A generic drug is a duplicate copy of original branded drug, which has same dosage form, active pharma ingredients (API), strength, route of administration, and also same intended use as the branded one. Regulatory authorities and governments have mandated that an authorized generic drug has to medicinally correspond to the branded drug and sanctioned as an Abbreviated New Drug Application (ANDA) by the Food and Drug Administration (FDA). An authorized generic is the branded company’s individual product, but repackaged and marketed as generic drug either via subsidiary or third party. These are already approved as a New Drug Application by the FDA, only they are promoted via private label. The authorized generics market grew rapidly in the past few years as these provide consumers with branded quality drugs at generic prices. Presently, there is a growing trend of original maker giving approvals to a subsidiary or a private label distribution company to sell its brand name drug as a generic drug at a subsequently low price.

An example of authorized generic drug is Azithromycin Pak which is sold under by the company name Greenstone. Pfizer’s original branded drug Z-pak was approved by the FDA. Before patent expiry of Z-pak, Pfizer allowed Greenstone to sell Z-pak using authorized generic name Azithromycin Pak. Greenstone is a wholly owned subsidiary of Pfizer.

The global authorized generics market is expected to witness strong growth. Authorized generic drugs are priced at significantly discounted rate i.e. 50% to 70% as compared to branded counterparts. Additionally, many of the popular branded drugs of pharma companies are losing patent protection rights, which is also termed as patent cliffs. This would pave the way for entry of new complex generics in the market. These factors are likely to drive the authorized generics market in the near future. Other factors driving the market are health care plans by governments across the world, rapidly increasing cost of branded drugs, and aging populations. On the other hand, possibility of side effects, and lack of regulatory awareness about products and quality management are factors likely to restrain the global authorized generics market.

The global authorized generics market can be classified based on product type, application, end-user, and region.

In terms of product type, the global authorized generics market can be segmented into biosimilars, simple generic, super generic, and others. Based on applications the market can be classified into cardiovascular, anti-infective, anti-arthritis, central nervous system, anti-cancer, respiratory, and others. 

Geographically, the global authorized generics market can be divided into North America, Asia Pacific, Europe, Latin America, and Middle East & Africa. North America accounted for the largest share of the market, primarily due to technological advancements, rise in demand for generic drugs, increase in overall cost of branded drugs, and presence of key players. Europe held a significant share of the market attributed to advancements in generic drugs, rise in various types of cancer, and blood related disorders. Asia Pacific, however, has been exhibiting high growth rate on account of growing demand for generic drugs, rise in geriatric population, increase in disposable income, and government initiatives to support generic drugs. Rapidly rising population in the region has increased demand for better health care and induced both private and government players to meet the demand. Developing economies such as India and China have also made a significant contribution to the rise of the global authorized generics market by focusing on establishing a better health care infrastructure.

Key players in the market are Teva Pharmaceuticals, Sandoz, Allergan, Mylan, Sun Pharmaceuticals, and STADA Arzneimittel. Other prominent vendors in the market are Abbott, Amgen, Apotex, Aspen, AstraZeneca, Aurobindo Pharma, Baxter, Berlin-Chemie, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Cipla, Coherus Biosciences, Dr. Reddy's Laboratories, Daiichi Sankyo, Eli Lilly and Company, Emcure Pharmaceuticals, Eurofarma Laboratories, Gedeon Richter, Gilead Sciences, and GlaxoSmithKline. 

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

The study is a source of reliable data on:

  • Market segments and sub-segments
  • Market trends and dynamics
  • Supply and demand
  • Market size
  • Current trends/opportunities/challenges
  • Competitive landscape
  • Technological breakthroughs
  • Value chain and stakeholder analysis

The regional analysis covers:

  • North America (U.S. and Canada)
  • Latin America (Mexico, Brazil, Peru, Chile, and others)
  • Western Europe (Germany, U.K., France, Spain, Italy, Nordic countries, Belgium, Netherlands, and Luxembourg)
  • Eastern Europe (Poland and Russia)
  • Asia Pacific (China, India, Japan, ASEAN, Australia, and New Zealand)
  • Middle East and Africa (GCC, Southern Africa, and North Africa)

The report has been compiled through extensive primary research (through interviews, surveys, and observations of seasoned analysts) and secondary research (which entails reputable paid sources, trade journals, and industry body databases). The report also features a complete qualitative and quantitative assessment by analyzing data gathered from industry analysts and market participants across key points in the industry’s value chain.

A separate analysis of prevailing trends in the parent market, macro- and micro-economic indicators, and regulations and mandates is included under the purview of the study. By doing so, the report projects the attractiveness of each major segment over the forecast period.

Highlights of the report:

  • A complete backdrop analysis, which includes an assessment of the parent market
  • Important changes in market dynamics
  • Market segmentation up to the second or third level
  • Historical, current, and projected size of the market from the standpoint of both value and volume
  • Reporting and evaluation of recent industry developments
  • Market shares and strategies of key players
  • Emerging niche segments and regional markets
  • An objective assessment of the trajectory of the market
  • Recommendations to companies for strengthening their foothold in the market  

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis. 

Custom Market Research Services

TMR offers custom market research services that help clients to get information on their business scenario required where syndicated solutions are not enough.


Authorized Generics Market

Pre Book