High Potency APIs Market/HPAPI Market by Type (Innovative, Generic), Type of Synthesis (Synthetic, Biotech, Biosimilars, mAbs, Vaccines), Manufacturers (Captive, Merchant), Application (Oncology, Hormonal Imbalance, Glaucoma)- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

According to Nova one advisor, the global High Potency APIs Market/HPAPI market size is expected to hit around USD 45.6 billion by 2030 from valued at USD 25.1 billion in 2022 and growing at a CAGR of 12.5% from 2022 to 2030.

The growth in this market is driven by factors such as increasing demand for oncology drugs, growing demand for antibody-drug conjugates, increasing focus of leading pharmaceutical companies on HPAPIs, advancements in HPAPI manufacturing technologies, and growing focus on precision medicine.

Impact of Covid-19 on HPAPI Market

During the COVID 19 pandemic, the HPAPI market was adversely affected. COVID 19 primarily affected the supply chain of the HPAPI market. Since Southeast Asia (specifically China and India) is the hub for producing API, the market was severely hampered as the impact of COVID-19 increased in this region. The growth of the HPPAI market has been significantly hampered by the economic situation triggered by the COVID-19 pandemic in 2020. Players are expected to benefit as the proportion of firms outsourcing to locations with low-cost production technology is escalating at a rapid pace. The importance of active pharmaceutical ingredient manufacturers in the pharmaceutical industry is evolving in response to new demands from customers and growing pressures from global competitors, thus, transforming the HPAPI market into an attractive area for investment. Firms with existing HPAPI capabilities are busily expanding their facilities, while many without having sought to acquire existing businesses or add HPAPI capacity to their mainstream. Many manufacturers across many territories and levels of experience are making a considerable number of investments in HPAPI capabilities and are getting acquainted with facing numerous challenges in terms of barriers to entry, regulatory requirements, sizeable investments, and expertise associated with APIs & HPAPIs development.

CDMOs with integrated capabilities in HPAPIs will have a competitive edge over others as they can add value to companies outsourcing these products in terms of cost and timelines. Also, dozens of manufacturers are investing in the space, not just the largest players, suggesting that emerging firms see an opportunity for accelerated growth from new product introductions and will, accordingly, compete aggressively. The rising trend toward outsourcing for HPAPI production along with the developments in favorable regulatory frameworks are the major factors expected to bolster the growth of the global HPAPI market. 

Report Scope of the High Potency APIs Market/HPAPI Market

HPAPI Market Dynamics

Driver: Increasing demand for oncology drugs

The rising demand for oncology drugs is anticipated to create a wide scope of opportunities in the global HPAPI market. HPAPIs are extremely effective pharmacologically active ingredients, which offer significant efficiency in the action and efficiency even at low doses. The growing incidence and prevalence of cancer, there is a growth in demand for more potent cancer therapeutics, including HPAPIs. To cater to the growing demand, various pharmaceutical companies such as Pfizer, Sanofi, F. Hoffmann-La Roche, and others are increasingly making efforts toward building pipelines for novel cancer therapeutics.

Opportunity: Growing opportunities for CMOs and CDMOs

A comprehensive HPAPI manufacturing facility requires extensive planning, the use of risk management and assessment tools, and a mechanism to determine which compounds are suitable for manufacturing in each facility. The production of such compounds poses hazards and risks to workers and the environment. Pharmaceutical manufacturers also need to have the capacity for the safe production, storage, and transport of a growing range of potent compounds. This makes it evident that implementing a successful HPAPI manufacturing strategy requires significant time and investment. Hence, various sponsor companies prefer going to CMOs and CDMOs for assistance with the development, manufacturing, and distribution of HPAPIs and their formulated drug products, as many of these companies have the necessary equipment.

Challenge: Need for appropriate process designs

Process designs are one of the most vital requirements for HPAPI production operations. Most HPAPI and ADC drug payloads need to be produced in small clinical and commercial quantities. However, the production of gram scale GMP APIs and payloads is challenging. Maintaining containment control when using flexible and small equipment, including glass equipment, is a definite challenge and requires an approach that is tailored for each process and unit operation. It is also important to maintain appropriate process designs at the developmental scale to ensure that the process fits the equipment and capabilities of the facility upon scale-up. Furthermore, industry-wide, there is an ambiguity regarding the classification of HPAPIs. Different pharmaceutical companies often have proprietary systems, and the classification of new APIs is unknown due to a lack of data. These issues can be mitigated with appropriate process designs and containment controls, which most companies lack. All these factors collectively are likely to present a significant challenge for players in the HPAPI market.

Restraints: High risk of cross-contamination

The biggest risks associated with HPAPI manufacturing is cross-contamination (detrimental contamination of a product with a different product). Growing pressure on the pharmaceutical industry to control costs and to make biopharmaceuticals economical to the consumers are major factors compelling the industry to utilize effective and efficient multi-product and multi-purpose facilities to the greatest extent possible. Along with high potency, HPAPIs often exhibit high cytotoxicity, therefore efforts to prevent cross-contamination are essential to a safe manufacturing process which guarantees the wellbeing of employees, the environment, and the patient.

The report divide the market into type, type of synthesis, type of manufacturer, by therapeutic application and region. Based on type, the market is divided into generic HPAPI and innovative HPAPI. In 2021, the innovative segment will grow largest share in the market. Some Factors contributing to the market growth can be increasing investments in R&D to drive the market growth of this segment.

Based on type of synthesis, the market is divided into biotech HPAPI and synthetic HPAPI segment. The synthetic HPAPI segment to command the largest share in 2021. Increasing number of new APIs, approvals and ease of production are driving the growth of synthetic segment.

Based on the type of manufacturer, the market is segmented into merchant HPAPI manufacturers and captive HPAPI manufacturers. In 2021 the captive HPAPI manufacturers market to account for largest share of market. Factors such as companies in-house manufacturing facilities for economic benefits to drive the segment.

Based on therapeutic application, the market is segmented into oncology, glaucoma, hormonal imbalance, and other therapeutic applications. The oncology segment to dominate the market during 2021. The growing prevalence of cancer and launch of new target therapies are the key factors for the growth in the segment.

By Region, the HPAPI market is segmented into North America, Europe, Asia, and the rest of World (RoW). North America is expected to dominate the market in 2021. Factors such as growing oncology sector, prevlance and incidence of chronic diseases and lifestyle diseases to drive the market segment in North America.

Recent Developments:

• In 2022, Pfizer acquired Arena Pharmaceuticals. The deal will benefit in bringing the pipeline of Arena Pharmaceuticals to the company’s Inflammation and Immunology Therapeutic Area, helping in the further developments to change the lives of those with immuno-inflammatory diseases.
• In 2021, Sandoz, a Novartis division, had successfully completed the acquisition of GSK’s Cephalosporin Antibiotics business. Through this transaction, Sandoz had acquired the rights to three established brands (Zinnat, Zinacef, and Fortum) in more than 100 markets, further reinforcing its leading global position in antibiotics.
• In 2020, La Roche collaborated with Atea Pharmaceuticals to develop a potential oral treatment for the COVID-19 patients.

Some of the prominent players in the High Potency APIs Market/HPAPI Market include:

Pfizer, Inc. (US), F. Hoffmann-La Roche (Switzerland), Sanofi (France), Bristol-Myers Squibb Company (US), Bayer AG (Germany), Novartis International AG (Switzerland), Boehringer Ingelheim International GmbH. (Germany), Teva Pharmaceutical Industries Ltd. (Israel), Eli Lilly and Company (US), Merck & Co., Inc. (US), AbbVie (US), and Viatris Inc. (US).

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global High Potency APIs Market/HPAPI market

Based on type

• Innovative API Market
• Generic API Market

Based on type of Synthesis

• Synthetic API Market
• Biotech API Market

Based on type of manufacturers

• Captive API Market
• Merchant API Market

Based on therapeutic application

• Oncology
• Hormonal Imbalance
• Glaucoma
• Other therapeutic applications

By Regional Outlook

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
• Rest of Middle East & Africa

Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global High Potency APIs Market/HPAPI industry analysis from 2022 to 2030 to identify the prevailing High Potency APIs Market/HPAPI industry opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the global High Potency APIs Market/HPAPI industry segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as global High Potency APIs Market/HPAPI industry trends, key players, market segments, application areas, and market growth strategies.