Press Release

Companion Diagnostic Market to Grow with a CAGR of 11.76% through 2028

Development of new biomarkers for various diseases and a surge in research & development of targeted therapies is expected to drive the Global Companion Diagnostic Market growth in the forecast period, 2024-2028.

 

According to TechSci Research report, “Companion Diagnostic Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2028”, the Global Companion Diagnostic Market stood at USD 5.63 billion in 2022 and is anticipated to grow with a CAGR of 11.76% in the forecast period, 2024-2028. The global companion diagnostics industry is experiencing growth driven by various factors. These include the advantages of companion diagnostics, the increasing demand for targeted therapy, the rising significance of personalized medicine, the growing global incidence of cancer, and the expanding application areas of companion diagnostics.

Additionally, the market's expansion is further propelled by the expanding need for next-generation sequencing, the growing importance of companion diagnostics in drug discovery, and the rising number of clinical trials.

           

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The companion diagnostics market is poised for significant growth during the forecast period due to the surge in research and development of targeted therapies, increasing demand for personalized medicine in emerging economies, discovery of new biomarkers for various conditions, and unmet needs in cancer treatment. These factors are major drivers of the global companion diagnostics market.

Advancements in genetic sequencing and genomics have led to the realization that drugs can have varying effects in different individuals. Understanding an individual's genetic traits or biomarkers is crucial in administering the right drug, at the right time, and in the right amount. Pharmaceutical and biopharmaceutical companies are actively integrating patient-selection diagnostic frameworks in early drug development stages to offer targeted therapies to suitable candidates. This trend contributes to the expansion of the companion diagnostics market.

Although companion diagnostics offer guaranteed returns on investment, the high initial cost often makes them inaccessible to a large portion of end-users, especially those in developing countries. Consequently, end-users such as pharmaceutical companies, reference laboratories, hospitals, and contract research organizations (CROs) turn to third-party companion diagnostic services to alleviate the financial burden associated with these tests.

Next-generation sequencing (NGS)-based companion diagnostic tests leverage molecular information from a patient's tumor genome to guide cancer therapy decisions. NGS detects numerous biomarkers for multiple medication regimens in a shorter time frame compared to other sequencing techniques. The use of NGS panels for biomarker evaluation in a single test has the potential to aid in the treatment of various malignancies.

The rising prevalence of cancer globally is driving market growth. According to statistics published by the World Health Organization (WHO) in February 2022, approximately 400,000 children worldwide develop cancer each year. Additionally, in 2020, there were 18,094,716 million cases of cancer diagnosed globally, as reported by the World Cancer Research Fund International. The International Agency for Research on Cancer estimates that the worldwide burden of cancer will increase to 27.5 million new cases by 2040. The increased incidence of cancer globally is leading to a higher utilization of companion diagnostic tests, thereby fueling market expansion. Furthermore, regulatory approvals of these tests for various indications are expected to contribute to market growth. For instance, in August 2022, the U.S. FDA approved Thermo Fisher Scientific Inc.'s Oncomine Dx Target Test as a companion diagnostic (CDx) for identifying non-small cell lung cancer tumors with HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion). Additionally, the co-development of drug and diagnostic technology, along with favorable government support, is creating lucrative opportunities in the market. However, the high cost of drug development and associated clinical trials may hinder market growth.

The increasing popularity of personalized medicines, rising cases of adverse drug reactions (ADRs), and unmet needs in cancer treatment are the driving factors accelerating the growth of the companion diagnostics market. Moreover, the growth is further propelled by increased healthcare expenditure globally and technological advancements in diagnostic techniques. The industry is witnessing additional growth with rising awareness, particularly in developing economies, and the discovery of new biomarkers for diverse conditions. The growth of the companion animal diagnostics market also contributes to the overall growth of the companion diagnostics industry. The oncology segment is expected to drive market growth due to the rising cases of cancer. Furthermore, the approval of companion diagnostics by government agencies like the FDA is anticipated to drive industry growth. Unfavorable reimbursement policies in some countries may impact the companion diagnostics market during the forecast period.

 

The Global Companion Diagnostic Market is segmented into product & services, technology, disease indication, application, end user, regional distribution, and company.

 

The PCR segment, based on technology, currently dominates the global market and is expected to maintain this trend in the forecast period. Several key factors contribute to market growth, including cost-effectiveness, high sensitivity, and specificity, along with the ability to be used in simple automated platforms. Additionally, PCR plays a crucial role in identifying unknown etiologies of various diseases. This drives the growth of the PCR segment. However, the next-generation sequencing segment is projected to experience rapid growth during the forecast period due to its advantages, such as higher sensitivity in detecting low-frequency variants, shorter turnaround time for processing large sample volumes, and the ability to simultaneously sequence hundreds to thousands of genes or gene regions. Notably, Oncomine Dx Target Test, FoundationOne CDx, FoundationFocus CDxBRCA Assay, and other platforms utilize next-generation sequencing for detection purposes.

Based on region, North America segment is expected to grow during the forecast period. North America is anticipated to maintain a substantial market share throughout the forecast period. The region, led by the United States, has emerged as a prominent contributor to the overall companion diagnostics market. Companion diagnostics play a crucial role as a treatment decision tool for various oncology drugs, as reflected by the FDA's risk classification of these assays. Despite the challenges posed by the COVID-19 pandemic, companion diagnostics clinical trials have gained prominence in the pharmaceutical industry, enhancing the prospects of clinical success. The demand for testing kits for SARS-CoV-2 identification remained high, with COVID-19 research and development being a primary focus for diagnostic test makers. In May 2020, MiraDx established a laboratory in the United States to provide COVID-19-based testing services, boasting accurate analysis of over 9,000 tests.

Furthermore, the increasing burden of cancer in the United States is projected to drive market growth. According to the American Cancer Society, by the end of 2022, an estimated 1.9 million new cancer cases are expected to occur in the United States. Additionally, individuals with chronic conditions are the primary consumers of companion diagnostics in the country, thereby stimulating market growth. Market expansion is also driven by product launches and government clearances by key players in the companion diagnostics sector. Notably, in October 2021, the United States Food and Drug Administration approved Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) for identifying high-risk patients with early breast cancer (EBC) prone to disease recurrence. This regulatory approval is poised to fuel market growth in North America throughout the forecast period. Considering the aforementioned factors, North America is anticipated to maintain a significant share of the global companion diagnostics market.

 

Major companies operating in Global Companion Diagnostic Market are:

  • Abbott Laboratories Inc.
  • Agilent Technologies Inc.
  • F.Hoffmann-La Roche Ltd
  • Biomerieux SA
  • Qiagen NV
  • Siemens Healthcare
  • Thermo Fisher Scientific Inc.
  • Danaher Corporation (Beckman Coulter Inc.)
  • Myriad Genetics Inc.
  • Illumina Inc.

 

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“The increasing prevalence of various types of cancer worldwide is driving the demand for more effective and targeted cancer treatments, thereby fueling market growth. Companion diagnostics play a crucial role in identifying patients who are most likely to benefit from specific cancer therapies, leading to improved patient outcomes. Furthermore, the growing demand for personalized medicines tailored to individual patient characteristics is creating a favorable market outlook. Additionally, the widespread adoption of targeted drugs and therapies for the treatment of infectious, cardiovascular, neurological, and inflammatory conditions is another significant factor contributing to market growth. Moreover, the development of innovative genomic technologies that enable the identification of genetic mutations and biomarkers for guiding treatment decisions is propelling market expansion. Factors such as the increasing use of biomarkers in drug development, substantial investments in precision medicine, and rising consumer awareness regarding the advantages of companion diagnostics are presenting lucrative growth opportunities for the market.,” said Mr. Karan Chechi, Research Director with TechSci Research, a research-based management consulting firm.

Companion Diagnostic Market Segmented By Product and Services (Kits and Reagents, Assays, Software, and Services), By Technology (PCR, NGS, In-Situ Hybridization, Immunohistochemistry, and Others), By Disease Indication (Oncology, Neurology, Cardiology, Infectious Diseases, and Others),            By Application (In-Vitro Diagnostics, Drug Discovery, and Others), By End User (Pharmaceutical & Biotechnology Companies, Research Laboratories, Contract Research Organization, and Others), By Region and Competition, Forecast & Opportunities, 2018-2028F”, has evaluated the future growth potential of Global Companion Diagnostic Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Companion Diagnostic Market.

 

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