The global anatomic pathology market size was valued at USD 19.39 billion in 2022. It is estimated to reach USD 45.27 billion by 2031, growing at a CAGR of 9.88% during the forecast period (2023–2031).
Anatomic pathology is a vast field comprising subdomains of cytopathology, gastrointestinal pathology, gynecological pathology, musculoskeletal pathology, renal pathology, dermatopathology, and others, as well as immunohistochemistry, in-situ hybridization, molecular pathology, electron microscopy, and flow cytometry. Anatomic pathological procedures study the effect of abnormalities in the structure of body organs, which can assist in diagnosing tumor prognosis and managing disease treatment. Anatomic pathology techniques are also valuable in evaluating other disorders, such as autoimmune diseases and liver and kidney diseases. Anatomic pathology differs somewhat from clinical pathology (also known as laboratory medicine), which is concerned with measuring the chemical components of blood and other body fluids, analyzing blood cells, and identifying microbes. Anatomic pathology is further divided into two sub-divisions: histopathology and cytopathology.
Clinically useful biomarkers are used to develop diagnostic tests and therapeutic drugs. Pathological laboratories can rely on these biomarkers to detect and track infections and disease progression during diagnostic procedures. Hence, biomarkers are gaining ground as diagnostic and prognostic markers. They are used to extract critical information related to the pathogenesis of the disease. Therefore, pathologists can use biomarkers in their anatomic activities to form foundation data to guide them in treatment planning. For instance, in the case of colon cancer, diagnostic biomarkers used in anatomic pathology aid a better understanding of the pathways of colon carcinogenesis and help detect both sporadic and hereditary colon cancer.
The role of biomarkers in pathological actions is also employed for improving precision medicine using predictive biomarkers. This is further aided by advancement in whole genome sequencing, which supplements highly accurate diagnostics and treatment. Moreover, biomarkers associated with cancer detection also help determine the composition of combination drugs for each patient. Therefore, rapid advancements in anatomic pathology, development of future biomarker assays, and validation are also essential to ensure accurate diagnosis, boosting the overall market growth.
The burden of chronic diseases is continuously rising along with rapid urbanization worldwide, the primary factor contributing to market growth. According to WHO, cancer is the leading cause of death globally, with around 9.6 million deaths recorded in 2018. The number of cancer cases diagnosed is anticipated to rise by about 70% over the following two decades. Africa, Asia, and Central and South America account for nearly 60% of cancer deaths worldwide, and more than 60% of new cancer cases are diagnosed annually in similar regions. On the other hand, the number of cancer survivors is increasing due to improvements in early diagnosis and treatment options. In January 2014, the number of cancer survivors in the U.S. was 14.5 million and was estimated to increase to around 19 million by 2024. This indicates the enormous scope of expansion in diagnostic methods for various types of cancers, driving the market growth.
Research laboratories and hospitals involved in pathology practices are subjected to laws and regulations about the safety and privacy of particular healthcare & personal information and test results. Guidelines laid by the Centers for Medicare & Medicaid Services (CMS), College of American Pathologists (CAP), and the Food and Drug Administration (FDA) predominantly regulate anatomic pathology activities in the labs. For instance, CMS is responsible for supervising clinical labs and their testing services and ensures that labs comply with the guidelines of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. These federal and state laboratory regulations aim to ensure the safety and accuracy of laboratory-developed tests. The presence of stringent regulatory guidelines about ongoing laboratory practices has impeded the growth of this space.
Several pathology-training programs are being organized or delivered by universities, public authorities, and private academic institutions. For instance, the fellowship examination in the Royal College of Pathologists (FRCPath) initiated the UK pathology training assessment. FRCPath examination evaluates a candidate'scandidate's training program, professional development, practicing, and possible entry into independent practice. This examination also contributes to the Certificate of Completion of Training (CCT) award that marks an endpoint of a defined specialist or specialty training program, which indicates an individual'sindividual's eligibility to work as a National Health Service (NHS) consultant.
Furthermore, several initiatives adopted by government authorities and universities in the form of conferences also aid market growth. For instance, in May 2021, the College of American Pathologists (CAP), in partnership with the Association for Pathology Informatics (API) and the American Society for Clinical Pathology (ASCP), published an updated guideline for Validating Whole Slide Imaging for Diagnostic Purposes in Pathology. This aims to support the rapidly advancing clinical applications of digital pathology and whole-slide imaging. Therefore, many training programs led by public and private entities increase awareness about proper training modules, fueling the market growth.
The global anatomic pathology market is segmented by product and service, application, and end-user.
Based on product and service, the global market is divided into instruments, consumables, and services.
The consumables segment is responsible for the largest market share and is anticipated to grow at a CAGR of 9.69% over the forecast period. Consumables are used in every anatomic pathology process and a range of general laboratory consumables aid in the routine laboratory workflow. The low cost and easy availability of pathology consumables are significant factors that contribute to the maximum share of this segment. Furthermore, high awareness about pathology techniques, an increase in the prevalence of chronic disorders, and a rise in the geriatric population are drivers of pathological methods, which consequently boost the uptake of consumables. The segment comprises reagents, kits, assays, antibodies, probes, and other consumables such as disks, forceps, blades, and slides.
Anatomic pathology instruments are designed to automate laboratory workflow, which reduces and saves time and delivers accurate results. Anatomic pathology instruments are high-quality equipment that ranges from microtomes to embedding stations, cryo-tomes, slides, cassette printers, and more. Key players deliver engineered and innovative designed instruments to efficiently manage to advance pathology applications while maximizing laboratory safety, space requirements, and ergonomics. For instance, in November 2018, Sakura Finetek USA, Inc. launched Tissue-Tek TEC 6 Embedding Console System, a highly reliable, comfortable, and user-friendly embedding system making histology processes faster and more efficient.
Based on application, the global market is segmented into disease diagnosis, drug discovery and development, and others.
The disease diagnosis segment owns the highest market share and is expected to grow at a CAGR of 9.68% over the forecast period. Anatomic pathology methods are employed to visualize disease from tissue or cell specimens, where pathologists inspect cells in suspected organs followed by analyzing changes and abnormalities. By understanding the symptoms and changes in the patient's cells, pathologists are able to reach a diagnosis and develop the best treatment plan. For instance, in cancer diagnosis, individualized, targeted therapy is the ongoing trend in disease treatment, stimulated by the involvement of anatomic pathologists who analyze tissue samples under the microscope. The rising prevalence of chronic conditions, like cancer, and the surging geriatric population are the major factors driving the anatomic pathology market for disease diagnosis.
Drug development from bench to bedside needs several technologies and methods to bring a particular molecule onto the market. As a result, anatomic pathologists study cellular and tissue response mechanisms to injuries or medical conditions, which play an essential role in bringing proper drugs to the market, thereby influencing segment growth. In addition, developing new pharmaceutical regulatory approvals demonstrates drugs' therapeutic efficacy and safety.
Based on end-user, the global market is bifurcated into hospitals, research laboratories, diagnostic laboratories, and others.
The hospital segment is the highest contributor to the market and is estimated to grow at a CAGR of 9.55% during the forecast period. Anatomic pathologists operating in hospitals investigate the effects of disease progression on the human body via microscopic examination of tissues or cell specimens and autopsies. In addition, anatomic pathologists in various settings, such as inpatient hospitals and emergency centers, deliver comprehensive anatomic pathology services. Hospital-based anatomic laboratories possess high sunk costs concerning staffing and equipment and hold excess capacity for revenue-generating services, such as cardiology and surgery. Moreover, hospital-based laboratories continuously increase their in-house testing volumes and improve outreach programs to attract community physicians.
Research laboratories deliver a comprehensive range of diagnostic services to patients with high-quality diagnostic accuracy and personalized services to clients. The College of American Pathologists (CAP) accredits these laboratories globally for development in pathology practice and laboratory medicine. Research laboratories hold a substantial share of the anatomic pathology market owing to many ongoing clinical studies, governmental programs, and entities related to anatomic pathology from governmental agencies and initiatives adopted by key vendors.
Based on region, the global anatomic pathology market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant shareholder in the global anatomic pathology market and is anticipated to grow at a CAGR of 8.27% during the forecast period. The presence of supportive public agencies focusing on pathology services in this region is attributed to the market growth. The growing implementation of digital pathology services with advanced imaging tools, increasing activities by various organizations, rising awareness about regular health screening, and favorable government reimbursement policies are other drivers of the North American market. In addition, the region's approvals and commercialization of products have supplemented the market growth. For instance, in May 2021, Hologic Inc. received premarket approval (PMA) from the U.S. FDA for ThinPrep Genesis Processor. This instrument offers a combination of sample aliquoting and cytology processing with improved workflow. The increasing number of regulatory approvals is expected to boost revenue generation. Moreover, operating service providers are undertaking various strategic initiatives to expand their presence in the market. Also, the North American anatomic pathology market is highly competitive due to the presence of well-established players, such as Cardinal Health, Agilent Technologies, Quest Diagnostics Incorporated, and others.
Europe is estimated to grow at a CAGR of 10.12% over the forecast period. Meetings and partnerships initiated by private entities increase pathology awareness in the European region, promoting market growth. Several national pathology societies regulate Anatomic pathology in Europe, among which the European Society of Pathology (ESP) is the key international organization. The ESP encourages young pathologists and promotes anatomic pathology practices by organizing numerous seminars and meetings with collaborations and partnerships, the primary factor boosting the regional market. In addition, the European market is expected to grow owing to the rise in the aging population coupled with an increase in access to healthcare. In August 2021, Unilabs, a Swiss company, in collaboration with Ibex Medical Analytics, announced the launch of a new AI-powered digital pathology platform across 16 European countries. Such initiatives are expected to boost market growth.
Asia-Pacific is expected to exhibit a high growth rate concerning anatomic pathology products and services. With two-thirds of the world's population, improving economies in this region and growing demand for testing are expected to boost market growth over the forecast period. Further, the presence of several organizations engaged in promoting knowledge for local and international audiences in various Asian nations attracts global companies to invest in this region. For instance, the 6th Digital Pathology & AI Congress: Asia is expected to be held in April 2022 in South Korea. This meeting aims to increase the implementation of digital pathology to enhance workflow efficiency and standardization of image analysis. In addition, the 9th Asia Pacific Pathology Congress will be held in November 2021. This conference will focus on improving the novel approach in pathology against SARS-CoV-2. Such conferences are expected to increase the adoption of advanced tools in the Asia-Pacific region.
Shifting preferences to implement many clinical trials by crucial companies in the Latin America region is propelling the regional market growth. The pharmaceutical industry in Latin America is witnessing developments and holds great potential due to the region's competitive costs compared to the U.S. and European nations. The regional distribution of clinical trials is shifting from developed to developing countries, attracting large pharmaceutical companies toward this region. Latin America and the Caribbean (LAC) report the highest incidence and mortality rates of cervical cancer. Therefore, the high burden of cervical cancer and the increase in the number of conference meetings conducted across countries in this region are factors expected to help address the problems and develop solutions in the field of cytology. Several initiatives by market players, such as collaborations, mergers, product development, and partnerships, are likely to drive the market.
The Middle East and Africa's anatomic pathology market is expected to exhibit the lowest growth, as this industry is nascent in the region. However, several initiatives adopted by pathology service providers and other related companies attract pathologists and customers with low awareness related to pathology. For instance, in October 2017, the National Reference Laboratory (NRL), one of the largest laboratory healthcare networks accredited by the College of American Pathologists, organized a training program associated with laboratory inspectors training in the Middle East. NRL works with LabCorp and operates through eight CAP-accredited laboratories in the Middle East.
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