Global Active Pharmaceutical Ingredient Market - 2021-2028
The global active pharmaceutical ingredient market size was valued at US$ XX million in 2019 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX% during the forecast period (2021-2028).
Active pharmaceutical ingredient (API) is a part of any drug that produces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways. They are produced using highly technological industrial processes, both during the R&D and the commercial production phase.
The global active pharmaceutical ingredient market growth is driven by an increase in the number of chronic diseases, an increase in the number of geriatric populations around the world. The increased utilization of biopharmaceuticals and rising investments in research and development for drug manufacturing are all contributing to the growth of the global active pharmaceutical ingredients (API) market.
The surge in the use of biosimilar products will drive the market growth
Biosimilars are generic versions of copyrighted biologic medications that do not meet the same severe regulatory criteria as branded biologic medicines. Thus, the patents and other intellectual property rights for originator biologics are likely to expire, allowing biosimilars to join the market. As a result, the surge in the use of biosimilar products is propelling the growth of the active pharmaceutical ingredients (API) market during the forecast period.
Moreover, the launches of new drugs and biological products, acquisitions, collaborations, and regional expansions are some of the strategic initiatives to maintain stability in the market. This is likely to fuel market growth in the near future. For instance, in 2020, Quartic.ai and Bright Path Labs collaborated to develop AI-based technology for the continuous manufacturing of critical AP The active pharmaceutical ingredients (API) market has traditionally been dominated by drugs, such as anti-infectives and diabetes, cardiovascular, analgesics, and pain management drugs. However, as per the R&D trends, the demand is shifting toward the development of complex APIs used in novel formulations, targeting niche therapeutic areas. Is that are required for producing crucial small-molecule drugs.
Another important growth driver is the rise in the geriatric population around the world. According to the United Nations, there were 703 million people aged 65 and above worldwide in 2019. Such a high geriatric population gives way to contract a lot of chronic and acute diseases which would require newer drugs to mitigate their effects, thus leading to a rise in market growth.
High manufacturing costs will hamper the market growth
The high manufacturing cost of APIs is one of the major challenges faced by market players. Manufacturers often have to make costly investments for improvements in their manufacturing facilities to ensure compliance with standards such as the cGMP. This includes the renovation of production facilities, inculcating familiarity with qualification requirements and processes, and building a dossier of product efficacy and safety tests that meet the requirements of regulatory authorities. Furthermore, the costs of obtaining regulatory approvals are relatively higher for firms with small volumes. The chemical synthesis of APIs also often requires expensive and uncommon building blocks and raw materials, which further adds to API manufacturing costs. These factors are hampering the growth of the market in the forecast period.
The COVID-19 pandemic had a favorable impact on the market as the countries and major players are manufacturing huge amounts of ingredients to maintain the demand for the treatment of COVID 19. The outbreak of COVID-19 has led drug manufacturers to redirect their models to focus on a larger pool of patients. For instance, the United States requested that hydroxychloroquine (HCQ) be imported from India as a treatment for coronavirus. The virus has also disrupted the drug supply chain in Canada and may cause problems for patients in the country. Canadian pharma majors expand their programs with countries other than China to gain access to new regions. On March 24, 2020, the WHO announced that it had initiated a global mega trial of the four most promising drugs against COVID-19. Countries are in a global race to develop and mass-produce an efficient vaccine to fight COVID-19. The economic and social burden of pandemics has prompted government bodies to increase funding for vaccine development on a global scale. These factors will drive the growth of the market during a pandemic.
The cardiovascular segment is expected to grow at the fastest CAGR during the forecast period (2021-2028)
The cardiovascular segment holds a significant share due to the vast population using various CVD drugs owing to the high prevalence of cardiovascular diseases. According to the European Society of Cardiology 2019 Statistics, cardiovascular diseases (CVD) remain the leading cause of mortality and a major cause of morbidity in Europe. Currently, there are more than 6 million new cases of CVD in the EU and more than 11 million in Europe as a whole, every year. With almost 49 million people living with the disease in the EU, the cost to the EU economies is high at EUR 210 billion a year. This factor will drive the growth of the segment in the forecast period.
North America region holds the largest market share of the global active pharmaceutical ingredient market
North America currently dominates the market for active pharmaceutical ingredients and is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future, owing to the increasing incidences of disease and rising aging population. The United States holds the majority of the market in the North American region.
The recent political and trade policies implemented by the US government to increase import duties and taxes are expected to drive operational costs and increase the pricing pressure on the manufacturers. The FDA has also increased the application fees for new drug approvals and has increased the number of periodic inspections conducted on various off-shore contract manufacturing facilities to ensure the supply of high-quality products to the US market. These factors are driving the growth of the market in the region.
The active pharmaceutical ingredient market is highly competitive with the presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Aurobindo Pharma, Teva Pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, BASF SE, Boehringer Ingelheim GmbH, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Mylan NV, Sun Pharmaceutical Industries Ltd among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the active pharmaceutical ingredient market globally. For instance, in April 2020, Boehringer Ingelheim acquired Northern Biologics. This acquisition broadened Boehringer Ingelheim's oncology product portfolio.
Overview: Novartis AG is a Switzerland-based pharmaceutical company. The Company develops, manufactures, and markets branded and generic prescription drugs, active pharmaceutical ingredients (APIs), biosimilars, and ophthalmic products.
Anti-Infectives: The Sandoz Anti-Infectives & API business is a fully-integrated provider of affordable, high-quality pharmaceutical intermediates, active pharmaceutical ingredients (APIs), and finished dosage forms.
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