Dublin, April 11, 2023 (GLOBE NEWSWIRE) -- 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. INTRODUCTION
3.1. Chapter Overview
3.2. Types 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 Dosage
3.4.2. Key Considerations while Selecting a CDMO Partner
3.4.3. Risks and Challenges Associated with Outsourcing Oral Solid Dosage 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: Overall Market Landscape
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions / Key Parameters
5.3. Methodology
5.4. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in North America
5.5. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Europe
5.6. Company Competitiveness Analysis: Oral Solid Dosage Contract Manufacturers based in Asia-Pacific and Rest of the World
5.7. Company Competitiveness Analysis: Benchmarking the Capabilities of Leading Players
6. REGIONAL CAPABILITY ANALYSIS
6.1. Chapter Overview
6.2. Key Assumptions and Methodology
6.3. Oral Solid Dosage Contract Manufacturing Capabilities in North America
6.4. Oral Solid Dosage Contract Manufacturing Capabilities in Europe
6.5. Oral Solid Dosage Contract Manufacturing Capabilities in Asia-Pacific and Rest of the World
6.6. Concluding Remarks
7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Alcami
7.2.1. Company Overview
7.2.2. Service Portfolio
7.2.2.1. Manufacturing Capabilities and Facilities
7.2.3. Recent Developments and Future Outlook
7.3. Cambrex
7.4. Catalent
7.5. CMIC
7.6. Contract Pharmacal
7.7. Aenova
7.8. Almac
7.9. Delpharm
7.10. Hetero Drugs
7.11. Madras Pharmaceuticals
7.12. Micro Lab
7.13. Recipharm
8. MAKE VERSUS BUY DECISION FRAMEWORK
8.1. Chapter Overview
8.2. Assumptions and Key Parameters
8.3. Oral Solid Dosage Contract Manufacturing: Make versus Buy Decision Making
8.4. Concluding Remarks
9. RECENT EXPANSIONS
9.1. Chapter Overview
9.2. Oral Solid Dosage Contract Manufacturing: List of Expansions
10. CAPACITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. Concluding Remarks
11. DEMAND ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Overall Demand for Oral Solid Dosage Forms, 2023-2035
11.4. Overall Commercial Demand for Oral Solid Dosage, 2023-2035
11.5. Overall Clinical Demand for Oral Solid Dosage, 2023-2035
11.6. Demand and Supply Analysis
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
12.7. Concluding Remarks
13. REGULATORY LANDSCAPE FOR ORAL SOLID DOSAGE CONTRACT MANUFACTURERS
13.1. Chapter Overview
13.2. Regulatory Guidelines in North America
13.3. Regulatory Guidelines in Europe
13.4. Regulatory Guidelines in Asia-Pacific and Rest of the World
13.5. Oral Solid Dosage CMOs: Information on Approvals 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 Service Providers
14.3. Taste Masking Services: Overall Market Landscape
14.4. Taste Masking Technologies: Overall Market Landscape
14.5. Taste Masking Technology Providers
15. CASE STUDY ON BIOAVAILABILITY ENHANCEMENT TECHNOLOGIES: MARKET LANDSCAPE
15.1. Chapter Overview
15.2. Bioavailability Enhancement Technologies: Technology Providers Landscape
15.3. Bioavailability Enhancement Technologies: Market Landscape
16. MARKET FORECAST
16.1. Chapter Overview
16.2. Key Assumptions and Forecast Methodology
16.3. 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/qidliw
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