Companion Diagnostics Market is Expanding at 8.74% Growth Through 2032

Published Date : 18 May 2023

The global companion diagnostics market revenue is growing at USD 9.34 billion in 2023 and is expected to touch around USD 16.8 billion by 2030, growing at a CAGR of 8.74% between 2022 to 2030.

A companion diagnostic is a piece of in vitro medical equipment that offers data necessary for the safe and efficient use of a matching medication or biological product. This diagnostic procedure enables a medical expert to decide whether the benefits of a given therapeutic product will outweigh any possible serious hazards or side effects for the patients.

During the course of the projection period, it is predicted that the market for companion diagnostics would expand considerably due to a rise in targeted treatment research and development. As the utilization of customized medications and the need for targeted therapies rise, so do customized CDx and the size of the worldwide companion diagnostics market. The advantages of CDx tests, such as their high sensitivity, cheap cost, and capacity for rapid, accurate findings, are also boosting the market for companion diagnostics. It is now well acknowledged that different people's responses to medications may differ thanks to advancements in genetic sequencing and genomics.

Market Growth:

The demand for companion diagnostics is projected to rise as a result of the accelerating pace of technological development and the rise in the prevalence of chronic diseases, with the oncology therapeutic field seeing the greatest influence. Technology advancements in the healthcare sector and an increase in the number of treatment options are now driving the global market for companion diagnostics.

As medical science and treatment methods become more widely used, more companion diagnostics may be approved for use with a single medicine. However, one major hindrance to the expansion of the worldwide companion diagnostics market is the expense associated with the most recent technologies.

Regional Analysis:

Oncology companion diagnostics sales in North America accounted for 42.05% of global sales in 2022, dominating the market. The industry in the region is predicted to benefit from funding and grants offered by organizations like the National Cancer Institute (NCI) to speed up the development of precision therapy. The U.S.'s effective laws governing the approval of oncology companion diagnostic testing for cancer and increased R&D for integrated and personalized medicine are anticipated to propel the market throughout the forecast period. Multiple conferences held in Canada to raise knowledge of the latest developments and trends in CDx also contribute to this expansion.

companion diagnostics Market Report Scope:

Report Coverage Details
Market Revenue in 2023 USD 9.34 Billion
Projected Forecast Revenue in 2030 USD 16.8 Billion
Growth Rate from 2022 to 2030 CAGR of 8.74%
Largest Market North America
Base Year 2022
Forecast Period 2022 to 2030
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Market Dynamics:

Market Drivers: Increasing need for specialized treatments

Companion diagnostics are widely and steadily being embraced as precision medicine in cancer progresses. This allows doctors to better and more accurately route patients to medicines that best suit their individual genetic profiles. Companion diagnostics can specifically be used to identify individuals who are most likely to respond to a certain therapeutic intervention as well as those who shouldn't get that therapy due to a high risk of unfavorable side effects. This latter realization is crucial given that many oncology medications are harmful and only benefit a small percentage of people with a certain kind of cancer.

Growing patient preferences for customized therapy, expanding uses for personalized medications, an increase in the prevalence of chronic diseases, and an increase in the incidence of allergies in patients as a result of adverse drug reactions all contribute to the development of customized CDx and the expansion of the global companion diagnostics market. The benefits of CDx tests, such as their affordability, high sensitivity, and ability to deliver accurate results quickly, also help the companion diagnostics market expand.

Market Restraints: The cost of immunotherapy is very high

While showing enormous promise in the treatment of cancer, the exorbitant cost of immunotherapy has limited general patient access. If physicians determine that it is advantageous to mix medications, the length of the treatment regimen might be extended from five months to more than three years. In this case, the price goes up as the time goes on. Compared to other forms of treatment like chemotherapy or radiation therapy, cancer immunotherapies can be significantly more expensive. As a result of the high price of immuno-oncology medications, it is projected that the market for companion diagnostics would expand slowly.

Market Opportunities: Demand for next-generation sequencing is rising

Traditionally used first-generation sequencing techniques like Sanger have been quickly replaced by more sophisticated second-generation sequencing techniques like NGS in recent years. Sanger sequencing has poor sensitivity, can be difficult and time-consuming, and is not standardized in terms of laboratory procedures while being very accurate. By fragmenting DNA and automatically sequencing those pieces in parallel, NGS enables the quick and precise sequencing of a whole genome at once. Transcriptome (RNA) sequencing, whole-genome sequencing, exome sequencing, and targeted sequencing of multigene panels are all possible with NGS. Major developments in our understanding of the molecular underpinnings of cancer have been made possible by genome-wide sequencing.

Technology Insights:

The market is divided into Frequency Immunohistochemistry, Polymerase Chain Reaction (PCR), next-generation sequencing (NGS), In Situ Hybridization, and others based on the type of technology used. The market share leader and sector expected to expand during the forecast period is Polymerase Chain Reaction (PCR). Simple automated systems can use cost-effectiveness, high sensitivity, and specificity, three key factors driving market expansion. Additionally, PCR, another crucial driver of this section, can identify the sequencing of many diseases with unidentified etiologies. However, the next-generation sequencing market is anticipated to expand quickly over the course of the forecast period because of important benefits like increased sensitivity to detect low-frequency variants, the quick turnaround for large sample volumes, simultaneous sequencing of hundreds to thousands of genes or gene regions, etc.

Indication Insights:

The market is divided into cancer, neurology, and other categories based on the indication. In 2022, the oncology industry held the greatest market share. Given that it is anticipated to expand with a sizable CAGR over the course of the forecast period, the category is anticipated to have the most share by 2032. Some of the key drivers driving the oncology segment's growth include rising cancer prevalence, rising cancer-related R&D efforts, rising unmet needs for cancer therapy, rising numbers of FDA-approved companion diagnostics, and rising patient awareness of customized medicine.

Recent Development:

  • In August 2022, Thermo Fisher Scientific's Oncomine Dx Target Test received premarket approval from the US FDA to be used as a companion diagnostic (CDx) to identify patients whose tumors have HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small-cell lung cancer (NSCLC), who may be candidates for ENHERTU (fam-trastuzumab deruxtecan-nxki).
  • In February 2022, A collaboration agreement was signed by Genetron Holdings Limited and HUTCHMED (China) Limited to create a companion diagnostic. Genetron Holdings Limited is a top precision oncology platform company in China that specializes in molecular profiling tests, early cancer screening products, and companion diagnostics development (CDx).
  • In January 2022, The AmoyDx Pan Lung Cancer PCR Panel (the "PLC Panel") was introduced by Amoy Diagnostics Co. Ltd. and PREMIA Holdings (HK) Limited in Japan as a reimbursed companion diagnostic for various anti-cancer medications.

Major Key Players:

  • F. Hoffmann-La Roche Ltd. (Switzerland)
  • Agilent Technologies, Inc. (US)
  • Qiagen N.V. (Germany)
  • Thermo Fisher Scientific, Inc. (US)
  • Abbott Laboratories, Inc. (US)

Market Segmentation:

By Indication

  • Cancer
    • Lung Cancer
    • Breast Cancer
    • Blood Cancer
    • Colorectal Cancer
    • Other Cancer Types
  • Neurological Disorders
  • Cardiovascular Diseases
  • Infectious Diseases
  • Other Indications

By Product & Service

  • Assays, Kits & Reagents
  • Software & Services

By Technology

  • Polymerase Chain Reaction
  • Next-generation Sequencing
  • In Situ Hybridization
  • Immunohistochemistry
  • Other

By Indication

  • Oncology
  • Neurology
  • Infectious Diseases
  • Others 

By End-User

  • Pharmaceutical & Biopharmaceutical Companies
  • Reference Laboratories
  • Contract Research Organizations
  • Other End Users

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