2023-2029 is the forecast period in the market report.
High potency active pharmaceutical ingredients (HPAPI) are compounds that are effective at much smaller dosage levels than traditional APIs. HPAPIs are in-demand for their ability to deliver highly targeted treatments at lower doses, resulting in fewer side effects. These ingredients are effective for a variety of indications, including cancer, asthma, diabetes, and autoimmune disorders. The growing applications of HPAPI, along with increasing prevalence of cancer are major factors which are expected to drive growth of the market. Furthermore, the technological advancements in manufacturing of HPAPIs are anticipated to further fuel the growth of the market during the estimated time period.
The growth of the market is driven by an increase in prevalence of cancer around the world. According to the estimates from the World Health Organization (WHO) in 2019, cancer is the first or second leading cause of death before the age of 70 years in 112 of 183 countries and ranks third or fourth in a further 23 countries. According to GLOBOCAN 2020, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. Thus, the rise in prevalence of cancer is expected to drive the demand for HPAPIs over the forecast period.
The market is expected to witness new growth opportunities with a rise in investment in R&D activities by the manufacturer to develop innovative and safer HPAPIs. Also, the rising healthcare expenditure in developing nations is expected to have a positive impact on the growth of the market. Furthermore, technological developments in pharmaceutical sectors are expected to provide strong growth opportunities for the market during the forecast period.
A high risk of cross-contamination associated with HPAPIs is expected to negatively impact on the growth of the market. Also, the majority of HPAPI payloads require just modest clinical and commercial production volumes, but it is difficult to produce gram-scale GMP APIs and payloads. It is expected to restrain the growth of the market.
Lack of skilled professionals and an established healthcare infrastructure in underdeveloped nations are some of the factors that is expected to hinder the growth of the market. Also, high operating costs, fluctuations in good manufacturing practice (GMP), stringent regulatory policies are expected to pose as a key challenge to the growth of the market.
The report provides an in-depth analysis of the global High Potency Active Pharmaceutical Ingredients market including, market size, and compound annual growth rate (CAGR) for the forecast period of 2023-2029, considering 2022 as the base year. An increasing prevalence of cancer is expected to stimulate the demand for high potency active pharmaceutical ingredients, and therefore, the market is expected to witness growth at a specific CAGR from 2022-2029.
Global High Potency Active Pharmaceutical Ingredients market comprises of different market segments like type, synthesis, manufacture, application and geography.
By type, the High Potency Active Pharmaceutical Ingredients market consists of key segments like
The innovative HPAPIs are expected to gain a major share of the market over the forecast period. The growth of the segment is driven by rising demand for personalized and precision medicines, along with the launch of innovative and effective drugs. For instance, in May 2021, Zydus Cadila launched the first biosimilar antibody-drug conjugate trastuzumab emtansine under the brand name Ujvira.
Also, generic segment is expected to witness high growth over the forecast period. Expiry of various drugs and increasing demand for cancer treatment, along with the huge number of cancer treatment drugs in the pipeline for the future are key factors driving the growth of the segment. According to the June 2021 American Journal of Managed Care Report, by 2023, patents of around 20 oncology biologics will expire, which may lead to the production of more biosimilars in cancer care and reduce costs.
On the basis of synthesis, the market includes segments such as
Synthetic HPAPI segment is expected to lead the market over the forecast period. The growth of the segment is attributed to factors like, ease of production, rise in the manufacture of new drugs, and technological advancements in synthesis process.
Also, biotech HPAPIs are expected to witness high growth over the forecast period. A growing demand for biologics, and increasing investment for R& D of new drugs, along with advancements in HPAPI manufacturing technologies are key factors driving the growth of the segment.
By manufacturer, the High Potency Active Pharmaceutical Ingredients market consists of segments like
In-house segment is likely to hold the largest market share in the market during the estimated time period. Key initiatives taken by key players for the development of products suggests that they are preferring in-house manufacturing over outsourcing. It is a major factor driving the growth of the segment. For example, in August 2021, Cipla, Inc. introduced an “API re-imagination” program for expanding its own manufacturing capabilities using recent government incentives, such as production subsidies.
Outsourced segment is expected to witness high growth over the forecast period. The increasing in the adoption of outsourcing in the manufacturing of high potency APIs is a key factor driving the growth of the segment. Also, the developing nations offer a lower cost of manufacturing which is a cost-effective measure for outsourcing. It is expected to positively impact the growth of the segment.
The market finds its major applications in
The oncology application segment is expected to lead the market over the estimated time period. The growth of the segment can be attributed to the increasing prevalence of cancer over the world. For instance, according to GLOBOCAN 2020, an estimated 19.3 million new cancer cases and almost 10.0 million cancer deaths occurred in 2020.
Also, the hormonal segment is expected to grow at a high rate over the forecast period. Thus, the rising prevalence of hormonal diseases, along with increasing awareness of hormonal therapy, are key factors driving the growth of the segment.
The Global High Potency Active Pharmaceutical Ingredients market is studied for the following regions:
North America is likely to dominate the market over the forecast period, owing to increase in prevalence of cancer, presence of advanced healthcare infrastructure, and increasing demand for fast acting and high-efficacy drugs are the most important factors that are expected to stimulate market growth in the region. According to the 2020 report by the American Cancer Society journal, there were an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in 2020. According to GLOBOCAN 2020, in Canada, around 225,800 new cancer cases and 83,300 cancer deaths were recorded in the year 2020. Around 30% of all deaths in Canada are caused by cancer.
Asia-Pacific region is expected to witness high growth over the forecast period. The presence of emerging economies in the region, innovations and technological developments in medical sector, along with increasing health expenditure, rising geriatric population, increasing rates of chronic diseases are key factors driving the growth of the market in the region.
Axiom MRC provides a 360-degree analysis of micro and macro-economic factors with regard to the High Potency Active Pharmaceutical Ingredients market. The report involves an exclusive study on COVID-19 impact analysis. In addition, the report also includes a complete analysis of changes in the global High Potency Active Pharmaceutical Ingredients market, expenditure, and economic and international policies on the supply and demand side. The report also studies the impact of pandemics on global economies, international trade, business investments, GDP, and marketing strategies of key players present in the market.
The market has been significantly impacted by the COVID-19 pandemic. During the COVID-19 pandemic, global the market was severely affected due to supply chain distribution, which has certainly affected the market growth to a major extent. Since China and India are key nations involved in the production of API, the market was severely hampered as COVID-19 increased in the region. According to the Germany Trade & Invest (GTAI) article titled "Covid-19 Fuels Debate over API Production Locations" published in April 2020, around 60% of APIs, including high-potency APIs of the world, are manufactured in India or China. India alone accounts for 18% of the global generic drug manufacturing market, most of which is exported to other countries. China is a major manufacturing location and produces 70% of the APIs, including high-potency APIs, for India's generics industry. This situation makes these two countries the biggest players in the global market for generic medicines. However, these countries were the most affected by the pandemic. As the virus spread globally, India temporarily placed an export curb on 26 drugs and various high-potent APIs, which accounted for around 10% of the country's pharmaceutical exports, to avoid domestic shortages. This factor further negatively impacted the growth of market. However, once the situation improves, the production, supply chains and demand for APIs is anticipated to gradually increase as various industries develop. This is expected to provide lucrative growth opportunities foe key players operating in the market in the upcoming years.
The competitive landscape analysis of the High Potency Active Pharmaceutical Ingredients market is majorly focused on expanding the global growth of high potency active pharmaceutical ingredients industry with new product innovation, and business expansion. An increasing presence of a range of manufacturers operating in high potency active pharmaceutical ingredients sector has led to growing demand for the market. Besides, the market offers a range of products in different applications to fulfil the requirements of consumers, which further contributes to healthy growth in the market.
The key players studied in the market are
June 2022: MilliporeSigma announced the inauguration of its HPAPI facility for oncology drugs worth USD 65 million.
March 2022: The Indian Minister of Health & Family Welfare and Chemical and Fertilisers announced that India had started the manufacturing of 35 pharmaceutical ingredients, which had been imported earlier.
March 2022: Sumitomo Chemical Co., Ltd. started the construction of a new manufacturing plant for active pharmaceutical ingredients (APIs) and intermediates for small molecule drugs in Japan. This project was initiated to enhance the company’s capacity to supply a variety of high-quality APIs and intermediates in response to the increasing demand for small molecule drugs.
The global High Potency Active Pharmaceutical Ingredients market include segments like type, synthesis, manufacture, application, and geography. By type, the High Potency Active Pharmaceutical Ingredients market includes key segments like innovative and generic. The innovative HPAPIs are expected to gain a major share of the market over the forecast period. On the basis of synthesis, the market includes segments such as synthetic and biotech. Synthetic HPAPI segment is expected to lead the market over the forecast period. By manufacturer, the High Potency Active Pharmaceutical Ingredients market consists of segments like synthetic, biotech, and others. In-house segment is likely to hold the largest market share in the market during the estimated time period. The market finds its major applications in oncology, hormonal disorders, glaucoma, and others. The oncology segment is expected to lead the market over the forecast period. The Global High Potency Active Pharmaceutical Ingredients Market is studied across various key countries of regions: North America, Europe, Asia-Pacific and the Rest of the World. North America is expected to dominate the market over the forecast period.
Sizing for Year:||2019-2029|
Segment studied:||USD Million|
Players and its Competitors:|
Players and its Competitors:|
Merck & Co., Inc.
Thermo Fisher Scientific Inc.
F. Hoffmann-La Roche Ltd.
Sun Pharmaceutical Industries, Ltd.
Boehringer Ingelheim International GmbH
Eli Lilly and Company
Bristol-Myers Squibb Company
Teva Pharmaceutical Industries Ltd.
Dr. Reddy’s Laboratories Ltd.Albany Molecular Research, Inc.
What would be forecast period in the market report?
2023-2029 is the forecast period in the market report.
Which is the leading application segment for High Potency Active Pharmaceutical Ingredients market?
Oncology has accounted the major market share, and is expected to witness the growth at highest pace during the forecast period.
Which region is gaining the majority of market share during the forecast period (2023-2029)?
North America is expected to gain a major market share during the forecast period (2023-2029).