バイオ医薬品賦形剤市場：業界動向と世界の予測 - 生物製剤タイプ別、賦形剤タイプ別、企業規模別、事業規模別、主要地域別

世界のバイオ医薬品賦形剤市場：概要

バイオ医薬品賦形剤の市場規模は、2035年までの予測期間中に4.8%のCAGRで拡大し、現在の27億3,000万米ドルから2035年までに45億8,000万米ドルに成長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：

生物製剤タイプ

• 抗体
• ワクチン
• 細胞治療薬
• その他

賦形剤タイプ

• 炭水化物
• ポリマー
• 可溶化剤／界面活性剤
• ポリオール
• タンパク質／アミノ酸
• 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
• ラテンアメリカ
• 中東・北アフリカ
• その他の地域

世界のバイオ医薬品賦形剤市場：成長と動向

生物製剤の開発において重要な役割を果たすため、生物製剤用賦形剤の需要はここ数年で大幅に伸びています。これらのバイオ医薬品賦形剤は、原薬（API）のpHと強壮度を制御することにより、生物製剤の溶解性とバイオアベイラビリティを向上させます。しかし、生物製剤用賦形剤の製造工程は非常に複雑で資本集約的であるため、現代の多くの生物製剤開発企業は、GMPグレードの賦形剤の供給をCMOに頼ることを好んでいます。さらに、臨床と商業の両方のスケールでバイオ医薬品賦形剤の需要の増大に対応するため、この分野の専門知識を持つCMOは、今後数年間でその能力と既存の能力を拡大すると予想されます。

調査中、脂質、トレハロース、乳糖、マンニトール、コハク酸塩、Tween 20、ベンジルアルコールなど、バイオ医薬品賦形剤の製造サービスを提供する様々な企業を確認しました。これらの企業は、革新的なバイオ医薬品の安定性と有効性を高めるために、共同加工された多機能バイオ医薬品賦形剤の開発に重点を置いています。実際、過去30年間にバイオ医薬品メーカーは、バイオ医薬品製剤の保存可能期間を3倍に延ばすと主張するいくつかの優れた賦形剤を開発してきました。

世界のバイオ医薬品賦形剤市場：主要インサイト

当レポートでは、世界のバイオ医薬品賦形剤市場の現状を調査し、潜在的な成長機会を特定しています。主な調査結果は以下の通りです。

• 現在、約45社が様々な種類のバイオ医薬品賦形剤を生物学的製剤開発者に提供していると主張しており、これらの企業は世界の規制基準に準拠して事業を展開しています。
• スポンサーの進化するニーズに応えるため、バイオ医薬品賦形剤を提供する企業は様々な地域で存在感を示しています。

• 市場情勢は断片化されており、さまざまな種類の生物製剤用賦形剤の製造に携わる既存企業と新規参入企業の両方が存在しています。
• 90％近くの企業が、あらゆる規模の液体製剤用賦形剤を提供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。
• メーカーの大部分（～75％）は先進地域に拠点を置いているが、インドや中国などのアジア諸国では最近多くの参入企業が台頭してきています。
• メーカーの60％近くが、ワクチンやタンパク質・ペプチドベースの治療薬にバイオ医薬品の賦形剤を提供していると主張しています。
• 各社は、それぞれのポートフォリオを強化し、進化する業界ベンチマークへの準拠を推進するため、既存の能力を着実に拡大しています。
• バイオ医薬品の賦形剤に焦点を当てたパートナーシップの増加は、この領域における利害関係者の関心の高まりを裏付けるものであり、過去3年間でこのような取引が最も多く締結されました。
• 2020年以降、この分野でのパートナーシップ活動は安定したペースで増加しています。特筆すべきは、取引の大半が過去2年間に成立したことです。
• この領域では過去5年間に40以上の契約が結ばれており、そのうちの32％が販売契約でした。この分野に携わる参入企業が採用しているその他の一般的なパートナーシップモデルには、買収（23％）や供給契約（13％）などがあります。
• 既存の参入企業はバイオ医薬品賦形剤に関して複数の契約を結んでいますが、そのほとんどは独自のバイオ医薬品賦形剤の販売に焦点を当てたものでした。
• 北米で複数の契約を結んだ企業の例としては、ABITEC、Aceto、Evonik、Merck、Roquetteが挙げられます（アルファベット順）。
• バイオ医薬品の賦形剤に対する需要の増加に対応するため、メーカーは最近、多くの拡張計画を実施しています。
• 拡張計画の45％以上が製造施設の能力拡張に重点を置いており、次いで既存施設の拡張（43％）でした。特筆すべきは、拡張計画のほとんど（78％）が欧州と北米で実施されたことです。
• この市場の供給サイドは、中堅・大手のバイオ医薬品賦形剤メーカーが牽引しています。興味深いことに、現在利用可能な生産能力の40％近くが、欧州にある生産工場に設置されています。
• 興味深いことに、現在利用可能な生産能力の40％近くが欧州の生産工場に設置されています。残りの5%はバイオ医薬品賦形剤の前臨床／臨床スケール製造に特化しています。さらに、現在の世界全体のバイオ医薬品賦形剤製造能力の50％以上が欧州に設置されています。
• 生物製剤に基づく治療介入への注目が高まる中、バイオ医薬品賦形剤市場は今後10年間、安定したペースで成長すると思われます。
• この機会は、様々な生物製剤、事業規模、主要な地域別に分類されると予想されます。
• 北米と欧州は、2035年までに市場シェアの70%以上を占めると予想されています。また、アジア太平洋地域の市場は長期的に比較的速いペース（6.4％）で成長するとみられます。さらに、2035年には抗体用バイオ医薬品賦形剤製造市場が市場全体の大半のシェア（～52%）を占めると予想されます。

バイオ医薬品賦形剤市場における参入企業例

• ABITEC
• Avantor
• BASF
• Corden Pharma
• DFE Pharma
• Evonik
• Kirsch Pharma
• Merck KGaA
• Pfanstiehl
• Roquette
• Spectrum Chemical Manufacturing
• SPI Pharma

当レポートでは、世界のバイオ医薬品賦形剤市場について調査し、市場の概要とともに、生物製剤タイプ別、賦形剤タイプ別、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
• バイオ医薬品賦形剤
• 理想的な賦形剤の特性
• バイオ医薬品賦形剤の分類
• バイオ医薬品賦形剤の用途
• 規制シナリオ
• 結論

第4章 市場情勢

• 章の概要
• バイオ医薬品賦形剤メーカー：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
• バイオ医薬品賦形剤メーカー：企業競争力分析

第6章 企業プロファイル：バイオ医薬品賦形剤メーカー

• 章の概要
• ABITEC
• Avantor
• BASF Pharma
• Corden Pharma
• DFE Pharma
• Evonik
• Kirsch Pharma
• Merck KGaA
• Pfanstiehl
• Roquette
• Spectrum Chemical Manufacturing
• SPI Pharma

第7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
• バイオ医薬品賦形剤製造市場：パートナーシップとコラボレーション

第8章 最近の拡張

第9章 容量分析

• 章の概要
• 主要な前提と調査手法
• バイオ医薬品賦形剤製造：世界の設備容量
• 結論

第10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年までの世界のバイオ医薬品賦形剤製造市場
• バイオ医薬品賦形剤製造市場：生物製剤タイプ別
• バイオ医薬品賦形剤製造市場：賦形剤タイプ別
• バイオ医薬品賦形剤製造市場：企業規模別
• バイオ医薬品賦形剤製造市場：事業規模別
• バイオ医薬品賦形剤製造市場：地域別

第11章 結論

第12章 エグゼクティブ洞察

第13章 付録1：表形式データ

第14章 付録2：企業・団体一覧

List of Tables

• Table 3.1 Classification of Biopharmaceutical Excipients based on Function
• Table 4.1 Biopharmaceutical Excipient Manufacturers: List of Companies
• Table 4.2 Biopharmaceutical Excipient Manufacturers: Information on Type of Excipient based on Chemical Composition and Function
• Table 4.3 Biopharmaceutical Excipient Manufacturers: Information on Scale of Operation, Type of Formulation, Type of Excipient (based on Chemical Structure), Type of Biologic and Global Regulatory Compliance
• Table 6.1 Leading Biopharmaceutical Excipient Manufacturers
• Table 6.2 ABITEC: Company Snapshot
• Table 6.3 ABITEC: Biopharmaceutical Excipient Offerings
• Table 6.4 ABITEC: Information on Manufacturing Facilities
• Table 6.5 ABITEC: Recent Developments and Future Outlook
• Table 6.6 Avantor: Company Snapshot
• Table 6.7 Avantor: Biopharmaceutical Excipient Offerings
• Table 6.8 Avantor: Information on Manufacturing Facilities
• Table 6.9 Avantor: Recent Developments and Future Outlook
• Table 6.10 BASF: Company Snapshot
• Table 6.11 BASF: Biopharmaceutical Excipient Offerings
• Table 6.12 BASF: Information on Manufacturing Facilities
• Table 6.13 BASF: Recent Developments and Future Outlook
• Table 6.14 Corden Pharma: Company Snapshot
• Table 6.15 Corden Pharma: Biopharmaceutical Excipient Offerings
• Table 6.16 Corden Pharma: Information on Manufacturing Facilities
• Table 6.17 Corden Pharma: Recent Developments and Future Outlook
• Table 6.18 DFE Pharma: Company Snapshot
• Table 6.19 DFE Pharma: Biopharmaceutical Excipient Offerings
• Table 6.20 DFE Pharma: Information on Manufacturing Facilities
• Table 6.21 DFE Pharma: Recent Developments and Future Outlook
• Table 6.22 Evonik: Company Snapshot
• Table 6.23 Evonik: Biopharmaceutical Excipient Offerings
• Table 6.24 Evonik: Information on Manufacturing Facilities
• Table 6.25 Evonik: Recent Developments and Future Outlook
• Table 6.26 Kirsch Pharma: Company Snapshot
• Table 6.27 Kirsch Pharma: Biopharmaceutical Excipient Offerings
• Table 6.28 Kirsch Pharma: Information on Manufacturing Facilities
• Table 6.29 Kirsch Pharma: Recent Developments and Future Outlook
• Table 6.30 Merck KGaA: Company Snapshot
• Table 6.31 Merck KGaA: Biopharmaceutical Excipient Offerings
• Table 6.32 Merck KGaA: Information on Manufacturing Facilities
• Table 6.33 Merck KGaA: Recent Developments and Future Outlook
• Table 6.34 Pfanstiehl: Company Snapshot
• Table 6.35 Pfanstiehl: Biopharmaceutical Excipient Offerings
• Table 6.36 Pfanstiehl: Information on Manufacturing Facilities
• Table 6.37 Pfanstiehl: Recent Developments and Future Outlook
• Table 6.38 Roquette: Company Snapshot
• Table 6.39 Roquette: Biopharmaceutical Excipient Offerings
• Table 6.40 Roquette: Information on Manufacturing Facilities
• Table 6.41 Roquette: Recent Developments and Future Outlook
• Table 6.42 Spectrum Chemical Manufacturing: Company Snapshot
• Table 6.43 Spectrum Chemical Manufacturing: Biopharmaceutical Excipient Offerings
• Table 6.44 Spectrum Chemical Manufacturing: Information on Manufacturing Facilities
• Table 6.45 SPI Pharma: Company Snapshot
• Table 6.46 SPI Pharma: Biopharmaceutical Excipient Offerings
• Table 6.47 SPI Pharma: Information on Manufacturing Facilities
• Table 6.48 SPI Pharma: Recent Developments and Future Outlook
• Table 7.1 Biopharmaceutical Excipient Manufacturers: List of Partnerships and Collaborations, Since 2016
• Table 8.1 Biopharmaceutical Excipient Manufacturers: Recent Expansions, Since 2016
• Table 9.1 Capacity Analysis: Information on Company Size of Biopharmaceutical Excipient Manufacturers
• Table 9.2 Capacity Analysis: Information on Average Capacity by Company Size
• Table 9.3 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Total Capacity by Company Size
• Table 12.1 DFE Pharma: Company Snapshot
• Table 13.1 Biopharmaceutical Excipient Manufacturers: Distribution by Year of Establishment
• Table 13.2 Biopharmaceutical Excipient Manufacturers: Distribution by Company Size
• Table 13.3 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters (Region-wise)
• Table 13.4 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters (Country-wise)
• Table 13.5 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters and Company Size
• Table 13.6 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Biopharmaceutical Excipient Manufacturing Facilities (Region-wise)
• Table 13.7 Biopharmaceutical Excipients Manufacturers: Distribution by Location of Biopharmaceutical Excipient Manufacturing Facilities (Country-wise)
• Table 13.8 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Chemical Composition
• Table 13.9 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Function
• Table 13.10 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Chemical Structure
• Table 13.11 Biopharmaceutical Excipient Manufacturers: Distribution by Scale of Operation
• Table 13.12 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Formulation
• Table 13.13 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Biologic
• Table 13.14 Biopharmaceutical Excipient Manufacturers: Distribution by Global Regulatory Compliance
• Table 13.15 BASF Pharma: Annual Revenues, Since 2016 (EUR Million)
• Table 13.16 Evonik: Annual Revenues, Since 2016 (EUR Million)
• Table 13.17 Merck KGaA: Annual Revenues, Since 2016 (EUR Million)
• Table 13.18 Partnerships and Collaborations: Cumulative Year-Wise Trend, Since 2016
• Table 13.19 Partnerships and Collaborations: Distribution by Type of Partnership
• Table 13.20 Partnerships and Collaborations: Year-wise Trend by Type of Partnership
• Table 13.21 Partnerships and Collaborations: Distribution by Type of Excipient
• Table 13.22 Partnerships and Collaborations: Distribution by Type of Drug Molecule
• Table 13.23 Partnerships and Collaborations: Year-Wise Trend of Partnerships by Type of Drug Molecule, Since 2016
• Table 13.24 Most Active Players: Distribution by Number of Partnerships
• Table 13.25 Partnerships and Collaborations: Distribution by Intercontinental and Intracontinental Deals
• Table 13.26 Partnerships and Collaborations: Distribution by International and Local Deals
• Table 13.27 Recent Expansions: Cumulative Year-wise Trend, Since 2016
• Table 13.28 Recent Expansions: Distribution by Type of Expansion
• Table 13.29 Recent Expansions: Distribution by Company Size and Location of Headquarters
• Table 13.30 Recent Expansions: Distribution by Location of Expanded Facility
• Table 13.31 Recent Expansions: Distribution by Location of Facility Expanded and Type of Expansion
• Table 13.32 Recent Expansions: Distribution by Type of Excipient
• Table 13.33 Recent Expansions: Distribution by Type of Drug Molecule
• Table 13.34 Most Active Players: Distribution by Number of Recent Expansions
• Table 13.35 Recent Expansions: Year-wise Distribution by Geography
• Table 13.36 Recent Expansions: Country-wise Distribution
• Table 13.37 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Range of Installed Capacity
• Table 13.38 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Company Size
• Table 13.39 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Scale of Operation
• Table 13.40 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Location of Manufacturing Facility (Continent-wise)
• Table 13.41 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Location of Manufacturing Facility (Country-wise)
• Table 13.42 Global Biopharmaceutical Excipient Manufacturing Market, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.43 Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Biologic (USD Billion)
• Table 13.44 Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Excipient (USD Billion)
• Table 13.45 Biopharmaceutical Excipient Manufacturing Market: Distribution by Company Size (USD Billion)
• Table 13.46 Biopharmaceutical Excipient Manufacturing Market: Distribution by Scale of Operation (USD Billion)
• Table 13.47 Biopharmaceutical Excipient Manufacturing Market: Distribution by Region, Conservative, Base and Optimistic Scenarios (USD Billion)
• Table 13.48 Biopharmaceutical Excipient Manufacturing Market in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.49 Biopharmaceutical Excipient Manufacturing Market in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.50 Biopharmaceutical Excipient Manufacturing Market in Asia Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.51 Biopharmaceutical Excipient Manufacturing Market in Latin America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.52 Biopharmaceutical Excipient Manufacturing Market in MENA, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)
• Table 13.53 Biopharmaceutical Excipient Manufacturing Market in Rest of the World, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Billion)

List of Figures

• Figure 2.1 Executive Summary: Market Forecast
• Figure 2.1 Executive Summary: Overall Market Landscape
• Figure 2.2 Executive Summary: Partnerships and Collaborations
• Figure 2.3 Executive Summary: Recent Expansions
• Figure 2.4 Executive Summary: Capacity Analysis
• Figure 2.5 Executive Summary: Market Forecast
• Figure 3.1 Properties of an Ideal Excipient
• Figure 3.2 Classification of Biopharmaceutical Excipients based on Ability to Interfere with Metabolization and Efflux Mechanisms
• Figure 3.3 Applications of Biopharmaceutical Excipients
• Figure 4.1 Biopharmaceutical Excipient Manufacturers: Distribution by Year of Establishment
• Figure 4.2 Biopharmaceutical Excipient Manufacturers: Distribution by Company Size
• Figure 4.3 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters (Region-wise)
• Figure 4.4 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters (Country-wise)
• Figure 4.5 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Headquarters and Company Size
• Figure 4.6 Biopharmaceutical Excipient Manufacturers: Distribution by Location of Biopharmaceutical Excipient Manufacturing Facilities (Region-wise)
• Figure 4.7 Biopharmaceutical Excipients Manufacturers: Distribution by Location of Biopharmaceutical Excipient Manufacturing Facilities (Country-wise)
• Figure 4.8 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Chemical Composition
• Figure 4.9 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Function
• Figure 4.10 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Excipient based on Chemical Structure
• Figure 4.11 Biopharmaceutical Excipient Manufacturers: Distribution by Scale of Operation
• Figure 4.12 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Formulation
• Figure 4.13 Biopharmaceutical Excipient Manufacturers: Distribution by Type of Biologic
• Figure 4.14 Biopharmaceutical Excipient Manufacturers: Distribution by Global Regulatory Compliance
• Figure 5.1 Company Competitiveness Analysis: Small Companies
• Figure 5.2 Company Competitiveness Analysis: Mid-sized Companies
• Figure 5.3 Company Competitiveness Analysis: Large Companies
• Figure 5.4 Company Competitiveness Analysis: Very Large Companies
• Figure 6.1 BASF Pharma: Annual Revenues, Since 2016 (EUR Million)
• Figure 6.2 Evonik: Annual Revenues, Since 2016 (EUR Million)
• Figure 6.3 Merck KGaA: Annual Revenues, Since 2016 (EUR Million)
• Figure 7.1 Partnerships and Collaborations: Cumulative Year-Wise Trend, Since 2016
• Figure 7.2 Partnerships and Collaborations: Distribution by Type of Partnership
• Figure 7.3 Partnerships and Collaborations: Year-wise Trend by Type of Partnership
• Figure 7.4 Partnerships and Collaborations: Distribution by Type of Excipient
• Figure 7.5 Partnerships and Collaborations: Distribution by Type of Drug Molecule
• Figure 7.6 Partnerships and Collaborations: Year-Wise Trend of Partnerships by Type of Drug Molecule, Since 2016
• Figure 7.7 Most Active Players: Distribution by Number of Partnerships
• Figure 7.8 Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
• Figure 7.9 Partnerships and Collaborations: International and Local Distribution
• Figure 8.1 Recent Expansions: Cumulative Year-wise Trend, Since 2016
• Figure 8.2 Recent Expansions: Distribution by Type of Expansion
• Figure 8.3 Recent Expansions: Distribution by Company Size and Location of Headquarters
• Figure 8.4 Recent Expansions: Distribution by Location of Expanded Facility
• Figure 8.5 Recent Expansions: Distribution by Location of Facility Expanded and Type of Expansion
• Figure 8.6 Recent Expansions: Distribution by Type of Excipient
• Figure 8.7 Recent Expansions: Distribution by Type of Drug Molecule
• Figure 8.8 Most Active Players: Distribution by Number of Recent Expansions
• Figure 8.9 Recent Expansions: Year-wise Distribution by Geography
• Figure 8.10 Recent Expansions: Country-wise Distribution
• Figure 9.1 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Range of Installed Capacity
• Figure 9.2 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Company Size
• Figure 9.3 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Scale of Operation
• Figure 9.4 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Location of Manufacturing Facility (Continent-wise)
• Figure 9.5 Biopharmaceutical Excipient Manufacturing Installed Global Capacity: Distribution by Location of Manufacturing Facility (Country-wise)
• Figure 10.1 Global Biopharmaceutical Excipient Manufacturing Market, Till 2035 (USD Billion)
• Figure 10.2 Biopharmaceutical Excipient Manufacturing Market: Likely Growth Scenarios
• Figure 10.3 Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Biologic (USD Billion)
• Figure 10.4 Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Excipient (USD Billion)
• Figure 10.5 Biopharmaceutical Excipient Manufacturing Market: Distribution by Company Size (USD Billion)
• Figure 10.6 Biopharmaceutical Excipient Manufacturing Market: Distribution by Scale of Operation (USD Billion)
• Figure 10.7 Biopharmaceutical Excipient Manufacturing Market: Distribution by Region (USD Billion)
• Figure 10.8 Biopharmaceutical Excipient Manufacturing Market in North America, Till 2035 (USD Billion)
• Figure 10.9 Biopharmaceutical Excipient Manufacturing Market in Europe, Till 2035 (USD Billion)
• Figure 10.10 Biopharmaceutical Excipient Manufacturing Market in Asia Pacific, Till 2035 (USD Billion)
• Figure 10.11 Biopharmaceutical Excipient Manufacturing Market in Latin America, Till 2035 (USD Billion)
• Figure 10.12 Biopharmaceutical Excipient Manufacturing Market in MENA, Till 2035 (USD Billion)
• Figure 10.13 Biopharmaceutical Excipient Manufacturing Market in Rest of the World, Till 2035 (USD Billion)
• Figure 11.1 Concluding Remarks: Overall Market Landscape
• Figure 11.2 Concluding Remarks: Partnerships and Collaborations
• Figure 11.3 Concluding Remarks: Recent Expansions
• Figure 11.4 Concluding Remarks: Capacity Analysis
• Figure 11.5 Concluding Remarks: Market Forecast

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: OVERVIEW

As per Roots Analysis, the biopharmaceutical excipients market is estimated to grow from USD 2.73 billion in the current year to USD 4.58 billion by 2035, at a CAGR of 4.8% during the forecast period, till 2035.

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

Type of Biologics

• Antibodies
• Vaccines
• Cell Therapies
• Other Biologics

Type of Excipient

• Carbohydrates
• Polymers
• Solubilizers / Surfactants
• Polyols
• Proteins / Amino Acids
• Others

Company Size

• Small
• Mid-sized
• Large / Very Large

Scale of Operation

• Preclinical
• Clinical
• Commercial

Key Geographical Regions

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

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: GROWTH AND TRENDS

The demand for biopharmaceutical excipients has grown considerably in the past few years as they play a critical role in development of biologics. These biopharmaceutical excipients enhance solubility and bioavailability of biologics, by controlling pH and tonicity of the active pharmaceutical ingredients (APIs). However, due to the highly complex and capital-intensive manufacturing processes of biopharmaceutical excipients, many contemporary biologic developers prefer to rely on CMOs for the supply of GMP grade excipients. Further, in order to cater to the growing demand for biopharmaceutical excipients across both clinical and commercial scales, CMOs with expertise in this field are expected to expand their capabilities and existing capacities in the coming years.

During our research, we identified various players that offer manufacturing services of biopharmaceutical excipients, including lipids, trehalose, lactose, mannitol, succinate, Tween 20 and benzyl alcohol. These companies are placing greater emphasis on developing co-processed multifunctional biopharmaceutical excipients to enhance the stability and efficacy of innovative biotherapeutics. In fact, over the past three decades biopharmaceutical manufacturers have developed some exceptional excipients which claim to increase the biopharmaceutical formulation shelf life by three times.

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: KEY INSIGHTS

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

• Presently, around 45 players claim to provide various types of biopharmaceutical excipients to biologic developers; these companies operate in compliance to global regulatory standards.
• In order to cater to the evolving needs of sponsors, companies offering biopharmaceutical excipients have established their presence in various geographical regions.

• The market landscape is fragmented, featuring the presence of both established players and new entrants involved in the manufacturing of excipients for different types of biologics.
• Close to 90% of companies claim to have the required capabilities and expertise to offer excipients for liquid drug formulations at all scales of operations.
• Although majority (~75%) of the manufacturers are based in developed regions, many players have recently emerged in some Asian countries, such as India and China.
• Nearly 60% of the manufacturers claim to provide biopharmaceutical excipients for vaccines and protein / peptide-based therapeutics.
• Companies are steadily expanding their existing capabilities in order to enhance their respective portfolios and drive compliance to evolving industry benchmarks.
• A rise in partnerships, focused on biopharmaceutical excipients, validates the growing interest of stakeholders in this domain; maximum number of such deals were signed in the last three years.
• Since 2020, the partnership activity has increased at a steady pace in this domain. It is worth mentioning that majority of the deals were established in the last two years.
• Over 40 agreements have been inked in the last 5 years in this domain; 32% of which were distribution agreements. Other popular types of partnership models adopted by players engaged in this domain include acquisitions (23%) and supply agreements (13%).
• Established players have forged multiple deals for biopharma excipients; most of these were focused on distribution of proprietary biopharmaceutical excipients.
• Examples of firms that have signed multiple deals within North America include (in alphabetical order) ABITEC, Aceto, Evonik, Merck and Roquette.
• To keep pace with the growing demand for biopharmaceutical excipients, manufacturers have undertaken many expansion initiatives in the recent past; ~80% of such instances involved facilities based in Europe.
• More than 45% of expansion initiatives were focused on capacity expansion of manufacturing facilities, followed by those undertaken for expanding existing facilities (43%). It is worth mentioning that most of the expansion initiatives (78%) were carried out in Europe and North America.
• The supply-side of this market is driven by mid-sized and large biopharmaceutical excipient manufacturers; interestingly, close to 40% of the currently available capacity is installed in production plants located in Europe.
• Approximately 95% of the total installed capacity is dedicated to commercial scale manufacturing. The remaining 5% of the installed capacity is focused on preclinical / clinical scale manufacturing of biopharmaceutical excipients. In addition, over 50% of the total current global, installed biopharmaceutical excipient manufacturing capacity is installed in Europe.
• With the growing focus on biologics based therapeutic interventions, the biopharmaceutical excipients market is likely to grow at a steady pace over the next decade.
• The opportunity is expected to be segregated across a variety of biologics, scales of operation and key geographical regions.
• North America and Europe are anticipated to capture over 70% of the market share by 2035. In addition, the market in Asia Pacific is likely to grow at a relatively faster pace (6.4%) in the long term. Further, in 2035, biopharmaceutical excipient manufacturing market for antibodies is expected to capture the majority share (~52%) of the total market.

Example Players in the Biopharmaceutical Excipients Market

• ABITEC
• Avantor
• BASF
• Corden Pharma
• DFE Pharma
• Evonik
• Kirsch Pharma
• Merck KGaA
• Pfanstiehl
• Roquette
• Spectrum Chemical Manufacturing
• SPI Pharma

GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global biopharmaceutical excipients market, focusing on key market segments, including [A] type of biologics, [B] type of excipient, [C] company size, [D] scale of operation and [E] key geographical regions.
• Market Landscape: A comprehensive evaluation of the current biopharmaceutical excipients, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facilities, [E] type of excipient, [F] scale of operation, [G] type of formulation, [H] type of biologic and [I] global regulatory compliance.
• Company Competitiveness Analysis: A comprehensive competitive analysis of biopharmaceutical excipient manufacturers, examining factors, such as [A] supplier power and [B] company competitiveness.
• Company Profiles: In-depth profiles of companies engaged in this domain, focused on [A] company overview, [B] financial information (if available), [C] biopharmaceutical excipients portfolio, [D] manufacturing facilities and [E] recent developments and an informed future outlook.
• Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the biopharmaceutical excipient market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] type of excipient, [D] type of drug molecule, [E] most active players (in terms of the number of partnerships signed) and [F] geography.
• Recent Expansions: In-depth analysis of recent expansions undertaken by various biopharmaceutical excipient manufacturers, focused on [A] year of expansion, [B] type of expansion, [C] company size, [D] location of headquarters, [E] location of expanded facility, [F] type of excipient, [G] type of drug molecule, [H] most active players and [I] geographical distribution.
• Capacity Analysis: A detailed analysis of the global installed capacity for biopharmaceutical excipients considering the capacities of various biopharmaceutical excipient manufacturers, based on several relevant parameters, such as [A] company size, [B] scale of operation and [C] key geographical regions.

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. Biopharmaceutical Excipients
• 3.3. Properties of Ideal Excipients
• 3.4. Classification of Biopharmaceutical Excipients
  • 3.4.1. Classification based on Route of Administration
  • 3.4.2. Classification of Excipients based on Structure
  • 3.4.3. Classification of Excipients based on Function
  • 3.4.4. Classification based on Ability to Interfere with Metabolization and Efflux Mechanisms
• 3.5. Applications of Biopharmaceutical Excipients
• 3.6. Regulatory Scenario
• 3.7. Concluding Remarks

4. MARKET LANDSCAPE

• 4.1. Chapter Overview
• 4.2. Biopharmaceutical Excipient Manufacturers: Overall Market Landscape
  • 4.2.1. Analysis by Year of Establishment
  • 4.2.2. Analysis by Company Size
  • 4.2.3. Analysis by Location of Headquarters
  • 4.2.4. Analysis by Location of Biopharmaceutical Excipient Manufacturing Facilities
  • 4.2.5. Analysis by Type of Excipient based on Chemical Composition
  • 4.2.6. Analysis by Type of Excipient based on Function
  • 4.2.7. Analysis by Type of Excipient based on Chemical Structure
  • 4.2.8. Analysis by Scale of Operation
  • 4.2.9. Analysis by Type of Formulation
  • 4.2.10. Analysis by Type of Biologic
  • 4.2.11. Analysis by Global Regulatory Compliance

5. COMPANY COMPETITIVENESS ANALYSIS

• 5.1. Chapter Overview
• 5.2. Assumptions and Key Parameters
• 5.3. Methodology
• 5.4. Biopharmaceutical Excipient Manufacturers: Company Competitiveness Analysis
  • 5.4.1. Company Competitiveness Analysis: Small Companies
  • 5.4.2. Company Competitiveness Analysis: Mid-Sized Companies
  • 5.4.3. Company Competitiveness Analysis: Large Companies
  • 5.4.4. Company Competitiveness Analysis: Very Large Companies

6. COMPANY PROFILES: BIOPHARMACEUTICAL EXCIPIENT MANUFACTURERS

• 6.1. Chapter Overview
• 6.2. ABITEC
  • 6.2.1. Company Overview
  • 6.2.2. Biopharmaceutical Excipient Offerings
  • 6.2.3. Manufacturing Facilities
  • 6.2.4. Recent Developments and Future Outlook
• 6.3. Avantor
  • 6.3.1. Company Overview
  • 6.3.2. Financial Information
  • 6.3.3. Biopharmaceutical Excipient Offerings
  • 6.3.4. Manufacturing Facilities
  • 6.3.5. Recent Developments and Future Outlook
• 6.4. BASF Pharma
  • 6.4.1. Company Overview
  • 6.4.2. Financial Information
  • 6.4.3. Biopharmaceutical Excipient Offerings
  • 6.4.4. Manufacturing Facilities
  • 6.4.5. Recent Developments and Future Outlook
• 6.5. Corden Pharma
  • 6.5.1. Company Overview
  • 6.5.2. Biopharmaceutical Excipient Service Offerings
  • 6.5.3. Manufacturing Facilities
  • 6.5.4. Recent Developments and Future Outlook
• 6.6. DFE Pharma
  • 6.6.1. Company Overview
  • 6.6.2. Biopharmaceutical Excipient Offerings
  • 6.6.3. Manufacturing Facilities
  • 6.6.4. Recent Developments and Future Outlook
• 6.7. Evonik
  • 6.7.1. Company Overview
  • 6.7.2. Financial Information
  • 6.7.3. Biopharmaceutical Excipient Offerings
  • 6.7.4. Manufacturing Facilities
  • 6.7.5. Recent Developments and Future Outlook
• 6.8. Kirsch Pharma
  • 6.8.1. Company Overview
  • 6.8.2. Biopharmaceutical Excipient Offerings
  • 6.8.3. Manufacturing Facilities
  • 6.8.4. Recent Developments and Future Outlook
• 6.9. Merck KGaA
  • 6.9.1. Company Overview
  • 6.9.2. Financial Information
  • 6.9.3. Biopharmaceutical Excipient Offerings
  • 6.9.4. Manufacturing Facilities
  • 6.9.5. Recent Developments and Future Outlook
• 6.10. Pfanstiehl
  • 6.10.1. Company Overview
  • 6.10.2. Biopharmaceutical Excipient Offerings
  • 6.10.3. Manufacturing Facilities
  • 6.10.4. Recent Developments and Future Outlook
• 6.11. Roquette
  • 6.11.1. Company Overview
  • 6.11.2. Biopharmaceutical Excipient Offerings
  • 6.11.3. Manufacturing Facilities
  • 6.11.4. Recent Developments and Future Outlook
• 6.12. Spectrum Chemical Manufacturing
  • 6.12.1. Company Overview
  • 6.12.2. Biopharmaceutical Excipient Offerings
  • 6.12.3. Manufacturing Facilities
  • 6.12.4. Recent Developments and Future Outlook
• 6.13. SPI Pharma
  • 6.13.1. Company Overview
  • 6.13.2. Biopharmaceutical Excipient Offerings
  • 6.13.3. Manufacturing Facilities
  • 6.13.4. Recent Developments and Future Outlook

7. PARTNERSHIPS AND COLLABORATIONS

• 7.1. Chapter Overview
• 7.2. Partnership Models
• 7.3. Biopharmaceutical Excipients Manufacturing Market: Partnerships and Collaborations
  • 7.3.1. Analysis by Year of Partnership
  • 7.3.2. Analysis by Type of Partnership
  • 7.3.3. Analysis by Year and Type of Partnership
  • 7.3.4. Analysis by Type of Excipient
  • 7.3.5. Analysis by Type of Drug Molecule
  • 7.3.6. Most Active Players: Analysis by Number of Partnerships
  • 7.3.7. Analysis by Geography
    • 7.3.7.1. Intercontinental and Intracontinental Deals
    • 7.3.7.2. International and Local Deals

8. RECENT EXPANSIONS

• 8.1. Chapter Overview
• 8.2. Biopharmaceutical Excipient Manufacturing Market: Recent Expansions
  • 8.2.1. Analysis by Year of Expansion
  • 8.2.2. Analysis by Type of Expansion
  • 8.2.3. Analysis by Company Size and Location of Headquarters
  • 8.2.4. Analysis by Location of Expanded Facility
  • 8.2.5. Analysis by Type of Excipient
  • 8.2.6. Analysis by Type of Drug Molecule
  • 8.2.7. Most Active Players: Analysis by Number of Recent Expansions
  • 8.2.8. Geographical Analysis
    • 8.2.8.1. Region-wise Distribution
    • 8.2.8.2. Country-wise Distribution

9. CAPACITY ANALYSIS

• 9.1. Chapter Overview
• 9.2. Key Assumptions and Methodology
• 9.3. Biopharmaceutical Excipient Manufacturing: Installed Global Capacity
  • 9.3.1. Analysis by Company Size
  • 9.3.2. Analysis by Scale of Operation
  • 9.3.3. Analysis by Location of Manufacturing Facility
• 9.4. Concluding Remarks

10. MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 10.1. Chapter Overview
• 10.2. Forecast Methodology and Key Assumptions
• 10.3. Global Biopharmaceutical Excipient Manufacturing Market, Till 2035
• 10.4. Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Biologic
• 10.5. Biopharmaceutical Excipient Manufacturing Market: Distribution by Type of Excipient
• 10.6. Biopharmaceutical Excipient Manufacturing Market: Distribution by Company Size
• 10.7. Biopharmaceutical Excipient Manufacturing Market: Distribution by Scale of Operation
• 10.8. Biopharmaceutical Excipient Manufacturing Market: Distribution by Region
  • 10.8.1. Biopharmaceutical Excipient Manufacturing Market in North America, Till 2035
  • 10.8.2. Biopharmaceutical Excipient Manufacturing Market in Europe, Till 2035
  • 10.8.3. Biopharmaceutical Excipient Manufacturing Market in Asia Pacific, Till 2035
  • 10.8.4. Biopharmaceutical Excipient Manufacturing Market in Latin America, Till 2035
  • 10.8.5. Biopharmaceutical Excipient Manufacturing Market in MENA, Till 2035
  • 10.8.6. Biopharmaceutical Excipient Manufacturing Market in Rest of the World, Till 2035

11. CONCLUDING REMARKS

12. EXECUTIVE INSIGHTS

• 12.1. Chapter Overview
• 12.2. Company A
  • 12.2.1. Company Snapshot
  • 12.2.2. Interview Transcript: Biopharma Sales Director

13. APPENDIX 1: TABULATED DATA

14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS