According to the new market research report, "Active Pharmaceutical Ingredient (API) Market by Type (Innovative, Generic), Manufacturer (Captive, Merchant), Synthesis (Synthetic, Biotech), By Product (Vaccines, Hormones), Drug (Otc, Rx), Application (Diabetes, Oncology, CVD) & Region - Global Forecast to 2025", The global active pharmaceutical ingredients market 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.

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Global Industry Growth Boosting Factors:

The rising drug R&D, the increasing incidence of chronic diseases, the growing importance of generics, and the increasing uptake of biopharmaceuticals. On the other hand, unfavorable drug price control policies across various countries and high manufacturing costs are expected to restrain the growth of this market are the major factors driving the growth of this market.

Overview:

This study involved four major activities in estimating the current size of the active pharmaceutical ingredients market. Exhaustive secondary research was carried out to collect information on the market, its peer markets, and its parent market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.

DRIVER: Increasing incidence of chronic diseases

Over the last few decades, the incidence of chronic diseases such as diabetes, coronary artery disease, chronic obstructive pulmonary disease (COPD), asthma, hepatitis, arthritis, and cancer has increased significantly in major regions across the globe. This can be attributed to the rising geriatric population across the globe (by 2050, more than 20% of the global population is expected to be aged over 65 years), changing lifestyles, and dietary changes as a result of rapid urbanization. According to the International Diabetes Federation, in 2019, 463 million people worldwide were diagnosed with diabetes. Moreover, the number of new cancer cases per year is expected to rise to 23.6 million by 2030. Apart from cancer, a number of other diseases have shown increasing prevalence rates.

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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.

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.

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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