Key Drivers:

  • Launch of cost effective generic epinephrine products by the manufacturers is majorly attributed to the high price of EpiPen developed by Mylan NV. the worth hike wasn’t accepted by the public, because the drug price increased to quite 400% over a decade.
  • According to data provided by Elsevier Clinical Solutions’ Gold Standard Drug Database, 2016, the value of EpiPen was US$ 103.50 in 2009, where the worth increased up to US$ 264.50 in 2013. The worth of the merchandise further increased by 75% costing around US$ 461 in 2015, whereas the worth reached to US$ 608.61 in 2016.

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  • Furthermore, support of regulatory agencies are predicted to streamline the approval of generic copies of medicine, thus allowing the launch of drug substitutes without affecting the clinical effect or safety profile. As an example, in November 2017, the FDA issued guidance for developing generic copies of complex medicines like EpiPen to succeed in the market, without affecting safety and efficacy, thereby providing a lower-cost option and to satisfy the demand of drug shortages.
  • Also, insurance companies and states Medicaid programs have stopped covering branded products like EpiPens, thereby favoring the adoption for alternative epinephrine auto-injectors, because the high cost of the products are directly shifted onto the payers. As an example, in 2017, the private insurer Cigna Corp. changed the policies for providing quick access of generic auto-injectors to patients, because the insurer will cover Mylan’s US$ 300 generic version of the EpiPen, which is cost-effective alternative as compared to the branded drug.

Key Restraints:

Unavailability of approved drugs thanks to increasing number of product recalls by various developers may be a factor hindering growth of the worldwide Epinephrine Market. As an example, in 2015, Sanofi US voluntarily recalled Auvi-Q (epinephrine injection, USP) on the market including both 0.15 mg and 0.3 mg strengths for hospitals, retailers, and consumers, because of the products had inaccurate dosage delivery, thus included failure to supply intend drug dose.

Statistics:

Figure 1. Global Epinephrine Market price (US$ Mn), by Region, 2017

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Figure 2. Global Epinephrine Market Share (%), by Product Type, 2018 and 2026

Key Opportunities:

  • Epinephrine is out there in several doses and concentrations for delivery by different routes and for various indications, including respiratory disorders. Consistent with the planet Health Organization (WHO), 2018, Chronic Respiratory Diseases (CRDs) affect quite 1 billion people worldwide and asthma may be a large contributor, affecting children, adults, and elderly population often throughout their entire lives. The WHO in 2017, stated that over 300 million patients suffered from asthma in 2013, and are expected to extend to over 400 million by 2025 globally.
  • North America dominates the worldwide epinephrine market, due to increasing number of patients affected by respiratory illness like asthma.
  • Also, various players within the region are involved in developing innovative products, which successively is predicted to reinforce market growth. As an example, in July 2016, MannKind Corporation initiated developmental process for single-use disposable epinephrine inhaler, thereby providing a reasonable and needle-free alternative.

Key Players

Major players operating within the global Epinephrine Market include Mylan N.V., Pfizer, Inc., Teva Pharmaceuticals Industries Ltd., Impax Laboratories, Inc., Kaleo, Inc., Adamis Pharmaceuticals Corporation, Bausch Health Companies, and ALK- Abello A/S.

Key Development:

Market players are focused on launching cost effective versions for patients affected by severe allergies, requiring constant access to life-saving epinephrine, thereby providing affordable options and propelling the market growth.
For instance, in August 2018, Teva Pharmaceuticals received the Food and Drug Administration (FDA) approval for first generic versions of EpiPen and EpiPen Jr, for the emergency treatment of allergies, including life-threatening allergies (anaphylaxis), in adults, and pediatric patients weighing quite 33 pounds.

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