Overview of This Study:

This study involved four major activities in estimating the current size of the active pharmaceutical ingredient 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.

Recent Developments in the Global Active Pharmaceutical Ingredient Market:

# In 2020, Pfizer (US) signed a multiyear agreement with Gilead Sciences to manufacture and supply Gilead’s antiviral drug (Remdesivir) for the treatment of COVID-19.

# In 2020, Novartis (Switzerland) acquired Aspen’s Japanese operations to strengthen its position in the global generics and off-patent medicines market.

# Novartis also entered into a manufacturing and supply agreement with Aspen.

# In April 2020, Boehringer Ingelheim (Germany) acquired Northern Biologics, which focuses on therapeutic antibodies targeting the tumor microenvironment. This acquisition broadened Boehringer Ingelheim’s oncology product portfolio.

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

Geographically, the active pharmaceutical ingredient market is segmented into North America, Europe, Asia, 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 Pacific. 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.

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