High Potency Active Pharmaceutical Ingredients Market Challenges: Addressing Safety Concerns

The global high potency active pharmaceutical ingredients market size is expected to reach USD 40.66 billion by 2030 and is expected to expand at a compound annual growth rate (CAGR) of 6.2% from 2023 to 2030, according to a new report by Grand View Research, Inc. 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.

Gather more insights about the market drivers, restrains and growth of the Global High Potency Active Pharmaceutical Ingredients Market

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.

High Potency Active Pharmaceutical Ingredients Market

  • 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

Browse through Grand View Research’s Pharmaceuticals Industry Research Reports.

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High Potency Active Pharmaceutical Ingredients Market Segmentation

Grand View Research has segmented the global high potency active pharmaceutical ingredients market report based on product, manufacturer type, drug type, application, and region:

High Potency Active Pharmaceutical Ingredients (HPAPI) Product Outlook (Revenue, USD Million, 2018 – 2030)

  • Synthetic
  • Biotech

High Potency Active Pharmaceutical Ingredients (HPAPI) Manufacturer Type Outlook (Revenue, USD Million, 2018 – 2030)

  • In-house
  • Outsourced

High Potency Active Pharmaceutical Ingredients (HPAPI) Drug Type Outlook (Revenue, USD Million, 2018 – 2030)

  • Innovative
  • Generic

High Potency Active Pharmaceutical Ingredients (HPAPI) Application Outlook (Revenue, USD Million, 2018 – 2030)

  • Oncology
  • Hormonal
  • Glaucoma
  • Others

High Potency Active Pharmaceutical Ingredients (HPAPI) Regional Outlook (Revenue, USD Million, 2018 – 2030)

  • North America
    • S.
    • Canada
  • Europe
    • K.
    • Germany
    • France
    • Spain
    • Italy
    • Denmark
    • Sweden
    • Norway
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • Thailand
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE
    • Kuwait

Order a free sample PDF of the High Potency Active Pharmaceutical Ingredients Market Intelligence Study, published by Grand View Research.

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