| 【英語タイトル】Pharmaceutical Continuous Manufacturing Market Size & Share Analysis - Growth Trends & Forecasts (2025-2030)
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 | ・商品コード：MOR884RE335
・発行会社（調査会社）：Mordor Intelligence
・発行日：2025年2月
・ページ数：約120
・レポート言語：英語
・レポート形式：PDF
・納品方法：Eメール（受注後2営業日）
・調査対象地域：グローバル
・産業分野：製薬
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❖ レポートの概要 ❖
世界の医薬品連続生産市場は2025年に7.3億米ドルと評価され、2030年には13.7億米ドルに達すると予測されており、年平均成長率は13.32％と他の多くの委託サービス分野を上回る見込みである。成長要因にはバイオ医薬品アウトソーシングの増加、コスト抑制圧力、経験豊富なCDMO（医薬品開発・製造受託機関）を優遇する規制環境が挙げられる。Industry 4.0技術（デジタルツイン、連続処理、リアルタイムリリース）への投資は効率性向上やサイクル短縮、失敗率低下を実現し、長期契約の獲得につながっている。一方、高薬理活性原薬（HPAPI）や先進的バイオ医薬品の供給制約が参入障壁を形成し、また「China+1」戦略が北米、欧州、アジア太平洋の新興拠点への分散を促進している。
2024年時点でサービス別では製剤製造が52.35％を占め、API製造は2030年まで年14.85％成長が見込まれる。分子タイプでは低分子が66.73％を占めつつ、バイオ医薬品は約14％成長と最も速い拡大を示す。運用規模別では商業生産が81.45％を占める一方、前臨床・臨床サービスは年14.18％で伸びる。顧客別では大手製薬が47.49％と最大シェアを持つが、バイオテク企業が年15％超で急成長している。地域別では北米が43.15％を占め優位を維持し、アジア太平洋は15.27％で最速成長している。
成長ドライバーとしては、バイオ医薬品アウトソーシング需要の増加（+2.8％）、コスト抑制圧力（+2.5％）、HPAPI供給制約（+2.1％）、規制の複雑化により経験豊富なCDMOが優位となる傾向（+1.9％）などがある。抑制要因としてはサプライチェーンや品質リスク（-1.5％）、規制監査強化（-0.9％）、mRNA分野での大手製薬の内製化（-0.7％）、高度人材不足（-0.6％）が挙げられる。
市場動向としては、バイオ医薬品の需要増により細胞治療・遺伝子治療、ウイルスベクター製造などでCDMOが不可欠なインフラとなっている。また製剤分野では固形製剤が依然主流であるが、注射剤など高付加価値製剤が成長を牽引している。商業生産では大規模契約が収益の柱であり、前臨床・臨床では連続生産設備が材料節約や迅速なスケールアップを可能にしている。顧客層では大手製薬が安定収益をもたらす一方、バイオテク企業は統合型サービスやリスクシェア型契約を重視して市場を拡大している。
地域別には北米が成熟した規制環境と資本投資によりリーダーシップを維持、アジア太平洋は人件費競争力と大規模投資により最速成長している。欧州もEMAガイドラインやバイオ医薬品クラスターを背景に堅調であり、中東・アフリカや南米も徐々に存在感を高めている。競争環境は中程度の分散状況にありながらも統合が進み、長期供給契約や共同投資を通じて差別化が進展している。大手から中堅まで幅広いCDMOが市場に参入し、今後も統合的なサービス提供と地域多角化が成長の鍵となる。 |
The pharmaceutical continuous manufacturing market is valued at USD 0.73 billion in 2025 and is on track to reach USD 1.37 billion by 2030, reflecting a 13.32% CAGR that outpaces most other contract-services segments. Demand is fueled by rising biologics outsourcing, mounting cost-containment pressure, and a regulatory environment that increasingly favors experienced CDMOs. Large-scale investments in Industry 4.0—digital twins, continuous processing, and real-time release—are improving efficiency, shortening cycle times, and lowering failure rates, allowing suppliers to secure premium, multi-year contracts. Capacity constraints in high-potency APIs (HPAPIs) and advanced biologics create natural barriers to entry, while “China + 1” reshoring strategies push sponsors to diversify footprints toward North America, Europe, and cost-competitive hubs across Asia-Pacific.
Segment Analysis
By Service Type: Formulation Drives Market Value
Finished dosage formulation generated 52.35% of 2024 revenues, underlining the premium commanded for converting APIs into patient-ready forms that comply with worldwide filing standards. Oral solids still dominate volume, yet sterile injectables, inhalables, and ophthalmics secure higher margins due to aseptic controls. The pharmaceutical continuous manufacturing market benefits as sponsors push rapid, small-batch changeovers made possible by continuous granulation and inline PAT. API manufacturing, while smaller in current share, is expected to post a 14.85% CAGR, reflecting unmet demand for HPAPI, peptide, and oligonucleotide lines capable of sub-microgram containment. Packaging and serialization are bolstered by DSCSA and EU FMD mandates that compel end-to-end traceability investments; CDMOs bundling these services capture greater wallet share and reduce supply-chain complexity for sponsors.
Growth in formulation is propelled by biopharma’s focus on patient-centric dosage forms—high-concentration biologics in pre-filled syringes, nano-enabled oral suspensions, and 505(b)(2) reformulations that extend life cycles. CDMOs like Serán BioScience are commissioning spray-drying and hot-melt-extrusion lines to improve bioavailability of poorly soluble drugs. Integrated analytical and regulatory consulting now accompany most manufacturing SOWs, helping clients shorten IND-to-NDA timelines. The pharmaceutical continuous manufacturing market is leveraging continuous tablet presses and modular isolators to cut footprint, minimize operator exposure, and accelerate changeovers, positioning service providers as critical enablers of cost-efficient launches.
By Molecule Type: Biologics Command Premium Positioning
Small molecules retain 66.73% share yet advance steadily on the back of oncology, CNS, and anti-infective pipelines. Mature process technologies, robust supply chains, and widening adoption of continuous flow reactors sustain competitiveness. Nevertheless, biologics represent the fastest-growing value pool: monoclonal antibodies, recombinants, and vaccines rely on bioreactors, single-use systems, and high-throughput purification that few sponsors wish to maintain in-house. The pharmaceutical continuous manufacturing market size for biologics is projected to reach USD 0.64 billion by 2030, expanding at nearly 14% CAGR as commercial cell-and-gene approvals multiply.
Capital inflow is evident in Charles River Laboratories’ expansion of its Memphis cell-therapy campus with nine new suites, as well as AstraZeneca’s USD 300 million cell-therapy site in Rockville. CDMOs with integrative analytical, viral-vector, and GMP plasmid services enjoy premium pricing and multi-product lock-ins. Continuous downstream bioprocessing, perfusion culture, and inline viral inactivation are boosting yields while shrinking batch footprints, reinforcing biologics as the value driver within the pharmaceutical continuous manufacturing market.
1. Introduction
- 1.1 Study Assumptions & Market Definition
- 1.2 Scope of the Study
2. Research Methodology
3. Executive Summary
4. Market Landscape
- 4.1 Market Overview
- 4.2 Market Drivers
- 4.2.1 Rising Demand For Biologics Outsourcing
- 4.2.2 Cost-Containment Pressure On Pharma Innovators
- 4.2.3 Capacity Constraints For High-Potency Apis
- 4.2.4 Regulatory Complexity Favouring Experienced Cmos
- 4.2.5 Multi-Regional “China + 1” Reshoring Strategies
- 4.2.6 Industry 4.0 Technologies—Digital Twins, Real-Time Release, And Continuous Manufacturing
- 4.3 Market Restraints
- 4.3.1 Supply-Chain And Quality-Failure Risk
- 4.3.2 Intensifying Regulatory Audits & Warning Letters
- 4.3.3 Big-Pharma Insourcing For Strategic Mrna Platforms
- 4.3.4 Skilled-Talent Shortage At Advanced-Modality Cmos
- 4.4 Value / Supply-Chain Analysis
- 4.5 Regulatory Landscape
- 4.6 Technological Outlook
- 4.7 Porter’s Five Forces Analysis
- 4.7.1 Threat of New Entrants
- 4.7.2 Bargaining Power of Buyers
- 4.7.3 Bargaining Power of Suppliers
- 4.7.4 Threat of Substitutes
- 4.7.5 Competitive Rivalry
5. Market Size & Growth Forecasts (Value)
- 5.1 By Service Type
- 5.1.1 API Manufacturing
- 5.1.2 Finished Dosage Formulation
- 5.1.2.1 Oral Solids
- 5.1.2.2 Parenterals
- 5.1.2.3 Topicals & Others
- 5.1.3 Packaging & Serialization
- 5.1.4 Other Support Services
- 5.2 By Molecule Type
- 5.2.1 Small Molecules
- 5.2.2 Large Molecules (Biologics)
- 5.2.2.1 mAbs
- 5.2.2.2 Cell & Gene Therapy
- 5.2.2.3 Vaccines & Others
- 5.3 By Scale of Operation
- 5.3.1 Pre-clinical & Clinical
- 5.3.2 Commercial
- 5.4 By Client Type
- 5.4.1 Big Pharma
- 5.4.2 Small & Mid-Sized Pharma
- 5.4.3 Biotech Companies
- 5.4.4 Generics Manufacturers
- 5.5 By Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia-Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East & Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East & Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America
6. Competitive Landscape
- 6.1 Market Concentration
- 6.2 Market Share Analysis
- 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
- 6.3.1 Lonza Group
- 6.3.2 Catalent Inc.
- 6.3.3 Thermo Fisher Scientific (Patheon)
- 6.3.4 Samsung Biologics
- 6.3.5 Recipharm AB
- 6.3.6 Siegfried Holding
- 6.3.7 WuXi AppTec
- 6.3.8 Jubilant Pharmova
- 6.3.9 Cambrex Corporation
- 6.3.10 Boehringer Ingelheim BioXcellence
- 6.3.11 Fareva
- 6.3.12 Delpharm
- 6.3.13 Famar
- 6.3.14 PCI Pharma Services
- 6.3.15 Ajinomoto Bio-Pharma Services
- 6.3.16 Piramal Pharma Solutions
- 6.3.17 Alcami Corporation
- 6.3.18 Aenova Group
- 6.3.19 BioVectra
- 6.3.20 Vetter Pharma
7. Market Opportunities & Future Outlook
- 7.1 White-space & Unmet-need Assessment
