High Potency Active Pharmaceutical Ingredient (HPAPI) Market: Patent Expiry of Blockbuster Drugs Propel Global Market Growth

Transparency Market Research (TMR) has published a new report titled, ‘High Potency Active Pharmaceutical Ingredients (HPAPI) Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027’. According to the report, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market was valued at US$ 17.46 Bn in 2018 and is projected to expand at a CAGR of over 8.7% from 2019 to 2027.

Overview

• High-potency active pharmaceutical ingredients (HPAPIs) are a niche but growing area for pharmaceutical manufacturers and contract manufacturing organizations (CMOs). Specialized considerations in facility design, equipment, operation, and process safety are needed to achieve the desired level of containment of the drug substance or finished-drug product. For drug-substance manufacturing, the HPAPI may be a small-molecule, biologic, or a hybrid of the two such as an antibody–drug conjugate, which links a cytotoxic small-molecule to a monoclonal antibody.
• High potency active pharmaceutical ingredients (HPAPI) form a significant proportion of new drugs under development. Production of HPAPI presents various challenges due to its cytotoxic nature; thus, it requires heavy investment to ensure safe environment for employees. Contract manufacturing of HPAPI has been preferred over captive production due to high degree of competition and reduced profitability. Contract manufacturing is also preferred due to geographical advantage and cost-effectiveness.
• North America dominate the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2019 and the trend is anticipated to continue during the forecast period. High demand for biological HPAPI, technological development in the pharmaceutical industry, and large number of manufacturing facilities are major factors driving the market growth in these regions.
• Asia Pacific is likely to be a highly lucrative region for the High Potency Active Pharmaceutical Ingredients (HPAPI) market and is expected to expand at a high CAGR during the forecast period due to rising focus on contract manufacturing and contract research organizations. Low labor cost, well-equipped manufacturing plants, and favorable foreign exchange policies in countries such as China have created lucrative opportunities for outsourcing businesses. Additionally, pharmaceutical manufacturers are currently focusing on countries in Latin America for contract manufacturing.

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Growing preference for outsourcing of HPAPI manufacturing and Patent expiry of blockbuster drugs to Drive Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• Pharmaceutical companies started to expand geographical boundaries, they started experiencing shortage of HPAPIs. Furthermore, increasing cost of drug development and commercialization added to the financial burden. With developing regulatory and legal framework, outsourcing proved to be the most optimal option for HPAPI manufacturing.
• Patent expiry and subsequent launch of generic versions is a lucrative opportunity for pharmaceutical companies to expand product portfolio and tap profitable market segments in this technology driven market.
• Various biosimilars have been approved in Europe, while the U.S. FDA has approved only one biosimilar to date. Increase in research and development activities and constant attempts toward mimicking branded biological drugs would pave the way for introduction of cost-effective treatment alternatives.
• Various blockbuster drugs are expected to loose patent protection in the near future, providing large opportunities in the biosimilars market. Avastin (bevacizumab), Herceptin (trastuzumab), Synagis (palivizumab), Erbitux (cetuximab), Humira (adalimumab), Remicade (infliximab), and Rituxan (rituximab) are some of the major drugs going off patent in the near future.

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Synthetic Segment to Dominate High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• In terms of API type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into Synthetic, Biological.
• Synthetic segment dominated the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2018 and the trend is projected to continue during the forecast period. Numerous drugs consisting synthetic HPAPI are slated to go off patent in the near future. This would unlock a huge market opportunity for generic drug manufacturers, resulting in augmented demand for synthetic HPAPIs.
• Majority of the biologics are manufactured in-house due to intellectual property concerns and quality issues. However, the manufacture of biological HPAPIs is becoming an increasingly complex and challenging process. Hence, innovator companies are outsourcing to contract manufacturers with biological production expertise.

Captive Segment Hold a Major Share of Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• In terms of manufacture type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been classified into captive and contract
• The captive segment is likely to dominate the High Potency Active Pharmaceutical Ingredients (HPAPI) market during the forecast period. High potency active pharmaceutical ingredients (APIs) are manufactured either in-house (captive) by the innovator/formulator company, or outsourced to contract manufacturing organizations. In-house or captive facility is preferred by most companies in case of exclusive drugs or when the production is limited to a specific geography.

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Branded Segment to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• Based on drug type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into branded and generic
• Branded HPAPIs, which account for the larger share of the global HPAPI market, are expected to witness continued growth, albeit at a slower pace than the generic HPAPIs market

Oncology drugs Segment to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• Based on therapeutic application, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into oncology drugs, anti-diabetic drugs, cardiovascular drugs, CNS drugs, musculoskeletal drugs and other drugs
• The oncology drugs segment witnessed a steep rise in the introduction of innovative therapeutic options. Antibody-drug conjugates, monoclonal antibodies, and cytotoxic drugs account for the largest share and are considered to be the key drivers of the high potency active pharmaceutical ingredients (HPAPI) market. Patent expiry of blockbuster drugs such as Herceptin, Humira, and Rituxan has unlocked immense opportunities for generic HPAPI manufacturers.

North America to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

• In terms of region, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2018, followed by Europe.
• North America accounted for major share of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2018. Demand for biological HPAPIs is high in North America, as technological developments in the pharmaceutical industry are paving the way for newer biotechnology drugs. Furthermore, biologics have replaced synthetic drugs as the top selling drugs in North America. Leading pharmaceutical companies also own manufacturing facilities in the region.
• The High Potency Active Pharmaceutical Ingredients (HPAPI) market in Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. Well-equipped manufacturing plants, low labor costs, and favorable foreign exchange policies are the major factors driving outsourcing business to Asia Pacific.

Competitive Landscape

• The global High Potency Active Pharmaceutical Ingredients (HPAPI) market is fragmented in terms of number of players. Key players in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market include Alkermes plc, Cambrex Corporation, Dr. Reddy’s Laboratories, Lonza Group, Novasep, Novartis AG, Pfizer, Sigma-Aldrich Co. LLC., WuXi AppTec, Bristol-Myers Squibb, F. Hoffmann-La Roche, Teva Pharmaceutical Industries, Eli Lilly and Company, Abbvie.

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