Overview of This Research:

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.

Market Size Estimation:

Both top-down and bottom-up approaches were used to estimate and validate the total size of the active pharmaceutical ingredients market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

# The key players in the industry and market have been identified through extensive secondary research.

# The revenues generated from the active pharmaceutical ingredients business of leading players have been determined through primary and secondary research.

# All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.

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Expected Revenue Growth:

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.The rising drug R&D, the increasing incidence of chronic diseases, the growing importance of generics, and the increasing uptake of biopharmaceuticals.

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.

Geographical Growth Scenario:

North America was the largest regional market for active pharmaceutical ingredients market in 2019

The global active pharmaceutical ingredients market is segmented into North America, Europe, Asia, Latin America, and Rest of the World. In 2019, North America accounted for the largest share of the active pharmaceutical ingredients market, followed by Europe and the Asia. The large share of North America in the global market is attributed to the growing incidence of preventable chronic diseases, increasing government focus on generic drugs, rising demand for biologics and specialty drugs, and technological advancements in the manufacturing processes of APIs. However, the market in the Asia is expected to grow at the highest CAGR during the forecast period. This can be attributed to the low manufacturing costs, growth in the increase in disposable income, the high prevalence of lifestyle- and age-related diseases, and government efforts to reform healthcare industry.

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Global Leaders:

The global active pharmaceutical ingredients market is highly consolidated. Prominent players in the active pharmaceutical ingredients market include Pfizer Inc. (US), Novartis International AG (Switzerland), Merck & Co. (US), Teva Pharmaceutical Industries Ltd. (Israel), Mylan N.V. (US), Boehringer Ingelheim (Germany), F. Hoffmann-La Roche AG (Switzerland), Sanofi (France), AbbVie (US), Eli Lilly and Company (US), AstraZeneca (UK), Bristol-Myers Squibb (US), and GlaxoSmithKline plc (UK).

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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