High Potency Active Pharmaceutical Ingredient (HPAPI) Market
Number of pages: 120 | Report Format: PDF | Published date: January 01, 2021
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 24.37 billion |
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Revenue Forecast in 2031 |
US$ 43.17 billion |
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CAGR |
6.56% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023-2031 |
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Historical Year |
2021 |
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Segments Covered |
Product, Drug Type, Manufacturer Type, Application, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global high potency active pharmaceutical ingredient (HPAPI) market was valued at US$ 24.37 billion in 2022 and is expected to register a revenue CAGR of 6.56% to reach US$ 43.17 billion by 2031.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market Fundamentals
High potency active pharmaceutical ingredients are pharmacologically active substances that exhibit biological activity at extremely low concentrations. Each HPAPI has a limit of daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an 8-hour average. In order to manufacture these compounds, specialized considerations must be made for the facility design, equipment, operation, and safety processes to achieve the best level of containment of the drug product. HPAPI can be a small-molecule, biologic, or a hybrid of the two, such as an antibody–drug conjugate, which links a cytotoxic small-molecule to a monoclonal antibody. Examples of HPAPIs include cytotoxic compounds as well as sex hormones such as estrogen.
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High Potency Active Pharmaceutical Ingredient (HPAPI) Market Dynamics
Factors contributing to the growth of the high potency active pharmaceutical ingredients market include an increasing number of patent expiration, rising incidence of chronic diseases, increasing demand for HPAPI, and stronger HPAPI pipeline. Cancer is the second leading of death worldwide, and the disease burden is constantly increasing. According to the American Cancer Society’s Cancer Statistics Center, in the U.S., almost 1.9 million new cancer cases are expected to be diagnosed in 2021, and approximately 608,570 Americans are expected to die of cancer in 2021. Therefore, many pharmaceutical companies are focused on developing highly potent oncology drugs, which in turn drive the growth of the HPAPI market. Furthermore, patents for various drugs have expired in the past few years. Many more drug patents are about to expire in the coming years. According to the Ministry of Food and Drug Safety (MFDS)’s Green List, a total of 62 drug-related patents covering 158 products are scheduled to expire in 2021. This has created lucrative opportunities for various drug manufacturers to develop similar potent drugs; thus, demand for HPAPIs will likely increase. For instance, in July 2022, for its site in Mourenx, the Novasep-PharmaZell Group invested USD 7.3 million as part of a bigger initiative backed by the "France Relance Plan” to increase API and HPAI production capacity. Moreover, companies are partnering to create innovative High Potency Active Pharmaceutical Ingredients (HPAPIs) to meet unmet medical needs. This enables businesses to leverage their resources to boost product development and improve their supply chain. For example, Lonza, BioGeneration Ventures (BGV), and Forbion in January 2022 expanded their collaboration to encompass the discovery and manufacture of small molecules (biologics). Lonza can customize services to BGV and Forbion's large molecular biologic portfolios.
However, cross-contamination is one of the most serious concerns related to HPAPI manufacture. Growing pressure on the pharmaceutical business to minimize costs and make biopharmaceuticals more affordable to consumers are important reasons encouraging the industry to use as many effective and efficient multi-product and multi-purpose facilities as feasible. HPAPIs frequently demonstrate significant cytotoxicity in addition to high potency, therefore, measures to minimize cross-contamination are critical to a safe production process that ensures the wellness of staff, the environment, and the patient. One of the most important criteria for HPAPI manufacturing operations is process design. The majority of HPAPI and ADC medication payloads must be manufactured in tiny clinical and commercial volumes. However, producing gram-scale GMP APIs and payloads takes a lot of work. Retaining proper process designs at the developmental size is also critical to guarantee that the process suits the facility's equipment and capabilities when scaled up. Furthermore, there is industry-wide disagreement regarding the categorization of HPAPIs. Different pharmaceutical firms frequently use proprietary methods, and the classification of new APIs is still being determined owing to a lack of data. These concerns may be minimized with adequate process designs and containment controls, which most businesses need more. All of these reasons, taken together, are expected to provide a considerable barrier for HPAPI market participants.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market Ecosystem
The global high potency active pharmaceutical ingredients market has been analyzed from the following perspectives: product, drug type, manufacturer type, application, and region.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Product
Based on the product, the high potency active pharmaceutical ingredients market has been segmented into synthetic HPAPI and biotech HPAPI.
The biotech HPAPI segment is anticipated to be the fastest-growing segment in the global HPAPI market. Several factors, such as increasing demand for biologics, advancements in HPAPI manufacturing technology, and rising investment in the R&D of new drugs, contribute to this segment’s growth. Furthermore, the biotech segment's rise can be due to significant investments in the biotechnology and biopharmaceutical industries. This enables the development of novel compounds that assist in treating illnesses like cancer. The cost of producing biotechnological goods is costly since it requires highly specialized equipment and skilled employees, which increases pharmaceutical corporations' preference for third-party producers.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Drug Type
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Based on the drug type, the market has been bifurcated into generics and innovative. The innovative drug segment accounts for the largest revenue share in the global market, with a share of ~60%. This can be attributed to the growing incidences of chronic diseases and, specifically, different cancers. High demand and rising R&D activities for the development of innovative drugs are driving the growth of the innovative drug segment. For instance, a pipeline drug called Nuvastatic TM (C5OSEW5050ESA) is in phase II/III. This drug was developed by Natureceuticals Sdn. Bhd. and is a special formulation derived from the standardized extract of O. stamineus leaves.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Manufacturer Type
The market has been segmented based on manufacturer type into captive HPAPI manufacturer and contract HPAPI manufacturer.
Captive HPAPI manufacturer dominates the global market with the largest revenue shares. The large share of this segment has attributed the factors such as a high preference for in-house manufacturing and the rising investments by pharmaceutical companies to develop in-house capabilities for manufacturing HPAPIs. Captive HPAPI manufacturers are typically integrated into the supply chain of pharmaceutical companies. These manufacturers are owned or closely aligned with pharmaceutical companies, allowing them direct control over the production and supply of HPAPIs. This vertical integration provides a competitive advantage in terms of timely availability and reliable supply, which is critical for pharmaceutical companies developing high potency drugs. Captive HPAPI manufacturers tend to focus on specific therapeutic areas or disease segments aligned with their parent pharmaceutical company's portfolio. Captive HPAPI manufacturers often have streamlined regulatory processes due to their close collaboration with their parent pharmaceutical companies. This collaboration facilitates efficient communication, aligned strategies, and a better understanding of regulatory requirements. As a result, they can navigate the complex regulatory landscape more effectively, obtaining necessary approvals and ensuring compliance with regulatory guidelines.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Application
Based on application, the market has been segmented into oncology, hormonal disorders, glaucoma, and other disorders.
Oncology dominates the largest share of the HPAPI market and is also expected to retain its dominance from 2023 to 2031. Cancer is a leading cause of mortality worldwide, and cancer incidence is rising. The growing prevalence of various types of cancers, such as lung, breast, colorectal, and prostate cancer, has increased the demand for effective oncology treatments. HPAPIs play a crucial role in developing potent and targeted cancer therapies, including chemotherapy drugs, targeted therapies, immunotherapies, and antibody-drug conjugates (ADCs). Cancer therapies often require highly potent and targeted drugs to effectively kill or inhibit cancer cells while minimizing damage to healthy cells. HPAPIs provide the necessary potency and selectivity required for these therapies. The oncology segment dominates the HPAPI market because of the specialized and complex manufacturing processes of producing high potency oncology drugs. Precision medicine aims to tailor treatment approaches based on an individual's specific genetic makeup and disease profile. Oncology is at the forefront of precision medicine, with targeted therapies and personalized treatment strategies becoming more common. HPAPIs enable the development of targeted therapies that specifically interact with molecular targets involved in cancer progression, providing more effective and personalized treatment options. The pharmaceutical industry has been heavily investing in oncology research and development, resulting in a robust pipeline of potential oncology drugs. Many of these drugs are high potency compounds that require specialized manufacturing capabilities. The significant number of ongoing clinical trials and drug development programs in the oncology field contributes to the dominance of the oncology segment in the HPAPI market.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Region
Regionally, the global high potency active pharmaceutical ingredients market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America dominated the market for high potency active pharmaceutical ingredients holding the largest share of the market in 2022. North America, particularly the United States, has a well-established and mature pharmaceutical industry. The region is home to numerous large pharmaceutical companies with significant expertise and experience in developing and producing high potency drugs. The established presence of these companies contributes to the dominance of North America in the HPAPI market. North America has a strong R&D infrastructure, including renowned universities, research institutions, and biopharmaceutical companies. These entities actively engage in research and development activities, including discovering and developing novel high potency drugs. The region's research capabilities and scientific expertise enable the efficient development and manufacturing of HPAPIs, supporting its dominance in the global market. The United States has a rigorous regulatory framework led by the U.S. Food and Drug Administration (FDA), which sets stringent standards for drug manufacturing, safety, and efficacy. Compliance with these regulatory requirements is essential for approving and commercializing high potency drugs. The robust regulatory system ensures the quality and safety of HPAPIs manufactured in North America, instilling confidence in the market. North America has a high prevalence of chronic diseases, such as cancer, cardiovascular disorders, and respiratory diseases. High potency drugs are often used to treat these conditions due to their enhanced efficacy and targeted therapeutic mechanisms. The rising incidence of these diseases in the region drives the demand for HPAPIs and contributes to North America's dominance in the market. North America has a well-developed infrastructure and supply chain supporting the manufacturing and distribution of HPAPIs. The region has advanced manufacturing facilities, logistics networks, and specialized containment technologies required to safely handle high potency compounds. This infrastructure, combined with efficient supply chain management, enables timely and reliable delivery of HPAPIs, contributing to North America's market dominance.
Competitive Landscape
Some of the prominent players operating in the global high potency active pharmaceutical ingredients market include:
Strategic Developments
HPAPI are pharmacological intermediates or compounds that are active at concentrations of 150 micrograms per kilogram of body weight or less. They are often extremely specific in action and can bind to specified receptors or particular molecules, which can cause sickness, reproductive difficulties, and even death at low doses.
The revenue CAGR for the high potency active pharmaceutical ingredients market is 6.56% from 2023 to 2031.
Thermo Fisher Scientific Inc., AbbVie Inc., Pfizer Inc., and other notable players are some of the major key players in the high potency active pharmaceutical ingredients market.
The Asia Pacific region is projected to grow at high revenue CAGR in the global high potency active pharmaceutical ingredients market.
The captive HPAPI manufacturer segment dominates the global high potency active pharmaceutical ingredients market.
*Insights on financial performance are subject to the availability of information in the public domain