The global high potency active pharmaceutical ingredients market size was exhibited at USD 24.28 billion in 2022 and is estimated to surpass around USD 55.66 billion by 2032, expanding at a compound annual growth rate (CAGR) of 8.7% during the forecast period 2023 to 2032.
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The high potency active pharmaceutical ingredients (HPAPI) are more effective than conventional APIs at considerably lower dosage levels, but their handling issues are unique due to their potency. One significant reason anticipated to propel the market for highly potent active pharmaceutical ingredients is the increased incidence of cancer (HPAPIs). The WHO estimates that cancer is the second leading cause of mortality, accounting for nearly 9.6 million deaths in 2019, with tobacco use accounting for 22% of those deaths. The entire burden of the disease has been attributed, according to the CDC, to risk factors including lifestyle modifications like smoking, obesity, drinking alcohol, and exposure to UV radiation from the sun or tanning beds. Furthermore, it is predicted that the cost of cancer treatment will rise to USD 174 billion by the end of 2022, which will likely drive market expansion.
The market for high-potency active pharmaceutical ingredients (HPAPI) is expected to increase as a result of factors such as the rising demand for outsourcing HPAPI manufacturing and the abundance of targeted therapeutic medications in the pipeline. The market for high-potency active pharmaceutical ingredients (HPAPI) is expected to grow quickly, but the concentration of technical competence in the hands of a select few significant businesses and the absence of global regulatory regulations and standards are expected to accelerate this expansion.
Scope of the High Potency Active Pharmaceutical Ingredients Market
|Market Size in 2023||USD 26.27 Billion|
|Market Size by 2032||USD 55.66 Billion|
|Growth Rate from 2023 to 2032||CAGR of 8.7%|
|Largest Market||North America|
|Fastest Growing Market||Asia Pacific|
|Forecast Period||2023 to 2032|
Key Market Drivers
Rising demand for drugs
Increasing clinical trials
Key Market Challenges
Key Market Opportunities
Opportunities for CMOs and CDMOs are expanding
The synthetic category accounted for the greatest revenue share in 2022. In the upcoming years, a number of synthetic compounds are also predicted to lose their patent protection, which is likely to spur industry expansion. Since 2007, the Japanese government has encouraged the use of generic medications to lower the overall cost of healthcare and lessen the financial strain on patients.
Due to technical improvements and the high level of efficacy of these substances, the biotech segment is anticipated to grow profitably during the forecast period.
Drug Type Insights
Due to increased R&D efforts for the creation of novel pharmaceuticals and advantageous government laws, innovative drugs made up the greatest revenue share in 2022. The development of innovative APIs is being driven by the increasing emphasis on personalized and precision medicines, such as Antibody Drug Conjugates (ADCs), to treat specific patient problems, making innovation in this field a high-impact market driver.
Over the projected period, generic medication molecules are anticipated to grow at the fastest rate. Lower prices and the patent expiration of branded medications are two factors that are driving this market segment. Due to the increase in patients in emerging nations with low per capita incomes, generic medications are also increasing their market share. The Association of Accessible Medicines reports that in 2017, the number of manufacturing facilities significantly increased in Asia, Australia, and the EU5.
Due to the substantial use of HPAPIs in oncology medications, the oncology segment had the greatest sales share in 2022. One significant element driving the increase in demand for HPAPIs is the rise in cancer prevalence. The WHO estimates that there were 18 million cancer diagnoses worldwide in 2018, with 8.5 million cases affecting women and 9.5 million cases affecting males.
As a result of glaucoma's rising incidence in both established and developing nations, the glaucoma market is expected to experience exponential expansion in the years to come. Additionally, the market for HPAPIs is anticipated to rise more quickly due to the increasing trend in the occurrence of infectious disorders with antibiotic resistance.
Manufacturer Type Insights
The in-house sector generated the most revenue in 2022, and it is anticipated that it will continue to lead during the forecast period. To create these compounds, the businesses make significant infrastructure and development expenditures.
Further evidence that important firms are more focused on internal production than outsourcing comes from recent developments and initiatives. For instance, Novartis stated in November 2019 that it had acquired Cell for Cure, a CDMO with offices in France, in order to make molecules internally that had previously been given to Cell for Cure on a contract manufacturing basis.
High Potency Active Pharmaceutical Ingredients Market Share, By Region, 2022 (%)
|Regions||Revenue Share in 2022 (%)|
On the basis of geography, North America is anticipated to dominate the market. When it comes to the prevalence of diseases like cancer and neurological illnesses, the U.S. was the most impacted nation in the entire world. The region's output of HPAPIs is rising as a result of the rising prevalence of these illnesses. In several therapeutic, drug-discovery, or other research investigations pertaining to oncology and other serious conditions, HPAPIs are frequently used. As a result of the region's growing patient population relative to other nations, the demand for the same will be considerably larger in North America.
Growing elderly population as well as the rising prevalence and incidence of infectious diseases in this region, North America is anticipated to account for a sizable portion of the market for high-potency APIs and HPAPIs. Incidence rates for chronic conditions like cancer are similarly high in the US. According to the American Cancer Society's 2020 report, there were 606,520 cancer deaths and 1.8 million newly diagnosed cases of cancer in 2020. The Parkinson's Foundation estimates that approximately 1 million Americans have Parkinson's disease, which is more than the combined number of people with muscular dystrophy, multiple sclerosis, and amyotrophic lateral sclerosis. By 2032, this number is projected to rise to 1.2 million.
In March 2022 – Pfizer successfully acquires Arena Pharmaceuticals. The agreement will boost the company's Inflammation and Immunology Therapeutic Area by bringing Arena Pharmaceuticals' pipeline there, advancing efforts to improve the lives of people with immuno-inflammatory illnesses.
In July 2022– A partnership between Albany Molecular Research, Inc. (AMRI) and Biasing Technologies, Inc. for the supply of merimepodib for the production of antivirals for the treatment of SARS-CoV-2 has been announced. The company can maintain its position in the market and increase its revenue thanks to this supply deal.
Key Market Players
Segments Covered in the Report
By Manufacturer Type
By Drug Type
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