Oral Macromolecular Formulation Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Afric

Oral Macromolecular Formulation Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)


The global Oral Macromolecule Formulation Market is experiencing remarkable growth, with revenues reaching US$ 18 million in 2024. Market analysts anticipate a steady Compound Annual Growth Rate (CAGR) of 7%, propelling the market to an estimated valuation of approximately US$ 28 million by the end of 2031.

Oral Delivery: The Preferred Route

Oral drug delivery has emerged as the most desirable route due to its advantages, including the potential for solid formulations with extended shelf life, continuous distribution, and enhanced immune response.

The numerous risks associated with injections, such as needle-related injuries, pain, and needle stick injuries, can be mitigated by oral macromolecule formulations. Approximately 385,000 sharp injuries occur among healthcare workers in the US each year, highlighting the importance of safer alternatives. Pediatric patients, in particular, have a high demand for oral formulations due to the discomfort associated with injections.

Growing Preference for Oral Administration

Oral administration has become the most popular method of drug delivery due to its non-invasiveness, patient compliance, and ease of use. It is especially crucial for elderly and physically fragile individuals, enabling self-administration of medications without the need for assistance.

Affordability and Accessibility

Oral macromolecule formulations are in significant demand, particularly in low-income regions, owing to their cost-effectiveness. Researchers and contract manufacturers specializing in oral macromolecule formulations are dedicated to simplifying patients' lives by offering novel and practical single-unit dosage forms.

Diabetes and Oral Macromolecular Formulations

The global rise in diabetes has driven the demand for oral macromolecular formulations, as diabetic patients may require insulin therapy. The oral formulation of biomolecules like insulin offers potential advantages over intravenous administration, which can be uncomfortable and challenging for patients.

Market Growth Drivers

Introduction of Novel Drug Delivery Systems: Pharmaceutical manufacturers are actively exploring various methods to enhance the oral administration of biologics, aiming to overcome enzymatic and acidic breakdown.

Challenges in Market Growth

Drawbacks and Poor Absorption: The absorption of oral macromolecule formulations faces physiological barriers, and many macromolecules are susceptible to rapid degradation by digestive enzymes. Gastric pH can also impact drug absorption.

Booming U.S. Market

The United States market is experiencing growth due to technological advancements, increased patent approvals, and regional research on nanotechnology applications for drug delivery.

Lucrative Market in Germany

Germany's market is set to advance with growing R&D activities focused on novel drug delivery systems.

China's Research Funding

The National Natural Science Foundation of China has funded various studies on the novel oral delivery of protein and peptide drugs, aligning with the booming market for these pharmaceuticals.

Competitive Landscape

Top pharmaceutical companies are forming strategic alliances with providers of oral macromolecule formulations, and the global market is expected to expand due to the rising demand for pharmaceutical outsourcing.

Key Companies Covered:
• Catalent, Inc
• Diabetology Ltd
• UPM Pharmaceuticals

Market Segmentation

Indication:
• Inflammatory Bowel Disorder
Crohn’s Disease
Ulcerative Colitis
• Diabetes
• Others

End User:
• Biopharmaceutical Companies
• Academic and Research Institutes

Region:
• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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1. Executive Summary
1.1. Global Oral Macromolecular Formulation Market Snapshot
1.2. Future Projections
1.3. Key Market Trends
1.4. Regional Snapshot, by Value, 2023
1.5. Analyst Recommendations
2. Market Overview
2.1. Market Definitions and Segmentations
2.2. Market Dynamics
2.2.1. Drivers
2.2.2. Restraints
2.2.3. Market Opportunities
2.3. Value Chain Analysis
2.4. Porter’s Five Forces Analysis
2.5. COVID-19 Impact Analysis
2.5.1. Supply
2.5.2. Demand
2.6. Impact of Ukraine-Russia Conflict
2.7. Economic Overview
2.7.1. World Economic Projections
2.8. PESTLE Analysis
3. Global Oral Macromolecular Formulation Market Outlook, 2018 – 2031
3.1. Global Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
3.1.1. Key Highlights
3.1.1.1. Inflammatory Bowel Disorder
3.1.1.1.1. Crohn’s Disease
3.1.1.1.2. Ulcerative Colitis
3.1.1.2. Diabetes
3.1.1.3. Others
3.2. Global Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
3.2.1. Key Highlights
3.2.1.1. Biopharmaceutical Companies
3.2.1.2. Academic and Research Institutes
3.3. Global Oral Macromolecular Formulation Market Outlook, by Region, Value (US$ Mn), 2018 – 2031
3.3.1. Key Highlights
3.3.1.1. North America
3.3.1.2. Europe
3.3.1.3. Asia Pacific
3.3.1.4. Latin America
3.3.1.5. Middle East & Africa
4. North America Oral Macromolecular Formulation Market Outlook, 2018 – 2031
4.1. North America Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
4.1.1. Key Highlights
4.1.1.1. Inflammatory Bowel Disorder
4.1.1.1.1. Crohn’s Disease
4.1.1.1.2. Ulcerative Colitis
4.1.1.2. Diabetes
4.1.1.3. Others
4.2. North America Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
4.2.1. Key Highlights
4.2.1.1. Biopharmaceutical Companies
4.2.1.2. Academic and Research Institutes
4.2.2. BPS Analysis/Market Attractiveness Analysis
4.3. North America Oral Macromolecular Formulation Market Outlook, by Country, Value (US$ Mn), 2018 – 2031
4.3.1. Key Highlights
4.3.1.1. U.S. Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
4.3.1.2. U.S. Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
4.3.1.3. Canada Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
4.3.1.4. Canada Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
4.3.2. BPS Analysis/Market Attractiveness Analysis
5. Europe Oral Macromolecular Formulation Market Outlook, 2018 – 2031
5.1. Europe Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
5.1.1. Key Highlights
5.1.1.1. Inflammatory Bowel Disorder
5.1.1.1.1. Crohn’s Disease
5.1.1.1.2. Ulcerative Colitis
5.1.1.2. Diabetes
5.1.1.3. Others
5.2. Europe Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
5.2.1. Key Highlights
5.2.1.1. Biopharmaceutical Companies
5.2.1.2. Academic and Research Institutes
5.2.2. BPS Analysis/Market Attractiveness Analysis
5.3. Europe Oral Macromolecular Formulation Market Outlook, by Country, Value (US$ Mn), 2018 – 2031
5.3.1. Key Highlights
5.3.1.1. Germany Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.2. Germany Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.3. U.K. Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.4. U.K. Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.5. France Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.6. France Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.7. Italy Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.8. Italy Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.9. Turkey Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.10. Turkey Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.11. Russia Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.12. Russia Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.1.13. Rest of Europe Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
5.3.1.14. Rest of Europe Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
5.3.2. BPS Analysis/Market Attractiveness Analysis
6. Asia Pacific Oral Macromolecular Formulation Market Outlook, 2018 – 2031
6.1. Asia Pacific Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
6.1.1. Key Highlights
6.1.1.1. Inflammatory Bowel Disorder
6.1.1.1.1. Crohn’s Disease
6.1.1.1.2. Ulcerative Colitis
6.1.1.2. Diabetes
6.1.1.3. Others
6.2. Asia Pacific Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
6.2.1. Key Highlights
6.2.1.1. Biopharmaceutical Companies
6.2.1.2. Academic and Research Institutes
6.2.2. Others BPS Analysis/Market Attractiveness Analysis
6.3. Asia Pacific Oral Macromolecular Formulation Market Outlook, by Country, Value (US$ Mn), 2018 – 2031
6.3.1. Key Highlights
6.3.1.1. China Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.2. China Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.1.3. Japan Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.4. Japan Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.1.5. South Korea Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.6. South Korea Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.1.7. India Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.8. India Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.1.9. Southeast Asia Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.10. Southeast Asia Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.1.11. Rest of Asia Pacific Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
6.3.1.12. Rest of Asia Pacific Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
6.3.2. BPS Analysis/Market Attractiveness Analysis
7. Latin America Oral Macromolecular Formulation Market Outlook, 2018 – 2031
7.1. Latin America Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
7.1.1. Key Highlights
7.1.1.1. Inflammatory Bowel Disorder
7.1.1.1.1. Crohn’s Disease
7.1.1.1.2. Ulcerative Colitis
7.1.1.2. Diabetes
7.1.1.3. Others
7.2. Latin America Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
7.2.1. Key Highlights
7.2.1.1. Biopharmaceutical Companies
7.2.1.2. Academic and Research Institutes
7.2.2. BPS Analysis/Market Attractiveness Analysis
7.3. Latin America Oral Macromolecular Formulation Market Outlook, by Country, Value (US$ Mn), 2018 – 2031
7.3.1. Key Highlights
7.3.1.1. Brazil Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
7.3.1.2. Brazil Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
7.3.1.3. Mexico Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
7.3.1.4. Mexico Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
7.3.1.5. Argentina Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
7.3.1.6. Argentina Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
7.3.1.7. Rest of Latin America Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
7.3.1.8. Rest of Latin America Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
7.3.2. BPS Analysis/Market Attractiveness Analysis
8. Middle East & Africa Oral Macromolecular Formulation Market Outlook, 2018 – 2031
8.1. Middle East & Africa Oral Macromolecular Formulation Market Outlook, by Indication, Value (US$ Mn), 2018 – 2031
8.1.1. Key Highlights
8.1.1.1. Inflammatory Bowel Disorder
8.1.1.1.1. Crohn’s Disease
8.1.1.1.2. Ulcerative Colitis
8.1.1.2. Diabetes
8.1.1.3. Others
8.2. Middle East & Africa Oral Macromolecular Formulation Market Outlook, by End User, Value (US$ Mn), 2018 – 2031
8.2.1. Key Highlights
8.2.1.1. Biopharmaceutical Companies
8.2.1.2. Academic and Research Institutes
8.2.2. BPS Analysis/Market Attractiveness Analysis
8.3. Middle East & Africa Oral Macromolecular Formulation Market Outlook, by Country, Value (US$ Mn), 2018 – 2031
8.3.1. Key Highlights
8.3.1.1. GCC Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
8.3.1.2. GCC Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
8.3.1.3. South Africa Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
8.3.1.4. South Africa Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
8.3.1.5. Egypt Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
8.3.1.6. Egypt Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
8.3.1.7. Nigeria Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
8.3.1.8. Nigeria Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
8.3.1.9. Rest of Middle East & Africa Oral Macromolecular Formulation Market by Indication, Value (US$ Mn), 2018 – 2031
8.3.1.10. Rest of Middle East & Africa Oral Macromolecular Formulation Market by End User, Value (US$ Mn), 2018 – 2031
8.3.2. BPS Analysis/Market Attractiveness Analysis
9. Competitive Landscape
9.1. Manufacturer vs by End User Heatmap
9.2. Company Market Share Analysis, 2023
9.3. Competitive Dashboard
9.4. Company Profiles
9.4.1. Catalent, Inc
9.4.1.1. Company Overview
9.4.1.2. Product Portfolio
9.4.1.3. Financial Overview
9.4.1.4. Business Strategies and Development
9.4.2. Diabetology Ltd
9.4.2.1. Company Overview
9.4.2.2. Product Portfolio
9.4.2.3. Financial Overview
9.4.2.4. Business Strategies and Development
9.4.3. UPM Pharmaceuticals
9.4.3.1. Company Overview
9.4.3.2. Product Portfolio
9.4.3.3. Financial Overview
9.4.3.4. Business Strategies and Development
10. Appendix
10.1. Research Methodology
10.2. Report Assumptions
10.3. Acronyms and Abbreviations

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