The State of the Biopharmaceutical Industry 2025 (Mid-Year) Edition

The State of the Biopharmaceutical Industry 2025 (Mid-Year) Edition

Summary

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 the adoption of technologies can offer 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 challenges. Factors such as constraints on drug pricing and reimbursement (P&R), the evolving regulatory landscape, uncertainties surrounding tariffs on pharmaceuticals, the introduction of international reference pricing (IRP) to the US, legislation such as America First and the BIOSECURE Act, as well as pressures to innovate and to address environmental, social, and governance (ESG) issues will continue to pose challenges to 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 or dominate the industry over the next 12 months.

  • Only 42% of survey respondents are optimistic about the biopharmaceutical industry growth prospects in 2025-a 31% decline from six months ago.
  • 40% of survey respondents shared a pessimistic or very pessimistic view of biotech funding recovery in May 2025, whereas earlier in the year, 50% of respondents were optimistic.
  • Anti-obesity drugs, immuno-oncology (IO) drug development, and artificial intelligence (AI) in pharma will be among the most impactful industry trends for the next 12 months.
  • Increase in real world evidence (RWE) clinical trials, 2024 was the highest year yet, and growth is projected to continue for RWE clinical trials.
  • Supply chain challenges were identified as the emerging pharmaceutical industry trend with the greatest impact expected for 2025.
  • Patent expiry of biologics, the launch of the Joint Clinical Assessment (JCA) in the EU and the actions of the Trump administration, expected to have the greatest positive impacts on the pharmaceutical industry.
  • The actions of the Trump administration, including tariffs and trade wars, and drug pricing and reimbursement constraints will be the main hindrances to growth in the biopharmaceutical sector.
  • Pharmaceutical industry professionals continue to be concerned about the new US administration's changes due to geopolitical and policy uncertainty.
  • Biosimilar competition and price linkage requirements have the potential to drive down the prices of both originator reference products and their biosimilars.
  • AI continues to be a key driver in technology, creating efficiencies across the pharmaceutical value chain.
  • The vanzacaftor calcium + deutivacaftor + tezacaftor for cystic fibrosis is expected to have the highest commercial success among the 2025 launches.
Scope
  • Benchmark the impact of major themes on the biopharmaceutical industry in the next 12 months, including: emerging technologies, regulatory trends, macroeconomic trends, and industry trends.
  • Identify themes that will have the greatest positive or negative impacts 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 shaping the biopharmaceutical industry in the next 12 months.
  • Analyse 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.


  • Executive Summary
  • Study Design
    • Objectives and Design
    • Respondent Mix
  • Emerging Industry Trends
    • The Most Impactful Emerging Industry Trends
    • Supply Chain Challenges Continue to Impact the Pharmaceutical Markets
    • Increased Demand for Drugs Tops the Reasons Leading to Supply Chain Challenges
    • Anti-obesity Medications Top the Trends Impacting the Pharmaceutical Industry
    • Highly Crowded Field of Anti-obesity Medications in Development
    • AI Is Expected to Have a Positive Impact on the Pharmaceutical Value Chain
    • Emerging Technologies Impacting the Pharmaceutical Value Chain
    • AI Is Predominantly Used in the Early Stages of Drug Discovery and Development
    • Antibody-Drug Conjugates
    • Successful Maturation of Early-Stage Antibody-Drug Conjugates Is Key for Projected Increase in ADC Market
    • Personalized/Precision Medicine: an Option for Improving Treatment Outcomes
    • Personalized/Precision Medicine Drugs: Recent Approvals and Launches
    • Cell and Gene Therapies Are Primarily Focused on Hematological Malignancies
    • Cell and Gene Therapy Approaches Are Expanding Beyond Oncology
    • Cell and Gene Therapy Markets Are Expected to Grow Significantly in Coming Years
    • RWE Is Becoming a Valuable and Necessary Source for the Pharmaceutical Industry
    • Increase in Real-Word Evidence Clinical Trials
    • IO Continues to Show Growth in Oncology, Despite Some Recent Setbacks
    • Immuno-oncology Drugs: Recent Approvals and Launches
    • Complexity and Rising Costs of Clinical Trials Impact Drug Development
    • Complexity and Increasing Cost of Clinical Trials
    • Tools and Technologies Supporting Decentralized/Virtual Clinical Trials
    • Utilization of Decentralized/Virtual Components in Clinical Trials Increases Post-Pandemic
    • Biosimilar Uptake Varies Across Markets and Diseases
    • Recent Approvals of Key Biosimilars May Impact Their Uptake in the Pharma Markets
    • Microbiome Drug Development
  • Emerging Regulatory and Macroeconomic Trends
    • Top Positive and Negative Emerging Regulatory and Macroeconomic Trends
    • Emerging Regulatory and Macroeconomic Trends
    • Geopolitical Conflicts Persist as an Ongoing Concern
    • Geopolitical Risk Summary
    • Pricing and Reimbursement Trends
    • P&R Policy Changes to Affect Market Access
    • Key Drivers of Changes to P&R Outlook in Major Markets
    • EU Pharmaceutical Reforms if Tariffs Are Implemented
    • Concerns in Relation to Trump's Tariffs on Pharmaceuticals
    • Respondents' Perspective on Pharmaceutical Manufacturing Moving in the Next Year
    • Changes Within the First 100 Days of the New US Administration
    • Introduction of IRP in the US Emerges as a Serious Concern
    • Trump's Funding and Job Cuts to US Healthcare Agencies Causes Concern Within the Pharma Industry
    • US Policies Urge Companies to Reconsider Production Site Location
    • Impact of Trump's Healthcare Agency Funding and Job Cuts
    • Emerging Regulatory and Macroeconomic Trends
    • Emerging Regulatory and Macroeconomic Trends - by Geography
    • Prescribing Shift and Biosimilars
    • Biosimilar Pricing
    • Respondents' Opinion on Emerging Regulatory and Macroeconomic Trends - Positives
    • Respondents' Opinion on Emerging Regulatory and Macroeconomic Trends - Negatives
  • Policies and Regulations
    • Inflation Reduction Act
    • Inflation Reduction Act Implementation Timeline
    • Inflation Reduction Act: First Round of Products Subject to Negotiation
      • Table First round of products selected for Medicare price negotiation
    • Inflation Reduction Act: Second Round of Products Subject to Negotiation
      • Table Products selected for second round of Medicare price negotiation
    • EU Pharmaceutical Reform
    • New IRP Corridors and Changes in Launch Strategies Inside EU
    • EU Pharmaceutical Reform
    • BIOSECURE Act
  • Emerging Technologies
    • Most Impactful Emerging Technologies
    • Most Impactful Emerging Technologies - Historical Data
    • AI Leads the Technologies Impacting Pharmaceutical Industry
    • AI Integration in Pharmaceutical Processes
    • AI's Impact on Improving R&D Productivity
    • AI to Enhance Productivity and Lower R&D Costs
    • Respondents' Perspective on AI and Big Data
  • Industry's Growth Prospects
    • View on Industry's Growth During the Next 12 Months
    • Optimism for the Industry's Growth
    • Respondents' Perspective on Industry's Growth During the Next 12 Months
  • Watch Outs
    • Pressure to Innovate in the Pharma Sector
    • Respondents' Perspective on Innovation Pipeline
    • Emergence of Radiopharmaceuticals for Safe and Effective Targeted Treatment in Oncology
    • Market Potential for Radiotherapeutics
    • ADCs and mAbs
    • mRNA Vaccines
    • mRNA Vaccines - Infectious Diseases
    • Recovery of Biotech Funding
    • Public Markets May Face Another Downturn
    • Downturn in Mergers & Acquisitions
    • Government Grants - An Alternative Source of Biotech Funding?
    • Region which will attract the most investment
    • Key Clinical Trials in 2025
    • Top 10 Selling Drugs - 2024 Versus 2025
    • Key Catalysts in 2025 - Neumora Therapeutics (NMRA)
    • Key Catalysts in 2025 - PTC Therapeutics (PTCT)
    • Key Catalysts in 2025 - Cytokinetics (CYTK)
    • Key Catalysts in 2025- Lenz Therapeutics (LENZ)
    • Blockbuster Drug Launches Expected in 2025
  • Summary of Key Findings
    • Key Findings
  • Appendix
    • Abbreviations
    • Related Reports
  • Authors and Contributors
    • Authors
    • Contributors
  • Contact Us
    • Deallus consulting offerings, leveraging content from Strategic Intelligence modules
    • Contact Us

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings