Active pharmaceutical ingredient (API) is any substance or combination of substances used in a finished pharmaceutical product (FPP) to provide pharmacological activity or to otherwise have a direct effect in disease diagnosis, cure, mitigation, treatment, or prevention, or to have a direct effect in restoring, correcting, or modifying physiological functions in humans. Some medications such as combination treatments include numerous active components that treat various symptoms or work in different ways. All drugs are manufactured by using two main constituents including API and excipient, wherein active pharmaceutical ingredient (API) is the essential ingredient, and the excipients are substances other than the drug that help in delivering the medication to body system.
The India active pharmaceutical ingredients market is estimated to be valued at US$ 19,993.2 million in 2021 and is expected to exhibit a CAGR of 8.3% during the forecast period (2021-2028).
Figure 1. India Active Pharmaceutical Ingredient Market in Terms of Value (US$ Million), By Region, 2021
Major pharmaceutical companies are focusing on expansion of their production in high potent APIs (HPAPIs), which is expected to boost the market growth during the forecast period
Rising number of key market players are focusing on the expansion of high potent active pharmaceutical ingredients (HPAPIs) production, considering investing in new HPAPIs production facilities, which is expected to drive the India active pharmaceutical ingredients market growth. For instance, in October 2017, Piramal Pharma Solutions (PPS), a contract development and manufacturing company, invested US$ 55 million to expand its API manufacturing capabilities and capacities across its Asia sites.
|Base Year:||2020||Market Size in 2021:||US$ 19,993.2 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2021 to 2028|
|Forecast Period 2021 to 2028 CAGR:||8.3%||2028 Value Projection:||US$ 34,968.7 Mn|
Teva Pharmaceutical Industries Ltd., Solara , Aurobindo Pharma Limited, Dr. Reddy's Laboratories, Lupin Limited, Sun Pharmaceutical Industries Limited, Divi’s Laboratories Ltd., Aarti Drugs Ltd., Hikal Ltd., Neuland Labs, Century Pharmaceuticals Ltd., Proventus Life Sciences Pvt Ltd, Chiral Drugs Pvt Ltd, USV Private Limited, and ASolution Pharmaceuticals Pvt. Ltd.
|Restraints & Challenges:||
Figure 2. India Active Pharmaceutical lngredients Market Share in Terms of Value (US$ Mn), By Product Type, 2021
Active pharmaceutical ingredients manufacturers are engaging in business development strategies such as mergers and agreements, which is a major factor propelling the market growth over the forecast period
Active pharmaceutical ingredients manufacturers are focusing on entering into definitive agreements, which is expected to drive the India active pharmaceutical ingredients market growth over the forecast period. For instance, in October 2020, PAG, a major Asia-focused private equity company, and its grouping partners CX Partners and Samara Capital agreed to buy a controlling position in Anjan Drug Pvt. Ltd., a Chennai-based maker of active pharmaceutical ingredients (API).
India Active Pharmaceutical Ingredient Market– Impact of Coronavirus (COVID-19) Pandemic
COVID-19 has a three major impact on the economy, it directly affects production and demand, it disrupts distribution channels, and it has a financial impact on firms and financial markets. Due to national lockdowns, India is experiencing difficulties in transporting APIs or medicines from one location to another, which is having a negative impact on the India active pharmaceutical ingredients market.
Furthermore, the COVID-19 pandemic has resulted in increasing medication prices. For instance, Penicillin's raw material, Penicillium chrysogenum, raised its price by 40% in just one month. In January 2020, according to the Pharmaceutical Export Promotion Council (PHARMEXCIL), which is part of India's Ministry of Commerce and Industry, the price of API Penicillin increased from Rs.454.00 (US$ 6.16) to Rs.639.00 (US$ 8.69) per unit.
India Active Pharmaceutical Ingredient Market: Restraint
Stringent regulatory activities included in the active pharmaceutical ingredient market is expected to hinder the market growth during the forecast period. Stringent global regulatory policies on enhanced Current Good Manufacturing Practice (CGMP) guidelines, facility certification, quality valuations of active pharmaceutical ingredients manufacturing, strict surprise inspection regimes, and increased supply chain security issues across emerging economies have a large impact on the cost of final active pharmaceutical ingredients products.
Major players operating in the India active pharmaceutical ingredient market include Teva Pharmaceutical Industries Ltd., Solara, Aurobindo Pharma Limited, Dr. Reddy's Laboratories, Lupin Limited, Sun Pharmaceutical Industries Limited, Divi’s Laboratories Ltd., Aarti Drugs Ltd., Hikal Ltd., Neuland Labs, Century Pharmaceuticals Ltd., Proventus Life Sciences Pvt Ltd, Chiral Drugs Pvt Ltd, USV Private Limited, and ASolution Pharmaceuticals Pvt. Ltd.
The active pharmaceutical ingredient (API) in a medication is the component that causes the desired effects. Active pharmaceutical ingredients are mostly manufactured at big manufacturing factories and its manufacturing process involves a series of operations such as multi-step chemical synthesis, fermentation, purification, crystallization, drying, milling, packing, labeling, and testing. They may also be examined by foreign government agencies, and third-party corporations may conduct audits at API facilities. APIs must meet the quality and safety requirements imposed by the producing country. Even if the production is outsourced, API businesses must adhere to the rigorous requirements of the relevant health authorities. Most of the active pharmaceutical ingredient companies are headquartered in India. However, because the bulk API production takes place in mostly Asian countries such as China, they are the source of the majority of APIs produced worldwide.
The active pharmaceutical ingredients manufacturers are starting production units in India to remain competitive and gain benefit over other competitors, which is projected to fuel the market growth during the forecast period. For instance, in February 2017, Nacto pharma, an Indian multinational pharmaceutical company, planned to invest around US$ 1 Billion and expand its active pharmaceutical ingredient (API) and intermediates manufacturing facility in Tamil Nadu.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.