Generic Drugs Market, By Drug Type (Monoclonal Antibodies, Cytokines, Vaccines, Insulin, Peptide Hormone, Immunoglobulin, Peptide Antibiotics, Blood Factors, and Others), By Therapeutic Application (Oncology, Cardiovascular Diseases, Neurology, Infectious Diseases, Musculoskeletal Diseases, and Others), By Route of Administration (Oral, Topical, Injectable, Intra-venous, and Others), and By Geography- (North America, Latin America, Europe, Asia Pacific, Middle East and Africa) - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2026

  • To Be Published : Nov 2018 |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Generic drugs refers to medication that have the same active ingredient as that of a branded drugs. These drugs also yield the same therapeutic effect and are prescribed in the same dosing, with the same quality, and same the way of consumption and usage. However, the inactive ingredients of generic drugs can differ as compared to their branded counter parts. These drugs are mainly marketed after a patent expiry of a branded drug and are significantly lower in costs as compared to the patented branded drugs. Generic drugs are of equivalent quality as compared to the branded drugs and are manufactured under the same safety and manufacturing procedures. Various manufacturers submit an abbreviated new drug application (ANDA) to the FDA after the completion of period of patent exclusivity.

Patent expiry of branded drugs is a factor expected to boost growth of the global generic drugs market

Manufacturers of generic drugs are focusing on development and introduction of various innovative medication and formulation such as biosimilars. According to IMS Health data, generic drugs accounted for over 80% of the prescriptions dispensed in the U.S. in 2013. The number of patents expiring in the near future serves to be a major driver for growth of generic drugs market. For instance, Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor that is indicated in the treatment of metastatic colorectal cancer and head and neck cancer. It is manufactured under the patent by Bristol-Myers Squibb and Eli Lily Company in Europe. The drug’s patent expires in 2018 and thus, is expected to provide opportunity for a large number of market players to manufacture its generic version. Furthermore, supportive initiative by FDA to promote development of biosimilars is encouraging manufacturers to focus towards its development. For instance, the Biologics Price Competition and Innovation Act in the U.S. gr ants 12 months patent exclusivity with higher profit margins to the first manufacturer than the conventional generic manufacturers bringing the drugs in market later. Various other factors contributing to growth of generic drugs market include rampant growth in incidence of chronic diseases. However, shortage of active pharmaceutical ingredients leading to unavailability of generics in the market and increasing FDA pressure on manufacturers regarding manufacturing quality of these drugs are hindering the market growth.

Market Taxonomy

The global generic drugs market is segmented on the basis of drug type, therapeutic application, route of administration, and region.

On the basis of Drug Type, the global generic drugs market is segmented into:

  • Monoclonal Antibodies
  • Cytokines
  • Vaccines
  • Insulin
  • Peptide Hormones
  • Immunoglobulin
  • Peptide Antibiotics
  • Blood Factors
  • Others

On the basis of Therapeutic Application, the global generic drugs market is segmented into:

  • Oncology
  • Cardiovascular Diseases
  • Neurology
  • Infectious Diseases
  • Musculoskeletal Diseases
  • Others

Based on Route of Administration, the global generic drugs market is segmented into:

  • Oral
  • Topical
  • Injectable
  • Intra-venous
  • Others

Asia Pacific to gain significant traction in the global generic drugs market owing to increasing number of local players

On the basis of region, the global generic drugs market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America held a dominant position in the global generic drugs market in 2016. This is attributed to favorable regulatory policies that are revised and amended to encourage generic drugs business in the region. For instance, Generic Drug User Fee Amendment (GDFUA) was reauthorized in 2017 after its initiation in 2012 by FDA for increasing consumer access to high quality, safe, and affordable drugs. On the other hand, Asia Pacific is expected to show a significant traction in the market over the forecast period. This is attributed to lower manufacturing costs and high skilled workforce in the Asian countries. According to India Brand Equity Foundation, India has the second largest number of U.S. FDA manufacturing plants outside the U.S. that are involved in generic drugs manufacturing. Additionally, the cost of manufacturing is 33% lower in India than that in the U.S., increasing accessibility to generics in these countries.

New drug launches and market approvals from the U.S. FDA to generic manufacturers are bolstering growth of the generic drugs market. For instance, in December 2017, Zydus Phamaceuticals — a subsidiary of Cadila Healthcare — received U.S. FDA approval to market Pramipexole Dihydrochloride extended-release tablets for the treatment of Parkinson ’s disease in the U.S. market. Key players operating in the global generic drugs market are Teva Pharmaceutical Industries, Mylan N.V., Novartis International AG, Pfizer, Inc., Allergan Plc, Sun Pharmaceuticals, Fresenius Kabi, Sanofi, Endo International, Lupin Ltd., Abbott Healthcare, AstraZeneca Plc, and Novo Nordisk.

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


Smiley face

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.
Smiley face

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

Choose License Type

"How Can I Help You" ?

Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.

[email protected]

Key Benefits

  • Custom Research Solution

    Talk to our research consultant to design an exclusive report as per your research needs.

  • Customer Fulfilment

    We aim to fulfil client's research demands with tailored research solutions.

  • Quick Turnaround Time Reports

    We aim to provide research studies in quickest turnaround time and in a much cost effective manner.

  • 360-degree Approach

    We cover each industry from supply and demand side with an aim to provide a most holistic research study.

  • Assured Quality

    We strive to provide most accurate and reliable research findings in our research reports.