Epinephrine Market Analysis | CMI

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2. EPINEPHRINE MARKET ANALYSIS • Epinephrine Market - Global Forecast to 2026, by Product Type (Auto-injector, Prefilled Syringes, and Ampoules and Vials), by Application (Anaphylaxis, Cardiac Arrest, Superficial Bleeding, Respiratory Disorders and Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026 • The global epinephrine market size was valued at US$ 2,040 million in 2017, and is expected to exhibit a CAGR of 11.0% over the forecast period (2018 – 2026).

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

4. Market Drivers • Increasing support from government and insurance agencies for generic products to propel Epinephrine Market growth • Launch of cost effective generic epinephrine products by the manufacturers is majorly attributed to the high price of EpiPen developed by Mylan NV. The price hike was not accepted by the public, as the drug price increased to more than 400% over a decade. • According to data provided by Elsevier Clinical Solutions’ Gold Standard Drug Database, 2016, the cost of EpiPen was US$ 103.50 in 2009, where the price increased up to US$ 264.50 in 2013. The price of the product further increased by 75% costing around US$ 461 in 2015, whereas the price reached to US$ 608.61 in 2016.

5. Furthermore, support of regulatory agencies is expected to streamline the approval of generic copies of drugs, thus allowing the launch of drug substitutes without affecting the clinical effect or safety profile. For instance, in October 2017, the commissioner of FDA announced plans to accelerate development of generic versions that combine a drug and a device. In November 2017, the FDA issued guidance for developing generic copies of complex medicines such as EpiPen to reach the market, without affecting safety and efficacy, thereby providing a lower-cost option and to meet the demand of drug shortages. • Also, insurance companies and state Medicaid programs have stopped covering branded products such as EpiPens, thereby favoring the adoption for alternative epinephrine auto-injectors, as the high cost of the products are directly shifted onto the payers. For instance, in 2017, the private insurer Cigna Corp. changed the policies for providing easy access of generic auto-injectors to patients, as the insurer will cover Mylan's US$ 300 generic version of the EpiPen, which is cost-effective alternative as compared to the branded drug.

6. Market Restraints • However, unavailability of approved drugs due to increasing number of product recalls by various developers is a factor hindering growth of the global epinephrine market. For instance, 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, as the products had inaccurate dosage delivery, thus included failure to provide intended drug dose.

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

8. Market Opportunities • Increase in prevalence of chronic respiratory diseases to bolster the market growth • Epinephrine is available in different doses and concentrations for delivery by different routes and for different indications, including respiratory disorders. According to the World Health Organization (WHO), 2018, Chronic Respiratory Diseases (CRDs) affect more than 1 billion people worldwide and asthma is 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 increase to over 400 million by 2025 globally. • North America dominates the global epinephrine market, owing to increasing number of patients suffering from respiratory disease such as asthma. For instance, according to the Asthma and Allergy Foundation of America, 2014, anaphylaxis is a severe life-threatening allergic reactions occurring at least 1 in every 50 people in the U.S., and its rate is as high as 1 in every 20 people. • Also, various players in the region are involved in developing innovative products, which in turn is expected to augment market growth. For instance, in July 2016, MannKind Corporation initiated developmental process for single-use disposable epinephrine inhaler, thereby providing an affordable and needle-free alternative.

9. Key Players • Major players operating in 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.

10. Key Development • Market players are focused on launching cost effective versions for patients suffering from 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 allergic reactions, including life-threatening allergies (anaphylaxis), in adults and pediatric patients weighing more than 33 pounds.

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