API Market – This is How Pandemic Has Affected the Global API Manufacturing

What the Market Looks Like?

The global active pharmaceutical ingredients market size is projected to reach USD 248.3 billion by 2025 from USD 187.3 billion in 2020, at a CAGR of 5.8% during the forecast period.

COVID-19 impact on the active pharmaceutical ingredients market

With the WHO declaring the COVID-19 outbreak a pandemic, a mix of established pharmaceutical and biopharmaceutical companies, as well as small startups, have stepped forward to develop treatments that target the infection. In just a few weeks, scientists found a list of molecules that target COVID-19. Currently, around 155 molecules are under clinical investigation, and 45 molecules are under preclinical development to be targeted against COVID-19. In this list, there are four promising drugs (Remdesivir, Chloroquine & Hydroxychloroquine, Lopinavir & Ritonavir, and Lopinavir with Ritonavir plus Interferon beta-1a) that have been repurposed for use against COVID-19. 

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. According to the WHO, as of June 2020, there were over 140 vaccines in various stages of development. Of these, 13 are now in the human clinical trial stage, while others remain at the very early stages of preclinical testing. Increase in funding and research for development of pharmaceutical products will drive growth for the market. However, coronavirus outbreak has disrupted business and economic activities globally.in the first quarter of 2020 It is expected to have a short-term impact on the active pharmaceutical ingredients market to a certain extent.

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What Drives the Market?

The growth of the global API Manufacturing Industry is primarily influenced by the following factors:

• Increasing Incidence of Chronic Diseases
• Technological Advancements in API Manufacturing
• Growing Importance of Generics
• Increasing Uptake of Biopharmaceuticals
• Growing Adoption of Artificial Intelligence-Based Tools for Drug Discovery
• Adoption of Organ-On-Chip Models in Drug Development
• Growing Focus on Precision Medicine
• Growing Investments in Real-World Evidence By Pharmaceutical Companies

RESTRAINT:  High manufacturing costs

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.

OPPORTUNITY: Emerging biosimilars market

The rising incidence of various diseases, the increasing number of off-patent biologic drugs, positive outcomes in ongoing clinical trials for biosimilars, and the rising demand for biosimilars in different therapeutic applications (such as rheumatoid arthritis and blood disorders) are the major factors driving the growth of the biosimilars market. Biosimilars are generic versions of patented biologic drugs; hence, they do not need to comply with the stringent requirements of various regulatory authorities (making them cost-effective as compared to patented biologics). The expiration of patents and other intellectual property rights for originator biologics over the next decade is expected to open up opportunities for biosimilars to enter the market.

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