Theragnostics Market By Therapeutic Area (Oncology, Neurology, Others) By Technology (Polymerase Chain Reaction (PCR), In Situ Hybridization, Others) By End-User (Hospitals, Diagnostic Laboratories, Others) Regional Analysis & Forecast - 2026

Theragnostics is a combination of targeted diagnostic tests with targeted therapy. It is also called as companion diagnostics, integrated medicine, Dx/Rx partnering, and pharmacodiagnostics. It provides a transition from conventional medicine to personalized medicine. It deals with the custom made a treatment plan based on the uniqueness of each individual hence results in the right drug for the right patient at the right time. Theranostics include the use of a specific diagnostic test that shows a particular molecular target on a tumor or any other disease-causing agent. Any disease pathophysiology includes specific biological pathways that are targeted with the help of diagnostic tests. Diagnostic images of the particular molecule then identify the presence of the specific mutation or receptors that can be targeted with the therapeutic agents. Thus, theranostics is a holistic transition from trial and error medicine to predictive, preventive and personalized medicine leading to improved quality care of pharmacotherapy.

Pharmacogenetics, proteomics and biomarker profiling forms the backbone of theranostics. Accurate dose calibration and precise targeting approach could highly be useful in the management of chronic diseases such as cancer, rheumatology, gastroenterology, dermatology, and others. Rheumatoid arthritis is particularly suited and consequently one of the more developed disease areas where biomarkers have been applied. However, the availability of biomarkers that support treatment choice (theranostic biomarkers) remains limited.

Market Overview

The global theranostics market is expected to reach USD xx billion by 2026. Development of novel diagnostic tests to be used with available treatment options is projected to boost the growth of global theranostics market over the forecast period. Leading manufacturers are engaging in introducing novel companion diagnostic tests in the market. Increase in adoption of companion diagnostic tests by laboratories is further expected to foster global theranostics market growth over the forecast period. Partnerships and collaborations by leading manufacturers for developing innovative companion diagnostics are expected to foster global theranostics market growth over the forecast period.

The increase in the cost of healthcare along with new opportunities for improved treatments puts ever-increasing pressures on healthcare budgets. In recent years the diagnostic industry has been the target of many cost-cutting exercises by governments and payers that are aimed at restricting the utilization of diagnostic tests. This has exerted significant pressure on the diagnostic industry for maintaining innovation and product enhancement in the face of restricted market growth.

A key challenge to the pharmaceutical industry is the ballooning cost and decrease in productivity of research and development that is driven to a large extent by the ever-increasing need for proving clinical efficacy and cost-effectiveness of new medicines. There is a need to satisfy these demands in advance to product launch has the effect of increasing product development times thereby also decreasing the window of opportunity afforded by the patent life of the compound. The selective application of theranostics has the potential to positively impact these challenges, reducing risk and costs, speeding market entry and, ultimately, enhancing the commercial success of the medicine.

Theranostics in Rheumatology

Signaling pathways involved in the propagation of chronic inflammatory processes are also potential sources of biomarkers for response to anti-inflammatory therapies such as anti-TNF.  With the advent of biologic treatments like anti-Tumour Necrosis Factor (anti-TNF) therapy, achieving disease remission has become a realistic endpoint for clinicians. The life-changing efficacy of these therapies, however, is restricted to the 60-70% of patients who respond. The immune reaction to anti-inflammatory therapy is thought to be influenced by many genes, which cumulatively contribute to a threshold for response. There is an inherent clinical need providing theranostic biomarkers, which could determine treatment outcome.

There exists a RABIOPRED - a validation study of theranostic test to predict treatment response of anti-tnfα biologicals in Rheumatoid Arthritis that includes the anti-TNF therapies such as adalimumab (Humira®, a fully human monoclonal antibody), infliximab (Remicade®, a chimeric monoclonal antibody), TNF receptor protein etanercept (Enbrel ®), Certolizumab (Cimzia ®, a pegylated humanized monoclonal antibody) and Golimumab (Simponi ®, a fully human monoclonal antibody), Infliximab Biosimilar (Remsima/ Inflectra), Entanercept biosimilar (Benepali), Infliximab Biosimilar (Flixabi).

FOI (fluorescence optical imaging) and labeling of macromolecular therapeutics with novel ICG (fluorophore indocyanine green) derivatives are providing a novel rationale for sensitive and quantitative monitoring of arthritis therapy in which the TNFa binding protein etanercept (Enbrel®, Pfizer) was chemically conjugated with an ICG derivative, which is suited for labeling of proteins. Further studies have to determine the effect of varying molecular size on the degree of targeting of inflamed joints.

Another approach is initiating combined methotrexate/etanercept therapy (MTX/ETZ) in which the serum S100A9 levels could be a useful predictor of response to MTX/ETZ in patients with RA. The theranostics targeting of macrophages holds great promise for diagnosis and treatment of the inflammatory diseases of rheumatoid arthritis, leading to effective disease management.

Theranostics in Gastroenterology

The feasibility of a novel theranostic approach to hepatocellular carcinoma (HCC) using [68Ga]DOTATATE, which is a approved positron emission tomography (PET) ligand recently to image somatostatin receptor (SSTR) positive tumors has found new therapeutic options for patients with HCC that is now under phase 1 and phase II stages of clinical trials. This radionuclide therapy was FDA approved in 2018 for treating neuroendocrine tumors (NETs) that arise from the gastrointestinal tract, but its clinical use in HCC has not been yet explored. The U.S. Food and Drug Administration (FDA) approved the use of gallium 68Ga-Dotatate, a radioactive diagnostic agent for positron emission tomography (PET) imaging to locate somostatin receptor positive neuroendocrine tumors in adult and pediatric patients in 2016. The commercial product, a single dose kit for the preparation of a 68Ga-Dotatate injection manufactured by Advanced Accelerator Applications of Saint Genis-Pouilly, France, has been given the market name NETSPOT™. The 68 Ga-labelled somatostatin analogues (68 Ga-DOTA-SSAs) are becoming popular as an important diagnostic tool in neuroendocrine tumors which is evidenced by a growing number of reports detailing institutional experience with various DOTA peptides. The combination of two radionuclide therapies of [131]Iodine-MIBG and [90]Yttrium-DOTATOC to treat Mid-gut Neuroendocrine Tumors is in the early phase of clinical trial development of theranostics.

Theranostics in Dermatology

In dermatology and cosmetics, nanotechnology provides therapeutic, diagnostic as well as preventive applications. However, there are still some unexplored possible grey areas regarding the safety of these nanoparticles, which makes an appeal for more meticulous studies on their safety profile. The use of nanoparticles for the treatment and diagnosis of metastatic skin cancers has increased along with efforts to identify new systems that can be used for the theranostics. Recent progress has been made in treating metastatic melanoma. Nevertheless, improved patient survival is still limited because of primary resistance and relapses. It is therefore important to continue to understand the molecular mechanisms involved in melanoma development and progression to improve the management of patients. Magnetic nanoparticles for using magnetic tracers, instead of radioactive tracers, to find the sentinel lymph nodes in patients with melanoma skin cancer is an another approach currently under clinical trials.

Key Developments

• In Jan 26, 2018, Novartis AG announced that Advanced Accelerator Applications, a subsidiary of Novartis Groupe S.A., has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for Lutathera® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroentero-pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults.


• In June 2016, the U.S. Food and Drug Administration approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging.

Segmentation

The global theranostics market is segmented based on the therapeutic area, technology, end users, and region

By Therapeutic Area: Oncology (Breast Cancer, Colorectal Cancer, Lung Cancer, Cervical Cancer, and Others), Cardiovascular Diseases, Neurological Disorders, Immunological Disorders, Rheumatology, Gastroenterology, Dermatology, and Others.

By Technology: Polymerase Chain Reaction (PCR), In Situ Hybridization, Sequencing, immunohistochemistry, and Others.

By End User: Hospitals, Diagnostic Laboratories, and Others

By Region: North America, Latin America, Europe, Asia Pacific, Middle East, Africa.

North America is anticipated to witness significant growth in the global theranostics market over the forecast period. Presence of leading manufacturers, robust research, collaborations, and development activities, and increase in adoption of companion diagnostics is expected to support the global theranostics market growth over the forecast period.

Asia Pacific theranostics market is anticipated to witness significant growth over the forecast period, due to collaborations by global organizations in the region and increase in awareness regarding companion diagnostics. For example, Qiagen collaborated with Japan-based clinical lab testing company, SRL, Inc. for introducing new companion diagnostics with new drug approvals in 2018.

The key players operating in the global theranostics market growth include Thermo Fisher Scientific, Inc., Beckman Coulter, Inc., AmeriPath, Inc., Illumina, Inc., F.Hoffmann LA-Roche Ltd., Focus Diagnostics, Qiagen NV, Myriad Genetics, Inc., Agilent Technologies, Abbott Laboratories, Foundation Medicine, Inc., and Oxford Cancer Biomarkers, Ltd.