HIGH POTENCY ACTIVE PHARMACEUTICAL INGREDIENTS MARKET ANALYSIS

Global high potency active pharmaceutical ingredients market size is expected to reach US$ 54.99 Bn by 2030, from US$ 27.80 Bn in 2023, exhibiting a compound annual growth rate (CAGR) of 10.2% during the forecast period. Global high potency active pharmaceutical ingredients market has been growing rapidly over the forecast period. Active pharmaceutical ingredients (APIs) are the core active components in pharmaceutical drugs that are responsible for the intended therapeutic effect. High potency APIs are those that require handling with extreme precaution and care due to their highly potent nature which could cause significant health issues even at very low concentrations. Strict manufacturing and testing standards are followed to ensure the strength, safety, quality and efficacy of these APIs.

Global High Potency Active Pharmaceutical Ingredients Market Regional Insights:

• North America is expected to be the largest market for high potency active pharmaceutical ingredients during the forecast period, accounting for over 35.0% of the market share in 2023. The North America high potency active pharmaceutical ingredients market is driven by factors such as increasing research and development (R&D) investments by pharmaceutical companies, development of novel drug molecules, and rising demand for highly effective therapeutic drugs.
• Europe is expected to be the second-largest market for high potency active pharmaceutical ingredients, accounting for over 25.0% of the market share in 2023. The Europe high potency active pharmaceutical ingredients market is witnessing favorable growth due to rising chronic disease incidence rates, and growing adoption of biologics and personalized medicines.
• Asia Pacific is expected to be the fastest-growing market for high potency active pharmaceutical ingredients, which is expected to grow at a CAGR of over 10.0% during the forecast period. The Asia Pacific high potency active pharmaceutical ingredients market is witnessing significant growth due to rising demand for oncology and anti-inflammatory drugs.

Figure 1. Global High Potency Active Pharmaceutical Ingredients Market Share (%), By Region, 2023

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Analyst’s Views:

Global high potency active pharmaceutical ingredients market is expected to grow rapidly over the forecast period driven by the growing demand for oncology and hormonal therapies. Biologics and large molecule drugs will contribute significantly to the market growth. New product innovations and development of antibody drug conjugates targeting specific diseases will open up opportunities in this market.

On the other hand, stringent quality regulations imposed by regulatory authorities and supply chain complications related to hazardous nature of high potency active pharmaceutical ingredients (HPAPIs) are likely to restrain market growth.

Global High Potency Active Pharmaceutical Ingredients Market Drivers:

• Rising prevalence of cancer and other chronic diseases: Rising incidence of cancer and other chronic diseases across the globe is a key factor fueling the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. For instance, according to the data published by the American Cancer Society of cancer facts and figures, in January 2023, an estimated 1.9 Mn new cancer cases was diagnosed in 2023, among which prostate cancer is estimated to be 288,300, followed by 238,340 cases of lung cancer, and 300,590 cases of female breast cancer.
• Increasing production of biologics and targeted therapies: The development and production of biologics and targeted therapies is one of the major factors fuelling the growth of the global high potency active pharmaceutical ingredients market. Biologics are medicines that are created from living cells and tissues rather than chemical compounds, and they are increasingly being used to treat a variety of complex chronic diseases like cancer, rheumatoid arthritis, and multiple sclerosis. Targeted therapies specifically attack cancer cells with genetic or molecular abnormalities while sparing normal cells and are becoming the mainstay of cancer treatment.
• Increased investments by major players: Increased investments by major pharmaceutical companies are significantly driving the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. For instance, in June 2019, Piramal Pharma Solutions (PPS), a leading contract development and manufacturing organization (CDMO), announced the grand opening of a new wing dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low occupational exposure levels (OELs). The total investment required to upgrade the site was approximately US$10 Mn.

Global High Potency Active Pharmaceutical Ingredients Market Opportunities:

• Outsourcing of manufacturing by large pharmaceutical companies: Outsourcing of manufacturing by large pharmaceutical companies presents a great opportunity in the global high potency active pharmaceutical ingredients market. As R&D costs soar and patent expirations open markets, pharmaceutical firms are under pressure to cut costs and improve efficiencies. Outsourcing non-core functions like HPAPI manufacturing allows them to focus on drug discovery and advance their pipelines. For instance, in June 2022, Wuxi STA announced the expansion of its HPAPI facility in China, which allows it to cater to CDMO customers that are looking for a complex manufacturing setup.
• Increased production of specialty drugs: Increased production of specialty drugs could unlock significant opportunities in the global high potency active pharmaceutical ingredients (HPAPI) market. Specialty drugs, which are used to treat complex conditions such as cancer, autoimmune diseases, growth hormone deficiencies, and others, often require HPAPIs due to their potent nature. With rising prevalence of chronic and complex diseases worldwide, the demand for specialty drugs is projected to grow substantially in the near future.
• Adoption of continuous manufacturing: Adoption of continuous manufacturing techniques is having a significant impact on the global high potency active pharmaceutical ingredients market. Continuous manufacturing allows for a more efficient, precise, and flexible production process as compared to traditional batch manufacturing. This trend is driven mainly by regulatory bodies pushing for more advanced quality control and production monitoring techniques.

Global High Potency Active Pharmaceutical Ingredients Market Trends:

• Increasing demand for biosimilars: Increasing demand for biosimilars is significantly impacting the global high potency active pharmaceutical ingredients (APIs) market. As biosimilars are becoming increasingly popular alternatives to biologics, their production requires potent APIs that are typically used in very low doses. This has driven greater focus on biosimilar development by pharmaceutical companies. Biosimilars are complex molecules that are nearly identical to the reference biologic drug but are much more affordable for patients. Due to their complex molecular structure, biosimilars require very potent APIs during the manufacturing process to elicit the intended therapeutic effect.
• Focus on cell-based production technologies: The trend of cell-based production technologies is having a significant influence on the global high potency active pharmaceutical ingredients (APIs) market. Cell-based production utilizes cultured mammalian cells like CHO cells as small scale bioreactors to manufacture APIs instead of traditional chemical synthesis or extraction from botanical/animal sources. This offers several advantages over conventional production methods.
• Automation and continuous processing: Automation and continuous processing is having a major influence on the global high potency active pharmaceutical ingredients (HPAPI) market. By implementing automated technologies and continuous manufacturing methods, drug makers are able to produce HPAPIs more efficiently, safely, and cost-effectively.

Global High Potency Active Pharmaceutical Ingredients Market Restraints:

• Stringent regulations for manufacturing APIs: Stringent regulations for manufacturing active pharmaceutical ingredients (APIs) are significantly restraining the growth of the global high potency APIs market. Government regulatory bodies across the world have implemented strict norms and quality standards to ensure the safety and efficacy of APIs. This is indispensable with the hazardous nature and potential health risks of high potency APIs. However, complying with these elaborate regulatory frameworks involves substantial funding, time, and
• High cost of production: High cost of production is one of the major factors restraining the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. HPAPIs are used in manufacturing medicines for critical illnesses like cancer, infectious diseases, and autoimmune disorders where a very small dose delivers maximum therapeutic benefit. However, their production process is complex and requires advanced manufacturing capabilities and technologies. This makes the overall production costs significantly high for pharmaceutical companies.

Counterbalance: To overcome this restraint, the key market players need to control all other unnecessary costs which might increase the cost of production, thereby aiding in the process of reduction of production cost.

• Supply chain issues: Supply chain issues are posing significant challenges for the growth of the global high potency active pharmaceutical ingredients (HPAPI) market. The HPAPI supply chain is a complex global network involving raw material suppliers, contract manufacturers, and finished dose producers across multiple countries. Even a small disruption anywhere in this delicate supply chain can potentially cause serious shortages of life-saving HPAPI drugs.

Figure 2. Global High Potency Active Pharmaceutical Ingredients Market Share (%), By Molecule Type, 2023

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Recent Developments:

New manufacturing facility launches:

• On February 15, 2023, Piramal Pharma Solutions, a patient-centric contract development and manufacturing organization (CDMO) and part of Piramal Pharma Ltd, announced that it had started the production of initial batches of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs) in new reactor suites at its facility in Riverview, Michigan, U.S.
• In September 2022, WuXi STA, a leading global contract research, development, and manufacturing organization (CRDMO), announced the opening of its first high potency (HP) oral drug product manufacturing facility at its Wuxi city campus. This new facility marks a milestone for WuXi STA to further extend its drug product capacity and capabilities to meet the growing demand for HP drug candidate development and manufacturing services.
• In June 2022, Merck, a leading science and technology company, announced that its life science business sector had doubled its high-potent active pharmaceutical ingredients (HPAPI) production capacity with the expansion of its facility in Verona, near Madison, Wisconsin, U.S.

Investments and Collaboration:

• On July 12, 2023, Evonik, a specialty chemicals company and Heraeus Precious Metals, a global leader in the precious metals industry, announced the collaboration to expand both companies’ range of services for highly potent active pharmaceutical ingredients (HPAPIs). The cooperative effort leverages the specific HPAPI competencies of both companies and provides customers with a fully integrated offering from the pre-clinical stage to commercial manufacturing.
• In November 2021, CordenPharma, a full-service contract development manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), Excipients, Drug Products & Packaging services, announced the investment of US$ 10.6 Mn into the design and installment of a new good manufacturing practice (GMP) clinical trial development (CTD) facility for the manufacturing of highly potent oral solid dosage drug products and APIs at CordenPharma Plankstadt facility located near Heidelberg, Germany.
• In November 2021, Hovione, the global leader in spray drying and particle engineering, announced the expansion of its industrial facilities around the world to support its ambitious growth objectives. The announcement of a US$ 170 Mn investment in Hovione units in Portugal, Ireland, and New Jersey, leading to a global capacity increase of approximately 25%.

Top Companies in the Global High Potency Active Pharmaceutical Ingredients Market

• • Lonza
  • Novartis International AG
  • BASF AG
  • SEQENS
  • Carbogen Amcis AG
  • Eli Lilly and Company
  • Teva Pharmaceutical Industries Ltd
  • Bristol-Myers Squibb
  • Pfizer Inc.
  • Roche Diagnostics
  • Boehringer Ingelheim
  • Merck & Co
  • Bayer AG
  • Ajinomoto Bio-Pharma Services
  • Cambrex Corporation
  • Minakem
  • Sanofi Aventis

Definition: High potency active pharmaceutical ingredients (HPAPIs) are pharmaceutical compounds that demonstrate high biological activity at low doses. These active ingredients are particularly effective in the treatment of various medical conditions and are typically used in the development of medications for cancer therapy, hormonal disorders, targeted therapies, and other chronic diseases wherein precision and efficacy are critical.