High Potency Active Pharmaceutical Ingredients Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)
The global High Potency Active Pharmaceutical Ingredients (HPAPI) market, with a valuation of approximately US$ 25 billion in 2024, is poised for significant growth during forecast period 2024 to 2031. The prevalence of cancer cases worldwide has driven the increased use of HPAPIs, propelling market expansion.
Impact of Patent Expiration on the Global HPAPI Market
The patent expiration of successful drugs in the pharmaceutical industry offers a lucrative opportunity for businesses to diversify their product portfolios and enter attractive market segments. Europe has seen several biosimilars approvals, while the United States FDA has approved a limited number so far. Continuous research and development efforts aimed at replicating branded biological medications are likely to lead to the introduction of cost-effective treatment options.
Several key medications, including Remicade (Infliximab), Herceptin (Trastuzumab), Avastin (Bevacizumab), Erbitux (Cetuximab), Synagis (Palivizumab), Humira (Adalimumab), and Rituxan (Rituximab), are expected to lose their patent protection, presenting significant opportunities for biosimilars in the market.
Acceleration of the HPAPI Market through Outsourcing
Stringent regulatory standards for pharmaceutical ingredient production in various countries have driven up in-house API manufacturing costs. Consequently, pharmaceutical companies are increasingly turning to outsourcing to optimize their operations. Asia Pacific, with its cost-effective production capabilities, has become a preferred destination for outsourcing API manufacturing.
Several manufacturers have established a strong presence in countries like China and India, leading to a surge in contract development and manufacturing firms (CDMOs). For instance, AGC Biologics, a global biopharmaceutical CDMO, collaborated with Ono Pharmaceutical Co., Ltd. in 2020 for the development of innovative biopharmaceuticals. This expertise and capacity to manufacture APIs at scale are expected to boost the market in the forecast period.
Region-wise Analysis
North America: The North American market is expected to be the most lucrative, driven by the increasing prevalence of chronic diseases and government initiatives to develop new medications. The rising adoption of biological pharmaceuticals among patients further contributes to the demand for biological APIs.
Asia Pacific: The market in Asia Pacific is set to surge, driven by the growing presence of contract manufacturing organizations and pharmaceutical companies in countries like China and India.
Competitive LandscapeKey Companies Profiled in the HPAPI Market:
• BASF SE
• CordenPharma
• Dr. Reddy’s Laboratories Ltd.
• CARBOGEN AMCIS AG
• Pfizer, Inc.
• Sun Pharmaceutical Industries, Ltd.
• Teva Pharmaceutical Industries Ltd.
• Albany Molecular Research, Inc.
• Sanofi S.A.
• Merck & Co., Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd.
• Bristol-Myers Squibb Company
• Boehringer Ingelheim International GmbH
• Cipla Inc.
Market Segments Covered in High Potency Active Pharmaceutical Ingredients Market Analysis
By Product Type
• Synthetic
• Biotech
By Manufacturer Type
• In-house
• Outsourced
By Drug Type
• Innovative
• Generic
By Application
• Oncology
• Hormonal Disorders
• Glaucoma
• Other Applications
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
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