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Jun 27, 2023

Global Oral Solid Dosage Manufacturing Market 2023 to 2035: Emergence of Virtual Pharmaceutical Companies Fuels the Sector

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11 Apr, 2023, 10:30 ET

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DUBLIN, April 11, 2023 /PRNewswire/ -- The "Oral Solid Dosage Manufacturing Market - Distribution by Type of Finished Dosage Form, Type of Packaging, Scale of Operation, Company Size, Therapeutic Area, and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study of the current market landscape and future opportunity for the players involved in the oral solid dosage contract manufacturing, over a span of 12 years. The reports answers following key questions related to this domain.

Over the years, rising complexity of active pharmaceutical ingredients (APIs) has led to the development of a myriad of novel formulations that enable efficient drug delivery to the intended site of action. Nonetheless, the demand for oral solid dosage (OSD) forms, including tablets and capsules, remains unparalleled.

In fact, over two-thirds of the total drugs prescribed worldwide are dispensed in the form of oral solids. In addition to being cost effective and relatively more stable as compared to their large molecule counterparts, these orally administered small molecules are patient-centric, and therefore play a critical role in fixing the drug adherence problem.

Since the demand for oral solid drugs is rising, the development of modified oral solid dosage formulations (including disintegrating tablets (ODTs), combination products and prolonged-, controlled-, and sustained- release dosage forms) that can improve API solubility and enhance bioavailability can offer the drug developers a huge opportunity to stand out in this mature and competitive market.

However, the manufacturing of specialized solid doses, especially those containing highly potent APIs, from early development formulations to scale-up is a complex process that requires multidisciplinary expertise.

Consequently, drug developers are increasingly relying on contract service providers with specialized equipment and a trained workforce to navigate the technical and routine operations-related challenges, including those associated with complex formulations, stringent regulatory requirements and multiple suppliers.

Considering the immense popularity of oral solid dosage forms, especially amongst the pediatric and geriatric populations, we believe that the demand for conventional as well as modified oral solid dosage formulations is likely to drive commendable growth within the contract manufacturing market in the coming years.

Frequently Asked Questions

Question 1: What is the global market size of oral solid dosage manufacturing market?

Answer: The current oral solid contract manufacturing market size is anticipated to be over USD 30 billion.

Question 2: Which are the top players in the oral solid dosage contract manufacturing market?

Answer: Presently, close to 300 companies are engaged in offering oral solid dosage contract manufacturing market, worldwide. The top players engaged in this domain (which have also been captured in this report) include Aenova, Alcami, Almac, Cambrex, Catalent, CMIC, Contract Pharmacal, Delpharm, Hetero Drugs, Madras Pharmaceuticals, Micro Labs and Recipharm.

Question 3: How many contract service providers possess capabilities to handle oral solid therapies based on highly potent APIs (HPAPIs)?

Answer: Over 40% of the contract service providers engaged in this domain claim to have the requisite capabilities for the safe handling and containment of highly potent oral solids.

Question 4: What are the factors driving the oral solid dosage contract manufacturing market?

Answer: The factors driving the oral solid dosage contract manufacturing market include the emergence of virtual pharmaceutical companies, and the surge in demand for novel oral solid formulations, such as such as pediatric / geriatric, taste-masked, abuse-deterrent and control release products that improve patient compliance.

Question 5: Which region has the highest market share in the oral solid dosage contract manufacturing market?

Answer: North America captures around 60% share in the current oral solid dosage contract manufacturing market, followed by Europe.

Question 6: What are the leading market segments in the oral solid dosage contract manufacturing market?

Answer: Currently, the oral solid dosage contract manufacturing market is dominated by tablet and capsule formulations. This can be attributed to several advantages offered by these dosage forms, including portability, ease in swallowing, excellent bioavailability and medical adherence. Further, in terms of company size, established players (with over 10,000 employees) are likely to capture over 50% of the current and future market, owing to their enhanced capabilities and huge production capacities.

Question 7: What is the growth rate (CAGR) in the oral solid dosage manufacturing market?

Answer: The oral solid dosage contract manufacturing market size is projected to grow at a CAGR of ~6% in the coming years.

Question 8: What are the upcoming trends in the oral solid dosage manufacturing market?

Answer: The market is presently witnessing the adoption of Industry 4.0 concepts, such as QbD and PAT. Further, several service providers are establishing / expanding their continuous manufacturing lines for the production of oral solids, thereby reducing manufacturing cost (by 15-30%), manpower (by 50-70%) and power consumption (by 40%).

Question 9: What are the current initiatives undertaken by big pharma players engaged in the oral solid dosage contract manufacturing market?

Answer: In order to tap the lucrative opportunity in this rapidly growing market, big pharma players have undertaken several initiatives, including strengthening product portfolio, establishing agreements, acquisitions and making investments. For instance, in August 2022, Catalent acquired Metrics Contract Services for USD 475 million to expand its high-potent and oral solid dosage manufacturing capabilities.

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION3.1. Chapter Overview3.2. Types of Dosage Forms3.3. Overview of Oral Solid Dosage Forms3.3.1. Components of Oral Solid Dosage Forms3.3.2. Classification of Oral Solid Dosage Forms3.3.3. Manufacturing of Oral Solid Dosage Forms3.3.4. Emerging Trends in Oral Solid Dosage Manufacturing3.4. Overview of Oral Solid Contract Manufacturing3.4.1. Services Offered by CMOs and CDMOs for Oral Solid Dosage3.4.2. Key Considerations while Selecting a CDMO Partner3.4.3. Risks and Challenges Associated with Outsourcing Oral Solid Dosage Manufacturing Operations3.5. Future Perspectives

4. ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS (CMOs): MARKET LANDSCAPE4.1. Chapter Overview4.2. Oral Solid Dosage CMOs: Overall Market Landscape

5. COMPANY COMPETITIVENESS ANALYSIS5.1. Chapter Overview5.2. Assumptions / Key Parameters5.3. Methodology5.4. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in North America5.5. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Europe5.6. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Asia-Pacific and Rest of the World5.7. Company Competitiveness Analysis: Benchmarking the Capabilities of Leading Players

6. REGIONAL CAPABILITY ANALYSIS6.1. Chapter Overview6.2. Key Assumptions and Methodology6.3. Oral Solid Dosage Contract Manufacturing Capabilities in North America6.4. Oral Solid Dosage Contract Manufacturing Capabilities in Europe6.5. Oral Solid Dosage Contract Manufacturing Capabilities in Asia-Pacific and Rest of the World6.6. Concluding Remarks

7. COMPANY PROFILES7.1. Chapter Overview7.2. Alcami7.2.1. Company Overview7.2.2. Service Portfolio7.2.2.1. Manufacturing Capabilities and Facilities7.2.3. Recent Developments and Future Outlook7.3. Cambrex7.4. Catalent7.5. CMIC7.6. Contract Pharmacal7.7. Aenova7.8. Almac7.9. Delpharm7.10. Hetero Drugs7.11. Madras Pharmaceuticals7.12. Micro Lab7.13. Recipharm

8. MAKE VERSUS BUY DECISION FRAMEWORK8.1. Chapter Overview8.2. Assumptions and Key Parameters8.3. Oral Solid Dosage Contract Manufacturing: Make versus Buy Decision Making8.4. Concluding Remarks

9. RECENT EXPANSIONS9.1. Chapter Overview9.2. Oral Solid Dosage Contract Manufacturing: List of Expansions

10. CAPACITY ANALYSIS10.1. Chapter Overview10.2. Key Assumptions and Methodology10.3. Concluding Remarks

11. DEMAND ANALYSIS11.1. Chapter Overview11.2. Key Assumptions and Methodology11.3. Overall Demand for Oral Solid Dosage Forms, 2023-203511.4. Overall Commercial Demand for Oral Solid Dosage, 2023-203511.5. Overall Clinical Demand for Oral Solid Dosage, 2023-203511.6. Demand and Supply Analysis

12. TOTAL COST OF OWNERSHIP FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURING ORGANIZATIONS12.1. Chapter Overview12.2. Key Parameters12.3. Assumptions and Methodology12.4. Sample Dataset for the Estimation of Total Cost of Ownership12.5. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations, Y0-Y2012.6. Total Cost of Ownership for Oral Solid Dosage Contract Manufacturing Organizations: Analysis by CapEx and OpEx, Y0 and Y2012.7. Concluding Remarks

13. REGULATORY LANDSCAPE FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURERS13.1. Chapter Overview13.2. Regulatory Guidelines in North America13.3. Regulatory Guidelines in Europe13.4. Regulatory Guidelines in Asia-Pacific and Rest of the World13.5. Oral Solid Dosage CMOs: Information on Approvals from Various Regulatory Authorities13.6. Bubble Analysis: Regional Regulatory Summary

14. CASE STUDY ON TASTE MASKING SERVICES AND TECHNOLOGIES: MARKET LANDSCAPE14.1. Chapter Overview14.2. Taste Masking Service Providers14.3. Taste Masking Services: Overall Market Landscape14.4. Taste Masking Technologies: Overall Market Landscape14.5. Taste Masking Technology Providers

15. CASE STUDY ON BIOAVAILABILITY ENHANCEMENT TECHNOLOGIES: MARKET LANDSCAPE15.1. Chapter Overview15.2. Bioavailability Enhancement Technologies: Technology Providers Landscape15.3. Bioavailability Enhancement Technologies: Market Landscape

16. MARKET FORECAST16.1. Chapter Overview16.2. Key Assumptions and Forecast Methodology16.3. Global Oral Solid Dosage Contract Manufacturing Market, 2023-2035

17. CONCLUDING REMARKS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/7yfe31

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