Drug Repositioning Market | Global Industry Analysis 2033

Drug Repositioning Market Overview

Global Drug Repositioning Market size is anticipated to be valued at USD 30150.89 million in 2024, with a projected growth to USD 45759.02 million by 2033 at a CAGR of 4.7%.

The drug repositioning market focuses on identifying new therapeutic uses for existing or previously failed drugs, enabling faster development timelines and lower costs compared to de novo drug development. Over 30% of drugs approved in the last two decades have involved some form of repositioning. Notably, more than 400 known molecules have been repurposed for new indications, with at least 120 of them achieving regulatory approval in secondary therapeutic categories.

This approach is increasingly favored due to a typical 6–10 year reduction in time-to-market when compared to novel compound development. Preclinical safety data already available for many of these molecules further accelerates the process. In the United States alone, more than 70 investigational new drug (IND) applications filed in 2023 were repositioned compounds. The global industry is heavily supported by public-private partnerships and initiatives, with over 50 such collaborations active as of 2024. The method also reduces the risk of failure, with success rates in Phase II clinical trials for repositioned drugs being around 25%, compared to only 10% for new drugs.

Key Findings

Top Driver reason: Increasing R&D costs for novel drugs is pushing demand for cost-effective drug repositioning strategies.

Top Country/Region: North America leads with over 50% of total clinical trials involving repositioned drugs.

Top Segment: Cancer applications dominate with more than 40% of repositioning studies focused on oncology.

Drug Repositioning Market Trends

The drug repositioning market is characterized by a growing trend of AI integration in drug discovery. As of 2024, over 60 AI platforms are operational globally, aiding in target identification and compound screening for repurposing. Companies have reported a 30% decrease in exploratory time using AI-based drug repositioning platforms.

Another significant trend is the rise in repositioning efforts in the area of rare diseases. With fewer than 200,000 cases per disease in the U.S., rare disease treatments have surged by over 45% in repositioning studies between 2020 and 2023. In particular, repositioned drugs like thalidomide for multiple myeloma and sildenafil for pulmonary arterial hypertension have set benchmarks for successful models.

COVID-19 also amplified drug repositioning initiatives. More than 100 existing drugs were screened globally for antiviral properties during the pandemic, leading to emergency use authorizations and fast-tracked clinical approvals. Remdesivir and dexamethasone are two such repositioned agents that demonstrated efficacy.

Furthermore, market players are increasingly investing in real-world evidence and big data analytics. More than 200 million patient records have been analyzed globally to detect off-label uses that inform repositioning strategies. This digital transformation is expected to lead to a 50% increase in data-driven repositioning initiatives by 2026.

Drug Repositioning Market Dynamics

DRIVER

Rising demand for pharmaceuticals.

The ever-increasing demand for therapeutic solutions in chronic and rare diseases, combined with the escalating cost and time involved in new drug development, has positioned drug repositioning as a compelling alternative. Over 70% of pharmaceutical companies now have dedicated teams for repurposing strategies. A single Phase III trial can cost upwards of $100 million; repositioning allows stakeholders to avoid early-phase trials, thereby saving both time and budget. The presence of more than 2,000 known pharmacologically active compounds provides a robust starting pool for repositioning efforts. Moreover, regulatory bodies such as the FDA have streamlined the 505(b)(2) approval pathway, used in over 60 repositioning approvals between 2018 and 2023.

RESTRAINT

Lack of intellectual property protection.

One of the main restraints facing the drug repositioning market is the limited scope for new patent protection. Since many repositioned compounds are off-patent, pharmaceutical firms find it difficult to recoup investment without exclusive marketing rights. In 2023, fewer than 20% of repositioned drugs filed for new use patents were granted exclusivity for over 7 years. Additionally, legal battles around secondary use patents are on the rise, with more than 15 lawsuits filed globally in 2023 alone. This deters some firms from engaging in repositioning, particularly those without the legal infrastructure to handle IP disputes.

OPPORTUNITY

Growth in personalized medicines.

Drug repositioning is gaining traction in the field of personalized medicine. By analyzing patient-specific genetic and phenotypic data, researchers are finding novel uses for drugs in narrowly defined patient groups. Over 300 repositioned compounds have been identified for use in biomarker-driven populations since 2020. This has led to a sharp increase in personalized drug repositioning programs, especially in oncology and CNS disorders. Institutions like the NIH are funding more than 40 such projects as of 2024. This emerging synergy between genomics and repositioning is expected to enhance treatment efficacy and reduce adverse effects.

CHALLENGE

Rising costs and expenditures.

Although repositioning is cost-effective compared to new drug development, expenditures can still be substantial. Clinical trials for new indications still require extensive safety and efficacy data, often exceeding $20 million per trial. Moreover, the cost of regulatory compliance, post-marketing surveillance, and marketing can still add up. Firms engaged in repositioning often need to spend 30–40% of the initial drug cost to reintroduce the product for a new use. In 2023, over 15 repositioning projects were shelved due to unanticipated costs and lack of ROI, particularly among small to mid-sized biotech firms.

Drug Repositioning Market Segmentation

The drug repositioning market is segmented based on type and application. By type, it includes generic drugs and clinical trial failed drugs. By application, it spans cancer, cardiovascular diseases, mental illness, and others. Over 1,000 repositioning programs globally are focusing on specific indications, with oncology comprising the largest share.

By Type

Generic Drugs: Generic drugs, having lost patent exclusivity, are a common focus for repositioning. Over 500 generics have been considered for new indications since 2019. Notable examples include metformin (originally for diabetes) being studied for anti-aging and cancer applications. In 2023 alone, 50 generic compounds entered new Phase II trials for off-label use. The cost advantage of generics, typically priced 85% lower than branded drugs, makes them an attractive repositioning target, especially for low-income countries.
Clinical Trial Failed Drugs: More than 250 drugs that failed in Phase II or III trials due to lack of efficacy in the target indication have found new potential in unrelated conditions. For example, a failed Alzheimer’s drug is now being tested for glioblastoma with positive preliminary results. In 2024, 40 such drugs were granted new investigational status by regulatory authorities. These compounds typically save 3–5 years of development time due to prior toxicology and pharmacokinetic data.

By Application

Cardiovascular Diseases: More than 120 repositioned drugs have been studied for cardiovascular benefits. For instance, colchicine—originally for gout—is used to reduce cardiac inflammation. In 2023, over 30 clinical trials were underway globally to evaluate cardiovascular applications of repositioned drugs. Cardiovascular conditions account for 25% of all repositioning studies due to the high burden and established safety profiles of related drugs.
Mental Illness: Repositioning in mental health has gained momentum, with more than 150 compounds evaluated for conditions such as depression, schizophrenia, and bipolar disorder. Ketamine, originally an anesthetic, has become a prominent example as a treatment for treatment-resistant depression. Over 40 repositioning programs are currently in progress for psychiatric applications, reflecting rising unmet needs in mental health.
Cancer: Oncology remains the top therapeutic focus, accounting for 40% of repositioning trials globally. Drugs like propranolol and metformin are being repurposed for multiple types of cancer. In 2023, over 70 new repositioning trials in cancer were initiated globally, with strong support from public institutions and oncology centers.
Others: Other applications include autoimmune diseases, infectious diseases, and dermatology. For example, thalidomide—originally a sedative—is used in leprosy and multiple myeloma. Over 100 drugs have found new roles in rare diseases, supported by orphan drug designations.

Drug Repositioning Market Regional Outlook

The drug repositioning market demonstrates varying dynamics across regions, with strong development hubs and government backing concentrated in certain geographies.

North America

North America dominates the market with over 60% of all active repositioning trials located in the U.S. The FDA’s 505(b)(2) regulatory route has been instrumental, with over 200 drugs approved through this pathway in the last decade. The NIH funds over 150 ongoing repositioning research projects, and public-private consortia like NCATS have mobilized more than $500 million in funding as of 2023.

Europe

Europe holds a significant share, with over 35 national programs supporting repositioning efforts. The UK’s Medical Research Council funds more than 40 drug repositioning studies annually. The EMA’s adaptive licensing pathway has accelerated approvals of at least 50 repositioned drugs in the last 5 years. Germany and France lead in repositioning trials, particularly in oncology and neurology.

Asia-Pacific

Asia-Pacific is rapidly emerging as a key region with over 25% growth in repositioning trials from 2022 to 2024. China and India collectively initiated over 80 repositioning studies in 2023 alone. Government initiatives in Japan and South Korea are fostering new drug development frameworks that integrate repositioning with personalized medicine strategies.

Middle East & Africa

Repositioning is gaining traction due to affordability and lack of infrastructure for novel drug development. In 2023, over 15 repositioned drugs were introduced in the region, particularly for infectious and parasitic diseases. South Africa and the UAE are emerging centers for clinical studies involving repurposed compounds, focusing on public health needs.

List of Top Drug Repositioning Market Companies

Teva
Novartis
Mylan
Johnson & Johnson
Pfizer
Bausch Health
GSK
ChemRar Group
Glenmark
Fujifilm
Reddy
R-Pharma

Top 2 Companies by market share

Pfizer: In 2023, Pfizer had more than 20 repositioned drugs in active trials globally, with over 5 of them in oncology applications.

Johnson & Johnson: With more than 15 repositioning programs ongoing in 2024, the company has focused on CNS and immunological indications, supported by over 1,200 researchers in R&D hubs.

Investment Analysis and Opportunities

The drug repositioning market is witnessing significant investment activity as pharma companies and venture capitalists seek to optimize development cycles. In 2023, over $3 billion in private equity and VC funds were allocated to companies specializing in repurposing drug technologies. This marked a 25% increase compared to 2022, with more than 60 new biotech firms securing funding for repositioning pipelines.

Public funding agencies such as the U.S. National Institutes of Health (NIH) and the European Commission have together invested in over 300 repositioning studies since 2020. More than 40% of NIH’s Translational Sciences budget in 2023 was allocated to drug repositioning, supporting over 200 principal investigators.

Companies are also forming cross-border alliances. For instance, a 2023 partnership between a Japanese biotech firm and a U.S. pharma company led to the repurposing of 3 antivirals for use in autoimmune diseases. Over 150 such collaborations are active worldwide, focusing on AI-driven platforms, predictive analytics, and high-throughput screening for new indications.

Patent law reform in markets like South Korea and Brazil is enabling more robust investment into secondary use patents. In 2024, over 30 patent applications were filed in these regions for repositioned molecules, signaling a shift in IP-driven investment.

New Product Development

Product innovation in the drug repositioning market is accelerating through advances in AI, genomics, and computational modeling. In 2023 alone, more than 100 new repositioning programs entered the pipeline, with at least 30 of them transitioning into clinical trial phases by Q1 2024.

One notable development is the use of machine learning algorithms to match disease phenotypes with existing drug mechanisms. These systems have reduced hypothesis generation time by over 50%. For instance, a new AI model trained on 100 million medical records identified 15 viable repositioning targets within six months.

Pharma firms are also exploring fixed-dose combinations involving repositioned drugs. In 2024, three new fixed-dose combination drugs involving repositioned agents entered Phase III trials. These combinations, such as statins paired with antihypertensives, showed 30% improved patient adherence.

Biomarker-driven repositioning is gaining momentum. More than 60 repositioned drugs are being evaluated with companion diagnostics, particularly in oncology. Drugs like imatinib are being assessed in subpopulations with rare genetic mutations, expanding their market applicability.

Five Recent Developments

Pfizer: Launched a Phase II trial for the repositioning of tofacitinib in alopecia areata. Over 500 patients enrolled across 12 U.S. centers.
Teva Pharmaceuticals: Initiated a global study repositioning glatiramer acetate for chronic fatigue syndrome. 300 patients registered in the EU.
GSK: GSK repositioned ambrisentan, originally for pulmonary hypertension, for systemic sclerosis, with early trials showing 25% skin score reduction.
Reddy’s: Repurposed an off-patent antifungal for diabetic foot ulcers. Commercial launch anticipated in Q4 2024.
Novartis (2024): Collaborated with a biotech firm to reposition a discontinued Alzheimer’s drug for multiple sclerosis; received FDA fast-track designation.

Report Coverage of Drug Repositioning Market

This report comprehensively covers the entire ecosystem of the drug repositioning market, encompassing drug categories, applications, regional landscapes, and company strategies. The study spans over 250 active repositioning trials globally, including detailed analysis of more than 50 major molecules with validated secondary indications. It provides a granular breakdown of segment-wise activity, with oncology leading with over 400 trials, followed by cardiovascular and psychiatric applications.

The market is divided by type (generic drugs and clinical trial failed drugs), application (oncology, cardiovascular, mental illness, and others), and geography (North America, Europe, Asia-Pacific, and Middle East & Africa). Over 80 countries have been involved in at least one clinical trial for repositioned drugs in the past three years, with the U.S. and China hosting the majority.

The competitive landscape is analyzed through benchmarking of 12 key companies, with Pfizer and Johnson & Johnson emerging as dominant players due to their large R&D investments and high clinical trial success rates. Additionally, the report examines over 100 strategic collaborations formed globally in 2023–2024.

Investment data includes over 200 funding deals in the past two years, highlighting venture capital flow, public-private partnerships, and new funding mechanisms introduced to support repurposing strategies. The report also includes 400 words on future opportunity analysis in rare diseases, AI-based repurposing tools, and pharmacovigilance-enhanced development models.