Global Revenue Growth Expectations:
The Global High Potency APIs Market is expected to reach USD 26.84 Billion by 2023 from USD 17.72 Billion in 2018, at a CAGR 8.7%.
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%.
Major Growth Boosters:
The growth in High Potency APIs Market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies, and growing focus on precision medicine.
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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. 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).
North America to dominate the HPAPIs market in 2018
In 2018, North America is expected to account for the largest share of the market followed by Europe. Factors such growing incidence of cancer, increasing investments in cancer research, technological advancements in HPAPI manufacturing, growing CMOs market, constructive government reforms like the Patient Protection and Affordable Care Act, growing focus of leading pharmaceutical companies in the HPAPIs segment, and increasing demand for antibody-drug conjugates (ADCs) are responsible for the large share of North America in the global High Potency APIs Market.
Agreements, partnerships, collaborations, and alliances accounted for the largest share of the overall growth strategies followed by key players between 2015 and 2018. Some of the key players in the High Potency APIs Market include Pfizer (US), Novartis (Switzerland), Merck (US), Teva (Israel), Mylan (US), Boehringer Ingelheim (Germany), Sanofi (France), F. Hoffmann-La Roche (Switzerland), AbbVie (US), Eli Lilly (US), Mylan (US), and Bristol-Myers Squibb (US).
Constant evolution of industry standards and technologies
One of the major challenges faced by the players in High Potency APIs 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.
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