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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

March 2023 | 296 pages | ID: OA6246A44DD6EN
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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
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
  8.3.2. Scenario
  8.3.3. Scenario
  8.3.4. Scenario
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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