世界のバイオテクノロジー受託製造市場は、2024年に約401億米ドルに達すると推定され、2025年から2035年の予測期間には11.10%という堅調な年平均成長率（CAGR）で拡大すると予測されています。バイオテクノロジー受託製造とは、プロセス開発、スケールアップ、商業生産において高度な能力を持つ専門サービスプロバイダーに、バイオ医薬品およびバイオシミラーの製造をアウトソーシングするものです。このモデルにより、製薬企業およびバイオテクノロジー企業は、業務効率を最適化し、設備投資を削減し、複雑なバイオ医薬品の市場投入までの時間を短縮することができます。市場の成長は、バイオ医薬品のパイプラインの増加、バイオシミラーの採用拡大、そして受託製造機関（CMO）の専門知識、インフラ、規制遵守能力を活用するために製造業務をアウトソーシングする傾向の高まりによって牽引されています。
バイオ医薬品およびバイオシミラーの製造は複雑化しており、高度な設備、厳格な品質管理、そして専門的な技術的専門知識が求められるため、バイオテクノロジー分野の受託製造の需要が急増しています。業界レポートによると、世界のバイオ医薬品市場は2023年と2024年に大幅な拡大が見込まれ、高容量の受託製造ソリューションへの需要が高まっています。さらに、製薬企業とCMO（受託製造受託機関）間の戦略的提携、合併、協業は、イノベーションの促進、生産能力の向上、そして市場リーチの拡大につながっています。しかしながら、規制当局の監視とバイオ医薬品製造の高コストは、小規模企業にとって課題となり、2025年から2035年の予測期間中の成長を抑制する可能性があります。
医薬品の種類別セグメントの中で、バイオ医薬品はバイオテクノロジー受託製造市場において圧倒的なシェアを占めると予想されており、予測期間を通じて最大のシェアを占めるでしょう。この優位性は、モノクローナル抗体、組み換えタンパク質、そして大容量の受託製造ソリューションを必要とするその他の先進治療薬の急速な開発と商業化が主な要因です。一方、バイオシミラーは、費用対効果の高さ、先行バイオ医薬品の特許満了、そして先進国市場と新興国市場の両方における採用の増加により、急成長セグメントとして台頭しています。バイオ医薬品は市場シェアにおいて依然として圧倒的な存在感を維持していますが、医療費の負担軽減と規制当局の承認取得の促進を背景に、バイオシミラーは大きな成長の可能性を秘めています。
サービス面では、プロセス開発、スケールアップ、商業生産能力を含む包括的なサービス提供により、受託開発製造（CDMO）が収益創出の大部分を占めています。このセグメントは、大規模な製造施設への投資なしに運用負担を軽減し、バイオ医薬品の生産を加速させることを目指す企業にとって極めて重要です。一方、確立されたバイオ医薬品の大量生産に対する継続的な需要により、純粋な受託製造サービスは引き続き着実に貢献しています。この二重市場のダイナミクスは、収益創出におけるCDMOの優位性と、運用効率と規制遵守への配慮から、従来の受託製造モデルが着実に採用されていることの両方を反映しています。
北アメリカは、確立されたCMO（受託製造受託機関）、高度なインフラ、そして強力なバイオ医薬品パイプラインの存在により、バイオテクノロジー受託製造市場において引き続き主導的な地位を維持しています。ヨーロッパは、堅牢な規制枠組み、大規模な研究開発投資、そしてバイオテクノロジー企業と製造パートナー間の活発な連携に支えられ、これに追随しています。一方、アジア太平洋地域は、バイオ医薬品生産の増加、政府の優遇措置、医療インフラの整備、そして中国やインドといった国々におけるコスト優位性に後押しされ、予測期間中に最も急速な成長を遂げる地域になると予測されています。ラテンアメリカと中東・アフリカは、戦略的パートナーシップとバイオ医薬品およびバイオシミラーの需要増加に牽引され、バイオテクノロジー受託製造能力を徐々に拡大しています。
本調査の目的は、近年における様々なセグメントおよび国における市場規模を定義し、今後数年間の価値を予測することです。本レポートは、調査対象国における業界の定性的および定量的側面の両方を網羅するように設計されています。また、市場の将来の成長を決定づける推進要因や課題といった重要な側面についても詳細な情報を提供しています。さらに、利害関係者が投資できるマイクロ市場における潜在的な機会、そして主要企業の競争環境と製品提供の詳細な分析も組み込んでいます。市場の詳細なセグメントとサブセグメントについては、上記で説明しました。
目次
Table of Contents
Chapter 1. Global Biotechnology Contract Manufacturing Market Report Scope & Methodology
1.1. Research Objective
1.2. Research Methodology
1.2.1. Forecast Model
1.2.2. Desk Research
1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
1.4.1. Market Definition
1.4.2. Market Segmentation
1.5. Research Assumption
1.5.1. Inclusion & Exclusion
1.5.2. Limitations
1.5.3. Years Considered for the Study
Chapter 2. Executive Summary
2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. key Findings
Chapter 3. Global Biotechnology Contract Manufacturing Market Forces Analysis
3.1. Market Forces Shaping The Global Biotechnology Contract Manufacturing Market (2024-2035)
3.2. Drivers
3.2.1. increasing pipeline of biologic drugs
3.2.2. rising adoption of biosimilars
3.3. Restraints
3.3.1. high cost of biologics manufacturing
3.4. Opportunities
3.4.1. growing trend of outsourcing manufacturing
Chapter 4. Global Biotechnology Contract Manufacturing Industry Analysis
4.1. Porter’s 5 Forces Model
4.1.1. Bargaining Power of Buyer
4.1.2. Bargaining Power of Supplier
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.2. Porter’s 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
4.3.1. Political
4.3.2. Economical
4.3.3. Social
4.3.4. Technological
4.3.5. Environmental
4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion
Chapter 5. Global Biotechnology Contract Manufacturing Market Size & Forecasts by Source 2025-2035
5.1. Market Overview
5.2. Global Biotechnology Contract Manufacturing Market Performance - Potential Analysis (2025)
5.3. Human-derived
5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.3.2. Market size analysis, by region, 2025-2035
5.4. Animal-derived
5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.4.2. Market size analysis, by region, 2025-2035
5.5. Microbial
5.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.5.2. Market size analysis, by region, 2025-2035
5.6. Plant-based
5.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.6.2. Market size analysis, by region, 2025-2035
Chapter 6. Global Biotechnology Contract Manufacturing Market Size & Forecasts by Service (Process Development) 2025-2035
6.1. Market Overview
6.2. Global Biotechnology Contract Manufacturing Market Performance - Potential Analysis (2025)
6.3. Cell Line Development
6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.3.2. Market size analysis, by region, 2025-2035
6.4. Upstream Processing
6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.4.2. Market size analysis, by region, 2025-2035
6.5. Downstream Processing
6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.5.2. Market size analysis, by region, 2025-2035
6.6. Analytical Services
6.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.6.2. Market size analysis, by region, 2025-2035
Chapter 7. Global Biotechnology Contract Manufacturing Market Size & Forecasts by Drug type 2025-2035
7.1. Market Overview
7.2. Global Biotechnology Contract Manufacturing Market Performance - Potential Analysis (2025)
7.3. Biologics
7.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
7.3.2. Market size analysis, by region, 2025-2035
7.4. Biosimilars
7.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
7.4.2. Market size analysis, by region, 2025-2035
Chapter 8. Global Biotechnology Contract Manufacturing Market Size & Forecasts by type 2025-2035
8.1. Market Overview
8.2. Global Biotechnology Contract Manufacturing Market Performance - Potential Analysis (2025)
8.3. Contract Manufacturing
8.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
8.3.2. Market size analysis, by region, 2025-2035
8.4. Contract Development and Manufacturing
8.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
8.4.2. Market size analysis, by region, 2025-2035
Chapter 9. Global Biotechnology Contract Manufacturing Market Size & Forecasts by Region 2025-2035
9.1. Growth Biotechnology Contract Manufacturing Market, Regional Market Snapshot
9.2. Top Leading & Emerging Countries
9.3. North America Biotechnology Contract Manufacturing Market
9.3.1. U.S. Biotechnology Contract Manufacturing Market
9.3.1.1. Source breakdown size & forecasts, 2025-2035
9.3.1.2. Service breakdown size & forecasts, 2025-2035
9.3.1.3. Drug type breakdown size & forecasts, 2025-2035
9.3.1.4. Type breakdown size & forecasts, 2025-2035
9.3.2. Canada Biotechnology Contract Manufacturing Market
9.3.2.1. Source breakdown size & forecasts, 2025-2035
9.3.2.2. Service breakdown size & forecasts, 2025-2035
9.3.2.3. Drug type breakdown size & forecasts, 2025-2035
9.3.2.4. Type breakdown size & forecasts, 2025-2035
9.4. Europe Biotechnology Contract Manufacturing Market
9.4.1. UK Biotechnology Contract Manufacturing Market
9.4.1.1. Source breakdown size & forecasts, 2025-2035
9.4.1.2. Service breakdown size & forecasts, 2025-2035
9.4.1.3. Drug type breakdown size & forecasts, 2025-2035
9.4.1.4. Type breakdown size & forecasts, 2025-2035
9.4.2. Germany Biotechnology Contract Manufacturing Market
9.4.2.1. Source breakdown size & forecasts, 2025-2035
9.4.2.2. Service breakdown size & forecasts, 2025-2035
9.4.2.3. Drug type breakdown size & forecasts, 2025-2035
9.4.2.4. Type breakdown size & forecasts, 2025-2035
9.4.3. France Biotechnology Contract Manufacturing Market
9.4.3.1. Source breakdown size & forecasts, 2025-2035
9.4.3.2. Service breakdown size & forecasts, 2025-2035
9.4.3.3. Drug type breakdown size & forecasts, 2025-2035
9.4.3.4. Type breakdown size & forecasts, 2025-2035
9.4.4. Spain Biotechnology Contract Manufacturing Market
9.4.4.1. Source breakdown size & forecasts, 2025-2035
9.4.4.2. Service breakdown size & forecasts, 2025-2035
9.4.4.3. Drug type breakdown size & forecasts, 2025-2035
9.4.4.4. Type breakdown size & forecasts, 2025-2035
9.4.5. Italy Biotechnology Contract Manufacturing Market
9.4.5.1. Source breakdown size & forecasts, 2025-2035
9.4.5.2. Service breakdown size & forecasts, 2025-2035
9.4.5.3. Drug type breakdown size & forecasts, 2025-2035
9.4.5.4. Type breakdown size & forecasts, 2025-2035
9.4.6. Rest of Europe Biotechnology Contract Manufacturing Market
9.4.6.1. Source breakdown size & forecasts, 2025-2035
9.4.6.2. Service breakdown size & forecasts, 2025-2035
9.4.6.3. Drug type breakdown size & forecasts, 2025-2035
9.4.6.4. Type breakdown size & forecasts, 2025-2035
9.5. Asia Pacific Biotechnology Contract Manufacturing Market
9.5.1. China Biotechnology Contract Manufacturing Market
9.5.1.1. Source breakdown size & forecasts, 2025-2035
9.5.1.2. Service breakdown size & forecasts, 2025-2035
9.5.1.3. Drug type breakdown size & forecasts, 2025-2035
9.5.1.4. Type breakdown size & forecasts, 2025-2035
9.5.2. India Biotechnology Contract Manufacturing Market
9.5.2.1. Source breakdown size & forecasts, 2025-2035
9.5.2.2. Service breakdown size & forecasts, 2025-2035
9.5.2.3. Drug type breakdown size & forecasts, 2025-2035
9.5.2.4. Type breakdown size & forecasts, 2025-2035
9.5.3. Japan Biotechnology Contract Manufacturing Market
9.5.3.1. Source breakdown size & forecasts, 2025-2035
9.5.3.2. Service breakdown size & forecasts, 2025-2035
9.5.3.3. Drug type breakdown size & forecasts, 2025-2035
9.5.3.4. Type breakdown size & forecasts, 2025-2035
9.5.4. Australia Biotechnology Contract Manufacturing Market
9.5.4.1. Source breakdown size & forecasts, 2025-2035
9.5.4.2. Service breakdown size & forecasts, 2025-2035
9.5.4.3. Drug type breakdown size & forecasts, 2025-2035
9.5.4.4. Type breakdown size & forecasts, 2025-2035
9.5.5. South Korea Biotechnology Contract Manufacturing Market
9.5.5.1. Source breakdown size & forecasts, 2025-2035
9.5.5.2. Service breakdown size & forecasts, 2025-2035
9.5.5.3. Drug type breakdown size & forecasts, 2025-2035
9.5.5.4. Type breakdown size & forecasts, 2025-2035
9.5.6. Rest of APAC Biotechnology Contract Manufacturing Market
9.5.6.1. Source breakdown size & forecasts, 2025-2035
9.5.6.2. Service breakdown size & forecasts, 2025-2035
9.5.6.3. Drug type breakdown size & forecasts, 2025-2035
9.5.6.4. Type breakdown size & forecasts, 2025-2035
9.6. Latin America Biotechnology Contract Manufacturing Market
9.6.1. Brazil Biotechnology Contract Manufacturing Market
9.6.1.1. Source breakdown size & forecasts, 2025-2035
9.6.1.2. Service breakdown size & forecasts, 2025-2035
9.6.1.3. Drug type breakdown size & forecasts, 2025-2035
9.6.1.4. Type breakdown size & forecasts, 2025-2035
9.6.2. Mexico Biotechnology Contract Manufacturing Market
9.6.2.1. Source breakdown size & forecasts, 2025-2035
9.6.2.2. Service breakdown size & forecasts, 2025-2035
9.6.2.3. Drug type breakdown size & forecasts, 2025-2035
9.6.2.4. Type breakdown size & forecasts, 2025-2035
9.7. Middle East and Africa Biotechnology Contract Manufacturing Market
9.7.1. UAE Biotechnology Contract Manufacturing Market
9.7.1.1. Source breakdown size & forecasts, 2025-2035
9.7.1.2. Service breakdown size & forecasts, 2025-2035
9.7.1.3. Drug type breakdown size & forecasts, 2025-2035
9.7.1.4. Type breakdown size & forecasts, 2025-2035
9.7.2. Saudi Arabia (KSA) Biotechnology Contract Manufacturing Market
9.7.2.1. Source breakdown size & forecasts, 2025-2035
9.7.2.2. Service breakdown size & forecasts, 2025-2035
9.7.2.3. Drug type breakdown size & forecasts, 2025-2035
9.7.2.4. Type breakdown size & forecasts, 2025-2035
9.7.3. South Africa Biotechnology Contract Manufacturing Market
9.7.3.1. Source breakdown size & forecasts, 2025-2035
9.7.3.2. Service breakdown size & forecasts, 2025-2035
9.7.3.3. Drug type breakdown size & forecasts, 2025-2035
9.7.3.4. Type breakdown size & forecasts, 2025-2035
Chapter 10. Competitive Intelligence
10.1. Top Market Strategies
10.2. Lonza Group AG
10.2.1. Company Overview
10.2.2. Key Executives
10.2.3. Company Snapshot
10.2.4. Financial Performance (Subject to Data Availability)
10.2.5. Product/Services Port
10.2.6. Recent Development
10.2.7. Market Strategies
10.2.8. SWOT Analysis
10.3. Samsung Biologics
10.4. WuXi AppTec
10.5. Catalent, Inc.
10.6. Boehringer Ingelheim GmbH
10.7. Fujifilm Diosynth Biotechnologies
10.8. Patheon N.V.
10.9. Recipharm AB
10.10. Baxter International Inc.
10.11. Cobra Biologics
10.12. Ajinomoto Bio-Pharma Services
10.13. Piramal Pharma Solutions
10.14. Sandoz International GmbH
10.15. Rentschler Biopharma SE
10.16. Novasep
List of Tables
Table 1. Global Biotechnology Contract Manufacturing Market, Report Scope
Table 2. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Region 2024-2035
Table 3. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 4. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 5. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 6. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 7. Global Biotechnology Contract Manufacturing Market Estimates & Forecasts By Segment 2024-2035
Table 8. U.S. Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 9. Canada Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 10. UK Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 11. Germany Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 12. France Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 13. Spain Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 14. Italy Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 15. Rest Of Europe Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 16. China Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 17. India Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 18. Japan Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 19. Australia Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
Table 20. South Korea Biotechnology Contract Manufacturing Market Estimates & Forecasts, 2024-2035
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List of Figures
Fig 1. Global Biotechnology Contract Manufacturing Market, Research Methodology
Fig 2. Global Biotechnology Contract Manufacturing Market, Market Estimation Techniques
Fig 3. Global Market Size Estimates & Forecast Methods
Fig 4. Global Biotechnology Contract Manufacturing Market, Key Trends 2025
Fig 5. Global Biotechnology Contract Manufacturing Market, Growth Prospects 2024-2035
Fig 6. Global Biotechnology Contract Manufacturing Market, Porter’s Five Forces Model
Fig 7. Global Biotechnology Contract Manufacturing Market, Pestel Analysis
Fig 8. Global Biotechnology Contract Manufacturing Market, Value Chain Analysis
Fig 9. Biotechnology Contract Manufacturing Market By Application, 2025 & 2035
Fig 10. Biotechnology Contract Manufacturing Market By Segment, 2025 & 2035
Fig 11. Biotechnology Contract Manufacturing Market By Segment, 2025 & 2035
Fig 12. Biotechnology Contract Manufacturing Market By Segment, 2025 & 2035
Fig 13. Biotechnology Contract Manufacturing Market By Segment, 2025 & 2035
Fig 14. North America Biotechnology Contract Manufacturing Market, 2025 & 2035
Fig 15. Europe Biotechnology Contract Manufacturing Market, 2025 & 2035
Fig 16. Asia Pacific Biotechnology Contract Manufacturing Market, 2025 & 2035
Fig 17. Latin America Biotechnology Contract Manufacturing Market, 2025 & 2035
Fig 18. Middle East & Africa Biotechnology Contract Manufacturing Market, 2025 & 2035
Fig 19. Global Biotechnology Contract Manufacturing Market, Company Market Share Analysis (2025)
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