The State of the Biopharmaceutical Industry 2026 Edition
Description
The State of the Biopharmaceutical Industry 2026 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.
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.
- AI, immuno-oncology, increasing cost of clinical trials, and personalized/precision medicine were rated as the most impactful emerging industry trends for the next 12 months.
- Trends identified to have the greatest impact on the industry by surveyed pharmaceutical professionals were AI in the pharma value chain, delay in generating product revenue due to pricing and reimbursement processes, and supply chain challenges.
- The largest proportion of surveyed pharmaceutical professionals ranked the actions of the Trump administration as the top positive emerging regulatory and macroeconomic trend, while the same was also ranked as the top negative.
- MFN pricing, alongside drug price constraints in the Inflation Reduction Act (IRA), add more pressure on drug pricing
- Most respondents see opportunities in collaboration with China and believe partnerships will continue.
- 52% of survey respondents felt optimistic or very optimistic about the biopharmaceutical industry’s growth prospects in 2025.
- 39% of pharmaceutical industry professionals surveyed reported optimistic or very optimistic sentiment on the recovery of biotech funding in the next 12 months - up from 24% in May 2025.
- Biosimilar competition and price linkage requirements have the potential to drive down the prices of both originator reference products and their biosimilars.
- Survey respondents believe that the EU and US will see the most investment in the next 12 months, followed by the EU and China.
- Top selling drugs for 2026 are expected to be Eli Lilly’s Mounjaro, rising from sixth to third place, while Novo Nordisk’s Wegovy joins the top 10 at eighth place.
- 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.
- 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.
Table of Contents
137 Pages
- Executive Summary
- Objectives and Design
- Respondent Mix
- The Most Impactful Emerging Industry Trends AI in pharma, IO drug development, the
- Trends With The Greatest Impact on The Industry When asked to identify the top industry
- AI Continues to Have a Positive Impact on the Pharmaceutical Value Chain
- AI Is Predominantly Used in the Early Stages of Drug Discovery and Development
- Delay in Generating Product Revenue Due to Pricing and Reimbursement Process
- Delay in Generating Product Revenue Due to P&R Process In many highly regulated markets, a product
- Supply Chain Challenges Continue to Impact the Pharmaceutical Markets
- Increased Demand for Drugs Tops the Reasons Leading to Supply Chain Challenges
- Anti-obesity Medications Still a Critical Trend Impacting the Pharmaceutical Industry
- Highly Crowded Field of Anti-obesity Medications in Development
- Personalized/Precision Medicine: an Option for Improving Treatment Outcomes
- Personalized/Precision Medicine Drugs: Recent Approvals and Launches
- 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
- Antibody-Drug Conjugates
- Successful Maturation of Early-Stage Antibody-Drug Conjugates Is Key for Projected Increase in ADC Market
- Complexity and Rising Costs of Clinical Trials Impact Drug Development
- Trial Complexity and Cost of Clinical Trials
- Tools and Technologies Supporting DCTs The advancements in network
- 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
- Cell and Gene Therapies Are Primarily Focused on Hematological Malignancies
- Cell and Gene Therapy Approaches Are Expanding Beyond Oncology
- Bispecific/Trispecific Therapies
- Bispecific and Trispecific Therapeutics: A $71B Market by 2031
- 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 Expected to Affect Market Access in the Next 12-18 Months
- Key Drivers of Pricing & Reimbursement Outlook in Major Markets
- Uncertainty if IRP Use Would Impact Company Strategies
- Among Companies Planning to Change Strategy, More than Half Plan to Amend Launch Sequencing
- Changes to Biotech Sector Funding
- Expected Impact of Cuts to Key US Healthcare Agencies
- Concerns in Relation to Trump's Tariffs on Pharmaceuticals
- Rising Pressure on Companies to Move Production Sites to US
- Respondents' Perspective on Pharmaceutical Manufacturing Moving in the Next Year
- Emerging Regulatory and Macroeconomic Trends
- Deeper Dive into the Positive Regulatory and Macroeconomic Trends - by Geography
- Biosimilar Pricing
- Prescribing Shift and Biosimilars
- Life Cycle Management of Blockbuster Drugs
- Respondents' Opinions on Emerging Regulatory and Macroeconomic Trends - Positives
- Respondents' Opinions on Emerging Regulatory and Macroeconomic Trends - Negatives
- Inflation Reduction Act
- Inflation Reduction Act Implementation Timeline for First Batch of Products
- Inflation Reduction Act: First Batch of Products Subject to Negotiation
- Inflation Reduction Act Implementation Timeline for Second Batch of Products
- Inflation Reduction Act: Second Batch of Products Subject to Negotiation
- Medicare Part D Price Negotiation Under IRA Triggers Average Reduction of 62% vs. List Price
- EU Pharmaceutical Reform
- Critical Medicines Act in the EU Market
- New IRP Corridors and Changes in Launch Strategies Inside EU
- The EU's Joint Clinical Assessment
- BIOSECURE Act
- Respondent Perceptions About Chinese Pharma Innovation
- China Has Restructured its Regulatory Framework to Advance Drug Development
- US Leads Drug Development, but China Continues to Advance
- 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
- View on Industry Growth During the Next 12 Months
- Optimism for the Industry's Growth
- Respondents' Perspective on Industry Growth During the Next 12 Months
- Pressure to Innovate in the Pharma Sector
- 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
- Government Grants - An Alternative Source of Biotech Funding?
- Public Markets Enter Another Downturn
- Upturn in Mergers & Acquisitions
- Sentiments for Exit Strategies for Biotechs
- Regions That Will Attract the Most Investment
- Key Clinical Trials in 2026
- Key Catalysts in 2026 - Xenon Pharmaceuticals (XENE)
- Key Catalysts in 2026 - DBV Technologies (DBV)
- Key Catalysts in 2026- Rhythm Pharmaceuticals' (RYTM)
- Key Catalysts in 2026 - GSK (GSK)
- Key Catalysts in 2025 - PTC Therapeutics (PTCT)
- Top 10 Selling Drugs - 2025 vs. 2026
- Blockbuster Drug Launches Expected in 2026
- Key Findings
- Abbreviations
- Related Reports
- Authors
- Contributors
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