Americas Drug Repurposing Market Size, Share, Trends and Forecasts 2031

Key Findings

• The Americas Drug Repurposing Market is expanding rapidly as pharmaceutical companies seek cost-effective and time-efficient alternatives to de novo drug discovery.
• Increasing prevalence of chronic and rare diseases, combined with rising R&D costs, is accelerating adoption of repurposing strategies across Americas.
• Advances in computational biology, AI, and machine learning are revolutionizing drug repositioning by enabling predictive modeling and target identification.
• The COVID-19 pandemic highlighted the potential of repurposed drugs, strengthening regulatory and industry support for this approach.
• Growing collaborations between biotech firms, academic institutions, and government agencies are fostering innovation in the Americas market.
• Challenges such as intellectual property (IP) barriers, data ownership, and limited regulatory clarity hinder broader commercialization.
• Integration of real-world evidence (RWE) and big data analytics is transforming drug repurposing from an opportunistic strategy into a structured discovery framework.
• Government incentives and public–private partnerships in Americas are expected to further enhance market maturity and clinical translation of repurposed therapies.

Americas Drug Repurposing Market Size and Forecast

The Americas Drug Repurposing Market is projected to grow from USD 25.4 billion in 2025 to USD 57.2 billion by 2031, at a CAGR of 14.5% during the forecast period. Growth is primarily driven by rising R&D productivity challenges and the increasing appeal of repositioning existing drugs with known safety profiles. The cost and time efficiency of repurposing—where development cycles are 40–60% shorter compared to traditional pipelines—make it particularly attractive for both large pharmaceutical companies and startups. In Americas, expanding AI-powered discovery platforms and improved clinical data integration are enabling identification of new therapeutic indications for existing molecules. Supportive government frameworks and rare disease programs are further promoting the adoption of repurposing strategies across oncology, neurology, infectious diseases, and metabolic disorders.

Introduction

Drug repurposing, also known as drug repositioning, refers to the process of identifying new therapeutic uses for existing approved or investigational drugs beyond their original indications. This approach capitalizes on established pharmacokinetic and safety data, significantly reducing the risks and costs associated with novel drug development. In Americas, the growing need for innovative therapies against complex diseases, coupled with high attrition rates in traditional pipelines, has fueled interest in repurposing strategies. The method has proven effective in discovering new treatments for rare and neglected diseases where commercial incentives are limited. Advances in bioinformatics, high-throughput screening, and AI-based drug-target mapping have transformed the repurposing ecosystem into a structured, data-driven process. As governments and investors recognize its value, drug repurposing is becoming a key pillar in pharmaceutical innovation across Americas.

Future Outlook

By 2031, the Americas Drug Repurposing Market will be defined by a synergistic integration of artificial intelligence, real-world data, and multi-omics technologies. Machine learning models capable of predicting molecular interactions and disease associations will drive high-throughput virtual screening for novel indications. The rise of open-access biological databases and collaborative R&D ecosystems will facilitate faster identification and validation of repositioning candidates. AI-enabled clinical trial optimization will further streamline the approval process, reducing costs and improving success rates. Personalized repurposing—matching existing drugs to patient-specific genomic profiles—will become a major trend in precision medicine. Furthermore, supportive intellectual property (IP) reforms and cross-sector partnerships will strengthen commercial viability. With continued innovation and regulatory harmonization, Americas is expected to emerge as a global leader in systematic and AI-driven drug repurposing.

Americas Drug Repurposing Market Trends

• Integration of Artificial Intelligence and Machine Learning in Drug Discovery
  Artificial intelligence and machine learning are transforming drug repurposing in Americas by enabling large-scale analysis of biological, chemical, and clinical datasets. Predictive models can identify hidden correlations between drug mechanisms and disease pathways, accelerating the identification of repurposing candidates. AI algorithms analyze omics data, literature databases, and adverse event reports to uncover potential off-target effects that can be therapeutically exploited. These tools significantly reduce the time required for hypothesis generation and experimental validation. As AI-driven drug discovery platforms mature, they are expected to dominate preclinical repurposing workflows.

• Rising Adoption of Drug Repurposing in Rare and Neglected Diseases
  In Americas, drug repurposing is emerging as a powerful strategy to address unmet medical needs in rare and neglected diseases. Traditional drug development for such conditions is often financially unviable due to small patient populations. Repurposing allows researchers to leverage existing compounds with known safety profiles, drastically reducing development timelines. Regulatory incentives such as orphan drug designations and market exclusivity extensions are further encouraging investment. Academic institutions and non-profit organizations are increasingly collaborating to identify affordable repurposed therapies for underserved patient groups.

• Expansion of Public–Private Collaborations and Open-Access Platforms
  Collaborative research initiatives and data-sharing platforms are strengthening the repurposing ecosystem in Americas. Governments, research institutes, and biopharmaceutical firms are pooling resources to create large-scale compound libraries and clinical data repositories. Open-access databases such as LINCS, DrugBank, and Open Targets are enabling cross-institutional innovation. Public–private partnerships are also helping to bridge translational gaps between computational predictions and clinical validation. This collaborative model is expected to accelerate market maturity and lower R&D duplication costs.

• Regulatory Recognition and Streamlined Approval Pathways
  Regulatory authorities in Americas are increasingly recognizing the value of drug repurposing as a low-risk, high-impact innovation pathway. Streamlined approval processes for drugs with prior safety data are improving time-to-market efficiency. Agencies are encouraging adaptive clinical trial designs and real-world evidence submissions to expedite approval. The inclusion of repurposing frameworks within national innovation policies is further catalyzing growth. As regulatory harmonization advances, market participants will benefit from improved predictability and transparency in approval cycles.

• Application of Real-World Evidence and Data Analytics
  Real-world data (RWD) from electronic health records (EHRs), patient registries, and insurance databases is becoming a cornerstone for validating repurposed drugs in Americas. Analytical tools are being used to identify population-level treatment outcomes and off-label usage patterns that may indicate new therapeutic benefits. These insights enable retrospective validation of drug efficacy in real-world settings, complementing clinical trial data. The integration of RWD into regulatory submissions enhances credibility and supports post-marketing surveillance of repurposed drugs.

Market Growth Drivers

• Rising R&D Costs and Declining Productivity in Traditional Drug Development
  The escalating costs and prolonged timelines of conventional drug discovery are prompting pharmaceutical firms in Americas to adopt repurposing strategies. Developing a new drug typically requires over a decade and billions of dollars, with high attrition rates during clinical trials. Drug repurposing reduces risk by leveraging existing safety and pharmacokinetic data, cutting development time by up to 60%. This cost efficiency makes it particularly attractive for small biotech firms and academic research organizations seeking rapid clinical translation.

• Advancements in Computational and Systems Biology
  The integration of computational modeling, bioinformatics, and network pharmacology is enhancing the precision of drug repurposing. In Americas, advanced algorithms are being used to simulate molecular interactions and predict drug-target binding across multiple pathways. Systems biology approaches enable mapping of disease networks, facilitating identification of new therapeutic intersections for existing compounds. These computational advancements are strengthening preclinical discovery pipelines and enabling scalable, hypothesis-free repurposing.

• Increased Prevalence of Chronic and Rare Diseases
  The growing burden of chronic diseases such as cancer, neurological disorders, and metabolic syndromes is intensifying demand for innovative therapeutic solutions. Repurposing existing drugs for new indications allows rapid expansion of treatment options without the high risks associated with novel molecules. In Americas, rising cases of Alzheimer’s, Parkinson’s, and autoimmune diseases are driving exploration of established drugs for new disease targets. This trend is supported by rising investment in translational medicine and targeted therapy research.

• Supportive Government Initiatives and Funding Programs
  Governments in Americas are actively promoting drug repurposing through research grants, policy reforms, and innovation incentives. National health agencies are funding cross-disciplinary projects focusing on neglected diseases, pandemic preparedness, and chronic illness management. Fast-track programs and flexible IP frameworks are improving the regulatory environment for repurposed drugs. This policy-driven momentum is expected to accelerate both academic and commercial participation in the market.

• Increasing Pharmaceutical Collaborations and Licensing Agreements
  Pharmaceutical and biotechnology companies in Americas are forming strategic partnerships to co-develop and commercialize repurposed drugs. Licensing agreements allow smaller firms with niche expertise to collaborate with larger players possessing clinical and distribution infrastructure. Such collaborations mitigate risk, enhance global reach, and optimize asset utilization. The growing trend of shared intellectual property and profit-sharing models is fostering innovation while reducing redundancy in drug development efforts.

Challenges in the Market

• Intellectual Property (IP) and Patent Protection Issues
  One of the major challenges in the Americas Drug Repurposing Market is establishing strong IP protection for repurposed drugs. Since the original compounds are often off-patent, obtaining new patents based on novel indications or formulations is complex. Weak IP protection reduces commercial incentives for investment. Developing effective data exclusivity and regulatory protection mechanisms will be essential for sustaining innovation and profitability in this sector.

• Regulatory and Clinical Validation Barriers
  Despite their safety profiles, repurposed drugs require robust clinical validation for new indications, leading to regulatory delays. In Americas, lack of standardized guidelines for data reuse and off-label indication approval complicates market entry. Moreover, the absence of harmonized global regulatory frameworks creates uncertainty in cross-border commercialization. Simplified approval pathways and consistent criteria for efficacy validation will be crucial to overcome these hurdles.

• Limited Access to High-Quality Clinical and Pharmacological Data
  Effective drug repurposing relies heavily on access to comprehensive pharmacological and clinical datasets. In Americas, data fragmentation and lack of interoperability between healthcare systems limit the usability of real-world evidence. Privacy regulations further restrict data sharing across research entities. Building secure, unified data-sharing frameworks with anonymization protocols is vital for accelerating computational and evidence-based repurposing.

• Funding Constraints for Translational Research
  Early-stage repurposing projects often struggle to attract sufficient funding, especially when targeting rare or neglected diseases. Investors tend to favor traditional drug development programs with stronger patent protection. In Americas, limited venture capital participation in translational research inhibits the transition from computational prediction to clinical validation. Strengthening public funding mechanisms and establishing dedicated repurposing consortia will help bridge this gap.

• Competition from Generic and Off-Label Usage
  Generic drug availability and widespread off-label prescribing practices limit the commercial potential of formal repurposing initiatives. In Americas, physicians often prescribe existing medications for secondary uses without regulatory approval, reducing incentives for formal clinical validation. Establishing value-based pricing models and differentiation through optimized formulations or delivery systems can help mitigate competitive pressures.

Americas Drug Repurposing Market Segmentation

By Drug Type

• Generic Drugs

• Patented Drugs

By Therapeutic Area

• Oncology

• Neurology

• Infectious Diseases

• Cardiovascular Disorders

• Autoimmune and Inflammatory Diseases

• Metabolic Disorders

• Rare Diseases

By Approach

• Computational (In Silico) Drug Repurposing

• Experimental (In Vitro/In Vivo) Drug Repurposing

• Mixed/Hybrid Approaches

By End-User

• Pharmaceutical and Biotechnology Companies

• Academic and Research Institutes

• Contract Research Organizations (CROs)

• Government and Non-Profit Organizations

Leading Key Players

• Pfizer Inc.

• Eli Lilly and Company

• Novartis AG

• AstraZeneca plc

• GlaxoSmithKline plc (GSK)

• Sanofi S.A.

• Takeda Pharmaceutical Company Limited

• Recursion Pharmaceuticals, Inc.

• BenevolentAI Ltd.

• Healx Ltd.

Recent Developments

• Pfizer Inc. expanded its AI-driven repurposing collaboration in Americas to identify novel therapeutic indications for existing oncology compounds.

• Eli Lilly and Company partnered with academic institutions in Americas to explore antidepressant repositioning for chronic pain management.

• Recursion Pharmaceuticals, Inc. launched a data-driven platform integrating AI and high-content imaging for large-scale drug repurposing in Americas.

• Healx Ltd. initiated a collaborative program with non-profits in Americas to accelerate repurposed drug development for rare pediatric diseases.

• AstraZeneca plc introduced a multi-omics-based repurposing pipeline in Americas targeting neurodegenerative and metabolic disorders.

This Market Report Will Answer the Following Questions

1. What is the projected market size and CAGR of the Americas Drug Repurposing Market by 2031?

2. How are AI, computational biology, and real-world evidence transforming repurposing workflows?

3. What regulatory and IP challenges impact commercialization in Americas?

4. Which therapeutic areas offer the greatest potential for repurposed drugs?

5. Who are the leading industry players, and what strategic collaborations are shaping market growth in Americas?