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.
This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe. According to an article published in Nature Reviews, the pharmaceutical industrys 20 top-selling cancer drugs generate annual sales of over USD 50 billion worldwide, with Roche's Rituxan, Avastin, and Herceptin in the leading position generating USD 21 billion in sales.
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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.
Manufacturers may also be required to invest in specialized facilities for HPAPI-antibody conjugations that incorporate both potent-compound handling and biologics processing capabilities. For instance, in October 2015, ADC Biotechnology (UK), invested USD 10 million to build a manufacturing facility for advanced anti-cancer drugs. These requirements of large investments is likely to restrain the growth of this market.
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%.
Furthermore, developing regions have lenient and flexible regulations, which make these markets highly lucrative for providers who are unable to meet the stringent standards set by the federal government in the US. Moreover, developing countries like India and China offer extremely low manufacturing and labor costs and highly skilled labor; this encourages players in developed regions to invest in this market.
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.
Research Methodology Followed for This Study:
The study estimates the market size for 2018 and projects its demand till 2023. In the primary research process, various sources from both demand side and supply side were interviewed to obtain qualitative and quantitative information for the report. Primary sources from the demand side included hospitals, research institutes, and laboratories.
For the market estimation process, both top-down and bottom-up approaches were used to estimate and validate the market size of the HPAPI market as well as to estimate the market size of various other dependent submarkets. All possible parameters that affect the market covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. This data was consolidated and added to detailed inputs and analysis from MarketsandMarkets and presented in this report.
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Secondary sources such as directories, databases, white papers, annual reports, company house documents, investor presentations, and SEC filings of companies were referred to. Some of the secondary sources include Active Pharmaceutical Ingredients Committee (APIC), Chemical Pharmaceutical Generic Association (CPA), Swiss Biotech Association, International Pharmaceutical Congress Advisory Association (IPCAA), World Health Organization (WHO), American Cancer Society (ACS), American Association for Cancer Research (AACR), Canadian Cancer Society, and European Association for Cancer Research (EACR).
