Active pharmaceutical ingredients (APIs) are the purified form of chemical drug substances that are used as building blocks for pharmaceutical drugs. APIs are carefully integrated during the production process of drugs to ensure effective delivery of treatment and therapy. APIs are available as branded or generic pharmaceutical formulations. The rising prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases has augmented the demand for pharmaceutical drugs worldwide. Moreover, the increasing affordability and acceptance of generic drugs due to their cost-effectiveness have boosted the API market growth. Growing emphasis on quality standards and process optimization by API manufacturers have played a pivotal role in establishing public confidence in generic drug therapies.

The global Active Pharmaceutical Ingredients Market is estimated to be valued at US$ 7.33 Mn in 2023 and is expected to exhibit a CAGR of 7.8% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Dynamics

The global API market is expected to be flourished by the growing demand for generic drugs. As mentioned in the heading, increasing acceptance of generic drugs owing to their cost-effectiveness has significantly augmented the demand for APIs. As per the World Health Organization, around 80% of the world’s population use generic drugs to meet their healthcare needs due to their affordability as compared to branded drugs. Furthermore, patent expiration of several blockbuster branded drugs is expected to open lucrative opportunities for generic drug manufacturers to produce low-cost alternatives, thus propelling the API demand. Additionally, rising R&D investments by API manufacturers on advanced drug delivery technologies and fermentation processes are also anticipated to boost the market growth over the forecast period.”

Segment Analysis

The global active pharmaceutical ingredients market can be segmented based on type, application, and region. Based on type, the market is segmented into synthetic APIs and biotech APIs. The synthetic API segment dominates the market as these are more affordable to manufacture. Additionally, the process technology and manufacturing costs are well established for synthetic APIS.

PEST Analysis

Political: Government regulations play a major role in the active pharmaceutical ingredients market. Regulatory bodies like the US FDA and EMA closely monitor the manufacturing of APIs to ensure safety and efficacy standards are met. Changes in regulations can impact approval timelines and market access.

Economic: The market is dependent on spending on pharmaceutical R&D. Rising healthcare budgets globally fuel demands for APIs from pharma companies developing new drug formulations. Economy downturns may impact R&D investments.
Social: With an aging global population and rising lifestyle diseases, demand for medicines is increasing steadily. This drives pharma companies to develop new drugs, boosting API needs. Additionally, social awareness on healthcare is pushing patients to have access to affordable medicines.

Technological: Advances in process chemistry and manufacturing technologies help bring down costs and improve efficiencies in API production. Technologies like continuous processing and crystallization are enabling companies to optimize resource usage. Adoption of digital transformation solutions is also helping optimize operations.

Key Takeaways

The global Active Pharmaceutical Ingredients Market Growth  is expected to witness high growth over the forecast period.

Regionally, North America is expected to dominate the market over the forecast period owing to presence of major API manufacturers and strong investments in pharmaceutical R&D by companies in the region.

Key players operating in the active pharmaceutical ingredients market are Endo International plc, Teva Pharmaceutical Industries Ltd, Viatris Inc. (Mylan N.V.), Teikoku Pharma USA, Inc., Hisamitsu Pharmaceuticals Co. Inc., Galen Limited, Sorrento Therapeutics, Inc., Amneal Pharmaceuticals, Inc., Rhodes Pharmaceuticals L.P., 6iPain Healthcare Private Limited, and Sanofi S.A. These players are focusing on expanding their manufacturing facilities and capabilities to cater to the rising global demands for APIs.

*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it