About In Vitro Diagnostics 2018
EuroScicon warmly welcomes experts around the globe to attend its much-awaited International Conference on In Vitro Diagnostics (In Vitro Diagnostics -2018), to be held on September 03-04, 2018, London, UK. This conference is based on the theme “In Vitro Diagnostics: Current trends, future challenges and opportunities”.
In Vitro Diagnostics Conference -2018 brings together the experts from both industry and academia associated with Invitro Diagnostics (IVD), Molecular Diagnostics, Companion Diagnostics, Point of Care Diagnostics/ Testing (POCT) and associated regulatory matters, R&D and Technology transfer etc.
This In Vitro Diagnostics Congress comprises of Plenary sessions, Panel discussions, Round table discussions and Q&A Rounds, Oral presentations, Poster Presentations, Workshops/Symposiums, Young Researcher Forums to discuss the current trends, challenges, regulatory matters and future opportunities in the arena of Invitro Diagnostics Devices (IVD).
Who Should Attend
In Vitro Diagnostics Conference 2018 Rome, Italy provides an international platform for experts working in the field of Invitro Diagnostics (IVD), Companion diagnostics, Point of care diagnostics/ testing (POCT). In Vitro Diagnostics 2018 welcomes In Vitro Diagnostics Device (IVD) manufacturers (IVD), technology providers, vendors, suppliers, regulatory authorities and regulatory service providers, companies in the segments of IVD and PCOT, and Laboratory as well as academic experts in the areas of In Vitro Diagnostics, Point of Care Diagnostics and Companion Diagnostics.
Professionals from Hospitals, Laboratories and Academics:
Directors, Deans, Research Professionals, Laboratory heads, Lab managers, Lab technicians, Medical/ Biomedical scientists, Professors, Associate Professors, Assistant Professors, Research Fellows working in the arena of In Vitro Diagnostics and its applied fields, but not limited to:
Industry partners and professionals in the arena of :
Top USA In Vitro Diagnostics (IVD) Companies:
Johnson & Johnson (J&J)
Thermo Fisher Scientific
Top Europe In Vitro Diagnostics (IVD) Companies:
Top Japan In Vitro Diagnostics (IVD) Companies:
Top Global Emerging In Vitro Diagnostics (IVD) Companies
Dako (Agilent Technologies)
Laboratory Corporation of America (LabCorp)
In Vitro Diagnostics (IVD)
are the medical devices, accessories, instruments, reagents and systems deployed to perform medical test on samples (e.g., blood, urine and tissue taken from human body) to diagnose diseases, detects infections, diagnose medical conditions
, monitor drug therapies, prevent diseases. Some tests usually performed in authorized laboratories by the trained healthcare professionals and some tests can be done at home.
Devices may range from simple tests to sophisticated DNA technology including calibrators, control materials, kits, reagents, software, or related instruments. IVD
is an important segment in the global healthcare industry. The marketplace is witnessed rapid growth supported by advancements in technologies, evolvement of new tools, improvement in disease monitoring, higher demand of OTC
tests, increased prevalence of infectious and other diseases like oncology, cardiovascular etc. IVD
products are classified into Class I, III and III by FDA regulations to assure their safety and effectiveness.
Point-of-care testing (POCT)
are the medical tests that are performed by trained healthcare professionals at or near the site of patient. Main POCT
s include blood and urine tests. POCT
is aimed to collect specimen and get accurate results in a very short span of time. POCT
s are mainly used in primary care, secondary care and community care based settings. POCT
are performed via portable instruments such as blood glucose meter, blood gas, pH, electrolyte, metabolite and haemoglobin measurement meters.
A Companion Diagnostic
is a medical device/ diagnostic test/ imaging tool, used companion to drugs, provides information regarding the applicability of drug or biologics to a specific person. It helps the healthcare professionals to determine whether the product will be beneficial to the patients or will have any risks or side effects.
is a collection of various techniques that are used to analyse biological markers in the proteome and genome and how their cells expressed the genes by the application of molecular biology to genetic testing. Globally the use of Molecular diagnostics
growing rapidly. Major clinical applications are in the areas of oncology, Infectious disease
, genetic diseases, pharmacogenomics, human leukocyte antigen typing; and coagulation.
Last five decades has seen a tremendous growth in immunodiagnostics tests and it emerged as a potential diagnostic technique. The radioimmunoassay and Enzyme Linked Immunosorbent Assay (ELISA
) were the predominant techniques during the initial era of immunodiagnostics.
Noninvasive prenatal testing (NIPT)
, Liquid biopsy, Next-generation sequencing (NGS
), and circulating tumor cell (CTC
) tests etc. are considered as the future of the In Vitro Diagnostics (IVD
). These areas of the IVD
market is expected to witness a rapid growth in coming few years. In coming five years, the cost of NGS test will rise from $250 million to $800 million with the total number of NGS
sales only rise from 100 million to 300 million.
Though globally, the growth of IVD
market is stagnant, it is predicted that NIPT will grow at a rate of 20% in USA and even more in abroad. Other future IVD
devices include point of care biochemistry analyser (eg. Abbott i-STAT) blood gas analyser (eg. biosurfit spinit), immunology, haematology, and clinical chemistry analyser (eg. Acon Blood Glucose, Total Cholesterol, Cholesterol 3-1, Haemoglobin Meters and Hemoccult), and FOB test.
The US Food and Drug Administration (FDA) is involved in the regulation of IVD
s or laboratory tests after the inception of the Medical Device Amendments of 1976. According to the guidelines of the FDA, IVD
products are classified into Class I, II, or III which is based on the level of regulatory control that is essential to ensure the safety and effectiveness of devices.
The Code of Federal Regulations liststhe classification of existing IVD
s in 21 CFR 862, 21 CFR 864, and 21 CFR 866. CLIA '88 is responsible for the quality standards of laboratory testing and an accreditation program for clinical laboratories. In the EU market, the In Vitro Diagnostics Directive (IVD
D) 98/79/EC is the main regulatory requirements that medical device manufacturers comply with to get a CE marking in their products.
As one of the fastest-growing areas of In Vitro Diagnostics
testing to become an $8 billion market in 2018, an indepedent firm expects. It is not surprising that the most strenuous efforts in medical science are aimed at the number two killer disease. Oncology
killed more than 7 million people worldwide in 2010, which is more than AIDS, masslaria, and tuberculosis combined. It is second heart leading disease-causing death across the globe. Oncology
is a branch of medicine that works with the prevention, diagnosis, and treatment of cancer.
, also known as transmissible disease or communicable disease. Infections are caused by infectious agents including viruses, viroids, prions, bacteria, nematodes such as parasitic roundworms and pinworms, arthropods such as ticks, mites, fleas, and lice, fungi such as ringworm, and other microparasites such as tapeworms and other helminths. Infectious diseases
are disorders that are caused by various organisms like bacteria, viruses, fungi or parasites.
They are transmitted through contaminated foods and through physical contacts. Infectious diseases
such as hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Herpes Simplex Virus (HSV), tuberculosis, measles, dengue, Chagas, cholera, and malaria are increasing across the globe, mostly in developing countries.
Medical Device defined as a device which, whether used alone or in combination for the in-vitro examination of specimens derived from the human body solely or principally to give information for diagnostic, monitoring or compatibility purposes. Biomarkers
can be a substance used for examining organ function and condition.
There are two major types of Biomarkers
: biomarkers of exposure, that are used in risk prediction, and biomarkers of disease, that are used in screening, diagnosis and monitoring of disease progression. Biomarkers
are used for personalized medicine are typically categorized as either prognostic or predictive.
(CVD) is a class of infections that include the heart or veins. Cardiovascular
sickness incorporates coronary corridor infections (CAD, for example, angina and myocardial dead tissue (usually known as a heart assault). Different CVDs incorporate stroke, heart disappointment, hypertensive coronary illness, rheumatic coronary illness, cardiomyopathy, heart arrhythmia, inherent coronary illness, valvular coronary illness, caritas, aortic aneurysms, fringe corridor sickness, thromboembolic infection, and venous thrombosis.
, is likewise knows as diabetes mellitus, is a gathering of metabolic issue where high glucose levels over a drawn-out period found. Side effects of high glucose incorporate regular pee, expanded thirst, and expanded appetite. They are two sorts of diabetes: Type1DM, comes about because of insulin inadequacy, and Type2DM, comes about because of insulin protection and gestational diabetes that outcomes from pregnant ladies with medicinal history of diabetes. Prevention and treatment involve maintaining a healthy diet, regular physical exercise, a normal body weight, and avoiding tobacco use.
Traditional biosensors like glucose meters and glycohemoglobin test kits are commonly used for In Vitro Diagnosis
of the disease and long-term management of diabetes. The increasing prevalence of diabetes and the demand for the diagnostic tests helps to drive the market and to go for new R&D in this sector to develop innovative products.Other Point of Care Tests
such as HbA1c are preferred due to their capability of Rapid Diagnosis
and management of diabetes with a reduced cost.
is a biochemical test that measures the nearness or convergence of a macromolecule or a little particle in a solution using a counter acting agent (for the most part) or an antigen (some of the time). The particle identified by the Immunoassay
is frequently alluded to as an "analyte" and is much of the time a protein, although it might be different sorts of atoms, of various size and sorts, if the best possible antibodies that have the sufficient properties for the test are created.
Analytes in organic fluids, for example, serum or pee are oftentimes measured utilizing Immunoassays
for restorative and research purposes. Some Immunoassays
are simply carried out by mixing the reagents and sample and making a physical measurement. This kind of Assays
are called homogenous Immunoassays
or less frequently non-separation Immunoassays
is a claim to fame of pharmaceutical and paediatrics that frets about the kidneys: the investigation of ordinary kidney capacity and kidney issues, the conservation of kidney wellbeing, and the treatment of kidney issues, from eating routine and medicine to renal substitution treatment (dialysis and kidney transplantation).
Fundamental conditions that influence the kidneys, (for example, diabetes and immune system malady) and foundational issues that happen in view of kidney issues, (for example, renal osteodystrophy and hypertension) are additionally examined in nephrology. A doctor who has attempted extra preparing to wind up plainly a specialist in nephrology may call themselves a nephrologist or renal doctor.
History and physical examination are diagnostic workup in Nephrology
. This may include inquiries regarding family history, general medical history, diet, medication use, drug use and occupation. Examination typically includes an assessment of volume state, blood pressure, skin, joints, abdomen and flank.
IVD Market Overview
In Vito Diagnostics Devices (IVD) Market:
The In Vitro Diagnostics Devices (IVDs) are one of the major segment in the healthcare industry globally. The IVD market place witnessed a rapid growth propelled by the better and newer diagnostic tools, evolvement of new technologies, improved disease monitoring, and readily available with increased demand of Point of Care Diagnostic Tests (POCTs), increased ageing population, rising of chronic, infectious and other lifestyle related diseases, and increasing healthcare expenditure. Moreover, the IVDs have added a significant value to the overall disease diagnosis, treatment process and healthcare industry. The IVD segment is also positively supported by the funding agencies like NIH, NHR, NHS Trust, WHO etc to offer novel diagnostic modalities. Uncertainty in the regulatory landscape remained a big challenge in the IVD industry. In our In European Vitro Diagnostics-2018 Conference, the experts will discuss thoroughly regarding these issues and will pave a way, how to comply with these regulatory issues to ensure the fulfilling of growing market demands of IVDS, PCOTs and Companion Diagnostics.
The global In Vitro Diagnostics (IVD) industry is under pressure because of incorporation of multi-disciplinary capabilities in chemistry, biology, and computational power that companies can leverage to develop new solutions to diagnose, treat and manage chronic diseases like cancer, diabetes and other cardiovascular diseases. There is a huge pressure on companies to build new competencies in product development, manufacturing and distribution of new technology platforms such as point-of-care molecular diagnostics and capture new growth opportunities in the precision medicine market. With the increased demand of IVDs, the re imbursement strategy is now a big challenge for the IVD companies in the western world. The rapid adaptation of Next Generation Sequencing (NGS) platforms, Liquid biopsies, Companion Diagnostics applications will rapidly drive the market in future.
As per a report the global revenues of IVD market will grow from $62bn in 2016 to $123bn by 2027 with a CAGR of 6.4% during the forecasted period. The major segments fuelling the growth include, Point of Care (POC) tests, Clinical Chemistry, Immunochemistry, Haematological Diagnostics, Microbiological applications and Genetic Testing.
The US, Japan and China remained were remained the top three markets of In Vitro Diagnostics in 2015 and will retain the same place till 2026, while India will be the fastest growing market during the same period and will be very close to China.
The European IVD market was worth $12.51Bn in 2015 and is expected to hit about $15.5Bn by 2024. This increase in market is attributed to the increased demand of promising and novel diagnostics technologies, increased numbers of geriatric population and increasing awareness among the population regarding the early diagnosis of life threatening diseases.In Europe, individuals aged 65 and above are expected to rise in number from 18.5% in 2014 to 28.7% of the total population, by the year 2080.
The Molecular Diagnosis market contributes a major share in the IVD space. Among all the countries, USA captured the major market in Molecular Diagnosis (43%), followed by Europe (24.8%), China (9.3%), and Japan (6.9%).
As per a report of European Diagnostic Manufacturers Association (EDMA), The revenues from IVD market in Europe (four largest European market) remained stagnant during 2007 to 2015 except Germany. In 2015, revenues increase 0.5% to reach €10,543M which was below the revenues of 2009 (€10,685). Though, the overall IVD revenues in Germany remained stagnated, modest growth observed in Germany (+1%). The growth has been observed in microbiology +2.2% and immunochemistry +2,5%. During the same period, the UK experienced the negative growth of -2.9% due to reduction in the cost of reagents mainly in Clinical Chemistry rapid test and POC. In Italy, market dropped with -1.3% compared to 2014. France IVD market remained stagnant with a small growth of +0.1%. Continuous economic crisis in Greece and Spain resulted a negative growth of -6,1% and -1,6% respectively. On the contrary, Portugal, though suffered economic chaos, showed positive +4,4 growth in IVD expenditure.
In Europe, an average of 10% of gross domestic product (GDP) is spent on healthcare. Among which around 7.3% is attributed to medical technologies, which is > 1% of GDP. The spending on medical technology is estimated to vary significantly across European countries,ranging from around 5% to 10% of the total healthcare expenditure9. Expenditure on medical technology per capita in Europe is at around €197.
The European Medical technology market is estimated is estimated to be €110Bn in 2015. As per the manufacturer prices, the European medical technology market is estimated to be contributed 28% of the global market. It placed second with 40% share the USA is placed number one. Among all European countries, Germany stood top (21%) in terms of share of the IVD market, followed by Italy 16%, France 13%, Spain 9% and the UK 8% and rest of the Europe 33%.
As predicated by Evaluate, on a worldwide perspective, the in vitro diagnostics market is the largest sector, followed by cardiology and diagnostic imaging. Among all the sector, in vitro diagnostics market is expected to grow highest till 2022 in terms of worldwide sales.