Companion Diagnostics Market Size By Technology Type (Frequency Immunohistochemistry, Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS)), By Indication (Oncology, Neurology), By Geographic Scope And Forecast

Companion Diagnostics Market Size And Forecast

Companion Diagnostics Market size was valued at USD 5.43 Billion in the year 2024, and it is expected to reach USD 13.34 Billion in 2031, at a CAGR of 13.11% over the forecast period of 2024 to 2031.

• Companion diagnostics are medical tests designed to be used alongside a specific therapeutic drug to determine whether that drug is likely to be effective for a particular patient.
• By analyzing a patient’s genetic makeup, the levels of specific molecules in their body, or even using specialized imaging techniques, companion diagnostics can tell the doctor if the patient has the right biological fingerprint to benefit from the drug.
• By understanding a patient’s unique biology, doctors can tailor treatment plans to maximize the effectiveness of the drug for the right patients. This not only increases the chance of a successful outcome but also minimizes the risk of unnecessary side effects.
• Companion diagnostics also play a crucial role in streamlining the development of new drugs. By providing clear data on the specific patient subgroups most likely to respond positively, these tests can help researchers design more efficient clinical trials. This not only accelerates the path of promising medications to patients who need them but also reduces the overall cost and complexity of drug development.
• Companion diagnostics are a powerful tool with the potential to transform medicine into a truly personalized and efficient system. By ensuring these tests are developed and used responsibly, we can unlock a new era of targeted therapies that benefit patients and healthcare systems alike.

Global Companion Diagnostics Market Dynamics

The key market dynamics that are shaping the global companion diagnostics market include

Key Market Drivers

• Rise of Personalized Medicine The increasing focus on personalized medicine is a major driver. This approach tailors treatments to a patient’s unique genetic makeup and disease profile. Companion diagnostics play a vital role in personalized medicine by identifying patients who are most likely to benefit from a specific drug.
• Growth in Targeted Therapies The development and adoption of targeted therapies for various diseases, particularly cancer, is another key driver. These therapies target specific molecular pathways involved in disease progression. Companion diagnostics help identify patients whose genetic mutations or biomarkers align with the targeted therapy’s mechanism of action, maximizing its effectiveness.
• Increasing Cancer Prevalence The alarming rise in cancer cases worldwide is creating a greater demand for companion diagnostics. These tests can aid in early detection, guide treatment decisions, and predict a patient’s response to specific cancer therapies.
• Regulatory RequirementsRegulatory agencies like the US FDA are increasingly mandating companion diagnostics for approval of certain targeted therapies. This ensures the drug’s safety and efficacy are well-established for the intended patient population.
• Technological AdvancementsAdvancements in technologies like genetic sequencing, molecular diagnostics, and bioinformatics are propelling the companion diagnostics market forward. These advancements allow for the development of more accurate, faster, and cost-effective companion diagnostic tests.
• Growing Awareness and AdoptionAs healthcare professionals and patients become more aware of the benefits of companion diagnostics, their adoption is rising. This is leading to increased market demand for these tests.
• Reimbursement PoliciesFavorable reimbursement policies by government and private insurance companies for companion diagnostics can significantly impact market growth. Wider coverage makes these tests more accessible to patients, promoting their use.

Key Challenges

• High Development and Implementation Costs Developing and implementing companion diagnostics can be a financially strenuous endeavor. This can stifle innovation, particularly for smaller companies, potentially limiting the range of tests available.
• Rapidly Evolving Field The medical field, particularly our understanding of diseases and drug targets, is constantly evolving. Companion diagnostics may need frequent updates or even complete replacements to reflect these advancements. Keeping pace with this rapid change can be challenging.
• Ethical Considerations The results of companion diagnostics can significantly impact a patient’s access to potentially life-saving therapies. There’s a crucial need to ensure fair and ethical use of these tests, avoiding any potential discrimination based on a patient’s genetic or biomarker profile.
• Reimbursement Challenges Not all healthcare systems or private insurance companies offer comprehensive reimbursement policies for companion diagnostics. This can limit patient access to these tests, hindering their widespread adoption.
• Data Integration Challenges Effectively integrating companion diagnostic data into existing healthcare systems and electronic health records (EHRs) can be complex. Streamlining this process is crucial to ensure healthcare providers can easily access and utilize this vital information for optimal patient care.

Key Trends

• Surge in Personalized Medicine The healthcare industry’s increasing focus on personalized medicine is a major driver. This approach tailors treatments to a patient’s unique genetic makeup and disease profile. Companion diagnostics play a starring role by identifying patients most likely to benefit from specific drugs, and optimizing treatment effectiveness.
• Targeted Therapies on the Rise The development and adoption of targeted therapies, particularly for cancers, are propelling the market forward. These therapies target specific molecular pathways involved in disease progression. Companion diagnostics act as valuable allies in this area by identifying patients whose genetic mutations or biomarkers align with the targeted therapy’s mechanism of action, maximizing its effectiveness.
• Alarming Cancer Rates The alarming rise in global cancer cases is fueling a greater demand for companion diagnostics. These tests have the potential to play a role in early detection, guiding treatment decisions, and predicting a patient’s response to specific cancer therapies.
• Regulatory Requirements as a Catalyst Regulatory agencies like the US FDA are increasingly mandating companion diagnostics for approval of certain targeted therapies. This requirement ensures the drug’s safety and efficacy are well-established for the intended patient population, acting as a catalyst for companion diagnostic development.
• Technological Advancements Propelling Growth Advancements in technologies like genetic sequencing, molecular diagnostics, and bioinformatics are propelling the companion diagnostics market forward. These advancements pave the way for the development of more accurate, faster, and cost-effective companion diagnostic tests, expanding their reach and impact.
• Growing Awareness and AdoptionAs healthcare professionals and patients become more aware of the benefits of companion diagnostics, their adoption is on the rise. This growing awareness translates into increased market demand for these tests.
• Favorable Reimbursement Policies Favorable reimbursement policies by government and private insurance companies can significantly impact market growth. Wider coverage for companion diagnostics makes these tests more accessible to patients, promoting their use.

Global Companion Diagnostics Market Regional Analysis

Here is a more detailed regional analysis of the companion diagnostics market

North America

• North America benefits from a well-established network of companies developing and offering companion diagnostics. This robust infrastructure fosters innovation and facilitates the accessibility of these tests.
• The US Food and Drug Administration (FDA) plays a crucial role. The FDA offers a flexible regulatory pathway for companion diagnostics, streamlining the co-development process with targeted therapies. This supportive environment encourages companies to invest in companion diagnostic development.
• The emphasis on personalized medicine in North America creates a fertile ground for companion diagnostics. These tests directly contribute to this approach by enabling healthcare providers to tailor treatments to individual patients.
• Rising Prevalence of Chronic DiseasesThe increasing prevalence of chronic diseases like cancer and neurological conditions in North America fuels the demand for companion diagnostics. These tests can aid in early detection, guide treatment decisions, and improve patient outcomes.
• Government InitiativesGovernment healthcare plans and initiatives in North America can play a role in promoting companion diagnostics. These initiatives can raise awareness, improve access, and potentially offer reimbursement for these tests.

Asia Pacific

• The Asia Pacific (APAC) region represents a promising market for companion diagnostics with significant growth potential. APAC countries are increasingly recognizing the value of personalized medicine. Companion diagnostics play a crucial role in this shift by enabling targeted therapies based on a patient’s unique genetic makeup.
• The APAC region faces a significant burden of chronic diseases like cancer, diabetes, and cardiovascular ailments. Companion diagnostics can aid in early detection, improve treatment selection, and potentially reduce healthcare costs associated with these diseases.
• The rapidly aging population in many APAC countries such as China and Japan increases the demand for advanced diagnostics, including Companion diagnostics.
• Several APAC governments are actively supporting the development and adoption of Companion diagnostics through funding initiatives and streamlined regulatory pathways.
• The growing adoption of advanced technologies like next-generation sequencing (NGS) in APAC is facilitating the development of more accurate and efficient Companion diagnostics tests.
• Rising healthcare expenditure in many APAC countries is creating a more favorable environment for the adoption of novel diagnostic tools like Companion diagnostics.

Global Companion Diagnostics Market Segmentation Analysis

The Companion Diagnostics Market is segmented based on Technology Type, Indication, and Geography.

Companion Diagnostics Market, By Technology Type

• Frequency Immunohistochemistry
• Polymerase Chain Reaction (PCR)
• Next Generation Sequencing (NGS)
• In Situ Hybridization
• Others

Based on Technology Type, the market is segmented into Frequency Immunohistochemistry, Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), In Situ Hybridization, and Others. The Polymerase Chain Reaction (PCR) segment is holding the largest market share and is projected to grow during the forecast period. Cost-effectiveness, high sensitivity, and specificity are some essential aspects driving market expansion, and they can be employed for simple automated platforms. Furthermore, the PCR, another essential driver of this segment, can determine the sequencing of unknown etiologies of many diseases. However, the next-generation sequencing segment is expected to multiply during the forecast period due to crucial advantages such as higher sensitivity to detect low-frequency variants, the shorter turnaround time for large sample volumes, the ability to sequence hundreds to thousands of genes or gene regions simultaneously, and so on.

Companion Diagnostics Market, By Indication

• Oncology
• Neurology
• Others

Based on Indication, the market is segmented into oncology, neurology, and others. The oncology segment accounted for the largest market share in 2021. Some key factors driving the growth of the oncology segment include increased cancer prevalence, an increase in the number of R&D activities for cancer, an increase in the number of unmet needs for cancer treatment, an increase in the number of FDA-approved companion diagnostics, and increased patient awareness about personalized medicine.

Companion Diagnostics Market, By Geography

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

Based on Geography, the market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America holds a significant market share, which is expected to grow during the forecast period. The high prevalence of different types of cancers amongst the American population is driving the North American market. The number of patients with cancer is increasing over time in Canada, and according to the Canadian Cancer Society, approximately 28.2% of deaths in Canada are caused by cancer. Canadian Cancer Researchers have predicted that there will be 229,200 new cancer cases in Canada, out of which 84,600 cancer patients will die.

Similarly, the number of cancer patients is rising in Mexico, leading to increased costs to the country per capita every year. According to the Pan American Health Organization, there were 190,667 cancer cases in Mexico, out of which 83,476 cancer patients died. The number of cancer cases is expected to rise in Mexico and reach 1,262,861 in the next decade, according to the American Society of Clinical Oncology. Asia-Pacific delivers lucrative prospects for critical players in the Companion Diagnostics Market due to its large population base, increased awareness of companion diagnostics, expansion of healthcare infrastructure, and increased demand for sophisticated therapeutics. However, the Companion Diagnostics Market’s expansion in Asia-Pacific may be hampered by increased R&D expenses for developed companion diagnostics.

Key Players

The “Companion Diagnostics Market” study report will provide valuable insight emphasizing the global market. The major players in the market are Abbott Laboratories Molecular, Inc., Agilent (Dako Denmark A/S), ARUP Laboratories, Inc., BioMerieux, Danaher Corporation (Leica Microsystems), Foundation Medicine, Inc., Eurofins, Myriad Genetics, Inc., Roche (Ventana Medical Systems, Inc), Thermo Fisher Scientific (Life Technologies Corporation), and QIAGEN N.V.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Companion Diagnostics Market Recent Developments

• In August 2022, the U.S. FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small-cell-lung cancer (NSCLC).
• In February 2022, Genetron Holdings Limited, a leading precision oncology platform company in China entered a collaboration agreement with HUTCHMED (China) Limited to develop a companion diagnostic (CDx).
• In May 2021, QIAGEN N.V. announced the expansion of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit following regulatory approval in the United States as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with LUMAKRASTM (sotorasib), a newly approved therapy developed and marketed by Amgen Inc. (AMGN).
• In May 2020, MBL (Medical and Biological Laboratories) announced the release of an in vitro diagnostic kit for the hereditary disorder Spinal Muscular Atrophy (SMA). The MEBCDX AAV9 test kit, licensed from Quest Diagnostics, was approved by the Ministry of Health, Labour, and Welfare (MHLW) on April 27 as a companion diagnostic (CDx) assay for Novartis International AG’s SMA gene therapy.

Report Scope

Research Methodology of Market Research