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Global Pathology Industry Report


Pathology involves the study of the damaging impact of disease on cells and tissues and the way in which the body seeks to protect and repair itself. The pathology sector is a part of the global pharmaceutical industry and can be divided into two main branches, namely clinical and anatomic.


1) Clinical pathology involves the analysis of bodily fluids to diagnose disease through laboratory testing. Pathologists study aspects of disease such as its cause, the way in which it develops, how disease changes cells and the clinical manifestations of this change. Chemical pathology involves biochemical testing of any bodily fluid, most commonly plasma or serum. This segment incorporates endocrinology, which is the study of endocrine gland cells and the tissues that produce them, immunology, and pharmacology, the study of drugs. In the branch of cytogenics pathologists study cells, particularly chromosomes. Cytogenetics has been used to study conditions such as Down syndrome. The Global Down Syndrome Foundation estimates Federal research funding was at $22 million in 2010.


Medical microbiology involves the analysis of microorganisms such as parasites, bacteria and viruses. This discipline provides information on how pathogens invade a host and the way in which the body protects itself. This allows medical professionals to determine how to best facilitate the immune system’s natural defense to heal infection. Advances in the field have led to vaccination against diseases such as tuberculosis. The discipline of medical microbiology includes the study of HIV. The Henry J. Kaiser Family Foundation reports 2011 federal spending on HIV/AIDS activities amounts to more than $20 billion in the US and almost $7 billion globally. With the World Health Organization estimating over 33 million people living with HIV in 2009 and close to 2 million deaths from AIDS, governments are likely to continue investing in pathology research into the disease.


2) The other main branch of pathology apart from clinical pathology is anatomic pathology, which involves the diagnosis of disease through laboratory analysis of the body. Anatomic pathology includes such fields of study as cytopathology, forensic pathology and surgical pathology. Forensic pathologists carry out autopsies on bodies to determine cause of death, disease or injury. It is a common practice in legal and criminal procedures and is often used to determine the circumstances of a person’s death.


Cytopathology involves the cellular study of disease and includes the screening process known as a pap smear, which is used to test for early signs of cervical cancer. Surgical pathology involves the analysis of biopsies and surgical resections. The former consists of removing a sample from a patient to make a diagnosis based on small structures to determine the presence of a tumor, and whether it is benign or malignant, in the treatment of cancer. Biopsy analysis is carried out to diagnose and treat other diseases such as those stemming from infection and inflammation. A surgical resection involves removing a diseased organ from a patient to avoid its continued damage to the body or its spreading to healthy surrounding organs.


Pathology Product Launches (2010)


New Mechanism Other Brands
Actemra® rheumatoid arthritis Ablavar® blood-pool agent
Egrifta™ lipodystrophy Actoplus Met®XR type 2 diabetes
Ella® emergency contraceptive Beyaz-28™ oral contraceptive
Gilenya™ multiple sclerosis Cysview™ imaging agent for bladder cancer
Halaven™ breast cancer Duet DHA™Balanced prenatal vitamins
Prolia™ osteoporosis Dulera® asthma
Provenge® prostate cancer Ilotycin® antibiotic
Victoza® diabetes Iprivask™ thrombosis
Vpriv® Gaucher disease Jalyn™ BPH
Existing Mechanism Kombiglyze™XR type 2 diabetes
Xgeva™ bone metastases Lo Loestrin™FE oral contraceptive
Fanapt® schizophrenia Lumizyme® Pompe disease
Jevtana® prostate cancer Menveo® meningococcal bacteria
Livalo® cholesterol Mirapex®ER™ Parkinson's disease
Natazia™ oral contraceptive MuGard™ chemotherapy oral protectant
Pradaxa® thrombosis Prevnar 13® pneumonia
Xeomin® muscle activity Quadramet® bone metastases
Orphan Tekamlo™ hypertension
Ampyra® multiple sclerosis, walking ability Tozal® macular degeneration
Folotyn® T-cell lymphoma (CTCL) Tribenzor™ hypertension
Istodax® T-cell lymphoma (CTCL) Vimovo™ osteoarthritis pain
Kalbitor® angioedema Zyclara® skin irritation
Zortress® renal cell carcinoma Zyprexa®Relprevv™ schizophrenia


Source: IMS Institute for Healthcare Informatics, The Use of Medicines in the United States: Review of 2010



Market Segments


Sub segments of clinical pathology include hematopathology, chemical pathology, cytogenics, and medical microbiology. Hematopathology deals with hematopoietic cells, which emanate from bone marrow and are involved in the production of blood cells such as platelets, red blood cells and white blood cells. When disease takes root within the hematopoietic network it can be detected and analyzed from a rise or fall in any of these cells. Hematopathologists study blood cells, bone marrow, lymph nodes, and biopsies to diagnose diseases such as lymphatic cancer and leukemia.



Pathology Industry Leaders


  • Headquartered in California, Aperio provides digital pathology solutions for research, analysis, diagnostics and archival of pathology information. The company’s ScanScope is a system for the scanning of digitized glass slides to make high-resolution color digital slide images of glass slides. Aperio also offers Spectrum, a tailor-made management system for web-based digital pathology. Spectrum allows viewing of digital slides, conferencing, archiving, retrieval and analysis of image data. Spectrum also facilitates access by multiple users in multiple locations.


  • Arizona-based Ventana Medical Systems Inc provides tissue-based diagnostic systems, in particular cancer testing from slides. In 2010 Ventana acquired Biolmagene to offer improved image analysis and data management. Ventana’s digital pathology solutions are used in clinical laboratories, hospitals, and pharmaceutical and biotech companies worldwide. Its products include iScan Coreo Au, a whole-slide scanner, and Virtuoso, a web-based software application used with iScan Coreo Au offering remote viewing, online conferencing, reporting and image analysis. The company equally sponsors PathXchange, a global online community for pathologists.



Digital Pathology


Substantial advances in pathology are being facilitated by the industry’s digitization. Pathologists are increasingly adopting digital pathology practices for speed, ease and cost reduction. Digital pathology represents a dynamic growth sector within the pathology industry. Through imaging pathologists can acquire and analyze pathology data from digitized glass slides. Slides are magnified 20, 40 or 100 times and digital equipment allows several pathologists to view and annotate the same slide from several sites simultaneously.



Leading Industry Associations




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