According to the new market research report, "High Potency APIs /HPAPI Market by Type (Innovative, Generic), Synthesis (Synthetic, Biotech, moAB, Vaccines, Recombinant Proteins), Manufacturer (Captive and Merchant), Therapy (Oncology, Glaucoma, Hormonal Imbalance) - Global Forecasts to 2023", The Global HPAPIs Market is expected to reach USD 26.84 Billion by 2023 from USD 17.72 Billion in 2018, at a CAGR 8.7%.

Browse and in-depth TOC on "High Potency APIs Market"
239 - Tables
42 - Figures
216 - Pages

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Increasing demand for oncology drugs

HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs.

Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. According to the WHO, in 2012, there were 14.1 million new cancer cases, 8.2 million cancer deaths, and 32.6 million people living with cancer (within 5 years of diagnosis) worldwide. The American cancer Society estimated that over 15.5 million American citizens were suffering from cancer as of January 2016, with over 1,688,780 new cancer cases expected to be diagnosed in 2017.

Requirement of large investments

The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure.

Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Specialized containment to ensure protection of the employees and their environment from exposure accounts for a major cost. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities; investments may sometimes amount to millions of dollars.

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Opportunity in emerging markets

Emerging economies such as India, China, and the Middle East present high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity (albeit at differing rates).

Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries. According to the WHO, in 2014, nearly 66% of all cancer-related deaths occurred in developing countries. Additionally, according to GLOBOCAN 2012, a total of 6.8 million new cancer cases were reported in 2012 in Asia; this is expected to reach 8.4 million cases by 2020, indicating an increase of ~24%.

Constant evolution of industry standards and technologies

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For example, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US in 2016 to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels. Such a rapidly evolving environment poses a challenge to the players in this market.

Target Audience for this Report:

# Manufacturers of HPAPI
# Distributors and suppliers of HPAPIs
# Potential investors in the HPAPI market
# Pharmaceutical companies
# Biotechnology companies
# Contract manufacturing organizations
# Life science research centers
# Healthcare payers

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