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製剤開発アウトソーシング市場レポート：サービス、剤形、用途、エンドユーザー、地域別、2024年～2032年

Formulation Development Outsourcing Market Report by Service, Dosage Form, Application, End User, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 144 Pages
納期
2～3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=144.36円
製剤開発アウトソーシング市場レポート：サービス、剤形、用途、エンドユーザー、地域別、2024年～2032年
出版日: 2024年09月10日
発行: IMARC
ページ情報: 英文 144 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の製剤開発アウトソーシング市場の市場規模は2023年に242億米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけて5.6%の成長率（CAGR）を示し、2032年には404億米ドルに達すると予測しています。研究開発（R&D）コストの増加、専門知識の必要性の高まり、医薬品開発スケジュールの前倒し、規制の複雑化、製薬セクターの成長は、市場の成長を促進する主な要因の一部です。

製剤開発アウトソーシング市場分析：

  • 主な市場促進要因：研究開発（R&D）コストの上昇と専門知識に対するニーズの高まりが、市場促進要因として挙げられます。製薬企業は、経費削減と医薬品開発効率を高める先端技術へのアクセスを目的として、アウトソーシングを行うケースが増えています。
  • 主な市場動向：人工知能（AI）や機械学習（ML）などの先端技術を医薬品製剤の最適化に広く採用することが、同市場の主要動向となっています。また、製薬企業とアウトソーシング・プロバイダーとの戦略的パートナーシップや長期的な協力関係へのシフトも見られます。
  • 地理的動向：製剤開発アウトソーシング市場の概要によると、北米が市場の最大地域を占めています。研究開発（R&D）コストの高さ、専門知識の必要性の高まり、規制要件の厳しさ、医薬品開発加速への注目の高まりが、同地域全体の市場成長を牽引しています。
  • 競合情勢：製剤開発アウトソーシング業界の主な市場参入企業には、Aizant Drug Research Solutions Private Limited、Catalent Inc.、Charles River Laboratories、Dr. Reddy's Laboratories Ltd.、Emergent BioSolutions Inc.、Intertek Group plc、Irisys LLC（Recro Pharma）、Laboratory Corporation of America Holdings、Lonza Group AG、Piramal Pharma Solutions、Quotient Sciences、Syngene International Limited（Biocon Limited）、Thermo Fisher Scientific Inc.などがあります。
  • 課題と機会：市場は、規制遵守の複雑さ、知的財産権に関する懸念、厳格な品質管理の必要性など、さまざまな課題に直面しています。しかし、先進的な製剤への需要の高まり、個別化医療の成長、人工知能（AI）や機械学習（ML）のような技術の進歩など、いくつかの機会にも直面しています。

製剤開発アウトソーシング市場動向：

研究開発コストの上昇

製薬企業は研究開発（R&D）コストの高騰に直面しており、経費削減とリソースの効率的配分のために製剤開発のアウトソーシングを進めています。例えば、業界レポートによると、メルク・アンド・カンパニーの売上は2023年度に601億米ドルに達し、研究開発（R&D）投資は305億米ドルでピークに達します。1年間で126％という驚異的な伸びを示した同社の研究開発投資は、2023年の総収入の50.8％を占めることになります。同様に、ジョンソン・エンド・ジョンソン（J&J）は2023年に力強い財務成長を示し、収益の面で主要製薬企業となった。研究開発費では第3位で、約151億米ドルを投資しており、これは同社にとって記録的な数字です。製薬業界の拡大は、製剤開発アウトソーシング市場の収益を積極的に高めています。

専門知識へのニーズの高まり

製剤の複雑化に伴い、専門的な知識や高度な技術が必要とされるが、多くの製薬会社では社内で不足している場合があります。例えば、業界レポートによると、バイオシミラーなどのジェネリック医薬品輸出におけるインドの製薬会社の世界のプレゼンスは、国際市場、特に米国でのさらなる拡大への戦略的シフトを示しています。このため、米国FDAによる製剤開発に関するガイダンスは、インドの製薬企業にとってこの追求を可能にする重要な役割を果たします。製剤開発に関するガイダンスの草案は、特に米国市場を対象とした医薬品の製剤開発に関する規制要件とベストプラクティスの概要を示しています。これらのガイドラインを遵守することは、コンプライアンスを保証するだけでなく、医薬品の品質と有効性を高めることにもなります。インドの製薬業界の専門家によると、世界展開を目指すインドの製薬企業にとって、このような指針は国際基準を満たす高品質の製剤を開発するためのロードマップとなり、世界な舞台での信頼性と競合力を強化することになるといいます。アウトソーシング・パートナーは、医薬品の品質と有効性を高める洗練された製剤を開発するために必要なスキルと最先端技術を提供し、それによって前向きな製剤開発アウトソーシング市場展望を生み出しています。

高まる規制遵守

厳しい規制要件により、包括的でコンプライアンスに準拠した製剤プロセスが必要となるが、規制に関する専門知識を有するアウトソーシング・パートナーはこれを効果的に管理することができます。例えば、業界レポートによると、インドの製薬会社は2024年に新たな製造基準を満たさなければならないが、これは連邦保健省の通達によるものです。改正されたスケジュールMガイドラインでは、製薬会社は医薬品の回収についてライセンシング当局に通知し、製品の欠陥、劣化、製造不良を報告しなければならなくなります。これまでは、医薬品の回収をライセンシング当局に通知する規定はありません。これにより、市場の成長がさらに促進されることが期待されます。

本レポートで扱う主な質問

  • 世界の製剤開発アウトソーシング市場はこれまでどのように推移してきたか？
  • 世界の製剤開発アウトソーシング市場における促進要因、抑制要因、機会は何か？
  • 各駆動要因、抑制要因、機会が世界の製剤開発アウトソーシング市場に与える影響は？
  • 主要な地域市場とは？
  • 最も魅力的な製剤開発アウトソーシング市場はどの国か？
  • サービス別の市場内訳は？
  • 製剤開発アウトソーシング市場で最も魅力的なサービスは？
  • 剤形別の市場内訳は？
  • 製剤開発アウトソーシング市場で最も魅力的な剤形は？
  • 用途別の市場内訳は？
  • 製剤開発アウトソーシング市場で最も魅力的な用途は？
  • エンドユーザー別の市場内訳は？
  • 製剤開発アウトソーシング市場で最も魅力的なエンドユーザーは？
  • 市場の競合構造は？
  • 世界の製剤開発アウトソーシング市場における主要プレイヤー／企業は？

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界の製剤開発アウトソーシング市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：サービス別

  • プレフォーミュレーションサービス
    • 市場動向
    • 主要セグメント
      • 探索および前臨床サービス
      • 分析サービス
    • 市場予測
  • フォーミュレーション最適化
    • 市場動向
    • 主要セグメント
      • フェーズI
      • フェーズII
      • フェーズIII
      • フェーズIV
    • 市場予測

第7章 市場内訳：剤形別

  • 注射
    • 市場動向
    • 市場予測
  • 経口
    • 市場動向
    • 市場予測
  • 外用
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第8章 市場内訳：用途別

  • 腫瘍学
    • 市場動向
    • 市場予測
  • 遺伝性疾患
    • 市場動向
    • 市場予測
  • 神経学
    • 市場動向
    • 市場予測
  • 感染症
    • 市場動向
    • 市場予測
  • 呼吸器
    • 市場動向
    • 市場予測
  • 心臓血管
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第9章 市場内訳：エンドユーザー別

  • 製薬・バイオ医薬品企業
    • 市場動向
    • 市場予測
  • 政府機関および学術機関
    • 市場動向
    • 市場予測

第10章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第11章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第14章 価格分析

第15章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Aizant Drug Research Solutions Private Limited
    • Catalent Inc.
    • Charles River Laboratories
    • Dr. Reddy's Laboratories Ltd.
    • Emergent BioSolutions Inc.
    • Intertek Group plc
    • Irisys LLC（Recro Pharma）
    • Laboratory Corporation of America Holdings
    • Lonza Group AG
    • Piramal Pharma Solutions
    • Quotient Sciences
    • Syngene International Limited（Biocon Limited）
    • Thermo Fisher Scientific Inc.
図表

List of Figures

  • Figure 1: Global: Formulation Development Outsourcing Market: Major Drivers and Challenges
  • Figure 2: Global: Formulation Development Outsourcing Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Formulation Development Outsourcing Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 4: Global: Formulation Development Outsourcing Market: Breakup by Service (in %), 2023
  • Figure 5: Global: Formulation Development Outsourcing Market: Breakup by Dosage Form (in %), 2023
  • Figure 6: Global: Formulation Development Outsourcing Market: Breakup by Application (in %), 2023
  • Figure 7: Global: Formulation Development Outsourcing Market: Breakup by End User (in %), 2023
  • Figure 8: Global: Formulation Development Outsourcing Market: Breakup by Region (in %), 2023
  • Figure 9: Global: Formulation Development Outsourcing (Pre-formulation Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 10: Global: Formulation Development Outsourcing (Pre-formulation Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 11: Global: Formulation Development Outsourcing (Formulation Optimization) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 12: Global: Formulation Development Outsourcing (Formulation Optimization) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 13: Global: Formulation Development Outsourcing (Injectable) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 14: Global: Formulation Development Outsourcing (Injectable) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Global: Formulation Development Outsourcing (Oral) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 16: Global: Formulation Development Outsourcing (Oral) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Global: Formulation Development Outsourcing (Topical) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 18: Global: Formulation Development Outsourcing (Topical) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Global: Formulation Development Outsourcing (Other Dosage Forms) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 20: Global: Formulation Development Outsourcing (Other Dosage Forms) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 21: Global: Formulation Development Outsourcing (Oncology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 22: Global: Formulation Development Outsourcing (Oncology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 23: Global: Formulation Development Outsourcing (Genetic Disorders) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 24: Global: Formulation Development Outsourcing (Genetic Disorders) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 25: Global: Formulation Development Outsourcing (Neurology) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 26: Global: Formulation Development Outsourcing (Neurology) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 27: Global: Formulation Development Outsourcing (Infectious Diseases) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 28: Global: Formulation Development Outsourcing (Infectious Diseases) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 29: Global: Formulation Development Outsourcing (Respiratory) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 30: Global: Formulation Development Outsourcing (Respiratory) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Global: Formulation Development Outsourcing (Cardiovascular) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 32: Global: Formulation Development Outsourcing (Cardiovascular) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Global: Formulation Development Outsourcing (Other Applications) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 34: Global: Formulation Development Outsourcing (Other Applications) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Global: Formulation Development Outsourcing (Pharmaceutical and Biopharmaceutical Companies) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 36: Global: Formulation Development Outsourcing (Pharmaceutical and Biopharmaceutical Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: Global: Formulation Development Outsourcing (Government and Academic Institutes) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 38: Global: Formulation Development Outsourcing (Government and Academic Institutes) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: North America: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 40: North America: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: United States: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 42: United States: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 43: Canada: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 44: Canada: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 45: Asia-Pacific: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 46: Asia-Pacific: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 47: China: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 48: China: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 49: Japan: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Japan: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 51: India: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 52: India: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 53: South Korea: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 54: South Korea: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 55: Australia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 56: Australia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 57: Indonesia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 58: Indonesia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 59: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 60: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 61: Europe: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 62: Europe: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 63: Germany: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 64: Germany: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 65: France: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 66: France: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 67: United Kingdom: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 68: United Kingdom: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 69: Italy: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 70: Italy: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 71: Spain: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 72: Spain: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 73: Russia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 74: Russia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 75: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 76: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 77: Latin America: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 78: Latin America: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 79: Brazil: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 80: Brazil: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 81: Mexico: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 82: Mexico: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 83: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 84: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 85: Middle East and Africa: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 86: Middle East and Africa: Formulation Development Outsourcing Market: Breakup by Country (in %), 2023
  • Figure 87: Middle East and Africa: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 88: Global: Formulation Development Outsourcing Industry: SWOT Analysis
  • Figure 89: Global: Formulation Development Outsourcing Industry: Value Chain Analysis
  • Figure 90: Global: Formulation Development Outsourcing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Formulation Development Outsourcing Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Formulation Development Outsourcing Market Forecast: Breakup by Service (in Million US$), 2024-2032
  • Table 3: Global: Formulation Development Outsourcing Market Forecast: Breakup by Dosage Form (in Million US$), 2024-2032
  • Table 4: Global: Formulation Development Outsourcing Market Forecast: Breakup by Application (in Million US$), 2024-2032
  • Table 5: Global: Formulation Development Outsourcing Market Forecast: Breakup by End User (in Million US$), 2024-2032
  • Table 6: Global: Formulation Development Outsourcing Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 7: Global: Formulation Development Outsourcing Market: Competitive Structure
  • Table 8: Global: Formulation Development Outsourcing Market: Key Players
目次
Product Code: SR112024A4747

The global formulation development outsourcing market size reached US$ 24.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 40.4 Billion by 2032, exhibiting a growth rate (CAGR) of 5.6% during 2024-2032. The increasing research and development (R&D) costs, the rising need for specialized expertise, accelerated drug development timelines, growing regulatory complexities, and the growing pharmaceutical sector are some of the major factors propelling the growth of the market.

Formulation Development Outsourcing Market Analysis:

  • Major Market Drivers: The rising research and development (R&D) costs and the growing need for specialized expertise represent the major drivers of the market. Pharmaceutical companies increasingly outsource to reduce expenses and access advanced technologies that enhance drug development efficiency.
  • Key Market Trends: The widespread adoption of advanced technologies such as artificial intelligence (AI) and machine learning (ML) to optimize drug formulations represents the key trend of the market. The market also experiences a shift toward strategic partnerships and long-term collaborations between pharmaceutical companies and outsourcing providers.
  • Geographical Trends: According to the formulation development outsourcing market overview, North America accounts for the largest region in the market. The high research and development (R&D) costs, the rising need for specialized expertise, strict regulatory requirements, and the increasing focus on accelerating drug development are driving the growth of the market across the region.
  • Competitive Landscape: Some of the major market players in the formulation development outsourcing industry include Aizant Drug Research Solutions Private Limited, Catalent Inc., Charles River Laboratories, Dr. Reddy's Laboratories Ltd., Emergent BioSolutions Inc., Intertek Group plc, Irisys LLC (Recro Pharma), Laboratory Corporation of America Holdings, Lonza Group AG, Piramal Pharma Solutions, Quotient Sciences, Syngene International Limited (Biocon Limited), and Thermo Fisher Scientific Inc., among many others.
  • Challenges and Opportunities: The market faces various challenges including regulatory compliance complexities, intellectual property concerns, and the need for stringent quality control. However, the market also faces several opportunities such as the increasing demand for advanced drug formulations, the growth of personalized medicine, and technological advancements like artificial intelligence (AI) and machine learning (ML).

Formulation Development Outsourcing Market Trends:

Rising Research and Development (R&D) Costs

Pharmaceutical companies face high costs in research and development (R&D), prompting them to outsource formulation development to reduce expenses and allocate resources more efficiently. For instance, according to industry reports, Merck & Co's revenues reached $60.1bn in FY 2023, with research and development (R&D) investments peaking at $30.5bn. Displaying a staggering 126% growth over the course of one year, the company's research and development (R&D) investments now represent 50.8% of its total revenue for 2023. Similarly, in 2023 Johnson & Johnson (J&J) displayed strong financial growth and was the leading pharmaceutical company in terms of revenues. The pharma giant ranked third in terms of R&D expenditure, investing approximately $15.1bna record-breaking figure for the company. The pharmaceutical industry's expansion is positively enhancing the formulation development outsourcing market revenue.

Increasing Need for Specialized Expertise

The growing complexity of drug formulations requires specialized expertise and advanced technologies, which many pharmaceutical companies may lack internally. For instance, according to industry reports, Indian pharma's global presence in generic medicine exports among others like biosimilars will indicate a strategic shift toward further expansion in the international markets, particularly the US. To this end, the guidance from the US FDA on formulation development serves as a crucial enabler for Indian pharma companies in this pursuit. The draft guidance on formulation development outlines the regulatory requirements and best practices for developing drug formulations, especially those intended for the US market. Adhering to these guidelines not only ensures compliance but also enhances the quality and efficacy of pharmaceutical products. According to Indian pharma industry experts, for Indian pharmaceutical firms eyeing global expansion, such guidance provides a roadmap for developing high-quality formulations that meet international standards, thereby bolstering their credibility and competitiveness in the global arena. Outsourcing partners offer the necessary skills and cutting-edge technologies to develop sophisticated drug formulations that enhance the quality and efficacy of pharmaceutical products, thereby creating a positive formulation development outsourcing market outlook.

Growing Regulatory Compliance

Stringent regulatory requirements necessitate comprehensive and compliant formulation processes, which outsourcing partners with regulatory expertise can effectively manage. For instance, according to industry reports, Indian pharmaceutical companies must meet new manufacturing standards in 2024, as per a Union Health Ministry notification, although small companies have asked for a delay, citing their debt load. Under the revised Schedule M guidelines, pharmaceutical companies will have to inform the licensing authority about recalling a drug and report product defects, deterioration, or faulty production. Till now there was no provision for informing the licensing authority about drug recall. This is further expected to facilitate the market growth.

Formulation Development Outsourcing Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on service, dosage form, application, and end user.

Breakup by Service:

  • Pre-formulation Services
    • Discovery and Preclinical Services
    • Analytical Services
  • Formulation Optimization
    • Phase I
    • Phase II
    • Phase III
    • Phase IV

Formulation Optimization accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the service. This includes pre-formulation services (discovery and preclinical services, analytical services) and formulation optimization (Phase I, Phase II, Phase III, and Phase IV). According to the report, formulation optimization represented the largest segment.

The demand for formulation optimization in the market is driven by the need for enhanced drug efficacy, stability, and bioavailability. Increasing regulatory scrutiny necessitates robust and compliant formulations. Additionally, the rise of complex and personalized medicines requires precise formulation techniques. Outsourcing provides access to specialized expertise and advanced technologies, enabling efficient optimization. Moreover, the pressure to accelerate time-to-market and reduce development costs further fuels the demand for optimized formulations in the pharmaceutical industry. For instance, in July 2024, Pfizer announced that it had selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Looking ahead, Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.

Breakup by Dosage Form:

  • Injectable
  • Oral
  • Topical
  • Others

Injectable holds the largest share of the industry

A detailed breakup and analysis of the market based on the dosage form have also been provided in the formulation development outsourcing market report. This includes injectable, oral, topical, and others. According to the report, injectable accounted for the largest market share.

The demand for injectable dosage forms in the market is driven by the growing prevalence of chronic diseases and the need for targeted and controlled drug delivery. Injectable forms offer rapid absorption and bioavailability, essential for critical care and biologic drugs. Additionally, the rise in biologics and biosimilars, which are predominantly administered via injection, fuels this demand. Outsourcing provides access to specialized manufacturing capabilities and regulatory expertise, ensuring high-quality and compliant injectable formulations. This, in turn, is enhancing the overall formulation development outsourcing market value.

Breakup by Application:

  • Oncology
  • Genetic Disorders
  • Neurology
  • Infectious Diseases
  • Respiratory
  • Cardiovascular
  • Others

Oncology represents the leading market segment

The report has provided a detailed breakup and analysis of the market based on the application. This includes oncology, genetic disorders, neurology, infectious diseases, respiratory, cardiovascular, and others. According to the report, oncology represented the largest segment.

The demand for formulation development outsourcing in oncology is driven by the complexity of cancer treatments and the need for specialized expertise. Advancements in targeted therapies and personalized medicine require innovative formulation techniques. High research and development (R&D) costs and stringent regulatory requirements also necessitate outsourcing to manage these challenges efficiently which is driving the formulation development outsourcing demand. Additionally, the urgency to accelerate time-to-market for new cancer drugs pushes pharmaceutical companies to seek external partners with advanced technologies and experience in oncology formulation development.

Breakup by End User:

  • Pharmaceutical and Biopharmaceutical Companies
  • Government and Academic Institutes

Pharmaceutical and biopharmaceutical companies exhibits a clear dominance in the market

A detailed breakup and analysis of the market based on the end user have also been provided in the report. This includes pharmaceutical and biopharmaceutical companies and government and academic institutes. According to the report, pharmaceutical and biopharmaceutical companies accounted for the largest market share.

The demand for formulation development outsourcing in pharmaceutical and biopharmaceutical companies is driven by high research and development (R&D) costs, the need for specialized expertise, and advanced technologies. Outsourcing helps accelerate drug development timelines and ensures regulatory compliance. The complexity of new drug formulations, including biologics and personalized medicines, necessitates external expertise which is further influencing formulation development outsourcing market growth positively. Additionally, outsourcing allows companies to focus on core competencies while leveraging innovative solutions from specialized partners to enhance drug efficacy, stability, and market readiness.

Breakup by Region:

  • North America
    • United States
    • Canada
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

North America leads the market, accounting for the largest formulation development outsourcing market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for formulation development outsourcing.

The high research and development (R&D) costs and the need for specialized expertise to develop complex drug formulations are driving the market growth in the region. The region's stringent regulatory environment necessitates compliance with rigorous standards, which outsourcing partners can manage efficiently. Additionally, the rise of biotechnology and personalized medicine requires advanced formulation solutions, further boosting the demand for outsourcing. According to the formulation development outsourcing market forecast across the region, the pressure to accelerate drug development timelines and reduce time-to-market also contributes to the growth of this market. For instance, in May 2024, Coriolis Pharma, a globally operating service provider for R&D and GMP drug product development, R&D and GMP analytics, and sterile drug product manufacturing support, announced the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise. U.S. customers will be served by the U.S.-based Coriolis commercial organization, which consists of business development and client project management professionals.

Competitive Landscape:

  • The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the formulation development outsourcing industry include Aizant Drug Research Solutions Private Limited, Catalent Inc., Charles River Laboratories, Dr. Reddy's Laboratories Ltd., Emergent BioSolutions Inc., Intertek Group plc, Irisys LLC (Recro Pharma), Laboratory Corporation of America Holdings, Lonza Group AG, Piramal Pharma Solutions, Quotient Sciences, Syngene International Limited (Biocon Limited) and Thermo Fisher Scientific Inc.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

  • The market for formulation development outsourcing is highly competitive, with numerous players offering specialized services. These formulation development outsourcing companies include Catalent, Lonza, and Charles River Laboratories, known for their extensive expertise and advanced technologies. Emerging firms and niche providers also compete by offering tailored solutions and innovative approaches. For instance, in April 2024, Charles River Laboratories launched its Alternative Methods Advancement Project (AMAP), an initiative to develop alternatives to reduce animal testing and to drive a new standard for drug discovery and development. The company's initial investment was $200 million over the past four years and its five-year goal is to invest an additional $300 million. This investment spans a portfolio of technology innovations, partnerships, and advocacy efforts to reduce the use of animal testing.

Formulation Development Outsourcing Market News:

  • In February 2023, Quotient Sciences, the drug development and manufacturing accelerator, announced that it had completed an expansion of its early-phase formulation development capabilities for oral dosage forms at its Nottingham, UK, facility. The expanded services build upon the site's existing formulation capabilities and increase capacity to support fully integrated drug development programs through the company's flagship platform, Translational Pharmaceutics.
  • In May 2024, AGC Biologics, a CDMO, and BioConnection, a CMO, agreed to partner to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug products using the development and manufacturing expertise of AGC Biologics and the specialized aseptic filling capabilities of BioConnection.
  • In October 2023, Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, announced the extension of a collaboration with a major biopharmaceutical partner for the commercial-scale filling of ADCs.

Key Questions Answered in This Report:

  • How has the global formulation development outsourcing market performed so far, and how will it perform in the coming years?
  • What are the drivers, restraints, and opportunities in the global formulation development outsourcing market?
  • What is the impact of each driver, restraint, and opportunity on the global formulation development outsourcing market?
  • What are the key regional markets?
  • Which countries represent the most attractive formulation development outsourcing market?
  • What is the breakup of the market based on the service?
  • Which is the most attractive service in the formulation development outsourcing market?
  • What is the breakup of the market based on the dosage form?
  • Which is the most attractive dosage form in the formulation development outsourcing market?
  • What is the breakup of the market based on the application?
  • Which is the most attractive application in the formulation development outsourcing market?
  • What is the breakup of the market based on the end user?
  • Which is the most attractive end user in the formulation development outsourcing market?
  • What is the competitive structure of the market?
  • Who are the key players/companies in the global formulation development outsourcing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Formulation Development Outsourcing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Service

  • 6.1 Pre-formulation Services
    • 6.1.1 Market Trends
    • 6.1.2 Key Segments
      • 6.1.2.1 Discovery and Preclinical Services
      • 6.1.2.2 Analytical Services
    • 6.1.3 Market Forecast
  • 6.2 Formulation Optimization
    • 6.2.1 Market Trends
    • 6.2.2 Key Segments
      • 6.2.2.1 Phase I
      • 6.2.2.2 Phase II
      • 6.2.2.3 Phase III
      • 6.2.2.4 Phase IV
    • 6.2.3 Market Forecast

7 Market Breakup by Dosage Form

  • 7.1 Injectable
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Oral
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Topical
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Others
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Oncology
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Genetic Disorders
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Neurology
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Infectious Diseases
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Respiratory
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast
  • 8.6 Cardiovascular
    • 8.6.1 Market Trends
    • 8.6.2 Market Forecast
  • 8.7 Others
    • 8.7.1 Market Trends
    • 8.7.2 Market Forecast

9 Market Breakup by End User

  • 9.1 Pharmaceutical and Biopharmaceutical Companies
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Government and Academic Institutes
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 United States
      • 10.1.1.1 Market Trends
      • 10.1.1.2 Market Forecast
    • 10.1.2 Canada
      • 10.1.2.1 Market Trends
      • 10.1.2.2 Market Forecast
  • 10.2 Asia-Pacific
    • 10.2.1 China
      • 10.2.1.1 Market Trends
      • 10.2.1.2 Market Forecast
    • 10.2.2 Japan
      • 10.2.2.1 Market Trends
      • 10.2.2.2 Market Forecast
    • 10.2.3 India
      • 10.2.3.1 Market Trends
      • 10.2.3.2 Market Forecast
    • 10.2.4 South Korea
      • 10.2.4.1 Market Trends
      • 10.2.4.2 Market Forecast
    • 10.2.5 Australia
      • 10.2.5.1 Market Trends
      • 10.2.5.2 Market Forecast
    • 10.2.6 Indonesia
      • 10.2.6.1 Market Trends
      • 10.2.6.2 Market Forecast
    • 10.2.7 Others
      • 10.2.7.1 Market Trends
      • 10.2.7.2 Market Forecast
  • 10.3 Europe
    • 10.3.1 Germany
      • 10.3.1.1 Market Trends
      • 10.3.1.2 Market Forecast
    • 10.3.2 France
      • 10.3.2.1 Market Trends
      • 10.3.2.2 Market Forecast
    • 10.3.3 United Kingdom
      • 10.3.3.1 Market Trends
      • 10.3.3.2 Market Forecast
    • 10.3.4 Italy
      • 10.3.4.1 Market Trends
      • 10.3.4.2 Market Forecast
    • 10.3.5 Spain
      • 10.3.5.1 Market Trends
      • 10.3.5.2 Market Forecast
    • 10.3.6 Russia
      • 10.3.6.1 Market Trends
      • 10.3.6.2 Market Forecast
    • 10.3.7 Others
      • 10.3.7.1 Market Trends
      • 10.3.7.2 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Brazil
      • 10.4.1.1 Market Trends
      • 10.4.1.2 Market Forecast
    • 10.4.2 Mexico
      • 10.4.2.1 Market Trends
      • 10.4.2.2 Market Forecast
    • 10.4.3 Others
      • 10.4.3.1 Market Trends
      • 10.4.3.2 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Trends
    • 10.5.2 Market Breakup by Country
    • 10.5.3 Market Forecast

11 SWOT Analysis

  • 11.1 Overview
  • 11.2 Strengths
  • 11.3 Weaknesses
  • 11.4 Opportunities
  • 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

  • 13.1 Overview
  • 13.2 Bargaining Power of Buyers
  • 13.3 Bargaining Power of Suppliers
  • 13.4 Degree of Competition
  • 13.5 Threat of New Entrants
  • 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 Aizant Drug Research Solutions Private Limited
      • 15.3.1.1 Company Overview
      • 15.3.1.2 Product Portfolio
    • 15.3.2 Catalent Inc.
      • 15.3.2.1 Company Overview
      • 15.3.2.2 Product Portfolio
      • 15.3.2.3 Financials
      • 15.3.2.4 SWOT Analysis
    • 15.3.3 Charles River Laboratories
      • 15.3.3.1 Company Overview
      • 15.3.3.2 Product Portfolio
      • 15.3.3.3 Financials
      • 15.3.3.4 SWOT Analysis
    • 15.3.4 Dr. Reddy's Laboratories Ltd.
      • 15.3.4.1 Company Overview
      • 15.3.4.2 Product Portfolio
      • 15.3.4.3 Financials
      • 15.3.4.4 SWOT Analysis
    • 15.3.5 Emergent BioSolutions Inc.
      • 15.3.5.1 Company Overview
      • 15.3.5.2 Product Portfolio
      • 15.3.5.3 Financials
      • 15.3.5.4 SWOT Analysis
    • 15.3.6 Intertek Group plc
      • 15.3.6.1 Company Overview
      • 15.3.6.2 Product Portfolio
      • 15.3.6.3 Financials
      • 15.3.6.4 SWOT Analysis
    • 15.3.7 Irisys LLC (Recro Pharma)
      • 15.3.7.1 Company Overview
      • 15.3.7.2 Product Portfolio
    • 15.3.8 Laboratory Corporation of America Holdings
      • 15.3.8.1 Company Overview
      • 15.3.8.2 Product Portfolio
      • 15.3.8.3 Financials
      • 15.3.8.4 SWOT Analysis
    • 15.3.9 Lonza Group AG
      • 15.3.9.1 Company Overview
      • 15.3.9.2 Product Portfolio
      • 15.3.9.3 Financials
      • 15.3.9.4 SWOT Analysis
    • 15.3.10 Piramal Pharma Solutions
      • 15.3.10.1 Company Overview
      • 15.3.10.2 Product Portfolio
      • 15.3.10.3 Financials
    • 15.3.11 Quotient Sciences
      • 15.3.11.1 Company Overview
      • 15.3.11.2 Product Portfolio
    • 15.3.12 Syngene International Limited (Biocon Limited)
      • 15.3.12.1 Company Overview
      • 15.3.12.2 Product Portfolio
      • 15.3.12.3 Financials
    • 15.3.13 Thermo Fisher Scientific Inc.
      • 15.3.13.1 Company Overview
      • 15.3.13.2 Product Portfolio
      • 15.3.13.3 Financials
      • 15.3.13.4 SWOT Analysis