Assessing the Major Growth and Ongoing Developments in the Clinical Diagnostics Market

Clinical Diagnosis (Dx) is the identification and confirmation of disease or disorder or exposure to xenobiotics to explain the clinical manifestations shown by the patient. It is also performed to assess the state of health of an individual (routine health checkup), functioning of any organ or associated metabolic process (such as the extent of damage caused to an organ due to disease or injury and improvement in organ function due to treatment) and to distinguish one disease from other especially when similar manifestations are associated with multiple diseases or comorbid condition occurs. It may also be conducted to identify the cause of death in case of posthumous diagnosis. Diagnosis is the most important aspect of the healthcare sector, essential to identify the cause of the patient’s abnormal state and enable subsequent palliation, postexposure prophylaxis, or treatment.

Clinical diagnostics include the various methods and equipment utilized to monitor the state of health and diagnose a medical condition. Some popular and routinely performed clinical diagnostic tests include general and organ function tests, infectious diseases tests, and imaging tests. The major driving forces behind the growth of the clinical diagnostics market include the increasing prevalence of infectious diseases, rising cases of lifestyle-based health problems, increasing geriatric population, increasing cases of infertility, and growing awareness of health, especially after the COVID-19 pandemic. Some key players operating in the clinical diagnostics market include Abbott, Becton, Dickinson and Company, Hologic Inc., bioMérieux SA, and others. 

Types of Clinical Samples in Clinical Diagnostics 

The clinical samples are categorized into the following categories: Solid and liquid samples. Solid clinical samples are collected during surgical or biopsies and include body tissue pieces. Liquid clinical samples comprise body fluids such as blood and urine. 

General Purpose Instruments, Equipment, and Apparatus Used in Clinical Diagnostics

The product type segment of the clinical diagnostics market is segmented based on the instruments, equipment, and apparatus.

Types of Clinical Diagnostic Tests

The test segment of clinical diagnostics market is segmented based on the complete blood count, metabolic panel, lipid panel, cancer testing panel, liver panel, infectious disease testing, and others.

In the test segment of the clinical diagnostics market, the cancer testing panel dominated the segment with a significant market share in 2021. 

Challenges Associated with Clinical Diagnostic Tests

Though clinical diagnostic tests are essential for disease diagnosis, several challenges are still associated with them. 

1. Incorrect diagnosis (false positives and false negatives) – In clinical diagnostics, the results are not always trustworthy, as there might be cases of false positives and false negatives. False positive is when diagnostic test results show the presence of the disease condition when it is not present. Similarly, in case of a false negative diagnostic test, results show the absence of the disease when it is present. For example, during the pandemic, there were many false positive and false negative cases, thus questioning the test’s accuracy. 
2. Undiagnosed conditions – Another case in clinical diagnostics is undiagnosed conditions. The clinician cannot identify the disease with certain symptoms and characteristics. This necessitates the need for technologically advanced diagnostics for specific disease identification. 
3. Delayed diagnosis – In most cases, the disease is diagnosed at later stages when the patient has fewer chances of survival. Some diseases do not show any signs and symptoms and may remain hidden for several years, such as in cases of cancer, HIV, and others. It is essential to have routine diagnostic tests so that any present health issue is diagnosed or treated on time. In a few cases, people don’t have accurate knowledge about the disease and thus may neglect the major signs and symptoms, leading to delays in diagnosis and treatment. 
4. Risks of diagnostic tests – Though diagnostic tests are widely utilized to diagnose several diseases, certain risks are still associated with some clinical diagnostic tests. For example, there is a risk of radiation exposure in imaging tests such as x-rays, CT scans, and others. Also, there is a risk of the spread of disease while sampling collection and testing, especially in the case of air-borne diseases such as COVID-19. In that case, it is advisable to wear proper protective gear to avoid exposure to disease-causing pathogens. 
5. Acceptability of the test – In the case of some clinical diagnostic tests, the patient might feel uneasy or uncomfortable while the sample is being collected. For example, in the case of a Digital Rectal Examination (DRE) test doctor to examine the prostate gland for certain bumps, soft or hard spots, or other abnormal areas will insert a lubricated, gloved finger into the rectum, which might not be acceptable to some of the patients leading to discomfort and other issues. 
6. Cost, availability, and accessibility – One of the major issues around clinical diagnostics is that not every test is available at every hospital and clinic, especially in the case of rural areas. Even if it is available, not everyone can afford it. Hence, government initiatives to make screening and treatment facilities available to vulnerable people will help overcome this challenge. 
7. Errors – The errors in clinical diagnostics can be divided into three phases – Pre-analytical, analytical, and post-analytical. The pre-analytical phase includes the maximum number of errors, such as incorrect test requests, damage to the sample while transporting and storing, inadequate samples, and others. The analytical phase starts with sample preparation for testing and ends with test interpretation by the technologist. The errors of the analytical phase are a mix-up of the sample, a procedure not followed, instrument or equipment malfunction, and others. Lastly, in the post-analytical phase, errors such as incorrect data entry and failure in reporting may occur. Proper guidelines from sample collection to reporting results should be followed without any negligence. 

Clinical Diagnostics and Artificial Intelligence (AI)

Artificial Intelligence (AI) has emerged as an important tool in the healthcare industry, including clinical diagnostics, and tends to make breakthrough advancements in medical science. AI-based clinical diagnostic tools and technologies assist healthcare professionals by providing quick, accurate, precise, and error-free diagnoses of diseases and helping them to make correct decisions regarding the treatment and management of the disease. Al-based diagnostic software makes judgments for diagnosing and identifying diseases based on existing data fed to it as a training set. Currently, AI-based techniques such as machine and deep learning are employed in detecting diseases such as cancer, cardiovascular diseases, Alzheimer’s, skin, liver, lung, eye, and others. For example, QUANTIB® Prostate, an AI-based software, analyzes MRI prostate scans and detects abnormalities to diagnose prostate cancer accurately.

Factors Driving the Clinical Diagnostics Market

There are several factors impacting the growth of the clinical diagnostics market. Some of the prominent factors include:

Increasing prevalence of infectious diseases 

The rise and spread of COVID-19 showed the vulnerability of the world toward dangerous infectious diseases. Within a short period, every country reported millions of cases, including deaths due to COVID. 

For instance, according to the World Health Organization (WHO) 2022, there were 5,543,556 confirmed cases of COVID-19 worldwide in June 2022. In that case, the increasing prevalence of infectious diseases, not only COVID-19 but others, can be considered one of the main reasons behind the growth of the clinical diagnostics market. Clinical diagnostic techniques are utilized in diagnosing, prognosis, and monitoring multiple infectious diseases. For instance, real-time PCR (qPCR) measures the amount of genetic material present by adding fluorescent dyes to the sample, which was widely used in the diagnosis of COVID-19. 

The growing number of tuberculosis cases is another factor in the growth of the clinical diagnostics market. For example, according to the WHO 2021, around 10 million people worldwide had tuberculosis, including 5.6 million men, 3.3 million women, and 1.1 million children in 2020. The Mantoux tuberculin skin test (TST) is one of the diagnostic tests used widely to screen tuberculosis.

The rising burden of cardiovascular diseases

One of the prominent factors that led to the growing popularity and high utilization of clinical diagnostics worldwide is the growing prevalence of cardiovascular diseases. CVDs are a group of disorders affecting the heart and blood vessels, including rheumatic heart disease, coronary heart disease, heart failure, and heart attack. As per WHO 2021, around 17.9 million people worldwide died from CVDs in 2019, indicating the growing need for diagnostic tools and techniques for accurate diagnosis of CVDs so that the doctor can make proper decisions regarding treatment and surgeries, which will reduce the mortality rate. Diagnostics techniques like blood tests, electrocardiograms (ECG), echocardiograms, and others are used to diagnose cardiovascular diseases. 

Growing incidence of cancers

Cancer associated with abnormal growth of cells is a group of diseases that may affect any part of the body, including the breast, colon, prostate, and lungs. The rising incidences of cancer are another crucial aspect behind the growth of the clinical diagnostics market. For instance, as per the WHO 2022, there were around 2.26 million cases of breast cancer, 2.21 million cases of lung cancer 1.93 million cases of colon and rectal cancer recorded in 2020. This indicates the growing need for clinical diagnostics techniques, including biopsies, imaging tests such as MRI, CT, nuclear scan, and others, along with certain lab tests that may indicate the presence of a tumor at early stages, increasing the rate of survival of a patient. 

Increasing cases of sexually transmitted diseases (STDs) and infertility 

The prevalence of sexually transmitted diseases such as HIV, AIDS, gonorrhea, chlamydia, and others is a major driving factor for the growth of the clinical diagnostics market. For instance, according to WHO 2021, around 1 million people worldwide acquire STDs every day. Also, as per the same source, it was estimated that there were around 129 million cases of chlamydia, 7.1 million cases of syphilis, 82 million cases of gonorrhea, and around 156 million cases of trichomoniasis recorded in 2020. 

Moreover, as per the data published by the Centers for Disease Control and Prevention (CDC) 2022, around 1,189,700 people in the US had HIV in 2019. Also, as per the same source, around 30,635 people received a diagnosis of HIV in 2020 in the US. 

Several clinical diagnostics techniques are utilized in the diagnosis of multiple STDs. For example, as per CDC, there are three types of tests for HIV detection, Nucleic acid tests (NATs) which detect RNA of HIV; antigen/antibody combination tests can detect p24 antigen and HIV antibodies in a single test; and lastly, the antibody tests that can detect IgM and/or IgG antibodies against HIV. Some of the FDA-approved HIV tests include Hologic Inc.’s NATs-based Aptima HIV-1 Quant Dx Assay and Bio-RAD’s GS HIV Combo Ag/Ab EIA which is an Enzyme immunoassay (EIA) for the simultaneous detection of HIV p24 antigen and antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma among others. 

Further, the rising infertility cases are another driver for the clinical diagnostics market. For instance, as per the WHO 2020, it was estimated that around 48 million couples were living with infertility in 2020. Infertility is the inability to have a first child, which may happen in males and females due to different causes. Male infertility may result due to some chronic health issues, infections, and injuries, among others. Female infertility may result from menstrual disorders such as PCOS, PCOD, STDs, etc. The clinical diagnostics tests for infertility include blood tests, ultrasound, x-ray, laparoscopy, and Chlamydia tests for females and semen analysis for males. 

Increasing geriatric population and rising awareness of health 

The increasing geriatric population is likely to accelerate the clinical diagnostics market. For instance, as per the WHO 2021, the world population is aging rapidly, and by 2050 there will be 80% of people living worldwide. 

The increasing age makes one susceptible to various health problems, including CVDs, diabetes, cancer, and eye and ear problems. For instance, according to the American Cancer Society (2022), breast cancer is highly prevalent in middle-aged and older women, with 62 being the median age for breast cancer diagnosis. Further, as per the National Institute on Deafness and Communication Disorders under the US Department of Health and Human Services 2022, approximately one in three people aged between 65 and 74 have hearing loss in the US. This indicates the increasing need for hearing tests which will further assist in making crucial decisions regarding the treatment and management of hearing loss problems. 

Moreover, another driving factor in the clinical diagnostics market is rising health awareness. Due to increasing concern over health among people, there has been a tremendous rise in routine health checkups escalating the market growth of clinical diagnostics. Also, doctors’ recommendation of annual tests for diseases, including breast cancer, prostate cancer, cervical cancer, STDs, and others, will further accelerate the clinical diagnostics market. For instance, many physicians recommend an annual prostate-specific antigen test (PSA) for males aged 50 or above.

Also, the rise in government initiatives worldwide to educate and inform people of various health-related aspects is another driving force for the growth of the clinical diagnostics market. For example, under National Chlamydia Screening Programme (NCSP) by the UK government, young women under 25 years are offered free chlamydia screening in community settings, such as GPs and pharmacies. The program aims to reduce the harm from untreated chlamydia infection. Further, CDC’s National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides timely breast and cervical cancer screening and diagnostic services to vulnerable women. 

Key Players in the Clinical Diagnostics Market

Clinical diagnostics is highly competitive, with numerous international and regional players in the market. 

Abbott

Abbott is one of the world’s largest healthcare companies with the central purpose of helping people to live their healthiest possible lives. It is a publicly-listed company and is headquartered in the United States. Its core business is nutrition, diagnostics, medicines, and medical devices.

BD

BD is one of the world’s largest global medical technology companies actively involved in advancing the world of health^TM by improving medical discovery, diagnostics, and care delivery. It is a publicly listed company headquartered in Franklin Lakes, New Jersey, and the United States. The company has three principal business segments: BD Medical, BD Life Sciences, and BD Interventional.

F Hoffmann-La Roche Ltd. 

Roche is one of the world’s largest biotech companies, a leading provider of in vitro diagnostics, and a global supplier of transformative, innovative solutions across major disease areas. The company is focused on finding new medicines and diagnostics and establishing data-based insights that evolve the practice of medicine and help patients live longer, better lives. It is a publicly listed company headquartered in Switzerland. The company operates worldwide under two divisions: Pharmaceuticals and diagnostics.

bioMérieux SA 

bioMérieux SA is a world leader in the field of in vitro diagnostics. It is privately owned and is headquartered in Marcy l’Etoile, France. The company’s strategic focus areas include antimicrobial resistance, acute care, sepsis, syndromic approach, and food and pharma safety. bioMérieux SA is involved in developing high-performance solutions based on three key areas of in vitro diagnostics: Microbiology, Immunoassays, and Molecular Biology.

Bio-Rad Laboratories, Inc.

Bio-Rad is a global leader in developing, manufacturing, and marketing various innovative products for the life science research and clinical diagnostic markets. The company believes in advancing the discovery process and improving healthcare by providing useful, high-quality products and services. The company was founded in 1952 and is publicly listed and headquartered in Hercules, California, US.

Recent Developments in the Clinical Diagnostics Market

• On July 2022, Novacy experts in clinical diagnostics received approval for their product EXSIG™ COVID-19 direct test in the UK under CTDA legislation. 
• On July 2022, Quotient Limited and InfYnity Biomarkers announced a collaboration under which InfYnity Biomarkers will assist Quotient in the research and design of infectious disease assays to enrich and expand the MosaiQ Serology Disease Screening (SDS) menu and reduce time and cost of development and commercialization.
• On December 2021, Lupin, a major pharmaceutical company, announced its diagnostic business launch in India. 
• On December 2021, Quidel Corporation, a diagnostic healthcare manufacturer, announced the acquisition of Ortho Clinical Diagnostics. 
• On November 19, 2020, Bio-Rad was granted authorization to sell or import the Platelia SARS-CoV-2 total Ab test for COVID-19 testing in Canada.
• On October 2020, Roche received the US Food and Drug Administration (FDA) approval for its COBAS® EGFR mutation test v2 as a companion diagnostic (CDx) for a broad group of therapies in the treatment of non-small cell lung cancer (NSCLC).
• On March 2020, Novacyt French received US FDA clearance for fast and easily transportable tests for the coronavirus disease. 
• On February 2020, Biocare Medical experts in innovative, automated immunohistochemistry (IHC) reagents and instrumentation announced the launch of seven novel IVD IHC antibody markers for clinical diagnostics and research applications.
• In May 2019, QIAGEN announced the launch of the FDA-approved THERASCREEN® PIK3CA RGQ PCR kit as a companion diagnostic to aid in identifying breast cancer. 

Conclusion

Clinical diagnostics describes various methods and techniques for diagnosing, identifying, and monitoring disease, condition, or injury. These techniques are reliable and accurate in most cases but also have certain challenges, including cases of false positive and false negative, risk of contamination, and spread of disease, especially in case of air-borne diseases. But owing to their numerous benefits in the healthcare sector, such as forming the basis for treatment and others, these are widely used and are always in demand. 

According to DelveInsight analysis, the clinical diagnostics market is expected to witness significant progress in growth. This can be attributed to several factors governing the clinical diagnostics market, including the rising prevalence of infectious diseases such as COVID-19, tuberculosis, and others. Further increasing cases of lifestyle-based diseases such as cancer, diabetes, cardiovascular, and kidney diseases are likely to increase the demand for various clinical diagnostic techniques.

The increasing number of sexually transmitted diseases (STDs), including HIV, gonorrhea, and others worldwide, is another major factor responsible for the growth of the clinical diagnostic market. Also, the increasing cases of infertility owing to factors such as infections, injuries, age, and others are further contributing to the growth of the clinical diagnostic market. 

Artificial intelligence can help overcome various limitations in clinical diagnostics by providing quick, accurate, and error-free diagnostic results, reducing the overall burden of healthcare professionals. 

Moreover, the rise in various awareness programs by various government and non-government organizations will also impact the clinical diagnostic market positively. These programs aim to reduce the prevalence and mortality rate of any disease by providing information regarding the disease, promoting early diagnosis, and providing access to free screening and treatment facilities. 

The demand for clinical diagnostics will increase further in the coming years owing to the huge prevalence of multiple diseases worldwide and the growing need for technologically advanced clinical diagnostic tools and techniques that can quickly, accurately, and precisely detect the presence of any disease.