한글목차

다양한 거시경제 및 지정학적 요인과 더불어 AI, 자동화 등 신기술의 등장이 현재의 비즈니스 환경을 형성하고 있습니다. 기술 도입은 업무 및 효율성 문제에 대한 잠재적인 해결책을 제공하지만, 기업들은 여전히 공급과 수요의 불균형, 시장 변동성, 지정학적 긴장 등의 문제에 직면해 있습니다. 제약 산업은 불황에 강한 산업으로 여겨지지만, 미래의 과제와 무관하지 않습니다. 가격 책정 및 상환(P&R) 제약, 진화하는 규제 환경, 바이오 보안법과 같은 새로운 법규에 대한 불확실성, 기술 혁신 및 ESG 문제 대응에 대한 압박은 향후 몇 년동안 제약업계에 계속 도전이 될 것입니다.

주요 조사 결과

• 바이오 의약품 산업은 2025년 성장 전망을 낙관하고 있지만, 그 수준은 반년 전보다 낮아졌습니다.
• 2024년 바이오테크놀러지 자금 회복에 대해 낙관적이거나 매우 낙관적이라고 답한 응답자는 전체의 50%로, 6개월 전 데이터 대비 6% 감소했습니다.
• 항비만제, 암 면역치료제(IO) 개발, 임상시험 비용 증가는 향후 12개월 동안 산업 동향에 가장 큰 영향을 미칠 것으로 보입니다.
• 항비만제는 2025년 가장 큰 영향을 미칠 새로운 제약 산업 트렌드로 꼽혔습니다.
• 거시적 규제 동향에서는 블록버스터 의약품의 라이프사이클 관리(LCM)와 생물학적 제제의 특허만료가 제약산업에 가장 큰 영향을 미칠 것으로 예상됩니다.
• 가격 책정 및 상환 제약과 지정학적 갈등은 바이오 의약품 부문 성장의 주요 장애물입니다.
• 제약업계 전문가들은 정책이 불투명한 상황에서 미국 대통령의 전환을 오히려 우려하고 있습니다.
• 빅데이터와 AI는 향후 1년 이내에 의료 부문을 변화시키는 힘으로 계속 우위를 점할 것으로 보입니다.
• AI는 새로운 치료법을 더 빠른 속도로 개발하고 비용 효율성을 높이는 중요한 촉진제가 될 수 있습니다.
• 낭포성 섬유증 치료제인 반자카프토르 칼슘 데우티바카프토르(Vanzacaftor calcium deutivacaftor tezacaftor)는 2025년 출시되는 약물 중 가장 높은 상업적 성공을 거둘 것으로 예상됩니다.
• 2025년 임상시험이 시작되는 분야는 암, 중추신경계(CNS), 심혈관이 주를 이룹니다.
• 암은 2025년 치료의 주류를 차지할 것으로 예상되지만, 가장 높은 성장세를 보이는 분야는 피부과입니다.

본 보고서에서는 세계 바이오 의약품 산업에 대해 조사 분석하여 2025년에 영향을 미칠 신기술, 산업 동향, 규제 동향, 거시경제적 요인 등의 정보를 제공합니다.

목차

제1장 주요 요약

제2장 조사 설계

• 목적과 설계
• 응답자 구성

제3장 새로운 산업 동향

제4장 새로운 규제와 거시경제 동향

제5장 정책과 규제

• 인플레이션 억제법
• 인플레이션 억제법 시행 스케줄
• 인플레이션 억제법 : 교섭 대상이 되는 최초 제품
• EU 의약품 개혁
• 새로운 IRP 회랑과 EU내에서의 출시 전략 변경
• EU의 의약품 개혁
• 바이오 시큐어법

제6장 신기술

• 가장 영향력 있는 신기술
• 가장 영향력 있는 신기술 - 과거 데이터
• AI가 제약 산업에 영향을 미치는 기술을 리드
• 제약 공정에서의 AI 통합
• R&D 생산성 향상에 대한 AI의 영향
• 생산성을 높여 비용을 삭감하는 AI
• AI와 빅데이터에 관한 응답자의 시점

제7장 산업 성장 전망

• 산업에 대한 견해
• 산업 성장에 대한 낙관
• 향후 12개월간 산업 성장에 관한 응답자의 견해

제8장 주의점

• 제약 산업의 혁신에 대한 압력
• 혁신 파이프라인에 관한 응답자의 시점
• 암의 안전하고 효과적인 표적 치료를 위한 방사성 의약품의 등장
• 방사선 치료 시장의 가능성
• mRNA 백신
• mRNA 백신 - 감염증
• 바이오테크놀러지 자금 감소와 회복
• 바이오 의약품 자금 회수
• 주식 시장의 회복
• 정부 보조금 - 바이오테크놀러지 대체 자금원이 될까?
• 임상시험 조기 프리뷰는 2025년에 개시
• 주요 임상시험(2025년)
• 2025년에 개시되는 임상시험
• 2025년으로 예정되는 시험 완료
• 판매 상위 10개 의약품(2024년·2025년)
• 의약품 판매 상위 10개 치료 분야와 예측(2024년·2025년)
• 2025년으로 예정되는 신약 출시
• 촉매 - Vertex Pharmaceuticals
• 촉매 - GSK
• 촉매 - AstraZeneca/Daiichi Sankyo

제9장 주요 조사 결과 요약

• 주요 조사 결과

제10장 부록

제11장 저자와 기고자

제12장 문의

영문목차

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