Companion Diagnostics Market 2022 – Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Market Size & Forecast 2030

The global companion diagnostics market is projected to witness growth at a CAGR of 20.0% during the forecast period of 2022-2030.

Companion diagnostic refers to an in vitro medical device used along with a therapeutic drug to analyze the effect & applicability of the drug on patients. It utilizes a combination of tests and therapies to provide critical information about corresponding therapeutic drugs or biological products to deliver safe and effective medical treatment. These diagnostics also provide an in-depth understanding of disease biology and the mechanism of action (MOA), which aid medical professionals in determining the potential side effects or risks of a therapeutic product on specific human bodies.

GROWTH DRIVERS:

Factors such as the ever-expanding application areas of companion diagnostics due to a variety of advantages offered by them; the rising significance of companion diagnostics in drug development; the soaring demand for in-vitro diagnostics and targeted therapies; the escalating demand for next-generation sequencing; the increasing number of clinical trials, the growing development of new biomarkers for various diseases, the burgeoning cases of adverse drug reactions related to drugs due to lack of efficacy and the rapidly surging number of technological advancements in healthcare are primarily driving the global companion diagnostics market.

Additionally, the incidence of cancer cases of different types has been surging at an unprecedented pace around the globe since the last few decades. According to a new report, the global cancer burden is projected to rise and reach up to about 22.0 million new cancer cases (with approximately 13.0 million cancer deaths) by the end of 2030. Companion diagnostics is extensively utilized to enhance the predictability of oncology drug development process. Thus, the proliferating incidences of cancer is expected to propel the adoption of companion diagnostics for the rapid development of drugs in cancer treatment. Alongside, the number of FDA approvals for cancer diagnostic tests is also rising, providing impetus to the global companion diagnostics market.

Moreover, the number of partnerships and collaborations between leading companies in the market for the development of novel companion diagnostics products is witnessing a swift increase. Such collaborations between companies for the development of better biomarkers and diagnostics are anticipated to create ample opportunities for the growth of the global companion diagnostics market in the upcoming years.

Furthermore, other factors such as the burgeoning significance and demand of personalized medicine, the existence of higher number of unfulfilled needs for the treatment of cancer, the increasing critical healthcare needs of aging population, the improvements in regulatory guidelines, the surging emphasis on the co-development of drugs and diagnostic technologies, the escalating R&D activities in the development of novel diagnostic tests for various chronic diseases, swift expansion in genomics and proteomics research and the growing number of government-based initiatives & spending are expected to further bolster the growth of the global companion diagnostics market during the forecast period.

However, factors such as the dearth of trained professionals, the high costs associated with companion diagnostics, and the presence of stringent government policies for product approvals are predicted to hinder the growth of the market to a certain extent during the forecast period.

COMPANION DIAGNOSTICS MARKET SEGMENTATION:

By Product & Services:

·         Assay Kits & Reagents

·         Software & Services

By Technology:

·         Polymerase Chain Reaction (PCR)

·         In Situ Hybridization (ISH)

·         Next-Generation Sequencing (NGS)

·         Immunohistochemistry (IHC)

·         Others

By Indication:

·         Cardiovascular

·         Neurological Diseases

·         Cancer

o   Breast Cancer

o   Lung Cancer

o   Colorectal Cancer

o   Melanoma

o   Gastric Cancer

o   Infectious Diseases

o   Others

By End User:

·         Pharmaceutical & Biopharmaceutical Companies

·         Reference Laboratories

·         Contract Research Organizations

·         Others

By Region:

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East & Africa

Based on products and services, the assay kits & reagents segment is projected to account for the largest market share in the companion diagnostics market during forecast period. The segment’s growth can be attributed to the rapidly surging demand for high-performance diagnostics kits in clinical trials and commercial application and the growing developments in sample processing. However, the software & services segment is expected to attain the highest CAGR of 17.5% in the market during the forecast period.

Based on technology, the polymerase chain reaction (PCR) segment held the largest share in the global companion diagnostics market in 2020. The segment is anticipated to retain its dominance in the market over the forecast period. The segment’s growth can be attributed to factors such as the widespread availability, ease of use and cost effectiveness of PCR; the growing applications of PCR in the high-throughput detection of mutants with a limited or low allele frequency of genes and the high turnaround time of PCR as compared to other technologies. However, the next-generation sequencing (NGS) segment is predicted to register the highest CAGR in the market during the forecast period.

Based on indication, the cancer segment captured the largest share of the global companion diagnostics market in 2020 and is expected to continue doing the same over the forecast period.  Factors such as the rapidly increasing prevalence of cancer cases across the globe; the existence of higher number of unfulfilled needs for treatment of cancer; the escalating number of R&D activities for cancer and the growing number of FDA approved companion diagnostics are among the predominant factors contributing to the segment’s growth.

Based on end-user, the pharmaceutical & biopharmaceutical companies segment held the largest share in the companion diagnostics market in 2020. The trend is poised to continue over the forecast period.

The massively increasing application of companion diagnostics in these companies due to their growing prominence in drug development is the major factor attributed to the segment’s growth.

REGIONAL OUTLOOK:

The North American region dominated the global companion diagnostics market in 2020 and is expected to further retain its position in the market during the forecast period. The growth of the market in the region can be attributed to various factors such as the surging prevalence of cancer cases in the region, the increasing number of technological advancements and adoption rate in the region, the high presence of leading market players in the region, the rising number of initiatives in genomics and precision medicines and the rapid development in healthcare infrastructure in the region. Furthermore, the escalating demand for personalized medicine, the increasing number of product launches, and the rising government spending are also anticipated to significantly contribute to the growth of the market in the region during the forecast period. Countries such as the U.S. and Canada are the major contributors to the growth of the market in the region.

The Asia Pacific region is projected to emerge as the fastest growing regional market for companion diagnostics during the forecast period of 2021-2030. The growth of the market in the region can be attributed to the soaring investments & research funding by pharmaceutical and biotechnology companies in the region, the rising awareness regarding personalized therapeutics & companion diagnostics in the region and the rapidly expanding healthcare infrastructure in the region. Moreover, the high population and patient base, the growing demand for advanced therapies, and the rising prevalence of cancer and neurology disease cases in the region are expected to further create tremendous growth opportunities for the companion diagnostics market in the region during the forecast period. Countries such as India, China and Japan are among the major contributors to the growth of the market in the region.

KEY COMPANIES IN COMPANION DIAGNOSTICS MARKET:

·         Hoffmann-La Roche AG

·         Agilent Technologies Inc.

·         Biogenex Laboratories Inc.

·         Abbott Laboratories Molecular Inc.

·         ARUP Laboratories Inc.

·         BioMerieux SA

·         Danaher Corporation

·         Foundation Medicine Inc.

·         Almac Group

·         Sysmex Corporation

·         Thermo Fisher Scientific Inc.

·         Abnova Corporation

·         Guardant Health Inc.

·         Icon Plc

·         Myriad Genetics Inc.

·         Qiagen N.V.