The global High Potency Active Pharmaceutical Ingredient market accounted for US$ 21.5 Bn in 2020 with a significant CAGR of 8.2% during the analysis period of 2021 to 2028

High potency active pharmaceutical ingredient (HPAPIs) are pharmacologically active substance exhibiting biological activity at extremely low concentrations, such as daily therapeutic dose of <10mg. The Drug, Chemical & Associated Technologies (DCAT) report states that, currently HPAPIs continue to be an area of interest to the pharmaceutical manufacturing sector. Furthermore, the majority of manufacturers are heavily investing in the high potency active pharmaceutical ingredient (HPAPI) market, that comprises includes not only large players, but also small players who see it as a lucrative opportunity, resulting in new product innovations for competing aggressively.

Key takeaway from HPAPIs market

The DCAT report states that HPAPI comprises of wide range of products starting from therapeutic areas but oncology focused medication is on the forefront lead when compared with other innovative product pipeline and upcoming generic entries reflecting broader coverage of pharmaceutical industry trends. For instance, with a strong consistency of atleast 27 high potency oncology targeted fighting molecules accounts for US$26 Bn every year is now facing loss of exclusivity (LOE) during 2020 to 2024. But this collection of 27 products, therefore, offers a useful reference point for reviewing opportunities completely for high-potency active ingredients with high explosion of HPAPIs.

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Market Drivers

Innovative therapies accelerate the growth of global high potency active pharmaceutical ingredients market

With advent of pharmaceutical ingredient gradually moving towards innovative therapies focusing on customized and patient centric treatment, pharmaceutical manufacturers are focusing on smaller batch size of more complex and potent compounds triggering high quality standards. The quarter of new chemical entities (NCEs) under development fall under the category of high potency active pharmaceutical ingredient (HPAPIs). For example, significant investment in research with a visible shift towards specialty drugs, particularly oncology has been an area of interest for global pharmaceutical players today. Such factors have positive influence for the growth of global high potency active pharmaceutical ingredients market.

Continuous production is the viable option for the growth of HPAPIs market

Consistent production has effectively assisted in manufacturing of HPAPIs that involve tablets and capsules that is evolving over the years and becoming a trend now. The basic manufacturing process comprises of different operations that involve weighing, drying, granulation, mixing, tableting, and coating that can be performed in a closed system and in same compression and tableting room. So this ultimately reduces production space up to 70% as compared to batch production. This ultimately results in improving production efficiency and resulting in reduction of GMP footprint. Also, there is less human involvement in continuous production that proves manufacturers to acquire the required knowledge and expertise for safe processing of molecules, safety of employees, and variance regulatory requirement.

Report coverage

Market	Liquid Nitrogen Cryopreservation Market
Analysis Period	2017 - 2028
Base Year	2020
Forecast Data	2021 - 2028
Segments Covered	By Product, By Manufacturer Type, By Drug Type, By Application, By End-Use and By Geography
Regional Scope	North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
Key Companies Profiled	CUSTOM BIOGENIC SYSTEMS, Chart Industries, Linde, Taylor-Wharton, Antech Group Inc., Abeyance Cryo Solutions, Thermo Fisher Scientific, Inc., Worthington Industries, Inc., BIOLOGIX GROUP LTD, and others
Report Coverage	Market Trends, Drivers, Restraints, Competitive Analysis, Player Profiling, Regulation Analysis
Customization Scope	10 hrs of free customization and expert consultation

Market Restraint and Challenges

High potent active pharmaceutical ingredient market faces a big challenge regarding containment. As API is considered highly potent if it has biological activity at smaller dose. With the increase of biological activity and specificity of highly potent drug substance results in increased risk of occupational handling of drug substance during product manufacturing. In order to mitigate such challenges there is a need for significant investment in specialized containment resources. Containment acts as an important tool to limit the spread of highly active substances, ensuring the safety of both employees and environment coupled with protection.

Market Segmentation

The global high potency active pharmaceutical ingredient market is segmented as product, manufacture type, drug type, and application. By product, the market is split into synthetic and biotech. Based on manufacturer type, the market is classified into in-house and outsourced. By drug type, the market is bifurcated into innovative and generic. Furthermore, application is segregated as oncology, hormonal disorders, glaucoma, and others.

Based on product, synthetic segment recorded major share responsible for the growth of global high potency active pharmaceutical ingredient market. Based on drug type, innovative drugs accounted considerable share in the past and is projected to continue this trend till the foreseeable future. Based on application, the oncology segment is expected to record maximum share in the coming years. Furthermore, based on manufacturer type, in-house segment will account largest revenue in the forecast period.

Regional Landscape

North America recorded considerable share for High Potency Active Pharmaceutical Ingredient market

North America recorded considerable revenue share in 2020 for high potency active pharmaceutical ingredient market. This is due to expansion facility of specifically designed manufacturing of HPAPIs and complex antibody drug conjugates (ADCs). For instance, Millipore Sigma announced US$65 Mn for expansion facility for HPAPI manufacturing capability facility in US. This is one of the key factors responsible for the growth of high potency active pharmaceutical ingredient market. 

On the other hand, Asia Pacific is projected to record fastest growing CAGR for high potency active pharmaceutical ingredient market. This is evaluated owing to large patient pool suffering from chronic disorders, surge in healthcare expenditure, and the existence of major players manufacturing HPAPI in this region. This is one of the prominent factors that make APAC a lucrative region.

Europe recorded second largest market share for high potency active pharmaceutical ingredient market in the coming years. Among European Union, Germany is the dominating country for high potency active pharmaceutical ingredient market. This is due to rising consumption of the active pharmaceutical ingredient (API).

Competitive Landscape

The influx of technology in companies, involving drug designing coupled with delivery technologies assist to develop novel treatment alternatives through collaboration with other key players that may increase the number of research initiatives. Through introduction of competitive strategies such as collaboration and partnerships it will help them to sustain in the market and generate high revenue.

The prominent players of the global high potency active pharmaceutical ingredient market involve BASF SE, Dr. Reddy’s Laboratories Ltd., Pfizer, Inc., Sanofi S.A., Merck & Co., Inc., Novartis AG, F. Hoffmann-La Roche Ltd., Bristol-Myers Squibb Company, Boehringer Ingelheim International GmbH, Cambrex, and Cipla Inc.

Market Segmentation

Market By Product

• Synthetic
• Biotech

Market By Manufacturer Type

• In-house
• Outsourced

Market By Drug Type

• Innovative
• Generic

Market By Application

• Oncology
• Hormonal Disorders
• Glaucoma
• Others

Market By Geography

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
  • Spain
  • Rest of Europe
• Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil 
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa

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