바이오 의약품 산업 현황(2025년) - Strategic Intelligence

A range of macroeconomic and geopolitical factors, along with the rise of emerging technologies, such as AI and automation, are shaping the current business landscape. While adoption of technologies can offer potential solutions to operational and efficiency challenges, businesses still face issues such as supply-demand imbalance, market volatility, and geopolitical tensions. Although the pharmaceutical industry is often considered as recession-resistant, it is not immune to future challenges. Factors such as constraints on drug pricing and reimbursement (P&R), the evolving regulatory landscape, uncertainties surrounding new legislations such as the BIOSECURE Act, and pressures to innovate and to address environmental, social, and governance (ESG) issues will continue to pose challenges for the pharmaceutical sector in the coming years.

In this The State of the Biopharmaceutical Industry report, GlobalData examines the business environment, challenges and trends that are going to impact the biopharmaceutical industry in 2025. The report highlights the most impactful emerging technologies, industry trends, regulatory trends, and macroeconomic factors that are going to impact and dominate the industry throughout the next 12 months

Key findings include -

• The biopharmaceutical industry is optimistic about its growth prospects in 2025, but the levels of optimism are lower than six months ago.
• A total of 50% of survey respondents shared optimistic or very optimistic sentiment on biotech funding recovery in 2024, down by 6% from the data obtained six months ago.
• Anti-obesity medications, immuno-oncology (IO) drug development, and increasing costs of clinical trials will be among the most impactful industry trends for the next 12 months.
• Anti-obesity medications were identified as the emerging pharmaceutical industry trend to have the greatest impact for 2025.
• From macro and regulatory trends, lifecycle management (LCM) of blockbuster drugs and patent expiration of biologics are expected to have the greatest positive impact on the pharmaceutical industry.
• Drug pricing and reimbursement constraints and geopolitical conflicts will be the main hindrances for the biopharmaceutical sector growth.
• Pharmaceutical industry professionals are rather concerned about the US presidential transition amid policy uncertainty.
• Big data and artificial intelligence (AI) will continue to dominate as transformational forces in the healthcare sector in the next 12 months.
• AI is poised to become a key driver in developing new treatments at a faster pace and with increased cost-effectiveness.
• Vanzacaftor calcium + deutivacaftor + tezacaftor for cystic fibrosis is expected to have the highest commercial success among the 2025 launches.
• Oncology, central nervous system (CNS), and cardiovascular are the dominant areas for clinical trials to be initiated in 2025.
• Oncology will dominate the therapy landscape in 2025, but dermatology will display the highest growth.

Scope

Benchmark the impact of major themes on the biopharmaceutical industry in the next 12 months, including -

• Emerging technologies
• Regulatory trends
• Macroeconomic trends
• Industry trends
• Identify themes that will have the greatest positive or negative impact in the next 12 months.
• Capture opinions on these themes from industry experts.
• Predict the industry's growth prospects in the next 12 months.

Reasons to Buy

• Understand the business environment and the industry, regulatory, and macroeconomic trends that are going to shape the biopharmaceutical industry in the next 12 months.
• Benchmark the impact of major themes on the biopharmaceutical industry in the next 12 months,
• Identify themes that will have the greatest positive or negative impact in the coming months.
• Comprehend the opinions of industry respondents on these themes.
• Predict the industry's growth prospects in the next 12 months.

Table of Contents

Table of Contents

1. Executive Summary

2. Study Design

• 2.1. Objectives and Design
• 2.2. Respondent Mix

3. Emerging Industry Trends

• 3.1. The Most Impactful Emerging Industry Trends
• 3.2. Anti-obesity Medications Top the Trends Impacting the Pharmaceutical Industry
• 3.3. Highly Crowded Field of Anti-obesity Medications in Development
• 3.4. Emerging Technologies Impacting the Pharmaceutical Value Chain
• 3.5. Artificial Intelligence is Expected to Have a Positive Impact on the in Pharmaceutical Value Chain
• 3.6. AI is Predominantly Used in the Early Stages of Drug Discovery and Development
• 3.7. Immuno-oncology Continues to Show Growth in Oncology, Despite Some Recent Setbacks
• 3.8. Immuno-oncology Drugs: Recent Approvals and Launches
• 3.9. Personalized/Precision Medicine: an Option for Improving Treatment Outcomes
• 3.10. Personalized/Precision Medicine Drugs: Recent Approvals and Launches
• 3.11. Real-World Evidence is Becoming a Valuable and Necessary Source for the Pharmaceutical Industry
• 3.12. Increase in Real-Word Evidence Clinical Trials
• 3.13. Increased Demand for Drugs Tops the Reasons Leading to Supply Chain Challenges
• 3.14. Complexity and Rising Costs of Clinical Trials Impact Drug Development
• 3.15. Complexity and Rising Costs of Clinical Trials
• 3.16. Cell and Gene Therapies Are Primarily Focused on Hematological Malignancies
• 3.17. Cell and Gene Therapy Approaches are Expanding Beyond Oncology
• 3.18. Cell and Gene Therapy Markets are Expected to Grow Significantly in Coming Years
• 3.19. Biosimilars Uptake Varies Across Markets and Diseases
• 3.20. Recent Approvals of Key Biosimilars May Impact Their Uptake in the Pharma Markets
• 3.21. Antibody-Drug Conjugates
• 3.22. Successful Maturation of Early-Stage Antibody-Drug Conjugates is Key for Projected Increase in ADC Market
• 3.23. Decentralized/Virtual Clinical Trials
• 3.24. Tools and Technologies Supporting Decentralized/Virtual Clinical Trials
• 3.25. Utilization of Decentralized/Virtual Components in Clinical Trials Remains Steady Post-Pandemic
• 3.26. Microbiome Drug Development

4. Emerging Regulatory and Macroeconomic Trends

• 4.1. Top Positive and Negative Emerging Regulatory and Macroeconomic Trends
• 4.2. Emerging Regulatory and Macroeconomic Trends
• 4.3. Geopolitical Conflicts Persist as an Ongoing Concern
• 4.4. Geopolitical Risk Summary
• 4.5. Pricing and Reimbursement Trends
• 4.6. P&R Policy Events in 2024 Expected to Affect Market Access
• 4.7. Key Drivers of Changes to P&R Outlook in Major Markets
• 4.8. Political Divide in the US and US Elections 2024
• 4.9. Implications Outside the US: EU Policymakers Assess Impact of Tariffs
• 4.10. Trump Presidency's Impact on Pharma
• 4.11. Pricing and Reimbursement Trends
• 4.12. Respondents Opinion on Emerging Regulatory and Macroeconomic Trends - Negatives
• 4.13. Emerging Regulatory and Macroeconomic Trends
• 4.14. Emerging Regulatory and Macroeconomic Trends - By Geography
• 4.15. Respondents' Opinion on Patent Expiration of Biologics
• 4.16. Biologic Patent Expiration and Biosimilars
• 4.17. Biosimilar Pricing
• 4.18. Lifecycle Management of Blockbuster Drugs
• 4.17. Manufacturing and Drug Shortages
• 4.18. Commercial Injectable Contract Manufacturing Trends
• 4.19. Respondents' Opinion on Emerging Regulatory and Macroeconomic Trends - Positives

5. Policies and Regulations

• 5.1. Inflation Reduction Act
• 5.2. Inflation Reduction Act Implementation Timeline
• 5.3. Inflation Reduction Act: First Products Subject to Negotiation
• 5.4. EU Pharmaceutical Reform
• 5.5. New IRP Corridors and Changes in Launch Strategies Inside EU
• 5.6. EU Pharmaceutical Reform
• 5.7. BIOSECURE Act

6. Emerging Technologies

• 6.1. Most Impactful Emerging Technologies
• 6.2. Most Impactful Emerging Technologies - Historical Data
• 6.3. AI Leads the Technologies Impacting Pharmaceutical Industry
• 6.4. AI Integration in Pharmaceutical Process
• 6.5. AI's Impact on Improving R&D Productivity
• 6.6. AI to Enhance Productivity and Lower the Costs
• 6.7. Respondents' Perspective on AI and Big Data

7. Industry's Growth Prospects

• 7.1. View on Industry's
• 7.2. Optimism for the Industry's Growth
• 7.3. Respondents' Perspective on Industry's Growth During the Next 12 Months

8. Watch Outs

• 8.1. Pressure to Innovate in the Pharma Sector
• 8.2. Respondents' Perspective on Innovation Pipeline
• 8.3. Emergence of Radiopharmaceuticals for Safe and Effective Targeted Treatment in Oncology
• 8.4. Market Potential for Radiotherapeutics
• 8.5. mRNA Vaccines
• 8.6. mRNA Vaccines - Infectious Diseases
• 8.7. Downturn and Recovery of Biotech Funding
• 8.8. Recovery of Biopharmaceutical Funding
• 8.9. Upturn in Public Markets
• 8.10. Government Grants - An Alternative Source of Biotech Funding?
• 8.11. An Early Preview of Clinical Trial Starts in 2025
• 8.12. Key Clinical Trials in 2025
• 8.13. Clinical Trials Anticipated to Initiate in 2025
• 8.14. Projected Trial Completion in 2025
• 8.15. Top 10 Selling Drugs - 2024 Versus 2025
• 8.16. Top 10 Therapy Areas for Drug Sales and Forecast - 2024 vs. 2025
• 8.17. Drug Launches Expected in 2025
• 8.18. Catalysts - Vertex Pharmaceuticals
• 8.19. Catalysts - GSK
• 8.20. Catalysts - AstraZeneca/Daiichi Sankyo

9. Summary of Key Findings

• 9.1. Key Findings

10. Appendix

• 10.1. Abbreviations
• 10.2. Related Reports

11. Authors and Contributors

• 11.1. Authors
• 11.2. Contributors

12. Contact Us

• 12.1. Contact Us
• 12.2. About GlobalData
• 12.3. A Connected Platform for a Dynamic World