세계의 임상 진단 시장 규모는 2023년에 701억 1,000만 달러에 달하며, 2024-2030년의 예측 기간에 CAGR로 7.02%의 성장이 전망됩니다. 임상 진단에 대한 수요의 증가는 주로 간질환, 혈액 질환, 암 등 다양한 만성질환의 부담 증가에 기인하고 있습니다. 또한 POC(Point of Care) 임상 진단 검사의 채택 증가, 전 세계에서 임상 진단 랩 신설을 향한 전략적 사업 활동의 증가, 제품 포트폴리오에서 기술의 진보 등이 2024-2030년의 예측 기간에 세계의 임상 진단 시장을 강화할 전망입니다.
임상 진단 시장 역학
임상 진단 시장은 심혈관질환, 당뇨병, 암 등 다양한 만성질환의 급증에 의해 현재 기세를 확대하고 있습니다.
2023년 발표된 국제당뇨병연맹(International Diabetes Federation)의 통계에 따르면 같은 해 5억 3,700만 명의 성인(20-79세)이 당뇨병을 앓고 있는 것으로 추정됩니다. 또한 이 통계는 2030년 당뇨병 환자가 6억 4,300만 명, 2045년까지 7억 8,300만 명으로 늘어날 것으로 예측했습니다.
임상 진단 검사는 모든 질병의 조기 진단에 결정적인 영향을 미치며, 나아가 적절한 관리에도 도움이 됩니다. 예를 들어 A1C 검사는 지난 2-3개월간의 평균 혈당치를 측정합니다. 검사 수치가 5.7% 미만이면 정상, 5.7-6.4%는 당뇨병, 6.5% 이상이면 당뇨병을 의미합니다.
또한 전 세계에서 암 환자가 증가함에 따라 임상 진단에 대한 수요도 증가하고 있습니다. 일반적으로 암의 조기 진단은 증상이 있는 환자를 가능한 한 빨리 발견하는 데 중점을 두어 더 나은 치료 가능성을 높입니다. 예를 들어 GLOBOCAN Observatory가 2020년에 발표한 데이터에 따르면 같은 해에 전 세계에서 약 1,930만 건의 새로운 암 사례가 보고되었습니다.
또한 COVID-19와 같은 바이러스성, 세균성, 진균성 질환과 같은 감염성 질환의 급증은 전 세계에서 임상 진단에 대한 수요를 증가시켜 예측 기간 중 시장을 촉진할 것으로 예상됩니다. 예를 들어 세계보건기구(WHO)가 2023년에 발표한 통계에 따르면 결핵은 13번째 사망 원인이며, COVID-19에 이어 두 번째로 많은 감염성 사망 원인입니다. 또한 2020년 전 세계에서 약 1,000만 명이 결핵에 걸릴 것으로 보고되고 있습니다. 따라서 전 세계에서 감염성 질환의 부담이 증가함에 따라 향후 수년간 임상 진단 시장의 성장을 가속할 가능성이 높습니다.
그러나 정확한 진단 검사 및 기기 개발의 어려움과 임상 진단 검사 장비의 높은 비용이 시장 성장을 저해하는 요인으로 작용하고 있습니다.
COVID-19 팬데믹은 초기에 다양한 의료 부문에 악영향을 끼쳤지만, 임상 진단 시장은 그대로 방치되어 있었습니다. 이는 COVID-19 진단을 늘리기 위한 정부 기관의 협력과 전략적 파트너십으로 인해 가능했습니다. 예를 들어 2020년 9월 28일 세계보건기구(WHO), 아프리카 질병통제예방센터(Africa CDC), 빌&멜린다 게이츠 재단(Bill & Melinda Gates Foundation), 클린턴 건강 접근 구상(Clinton Health Access Initiative, CHAI), 혁신적 신진단 재단(Foundation for Innovative New Diagnostics(FIND), Global Fund, Unitaid는 중저소득 국가에 고품질 COVID-19 항원 신속 검사를 제공하는 계약을 체결했습니다.
또한 COVID-19 검출을 위한 다양한 진단 키트가 승인된 것도 팬데믹 기간 중 임상 진단 시장을 빠르게 성장시켰습니다. 예를 들어 2022년 3월 17일 미국 식품의약국(FDA)은 Biofire Diagnostics, LLC에 SARS-CoV-2 호흡기 감염을 유발하는 미생물 및 기타 미생물의 호흡기 검체에서 핵산 표적을 검출하고 식별하는 다중 표적 검사에 대한 허가를 부여했습니다. 'BioFire Respiratory Panel 2.1(RP2.1)'의 판매 승인을 받았습니다. 이처럼 앞서 언급한 모든 요인들이 팬데믹 기간 중 임상 진단 시장의 성장에 기여했습니다.
세계의 임상 진단 시장에 대해 조사분석했으며, 시장 규모와 예측, 촉진요인과 과제, 기업과 제품 개요 등을 제공하고 있습니다.
Clinical Diagnostics Market By Type (Product Type [Instruments, Kits & Reagents], Services), By Test (Complete Blood Count, Metabolic Panel, Lipid Panel, Cancer Testing Panel, Liver Panel, Infectious Disease Testing, Others), By End-User (Hospitals, Pathology Labs, Clinics, And Others), by geography, is expected to expand at a significant CAGR till 2030 owing to the growing cases of various chronic diseases & infectious diseases across the globe and rise in integration of technological advancements in the product portfolio
The global clinical diagnostics market was valued at USD 70.11 billion in 2023, growing at a CAGR of 7.02% during the forecast period from 2024 to 2030. The escalating demand for clinical diagnostics is primarily attributed to the rising burden of various chronic disorders such as liver disorder, blood disorder, and cancer among others. In addition, an increase in the adoption of point of care clinical diagnostic tests, rising strategic business activities for establishing new clinical diagnostic labs, worldwide, and growing technological advancement in the product portfolio, among others are expected to bolster the global clinical diagnostic market during the forecast period from 2024-2030.
Clinical Diagnostics Market Dynamics:
The market for clinical diagnostics is gaining momentum at present owing to the surge in the cases of various chronic disorder such as cardiovascular disorder, diabetes, cancer, and others.
According to the International Diabetes Federation's statistics published in the year 2023, an estimated 537 million adults (20-79 years) were living with diabetes in the same year. Moreover, the stats also projected the diabetes cases to rise to 643 million by 2030 and 783 million by 2045.
Clinical diagnostic tests have a decisive impact in the early diagnosis of all kinds of diseases and further help in their proper management. For instance, the A1C test measures the average blood sugar level over the past 2 or 3 months. The test value below 5.7% is normal, between 5.7 and 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes.
Furthermore, the rising cases of cancer across the globe are also likely to increase the demand for clinical diagnosis. Early diagnosis of cancer generally increases the chances of an improved treatment by focusing on detecting symptomatic patients as early as possible. For instance, according to the data published by the GLOBOCAN Observatory in the year 2020, approximately 19.3 million new cancer cases were reported across the globe in the same year.
Additionally, the spike in infectious diseases such as viral diseases such as COVID-19, bacterial diseases, fungal diseases, among others is also expected to raise the demand for clinical diagnosis, worldwide thereby increasing the market during the forecasted period. For instance, according to the statistic revealed by the World Health Organization (WHO) in the year 2023, tuberculosis (TB) is the 13th leading cause of death and the second-leading infectious killer after COVID-19. Moreover, the data also reported that in the year 2020, about 10 million people fell ill with tuberculosis (TB) worldwide. Hence, the growing burden of infectious diseases across the globe is likely to drive the growth of the clinical diagnostics market in the upcoming years.
However, the challenges in the development of accurate diagnostic tests and equipment and the high cost associated with clinical diagnostic lab equipment are some of the factors likely to sluggish the market growth.
Although the COVID-19 pandemic had an adverse impact on various healthcare sectors during the initial phases but the market for clinical diagnostics remained untouched. This is owing to the collaborations and strategic partnerships among the governmental organizations to increase the diagnosis of COVID-19 infection. For instance, on September 28, 2020, the World Health Organization (WHO), the Africa Centres for Disease Control and Prevention (Africa CDC), the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative (CHAI), the Foundation for Innovative New Diagnostics (FIND), the Global Fund, Unitaid entered into an agreement to make available high quality COVID-19 antigen rapid tests to low and middle-income countries.
Moreover, approval of various diagnostic kits for the detection of COVID-19 infection also surged the market for clinical diagnostics during the pandemic. For instance, on March 17, 2022, the US Food and Drug Administration (FDA) granted marketing authorization to Biofire Diagnostics, LLC for "BioFire Respiratory Panel 2.1 (RP2.1)" a device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test. Thus, all the aforementioned factors contributed to the growth of the clinical diagnostic market during the pandemic.
Clinical Diagnostics Market Segment Analysis:
Clinical Diagnostics Market By Type (Product Type [Instruments, Kits & Reagents], Services), By Test (Complete Blood Count, Metabolic Panel, Lipid Panel, Cancer Testing Panel, Liver Panel, Infectious Disease Testing, Others), By End-User (Hospitals, Pathology Labs, Clinics, And Others), and By Geography (North America, Europe, Asia-Pacific, and Rest of the World).
In the test segment of Clinical Diagnostics market, the cancer testing panel is expected to hold a significant market share in the year 2023. The rising incidence of various cancers such as prostate cancer, lung cancer, and stomach cancer among others is likely to increase the demand for various tests available in the cancer testing panel, thus increasing the overall segment market. For instance, as per the WHO 2022 report, there were an estimated 2.21 million lung cancer cases were diagnosed in the year 2020. Moreover, as per the same data source, lung cancer affected approximately 2.21 million cases, globally in the year 2020.
In addition, various cancer tests obtaining reimbursement or insurance coverage could also be a potential factor driving the market for cancer testing panels. For instance, on January 01, 2020, ipsogen JAK2 DX reagent (a gene testing kit that measures the JAK2V617F mutation1 quantitatively, was used in the diagnosis of certain hematopoietic tumors generally referred to as blood cancers, specifically polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF)) developed by Sysmex Corporation obtained health insurance coverage and became Japan's first diagnostic aid for PV, ET, and PMF to be covered.
Moreover, companies collaborating to develop new blood-based cancer detection test would also increase the adoption of cancer detection tests among the population as they are non-invasive tests for detecting cancer, thereby augmenting the segmental market growth. For instance, in May 2022, Singaporean molecular diagnostic company Tzar Labs in collaboration with India-based Epigeneres Biotechnology has developed a new blood-based test to identify and categorize solid tumors, hematological malignancies, and sarcomas according to their stage.
Thus, all the above-mentioned factors are likely to upsurge the market for cancer detection panels in clinical diagnostics.
North America is expected to dominate the overall Clinical Diagnostics Market:
Among all the regions, North America is expected to hold a major share in the overall clinical diagnostics market in the year 2023. This domination is owing to the growing prevalence of various ailments such as infectious diseases, chronic disorders, deficiency disorders, and others in the region. In addition, rising product approvals, growing focus on R&D activities by the key manufacturers for developing and launching various clinical diagnosis products, and rising government initiatives in the region for promoting wider adoption of point-of-care clinical diagnosis methods, among others are the factors responsible for the growth of North America clinical diagnostic market.
For instance, as per the data published by the Centers for Disease Control and Prevention (CDC) in the year 2020, approximately 24.6% (61 million) of adults had 1 chronic condition, and 27.2% (68 million) had >=2 chronic conditions in America in the year 2018.
Also, increasing lifestyle-associated disorders such as obesity, hypertension, among others could increase the market for clinical diagnoses in the country. According to the CDC 2020 report, the age-adjusted prevalence of obesity among U.S. adults was 42.4% from 2017 to 2018.
Furthermore, companies scaling up laboratory testing by launching new products would also increase the clinical diagnostic market in the country.
For instance, on May 04, 2022, Beckman Coulter, a clinical diagnostics leader, launched the DxA 5000 Fit, a workflow-automation solution designed to fit into medium-sized labs that run fewer than 5,000 tests a day.
Moreover, as per the US Department of Health and Human Services (HHS) press release in the year 2023, the US government had invested USD 650 million in rapid diagnostic testing in the latest action to increase access to tests.
Thus, all the above-mentioned factors are likely to increase the market for clinical diagnostics in the region during the forthcoming years.
Clinical Diagnostics Market Key Players:
Some of the key market players operating in the Clinical Diagnostics market include Abbott, BD, bioMerieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Siemens AG, Hologic, Inc., Qiagen NV, Quest Diagnostics Inc., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Sysmex, Sonic Healthcare Ltd, Exact Sciences Corporation, NeoGenomics, Inc., BioReference Laboratories, Laboratory Corporation of America® Holdings, DiaSorin, PerkinElmer Inc., FUJIFILM Corporation, and others.
Recent Developmental Activities in the Clinical Diagnostics Market:
On July 26, 2022, Beckman Coulter, a global clinical diagnostics leader, entered into definitive agreements with Quidel Corporation to obtain all rights related to the manufacture, distribution, and sale of a BNP assay for Beckman Coulter analyzers. Under the terms of the agreements, Quidel will continue to manufacture and supply certain components to Beckman Coulter related to the assay, and Beckman Coulter will exclusively manufacture and sell to customers the BNP assay currently sold as TRIAGE® BNP by Quidel, under the brand name Access BNP.
On April 13, 2022, Ortho Clinical Diagnostics, one of the world's largest in-vitro diagnostics companies received CE Marking for its VITROS® SARS-CoV-2 Antigen Test.
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.
Key Takeaways from the Clinical Diagnostics Market Report Study
Target Audience who can be benefited from the Clinical Diagnostics Market Report Study
Frequently Asked Questions for the Clinical Diagnostics Market:
Clinical diagnostic is a process of identifying a disease or a condition based on the signs and symptoms of a patient by physical examination or lab test. Clinical diagnostics may include a variety of tests such as lipid panel tests, blood tests, cancer tests, among others
The global Clinical Diagnostics Market was valued at USD 70.11 billion in 2023, growing at a CAGR of 7.02% during the forecast period from 2024 to 2030.
The major factors driving the demand for Clinical Diagnostics are the rising burden of various chronic disorders such as liver disorders, blood disorders, and cancer among others. In addition, an increase in the adoption of point of care clinical diagnostic tests, rising strategic business activities for establishing new clinical diagnostic labs, worldwide, and growing technological advancement in the product portfolio, among others are expected to bolster the global clinical diagnostic market during the forecast period from 2024-2030.
Some of the key market players operating in the Clinical Diagnostics market include Abbott, BD, bioMerieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Siemens AG, Hologic, Inc., Qiagen NV, Quest Diagnostics Inc., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Sysmex, Sonic Healthcare Ltd, Exact Sciences Corporation, NeoGenomics, Inc., BioReference Laboratories, Laboratory Corporation of America® Holdings, DiaSorin, PerkinElmer Inc., FUJIFILM Corporation, and others.
Among all the regions, North America is expected to hold a major share in the overall clinical diagnostics market during the forecasted period. This domination is owing to the growing prevalence of various ailments such as infectious diseases, chronic disorders, deficiency disorders, and others in the region. In addition, rising product approvals, growing focus on R&D activities by the key manufacturers for developing and launching various clinical diagnosis products, and rising government initiatives in the region for promoting wider adoption of point-of-care clinical diagnosis methods, among others are the factors responsible for the growth of clinical diagnostic market.