Theranostics Market

The global Theranostics Market is valued at USD 2..64 Billion in 2024 and is projected to reach a value of USD 12.15 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 14.9% between 2025 and 2035.

Key highlights of Theranostics Market

• North America dominated the market in 2024, obtaining the largest revenue share of 56.5%,
• In 2024, the Asia Pacific region had a substantial market share and will witness remarkable growth with a CAGR of 16.4% during the forecast period,
• The Radiopharmaceuticals segment dominated the Theranostics market with the largest market share of 81.9% in 2024,
• The Prostate Cancer segment continued to assert its dominance by the End User segmentation, capturing the largest market share of 41.2% in 2024,
• Hospitals and Cancer Care Centers dominated the market with a significant market share of 78.3% in 2024,
• Advancements in imaging technologies, molecular diagnostics, and targeted therapies contribute to the expansion of the Theranostics market, enabling clinicians to accurately diagnose diseases, predict treatment responses, and optimize therapeutic outcomes.

Theranostics Market: Regional Overview

North America Dominated Sales with a 56.5% share in 2024. North America, particularly the United States and Canada, spearheads the Theranostics market, fueled by a sophisticated healthcare infrastructure, robust R&D activities, and favorable regulatory conditions. The region commands the largest share, driven by factors such as increasing cases of chronic diseases, demand for personalized medicine, and advancements in diagnostic imaging and molecular biology. The United States leads with its high healthcare spending, innovation focus, and many industry leaders, bolstered by stringent FDA approvals. Canada contributes significantly, boasting top-tier research institutions and collaborative networks exploring theranostic applications in various diseases. For instance, in November 2023, GE HealthCare announced a collaboration with Grand Rapids-based cancer treatment center BAMF Health to advance the adoption of theranostics in the U.S. Mexico is enhancing its regulatory framework headed by COFEPRIS to facilitate the safe and efficient commercialization of theranostic technologies, thereby promoting industry expansion and guaranteeing patient security.

U.S. Theranostics Market Overview

The US Theranostics market, valued at USD 1.08 Billion in 2024 to USD 3.49 Billion in 2035, is anticipated to grow at a CAGR of 14.8% from 2025 to 2035. The United States serves as a pivotal center within the Theranostics market, benefitting from an extensive healthcare ecosystem encompassing advanced medical facilities and leading academic institutions like the National Institutes of Health (NIH), fosters a ground for research and development, driving advancements in theranostic technologies.

The necessity for individualized diagnostics and treatments is highlighted by the increasing prevalence of chronic illnesses, which makes theranostic a viable option for early detection, accurate diagnosis, and customized therapies that meet the needs of each patient. For instance, Six out of ten persons in the US have a chronic condition, according to the CDC. Furthermore, strict regulatory monitoring by organizations such as the Food and Drug Administration (FDA) ensures thorough evaluation of theranostic products, accelerating approvals for promising inventions and enabling market entry.

The global Theranostics market can be categorized as Products, Application, End User, and Region.

Theranostics Market: Products Overview

In 2024, the Radiopharmaceuticals segment dominated the market with the largest market share, accounting for 81.9% of the overall market. The Theranostics market, segmented by the products, includes Diagnostic Imaging, Radiopharmaceuticals, IVD/Biomarker Screening, Software and Services. A novel class of pharmaceuticals known as radiopharmaceuticals has transformed nuclear medicine imaging and treatment, and it has been crucial in the development of theranostics. Radiopharmaceuticals are meant to target particular physiological processes or disease markers within the body by adding radioactive isotopes to biologically active molecules. This allows for individualized and precise medical care. In nuclear medicine imaging, techniques like PET and SPECT utilize radiopharmaceuticals to visualize and quantify molecular and cellular-level physiological processes, providing valuable insights into organ function, tissue perfusion, and metabolic activity, thus aiding in disease diagnosis, staging, and monitoring. Furthermore, radiopharmaceuticals are increasingly employed in targeted radionuclide therapy, which spares healthy tissues while administering therapeutic radiation doses specifically for injured tissues, improving treatment effectiveness, and lowering side effects. Leveraging the synergistic combination of diagnostic imaging and targeted therapy, theranostic applications of radiopharmaceuticals enable personalized treatment strategies tailored to individual patients, optimizing outcomes and minimizing toxicity.

Theranostics Market: Application Overview

In 2024, the Prostate Cancer application generated 41.2% of the revenue. The Application segment is divided into Prostate Cancer, Bone Metastasis, and Others. Due to its vast prevalence and diversity, prostate cancer is the second most common in males worldwide and presents a serious healthcare problem. For instance, according to the American Cancer Society, Prostate cancer will take the lives of 1 in 44 men. Theranostics, a potential approach for treating prostate cancer, combines diagnostics and remedies to allow early detection, specific staging, and custom-designed treatment. Prostate cancers can be detected with extra sensitivity and specificity using diagnostic imaging strategies such as PSMA PET imaging and mpMRI, allowing prompt treatment and higher affected person results. Accurate staging, crucial for treatment decisions, is achieved through MRI and PET imaging, determining disease spread and guiding therapy selection. Using molecular imaging to target cancer-specific antigens like PSMA, theranostics revolutionizes treatment planning and makes it possible to precisely deliver medicines like Ac-225 PSMA and Lu-177 PSMA for targeted radiotherapy while reducing systemic damage.

Theranostics Market: End User Overview

The Hospitals and Cancer Care Centers segment had a significant market share of 78.3% in 2024. The End User segment is bifurcated into Hospitals and Cancer Care Centers, Theranostics Centers, and Research and Academic Centers. Hospitals and cancer care centers play pivotal roles in advancing theranostics technologies, serving as crucial hubs for delivering complete oncology services that encompass diagnostic imaging, radiopharmaceutical therapy, and biomarker screening. Those organizations have cutting-edge imaging facilities with various diagnostic modalities available, including MRI, PET/CT, and ultrasound. This ensures a set-off and accurate diagnosis, even allowing clinicians to visualize tumors, screen remedy responses, and examine the improvement of the disorder. Furthermore, they administer radiopharmaceutical remedies, which include theranostic approaches like PRRT and TAT, which selectively deliver therapeutic radiation to most cancer cells while minimizing systemic toxicity, which is especially beneficial for refractory cancers. Hospitals and cancer care centers also provide biomarker screening and molecular diagnostics to identify particular cancer-related molecular alterations, guiding treatment choice and facilitating precision remedy tactics.

Key Trends

• Integrating multi-omics approaches is a prominent trend in theranostics. This approach involves the comprehensive analysis of numerous biological data types, including genomics, transcriptomics, proteomics, metabolomics, and imaging information. This approach makes it easier to gain a deeper understanding of the biology of sickness, discover novel biomarkers, and create individualized treatment plans, all enhancing patient results.
• The expansion of liquid biopsies represents a significant advancement in theranostics, as these tests examine circulating biomarkers, including CTCs, cfDNA, and EVs, from blood samples. Their rise as noninvasive diagnostic and monitoring tools is fueled by their capacity to offer benefits like minimum invasiveness and real-time tracking of disease development. Liquid biopsies are critical in guiding personalized treatment selections by imparting insights into remedy response and disorder recurrence, which improves the efficacy of healing interventions in theranostics.
• The rise of theranostic imaging agents marks a huge development in customized medicine within theranostics, as those agents seamlessly merge diagnostic imaging with therapeutic capabilities. Their emergence as effective tools is characterized by their ability to allow simultaneous visualization of disease biomarkers and focused therapy delivery. This integration enables real-time monitoring and optimization of treatment, promising enhancements in healing efficacy and protection across diverse illnesses within theranostics.

Premium Insights

The Theranostics market will see a rise in demand for personalized medicines, particularly in precision oncology, due to the growing prevalence of chronic illnesses such as cardiovascular disorders, neurological conditions and types of cancers. For instance, according to the WHO, chronic diseases account for 74% of all deaths worldwide, underscoring the critical need for efficient healthcare solutions. This requires a variety of stakeholders to work together to drive innovation and implement new findings into clinical practice. The market for theranostics emerges as a dynamic industry that combines therapeutic and diagnostic modalities to offer individualized treatment approaches. Spanning diagnostic imaging, biomarker screening, molecular diagnostics, and targeted therapies, theranostics optimizes patient care through tailored interventions.

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Market Dynamics

Increasing Demand for Personalized Medicine due to the understanding that individuals respond uniquely to treatments based on their genetic makeup, disease characteristics, and lifestyle factors

Theranostics has emerged as a revolutionary paradigm, integrating diagnostic and therapeutic modalities to deliver personalized treatment strategies. Theranostics uses advanced molecular profiling technologies to characterize disease molecular signatures and identify specific biomarkers associated with treatment response, enabling tailored treatment regimens while minimizing adverse reactions. Its real-time guidance in treatment decisions, such as in oncology, where it identifies tumor-specific mutations for targeted therapies, not only enhances treatment outcomes but also reduces unnecessary treatments and associated side effects. Additionally, theranostic technologies enable early disease detection and intervention, enhancing patient outcomes by facilitating timely and effective treatments, ultimately leading to improved prognosis, increased survival rates, and enhanced quality of life.

The regulatory landscape surrounding theranostic products presents significant challenges and compliance burdens for manufacturers aiming to develop and commercialize these innovative solutions

Stringent regulatory requirements imposed by agencies worldwide, such as the U.S. FDA in the United States and the EMA in the European Union, demand extensive preclinical testing, clinical trials, and regulatory submissions to ensure safety, efficacy, and quality. Navigating diverse regulatory frameworks adds complexity, with regulations varying across jurisdictions and evolving alongside technological advancements. Compliance efforts often entail substantial investments in time, resources, and expertise, which is particularly challenging for small and medium-sized enterprises (SMEs) and academic institutions that need more resources and expertise, leading to delays in product development and increased costs.

The growing emphasis on companion diagnostics presents a significant opportunity for the theranostic market, serving as vital tools for clinicians to identify patients who would benefit most from specific therapies, thereby enabling personalized treatment strategies tailored to individual patient characteristics

In the targeted treatment options, companion diagnostics aid in pinpointing patients with unique biomarkers or genetic mutations predisposing them to favorable remedy responses, making sure treatments are directed effectively, and minimizing unnecessary exposure to ineffective or dangerous healing procedures, ultimately improving patient outcomes and reducing healthcare costs. Moreover, companion diagnostics streamline clinical trials with the aid of preselecting patients primarily based on their biomarker status, facilitating the enrollment of populations much more likely to respond to investigational treatment plans, expediting the drug development process, and swiftly bringing new healing procedures to market. Essential to regulatory approval processes, companion diagnostics provide evidence of predictive value and are closely incorporated with drug development to ensure compliance with regulatory requirements.

Competitive Landscape

The Theranostics market is extremely competitive, with well-known healthcare giants like GE Healthcare, Siemens Healthineers, and Philips Healthcare interacting in a dynamic way to develop integrated theranostic solutions by utilizing their vast knowledge of diagnostic imaging and molecular diagnostics. Additionally, emerging biotechnology organizations like Novartis and Bayer are making significant strides in the field, specifically in growing progressive targeted remedies and accomplice diagnostics. Collaborations among pharmaceutical businesses, diagnostic firms, and academic institutions also are shaping the market, fueling research and improvement efforts to strengthen personalized medication via the convergence of diagnostics and therapeutics.

The key players in the global Theranostics market include - GE Healthcare Technologies (U.S.) among others.

Recent Market Developments

• In January 2023, Cargill and BASF announced expanding their partnership in feed enzyme distribution and development to encompass the United States. The goal is to create an innovation pipeline to support the regions animal protein producers, who are grappling with the increasing demand for animal protein.
• In November 2023, GE HealthCare and BAMF Health are excited to announce a collaboration to enable BAMF Health to scale turnkey offerings, including leading GE HealthCare technologies and services. The partnership aims to ensure an agile go-to-market approach to enhance the adoption of Theranostics solutions in the U.S.
• In September 2023, The Mayo Clinic is expanding its decade-plus ties with GE HealthCare with a slate of new joint R&D projects that will explore the use of digital imaging and theranostics. The goal is to advance the clinics research closer to the commercial market.
• In February 2024, Curasight A/S announced that it is accelerating and expanding its clinical therapeutic strategy by adding a new Phase I/IIa trial to include five cancer indications in a so-called basket trial design. The trial will investigate Curasights theranostic approach by testing the diagnostic platform uTRACE and the treatment platform uTREAT in brain cancer (Glioblastoma), neuroendocrine tumors, head-and-neck cancer, non-small cell lung cancer, and pancreatic cancer.
• In March 2023, Radiopharm Theranostics announced that through its wholly owned subsidiary, Radiopharm Theranostics (USA) Inc., it has entered into an agreement to acquire Pharma15 Corporation (Pharma15). This private US-based venture is developing next-generation therapeutic radiopharmaceuticals for Prostate Cancer.