The global highly potent active pharmaceutical ingredients (HPAPIs) market to reach nearly US$ 19.6 Billion in 2021, at a CAGR of 6.2% from 2017 to 2021, majorly due to patent expiry of blockbuster drugs and growing trend in pharmaceutical outsourcing.
The HP APIs are classified based on their toxicity, pharmacological potency and occupational exposure limits (OELs). These APIs are frequently characterized by complex structures requiring multi-step processes or semi-synthesis, often involving more than 10 steps. A significant proportion of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is leading to explosive growth in demand for their production, and the new molecules that are proven to be effective at much smaller dosage levels than traditional APIs. During the last decade, the demand for HPAPIs has grown rapidly, mainly as a result of advances in clinical pharmacology and oncology research. There is particular interest in HPAPI–antibody conjugate technology, which uses monoclonal antibodies to selectively deliver HPAPIs to specific cancer tumors.
High-containment manufacturing requires specialized approaches in facility design, equipment selection and manufacturing processes to achieve desired levels of containment, minimize operator exposure, and ensure worker protection and safety. The global market for Highly Potent Active Pharmaceutical Ingredients is currently on a growth fast track, largely driven by its major use in oncology for cancer treatment and more often in the form of antibody-drug conjugates (ADCs). Over a quarter of drugs worldwide now contain HPAPIs, as they have proven to be more effective than other APIs.
Highly potent active pharmaceutical ingredients (HPAPIs) represent a significant change in the way pharmaceutical innovators are using small molecules to deliver new patient therapies. This shift toward highly potent APIs has not only led to a pipeline of more effective medicines that require lower doses and lead to fewer side effects, but also to new manufacturing challenges. Therefore, working with APIs high in potency and cytotoxicity comes with many regulations and requirements, and presents pharmaceutical companies with challenges such as handling, containment, cost and security concerns. Many contract manufacturers are also building new facilities that are designed specifically for the manufacture of HPAPIs, which require an investment of millions of dollars beyond typical GMP (good manufacturing practices) production facilities. This investment may include specialized facilities for HPAPI–antibody conjugations that incorporate both potent-compound handling and biologics processing capabilities.
Global Highly Potent Active Pharmaceutical Ingredients Market by API (Biological, Chemical), Drugs (Branded, Generic, OTC), Manufacturing (In-House, Outsourcing or Contact-Based), Therapeutic Area (Diabetes, Cardiovascular, CNS, Oncology, Musculoskeletal Drugs) 2017-2021. The global highly potent active pharmaceutical ingredients (HPAPIs) market report estimates the market size (Revenue US$ million – 2014 to 2021) for key market segments based on the API (biological, chemical), drug (branded, generic, OTC), manufacturing (in-house, outsourcing or contact-based), therapeutic area (diabetes, cardiovascular, CNS, oncology, musculoskeletal drugs, etc.), and forecasts growth trends (CAGR% – 2017 to 2021). The global highly potent active pharmaceutical ingredients market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global highly potent active pharmaceutical ingredients market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.
Major players operating in the global highly potent active pharmaceutical ingredients (HPAPIs) market and included in this report are Alkermes plc, Cambrex Corporation, Dr. Reddy’s Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC, and WuXi AppTec.
1. Highly Potent Active Pharmaceutical Ingredients
2.1. Branded (Innovative) Prescription Drugs
2.2. Generic Prescription Drugs
3.1. Contract or Outsourcing Manufacturing
3.2. Captive (In-House) Manufacturing
4. Therapeutic Application
4.1. Anti-diabetic Drugs
4.2. Cardiovascular Drugs
4.3. Central Nervous System Drugs
4.4. Musculoskeletal Drugs
4.5. Oncology Drugs
4.6. Others (Antibacterial, Antiviral, Antifungal)
5. Company Profiles
5.1. Alkermes plc.
5.2. Cambrex Corporation
5.3. Dr. Reddy’s Laboratories
5.4. Lonza Group
5.6. Pfizer, Inc.
5.7. Sandoz International GmbH
5.8. Sigma-Aldrich Co. LLC.
5.9. WuXi AppTec
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