Analysis And Trends In HPAPI (High Potency Active Pharmaceutical Ingredients) Market

High Potency Active Ingredient (HPAPI) is an active ingredient with an OEL (Occupational Exposure Limit) at or below 10 micro grams per cubic meter of air as an eight-hour time-weighted average and differs from API in terms of Potency. In the form of Antibody Drug Conjugates (ADCs) HPAPI are used to selectively target cancer cells. The major advantage of using HPAPI drugs is they show effective treatment even at low concentration than traditional APIs. They have improved development standards and progress for important treatments in the area of oncology and cover major therapeutic areas from Glaucoma to Hormonal disorders, infectious diseases, metabolic disorders and CNS (Central Nervous System) disorders.

According to IQ4I estimation, the HPAPI global market is expected to grow at a CAGR of 7.9% to reach $27,293.4 million by 2023. North American region held the largest market share where as Asia-Pacific region is projected to grow with a strong double-digit CAGR. Some of the factors driving the HPAPI market include increasing the incidence of chronic and age-related diseases, rapid growth in oncology market, growing demand for Antibody Drug Conjugates (ADCs), Technological Advancements in HPAPI market, growing Contract Manufacturing Organizations (CMOs) market. However, the requirement of large investment, stringent safety and handling specifications associated with the production of HPAPI, stringent regulations may hinder the growth of HPAPI market.

The HPAPI market is segmented into Innovative HPAPI and Generic HPAPI based on the customer base where Innovative HPAPI holds the maximum share. However in future it is predicted that Generic HPAPI are expected to grow at a double digit CAGR because of increase in number of generic HPAPI manufacturers, increase in government initiatives to use of generic HPAPI drugs, nearing patent expires (Patent Cliffs) of drugs. The manufacturing of HPAPI requires large investments and very stringent safety and handling specifications. Large investments of approximately $10-30 million are required for proper facility design, equipment, production processes and highly skilled team of staff with right experience. Many larger pharmaceutical companies are in the race to have a high market share by investments, expansions and along with the acquisitions. For instance, Dishman group’s (India) Swiss arm Carbogen Amics expanded its HPAPI capabilities in January 2017, by acquiring the land and buildings of GEA Pharma Systems AG (Switzerland) in Bubendorf. Cambrex Corporation has expanded its HPAPI capacity at Lowa site (U.S.) with the investment of $50 million in July 2016.

However, Contract manufacturing will emerge as a strategic option for many pharmaceutical companies because few smaller companies lacking in-house laboratory infrastructure, expertise, and/or chemistry personnel for transition of a laboratory synthesis of a development candidate to a chemical process suitable to cGMP manufacture and scale-up. So they will outsource HPAPI production to contract manufacturer who has a sustained and exemplary record of accomplishment for safety, regulatory compliance, and a successful audit history when working with HPAPIs. A growing number of small and midsized Life Science companies developing innovator small-molecule therapeutics are driving demand for an increase in these CMOs. Though some pharmaceutical companies have invested in infrastructure like in building in-house capabilities, the capital-intensive nature and specialized containment requirements which are really needed in HPAPI manufacturing make the role of CMO crucial. On the other hand, In future, the challenge for pharmaceutical companies is to find out the right CMO with the production capabilities, technical knowledge and experience for HPAPI service.

The HPAPI global market is highly fragmented with the presence of several hundred companies and the major ten players occupy the share of less than 10%. Major players in the HPAPI global market include Alkermes plc (Ireland), Cambrex Corporation (U.S.), Dishman Group (India), Dr. Reddy’s Laboratories (India), Lonza Group (Switzerland), Novasep (U.S.),Patheon N.V.(Netherland),(Acquired by ThermoFisher Scientific), Pfizer (U.S.), Merck KGaA (Germany), Teva Pharmaceutical Industries (Israel).

Some of the top bestselling HPAPIs are Revlimid from Celgene Biotechnology (U.S.), Velcade from Dr Reddy’s Laboratories (India) for Oncology, Azilect from Teva Pharmaceutical Industries (Israel) for CNS disorders, Victoza for Metabolic disorders.


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