Indian pharmaceutical industry is predicted to grow at a CAGR of 9-12% during the 2018-22 period to reach a size of USD 26-31 billion.
- Definition / Scope
- Market Overview
- Market Risks
- Top Market Opportunities
- Market Drivers
- Market Restraints
- Industry Challenges
- Pricing Trends
- Regulatory Trends
- Other Key Market Trends
- Market Size and Forecast
- Market Outlook
- Technology Roadmap
- Distribution Chain Analysis
- Competitive Landscape
- Competitive Factors
- Key Market Players
- Strategic Conclusion
Definition / Scope
The definition of a drug includes medicines that are meant for internal as well as external use including substance used for the diagnosis, treatment or prevention of disease. It also includes components of the drug as well as devices that are used internally or externally for the diagnosis, treatment or prevention of disease.
A generic drug contains the same active ingredients as the branded drug and gives the same therapeutic effect as branded drugs. It is not necessary for them to contain the same inactive ingredients. It is identical in strength, dosage form and route of administration and has the same use indications.
A branded drug is originally developed and manufactured by a pharmaceutical company with a huge investment in research & development and the drug is exclusively sold by the company in the market with patent protection so that the company can recover the investments it made for the manufacturing of the drug.
ANDA: Drug manufacturers need to clear the Abbreviated New Drug Application (ANDA) process with the United States Food and Drug Administration (USFDA) to market the generic drug. It involves seeking approval from the USFDA by drug formulators through submission of supporting documents to market a generic drug in the USA.
NDA: To market the drug in the USA, the pharmaceutical company has to submit New Drug Application (NDA) to the USFDA and get approval from it regarding the safety and efficacy of the drug.
OTC drugs refer to those drugs which do not require a prescription from doctors for its purchase and are sold over the counter. These drugs can be easily bought from local chemists, general stores, supermarkets, etc.
The pharmaceutical industry is categorized into five sub-segments - Domestic Formulation Companies (DFC), Export Oriented Formulation Companies (EOFC), API Manufacturers (APIM), Contract Manufacturing of Formulations (CMF), and Nutraceuticals Products (NP).
Active Pharmaceutical Ingredients Manufacturing (APIM) is the primary active ingredient that is manufactured in the initial stage of pharmaceutical and drug production. It is the ingredient that results in the desired therapeutic effect in the human body.
Contract Research and Manufacturing Services (CRAMS) is an outsourcing process that implies the outsourcing of research and product manufacturing services at a lower cost.