Overview of This Study:
The study involved four major activities in estimating the current size of the global active pharmaceutical ingredient market. Exhaustive secondary research was done 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. Thereafter, market breakdown and data triangulation were used to estimate the market size of segments and subsegments.
Major Growth Influencing Factors:
Some of the key factors propelling this market’s growth are the expansion of production capacity by biopharmaceutical and pharmaceutical companies, the increasing significance of generics, and technological developments in API manufacturing. However, it is anticipated that in the upcoming years, the market for active pharmaceutical ingredients will be restrained by the unfavorable drug price control policies in many different countries as well as the growing prevalence of counterfeit drugs.
Projected Surge in Global Revenue Growth:
The global active pharmaceutical ingredient market in terms of revenue was estimated to be worth $145.9 billion in 2022 and is poised to reach $216.4 billion by 2027, growing at a CAGR of 8.2% from 2022 to 2027.
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Major Growth Driver & Global Opportunities
Driver: Focus on precision medicine
Precision medicine takes into account the individual differences in genetics, environment, and lifestyle. This method has improved the accuracy of predicting preventive and treatment plans for a given disease in specific populations. By using this approach, patients are guaranteed to receive therapeutic or preventive interventions that maximize benefits while minimizing costs and complications.
The acceptance of precision medicine is growing among physicians, insurance companies, governments, patients, and pharmaceutical companies. Precision medicine has already yielded significant findings and a number of novel FDA-approved treatments that are customized to each patient’s unique set of characteristics. The US government established the All of US research program in 2018 after realizing the potential of precision medicine. The program aims to oversample communities that are underrepresented in research by enrolling one million or more volunteers. The program’s main objective is to make advances in precision medicine. In order to support their participation in the program, 46 community health centers received a grant of USD 21 million from the HHS Health Resources and Services Administration (HRSA).
Opportunity: Emerging biosimilars market
The rising prevalence of various diseases, the increasing number of off-patent biologic drugs, positive results in ongoing clinical trials for biosimilars, and rising demand for biosimilars in various therapeutic applications (such as rheumatoid arthritis and blood disorders) are the major factors driving the biosimilars market’s growth. Biosimilars are generic versions of patented biologic drugs that do not have to meet the stringent requirements of various regulatory authorities, making them less expensive than patented biologics. Over the next decade, the expiration of patents and other intellectual property rights for originator biologics is expected to create opportunities for biosimilars to enter the market.
Geographical Growth Dynamics:
North America dominated the market in 2021.
In 2021, North America was expected to dominate the market, followed by Europe. Major factors driving the overall growth of the APIs market in this region include technological advancements in the manufacturing processes of APIs, the presence of major pharmaceutical & biopharmaceutical manufacturing facilities, and increasing government focus on generic drugs.
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Recent Developments of Active Pharmaceutical Ingredient Industry:
# In 2022, Pfizer entered into an agreement with Acuitas to deliver a lipid nanoparticle delivery system for use in mRNA vaccines such as COMIRNATY ((tozinameran) and therapeutics.
# In 2022, Sanofi and IGM announced a strategic collaboration agreement to streamline and optimize the development and commercialization of IgM antibody agonists for oncology, immunology, and inflammation target.
# In 2022, Boehringer Ingelheim and Mabgenesis collaborated to develop novel monoclonal antibodies for canine therapeutic treatments.
# In 2021, Pfizer invested USD 68.5 million in in new state-of-the-art facility in Durham, NC, to further advance gene therapy capabilities.