Diagnostic Testing Market Size to Reach USD 449.78 Billion by 2033

According to Nova One Advisor, the global diagnostic testing market is valued at USD 211.27 billion in 2023, and it is expected to reach USD 449.78 billion by 2033, with a CAGR of 7.9% during the forecast period of 2024-2033.

Diagnostic testing is a cornerstone of healthcare worldwide, playing a pivotal role in detecting diseases, assessing their progression, and understanding their impact on the body. From cancer to infectious diseases, diagnostics are indispensable for healthcare providers, enabling them to gather precise information crucial for early detection, prevention, and monitoring. Furthermore, diagnostics are essential for optimizing care pathways and developing effective treatment plans. Despite their critical role, diagnostics are often undervalued, leading to a lack of awareness and integration within healthcare systems globally. This gap presents significant opportunities for growth in the diagnostic testing market.

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Market Overview

The diagnostic testing market is experiencing rapid growth, driven by the increasing demand for diagnostic genetic testing. These tests play a crucial role in identifying specific genetic conditions that healthcare providers may be concerned about. Diagnostic testing is essential for individuals exhibiting symptoms associated with a medical problem, as it helps establish the presence or absence of disease. Physicians often recommend diagnostic tests to confirm diagnoses in symptomatic individuals or screen-positive asymptomatic individuals. Despite being invasive and expensive, diagnostic tests are justified as necessary to establish a diagnosis accurately. They prioritize accuracy and precision over patient acceptability, with higher costs deemed justifiable for the sake of diagnosis accuracy. Accurate and timely diagnostics are vital in disease management, minimizing the risks of misdiagnosis, missed diagnosis, or delayed diagnosis. As both diseases and diagnostic approaches evolve, it's crucial to select the appropriate diagnostic tests for individual patients and conditions to avoid over- or underdiagnosis, which can lead to unnecessary treatments and harm to both patients and healthcare systems.

  • In February 2024, Thyrocare acquired Think Health Diagnostics to enter into providing ECG services at home.

Diagnostic Testing Market Size in the U.S. 2024 To 2033

The U.S. diagnostic testing market size was valued at USD 84.85 billion in 2023 and is anticipated to reach around USD 158.77 billion by 2033, growing at a CAGR of 6.5%% from 2024 to 2033.

The diagnostic testing market in North America is thriving, primarily fueled by the region's expanding elderly population. North America, particularly the United States, is a key player in the global healthcare landscape, with diagnostic tests being a cornerstone of its healthcare system. These tests, which analyze samples from the body, serve diverse purposes across medical care stages, including prevention, detection, diagnosis, treatment, and disease management. They facilitate evidence-based medicine, enhance quality of care, promote wellness, enable early disease detection, and contribute to reducing overall healthcare costs.

 The medical technology industry in North America is dynamic, continuously innovating to enhance patient health and well-being worldwide. Recently, regulatory reforms in Canada have been announced in response to international scrutiny over flawed regulations for medical implants, signaling a commitment to improving patient safety and oversight. Molecular diagnostics are gaining prominence in North America, playing crucial roles in controlling infectious diseases, diagnosing hereditary conditions, and advancing oncology practices. In the United States alone, over 13 billion diagnostic tests are conducted annually to confirm or rule out various conditions and diseases. Healthcare organizations in the region are adopting sophisticated scheduling systems to minimize patient waiting times, distinguishing themselves from social security or public healthcare facilities. Additionally, a strategic cross-selling approach, such as offering health packages to patients, has been implemented to enhance patient care and organizational revenue streams.

In the Asia-Pacific (APAC) region, significant growth in the diagnostic testing market is expected from 2024 to 2033, driven by the availability of affordable diagnostic tests for chronic illnesses. To enhance the quality of laboratory testing, a systematic approach aimed at reducing variation is crucial. Accreditation activities have been recognized to lead to improvements in patient safety and outcomes, contributing to the region's focus on enhancing healthcare standards. APAC is characterized by cultural and economic diversity, with a strong emphasis on improving healthcare standards.

Key to achieving this is the advancement of laboratory medicine, enabling better medical diagnosis and treatment for large populations. Notably, blood cultures, one of the highest volume and costly tests in microbiology, play a crucial role in disease diagnosis and treatment. In the Chinese market, Becton Dickinson and BioMerieux dominate with their systems capable of determining antibiotic sensitivities, such as the Bactec system. These systems are also utilized in tuberculosis (TB) diagnosis, particularly in cases of multiple drug resistance due to the slow growth of TB. Chinese companies are employing various methods for real-time detection of bacterial growth in individual blood culture bottles, including continuous individual monitoring techniques. Additionally, efforts are underway to utilize metabolomic databases to identify growing organisms, with built-in probes monitoring metabolic products in the bottles.

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Report Highlights                              

By Type        

 In 2023, the clinical diagnostics segment led the market. Clinical diagnostics encompasses a comprehensive range of medical tests conducted in various healthcare settings, including pathology labs, diagnostic centers, and hospitals. These tests, both invasive and non-invasive, are instrumental in accurately detecting and monitoring human diseases. Achieving an accurate disease diagnosis is paramount to ensuring timely and appropriate treatment and improving patient outcomes. Common examples of clinical diagnostic tests include total blood count, comprehensive metabolic panel, X-ray, ultrasonography, magnetic resonance imaging (MRI), computer tomography (CT) scan, and polymerase chain reaction (PCR). These tests play a crucial role in diagnosing a wide array of medical conditions, aiding physicians in making informed treatment decisions. In recent years, there have been significant advancements in infectious disease diagnosis, particularly with the development of laboratory-quality, point-of-care molecular testing platforms. These platforms utilize real-time PCR-based amplification and detection of viral nucleic acid, enabling rapid and accurate diagnosis of infectious diseases at the point of care. Such advancements contribute to improved patient management and disease control strategies.

  • In January 2023, Agilent announced the acquisition of Avida Biomed, the developer of high-performance NGS target enrichment workflows for cancer research

 Home diagnostics, also known as at-home diagnostics, empowers patients to conduct various tests conveniently within the comfort of their homes. These tests offer enhanced accuracy and contribute to ongoing medical care. In contrast, point-of-care tests, which are often more accessible and less expensive, do not require medical oversight. Both home diagnostics and point-of-care tests represent valuable innovations in comparison to traditional laboratory testing.

At-home diagnostic testing offers convenience and affordability, addressing common barriers to accessing healthcare. By eliminating the need for appointments, travel to medical facilities, and waiting for test results, these tests enable individuals to take control of their health. Users can perform tests at their convenience, wherever they are, and at a time that suits their schedule. This accessibility enhances overall healthcare accessibility and facilitates proactive health management.

 By Approach

The diagnostic tests market encompasses molecular diagnostic tools, in-vitro diagnostic tools, and point-of-care testing tools, each employing distinct techniques. In vitro diagnostics (IVD) involve conducting tests or examinations on samples obtained from the human body, such as blood or tissue samples. The term "in vitro," translating to "in glass," signifies that these tests are typically conducted using equipment like test tubes or petri dishes. IVD tests are non-invasive and offer versatility, with some designed for professional healthcare settings while others are suitable for consumer use at home. These tests serve various purposes, including monitoring overall health, detecting and preventing diseases, and identifying optimal treatment pathways in precision medicine for specific patients. Understanding the key benefits of IVD tests is essential for informed decision-making in healthcare management.

 Point-of-care (POC) diagnostics play a crucial role in the research, diagnosis, and monitoring of various diseases such as cancer, diabetes, and heart disorders. Conducted at or near the point of patient care, these tests offer rapid diagnosis, expediting the treatment decision-making process. Particularly beneficial in regions with limited access to laboratory equipment, POC tests enhance patient care while reducing testing costs. POC testing, also termed near-patient testing, involves conducting tests using devices or kits directly in the presence of the patient, eliminating the need to send samples to a laboratory. This streamlined process enables swift and reliable results, empowering medical staff to make informed treatment decisions promptly. The primary advantage of POC testing lies in its ability to deliver quick results, facilitating efficient patient management and care.

 By Application

The diagnostic tests market is segmented into several application categories, including cardiology, oncology, neurology, orthopaedics, gastrointestinal, gynaecology, odontology, and others. With the global increase in heart patients and cardiovascular disorders, the cardiology segment is expected to lead the market. Various diagnostic tests are employed in the diagnosis of heart disease. An electrocardiogram (ECG) is a rapid and painless test that records the heart's electrical signals, providing insights into its rhythm. Additionally, a Holter monitor, a portable ECG device worn for extended periods, captures the heart's activity during daily activities, aiding in the detection of irregular heartbeats not identified during standard ECG exams.

By End Use

The diagnostic tests market encompasses a diverse range of end users, including hospitals, diagnostic centres, research laboratories and institutes, research institutions, homecare, blood banks, specialised clinics, ambulatory surgery centres, and others. These tests play a pivotal role in identifying diseases at their earliest stages, often before symptoms manifest. This early detection enables healthcare professionals to intervene promptly, offering patients access to better treatment options and potentially saving lives. The significance of diagnostic tests in healthcare is paramount, from facilitating early detection to tailoring personalized treatment plans. As technology and medical knowledge continue to advance, diagnostic testing will undoubtedly assume an even more critical role in shaping the future of healthcare, offering hope and healing to countless individuals worldwide.

Market Dynamics

Driver

  • Advancements in Diagnostic Testing

The effectiveness of diagnostic tests hinges on key factors such as reproducibility, accuracy, feasibility, and their impact on clinical decisions. As healthcare evolves rapidly, driven by advancements in disease understanding, emergence of new pathologies, and technological innovations, the landscape of diagnostic testing undergoes significant transformations. The advent of personalized medicine, which places the patient at the center of decision-making, has revolutionized healthcare delivery. Tailored diagnostic methods and treatments, customized to individual needs, are becoming increasingly prevalent, reshaping the healthcare paradigm. This shift towards personalized care not only enhances patient outcomes but also fuels the growth of the diagnostic testing market, driving accessibility and affordability of innovative diagnostic solutions.

  • In January 2024, Agilent announced a collaboration with Incyte to develop advanced companion diagnostics in hematology and oncology

Restraint

  • Cost Containment Challenges

As healthcare costs soar beyond US$2.7 trillion, controlling expenditures has become an economic necessity. Diagnostic testing expenses, comprising over 10% of total healthcare costs, are escalating rapidly, driven primarily by advanced diagnostic imaging and molecular diagnostic testing for personalized medicine. Misuse and overuse of diagnostic tests, particularly in imaging, contribute to substantial waste, estimated at over US$25 billion. The repercussions of diagnostic errors, including failure to treat the actual condition, inappropriate testing and treatments for misdiagnosed ailments, and associated medicolegal costs, further strain the healthcare system. These challenges impede the growth potential of the diagnostic testing market, necessitating innovative strategies to contain costs while maintaining diagnostic accuracy and efficacy.

 Opportunity

  • AI-Based Medical Diagnostics

 The advancement of technology, particularly in the realm of AI-based medical diagnostics, presents a significant opportunity for the diagnostic testing market. Leveraging AI algorithms to analyze extensive medical data sets holds the potential to revolutionize medicine by enhancing diagnostic accuracy and efficiency, ultimately leading to improved patient outcomes. As AI technology continues to evolve, it offers the promise of streamlining diagnostic processes and providing more consistent and reliable information to both patients and healthcare providers. However, the full realization of AI's potential in medical diagnostics is hindered by technical, regulatory, and ethical challenges that require addressing. Nevertheless, overcoming these obstacles can pave the way for widespread adoption of AI in diagnostics, opening up new avenues for growth and innovation in the diagnostic testing market.

Recent Developments

  • In July 2023, EDP Biotech Corp. and New Day Diagnostics, LLC announced an asset merger, building a vertically integrated diagnostics powerhouse

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Diagnostic Testing Market Players

  • F-Hoffman La-Rcohe Ltd. (Switzerland)
  • Danaher (US)
  • BD (US)
  • Thermo Fisher Scientific Inc. (US)
  • ACON Laboratories Inc. (US)
  • Hemosure, Inc. (US)
  • MicroGen Diagnostics (US)
  • Grifols, S.A (Spain)
  • BODITECH MED INC. (South Korea)
  • Chembio Diagnostic Systems, Inc. (US)
  • Nanoentek (South Korea)
  • DiaSorin S.p.A. (Italy)
  • Bio-Rad Laboratories, Inc. (US)
  • BIOMEDOMICS INC (US)
  • EKF Diagnostics Holdings plc (UK)
  • Siemens Healthcare GmbH (Germany)
  • PerkinElmer Inc. (US)
  • bioMérieux SA (France)
  • ARKRAY USA, Inc. (US)
  • Biohit Oyj (Finland)
  • Quidel Corporation (US)
  • Illumina, Inc. (US)
  • Lamdagen Corporation (US)
  • LifeSign LLC. (US)
  • Medixbiochemica (Finaland)
  • Nova Biomedical (US)
  • Ortho Clinical Diagnostics (US)
  • Sannuo Biosensing Co., Ltd. (US)
  • STRECK (US)
  • Sysmex Corporation (Japan)

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Diagnostic Testing market.

By Type

By Application

  • Cardiology
  • Oncology
  • Neurology
  • Orthopedics
  • Gastroenterology
  • Gynecology
  • Odontology
  • Others

By Approach

  • Molecular Diagnostic Instrument
  • In-Vitro Diagnostic Instrument
  • Point Of Care Testing Instrument

By Solution

  • Services
  • Products

By Technology

  • Immunoassay-Based
  • PCR-Based
  • Next-generation Sequencing
  • Spectroscopy-Based
  • Chromatography-Based
  • Microfluidics
  • Substrate Technology
  • Others

By Mode of Testing

  • Prescription Based Testing
  • OTC Testing

By Sample Type

  • Urine
  • Saliva
  • Blood
  • Hair
  • Sweat
  • Others

By Testing Type

  • Biochemistry
  • Hematology
  • Microbiology
  • Histopathology
  • Others

By Age

  • Pediatric
  • Adult & Geriatric

By Distribution Channel

  • Direct Tenders
  • Retail Sales
  • Online Sales

By End User

  • Hospitals, Diagnostic Center
  • Research Labs and Institutes
  • Research Institute
  • Homecare
  • Blood Banks
  • Specialty Clinics
  • Ambulatory Surgical Centers
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

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