High Potency APIs Market Expected to Reach $41.4 Billion by 2031—Allied Market Research

According to a new report published by Allied Market Research, titled, “High Potency APIs Market," The high potency apis market size was valued at $19.7 billion in 2021, and is estimated to reach $41.4 billion by 2031, growing at a CAGR of 7.7% from 2022 to 2031.

A significant aspect of the pharmaceutical manufacturing industry is high-potency active pharmaceutical ingredients (HPAPIs). The high potency APIs market analysis offers a range of different products from clinical domains, including drugs having application in oncology and hormonal imbalance. Nevertheless, the majority of HPAPIs are utilized for the production of anti-cancer drugs with a number of innovations, including packaging, which are fostering the market's expansion.

According to the NCBI, National Center for Biotechnology Information, atrial fibrillation is the most frequent cardiac arrhythmia and is estimated that 6-12 million people worldwide will suffer with this condition in the U.S. by 2050 and 17.9 million people in Europe by 2060. Also, people of European descent are more likely to have atrial fibrillation than African Americans. Thus, the prevalence of the cardiovascular disease cases around the globe along with rise in the number of other multi-genetic disorders, is projected to lead towards the growth of the high potency APIs market trends.

Furthermore, the rise in the outsourcing process for HPAPI production, along with the developments in favorable regulatory frameworks, production of extremely effective high potency APIs, surge in demand for antibody-drug conjugates, and government initiatives to expand the usage of the generic drugs are the factors accelerating the growth of the high potency APIs market size.

Also, the high potency drugs hold the larger percentage of medicines, including both that are being developed and innovated recently and those that are already available in the market. The patent expiry of the drugs available in the market provides lucrative opportunities for the market players to enter this market. This is boosting the ability and capacity of the key market players to produce highly potent APIs (HPAPIs), especially for the contract manufacturing businesses (CMOs), and thus leading to the expansion of the market.

Furthermore, rise in the advancements in the high potency APIs manufacturing technologies will favor the growth of the high potency APIs industry during the forecast period. These advancements offer faster results, accuracy and better efficacy than the existing technologies. In addition, a growing digital toolbox is enabling pharmaceutical developers to advance the high potency API production. Digital modelling and simulation, process analytical technology (PAT), automated visual assessment and documentation, virtual and augmented reality, and machine learning and data analysis are the digital technologies that helps to safely and effectively advance HPAPI production at various points in the development process, which further propels the growth of the market

However, the market is expected to be significantly constrained in the near future due to high risk of cross-contamination and high development cost associated with the manufacturing process.

By product type, the innovative high-potency API segment was the largest segment in the 2021 and is expected to grow at a highest CAGR during the high potency APIs market forecast period, due to increase in the number of patents approvals, rise in patients’ trust in the branded drugs, and surge in the investment by the key market players in research and development of new HPAPIs.

By application, the oncology segment held a dominant portion in the global high potency APIs industry in 2021 and is expected to grow at the fastest CAGR during the forecast period due to the new innovations in the oncology sector and the advantages that the HPAPIs provides in the cancer treatment.

By type of synthesis, the biotech segment held the largest high potency APIs market share in 2021 and is expected to grow at the highest CAGR during the forecast period, because of the adoption of advanced and precise techniques by the pharmaceutical manufacturers for synthesizing APIs on the large scale and rising awareness about the biotechnology sector in the treatment of disease.

Region wise, North America acquired a major high potency APIs market share in 2021, due to the manufacturers in this region, who have been concentrating on creating innovative and effective solutions using HPAPIs. However, Asia-Pacific is expected to witness the highest CAGR for the high potency APIs market throughout the forecast period due to increase in innovations in the high potency APIs, rise in number of the hormonal imbalance diseases, and surge in number of cancer patients in the region.

KEY FINDINGS OF THE STUDY

• By product type, the innovative high-potency API segment was the highest contributor to the market in 2021.
• By application, the oncology segment was the highest contributor to the market in 2021, and is expected to continue this trend during the forecast period.
• Depending on type of synthesis, the biotech segment was highest contributor in 2021 and is expected to grow at the fastest CAGR during the forecast period.
• Region wise, North America garnered the largest revenue share in 2021, whereas Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.