Branded Generics Market Analysis (2019-2027)

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2. BRANDED GENERICS MARKET ANALYSIS(2019-2027) • Branded Generics Market, By Drug Class (Alkylating Agents, Antimetabolites, Hormones, Anti-Hypertensive, Lipid Lowering Drugs, Anti-Depressants, Anti-Psychotics, Anti-Epileptics, Others), By Formulation (Oral, Parenteral, Topical, Others), By Indication (Oncology, Cardiovascular Diseases, Diabetes, Neurology, Gastrointestinal Diseases, Dermatology Diseases, Analgesics and Anti-inflammatory, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Drug Stores), and By Region (North America, Europe, Asia Pacific, Latin America, Middle East and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027

3. Branded Generics Market – Insights • A branded generic is a generic drug that has gone through the Abbreviated New Drug Application (ANDA) process, and is assigned a name other than the chemical name. Branded generics are bioequivalent to original products and are marketed under a company’s brand name to differentiate themselves from the generic products. • The global branded generics market is estimated to account for US$ 247.0 Mn in terms of value in 2019 and is expected to reach US$ 444.0 Mn by the end of 2027.

4. Global Branded Generics Market: Drivers • Off-invoice discounts to fuel growth of the global branded generics market over the forecast period. In developed markets such as the U.S., the demand for branded generic drugs is expected to be high, owing to higher discounts offered by players. The off-invoice discounts are approximately at 30% in the U.S. as compared to 17% in the EU. • Moreover, conducive regulatory environment in developing markets is also expected to aid in growth of the market. For instance, in 2012, Central Drugs Standard Control Organization, Gov. of India released regulatory requirements for marketing approval of similar biologics in India, which was revised in 2016 for more clarity. According to the revision, the reference biologic may be approved or marketed either in India or any other International Council for Harmonisation countries. • Asia Pacific region held dominant position in the global branded generics market in 2018, accounting for 32.3% share in terms of value, followed by Europe.

5. Global Branded Generics Market: Drivers • Off-invoice discounts to fuel growth of the global branded generics market over the forecast period. In developed markets such as the U.S., the demand for branded generic drugs is expected to be high, owing to higher discounts offered by players. The off-invoice discounts are approximately at 30% in the U.S. as compared to 17% in the EU. • Moreover, conducive regulatory environment in developing markets is also expected to aid in growth of the market. For instance, in 2012, Central Drugs Standard Control Organization, Gov. of India released regulatory requirements for marketing approval of similar biologics in India, which was revised in 2016 for more clarity. According to the revision, the reference biologic may be approved or marketed either in India or any other International Council for Harmonisation countries.

6. Asia Pacific region held dominant position in the global branded generics market in 2018, accounting for 32.3% share in terms of value, followed by Europe.

7. Global Branded Generics Market: Restraints • Price pressure from payers is expected to hinder growth of the global branded generics market. Governments and insurers in emerging economies encourage consumers to switch from branded generics to low cost generics in order to contain healthcare costs. Moreover, several emerging countries taking lower benchmark prices from European/International core countries cluster to drive down the prices. For Instance in countries like Turkey, South Africa, payers adopted international benchmarking of prices and purchasing large volumes of inexpensive generic medicines to curtail the healthcare expenditure.

8. Moreover, payer pressure to reduce costs via the commoditization of the generics market is also expected to hinder growth of the market. In many countries, balance may shift from the branded model for pharmaceuticals to a commodity model where it helps to increase the competition in the market.

9. Global Branded Generics Market: Opportunities • Differentiation in the final product is expected to offer lucrative growth opportunities for the players in the market. Generic drugs contain the same active pharmaceutical ingredients as the brand-name product. However, differentiation in color, shape, taste, inactive ingredients, preservatives, and packaging may lead to high demand for branded generics. • Key players in the market can also focus on offering low-cost branded generics in order to remain competitive in the market. This can be achieved by strategic sourcing of raw materials from emerging economies and partnering with suppliers.

10. Oral segment in the global branded generics market was valued at US$ 134.8 Mn in 2018 and is expected to reach US$ 258.9 Mn by 2027 at a CAGR of 7.3% during the forecast period.

11. Market Trends/Key Takeaways • Major players in the market are focused on enhancing their share in developed markets. For instance, in January 2020, Endo International plc announced that one of its operating companies, Par Pharmaceutical, has begun shipping an authorized generic version of Allergan's Carafate (sucralfate) oral suspension 1gm/10 mL to the U.S. • The patent expiry of drug vildagliptin has led to major generic manufactures focusing on launch of generic version of vildagliptin. In India, over 50 companies including Dr. Morepen Labs, Amigoz Life Sciences, Microlabs, Macleods, Ikon Remedies, Mankind, Medico Labs, Innovative Pharma, and Wynclark Pharmaceuticals are expected to launch generics of Vildagliptin.

12. Regulations U.S. • In the U.S Federal Food Drugs and Cosmetics Act (FD&C Act) and Controlled Substances Act, or CSA govern all the activities related to branded generics including development, manufacturing, testing, labelling, distribution, advertising & promotion, sales, import export of generic products • The manufacturer of branded generic products required to obtain abbreviated new drug application (ANDA) approval under section 505(b)(2) of Federal Food Drug and Cosmetics Act • Requirements for obtaining ANDA are given in 21CFR314.54, which explains Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug (innovator product listed in Orange book)

13. The 505(b)(2) regulation offers a less expensive and faster new drug development pathway. 505 (b)(2) was added to FD&C act by Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman act). • When the generic company files ANDA with Paragraph IV certification, the first applicant to submit substantially completed ANDA is given 180 days market exclusivity under para IV of Hatch-Waxman act • In October 1999, U. S. Department of Health and Human Services Food and Drug Administration published a draft guidance for applications covered by section 505 (b)(2)

14. Global Branded Generics Market: Competitive Landscape • Major players operating in the global branded generics market include, Mylan N.V, Novartis AG, Teva Pharmaceutical Industries Ltd., Pfizer Inc., Sun Pharmaceutical Industries Ltd., Aspen Pharmacare Holding Ltd., Abbott Laboratories, and Valeant Pharmaceuticals International, Inc.

15. Global Branded Generics Market: Key Developments  • Major players in the market are focused on adopting collaboration and partnership strategies to enhance their market share. For instance, in January 2020, Greenstone, a wholly owned subsidiary of Pfizer Inc., announced a supply agreement with Roman, an innovative digital healthcare clinic, to offer Roman members access to the only FDA-approved authorized generic version of Viagra (sildenafil citrate). • Major players in the market are offering discounts on their branded generics. For instance, in November 2019, Novo Nordisk announced to offer an authorized generic or follow-on brand version of insulin aspart and insulin aspart mix at 50% off the current list price for its NovoLog and NovoLog Mix, in January 2020.

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