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経口固形剤受託製造市場:最終剤形(錠剤、カプセル剤、粉末剤、多粒子剤、その他)、包装形態(ボトル、ブリスター、小袋、吸入剤、その他)、事業規模(プレコマーシャル、コマーシャル)、企業規模(小規模、中規模、大規模、超大規模)、治療領域(がん疾患、主要地域(北米、欧州、アジア太平洋、中南米、中東・北アフリカ):業界動向と世界予測


Oral Solid Dosage Contract Manufacturing Market: Distribution by Type of Finished Dosage Form (Tablets, Capsules, Powders, Multi-particulates and Others), Type of Packaging (Bottles, Blisters, Sachets, Inhalers and Others), Scale of Operation (Pre-commercial and Commercial), Company Size (Small, Mid-sized, Large and Very Large), Therapeutic Area (Oncological Disorders, Infectious Diseases, Cardiovascular Disorders, Metabolic Disorders, Neurological Disorders, Genetic Disorders, Respiratory Disorders, Immunological Disorders, and Other Disorders), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts

世界の経口固形剤受託製造市場は、2023年には210億米ドルに達し、予測期間2023-2035年には年平均成長率5%で成長すると予測されている。 医薬品有効成分(API)の複雑化に伴い、標的薬物送達を可能にする様々... もっと見る

 

 

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Roots Analysis
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2023年3月30日 US$4,799
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296 英語

 

サマリー

世界の経口固形剤受託製造市場は、2023年には210億米ドルに達し、予測期間2023-2035年には年平均成長率5%で成長すると予測されている。

医薬品有効成分(API)の複雑化に伴い、標的薬物送達を可能にする様々な革新的製剤が生み出されている。しかし、錠剤やカプセルのような経口固形製剤(OSD)の需要は依然として他の追随を許さず、世界中で処方される医薬品の3分の2以上を占めている。これらのOSDは、費用対効果、高分子に比べた安定性、患者の服薬アドヒアランスを大幅に向上させる投与の容易さなどの点で支持されている。経口投与低分子の注目度が高まるにつれて、服薬アドヒアランスの問題が解決され、薬物送達において重要な役割を果たすようになります。経口固形製剤のニーズが高まるにつれ、崩壊錠(ODT)から配合剤、徐放性製剤に至る改良型固形製剤の開発は、医薬品開発企業にとって、この競争の激しい成熟市場で抜きんでる大きなチャンスとなっています。これらの製剤は、原薬の溶解性を高め、バイオアベイラビリティを向上させ、市場の要求や患者の要求に応えることを目的としている。しかし、特殊な固形製剤、特に高活性原薬を用いた製剤の製造には、初期の製剤開発からスケールアップに至る複雑なプロセスが伴い、多様な専門知識と複数の分野の深い理解が要求される。その結果、医薬品開発企業は、専門的な機械と熟練したチームを擁する製造受託機関への依存度を高めている。これらの受託製造業者は、複雑な製剤、厳しい規制要件、複数のサプライヤーの対応など、技術的に複雑で運用上の課題に取り組んでいる。経口固形製剤は、特に小児や老年人口の間で広く嗜好されており、従来型製剤と改良型製剤の両方を含む経口固形製剤の受託製造市場は、当面の成長を大きく牽引すると予想される。

レポート対象範囲
 当レポートでは、完成剤形の種類、包装の種類、事業規模、企業規模、治療領域、主要地域など、さまざまなパラメータにわたって経口固形剤製造市場を調査しています。
 市場成長要因(促進要因、阻害要因、機会、課題を含む)の分析を行っています。
 本レポートでは、市場環境における関係者の潜在的な利点と課題を評価し、主要市場プレイヤー間の競争環境に関する洞察を提供しています。
 当レポートは、主要5地域に関する市場セグメントの収益予測を提供しています。
 包括的な調査を通じて、経口固形剤受託製造市場の詳細な分析を提示しています:
 経口固形製剤の種類と構成成分の説明、製造工程の概要、製造委託業務の新たな動向について論じています。
 経口固形剤製造サービスを提供する企業について、設立年、企業規模、所有者、提供サービス、製造剤形、包装タイプ、業務規模、追加能力に基づいて分析。
 経験、提供サービス、剤形、包装、業務規模、認証、施設所在地を考慮し、サプライヤーとサービスの強みに基 づいてメーカーの競争力を評価する。
 主要地域におけるメーカーの能力を調査し、提供サービス、剤形、包装、事業規模、施設所在地を詳述。
 著名な経口固形剤受託製造業者の詳細なプロフィール。会社概要、財務データ(入手可能な場合)、サービス・ポートフォリオ、製造能力、最近の動向、将来の展望を網羅。
 自社製造と経口固形剤製造のためのCMOまたはCDMOとの提携の間の医薬品開発者の意思決定に影響を与える要因に関する議論。
 2018年以降の拡張の分析、その目的、種類、企業間、事業規模、剤形、地域間の世界設置能力分布の推定。
 経口固形製剤の年間臨床需要および商業需要の推定と、20年間の製造施設の総所有コストの詳細な分析。
 各国の規制ガイドラインのレビュー、300以上のCMOの業務承認、認証、規制遵守の評価、主要地域の規制シナリオの比較分析。
 味覚マスキングとバイオアベイラビリティ向上サービスプロバイダーに関する詳細なケーススタディ(技術、事業規模、エンドユーザー、採用技術、地域能力、市場ランドスケープに関する情報を含む)。

主要市場企業
 アエノバ、アルカミ
 アルマック
 Cambrex
 キャタレント
 ヘテロドラッグス
 インドスウィフト
 ラボラトリーズ
 ロンザ
 ルビコンリサーチ

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目次

1. PREFACE
1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Type of Dosage Forms
3.3. Overview of Oral Solid Dosage Forms
3.3.1. Components of Oral Solid Dosage Forms
3.3.2. Classification of Oral Solid Dosage Forms
3.3.3. Manufacturing of Oral Solid Dosage Forms
3.3.4. Emerging Trends in Oral Solid Dosage Manufacturing
3.4. Overview of Oral Solid Contract Manufacturing
3.4.1. Services Offered by CMOs and CDMOs for Oral Solid Manufacturing
3.4.2. Key Considerations While Selecting a CDMO or CMO Partner
3.4.3. Risks and Challenges Associated with Outsourcing Pharmaceutical Manufacturing Operations
3.5. Future Perspectives
4. ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS (CMOs): MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Oral Solid Dosage CMOs: List of Companies
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 Company Ownership
4.2.5. Analysis by Type of Service(s) Offered
4.2.6. Analysis by Type of Finished Dosage Form
4.2.7. Analysis by Type of Tablet(S) Manufactured
4.2.8. Analysis by Type of Capsule(s) Manufactured
4.2.9. Analysis by Type of Multi-particulate(s) Manufactured
4.2.10. Analysis by Type of Primary Packaging Offered
4.2.11. Analysis by Scale of Operation
4.2.12. Analysis by High Potency Drug Manufacturing
4.2.13. Analysis by Availability of Continuous Manufacturing
4.2.14. Analysis by Regulatory Certifications / Accreditations
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions and Key Parameters
5.3. Methodology
5.4. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers in North America
5.4.1. Peer Group I: Companies in the US
5.4.2. Peer Group II: Companies in Canada
5.5. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Europe
5.5.1. Peer Group III: Companies in EU5
5.5.2. Peer Group IV: Other European Countries
5.6. Company Competitiveness Analysis: Oral Solid Contract Manufacturers based in Asia-Pacific and Rest of the World
5.6.1. Peer Group V: Companies in India
5.6.2. Peer Group VI: Companies in China
5.6.3. Peer Group VII: Companies in Japan
5.6.4. Peer Group VIII: Companies in Other Asia-Pacific and rest of the World
5.7. Company Competitiveness Analysis of Oral Solid Dosage Contract Manufacturers: Competitiveness Score of Top Service Providers
6. REGIONAL CAPABILITY ANALYSIS
6.1. Chapter Overview
6.2. Key Assumptions and Methodology
6.3. Overall Landscape of Oral Solid Dosage Contract Manufacturing Facilities
6.4. Oral Solid Dosage Contract Manufacturers in North America
6.5. Oral Solid Dosage Contract Manufacturers in Europe
6.6. Oral Solid Dosage Contract Manufacturers in Asia-Pacific and Rest of the World
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Oral Solid Dosage Contract Manufacturing Service Providers: North America
7.2.1. Alcami
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.2.1. Manufacturing Capabilities and Facilities
7.2.1.3. Recent Developments and Future Outlook
7.2.2. Cambrex
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.2.1. Manufacturing Capabilities and Facilities
7.2.2.3. Recent Developments and Future Outlook
7.2.3. Catalent
7.2.3.1. Company Overview
7.2.3.2. Financial Information
7.2.3.3. Service Portfolio
7.2.3.3.1. Manufacturing Capabilities and Facilities
7.2.3.4. Recent Developments and Future Outlook
7.3. Oral Solid Dosage Contract Manufacturing Service Providers: Europe
7.3.1. Aenova
7.3.1.1. Company Overview
7.3.1.2. Financial Information
7.3.1.3. Service Portfolio
7.3.1.3.1. Manufacturing Capabilities and Facilities
7.3.1.4. Recent Developments and Future Outlook
7.3.2. Almac
7.3.2.1. Company Overview
7.3.2.2. Financial Information
7.3.2.3. Service Portfolio
7.3.2.3.1. Manufacturing Capabilities and Facilities
7.3.2.4. Recent Developments and Future Outlook
7.3.3. Lonza
7.3.3.1. Company Overview
7.3.3.2. Financial Information
7.3.3.3. Service Portfolio
7.3.3.3.1. Manufacturing Capabilities and Facilities
7.3.3.4. Recent Developments and Future Outlook
7.4. Oral Solid Dosage Contract Manufacturing Service Providers: Asia-Pacific and Rest of the World
7.4.1. Hetero Drugs
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.2.1. Manufacturing Capabilities and Facilities
7.4.1.3. Recent Developments and Future Outlook
7.4.2. Ind-Swift Laboratories
7.4.2.1. Company Overview
7.4.2.2. Financial Information
7.4.2.3. Service Portfolio
7.4.2.3.1. Manufacturing Capabilities and Facilities
7.4.2.4. Recent Developments and Future Outlook
7.4.3. Rubicon Research
7.4.3.1. Company Overview
7.4.3.2. Service Portfolio
7.4.3.2.1. Manufacturing Capabilities and Facilities
7.4.3.3. Recent Developments and Future Outlook
8. MAKE VERSUS BUY DECISION FRAMEWORK
8.1. Chapter Overview
8.2. Assumptions and Key Parameters
8.3. Oral Solid Dosage Manufacturers: Make versus Buy Decision Making
8.3.1. Scenario 1
8.3.2. Scenario 2
8.3.3. Scenario 3
8.3.4. Scenario 4
8.4. Concluding Remarks
9. RECENT EXPANSIONS
9.1. Chapter Overview
9.2. Oral Solid Dosage Contract Manufacturers: Recent Expansions
9.2.1. Analysis by Year of Expansion
9.2.2. Analysis by Type of Expansion
9.2.3. Analysis by Year and Type of Expansion
9.2.4. Analysis by Type of Oral Solid Dosage Form(s) Involved
9.2.5. Analysis by Type of Expansion and Oral Solid Dosage Form(s) Involved
9.2.6. Analysis by Type of Service(s) Offered
9.2.7. Analysis by Scales of Operation
9.2.8. Analysis by Location of Facility
9.2.9. Expansions Focused on Highly Potent Compounds
10. CAPACITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.2.1. Oral Solid Dosage Contract Manufacturing: Annual Global Capacity (Number of Finished Dosages)
10.2.1.1. Analysis by Company Size
10.2.1.2. Analysis by Scale of Operation
10.2.1.3. Analysis by Type of Finished Dosage Form
10.2.1.4. Analysis by Location of Manufacturing Facility
10.2.1.5. Analysis by Company Size and Type of Finished Dosage Form
10.2.1.6. Analysis by Company Size and Location of Manufacturing Facility
10.2.1.7. Analysis by Scale of Operation and Location of Manufacturing Facility
10.2.2. Oral Solid Dosage Contract Manufacturing: Annual Global Capacity (Amount of API)
10.2.2.1. Analysis by Company Size
10.2.2.2. Analysis by Scale of Operation
10.2.2.3. Analysis by Type of Finished Dosage Form
10.2.2.4. Analysis by Company Size and Type of Finished Dosage Form
10.2.2.5. Analysis by Company Size and Location of Manufacturing Facility
10.2.2.6. Analysis by Scale of Operation and Location of Manufacturing Facility
11. DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Overall Annual Demand for Oral Solid Doses, 2023-2035
11.4. Annual Outsourced Commercial Demand for Oral Solid Doses, 2023-2035
11.4.1. Annual Outsourced Commercial Demand for Oral Solid Doses: Distribution by Geography, 2023 and 2035
11.4.1.1. Annual Outsourced Commercial Demand for Oral Solid Doses in North America, 2023-2035
11.4.1.2. Annual Outsourced Commercial Demand for Oral Solid Doses in Europe, 2023-2035
11.4.1.3. Annual Outsourced Commercial Demand for Oral Solid Doses in Asia-Pacific and Rest of the World, 2023-2035
11.4.2. Annual Outsourced Commercial Demand for Oral Solid Doses: Distribution by Therapeutic Area, 2023 and 2035
11.4.2.1. Annual Outsourced Commercial Demand for Oral Solid Doses for Oncological Disorders, 2023-2035
11.4.2.2. Annual Outsourced Commercial Demand for Oral Solid Doses for Infectious Diseases, 2023-2035
11.4.2.3. Annual Outsourced Commercial Demand for Oral Solid Doses for Cardiovascular Disorders, 2023-2035
11.4.2.4. Annual Outsourced Commercial Demand for Oral Solid Doses for Metabolic Disorders, 2023-2035
11.4.2.5. Annual Outsourced Commercial Demand for Oral Solid Doses for Neurological Disorders, 2023-2035
11.4.2.6. Annual Outsourced Commercial Demand for Oral Solid Doses for Genetic Disorders, 2023-2035
11.4.2.7. Annual Outsourced Commercial Demand for Oral Solid Doses for Respiratory Disorders, 2023-2035
11.4.2.8. Annual Outsourced Commercial Demand for Oral Solid Doses for Immunological Disorders, 2023-2035
11.4.2.9. Annual Outsourced Commercial Demand for Oral Solid Doses for Other Disorders, 2023-2035
11.5. Annual Outsourced Clinical Demand for Oral Solid Doses, 2023-2035
11.5.1. Annual Outsourced Clinical Demand for Oral Solid Doses: Distribution by Trial Phase, 2023-2035
11.5.1.1. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase I Trials, 2023-2035
11.5.1.2. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase II Trials, 2023-2035
11.5.1.3. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase III Trials, 2023-2035
11.6. Correlation between Annual Demand and Capacity
12. TOTAL COST OF OWNERSHIP FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS
12.1. Chapter Overview
12.2. Key Parameters
12.3. Assumptions and Methodology
12.4. Sample Dataset for the Estimation of Total Cost of Ownership
12.5. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations, Y0-Y20
12.6. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations: Analysis by CapEx and OpEx, Y0 and Y20
12.6.1. Total Cost of Ownership for Oral Solid Contract Manufacturing Organizations: Analysis by CapEx, Y0
12.6.2. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations: Analysis by OpEx, Y0-Y20
12.7. Concluding Remarks
13. REGULATORY LANDSCAPE FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURERS
13.1. Chapter Overview
13.2. Regulatory Guidelines in North America
13.2.1. The US Scenario
13.2.1. Canadian Scenario
13.3. Regulatory Guidelines in Europe
13.4. Regulatory Guidelines in Asia-Pacific and Rest of the World
13.4.1. Chinese Scenario
13.4.2. Indian Scenario
13.4.3. Japanese Scenario
13.4.4. South Korean Scenario
13.4.5. Australian Scenario
13.4.6. Brazilian Scenario
13.5. Oral Solid Dosage CMOs: Information on Approval From Various Regulatory Authorities
13.6. Bubble Analysis: Regional Regulatory Summary
14. CASE STUDY ON TASTE MASKING SERVICES AND TECHNOLOGIES: MARKET LANDSCAPE
14.1. Chapter Overview
14.2. Taste Masking and Taste Assessment Service Providers
14.2.1. Analysis by Year of Establishment
14.2.2. Analysis by Company Size
14.2.3. Analysis by Location of Headquarters
14.2.4. Analysis by Year of Establishment and Location of Headquarters
14.3. Taste Masking and Taste Assessment Services: Overall Market Landscape
14.3.1. Analysis by Service(s) Offered
14.3.2. Analysis by Scale of Operation
14.3.3. Analysis by Other Service(s) Offered
14.3.4. Analysis by Type of Formulation(s)
14.3.5. Analysis by End Users
14.3.6. Analysis by Techniques Used for Taste Masking
14.3.7. Analysis by Branch of Healthcare
14.3.8. Analysis by Regional Capability
15. CASE STUDY ON BIOAVAILABILITY ENHANCEMENT TECHNOLOGIES: MARKET LANDSCAPE
15.1. Chapter Overview
15.2. Bioavailability Enhancement Service Providers: Overall Market Landscape
15.2.1. Analysis by Year of Establishment
15.2.2. Analysis by Company Size
15.2.3. Analysis by Location of Headquarters
15.2.4. Analysis by Bioavailability Enhancement Principle
15.2.5. Analysis by Bioavailability Enhancement Approach
15.2.5.1. Analysis by Solid Dispersion Approaches
15.2.5.2. Analysis by Size Reduction Approaches
15.2.5.3. Analysis by Lipid-Based Approaches
15.2.5.4. Analysis by Other Bioavailability Enhancement Approaches
15.2.6. Analysis by Dosage Form
15.2.7. Analysis by Route of Administration
16. MARKET FORECAST
16.1. Chapter Overview
16.2. Forecast Methodology and Key Assumptions
16.2.1. Overall Oral Solid Dosage Contract Manufacturing Market, 2023-2035
16.2.2. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Type of Finished Dosage Form
16.2.2.1. Tablet Manufacturing Market, 2023-2035
16.2.2.2. Capsule Manufacturing Market, 2023-2035
16.2.2.3. Powder Manufacturing Market, 2023-2035
16.2.2.4. Multi-particulates Manufacturing Market, 2023-2035
16.2.2.5. Other Finished Dosage Forms Manufacturing Market, 2023-2035
16.2.3. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Type of Packaging
16.2.3.1. Oral Solid Dosage Contract Manufacturing Market for Bottles, 2023-2035
16.2.3.2. Oral Solid Dosage Contract Manufacturing Market for Blisters, 2023-2035
16.2.3.3. Oral Solid Dosage Contract Manufacturing Market for Inhalers, 2023-2035
16.2.3.4. Oral Solid Dosage Contract Manufacturing Market for Sachets, 2023-2035
16.2.3.5. Oral Solid Dosage Contract Manufacturing Market for Strips, 2023-2035
16.2.3.6. Oral Solid Dosage Contract Manufacturing Market for Stick Packs, 2023-2035
16.2.4. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Scale of Operation
16.2.4.1. Oral Solid Dosage Contract Manufacturing Market for Pre-Commercial Scale, 2023-2035
16.2.4.2. Oral Solid Dosage Contract Manufacturing Market for Commercial Scale, 2023-2035
16.2.5. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Company Size
16.2.5.1. Oral Solid Dosage Contract Manufacturing Market for Small Companies, 2023-2035
16.2.5.2. Oral Solid Dosage Contract Manufacturing Market for Mid-sized Companies, 2023-2035
16.2.5.3. Oral Solid Dosage Contract Manufacturing Market for Large Companies, 2023-2035
16.2.5.4. Oral Solid Dosage Contract Manufacturing Market for Very Large Companies, 2023-2035
16.2.6. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Therapeutic Area
16.2.6.1. Oral Solid Dosage Contract Manufacturing Market for Oncological Disorders, 2023-2035
16.2.6.2. Oral Solid Dosage Contract Manufacturing Market for Infectious Diseases, 2023-2035
16.2.6.3. Oral Solid Dosage Contract Manufacturing Market for Cardiovascular Disorders, 2023-2035
16.2.6.4. Oral Solid Dosage Contract Manufacturing Market for Metabolic Disorders, 2023-2035
16.2.6.5. Oral Solid Dosage Contract Manufacturing Market for Neurological Disorders, 2023-2035
16.2.6.6. Oral Solid Dosage Contract Manufacturing Market for Genetic Disorders, 2023-2035
16.2.6.7. Oral Solid Dosage Contract Manufacturing Market for Respiratory Disorders, 2023-2035
16.2.6.8. Oral Solid Dosage Contract Manufacturing Market for Immunological Disorders, 2023-2035
16.2.6.9. Oral Solid Dosage Contract Manufacturing Market for Other Disorders, 2023-2035
16.2.7. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Geographical Regions
16.2.7.1. Oral Solid Dosage Contract Manufacturing Market in North America, 2023-2035
16.2.7.2. Oral Solid Dosage Contract Manufacturing Market in Europe, 2023-2035
16.2.7.3. Oral Solid Dosage Contract Manufacturing Market in Asia-Pacific, 2023-2035
16.2.7.4. Oral Solid Dosage Contract Manufacturing Market in Latin America, 2023-2035
16.2.7.5. Oral Solid Dosage Contract Manufacturing Market in Middle East and North Africa, 2023-2035
17. EXECUTIVE INSIGHTS
18. CONCLUDING REMARKS
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

 

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Summary

The global oral solid dosage contract manufacturing market is expected to reach USD 21 billion in 2023 anticipated to grow at a CAGR of 5% during the forecast period 2023-2035.

Over time, the growing complexity of active pharmaceutical ingredients (APIs) has driven the creation of various innovative formulations, enabling targeted drug delivery. However, the demand for oral solid dosage (OSD) forms like tablets and capsules remains unmatched, constituting more than two-thirds of prescribed medications worldwide. These OSDs are favored for their cost-effectiveness, stability compared to larger molecules, and ease of patient administration, which greatly improves medication adherence. The increasing prominence of orally administered small molecules addresses adherence issues, leading to a crucial role in medication delivery. As the need for oral solid drugs rises, the development of modified solid formulations—from disintegrating tablets (ODTs) to combination products and extended-release forms—provides a significant opportunity for drug developers to stand out in this competitive and mature market. These formulations aim to enhance API solubility and increase bioavailability, meeting market demands and patient requirements. However, manufacturing specialized solid doses, especially those with highly potent APIs, involves a complex process spanning early formulation development to scaling up, demanding diverse expertise and a deep understanding of multiple disciplines. Consequently, drug developers increasingly rely on contract manufacturing organizations with specialized machinery and skilled teams. These contract manufacturers tackle technical complexities and operational challenges, such as intricate formulations, strict regulatory requirements, and handling multiple suppliers. The widespread preference for oral solid dosage forms, particularly among pediatric and geriatric populations, is expected to significantly drive the growth of the oral solid dosage contract manufacturing market in the foreseeable future, encompassing both conventional and modified formulations.

Report Coverage
 The report examines the oral solid dosage manufacturing market across various parameters such as the type of finished dosage form, type of packaging, scale of operation, company size, therapeutic area, and key geographical regions.
 An analysis of market growth factors (including drivers, restraints, opportunities, and challenges) is conducted within the report.
 It evaluates the potential advantages and challenges within the market landscape for stakeholders and offers insights into the competitive environment among leading market players.
 The report provides revenue forecasts for market segments concerning five major regions.
 Through comprehensive research, it presents an in-depth analysis of the oral solid dosage contract manufacturing market, encompassing:
 Explanation of oral solid dose form types and components, outlining the manufacturing process, and discussing emerging trends in outsourced manufacturing operations.
 Analysis of companies providing oral solid dosage manufacturing services based on establishment year, company size, ownership, offered services, manufactured dosage forms, packaging types, operational scales, and additional capabilities.
 Evaluation of manufacturers' competitiveness based on supplier and service strengths, considering experience, offered services, dosage forms, packaging, operational scales, certifications, and facility locations.
 Examination of manufacturers' capabilities across key regions, detailing service offerings, dosage forms, packaging, operational scales, and facility locations.
 Detailed profiles of prominent oral solid dosage contract manufacturers, covering company overview, financial data (if available), service portfolios, manufacturing capabilities, recent developments, and future outlook.
 Discussion on factors influencing drug developers' decisions between in-house manufacturing and partnering with CMO or CDMO for oral solid dosage production.
 Analysis of expansions since 2018, their purpose, types, estimation of global installed capacity distribution among firms, operational scales, dosage forms, and regions.
 Estimation of annual clinical and commercial demand for oral solid doses, coupled with a detailed analysis of the total cost of ownership for manufacturing facilities over a 20-year period.
 Review of regulatory guidelines across countries, assessment of over 300 CMOs for operational approvals, certifications, and regulatory compliance, along with a comparative analysis of regulatory scenarios in key regions.
 Detailed case studies on taste masking and bioavailability enhancement service providers, including information on technologies, scale of operation, end users, techniques employed, regional capabilities, and market landscapes.

Key Market Companies
 Aenova, Alcami
 Almac
 Cambrex
 Catalent
 Hetero Drugs
 Ind-Swift
 Laboratories
 Lonza
 Rubicon Research



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Table of Contents

1. PREFACE
1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Type of Dosage Forms
3.3. Overview of Oral Solid Dosage Forms
3.3.1. Components of Oral Solid Dosage Forms
3.3.2. Classification of Oral Solid Dosage Forms
3.3.3. Manufacturing of Oral Solid Dosage Forms
3.3.4. Emerging Trends in Oral Solid Dosage Manufacturing
3.4. Overview of Oral Solid Contract Manufacturing
3.4.1. Services Offered by CMOs and CDMOs for Oral Solid Manufacturing
3.4.2. Key Considerations While Selecting a CDMO or CMO Partner
3.4.3. Risks and Challenges Associated with Outsourcing Pharmaceutical Manufacturing Operations
3.5. Future Perspectives
4. ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS (CMOs): MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Oral Solid Dosage CMOs: List of Companies
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 Company Ownership
4.2.5. Analysis by Type of Service(s) Offered
4.2.6. Analysis by Type of Finished Dosage Form
4.2.7. Analysis by Type of Tablet(S) Manufactured
4.2.8. Analysis by Type of Capsule(s) Manufactured
4.2.9. Analysis by Type of Multi-particulate(s) Manufactured
4.2.10. Analysis by Type of Primary Packaging Offered
4.2.11. Analysis by Scale of Operation
4.2.12. Analysis by High Potency Drug Manufacturing
4.2.13. Analysis by Availability of Continuous Manufacturing
4.2.14. Analysis by Regulatory Certifications / Accreditations
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions and Key Parameters
5.3. Methodology
5.4. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers in North America
5.4.1. Peer Group I: Companies in the US
5.4.2. Peer Group II: Companies in Canada
5.5. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Europe
5.5.1. Peer Group III: Companies in EU5
5.5.2. Peer Group IV: Other European Countries
5.6. Company Competitiveness Analysis: Oral Solid Contract Manufacturers based in Asia-Pacific and Rest of the World
5.6.1. Peer Group V: Companies in India
5.6.2. Peer Group VI: Companies in China
5.6.3. Peer Group VII: Companies in Japan
5.6.4. Peer Group VIII: Companies in Other Asia-Pacific and rest of the World
5.7. Company Competitiveness Analysis of Oral Solid Dosage Contract Manufacturers: Competitiveness Score of Top Service Providers
6. REGIONAL CAPABILITY ANALYSIS
6.1. Chapter Overview
6.2. Key Assumptions and Methodology
6.3. Overall Landscape of Oral Solid Dosage Contract Manufacturing Facilities
6.4. Oral Solid Dosage Contract Manufacturers in North America
6.5. Oral Solid Dosage Contract Manufacturers in Europe
6.6. Oral Solid Dosage Contract Manufacturers in Asia-Pacific and Rest of the World
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Oral Solid Dosage Contract Manufacturing Service Providers: North America
7.2.1. Alcami
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.2.1. Manufacturing Capabilities and Facilities
7.2.1.3. Recent Developments and Future Outlook
7.2.2. Cambrex
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.2.1. Manufacturing Capabilities and Facilities
7.2.2.3. Recent Developments and Future Outlook
7.2.3. Catalent
7.2.3.1. Company Overview
7.2.3.2. Financial Information
7.2.3.3. Service Portfolio
7.2.3.3.1. Manufacturing Capabilities and Facilities
7.2.3.4. Recent Developments and Future Outlook
7.3. Oral Solid Dosage Contract Manufacturing Service Providers: Europe
7.3.1. Aenova
7.3.1.1. Company Overview
7.3.1.2. Financial Information
7.3.1.3. Service Portfolio
7.3.1.3.1. Manufacturing Capabilities and Facilities
7.3.1.4. Recent Developments and Future Outlook
7.3.2. Almac
7.3.2.1. Company Overview
7.3.2.2. Financial Information
7.3.2.3. Service Portfolio
7.3.2.3.1. Manufacturing Capabilities and Facilities
7.3.2.4. Recent Developments and Future Outlook
7.3.3. Lonza
7.3.3.1. Company Overview
7.3.3.2. Financial Information
7.3.3.3. Service Portfolio
7.3.3.3.1. Manufacturing Capabilities and Facilities
7.3.3.4. Recent Developments and Future Outlook
7.4. Oral Solid Dosage Contract Manufacturing Service Providers: Asia-Pacific and Rest of the World
7.4.1. Hetero Drugs
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.2.1. Manufacturing Capabilities and Facilities
7.4.1.3. Recent Developments and Future Outlook
7.4.2. Ind-Swift Laboratories
7.4.2.1. Company Overview
7.4.2.2. Financial Information
7.4.2.3. Service Portfolio
7.4.2.3.1. Manufacturing Capabilities and Facilities
7.4.2.4. Recent Developments and Future Outlook
7.4.3. Rubicon Research
7.4.3.1. Company Overview
7.4.3.2. Service Portfolio
7.4.3.2.1. Manufacturing Capabilities and Facilities
7.4.3.3. Recent Developments and Future Outlook
8. MAKE VERSUS BUY DECISION FRAMEWORK
8.1. Chapter Overview
8.2. Assumptions and Key Parameters
8.3. Oral Solid Dosage Manufacturers: Make versus Buy Decision Making
8.3.1. Scenario 1
8.3.2. Scenario 2
8.3.3. Scenario 3
8.3.4. Scenario 4
8.4. Concluding Remarks
9. RECENT EXPANSIONS
9.1. Chapter Overview
9.2. Oral Solid Dosage Contract Manufacturers: Recent Expansions
9.2.1. Analysis by Year of Expansion
9.2.2. Analysis by Type of Expansion
9.2.3. Analysis by Year and Type of Expansion
9.2.4. Analysis by Type of Oral Solid Dosage Form(s) Involved
9.2.5. Analysis by Type of Expansion and Oral Solid Dosage Form(s) Involved
9.2.6. Analysis by Type of Service(s) Offered
9.2.7. Analysis by Scales of Operation
9.2.8. Analysis by Location of Facility
9.2.9. Expansions Focused on Highly Potent Compounds
10. CAPACITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.2.1. Oral Solid Dosage Contract Manufacturing: Annual Global Capacity (Number of Finished Dosages)
10.2.1.1. Analysis by Company Size
10.2.1.2. Analysis by Scale of Operation
10.2.1.3. Analysis by Type of Finished Dosage Form
10.2.1.4. Analysis by Location of Manufacturing Facility
10.2.1.5. Analysis by Company Size and Type of Finished Dosage Form
10.2.1.6. Analysis by Company Size and Location of Manufacturing Facility
10.2.1.7. Analysis by Scale of Operation and Location of Manufacturing Facility
10.2.2. Oral Solid Dosage Contract Manufacturing: Annual Global Capacity (Amount of API)
10.2.2.1. Analysis by Company Size
10.2.2.2. Analysis by Scale of Operation
10.2.2.3. Analysis by Type of Finished Dosage Form
10.2.2.4. Analysis by Company Size and Type of Finished Dosage Form
10.2.2.5. Analysis by Company Size and Location of Manufacturing Facility
10.2.2.6. Analysis by Scale of Operation and Location of Manufacturing Facility
11. DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Overall Annual Demand for Oral Solid Doses, 2023-2035
11.4. Annual Outsourced Commercial Demand for Oral Solid Doses, 2023-2035
11.4.1. Annual Outsourced Commercial Demand for Oral Solid Doses: Distribution by Geography, 2023 and 2035
11.4.1.1. Annual Outsourced Commercial Demand for Oral Solid Doses in North America, 2023-2035
11.4.1.2. Annual Outsourced Commercial Demand for Oral Solid Doses in Europe, 2023-2035
11.4.1.3. Annual Outsourced Commercial Demand for Oral Solid Doses in Asia-Pacific and Rest of the World, 2023-2035
11.4.2. Annual Outsourced Commercial Demand for Oral Solid Doses: Distribution by Therapeutic Area, 2023 and 2035
11.4.2.1. Annual Outsourced Commercial Demand for Oral Solid Doses for Oncological Disorders, 2023-2035
11.4.2.2. Annual Outsourced Commercial Demand for Oral Solid Doses for Infectious Diseases, 2023-2035
11.4.2.3. Annual Outsourced Commercial Demand for Oral Solid Doses for Cardiovascular Disorders, 2023-2035
11.4.2.4. Annual Outsourced Commercial Demand for Oral Solid Doses for Metabolic Disorders, 2023-2035
11.4.2.5. Annual Outsourced Commercial Demand for Oral Solid Doses for Neurological Disorders, 2023-2035
11.4.2.6. Annual Outsourced Commercial Demand for Oral Solid Doses for Genetic Disorders, 2023-2035
11.4.2.7. Annual Outsourced Commercial Demand for Oral Solid Doses for Respiratory Disorders, 2023-2035
11.4.2.8. Annual Outsourced Commercial Demand for Oral Solid Doses for Immunological Disorders, 2023-2035
11.4.2.9. Annual Outsourced Commercial Demand for Oral Solid Doses for Other Disorders, 2023-2035
11.5. Annual Outsourced Clinical Demand for Oral Solid Doses, 2023-2035
11.5.1. Annual Outsourced Clinical Demand for Oral Solid Doses: Distribution by Trial Phase, 2023-2035
11.5.1.1. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase I Trials, 2023-2035
11.5.1.2. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase II Trials, 2023-2035
11.5.1.3. Annual Outsourced Clinical Demand for Oral Solid Doses in Phase III Trials, 2023-2035
11.6. Correlation between Annual Demand and Capacity
12. TOTAL COST OF OWNERSHIP FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS
12.1. Chapter Overview
12.2. Key Parameters
12.3. Assumptions and Methodology
12.4. Sample Dataset for the Estimation of Total Cost of Ownership
12.5. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations, Y0-Y20
12.6. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations: Analysis by CapEx and OpEx, Y0 and Y20
12.6.1. Total Cost of Ownership for Oral Solid Contract Manufacturing Organizations: Analysis by CapEx, Y0
12.6.2. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations: Analysis by OpEx, Y0-Y20
12.7. Concluding Remarks
13. REGULATORY LANDSCAPE FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURERS
13.1. Chapter Overview
13.2. Regulatory Guidelines in North America
13.2.1. The US Scenario
13.2.1. Canadian Scenario
13.3. Regulatory Guidelines in Europe
13.4. Regulatory Guidelines in Asia-Pacific and Rest of the World
13.4.1. Chinese Scenario
13.4.2. Indian Scenario
13.4.3. Japanese Scenario
13.4.4. South Korean Scenario
13.4.5. Australian Scenario
13.4.6. Brazilian Scenario
13.5. Oral Solid Dosage CMOs: Information on Approval From Various Regulatory Authorities
13.6. Bubble Analysis: Regional Regulatory Summary
14. CASE STUDY ON TASTE MASKING SERVICES AND TECHNOLOGIES: MARKET LANDSCAPE
14.1. Chapter Overview
14.2. Taste Masking and Taste Assessment Service Providers
14.2.1. Analysis by Year of Establishment
14.2.2. Analysis by Company Size
14.2.3. Analysis by Location of Headquarters
14.2.4. Analysis by Year of Establishment and Location of Headquarters
14.3. Taste Masking and Taste Assessment Services: Overall Market Landscape
14.3.1. Analysis by Service(s) Offered
14.3.2. Analysis by Scale of Operation
14.3.3. Analysis by Other Service(s) Offered
14.3.4. Analysis by Type of Formulation(s)
14.3.5. Analysis by End Users
14.3.6. Analysis by Techniques Used for Taste Masking
14.3.7. Analysis by Branch of Healthcare
14.3.8. Analysis by Regional Capability
15. CASE STUDY ON BIOAVAILABILITY ENHANCEMENT TECHNOLOGIES: MARKET LANDSCAPE
15.1. Chapter Overview
15.2. Bioavailability Enhancement Service Providers: Overall Market Landscape
15.2.1. Analysis by Year of Establishment
15.2.2. Analysis by Company Size
15.2.3. Analysis by Location of Headquarters
15.2.4. Analysis by Bioavailability Enhancement Principle
15.2.5. Analysis by Bioavailability Enhancement Approach
15.2.5.1. Analysis by Solid Dispersion Approaches
15.2.5.2. Analysis by Size Reduction Approaches
15.2.5.3. Analysis by Lipid-Based Approaches
15.2.5.4. Analysis by Other Bioavailability Enhancement Approaches
15.2.6. Analysis by Dosage Form
15.2.7. Analysis by Route of Administration
16. MARKET FORECAST
16.1. Chapter Overview
16.2. Forecast Methodology and Key Assumptions
16.2.1. Overall Oral Solid Dosage Contract Manufacturing Market, 2023-2035
16.2.2. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Type of Finished Dosage Form
16.2.2.1. Tablet Manufacturing Market, 2023-2035
16.2.2.2. Capsule Manufacturing Market, 2023-2035
16.2.2.3. Powder Manufacturing Market, 2023-2035
16.2.2.4. Multi-particulates Manufacturing Market, 2023-2035
16.2.2.5. Other Finished Dosage Forms Manufacturing Market, 2023-2035
16.2.3. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Type of Packaging
16.2.3.1. Oral Solid Dosage Contract Manufacturing Market for Bottles, 2023-2035
16.2.3.2. Oral Solid Dosage Contract Manufacturing Market for Blisters, 2023-2035
16.2.3.3. Oral Solid Dosage Contract Manufacturing Market for Inhalers, 2023-2035
16.2.3.4. Oral Solid Dosage Contract Manufacturing Market for Sachets, 2023-2035
16.2.3.5. Oral Solid Dosage Contract Manufacturing Market for Strips, 2023-2035
16.2.3.6. Oral Solid Dosage Contract Manufacturing Market for Stick Packs, 2023-2035
16.2.4. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Scale of Operation
16.2.4.1. Oral Solid Dosage Contract Manufacturing Market for Pre-Commercial Scale, 2023-2035
16.2.4.2. Oral Solid Dosage Contract Manufacturing Market for Commercial Scale, 2023-2035
16.2.5. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Company Size
16.2.5.1. Oral Solid Dosage Contract Manufacturing Market for Small Companies, 2023-2035
16.2.5.2. Oral Solid Dosage Contract Manufacturing Market for Mid-sized Companies, 2023-2035
16.2.5.3. Oral Solid Dosage Contract Manufacturing Market for Large Companies, 2023-2035
16.2.5.4. Oral Solid Dosage Contract Manufacturing Market for Very Large Companies, 2023-2035
16.2.6. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Therapeutic Area
16.2.6.1. Oral Solid Dosage Contract Manufacturing Market for Oncological Disorders, 2023-2035
16.2.6.2. Oral Solid Dosage Contract Manufacturing Market for Infectious Diseases, 2023-2035
16.2.6.3. Oral Solid Dosage Contract Manufacturing Market for Cardiovascular Disorders, 2023-2035
16.2.6.4. Oral Solid Dosage Contract Manufacturing Market for Metabolic Disorders, 2023-2035
16.2.6.5. Oral Solid Dosage Contract Manufacturing Market for Neurological Disorders, 2023-2035
16.2.6.6. Oral Solid Dosage Contract Manufacturing Market for Genetic Disorders, 2023-2035
16.2.6.7. Oral Solid Dosage Contract Manufacturing Market for Respiratory Disorders, 2023-2035
16.2.6.8. Oral Solid Dosage Contract Manufacturing Market for Immunological Disorders, 2023-2035
16.2.6.9. Oral Solid Dosage Contract Manufacturing Market for Other Disorders, 2023-2035
16.2.7. Oral Solid Dosage Contract Manufacturing Market, 2023-2035: Distribution by Geographical Regions
16.2.7.1. Oral Solid Dosage Contract Manufacturing Market in North America, 2023-2035
16.2.7.2. Oral Solid Dosage Contract Manufacturing Market in Europe, 2023-2035
16.2.7.3. Oral Solid Dosage Contract Manufacturing Market in Asia-Pacific, 2023-2035
16.2.7.4. Oral Solid Dosage Contract Manufacturing Market in Latin America, 2023-2035
16.2.7.5. Oral Solid Dosage Contract Manufacturing Market in Middle East and North Africa, 2023-2035
17. EXECUTIVE INSIGHTS
18. CONCLUDING REMARKS
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

 

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