Theranostics Market
By Therapeutic Area;
Oncology - Breast Cancer, Colorectal Cancer, Lung Cancer, Cervical Cancer and Others, Cardiovascular Diseases, Neurological Disorders, Immunological Disorders, and OthersBy Radiopharmaceuticals;
Lu-177, Sm-153, Ra-223, I-131, Biomarker Screening, and SoftwareBy Technology;
Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Sequencing, and OthersBy End User;
Hospitals & Clinics, Diagnostic Laboratories, and OthersBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Introduction
Global Theranostics Market (USD Million), 2021 - 2031
In the year 2024, the Global Theranostics Market was valued at USD 6,710.89 million. The size of this market is expected to increase to USD 14,180.78 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 11.3%.
Theranostics Market
*Market size in USD million
CAGR 11.3 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 11.3 % |
Market Size (2024) | USD 6,710.89 Million |
Market Size (2031) | USD 14,180.78 Million |
Market Concentration | Low |
Report Pages | 325 |
Major Players
- Thermo Fisher Scientific Inc
- Beckman Coulter Inc
- F. Hoffmann-La Roche Ltd
- Focus Diagnostics
- Illumina Inc
- Agilent Technologies Inc
- QIAGEN, Myriad Genetics
- Foundation Medicine
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Theranostics Market
Fragmented - Highly competitive market without dominant players
The global theranostics market is experiencing significant growth, driven by advancements in personalized medicine and the increasing demand for more targeted treatment options. Theranostics is an emerging field that combines diagnostics and therapeutics to enable the development of personalized treatment plans for patients. This approach allows for the identification of specific biomarkers associated with various diseases, including cancer, cardiovascular conditions, and neurological disorders, enabling the development of tailored therapies. The growing prevalence of chronic diseases and the increasing focus on precision medicine are major factors fueling the demand for theranostic solutions, as they offer the potential for more effective treatments with fewer side effects.
The theranostics market is being shaped by advancements in diagnostic technologies, such as molecular imaging, biomarker discovery, and next-generation sequencing, which enable healthcare providers to better understand the molecular characteristics of diseases. In cancer treatment, for example, theranostics combines imaging techniques like PET scans with specific targeted therapies to treat tumors more effectively. The application of theranostic approaches has the potential to improve clinical outcomes by providing real-time monitoring of treatment responses and adjusting therapies accordingly. As a result, theranostics is being widely adopted across various therapeutic areas, with oncology being the leading sector for theranostic applications, followed by cardiology, neurology, and infectious diseases.
Despite the promising potential of theranostics, the market faces challenges related to the high cost of developing and implementing these advanced diagnostic and therapeutic technologies. The regulatory approval process for theranostic agents can be lengthy and complex, limiting the speed at which new products reach the market. Additionally, there is a need for more comprehensive clinical evidence to support the efficacy and safety of theranostic approaches, which can sometimes delay adoption. However, with the growing investments in research and development, particularly in molecular diagnostics and personalized treatments, the theranostics market is expected to continue expanding, driven by the increasing shift toward precision medicine and the demand for more efficient and effective healthcare solutions.
Global Theranostics Market Recent Developments
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Advanced Accelerator Applications (France) received FDA approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan). Pluvicto is a targeted radioligand therapy for patients with prostate cancer with a therapeutic radioisotope.
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Bayer AG (Germany) and the Broad Institute of MIT and Harvard (US) extended their long term collaboration for the advancement of new therapeutic approaches in cancer.
Theranostics Market Segment Analysis
In this report, the Theranostics Market has been segmented by Therapeutic Area, Radiopharmaceuticals, Technology, End User and Geography.
Theranostics Market, Segmentation by Therapeutic Area
The Theranostics Market has been segmented by Therapeutic Area into Oncology - Breast Cancer, Colorectal Cancer, Lung Cancer, Cervical Cancer and Others, Cardiovascular Diseases, Neurological Disorders, Immunological Disorders, and Others.
Oncology - Breast Cancer
Breast cancer accounts for around 18% of the theranostics market, driven by the increasing adoption of personalized medicine and advanced imaging-guided therapies. Rising incidence rates and strong demand for targeted treatment approaches are boosting growth in this segment.
Oncology - Colorectal Cancer
Colorectal cancer holds approximately 14% market share, supported by the growing use of companion diagnostics and precision treatment methods. Early detection initiatives and technological advancements in molecular imaging are key growth factors.
Oncology - Lung Cancer
Lung cancer represents about 20% of the market, making it one of the largest segments in oncology theranostics. Increased prevalence, combined with advances in biomarker-based therapies, is driving the adoption of integrated diagnostic and treatment solutions.
Oncology - Cervical Cancer and Others
This category covers nearly 10% of the market, focusing on cancers such as cervical, prostate, and ovarian. Growing awareness programs and the development of cost-effective diagnostic tools are expanding access to these therapies.
Cardiovascular Diseases
Cardiovascular diseases account for roughly 12% of the market, with theranostics enabling early detection and personalized treatment strategies. Advances in molecular imaging and nanotechnology-based diagnostics are enhancing patient outcomes in this area.
Neurological Disorders
Neurological disorders hold about 9% of the theranostics market, driven by increasing demand for neuroimaging techniques and targeted therapies for conditions like Alzheimer’s and Parkinson’s disease. Research in molecular biomarkers is further supporting growth.
Immunological Disorders
Immunological disorders make up approximately 8% of the market, fueled by the rise in autoimmune diseases and the need for precise immune profiling. Theranostic tools are enabling better monitoring of treatment response in diseases such as rheumatoid arthritis and lupus.
Others
The remaining 9% of the market includes applications in infectious diseases, metabolic disorders, and other emerging therapeutic areas. Expansion of point-of-care diagnostics and increased R&D investment are supporting the growth of this segment.
Theranostics Market, Segmentation by Radiopharmaceuticals
The Theranostics Market has been segmented by Radiopharmaceuticals into Lu-177, Sm-153, Ra-223, I-131, Biomarker Screening and Software.
Lu-177
Lu-177 leads the theranostics radiopharmaceuticals market with an estimated 34% share, widely used for targeted radionuclide therapy in cancers such as neuroendocrine tumors and prostate cancer. Its high precision in delivering radiation directly to cancer cells while minimizing damage to healthy tissue drives its adoption.
Sm-153
Sm-153 accounts for approximately 18% of the market, primarily used for the palliative treatment of bone metastases. Its ability to provide rapid pain relief in advanced cancer patients makes it an important therapeutic option in oncology care.
Ra-223
Ra-223 holds around 16% market share, valued for its alpha-emitting properties and effectiveness in treating metastatic castration-resistant prostate cancer. Clinical evidence supporting improved patient survival rates has boosted its global demand.
I-131
I-131 represents about 14% of the market, widely recognized for its role in treating thyroid cancer and hyperthyroidism. Its proven track record and cost-effectiveness have secured its continued relevance in theranostic applications.
Biomarker Screening
Biomarker screening contributes nearly 10% of the market, enabling precise patient selection for targeted therapies. By identifying specific molecular signatures, it enhances treatment outcomes and minimizes unnecessary interventions.
Software
Software solutions account for roughly 8% of the market, supporting the integration of diagnostic imaging and treatment planning. Advanced platforms are enabling real-time data analysis and improving the accuracy of personalized therapy approaches.
Theranostics Market, Segmentation by Technology
The Theranostics Market has been segmented by Technology into Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Sequencing and Others.
Polymerase Chain Reaction (PCR)
Polymerase Chain Reaction accounts for approximately 29% of the theranostics technology market, widely used for genetic testing and biomarker identification. Its high sensitivity and accuracy in detecting molecular alterations make it a cornerstone in personalized medicine.
Immunohistochemistry (IHC)
Immunohistochemistry holds around 24% of the market, playing a key role in detecting protein expression patterns within tissue samples. This technology supports precise tumor classification and guides targeted therapy selection in oncology.
In Situ Hybridization (ISH)
In Situ Hybridization represents about 18% of the market, offering powerful capabilities for visualizing specific DNA or RNA sequences in cells. It is extensively applied in cancer diagnostics and infectious disease detection.
Sequencing
Sequencing technologies make up roughly 20% of the market, enabling comprehensive analysis of genomic variations. The adoption of next-generation sequencing (NGS) is accelerating personalized treatment planning and advancing precision medicine initiatives.
Others
The remaining 9% of the market includes emerging technologies such as mass spectrometry and advanced molecular imaging. These innovations are expanding the scope of theranostics across diverse therapeutic areas.
Theranostics Market, Segmentation by End User
The Theranostics Market has been segmented by End User into Hospitals & Clinics, Diagnostic Laboratories and Others.
Hospitals & Clinics
Hospitals & clinics dominate the theranostics market with an estimated 54% share, driven by their access to advanced diagnostic technologies and comprehensive treatment facilities. The integration of personalized medicine into hospital care models is enhancing patient outcomes and boosting adoption rates.
Diagnostic Laboratories
Diagnostic laboratories account for approximately 33% of the market, serving as critical hubs for specialized testing and biomarker analysis. Their role in supporting precision diagnostics and enabling early disease detection continues to expand with advancements in molecular testing.
Others
The remaining 13% of the market includes research institutions, academic centers, and specialty clinics. These facilities contribute to innovation in theranostics through clinical trials and the development of novel diagnostic-therapeutic solutions.
Theranostics Market, Segmentation by Geography
In this report, the Theranostics Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East Africa and Latin America.
Regions and Countries Analyzed in this Report
Theranostics Market Share (%), by Geographical Region
North America
North America leads the theranostics market with an estimated 41% share, supported by advanced healthcare infrastructure, high adoption of personalized medicine, and strong research and development initiatives. The presence of leading biopharmaceutical companies and favorable regulatory frameworks further strengthens the region’s dominance.
Europe
Europe holds around 28% of the market, driven by robust public healthcare systems, government-backed research funding, and growing adoption of companion diagnostics. Collaborative efforts between academic institutions and industry players are accelerating innovation in the region.
Asia Pacific
Asia Pacific accounts for approximately 21% of the market, fueled by rising healthcare investments, increasing cancer prevalence, and expanding access to advanced diagnostic facilities. Rapid growth in medical tourism and the adoption of cutting-edge theranostic technologies are further boosting regional demand.
Middle East Africa
The Middle East & Africa region captures about 6% of the market, with growth supported by improving healthcare infrastructure and a gradual shift toward specialized diagnostic services. Increasing government initiatives for non-communicable disease management are driving market expansion.
Latin America
Latin America holds close to 4% of the market, driven by rising private healthcare investments and growing awareness of precision medicine. Expanding availability of affordable diagnostic tools is improving access to theranostic solutions in the region.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Theranostics Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Increasing Prevalence of Chronic Diseases
- Advancements in Personalized and Precision Medicine
- Rising Demand for Targeted Therapies
- Growth in Molecular Diagnostics and Biomarker Discovery
- Increasing Adoption of Imaging Techniques for Diagnosis and Treatment:
The increasing adoption of imaging techniques for diagnosis and treatment is a key driver in the growth of the theranostics market. Imaging technologies, such as molecular imaging, positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT), have become essential tools in detecting diseases at an early stage and monitoring treatment responses in real-time. These technologies allow for the visualization of molecular and cellular processes within the body, which is crucial for accurately diagnosing conditions such as cancer, cardiovascular diseases, and neurological disorders. By combining these imaging modalities with therapeutic interventions, theranostic approaches enable healthcare professionals to provide more personalized and precise treatments, improving patient outcomes and reducing unnecessary side effects.
The integration of advanced imaging techniques with theranostic agents, such as targeted probes and biomarker-based therapies, is revolutionizing the way medical conditions are treated. For example, in oncology, the use of PET imaging to locate tumors and simultaneously administer targeted therapies ensures that treatments are delivered to the right site with minimal damage to surrounding healthy tissue. This precision not only increases the efficacy of treatment but also reduces the need for invasive procedures and improves the overall quality of care. As imaging technologies continue to advance, their integration with theranostics will play an even larger role in improving the precision and effectiveness of treatments, particularly in complex diseases like cancer and neurological conditions.
Furthermore, the widespread adoption of imaging techniques is being driven by the growing availability and affordability of advanced diagnostic equipment. As healthcare systems worldwide invest in state-of-the-art imaging devices, the potential for theranostics to become more mainstream increases. In addition, the development of novel imaging biomarkers and the increasing use of artificial intelligence (AI) to analyze imaging data are expected to enhance the accuracy and speed of diagnosis. This trend also enables healthcare providers to tailor treatments based on a patient’s specific disease profile, further advancing the shift toward personalized medicine. As these imaging technologies become more accessible, the adoption of theranostic approaches is expected to rise, improving both diagnostic and therapeutic outcomes for a wide range of diseases.
Restraints
- High Cost of Theranostic Technologies
- Complex Regulatory Approval Processes
- Limited Clinical Evidence Supporting Efficacy and Safety
- Lack of Skilled Professionals for Advanced Diagnostics
- Challenges in Reimbursement Policies for Theranostic Products:
One of the major challenges in the theranostics market is the complexity of reimbursement policies for theranostic products, which can significantly impact their accessibility and adoption. Reimbursement policies vary widely across countries and healthcare systems, and in many cases, theranostic products do not receive adequate coverage due to their innovative and costly nature. Healthcare insurers, including public and private payers, often hesitate to cover advanced diagnostic tools and targeted therapies, particularly when these products are not yet widely proven or have limited clinical evidence to demonstrate their effectiveness. This reluctance to reimburse can result in higher out-of-pocket costs for patients, which may limit the widespread use of theranostic technologies, especially in low- and middle-income regions.
Additionally, the lack of standardized reimbursement frameworks for theranostic products poses a significant hurdle for market growth. Theranostics often involve the combination of diagnostic and therapeutic components, which complicates the process of obtaining reimbursement. The need for both diagnostic imaging procedures and associated therapies to be reimbursed separately, or in some cases bundled together, creates challenges in aligning the interests of various stakeholders, including healthcare providers, payers, and patients. This fragmentation can lead to delays in patient access to essential theranostic treatments, hindering the full potential of these technologies to improve patient outcomes in a cost-effective manner.
To overcome these challenges, there is a growing need for policy reforms and collaborations between healthcare providers, governments, and industry stakeholders to establish clearer and more consistent reimbursement models. For instance, governments and insurance companies can work together to create more inclusive reimbursement structures that take into account the long-term benefits of theranostic treatments, such as improved treatment efficacy, reduced side effects, and overall cost savings by preventing disease progression. Additionally, as more clinical evidence supporting the efficacy and safety of theranostics becomes available, it is likely that reimbursement policies will evolve to better accommodate these advanced technologies. Addressing reimbursement challenges will be crucial for making theranostics more accessible and ensuring their integration into routine clinical practice.
Opportunities
- Expanding Applications of Theranostics in Oncology, Cardiology, and Neurology
- Growth in Healthcare Investments for Personalized Medicine
- Advancements in Next-Generation Sequencing and Molecular Imaging
- Increasing Collaboration Between Pharmaceutical and Diagnostic Companies
- Rising Focus on Early Disease Detection and Monitoring:
The rising focus on early disease detection and monitoring is a significant factor driving the growth of the theranostics market. Early detection of diseases, particularly chronic conditions such as cancer, cardiovascular diseases, and neurological disorders, plays a critical role in improving patient outcomes and reducing healthcare costs. The ability to identify diseases at their earliest stages allows for the implementation of more effective and less invasive treatment options, which can greatly enhance the chances of successful recovery. As a result, there is an increasing demand for diagnostic technologies that can detect diseases with high accuracy and minimal patient discomfort, making theranostic approaches particularly attractive. By combining diagnostic tools with targeted therapies, theranostics enables real-time monitoring and adjustment of treatment strategies, further improving disease management.
Advancements in molecular diagnostics, imaging technologies, and biomarker identification have significantly contributed to the focus on early disease detection and monitoring. These technologies allow healthcare providers to detect disease at a molecular level, often before symptoms appear, providing a critical window for intervention. In oncology, for example, theranostic techniques that combine imaging with molecular probes can identify the exact location of tumors and monitor their growth over time, enabling personalized treatment plans. Similarly, in cardiology, theranostics can help detect early signs of heart disease, allowing for timely interventions that can prevent severe complications. As diagnostic accuracy improves, patients benefit from more tailored treatments, leading to better clinical outcomes and improved quality of life.
As the healthcare industry continues to emphasize preventative care and personalized medicine, theranostics plays a key role in shifting the focus from reactive treatment to proactive disease management. Governments, healthcare organizations, and research institutions are investing in the development of technologies that support early detection and continuous monitoring of diseases, recognizing the long-term benefits they offer in terms of cost savings and patient health outcomes. With the integration of artificial intelligence (AI) and machine learning (ML) to analyze vast amounts of diagnostic data, theranostics is poised to enhance precision in early disease detection and monitoring, enabling healthcare providers to offer more targeted, effective treatments and improving overall healthcare efficiency. This rising focus on early detection is expected to drive further innovation and adoption of theranostic solutions across various therapeutic areas.
Competitive Landscape Analysis
Key players in Global Theranostics Market include,
- Thermo Fisher Scientific Inc
- Beckman Coulter Inc
- F. Hoffmann-La Roche Ltd
- Focus Diagnostics
- Illumina Inc
- Agilent Technologies Inc
- QIAGEN, Myriad Genetics
- Foundation Medicine
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Therapeutic Area
- Market Snapshot, By Radiopharmaceuticals
- Market Snapshot, By Technology
- Market Snapshot, By End User
- Market Snapshot, By Region
- Theranostics Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Prevalence of Chronic Diseases
- Advancements in Personalized and Precision Medicine
- Rising Demand for Targeted Therapies
- Growth in Molecular Diagnostics and Biomarker Discovery
- Increasing Adoption of Imaging Techniques for Diagnosis and Treatment
- Restraints
- High Cost of Theranostic Technologies
- Complex Regulatory Approval Processes
- Limited Clinical Evidence Supporting Efficacy and Safety
- Lack of Skilled Professionals for Advanced Diagnostics
- Challenges in Reimbursement Policies for Theranostic Products
- Opportunities
- Expanding Applications of Theranostics in Oncology, Cardiology, and Neurology
- Growth in Healthcare Investments for Personalized Medicine
- Advancements in Next-Generation Sequencing and Molecular Imaging
- Increasing Collaboration Between Pharmaceutical and Diagnostic Companies
-
Rising Focus on Early Disease Detection and Monitoring
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Theranostics Market, By Therapeutic Area, 2021 - 2031 (USD Million)
- Oncology
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Cervical Cancer
- Others
- Cardiovascular Diseases
- Neurological Disorders
- Immunological Disorders
- Others
- Oncology
- Theranostics Market, By Radiopharmaceuticals, 2021 - 2031 (USD Million)
- Lu-177
- Sm-153
- Ra-223
- I-131
- Biomarker Screening
- Software
- Theranostics Market, By Technology, 2021 - 2031 (USD Million)
- Polymerase Chain Reaction (PCR)
- Immunohistochemistry (IHC)
- In Situ Hybridization (ISH)
- Sequencing
- Others
- Theranostics Market, By End User, 2021 - 2031 (USD Million)
- Hospitals & Clinics
- Diagnostic Laboratories
- Others
- Theranostics Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Theranostics Market, By Therapeutic Area, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Thermo Fisher Scientific Inc
- Beckman Coulter Inc
- F. Hoffmann-La Roche Ltd
- Focus Diagnostics
- Illumina Inc
- Agilent Technologies Inc
- QIAGEN
- Myriad Genetics Inc
- Foundation Medicine Inc
- Company Profiles
- Analyst Views
- Future Outlook of the Market