Auto-injectors Market - Application, and Distribution Channel
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In 2017, Kaleo Pharmaceutical announced supplemental new drug application (sNDA) named as – AUVI-Q (0.1mg), which was granted a priority review by the U.S. Food and Drug Administration (US FDA). AUVI-Q is the first known epinephrine auto-injector, which is designed to treat an allergic reactions especially in infants, weighing around 16.6 to 33 pounds. According to the study by Allergy, Asthma & Clinical Immunology, children’s treated with anaphylaxis has limit of around 0.15 mg per auto-injector, which should have 12.7mm needle length and mainly used for patients with high-risk. The high dose of drug use in life-threatening condition, could strike the bone during the administration of epinephrine. Moreover, National Institute of Health (NIH) guidelines recommended AUVI-Q 0.1 mg for peanut allergy, as it contains no epinephrine auto-injector (EAI). Thus, AUVI-Q 0.1mg is mainly designed to minimize complications during treatment of pediatric patients. Furthermore, Kaleo pharmaceutical announced new program called – Q Your School in 2017, this program will provide free AUVI-Q epinephrine auto injector devices to over 67,000 public elementary schools in U.S. AUVI-Q has new advance features such as voice-activated prompts that will give precise guidelines. Thus, it is expected to propel growth of the auto-injectors market.
Moreover, Kmart Pharmacy is recognized as the national leader in customer’s satisfaction in U.S., ranked by the American Customer Satisfaction Index. Due to the high cost of epinephrine auto-injector pens, in 2017, Kmart pharmacy decided to lower cost of generic version of Adrenaclick (epinephrine injection), as low with manufacturer’s coupons. This scheme will provide affordable access to the patients, with health insurance costing no money and on the purchase of two pack of auto-injector, it will cost up to US$ 199.99. Thereby, Kmart Pharmacy is trying to serve auto-injector in affordable price, which is expected to fuel growth of the auto-injectors market.
In 2016, Mylan launched generic EpiPen at a wholesale acquisition cost of US$ 300 per epinephrine injection and USP two pack cost less than 50% as compared to EpiPen 2–Pak auto-injector. It provides substantial savings which will access more patients to use generic EpiPen.
In 2017, Bayer received FDA approval for a connected auto-injector named Betaconnect Electronic Autoinjector with myBetaApp. It offers many advantages such as Bluetooth connectivity, which allows the patient to automatically record all type of auto-injectors and can share with a nurse or physician. MyBetaApp keep a record of injection date and time, speed and depth and help to set a reminder by emails with timings and site of injection. Advantages over conventional auto-injector is expected to augment growth of the auto-injectors market in the near future.
Maintaining good quality product is essential to avoid product recalls. For instance, In March 2017, U.S. FDA recalled product EpiPen and EpiPen Jr, which is manufactured by Meridian Medical Technologies and distributed by Mylan. This is mainly due to significant violations of current good manufacturing process (cGMP) in auto injector. FDA found the defective part in device, which results in failure to activate and marked as a major restraining factor.
Increasing incidence of life-threatening allergic cases and increasing demand for injector device for instant treatment is expected to fuel growth of the market
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According to World Allergy Organization (WAO), in 2017, an estimated number of anaphylaxis cases were around 222 people in around 10.2 million population in Hungary, followed by Japan, estimated to around 300-350 patients per year in around 100 million people. In China, around 3000 people suffered from anaphylaxis in around 1,200 million population per year. According to the Allergy, Asthma & Clinical Immunology, in 2015, around 15 million people suffered from food allergies in U.K. Moreover, according to the European Academy of Allergy and Clinical Immunology (EAACI), in 2015, around 17 million people suffered from food allergies, among which around 3.5 million were children’s.in U.K. Furthermore, according to World Health Organization (WHO), around 200 to 250 million people suffered from food allergies worldwide in 2015. This data represents an increasing number of incidence of allergy cases and prevalence. Thereby, it is expected to fuel growth of the auto-injectors market during the forecast period.
Key players operating in the global auto-injectors market include Pfizer, Inc., Scandinavian Health Ltd., Novartis International AG, Unilife Corporation, Antares Pharma, Inc., Kaleo Pharmaceutical, Mylan N.V., Biogen Idec, Inc., Becton, Dickinson and Company, and Ypsomed Holdings AG.
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