4. Evonik
    • 7.4.1. Company Overview
    • 7.4.2. Lipid Manufacturing Service Offerings
    • 7.4.3. Manufacturing Facilities
    • 7.4.4. Recent Developments and Future Outlook
  • 7.5. Fresenius Kabi
    • 7.5.1. Company Overview
    • 7.5.2. Lipid Manufacturing Service Offerings
    • 7.5.3. Manufacturing Facilities
    • 7.5.4. Recent Developments and Future Outlook
  • 7.6. Merck KGaA
    • 7.6.1. Company Overview
    • 7.6.2. Lipid Manufacturing Service Offerings
    • 7.6.3. Manufacturing Facilities
    • 7.6.4. Recent Developments and Future Outlook

8. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN ASIA-PACIFIC

  • 8.1. Chapter Overview
  • 8.2. Fujifilm
    • 8.2.1. Company Overview
    • 8.2.2. Lipid Manufacturing Service Offerings
    • 8.2.3. Manufacturing Facilities
    • 8.2.4. Recent Developments and Future Outlook
  • 8.3. Nagase Medicals
    • 8.3.1. Company Overview
    • 8.3.2. Lipid Manufacturing Service Offerings
    • 8.3.3. Manufacturing Facilities
    • 8.3.4. Recent Developments and Future Outlook
  • 8.4. Nippon Fine Chemical
    • 8.4.1. Company Overview
    • 8.4.2. Lipid Manufacturing Service Offerings
    • 8.4.3. Manufacturing Facilities
    • 8.4.4. Recent Developments and Future Outlook
  • 8.5. TTY Biopharm
    • 8.5.1. Company Overview
    • 8.5.2. Lipid Manufacturing Service Offerings
    • 8.5.3. Manufacturing Facilities
    • 8.5.4. Recent Developments and Future Outlook
  • 8.6. VCARE Bio Labs
    • 8.6.1. Company Overview
    • 8.6.2. Lipid Manufacturing Service Offerings
    • 8.6.3. Manufacturing Facilities
    • 8.6.4. Recent Developments and Future Outlook

9. PARTNERSHIPS AND COLLABORATIONS

  • 9.1. Chapter Overview
  • 9.2. Partnership Models
  • 9.3. Lipid Contract Manufacturing Market: Partnerships and Collaborations
    • 9.3.1. Analysis by Year of Partnership
    • 9.3.2. Analysis by Type of Partnership
    • 9.3.3. Analysis by Type of Product
    • 9.3.4. Analysis by Type of Focus Area
    • 9.3.5. Most Active Players: Analysis by Number of Partnerships
    • 9.3.6. Geographical Analysis
      • 9.3.6.1. Region-wise Distribution
      • 9.3.6.2. Country-wise Distribution

10. RECENT EXPANSIONS

  • 10.1. Chapter Overview
  • 10.2. Lipid Contract Manufacturing Market: Recent Expansions
    • 10.2.1. Analysis by Year of Expansion
    • 10.2.2. Analysis by Type of Expansion
    • 10.2.3. Analysis by Type of Expansion and Scale of Operation
    • 10.2.4. Analysis by Type of Product
    • 10.2.5. Analysis by Amount Invested
    • 10.2.6. Analysis by Company Size and Location of Headquarters
    • 10.2.7. Analysis by Location of Expanded Facility
    • 10.2.8. Most Active Players: Analysis by Number of Recent Expansions
    • 10.2.9. Geographical Analysis
      • 10.2.9.1. Region-wise Distribution
      • 10.2.9.2. Country-wise Distribution

11. CAPACITY ANALYSIS

  • 11.1. Chapter Overview
  • 11.2. Key Assumptions and Methodology
  • 11.3. Lipid Contract Manufacturing: Installed Global Capacity (Million Liters)
    • 11.3.1. Analysis by Company Size
    • 11.3.2. Analysis by Scale of Operation
    • 11.3.3. Analysis by Location of Manufacturing Facility
  • 11.4. Concluding Remarks

12. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

  • 12.1. Chapter Overview
  • 12.2. Assumptions and Parameter Definitions
  • 12.3. Lipid Contract Manufacturing: Make Versus Buy Decision Making
    • 12.3.1. Scenario 1
    • 12.3.2. Scenario 2
    • 12.3.3. Scenario 3
    • 12.3.4. Scenario 4
  • 12.4. Concluding Remarks

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS

  • 13.1. Chapter Overview
  • 13.2. Forecast Methodology and Key Assumptions
  • 13.3. Global Lipid Contract Manufacturing Market, Till 2035
  • 13.4. Lipid Contract Manufacturing Market, Till 2035: Distribution by Type of Lipid
  • 13.5. Lipid Contract Manufacturing Market, Till 2035: Distribution by Company Size
  • 13.6. Lipid Contract Manufacturing Market, Till 2035: Distribution by Scale of Operation
  • 13.7. Lipid Contract Manufacturing Market, Till 2035: Distribution by Region
    • 13.7.1. Lipid Contract Manufacturing Market in North America, Till 2035
    • 13.7.2. Lipid Contract Manufacturing Market in Europe, Till 2035
    • 13.7.3. Lipid Contract Manufacturing Market in Asia-Pacific, Till 2035
    • 13.7.4. Lipid Contract Manufacturing Market in MENA, Till 2035
    • 13.7.5. Lipid Contract Manufacturing Market in Latin America, Till 2035
    • 13.7.6. Lipid Contract Manufacturing Market in Rest of the World, Till 2035

14. CASE STUDY: APPLICATIONS OF LIPIDS AND LIPID FORMULATION TECHNOLOGIES

  • 14.1. Chapter Overview
  • 14.2. Biopharmaceutical Drug Classification System
  • 14.3. Lipid-based Formulations as Drug Delivery Systems
    • 14.3.1. Role of Lipids in mRNA Vaccines
    • 14.3.2. Recent Developments in Lipid Nanoparticles
  • 14.4. Lipid-based Formulation Technology Developers
    • 14.4.1. Analysis by Year of Establishment
    • 14.4.2. Analysis by Company Size
    • 14.4.3. Analysis by Location of Headquarters

15. CONCLUDING REMARKS

16. EXECUTIVE INSIGHTS

  • 16.1. Chapter Overview
  • 16.2. Company A
    • 16.2.1. Company Snapshot
    • 16.2.2. Interview Transcript: Founder and CEO
  • 16.3. Company B
    • 16.3.1. Company Snapshot
    • 16.3.2. Interview Transcript: Associate Director, Formulation Development
  • 16.4. Company C
    • 16.4.1. Company Snapshot
    • 16.4.2. Interview Transcript: Acting Manager, Biotech Process Development and Director, Process Development - Chemistry

17. APPENDIX 1: TABULATED DATA

18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS