According to Vision Research Reports, the global high potency active pharmaceutical ingredients market size was valued at USD 26.75 billion in 2023 and it is expected to surpass around USD 49 billion by 2033 with a CAGR of 6.24% from 2024 to 2033.
According to Vision Research Reports, the global high potency active pharmaceutical ingredients market size was valued at USD 26.75 billion in 2023 and it is expected to surpass around USD 49 billion by 2033 with a CAGR of 6.24% from 2024 to 2033.
What is the High Potency Active Pharmaceutical Ingredients Market?
The High Potency Active Pharmaceutical Ingredients (HPAPI) Market refers to the sector that deals with the production, distribution, and consumption of potent substances used in pharmaceutical products. These ingredients are characterized by their high level of potency and often require special handling due to their toxicity and sensitivity. The market encompasses various aspects such as manufacturing technologies, regulatory compliance, market trends, and the demand for HPAPIs in the pharmaceutical industry.
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Key Pointers
- North America held the largest market share in 2023, dominating the market.
- The Asia Pacific region is expected to demonstrate the most rapid growth throughout the forecast period.
- In terms of product, the biotech segment is projected to achieve the highest Compound Annual Growth Rate (CAGR) during the forecast period.
- Within the HPAPI market, the in-house segment secured the largest market share by manufacturer type.
- The outsourced segment is forecasted to register the swiftest CAGR from 2024 to 2033 by manufacturer type.
- Among drug types, the generic medicine segment is poised for the fastest growth rate.
- The oncology segment accounted for the largest market share in 2023 by application.
- The hormonal segment is expected to experience significant CAGR growth from 2024 to 2033 by application.
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Product Insights
By 2023, the synthetic division had risen as the primary revenue driver in the HPAPI market. Its ascendancy owes much to the enhanced effectiveness of synthetic HPAPIs in combatting various ailments with minimal doses. Furthermore, as patents on synthetic molecules expired, generics gained entry into the market, further amplifying the segment’s growth. The FDA’s generic drug initiative, particularly active amidst the COVID-19 pandemic, played a pivotal role in ensuring the availability of quality, cost-efficient drugs in the U.S. This move not only trims healthcare expenses but also lightens the financial load on patients by encouraging the use of generic alternatives. Notably, in 2020, the FDA greenlit 948 ANDA applications, including 72 first generic drugs.
Forecasts indicate that the biotech sector will undergo the swiftest expansion in the upcoming period. This surge stems from technological strides within biotech alongside the notable efficacy of biotech HPAPIs. Mainly consisting of peptides and diverse enzyme variants, these HPAPIs hold significant promise for therapeutic applications. Moreover, the biotech segment’s growth is fueled by substantial investments in biotechnology and biopharmaceuticals, fostering the development of novel molecules for treating diseases, especially in oncology. However, it’s essential to note that the production costs of biotechnological products are relatively high due to the necessity for specialized facilities and skilled personnel. Consequently, pharmaceutical firms are increasingly resorting to third-party manufacturers, thus augmenting suppliers’ bargaining power within the HPAPI market.
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- Active Pharmaceutical Ingredients Market: https://www.visionresearchreports.com/active-pharmaceutical-ingredients-market/38528
Manufacturer Type Insights
In 2023, the in-house sector dominated the HPAPI market, boasting the largest market share. This supremacy is chiefly credited to strategic endeavors by key players, highlighting a strong inclination towards in-house production rather than outsourcing. Notably, in August 2021, Cipla, Inc. initiated an “API re-imagination” program aimed at broadening its manufacturing capabilities, leveraging recent governmental incentives like production subsidies.
The outsourced division is projected to experience the most rapid growth in the forecast period. This upsurge is fueled by the increasing adoption of outsourcing within the high potency APIs market. Outsourced manufacturing offers benefits such as risk mitigation, reduced resource allocation, and streamlined product complexity for companies. Additionally, developing nations present a cost-effective option for outsourcing due to lower manufacturing expenses, enabling companies to boost profits and stimulate market demand. An illustrative instance is the expansion of Wuxi STA’s HPAPI facility in China, announced in June 2023, empowering the company to serve CDMO customers seeking intricate manufacturing setups.
Drug Type Insights
In the HPAPI market, innovative drugs have secured the largest share of revenue, propelled by the growing focus on personalized and precision medicines such as Antibody-Drug Conjugates (ADCs). The development of innovative HPAPIs tailored to address specific diseases within patient populations has emerged as a major market driver. A notable example is the introduction of innovative drugs like the biosimilar antibody-drug conjugate trastuzumab emtansine, marketed as Ujvira by Zydus Cadila in May 2021, which exemplifies this trend.
Conversely, the generic medicine segment is set to witness the most rapid growth. This surge is powered by the crucial role generics play in ensuring access to life-saving medications, with the U.S. FDA prioritizing generics as a public health necessity to conserve healthcare resources. As of November 2021, there are already over 10,000 FDA-approved generic medications on the market, with generics accounting for nine out of ten prescriptions in the U.S. This underscores the vital role of the generic medicine segment in propelling market expansion and improving patient access to cost-effective healthcare solutions.
Application Insights
The oncology sector emerged as the leading force in the HPAPI market, capturing the largest market share in 2023 and is anticipated to maintain its position as the fastest-growing segment. This dominance is attributed to the escalating global prevalence of cancer. According to GLOBOCAN 2020, approximately 19.3 million new cancer cases and nearly 10.0 million cancer-related deaths were recorded in 2020 alone. Notably, breast and lung cancers were identified as the most prevalent cancer types worldwide. Responding to the surge in cancer incidence, key market players are expanding their manufacturing capacities to meet the growing demand for cancer treatment components. For instance, in June 2023, Merck announced a twofold expansion of its U.S.-based Verona HPAPI facility to cater to the rising demand for cancer therapeutics.
Conversely, the hormonal segment is poised for significant growth in the forecast period. This upward trajectory is propelled by the increasing prevalence of the geriatric population alongside growing awareness of hormonal therapy. Common hormone-dependent conditions in women, such as Alzheimer’s disease, osteoporosis, coronary atherosclerosis, and urinary incontinence, underscore the importance of hormonal treatments. The rising prevalence of hormonal disorders is expected to further fuel segmental growth, presenting lucrative opportunities in the HPAPI market.
Regional Insights
In 2023, North America solidified its position as a dominant force in the high potency active pharmaceutical ingredients (HPAPI) market, claiming a significant share. Several factors contribute to this regional supremacy, including the increasing prevalence of cancer, well-established infrastructure, and the presence of key market players. For instance, in 2021, the United States alone witnessed approximately 1.9 million new cancer cases and around 608,570 deaths, highlighting the urgent need for advanced pharmaceutical solutions. North America is poised for further expansion, driven by growing regulatory support and the rising incidence of chronic diseases, which fuels demand for fast-acting and highly effective drugs.
Meanwhile, the Asia Pacific region is set to experience the most rapid growth throughout the forecast period. This upward trajectory is fueled by the presence of emerging economies within the region, particularly India and China, which serve as major suppliers of HPAPIs to various global markets. The availability of APIs and HPAPIs at lower costs in the region further accelerates market growth. Additionally, the rise of generics and improvements in healthcare infrastructure contribute to the region’s momentum, facilitating increased access to advanced pharmaceutical treatments.
High Potency Active Pharmaceutical Ingredients Market Key Companies
- BASF SE
- CordenPharma
- Bristol-Myers Squibb Company
- CARBOGEN AMCIS AG
- Pfizer, Inc.
- Boehringer Ingelheim International GmbH
- Dr. Reddy’s Laboratories Ltd.
- Sun Pharmaceutical Industries, Ltd.
- Albany Molecular Research, Inc.
- Sanofi
- Lonza
- Cipla Inc.
- Merck & Co., Inc.
- Teva Pharmaceutical Industries Ltd.
- Novartis AG
- F. Hoffmann-La Roche Ltd.
High Potency Active Pharmaceutical Ingredients Market Segmentations:
By Product
- Synthetic
- Biotech
By Manufacturer Type
- In-house
- Outsourced
By Drug Type
- Innovative
- Generic
By Application
- Oncology
- Hormonal
- Glaucoma
- Others
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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