High Potency Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Product (Synthetic, Biotech), By Manufacturer Type (In-house), By Drug Type, By Application, By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global high potency active pharmaceutical ingredients market size was exhibited at USD 26.19 billion in 2022 and is projected to hit around USD 48.25 billion by 2032, growing at a CAGR of 6.3% during the forecast period 2023 to 2032.

Key Pointers:

• In 2022, synthetic segment held a dominant share in the HPAPI market owing to its easier synthesis and effectiveness in treatment offered by synthetic HPAPI
• Outsourced segment is projected to grow at the fastest rate over the forecast period owing to the increasing adoption of outsourcing of HPAPI
• Innovative HPAPI segment is the highest revenue-generating segment in 2022 owing to the increased focus on R&D.
• Oncology segment dominated the overall market owing to the rising cancer incidence worldwide along with an enhanced focus on targeted therapies
• Asia Pacific is expected to witness the fastest growth during the forecast period owing to the improved manufacturing facilities and the availability of many generic HPAPI producers

High Potency Active Pharmaceutical Ingredients Market Report Scope

The growth of the HPAPI market is attributed to rising incidence of cancer, growing targeted therapies, and increasing application of high potency active pharmaceutical ingredients (HPAPI) in treating target diseases. Rising prevalence of cancer is expected to be a major factor. According to the WHO, cancer is the second leading cause of death, accounting for around 9.9 million deaths in 2020. Due to the growing number of people who contract the disease, cancer is regarded as one of the major health risks. The CDC states that factors such as smoking, obesity, alcohol use, and UV radiation exposure are risk factors for cancer since they contribute to the overall burden of the illness.

With limited treatment options and side effects associated with chemotherapy, there is a rising popularity of targeted therapy as it does not damage non-cancerous cells. In May 2021, Amgen, Inc. received the U.S. FDA approval for the launch of LUMAKRAS for treating patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. LUMAKRAS is the first targeted product for the treatment of G12C-mutated KRAS NSCLC patients. This is likely to increase the demand for HPAPIs in the coming years. Characteristics of these anti-cancerous drugs, such as minimum exposure of drugs to non-cancerous cell and their effectiveness, are contributing to market growth.

The proprietary technology of companies, such as drug designing & delivery technology helps develop novel treatment and HPAPI alternatives through collaborations with other key players, which may increase the number of research initiatives. For instance, in November 2021, the company launched a novel technology ChetoSensar to enhance the development of Antibody–Drug Conjugates (ADCs) therapies. This initiative is aimed at significantly doubling the company’s efforts to boost its production of HPAPIs and ADCs.

Moreover,a closed containment facility is needed to manufacture HPAPIs because they are complex substances. To sustain continuous production, generic manufacturers are investing in the development of their facilities for manufacturing and technology improvements within these facilities, which is anticipated to propel the growth of the generic medication market throughout the course of the forecast period. Furthermore, key players operating in the HPAPI market are focusing on expanding. For instance, in March 2022, Lonza announced the laboratory expansion completion for its Nansha, China facility. The expansion was aimed at capacity enhancement of its small scale facilities for CGMP production of high potency APIs. 

North America dominated the high potency active pharmaceutical ingredients market with a share in 2022. The dominance of the region is due to the increase in prevalence of cancer, developed infrastructure and the presence of key market players operating in the market. For instance, in 2021, the estimated numbers of new cancer cases were 1.9 million and the number of deaths were around 608,570 in the United States. The region is anticipated to grow as a result of rising regulatory support and the increasing incidences of chronic diseases with an increasing demand for fast acting and high-efficacy drugs.

The Asia Pacific is estimated to show the fastest growth over the forecast period. The growth of the region is attributed to the presence of emerging economies in the region. Presence of India and China which are major suppliers of HPAPI across different regions further makes it a source of reliance for manufacturers. Moreover, the region offers API and HPAPI at a lower cost which further boosts the market growth. Furthermore, the advent of generics and improvement in healthcare facilities further facilitate growth.

High Potency Active Pharmaceutical Ingredients Market Segmentation