High Potency API’s Market- Global Analysis and Forecast (2022-2029)

High Potency API’s Market was valued at US$ 19.60 Bn. in 2021. Global High Potency API’s Market size is expected to grow at a CAGR of 8.6% through the forecast period.
High Potency API’s Market Overview:
The utilization of highly potent active pharmaceutical ingredients (HPAPIs) has resulted in a pipeline of more effective medicines with lower doses and fewer adverse effects, which is the primary reason driving market growth. The market has been stimulated to a large part by increased investments by enterprises in the production of HPAPIs. Partnerships and collaborations with major contract manufacturing organizations throughout the world are also boosting the high potency API business. The rising occurrence of various types of cancer around the world is also propelling the market forward. The rise of targeted therapy approaches in the treatment of various disorders is to boost the market for high potency APIs significantly.

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High Potency API’s Market Dynamics:
Market Drivers: Increased demand for pharmaceuticals (oncology and antibody-drug conjugates), increased focus on precision medicine and high potency APIs, and technological developments in high potency API manufacturing are some of the reasons driving the market growth. The International Agency for Research on Cancer (IARC) shows that the cancer burden has increased to 19.3 million cases and 10 million cancer deaths in 2021. More than 50 million people will be diagnosed with cancer within the next five years. Aging populations and socioeconomic risk factors are two of the most common causes of cancer cases.

For example, the US Center for Drug Evaluation and Research (CDER) approved novel cancer medicines in 2021 for a wide range of tumors, including lung, thyroid, and breast cancers. Small compounds and big molecules are used in these medicines. The fundamental components of these medications are high-potency APIs. As the number of cancer cases increases, so will the demand for cancer treatments. Similarly, roughly 60,000 Americans are diagnosed with Parkinson's disease each year. In recent years, there has also been an emphasis on precision medicine. Because not every patient will respond to the same therapy, in the same way, personal medicine is essential for greater efficacy.

Market Restraints: Cross-contamination is one of the most significant concerns related to HPAPI production. Growing pressure on the pharmaceutical business to cut costs and make biopharmaceuticals more affordable to consumers is driving the market to use as many effective and efficient multi-product and multi-purpose facilities as possible. HPAPIs are generally cytotoxic, therefore efforts to prevent cross-contamination are critical for a safe production process that protects staff, the environment, and patients. Advanced HPAPI antibody conjugation facilities, including potent drug handling and biologics processing, will be expected of manufacturers.

The necessity for large investments is except to stifle this market's growth. Despite the fact that the demand for high potency APIs is growing, pharmaceutical companies face significant hurdles in modernizing their current facilities, which can only handle low or medium-strength APIs. A large percentage of the budget is set out for specialist containment, which protects workers and their surroundings from exposure. Aside from standard GMP manufacturing facilities, contract manufacturers are likely to invest heavily in new facilities designed expressly for HPAPI production.

Market Challenges: One of the most important criteria for HPAPI production operations in process designs. The majority of HPAPI and ADC medication payloads require tiny clinical and commercial volumes. However, creating gram-scale GMP APIs and payloads is difficult. Maintaining containment control while employing flexible and compact equipment, such as glass equipment, is a difficult task that necessitates a unique approach for each process and unit operation. Maintaining proper process designs at the developmental size ensures that the process suits the facility's equipment and capabilities when scaled up.

Moreover, there is confusion about the classification of HPAPIs across the market. Different pharmaceutical companies have their own systems, and due to a lack of data, the classification of new APIs is unknown. Most organizations lack suitable process designs and containment controls, which can reduce these concerns. All of these issues together are except to provide a considerable challenge to HPAPI market competitors.

Covid-19 Impact: The High Potency APIs/HPAPI Market was negatively affected during the COVID 19 epidemic. COVID 19 primarily impacted the API market's supply chain. The business was severely affected as COVID spread throughout Southeast Asia (particularly China and India) because this area is the production hub for API. India and China manufacture over 60% of all APIs, including high potency APIs. India alone produces 18 % of the world's generic drugs, the majority of which are shipped to other countries. China is not just a key manufacturing location, but it also supplies 70% of APIs for India's generics business, including high potency APIs.

As a result of this circumstance, these two countries are the largest players in the generic medication business. These countries, however, were among the hardest hit by the pandemic. To avoid internal shortages as the virus spread around the world, India temporarily halted the export of 26 medicines and several High powerful APIs, which amount to roughly 10% of the country's pharmaceutical exports. This exacerbated the market's difficulties. As a result, the COVID 19 has a negative impact on the market. COVID 19 vaccines, on the other hand, are made with a variety of APIs. Overall, the market will be hampered for a short time; however, if the sector strengthens its supply chain with current innovations and protocols, the market will rise tremendously.

Recent Market Developments:

1. In 2022, Arena Pharmaceuticals was bought by Pfizer. Arena Pharmaceuticals' pipeline will be included in the company's Inflammation and Immunology Therapeutic Area, assisting in future research to improve the lives of patients suffering from immuno-inflammatory disorders.

2. In 2021, Sandoz, a Novartis subsidiary, completed the acquisition of GSK's Cephalosporin Antibiotics business. Sandoz had obtained the rights to three well-known brands (Zinnat, Zinacef, and Fortum) in over 100 markets as part of this deal, bolstering its leadership in antibiotics.

3. In 2021, La Roche and Atea Pharmaceuticals partnered to research a viable oral therapy for COVID-19 patients.
High Potency API’s Market Segment Analysis:
Based on Type, Innovative drugs accounted for the greatest revenue share of more than 70.0 % in 2021, due to increased R&D initiatives for novel drug development and favorable government regulations. The increased focus on tailored and precision medicines to treat specific patient ailments, such as Antibody Drug Conjugates (ADCs), is pushing the creation of innovative APIs, making this sector a high-impact key driver of the market.

During the forecast period, generic medication molecules are expected to grow at the fastest rate. The segment is driven by reasons such as branded drug patent expiration and decreased costs. Because of the growing number of patients in developing economies with low per capita income, generic pharmaceuticals are increasing their market share.

Based on the Application, The oncology category dominated the market with 75% in 2021. An estimated 18 million cancer cases were reported, with 8.5 million cases among women and 9.5 million cases among males. The rising prevalence of cancer and the introduction of novel target therapy are driving the segment's rise. The rising incidence and prevalence of cancer around the world, as well as the introduction of new target therapies and technological developments in oncology HPAPI-antibody conjugate technology, are all contributing to the segment's growth.

The glaucoma segment is expected to increase at an exponential rate in the coming years, because of its rising prevalence in both established and developing nations. High-potency compounds are required for the treatment of diseases like HIV, and demand for these molecules is to rise as the number of HIV patients rises. Also, the rising occurrence of infectious disorders associated with antibiotic resistance is likely to propel the HPAPIs market forward.
High Potency API’s Market Regional Insights:
The North American region dominated the market with a 35 % share in 2021. In the North American region, Chronic disorders, such as cancer. There were an estimated 1.8 million new cancer cases identified and 606,520 cancer deaths. Furthermore, roughly 60% of Americans have at least one chronic disease, and chronic diseases are the top causes of mortality and disability in the United States. 1 million people in the United States have Parkinson's disease, which is greater than the total number of people hospitalized with muscular dystrophy, multiple sclerosis, and Amyotrophic Lateral Sclerosis. This number is expected to reach 1.2 million by 2029. In Canada, roughly 225,800 new cancer cases and 83,300 cancer deaths are expected in 2022. Cancer is responsible for over 30% of all fatalities in Canada. However, Canada's residents have access to a universal healthcare system. As a result, everyone has access to healthcare. As a result, demand in the region is distributed equitably. As a result, the market has grown positively through forecast period.

Following North America, Europe had the second-largest revenue share in 2021. The market is likely to be driven by an increase in research funding and the presence of prominent market players in this area. Due to increased investments, the number of biopharmaceutical companies in Europe is increasing. For example, the biopharma market raised USD 20 billion in investment in 2017, which climbed by 28% to USD 27.5 billion in 2021. During the forecast period, the availability of advanced technology and increased R&D in Europe are expected to drive market growth.

The Asia Pacific region is expected to witness significant growth at a CAGR of 7.46% through the forecast period. Growth in the geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government attempts to change healthcare and encourage the adoption of generics, and a growing market for merchant manufacturers in Asia due to low labour and manufacturing costs are driving the market in Asia. Japan and China are among the top countries in the production of HPAPIs, with various biotech businesses involved. The existence of big corporations such as Takeda and Sankyo has helped these countries create biotechnology-derived APIs.

The objective of the report is to present a comprehensive analysis of the High Potency API’s Market to the stakeholders in the market. The past and current status of the market with the forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the market with a dedicated study of key players that include market leaders, followers, and new entrants.

PORTER, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the market to the decision-makers.

The reports also help in understanding the High Potency API’s Market dynamic, structure by analyzing the market segments and projecting the High Potency API’s Market size. Clear representation of competitive analysis of key players by Vehicle type, price, financial position, product portfolio, growth strategies, and regional presence in the High Potency API’s Market make the report investor’s guide.
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Global High Potency API’s Market


Report Coverage
Details


Base Year:
2021
Forecast Period:
2022-2029


Historical Data:
2017 to 2021
Market Size in 2021:
US$ 19.60 Bn.


Forecast Period 2022 to 2029 CAGR:
8.6%
Market Size in 2029:
US$ 37.92 Bn.


 Segments Covered:
by Type
• Innovative HPAPI
• Generic HPAPI


by Therapeutic Application
• Oncology
• Glaucoma
• Hormonal Disorder
• Others


by Synthesis Type
• Synthetic HPAPI
• Biotech HPAPI



High Potency API’s Market by Region
• North America
• Europe
• Asia Pacific
• South America
• Middle East and Africa
High Potency API’s Market Key Players
• Lonza
• BASE SE
• Cordenpharma
• Dr, Reddy’s Lab
• Carbogen Amcis
• Pfizer
• Sun Pharmaceuticals
• Teva Pharmaceuticals
• Albany Molecular
• Sanofi SA
• Merck & Co.
• Novartis AG
• F. Hoffmann LA Roche
• Bristrol Myers Squibb
• Boehringer Ingelheim
• Cipla
• Eli Lily & Company
• Abbvie Inc

Frequently Asked Questions:

1] What segments are covered in the Global High Potency API’s Market report?
Ans. The segments covered in the High Potency API’s Market report are based on Type, Synthesis Type and Therapeutic Application.

2] Which region is expected to hold the highest share in the Global High Potency API’s Market?
Ans. The North America region is expected to hold the highest share in the High Potency API’s Market.

3] What is the market size of the Global High Potency API’s Market by 2029?
Ans. The market size of the High Potency API’s Market by 2029 is expected to reach US$ 37.92 Bn.

4] What is the forecast period for the Global High Potency API’s Market?
Ans. The forecast period for the High Potency API’s Market is 2022-2029.

5] What was the market size of the Global High Potency API’s Market in 2021?
Ans. The market size of the High Potency API’s Market in 2021 was valued at US$ 19.60 Bn.