Market Challenges And Opportunities

On the other hand, stringent quality regulations imposed by regulatory authorities and supply chain complications related to hazardous nature of high potency active pharmaceutical ingredients (HPAPIs) are likely to restrain market growth.

Global High Potency Active Pharmaceutical Ingredients Market Drivers:

Rising prevalence of cancer and other chronic diseases: Rising incidence of cancer and other chronic diseases across the globe is a key factor fueling the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. For instance, according to the data published by the American Cancer Society of cancer facts and figures, in January 2023, an estimated 1.9 Mn new cancer cases was diagnosed in 2023, among which prostate cancer is estimated to be 288,300, followed by 238,340 cases of lung cancer, and 300,590 cases of female breast cancer.
Increasing production of biologics and targeted therapies: The development and production of biologics and targeted therapies is one of the major factors fuelling the growth of the global high potency active pharmaceutical ingredients market. Biologics are medicines that are created from living cells and tissues rather than chemical compounds, and they are increasingly being used to treat a variety of complex chronic diseases like cancer, rheumatoid arthritis, and multiple sclerosis. Targeted therapies specifically attack cancer cells with genetic or molecular abnormalities while sparing normal cells and are becoming the mainstay of cancer treatment.
Increased investments by major players: Increased investments by major pharmaceutical companies are significantly driving the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. For instance, in June 2019, Piramal Pharma Solutions (PPS), a leading contract development and manufacturing organization (CDMO), announced the grand opening of a new wing dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low occupational exposure levels (OELs). The total investment required to upgrade the site was approximately US$10 Mn.

Global High Potency Active Pharmaceutical Ingredients Market Opportunities:

Outsourcing of manufacturing by large pharmaceutical companies: Outsourcing of manufacturing by large pharmaceutical companies presents a great opportunity in the global high potency active pharmaceutical ingredients market. As R&D costs soar and patent expirations open markets, pharmaceutical firms are under pressure to cut costs and improve efficiencies. Outsourcing non-core functions like HPAPI manufacturing allows them to focus on drug discovery and advance their pipelines. For instance, in June 2022, Wuxi STA announced the expansion of its HPAPI facility in China, which allows it to cater to CDMO customers that are looking for a complex manufacturing setup.
Increased production of specialty drugs: Increased production of specialty drugs could unlock significant opportunities in the global high potency active pharmaceutical ingredients (HPAPI) market. Specialty drugs, which are used to treat complex conditions such as cancer, autoimmune diseases, growth hormone deficiencies, and others, often require HPAPIs due to their potent nature. With rising prevalence of chronic and complex diseases worldwide, the demand for specialty drugs is projected to grow substantially in the near future.
Adoption of continuous manufacturing: Adoption of continuous manufacturing techniques is having a significant impact on the global high potency active pharmaceutical ingredients market. Continuous manufacturing allows for a more efficient, precise, and flexible production process as compared to traditional batch manufacturing. This trend is driven mainly by regulatory bodies pushing for more advanced quality control and production monitoring techniques.

Global High Potency Active Pharmaceutical Ingredients Market Restraints:

Stringent regulations for manufacturing APIs: Stringent regulations for manufacturing active pharmaceutical ingredients (APIs) are significantly restraining the growth of the global high potency APIs market. Government regulatory bodies across the world have implemented strict norms and quality standards to ensure the safety and efficacy of APIs. This is indispensable with the hazardous nature and potential health risks of high potency APIs. However, complying with these elaborate regulatory frameworks involves substantial funding, time, and
High cost of production: High cost of production is one of the major factors restraining the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. HPAPIs are used in manufacturing medicines for critical illnesses like cancer, infectious diseases, and autoimmune disorders where a very small dose delivers maximum therapeutic benefit. However, their production process is complex and requires advanced manufacturing capabilities and technologies. This makes the overall production costs significantly high for pharmaceutical companies.

Counterbalance: To overcome this restraint, the key market players need to control all other unnecessary costs which might increase the cost of production, thereby aiding in the process of reduction of production cost.

Supply chain issues: Supply chain issues are posing significant challenges for the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. The HPAPI supply chain is a complex global network involving raw material suppliers, contract manufacturers, and finished dose producers across multiple countries. Even a small disruption anywhere in this delicate supply chain can potentially cause serious shortages of life-saving HPAPI drugs.

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