High Potency APIs /HPAPI Market- Growth, Trends, Covid-19 Impact, And Forecasts (2022 - 2027)

High Potency APIs /HPAPI Market- Growth, Trends, Covid-19 Impact, And Forecasts (2022 - 2027)

The High Potency APIs /HPAPI Market is projected to register a CAGR of 8.5% during the forecast period.

During the COVID 19 pandemic, the High Potency APIs /HPAPI Market was adversely affected. COVID 19 primarily affected the supply chain of the API market. Since Southeast Asia (specifically China and India) is the hub for the production of API, the market was severely hampered as COVID increased in this region. According to the Germany Trade & Invest (GTAI) around 60% of APIs including high potency APIs of the world are manufactured either 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 also not only a major manufacturing location itself but also 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 also were one of 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 account for around 10% of the country's pharmaceutical exports – to avoid domestic shortages. This further fueled the adversity in the market. Due to this, the market is adversely affected by the COVID 19. However, various APIs are used in the production of COVID 19 vaccines. Overall, the market would be hindered for short-term durations however, the market will grow significantly once the industry reinforces its supply chain with modern advancements and protocols.

Certain factors that are driving the market growth include increasing demand for drugs (oncology and antibody-drug conjugates), increasing focus on precision medicine and high potency APIs, and technological advancements in high potency API manufacturing. International Agency for Research on Cancer (IARC) updated Globocan 2020 with new estimates about the global cancer burden, which indicates that it has risen to 19.3 million cases and 10 million cancer deaths in 2020. This new study suggests that more than 50 million people are living within 5 years with a cancer diagnosis. Some of the common factors for increasing cancer cases globally are aging populations and socio-economic risk factors. For instance, United States Center for Drug Evaluation and Research (CDER’s) has approved new therapies in 2020 for a wide array of cancers, particularly lung cancers, thyroid cancers, and breast cancers. These therapies include small molecules and large molecules for treatments. High potency APIs are the primary constituents of these drugs. With the growing number of cancer cases, the market will simultaneously grow to provide solutions for the disease. Similarly, according to Parkinson’s foundation around 60,000 Americans are diagnosed with Parkinson's disease each year Additionally, there is a focus on precision medicine in past few years. As not every patient will respond to the same drug, in the same way, it is required to have a personalized medicine to have higher efficacy. These generic drugs are known as pharmacogenetic. In 2020, United States Food and Drug Administration lists around marker information relating to 200 pharmacogenetic drugs. Similarly, in the United Kingdom, the National Health Scheme aiming to integrate genomic medicines into its routine care by 2025. Due to the aforementioned factors, the tracked market is estimated to witness a healthy growth rate during the forecasted period.

Key Market TrendsGeneric High-Potency Active Pharmaceutical Ingredients Segment is Expected to Hold Significant Growth

The High Potency APIs /HPAPI Market is broadly segmented into innovative high-potency active pharmaceutical ingredients and generic high-potency active pharmaceutical ingredients. The primary factor for the growth is the patent expiration of various drugs and increasing demand for cancer treatment combining with the huge cancer treatment drug and pipeline for upcoming years as mentioned above. According to the report published by the American Journal of Managed Care in June 2021, by the year 2023, patents of around 20 oncology biologics will expire, which would lead to the production of more biosimilars in cancer care and therefore reduced costs. According to Roche, Drugs such as Rituxan (a drug for blood cancer) are already facing competition due to the loss of its patent in 2018. Loss of patents leads to low manufacturing costs which leads to more competition, thus propelling the market growth. Due to these reasons, the market will see a high growth period during the forecast period.

North America is Expected to Hold a Major Share in the Market

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

The United States is the most affected country across the world, with the prevalence of disorders such as cancer, neurological disorder, etc. As these disorders are increasing in the past few years to provide the solution for the same the production of high potency APIs is also increasing in the region. As the High potency APIs are widely used in many therapeutic, drug discovery, or other research related to oncology as well other major disorders. Thus, the demand for the same will be significantly higher in the North American region as the patient population is increasing compared to other countries.

North America is expected to hold a major market share in the global High Potency APIs /HPAPI Market due to the rise in the geriatric population, increasing prevalence and incidence of infectious diseases in this region. The incidence of chronic diseases, like cancer, is also high in the United States. As per 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. In addition, as per a 2018 report by the Center for Disease Control and Prevention, there are around 60% of Americans are living with at least one chronic disease and chronic diseases are the leading causes of death and disability in America. Additionally, according to the Parkinson’s foundation, around 1 million people in the United States are living with Parkinson's disease, which is more than the combined number of people diagnosed with muscular dystrophy, multiple sclerosis, and Amyotrophic Lateral Sclerosis. This is expected to rise to 1.2 million by 2030. Similarly, in Canada in 2020, around 225,800 new cancer cases and 83,300 cancer deaths are found. Around 30% of all deaths are caused by cancer alone in Canada. However, Canada has a universal healthcare system for its citizens. Due to this, healthcare is accessible to all. This creates an evenly demand in the region. Due to this, the market has had positive growth during the forecast period.

Moreover, the increase in research and development activities and the presence of favorable healthcare infrastructure are fueling the growth of the overall regional market. ​

Competitive Landscape

The High Potency APIs /HPAPI Market is fragmented competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Thermo Fisher Scientific, Inc, Merck KGaA, Pfizer, Novartis International Ag, and Teva Pharmaceutical Industries.

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AbbVie Inc.
Merck & Co., Inc.
Corden Pharma International
Pfizer Inc.
Sanofi (EUROAPI)
SK biotek
Sun Pharmaceutical Industries Ltd
Teva Pharmaceutical Industries Ltd.
Thermo Fisher Scientific Inc.
Viatris Inc.

1 INTRODUCTION 1.1 Study Assumptions 1.2 Scope of the Study 2 RESEARCH METHODOLOGY 3 EXECUTIVE SUMMARY 4 MARKET DYNAMICS 4.1 Market Overview 4.2 Market Drivers 4.2.1 Increasing Demand for Drugs (Oncology and Antibody-Drug Conjugates) 4.2.2 Increasing Focus On Precision Medicine and High Potency APIs 4.2.3 Technological Advancements In High Potency API Manufacturing 4.3 Market Restraints 4.3.1 Huge Capital Investment 4.3.2 Ever Changing Industry Standards and Guidelines 4.4 Porter's Five Force Analysis 4.4.1 Threat of New Entrants 4.4.2 Bargaining Power of Buyers/Consumers 4.4.3 Bargaining Power of Suppliers 4.4.4 Threat of Substitute Products 4.4.5 Intensity of Competitive Rivalry 5 MARKET SEGMENTATION 5.1 By Poduct Type 5.1.1 Innovative High-Potency Active Pharmaceutical Ingredients 5.1.2 Generic High-Potency Active Pharmaceutical Ingredients 5.2 By Application 5.2.1 Oncology 5.2.2 Hormonal Imbalance 5.2.3 Glaucoma 5.2.4 Other Applications 5.3 By Synthesis 5.3.1 Synthetic High-Potency Active Pharmaceutical Ingredients 5.3.2 Biotech High-Potency Active Pharmaceutical Ingredients 5.4 By Manufacturer 5.4.1 Captive Hpapi Manufacturers 5.4.2 Merchant Hpapi Manufacturers 5.5 Geography 5.5.1 North America United States Canada Mexico 5.5.2 Europe Germany United Kingdom France Italy Spain Rest of Europe 5.5.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific 5.5.4 Middle East and Africa GCC South Africa Rest of Middle East and Africa 5.5.5 South America Brazil Argentina Rest of South America 6 COMPETITIVE LANDSCAPE 6.1 Company Profiles 6.1.1 AbbVie Inc. 6.1.2 Merck & Co., Inc. 6.1.3 Corden Pharma International 6.1.4 Pfizer Inc. 6.1.5 Sanofi (EUROAPI) 6.1.6 SK biotek 6.1.7 Sun Pharmaceutical Industries Ltd 6.1.8 Teva Pharmaceutical Industries Ltd. 6.1.9 Thermo Fisher Scientific Inc. 6.1.10 Viatris Inc. 7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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