HPAPI Market

Global HPAPI Market Size (2023 to 2028)

The global HPAPI market is forecasted to value USD 34.97 billion by 2028 and be worth USD 23.04 billion in 2023, registering a CAGR of 8.7% from 2023 to 2028.

High-potency active pharmaceutical ingredients (HPAPI) can be defined as pharmacological intermediates or substances active at concentrations of 150 micrograms per kilogram of body weight or below. They are usually highly selective and can bind to specific receptors or bind specific enzymes, which can cause cancer, developmental disorders, and reproductive problems at low doses. Many new drugs have these high-potency active pharmaceutical ingredients; hence the growth of this market is high.

These High potency active pharmaceutical ingredients (HPAPI) have new cures for many diseases, especially cancer. After the human genome was mapped, cancer drugs were made for different cancers and other patients. However, producing these drugs is challenging since they are active at low concentrations. They can pose health hazards to workers if they leak during production, and monitoring must be done mainly against the contamination of drugs with foreign substances. Hence it requires specialized equipment for handling HPAPIs and managing air quality.

MARKET DRIVERS:

The global HPAPI market is driven by factors such as their low price, a growing number of pharmaceutical manufacturers and patients, rising healthcare prices, and government initiatives to expand generic drugs' usage to cut healthcare costs.

The global high-potency active pharmaceutical ingredients market is further growing due to a growing number of new entrants in developing countries generating quick relief therapeutics. Additionally, favorable government regulations for commercializing, researching, and producing novel drug molecules are expected to drive market expansion. Other factors driving market growth include the demand for oncology drugs, antibody-drug conjugates, and advances in HPAPI manufacturing technologies.

Companies in the HPAPIs market should leverage emerging economies such as India, China, and the Middle East for high-growth opportunities. Due to their large population, growing stability, and improving longevity, the demand in most of these geographies is expected to expand rapidly in the coming years. In addition, diseases such as musculoskeletal disorders, glaucoma, and cancer significantly affect people's health worldwide, with developed countries experiencing faster growth rates. For instance, according to the WHO, developing countries accounted for approximately 66% of all cancer-related deaths in 2014. Furthermore, according to GLOBOCAN 2012, 6.8 million new cancer cases were registered in Asia in 2012; this figure is projected to grow to 8.4 million cases by 2020, suggesting a 24% increase. Furthermore, emerging areas have more lenient and flexible laws, making these markets highly profitable for providers unable to meet the federal government's stringent requirements. Besides that, developing countries such as India and China deliver extremely low manufacturing and labor costs and highly skilled labor, enticing players from developed regions to enter the market.

MARKET RESTRAINTS:

High equipment costs, a scarcity of skilled workers, and stringent regulatory criteria are all stumbling blocks for the HPAPI market.

Manufacturers will also be expected to invest in advanced HPAPI-antibody conjugation facilities, including potent compound handling and biologics processing. For instance, ADC Biotechnology (UK) invested USD 10 million in October 2015 to construct a manufacturing facility for advanced anti-cancer drugs. However, the need for significant investments likely hinders this market's growth. Even though the demand for high-potency APIs is new and increasing, pharmaceutical companies face significant challenges in updating their current facilities, which can only accommodate low- or medium-potency APIs. A significant portion of the budget is allocated to specialized containment to shield workers and their surroundings from exposure. Apart from the normal GMP production facilities, contract manufacturers are expected to invest extensively in constructing new facilities built explicitly for HPAPI manufacturing; these expenditures can often amount to millions of dollars.

Impact of COVID-19 on the global HPAPI market:

COVID-19 has had a negative influence on the global economy and has affected every sector. Pharmaceuticals are one of the industries that COVID-19 has hit. High potency APIs, or HPAPIs, are highly efficient and pharmacologically active ingredients. The high-potency APIs have an exact action and can provide substantial efficacy even at low daily therapeutic doses. The COVID-19 virus has wreaked havoc on the pharmaceutical industry's manufacturing and supply chain. China is a significant source of active pharmaceutical ingredients. Since China was at the epidemic's epicenter, all production and export were stopped, and factories were shut down to prevent the virus from spreading further. These firms have been shut down due to the lockdown, preventing API manufacturing and import-export in and around China. The disruption of logistic and transportation networks, limiting access and movement of goods to and from ports, further affected supplies. These demand and supply disruptions will inevitably affect production, affecting the HPAPI market's growth.

REPORT COVERAGE:

This research report on the global HPAPI market has been segmented and sub-segmented based on type, synthesis, therapeutic application, and region.

HPAPI market – By type:

• Innovative HPAPI's
• Generic HPAPI's

Based on type, Innovative HPAPI’s had the largest market share due to many patented numbers, higher prices compared to generics, pharmaceutical manufacturers focusing on producing new drugs, and demand for novel anti-cancer medicines.

HPAPI market – By synthesis:

• Biotech HPAPI's
• Synthetic HPAPI's

Based on the synthesis, the synthetic HPAPIs accounted for the leading share of the HPAPI market in 2022 owing to the rise of new drugs, ease of production, technological improvements in synthesis, and approval for new drugs.

HPAPI market – By Therapeutic Application:

• Oncology
• Glaucoma
• Hormonal Balance

Based on therapeutic application, oncology had the largest share of the market in 2022. Factors such as the rising incidence of cancer and the launch of new target therapies propel this segment's growth.

HPAPI market – By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

Geographically, North America had the largest share of the world market in 2022, followed by Europe. However, Asia-Pacific is the fastest-growing market in the world. Factors like the rising incidence of cancer, increased cancer research funding, and growing demand for cancer HPAPIs are the essential factors that are likely to propel this market's growth in the future.

KEY MARKET PLAYERS:

Some of the most promising companies in the Global HPAPI market are Pfizer, Inc. (U.S.), Novartis International AG (Switzerland), Sanofi (France), F. Hoffmann-La Roche Ltd. (Switzerland), Eli Lilly and Company (U.S.), Bristol-Myers Squibb (U.S.), Boehringer Ingelheim (Germany), Teva Pharmaceutical Industries Ltd. (Israel), Merck & Co., Inc. (U.S.), AbbVie Inc. (U.S.) and Mylan Inc. (U.S.).

RECENT MARKET HAPPENINGS:

• In April 2019, Cambrex Corporation, a drug material supplier, revealed that they had completed the construction of a $24 million highly potent API (HPAPI) manufacturing facility in Charles City, Iowa, which will add flexibility to the manufacturing network and accelerate the project development.
• In June 2019, Lonza constructed new facilities at its Visp, CH site to meet customer demand for highly potent API (HPAPI), especially in the oncology sector. 
• In August 2019, Permira Funds, a multinational investment company headquartered in the United Kingdom, purchased Cambrex Corporation for USD 2.4 million. Due to the acquisition, Permira Funds will provide financial support to Cambrex Corporation to expand its commodity manufacturing and analytical testing services.