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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Theranostics involves combination of targeted diagnostic tests with targeted therapy. It is also known as companion diagnostics, integrated medicine, Dx/Rx partnering, and pharmacodiagnostics. Implementation of theranostics into the patient care plan (in case of selected diseases for which diagnostic tests are available along with respective therapy) may turn into personalized therapy, which could further improve medical outcomes.

Theranostics include use of specific diagnostic test, which shows a particular molecular target on a tumor or any other disease causing agent. Any disease pathophysiology involves specific biological pathways, which are targeted with the help of diagnostic tests. Diagnostic images of the particular molecule then identifies presence of the specific mutation or receptors (in case of cancer), which can be targeted with the help of therapeutic agents. This approach avoids trial and error treatment and could be used to offer patient specific treatment at the right time. Accurate dose calibration and precisely targeted approach could highly be useful in management of chronic diseases such as cancer.

For instance, neuro endocrine tumors can be diagnosed to assess extent of disease via PET-CT (Positron Emission Tomography – Computer Tomography) using Ga-68 DOTATOC (a radioactive positron emitter). Ga-68 targets somatostatin receptor (SSTR2) on the tumor cell membrane, and is injected through vein, which travels and binds to the SSTR2 indication the presence of tumor on PET scan. Furthermore, Ga-68 can be replaced by a therapeutic agent to target the tumor.

Global Theranostics Market Drivers:-

Development of novel companion diagnostic tests to be used with available treatment options is expected to boost the global theranostics market growth over the forecast period. Leading manufacturers are engaged in introduction of novel companion diagnostic tests in market. For instance, Illumina, Inc. announced launch of the U.S. Food & Drug Administration (FDA) approved extended RAS panel for identification of patients eligible for treatment of metastatic colorectal cancer with Vectibix (panitumumab) in 2017.

Increasing adoption of companion diagnostic tests by laboratories is further expected to foster global theranostics market growth over the forecast period. BloodCenter of Wisconsin's Diagnostic Laboratories started offering Abbott RealTime IDH1 assay for patients with acute myeloid leukemia (AML) in July 2018. Moreover, Cancer Genetics, Inc. started offering FDA approved companion diagnostic Thermo Fisher Scientific's Oncomine Dx Target - the first Next-Generation Sequencing (NGS)-based Companion Diagnostic (CDx) test in 2017. Laboratory Corporation of America Holdings launched OmniSeq Advance in partnership with OmniSeq for tumor cancers in June 2018.

Partnerships and collaborations by leading manufacturers to develop innovative companion diagnostics is expected to foster global theranostics market growth over the forecast period. For instance, Foundation Medicine, Inc. and Pfizer, Inc. entered into a partnership for development, regulatory support, and commercialization of companion diagnostics (CDx) in January 2018. Moreover, Qiagen, Inc., and Freenome partnered in June 2018, to accelerate the development and commercialization of Next-Generation Sequencing (NGS) tests to enable precision medicine in cancer treatment.

Pierre Fabre and Roche have been working on development of a robust prototype immunohistochemistry assay as a future companion diagnostic test for W0101 (the drug candidate which they are developing together) and extended this collaboration in May 2018. Abbott Laboratories, Inc. collaborated with Celgene Corporation, and Agios Pharmaceuticals, to develop diagnostic tests on Abbott’s m2000 RealTime system that identifies certain genomic mutations associated with acute myeloid leukemia (AML) in 2016. These factors are expected to support global theranostics market growth over the forecast period.

However, improperly defined regulations for these tests coupled with inadequate reimbursement facilities are expected to hamper growth of the global theranostics market over the forecast period.

Global Theranostics Market Regional Insights:-

North America is expected to witness significant growth in the global theranostics market over the forecast period. Presence of leading manufacturers, collaborations, robust research, and development activities, and increasing adoption of companion diagnostics is expected to support global theranostics market growth over the forecast period. Biocartis Group NV and Amgen, Inc. partnered to develop companion diagnostic test for Amgen's drug Vectibix (panitumumab) in 2017. For instance, Genome Canada launched a national initiative for clinical implementation of precision health in June 2018, which would ultimately impact global theranostics market growth over the forecast period.

Asia Pacific theranostics market is expected to witness significant growth over the forecast period, owing to collaborations in the region by global organizations and increasing awareness regarding companion diagnostics. For instance, Qiagen collaborated with Japan based clinical lab testing company, SRL, Inc. for introduction of new companion diagnostics with new drug approvals in August 2018.

Key players of Global Theranostics Market:-

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

Key Development:-

  • In 2018, THERADIAG, a company specialized in vitro diagnostics and theranostics entered into partnership agreement with Biogaran to supply its Lisa Tracker kits for Biogaran biosimilar monitoring.
  • In 2018, Novartis AG, entered into an agreement with Endocyte, a US-based Biopharmaceutical Company which develops targeted therapeutics for cancer treatment.
  • In 2018 RadioMedix Inc. and AREVA Med LLC, announced the Phase 1 trial for AlphaMedixTM in patients with somatostatin receptor positive neuroendocrine tumors in the U.S. AlphaMedixTM is composed of a somatostatin (SST) analogue radiolabeled with 212Pb, an isotope used for Targeted Alpha-emitter Therapy (TAT).
  • In 2016, avant diagnostics and Amarantus Diagnostics have signed a letter of intent to acquire theranostics health, a protein analysis service provider.

Global Theranostics Market Taxonomy:-

Global theranostics market is segmented on the basis of therapeutic area, technology, end users, and region

By Therapeutic Area-

  • Oncology
    • Breast Cancer
    • Lung Cancer
    • Colorectal Cancer
    • Cervical Cancer
    • Others
  • Cardiovascular Diseases
  • Neurological Disorders
  • Immunological Disorders
  • Others

By Technology:-

  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry
  • In Situ Hybridization
  • Sequencing
  • Others

By End User:-

  • Hospitals
  • Diagnostic Laboratories
  • Others

By Region:-

  • North America
  • Europe
  • Latin America
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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