Tuesday, 12 January 2016

Allergic reactions occur due to a hypersensitivity disorder of the immune system against certain substances present in the environment, which are often referred as allergens such as dust mites excretion, pollen, and pet dander. Allergic reactions have a detrimental impact on the human health causing significant morbidity due to otolaryngologic, pulmonary, and dermatologic disorders. According to an article published by the National Center for Biotechnology Information (NCBI), over 500 million people are suffering from allergic rhinitis globally.

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The morbidity pattern varies from chronic illnesses such as allergic rhinitis and allergic asthma to acute anaphylaxis from venom or medication. Allergies are observed to affect all age groups, races and ethnicity and economic classes, although, young children and elderly are at higher risk. Factors such as alarming rise in pollution and environmental toxicity, overcrowding due to population rise, lifestyle factors are leading to weakened immune systems and heightened vulnerability towards allergic reactions.

According to the World Allergy Organization, nearly 30% to 40% of the global population is affected by one or the other allergic conditions and currently no cure is available for these disorders. Consequently, there is a burgeoning global market for diagnostic services to detect allergies caused by different allergens. The positive test alone demonstrates sensitization but do not always indicate clinical reactivity. The complexity of the allergy diagnosis lies in the fact that the diagnosis does not rest entirely on test results but also needs to incorporate patient’s medical history and the genetic predisposition towards certain allergies. Accurate diagnosis and immunotherapy is the only ray of hope for seeking cure against most of the allergen sensitivities.

Some of the allergy diagnostic products and services include allergy markers, ImmunoCAP, recombinant gene technology, and EliA blood tests among others. Allergy diagnostics market is bound to grow in future owing to the current health scenario with parallel rise in demand for accurate diagnostic tools and services. To enable diagnosis and disease management of allergies and autoimmune disorders, allergens have been classified on the basis of product type and end-users:

The end-users segment includes healthcare institutions such as medical research centers, laboratories, hospitals, and health insurance companies. Product types can be further subdivided into:
Assay Kits and immunoassay analyzers

Immunoassay analyzers are expected to capture a huge share among the global allergy diagnostics market and is poised to grow at the highest rate. To map out the diagnostic allergy market on a global scale, North America accounts for the largest regional market followed by Europe and opening up newer avenues for the rapidly growing markets in Asia-Pacific. This trend is further backed by the statistical information from the European Academy of Allergy and Clinical Immunology (EAACI) which reported in 2012 that nearly 17 million Europeans have food allergies and there has been seven-fold rise in allergic reactions among children over the past decade. One in every thirteen children (under 18 years of age) in the U.S is exposed to this potentially serious condition. Consequently, the market has witnessed a remarkably high growth owing to the increasing awareness coupled with government initiatives for the unmet needs of the population in many countries. It is anticipated that the sector will experience a tremendous growth as a result of the demand side factors, investments in the products and services for detecting the allergic trigger.

Some of the key players contributing to this market segment are Allercheck Laboratories, Inc., bioMérieux SA, Danaher Corporation, Hitachi Chemical Diagnostics, Inc., HOB Biotech Group Co., Ltd., HYCOR BioMedical, Lincoln Diagnostics, Inc., Omega Diagnostics Group plc, Siemens Healthcare, Stallergenes, and Thermo Fisher Scientific, Inc.

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Spinal muscular atrophy is primarily a hereditary autosomal recessive disease that affects the nervous system areas that controls voluntary muscular movement. SMA is commonly identified as a genetic disorder causing mortality among people, especially infants. As per Orphanet, 1 infant out of 6,000 births is predicted to suffer spinal muscular atrophy. More than 10 mn individuals in the United States are carriers of spinal muscular atrophy. The spinal muscular atrophy market phase 3 candidate ISIS-SMNRx is predicted to reach US$0.47 bn by 2023.

Increasing Number of Infants with SMA to Drive Global Market

Recently, as per a news report, a few families in Morgantown found hope for their children who were suffering from spinal muscular atrophy. The families were denied access to the clinical trial drug SMNRx from ISIS Pharmaceuticals. Since then, the families, with the support of many others, have been trying to sign a petition to allow SMA-diagnosed children to have clear access to the relevant drugs for treatment.

Such and other events have occurred as the result of the growing prevalence of SMA among children. This will propel the global spinal muscular atrophy market in the coming years.

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Type 1 Spinal Muscular Atrophy to Lead Demand for Global SMA Market by 2023

Considering the increasing number of infants being diagnosed with spinal muscular atrophy, the spinal muscular atrophy market is expected to expand during the period from 2015 to 2023. On the basis of the symptoms and the age of onset, the SMA market is classified into Type 1 SMA, Type 2 SMA, Type 3 SMA, and Type 4 SMA. Type 1 spinal muscular atrophy is the most severe type and is found in infants aged up to six months. More than 60% of SMA cases are found to be Type 1 SMA, in which infants do not live for more than two years. Type 2 SMA affects children aged from six months to 18 months. Type 3 and 4 SMA are comparatively less severe and carry a prognosis of a normal lifespan. Physiotherapy is the best treatment suggested for SMA when it is at its early stage.

ISIS-SMNRx is an antisense medicine introduced by Isis Pharmaceutical and has shown positive results in clinical trials. Some other potential candidates are Olesoxime (TRO19622), RO6885247, scAAV9.CB.SMN, RG3039, LMI070, and CK-2127107. Phase 3 study of ISIS-SMNRx for treating Type 1 and Type 2 SMA is expected to be completed by 2016.

SMA is commonly diagnosed by recognizing mutation in the survival of motor neuron (SMN) gene. Muscle biopsy, nerve condition velocity, and electromyogram are some other ways by which SMA can be diagnosed. AveXis, Inc., F. Hoffmann-La Roche Ltd., Isis Pharmaceuticals, Inc., Cytokinetics, Inc., and Novartis AG are some of the prominent players in the spinal muscular atrophy market. 

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At present, there is no well-defined cure for treating spinal muscular atrophy. ISIS-SMNRx is the only drug that is expected to be made available on large scale by 2017. The drug is expected to reach record sales of US$468.2 mn in the U.S. by 2023.