Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
An Active Pharmaceutical Ingredient (API) is the biologically active component of a drug that produces the intended effects. These ingredients are chemical or natural substances or a combination of substances used in a finished pharmaceutical products (FPP) intended to furnish pharmacological activity or to otherwise have a direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings. Active pharmaceutical ingredients manufacturing process is a related series of operations which result in the preparation of active pharmaceutical ingredients. Major operations or steps in the API process may include multi-step chemical synthesis and fermentation, purification, crystallization, drying, milling, packing, labeling, and testing.
The global active pharmaceutical ingredients market is estimated to be valued at US$ 180.4 billion in 2020 and is expected to exhibit a CAGR of 6.7% during the forecast period (2020-2027).
Figure 1. Global Active Pharmaceutical Ingredients Market Share (%) in Terms of Value, By Region, 2020
Factors such as the increasing prevalence of chronic diseases, and investments in research and development are expected to drive the market growth during the forecast period.
The growing prevalence of chronic diseases is expected to drive demand for drugs and fuel the global active pharmaceutical ingredients market growth in near future. According to the World Health Organization’s mortality and global health estimates of 2015, ischemic heart disease, stroke, chronic obstructive lung disease, and lower respiratory infections have been the cause for maximum number of deaths in the past decade.
Furthermore, increasing number of major pharmaceutical companies are focusing on expansion of their product lines in HPAPIs or considering investing in new HPAPIs production facilities, and further outsourcing manufacturing of APIs to contract manufacturers. For instance, in October 2017, Piramal Pharma Solutions (PPS), a contract development and manufacturing organization invested US$ 55 million across its sites in Asia to expand its API manufacturing capabilities and capacities.
Active Pharmaceutical Ingredients Market Report Coverage
||Market Size in 2020:
||US$ 180.4 Bn
|Historical Data for:
||2016 to 2019
||2020 to 2027
|Forecast Period 2020 to 2027 CAGR:
||2027 Value Projection:
||US$ 284.3 Bn
- North America: U.S. and Canada
- Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
- Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
- Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
- Middle East: GCC Countries, Israel, and Rest of Middle East
- Africa: South Africa, North Africa, and Central Africa
- By Product Type: Low Potent APIs, High Potent APIs.
- By Molecule Type: Small Molecules, Large Molecules.
- By Formulation: Oral, Topical, Injectables, Drops.
- By Application: Diabetes, Oncology, Cardiovascular, CNS, Analgesics, Ophthalmic, Respiratory, Dermatology, Others.
Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Endo International plc, Dr. Reddy’s Laboratories Ltd., Novartis AG, Mylan N.V., Amneal Pharmaceuticals LLC, Lonza Group, Stada Arzneimittel AG, Lupin Limited, Fresenius Kabi, Hikma Pharmaceuticals, Aurobindo Pharma Limited, Apotex Inc., Cipla Limited, Taro Pharmaceutical Industries Ltd., Biological E. Limited, CordenPharma International, Evonik Industries AG, Sun Pharmaceutical Industries Ltd., Glenmark Pharma, and Krka Pharmaceuticals
- Increasing prevalence of chronic diseases
- Geographic expansion of active pharmaceutical ingredient manufacturers in Asia
- Increasing investment in research and development by manufacturers
|Restraints & Challenges:
- Strict Regulatory Scenario
Figure 2. Global Active Pharmaceutical Ingredients Market Share (%), by Product Type, 2020
Geographic expansions by API manufacturers are expected to drive the market growth during the forecast period.
Several active pharmaceutical ingredients manufacturers are expanding their presence across the globe. API manufacturers are establishing their commercial production units in Asia Pacific to remain competitive and gain advantage over other competitors.
For instance, in May 2019, BASF and SINOPEC have started production at the propionic acid plant at the Verbund site, China. The new plant has an annual production capacity of 30,000 metric tons of propionic acid.
Global Active Pharmaceutical Ingredients Market – Impact of Coronavirus (COVID-19) Pandemic
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency. According to the World Health Organization’s report, the manifestation of coronavirus disease (COVID-19) has resulted in more than 58.6 million infected individuals worldwide as of November 23, 2020. As most API manufacturers are based in China and India, the global supply has been impacted significantly due to the COVID-19 outbreak in these countries. For instance, as per US FDA Center for Drug Evaluation and Research, total API demand from the U.S. biopharmaceutical companies is fulfilled by 230 API manufacturing facilities in China (13% of total supply facilities), 510 in the U.S. (28%), and remaining 59% or 1,048 facilities other countries. Manufacturing sites which are based in countries worst hit by COVID-19 have been affected severely due to severe shortage of medical resources and raw materials at these countries. This has led to global supply disruption.
Global Active Pharmaceutical Ingredients Market - Restraint
Stringent regulatory guidelines are expected to hinder growth of the global active pharmaceutical ingredients market. Stringent global regulatory policies on quality assessments of active pharmaceutical ingredients manufacturing, facility certification, enhanced cGMP guidelines tightening surprise inspection regimes, and increased supply chain security issues in emerging countries impacted cost of final active pharmaceutical ingredients products.
Major players operating in the global active pharmaceutical ingredients market are Teva Pharmaceutical Industries Ltd., Pfizer, Inc., Endo International plc, Dr. Reddy’s Laboratories Ltd., Novartis AG, Mylan N.V., Amneal Pharmaceuticals LLC, Lonza Group, Stada Arzneimittel AG, Lupin Limited, Fresenius Kabi, Hikma Pharmaceuticals, Aurobindo Pharma Limited, Apotex Inc., Cipla Limited, Taro Pharmaceutical Industries Ltd., Biological E. Limited, CordenPharma International, Evonik Industries AG, Sun Pharmaceutical Industries Ltd., Glenmark Pharma, and Krka Pharmaceuticals.