The Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is projected to reach $50.45 billion by 2028, from a value of $27.41 billion in 2022, by registering a CAGR of 10.7% during the forecast period. Increasing incidence of cancer, advancements in HPAPI manufacturing technologies, growing focus on precision medicine, and increasing focus of leading pharmaceutical companies on HPAPIs, are the major factors propelling the growth of the market. However, large initial investments, and the continual evolution of industry standards, are hampering the market growth. Moreover, developments in emerging regions, and growing opportunities for CMOs and CDMOs, are creating ample opportunities across the globe.
Recent Developments
In March 2022, Pfizer acquired Arena Pharmaceuticals. The deal will benefit in bringing the pipeline of Arena Pharmaceuticals to the companys Inflammation and Immunology Therapeutic Area, helping in the further developments to change the lives of those with immuno-inflammatory diseases.
In October 2021, La Roche collaborated with Atea Pharmaceuticals to develop a potential oral treatment for the COVID-19 patients. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible.
In October 2021, Sandoz, a Novartis division, had successfully completed the acquisition of GSKs 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 June 2019: Lonza, a CDMO partner to the biopharma industry, announced an investment in a major expansion of Highly Potent API (HPAPI) capacity at its Visp, CH site to meet increased market demand. Lonza has entered into a long-term manufacturing agreement with AstraZeneca, and the new facility will support the delivery of a number of products from across their portfolio. The remaining capacity will allow Lonza to expand the offer to other clients.
In April 2019: Cambrex Corporation announced that it has established its new facility high-potency API production in the United States. The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and contain 4 reactors ranging from 200 to 1,000 gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg. With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.
Competitive Landscape
WuXi AppTec, Teva Pharmaceutical Industries , Sigma-Aldrich Co LLC, Sanofi, Pfizer, Novasep, Novartis AG, F. Hoffmann-La Roche, Eli Lilly and Company, Dr. Reddy’s Laboratories, Cambrex Corporation, Bristol-Myers Squibb, Alkermes plc, Abbvie, Lonza Group, Sandoz are some of the major players in the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market.
The Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is projected to reach $50.45 billion by 2028, from a value of $27.41 billion in 2022, by registering a CAGR of 10.7% during the forecast period. Increasing incidence of cancer, advancements in HPAPI manufacturing technologies, growing focus on precision medicine, and increasing focus of leading pharmaceutical companies on HPAPIs, are the major factors propelling the growth of the market. However, large initial investments, and the continual evolution of industry standards, are hampering the market growth. Moreover, developments in emerging regions, and growing opportunities for CMOs and CDMOs, are creating ample opportunities across the globe.
Recent Developments
In March 2022, Pfizer acquired Arena Pharmaceuticals. The deal will benefit in bringing the pipeline of Arena Pharmaceuticals to the companys Inflammation and Immunology Therapeutic Area, helping in the further developments to change the lives of those with immuno-inflammatory diseases.
In October 2021, La Roche collaborated with Atea Pharmaceuticals to develop a potential oral treatment for the COVID-19 patients. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible.
In October 2021, Sandoz, a Novartis division, had successfully completed the acquisition of GSKs 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 June 2019: Lonza, a CDMO partner to the biopharma industry, announced an investment in a major expansion of Highly Potent API (HPAPI) capacity at its Visp, CH site to meet increased market demand. Lonza has entered into a long-term manufacturing agreement with AstraZeneca, and the new facility will support the delivery of a number of products from across their portfolio. The remaining capacity will allow Lonza to expand the offer to other clients.
In April 2019: Cambrex Corporation announced that it has established its new facility high-potency API production in the United States. The production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m3 and contain 4 reactors ranging from 200 to 1,000 gallon capacity enabling manufacturing campaigns of batch sizes up to 300 kg. With the completion of this new facility, the Charles City site now has the flexibility to support all phases of development and offer all scales of HPAPI manufacture across the full OEL band spectrum.
Competitive Landscape
WuXi AppTec, Teva Pharmaceutical Industries , Sigma-Aldrich Co LLC, Sanofi, Pfizer, Novasep, Novartis AG, F. Hoffmann-La Roche, Eli Lilly and Company, Dr. Reddy’s Laboratories, Cambrex Corporation, Bristol-Myers Squibb, Alkermes plc, Abbvie, Lonza Group, Sandoz are some of the major players in the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market.
