High Potency Active Pharmaceutical Ingredient Hpapi
PUBLISHED: 2024 ID: SMRC26386
SHARE
SHARE

High Potency Active Pharmaceutical Ingredient Hpapi

High Potency Active Pharmaceutical Ingredient (HPAPI) Market Forecasts to 2030 - Global Analysis By Product (Biologic, Biosimilar and Biotech), Manufacturer (Outsourced/ Contract and In-House (Captive)), Drug Type, Application and By Geography

4.8 (62 reviews)
4.8 (62 reviews)
Published: 2024 ID: SMRC26386

This report covers the impact of COVID-19 on this global market
Loading...

According to Stratistics MRC, the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is accounted for $34.51 billion in 2024 and is expected to reach $67.02 billion by 2030 growing at a CAGR of 11.7% during the forecast period. High potency active pharmaceutical ingredients are biologically active compounds that exhibit biological activity at extremely low dose levels. After the human genome was depicted, cancer drugs were produced not only for distinct cancer but also for different patients. The global high potency active ingredient is classified as Generic HPAPI and Innovative HPAPI. The generic HPAPI involve the same chemical agent as a drug that was once secured by chemical patent claims Whereas, Innovative HPAPI involves different chemical molecule.

According to the Alzheimer's Association, roughly 6.2 Million people in the United States over the age of 65 have Alzheimer's dementia, with the number expected to rise to 12.7 Million by 2050.

Market Dynamics: 

Driver: 

Increasing incidence of cancer

HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe.

Restraint:

Large initial investments

The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities.

Opportunity:

Developments in emerging regions

Developing economies such as India, China, and the Middle East presents high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.

Threat:

Continual evolution of industry standards

One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For instance, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels. 

Covid-19 Impact: 

The COVID-19 pandemic significantly impacted the high-potency active pharmaceutical ingredient (HPAPI) market. The surge in demand for effective treatments and vaccines led to increased investment and production capacity in the pharmaceutical sector, including HPAPIs. Supply chain disruptions and lockdown measures initially posed challenges, causing delays and shortages. However, the crisis also accelerated technological advancements and regulatory approvals, fostering innovation and efficiency in HPAPI manufacturing.

The oncology segment is expected to be the largest during the forecast period

The oncology segment has the largest share of the market because of the greater amount of HPAPIs found in oncology drugs. The rising prevalence of cancer is a major factor driving up demand for HPAPI. And also, some of the factors like rising demand for cancer and initiate of recent target therapy are the main cause of the increase in the development of oncology as compared to other therapeutic applications such as hormonal disorder and glaucoma.

The synthetic segment is expected to have the highest CAGR during the forecast period

The synthetic HPAPI market is growing at a faster rate because, at very low doses, these molecules are very effective in the treatment of a variety of diseases. Many synthetic molecules are also predicted to lose their patents in the years ahead, boosting market growth. The Japanese government has been advocating for the utilize of generic medicines in lowering the overall healthcare costs and the economic burden placed on patients

Region with largest share:

North America is projected to hold the largest market share in the High Potency Active Pharmaceutical Ingredient (HPAPI) market due to its advanced pharmaceutical infrastructure, stringent regulatory standards, and significant investments in R&D. The presence of key pharmaceutical companies and contract manufacturing organizations (CMOs) in the region further drives market growth. Additionally, the increasing prevalence of chronic diseases and the demand for targeted cancer therapies boost the need for HPAPIs, reinforcing North America's leading position in the market.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR due to the growth in geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government efforts to reform healthcare and encourage the adoption of generics. The growing market for merchant manufacturers in this region is attributed to the low labour and manufacturing costs are driving the growth of the market in Asia.

Key players in the market

Some of the key players in High Potency Active Pharmaceutical Ingredient (HPAPI) market include Abbvie, Alkermes plc, Bristol-Myers Squibb, Cambrex Corporation, Corden Pharma International, Dr. Reddy's Laboratories, Eli Lilly and Company, F. Hoffmann-La Roche, Lonza Group, Merck KGaA, Novartis AG, Novasep, Pfizer, Sanofi, Sigma-Aldrich Co LLC, SK Biotek, Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries, Thermo Fisher Scientific Inc., Viatris Inc. and WuXi AppTec   

Key Developments:

In May 2024, Alkermes plc has completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. In connection with the closing of the transaction, Alkermes will receive a one-time cash payment for the facility and certain related assets of approximately $91 million.

In April 2024, Bio-Techne Corporation announced a significant milestone in its commitment to providing cutting-edge solutions to its customers. Effective May 1, 2024, Bio-Techne will enter into a strategic distribution agreement with Thermo Fisher Scientific, a leading provider of laboratory products and services, in Europe. This partnership marks an important collaboration between two industry leaders in the fields of scientific research, diagnostics, and biotechnology.

Products Covered:
• Biologic   
• Biosimilar   
• Synthetic   
• Biotech    

Manufacturers Covered:
• Outsourced/ Contract
• In-House (Captive)

Drug Types Covered:
• Innovative/Novel 
• Generic  

Applications Covered:
• Metabolic Disorders  
• Hormonal Disorders  
• Central Nervous System Disorders
• Glaucoma  
• Infectious Diseases  
• Inflammation  
• Musculoskeletal Drugs 
• Oncology   
• Respiratory Disorders
• Erectile Dysfunction 
• Cosmetology 
• Cardiovascular Drugs 
• Anti-Diabetic Drugs 
• Other Applications   

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan        
o China        
o India        
o Australia  
o New Zealand
o South Korea
o Rest of Asia Pacific    
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa 
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings: 
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary      
       
2 Preface      
 2.1 Abstract     
 2.2 Stake Holders     
 2.3 Research Scope     
 2.4 Research Methodology     
  2.4.1 Data Mining    
  2.4.2 Data Analysis    
  2.4.3 Data Validation    
  2.4.4 Research Approach    
 2.5 Research Sources     
  2.5.1 Primary Research Sources    
  2.5.2 Secondary Research Sources    
  2.5.3 Assumptions    
       
3 Market Trend Analysis      
 3.1 Introduction     
 3.2 Drivers     
 3.3 Restraints     
 3.4 Opportunities     
 3.5 Threats     
 3.6 Product Analysis     
 3.7 Application Analysis     
 3.8 Emerging Markets     
 3.9 Impact of Covid-19     
       
       
4 Porters Five Force Analysis      
 4.1 Bargaining power of suppliers     
 4.2 Bargaining power of buyers     
 4.3 Threat of substitutes     
 4.4 Threat of new entrants     
 4.5 Competitive rivalry     
       
5 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Product      
 5.1 Introduction     
 5.2 Biologic        
 5.3 Biosimilar        
 5.4 Synthetic        
 5.5 Biotech        
  5.5.1 Vaccines      
  5.5.2 Recombinant Proteins    
  5.5.3 Monoclonal Antibodies    
       
6 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Manufacturer      
 6.1 Introduction     
 6.2 Outsourced/ Contract     
 6.3 In-House (Captive)     
       
7 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Drug Type      
 7.1 Introduction     
 7.2 Innovative/Novel     
 7.3 Generic     
       
8 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Application      
 8.1 Introduction     
 8.2 Metabolic Disorders       
 8.3 Hormonal Disorders       
 8.4 Central Nervous System Disorders     
 8.5 Glaucoma       
 8.6 Infectious Diseases       
 8.7 Inflammation       
 8.8 Musculoskeletal Drugs      
 8.9 Oncology        
 8.10 Respiratory Disorders     
 8.11 Erectile Dysfunction      
 8.12 Cosmetology      
 8.13 Cardiovascular Drugs      
 8.14 Anti-Diabetic Drugs      
 8.15 Other Applications       
       
9 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market, By Geography      
 9.1 Introduction     
 9.2 North America     
  9.2.1 US    
  9.2.2 Canada    
  9.2.3 Mexico    
 9.3 Europe     
  9.3.1 Germany    
  9.3.2 UK    
  9.3.3 Italy    
  9.3.4 France    
  9.3.5 Spain    
  9.3.6 Rest of Europe    
 9.4 Asia Pacific     
  9.4.1 Japan    
  9.4.2 China    
  9.4.3 India    
  9.4.4 Australia    
  9.4.5 New Zealand    
  9.4.6 South Korea    
  9.4.7 Rest of Asia Pacific    
 9.5 South America     
  9.5.1 Argentina    
  9.5.2 Brazil    
  9.5.3 Chile    
  9.5.4 Rest of South America    
 9.6 Middle East & Africa     
  9.6.1 Saudi Arabia    
  9.6.2 UAE    
  9.6.3 Qatar    
  9.6.4 South Africa    
  9.6.5 Rest of Middle East & Africa    
       
10 Key Developments      
 10.1 Agreements, Partnerships, Collaborations and Joint Ventures     
 10.2 Acquisitions & Mergers     
 10.3 New Product Launch     
 10.4 Expansions     
 10.5 Other Key Strategies     
       
11 Company Profiling      
 11.1 Abbvie            
 11.2 Alkermes plc       
 11.3 Bristol-Myers Squibb       
 11.4 Cambrex Corporation      
 11.5 Corden Pharma International     
 11.6 Dr. Reddy's Laboratories      
 11.7 Eli Lilly and Company       
 11.8 F. Hoffmann-La Roche      
 11.9 Lonza Group       
 11.10 Merck KGaA     
 11.11 Novartis AG       
 11.12 Novasep        
 11.13 Pfizer        
 11.14 Sanofi        
 11.15 Sigma-Aldrich Co LLC       
 11.16 SK Biotek     
 11.17 Sun Pharmaceutical Industries Ltd     
 11.18 Teva Pharmaceutical Industries      
 11.19 Thermo Fisher Scientific Inc.     
 11.20 Viatris Inc.     
 11.21 WuXi AppTec       
       
List of Tables       
1 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Region (2022-2030) ($MN)      
2 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Product (2022-2030) ($MN)      
3 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Biologic    (2022-2030) ($MN)      
4 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Biosimilar    (2022-2030) ($MN)      
5 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Synthetic    (2022-2030) ($MN)      
6 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Biotech    (2022-2030) ($MN)      
7 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Vaccines   (2022-2030) ($MN)      
8 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Recombinant Proteins (2022-2030) ($MN)      
9 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Monoclonal Antibodies (2022-2030) ($MN)      
10 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Manufacturer (2022-2030) ($MN)      
11 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Outsourced/ Contract (2022-2030) ($MN)      
12 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By In-House (Captive) (2022-2030) ($MN)      
13 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Drug Type (2022-2030) ($MN)      
14 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Innovative/Novel (2022-2030) ($MN)      
15 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Generic (2022-2030) ($MN)      
16 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Application (2022-2030) ($MN)      
17 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Metabolic Disorders   (2022-2030) ($MN)      
18 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Hormonal Disorders   (2022-2030) ($MN)      
19 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Central Nervous System Disorders (2022-2030) ($MN)      
20 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Glaucoma   (2022-2030) ($MN)      
21 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Infectious Diseases   (2022-2030) ($MN)      
22 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Inflammation   (2022-2030) ($MN)      
23 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Musculoskeletal Drugs  (2022-2030) ($MN)      
24 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Oncology    (2022-2030) ($MN)      
25 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Respiratory Disorders (2022-2030) ($MN)      
26 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Erectile Dysfunction  (2022-2030) ($MN)      
27 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Cosmetology  (2022-2030) ($MN)      
28 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Cardiovascular Drugs  (2022-2030) ($MN)      
29 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Anti-Diabetic Drugs  (2022-2030) ($MN)      
30 Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market Outlook, By Other Applications   (2022-2030) ($MN)      
       
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.       

List of Figures

RESEARCH METHODOLOGY


Research Methodology

We at Stratistics opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.

Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.

Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.

Data Mining

The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.

Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.

Data Analysis

From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:

  • Product Lifecycle Analysis
  • Competitor analysis
  • Risk analysis
  • Porters Analysis
  • PESTEL Analysis
  • SWOT Analysis

The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.


Data Validation

The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.

We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.

The data validation involves the primary research from the industry experts belonging to:

  • Leading Companies
  • Suppliers & Distributors
  • Manufacturers
  • Consumers
  • Industry/Strategic Consultants

Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.


For more details about research methodology, kindly write to us at info@strategymrc.com

Frequently Asked Questions

In case of any queries regarding this report, you can contact the customer service by filing the “Inquiry Before Buy” form available on the right hand side. You may also contact us through email: info@strategymrc.com or phone: +1-301-202-5929

Yes, the samples are available for all the published reports. You can request them by filling the “Request Sample” option available in this page.

Yes, you can request a sample with your specific requirements. All the customized samples will be provided as per the requirement with the real data masked.

All our reports are available in Digital PDF format. In case if you require them in any other formats, such as PPT, Excel etc you can submit a request through “Inquiry Before Buy” form available on the right hand side. You may also contact us through email: info@strategymrc.com or phone: +1-301-202-5929

We offer a free 15% customization with every purchase. This requirement can be fulfilled for both pre and post sale. You may send your customization requirements through email at info@strategymrc.com or call us on +1-301-202-5929.

We have 3 different licensing options available in electronic format.

  • Single User Licence: Allows one person, typically the buyer, to have access to the ordered product. The ordered product cannot be distributed to anyone else.
  • 2-5 User Licence: Allows the ordered product to be shared among a maximum of 5 people within your organisation.
  • Corporate License: Allows the product to be shared among all employees of your organisation regardless of their geographical location.

All our reports are typically be emailed to you as an attachment.

To order any available report you need to register on our website. The payment can be made either through CCAvenue or PayPal payments gateways which accept all international cards.

We extend our support to 6 months post sale. A post sale customization is also provided to cover your unmet needs in the report.

Request Customization

We provide a free 15% customization on every purchase. This requirement can be fulfilled for both pre and post sale. You may send your customization requirements through email at info@strategymrc.com or call us on +1-301-202-5929.

Note: This customization is absolutely free until it falls under the 15% bracket. If your requirement exceeds this a feasibility check will be performed. Post that, a quote will be provided along with the timelines.

WHY CHOOSE US ?

Assured Quality

Assured Quality

Best in class reports with high standard of research integrity

24X7 Research Support

24X7 Research Support

Continuous support to ensure the best customer experience.

Free Customization

Free Customization

Adding more values to your product of interest.

Safe and Secure Access

Safe & Secure Access

Providing a secured environment for all online transactions.

Trusted by 600+ Brands

Trusted by 600+ Brands

Serving the most reputed brands across the world.

Testimonials