The global high potency APIs market reached a value of nearly $19,772.2 million in 2021, having grown at a compound annual growth rate (CAGR) of 5.2% since 2016. The market is expected to grow from $19,772.2 million in 2021 to $30,405.1 million in 2026 at a rate of 9.0%. The market is then expected to grow at a CAGR of 9.5% from 2026 and reach $47,914.6 million in 2031.
The global high potency APIs market is fragmented, with a large number of small players. The top ten competitors in the market made up to 9.12% of the total market in 2021. This can be due to the existence of number of local players in the market serving customers in particular geographies. Merck KGaA was the largest competitor with 2.68% share of the market, followed by Pfizer, Inc with 1.31%, Thermo Fisher Scientific, Inc with 1.13%, Teva Pharmaceuticals with 1.05%, Lonza Group AG with 0.80%, Sanofi (EUROAPI) with 0.62%, Corden Pharma International with 0.54%, Dr. Reddy’s Laboratories Ltd. with 0.43%, Siegfried Holding AG with 0.35%, and Novartis with 0.21%.
Growth in the historic period resulted from increasing demand for oncology therapies, rising emphasis of pharmaceutical companies on manufacturing of HPAPIs, a rise in healthcare awareness and expenditure, strong economic growth in emerging markets and increasing government initiatives. Factors that negatively affected growth in the historic period were challenges due to regulatory changes and high costs of drug approval. Going forward, a rise in the number of cancer cases, growing focus on precision medicine and increasing ageing population will drive the growth. Factors that could hinder the growth of the high potency APIs market in the future include rising popularity of alternative therapies and natural remedies and high manufacturing costs.
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The high potency APIs market is segmented by type into innovative HPAPI and generic HPAPI. The innovative HPAPI market was the largest segment of the high potency APIs market segmented by type, accounting for 73.9% of the total in 2021. Going forward, the innovative HPAPI segment is expected to be the fastest growing segment in the high potency APIs market segmented by type, at a CAGR of 9.4% during 2021-2026.
The high potency APIs market is also segmented by therapeutic application into oncology, hormonal disorder, glaucoma and other therapeutic applications. The oncology market was the largest segment of the high potency APIs market segmented by therapeutic application, accounting for 43.2% of the total in 2021. Going forward, the glaucoma segment is expected to be the fastest growing segment in the high potency APIs market segmented by therapeutic application, at a CAGR of 9.9% during 2021-2026.
The high potency APIs market is also segmented by synthesis type into synthetic HPAPI and biotech HPAPI. The synthetic HPAPI market was the largest segment of the high potency APIs market segmented by synthesis type, accounting for 77.2% of the total in 2021. Going forward, the biotech HPAPI segment is expected to be the fastest growing segment in the high potency APIs market segmented by synthesis type, at a CAGR of 9.7% during 2021-2026.
North America was the largest region in the high potency APIs market, accounting for 36.6% of the total in 2021. It was followed by Asia Pacific, and then the other regions. Going forward, the fastest-growing regions in the high potency APIs market will be Asia Pacific and North America where growth will be at CAGRs of 9.8% and 9.5% respectively. These will be followed by Western Europe and South America where the markets are expected to grow at CAGRs of 8.4% and 7.0% respectively.
The top opportunities in the high potency APIs market segmented by type will arise in the innovative HPAPI segment, which will gain $8,262.5 million of global annual sales by 2026. The top opportunities in the high potency APIs market segmented by synthesis type will arise in the synthetic HPAPI segment, which will gain $7,980.4 million of global annual sales by 2026. The top opportunities in the high potency APIs market segmented by therapeutic application will arise in the oncology segment, which will gain $4,085.8 million of global annual sales by 2026. The high potency APIs market size will gain the most in the USA at $4,074.7 million.
Market-trend-based strategies for the high potency APIs market include focus on strategies such as production facility expansion and mergers and acquisitions, focus on increasing investments to grow HPAPI production, use of artificial intelligence (AI) in manufacturing APIs, focus on green manufacturing and focus on launch of new, innovative products.
Player-adopted strategies for the high potency APIs market include focus on strategic investments to expand operations, focus on new product approvals and focus on improving production capabilities through strategic investments.
To take advantage of the opportunities, Altus Market Research recommends the HP (high potency) APIs companies to use artificial intelligence (AI), focus on green manufacturing, launch new, innovative products, expand in emerging markets, scale up through merger and acquisition activity, provide competitively priced offerings, continue to participate in events and conferences, focus on fast-growing therapeutic applications and focus on securing long-term supply contracts with pharmaceutical companies.