Active Pharmaceutical Ingredient Market
Active Pharmaceutical Ingredient Market Forecasts to 2030 - Global Analysis By Product (Hormones, Monoclonal Antibodies, Cytokines, Recombinant Proteins, Therapeutic Enzymes, Vaccines, Blood Factors and Other Products), Type, Synthesis Process, Expression System, Application, End User and By Geography
Years Covered |
2021-2030 |
Estimated Year Value (2023) |
US $160.7BN |
Projected Year Value (2030) |
US $317.2 BN |
CAGR (2023 - 2030) |
10.2% |
Regions Covered |
North America, Europe, Asia Pacific, South America, and Middle East & Africa |
Countries Covered |
US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa |
Largest Market |
Asia Pacific |
Highest Growing Market |
North America |
According to Stratistics MRC, the Global Active Pharmaceutical Ingredient Market is accounted for $160.7 billion in 2023 and is expected to reach $317.3 billion by 2030 growing at a CAGR of 10.2% during the forecast period. Active Pharmaceutical Ingredient (API) is the biologically active component of a medication, responsible for its therapeutic effects. It's the substance that produces the intended pharmacological activity within the body. APIs undergo rigorous testing for purity, potency, and stability to ensure they meet regulatory standards. They can be synthesized through chemical processes or derived from natural sources. Their quality and consistency are crucial for the safety and efficacy of pharmaceutical products, making them central to the development and manufacturing of medicines.
According to WHO, cardiovascular diseases cause death of 17.9 million people per day and are expected to cause approximately 25 million deaths by 2030.
Market Dynamics:
Driver:
Growing global populations and prevalence of diseases
As the global population grows, the demand for pharmaceuticals rises correspondingly. More people mean more patients requiring treatment for various ailments, ranging from chronic diseases to infectious illnesses. Moreover, with the increasing prevalence of diseases, especially in developing regions where healthcare infrastructure is expanding, there's a higher demand for APIs to produce medicines. Governments and private healthcare providers invest in building hospitals, clinics, and pharmacies, thereby stimulating the demand for pharmaceutical products, including active pharmaceutical ingredient thus propel the market growth.
Restraint:
Competition from low-cost manufacturers
Low-cost manufacturers often operate in regions with lower labor and production costs, allowing them to offer APIs at significantly lower prices compared to established manufacturers. This price competition can lead to price erosion in the API market, reducing profit margins for existing players. Additionally, intense competition from low-cost manufacturers may lead to market consolidation as smaller or less competitive players struggle to survive which limit choices for pharmaceutical companies, and potentially result in monopolistic practices by dominant players.
Opportunity:
Advancements in medical science and technology
Advancements in medical science, such as genomics, proteomics, and high-throughput screening techniques, enable more efficient drug discovery processes. This leads to the identification of novel drug targets and the development of new APIs to address previously unmet medical needs. Additionally, technological advancements in areas like computational chemistry and molecular modelling facilitate the design of more effective and targeted active pharmaceutical ingredient encouraging the market.
Threat:
Intellectual property issues
Patent protection grants innovator pharmaceutical company’s exclusivity over their APIs for a certain period, typically 20 years. IP issues such as patent infringement lawsuits or challenges can delay the entry of generic versions of APIs into the market. Both innovator and generic manufacturers may incur significant expenses in defending their intellectual property rights or challenging existing patents. This delay restricts competition and can result in higher prices for active pharmaceutical ingredient, limiting access to essential medicines for patients.
Covid-19 Impact
Increased demand for medications like antivirals, corticosteroids, and antibiotics surged production, challenging supply chains, lockdowns disrupted logistics, leading to shortages of raw materials and hindering manufacturing. Additionally, countries prioritized domestic production, affecting global trade. Stricter regulations and safety protocols slowed production rates. Conversely, demand for non-COVID-related APIs declined due to postponed surgeries and reduced healthcare visits. Overall, the pandemic exposed vulnerabilities in API supply chains, prompting efforts to diversify sourcing and enhance resilience for future disruptions.
The hormones segment is expected to be the largest during the forecast period
The hormones segment is estimated to have a lucrative growth, owing to driving demand for hormone-based medications used in various therapeutic areas like endocrinology, gynecology, and oncology. Growth hormones, insulin, thyroid hormones, and sex hormones are among the key APIs manufactured. Factors such as aging populations, rising prevalence of hormonal disorders, and increasing awareness of hormone replacement therapies contribute to market growth. Additionally, advancements in hormone therapy formulations and delivery methods further stimulate demand.
The high potency active pharmaceutical ingredient segment is expected to have the highest CAGR during the forecast period
The high potency active pharmaceutical ingredient segment is anticipated to witness the highest CAGR growth during the forecast period, due to their increased potency and therapeutic efficacy in treating complex diseases such as cancer and autoimmune disorders. The growing demand for targeted therapies and personalized medicine drives the market for HPAPIs. However, their specialized manufacturing requirements, stringent regulatory oversight, and safety concerns pose challenges.
Region with largest share:
Asia Pacific is projected to hold the largest market share during the forecast period owing to factors such as increasing demand for generic drugs, expanding pharmaceutical production capacities, and favorable government initiatives. Moreover, China and India are the dominant players in the Asia Pacific API market. Both countries have established themselves as major manufacturing hubs for pharmaceuticals and APIs due to factors like low labor costs, skilled workforce, and favorable regulatory environments driving the market growth in this region.
Region with highest CAGR:
North America is projected to have the highest CAGR over the forecast period, owing to the demand for biopharmaceuticals, including biologics and biosimilars, is increasing in North America. Biopharmaceutical APIs are complex molecules produced using biotechnological processes and are used in the treatment of various diseases such as cancer, autoimmune disorders, and infectious diseases. Many pharmaceutical companies in North America outsource API manufacturing to contract development and manufacturing organizations (CDMOs) to reduce costs, improve efficiency, and focus on core competencies such as drug development and commercialization.
Key players in the market
Some of the key players in the Active Pharmaceutical Ingredient Market include Abbott , AbbVie Inc., AstraZeneca, Bausch Health Companies Inc., Cadila Pharmaceuticals, Cipla Inc., Dr. Reddy’s Laboratories Ltd , GSK plc, H. Lundbeck A/S, Jazz Pharmaceuticals, Inc., Johnson & Johnson Private Limited, Mylan N.V., Novartis AG, Pfizer Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd, Sun Pharmaceutical Industries Ltd, Sunovion Pharmaceuticals Inc, Takeda Pharmaceutical Company Limited and Teva Pharmaceutical Industries Ltd.
Key Developments:
In March 2024, Abbott, Real Madrid and the Real Madrid Foundation announced the extension of their partnership through Real Madrid's 2026-27 season. Abbott will remain Global Health Sciences and Nutrition Partner of Real Madrid Football Club and Global Partner of the Real Madrid Foundation.
In March 2024, Allergan Aesthetics Launches ""Moving the Needle on Ethics"" to Elevate the Conversation Around Ethics in Aesthetics. The collection of interviews highlights the need for industry-wide transparency and integrity to meet the expected increase in global demand for aesthetics treatments.
In January 2024, Abbott announced the launch of its new PROTALITY™ brand. The high-protein nutrition shake is the first product in this line to support the growing number of adults interested in pursuing weight loss while maintaining muscle mass and good nutrition.
Products Covered:
• Hormones
• Monoclonal Antibodies
• Cytokines
• Recombinant Proteins
• Therapeutic Enzymes
• Vaccines
• Blood Factors
• Other Products
Types Covered:
• Synthetic Active Pharmaceutical Ingredient
• Biotech Active Pharmaceutical Ingredient
• High Potency Active Pharmaceutical Ingredient
• Other Types
Synthesis Processes Covered:
• Chemical Synthesis
• Biotechnological Synthesis
• Fermentation
• Extraction
• Other Synthesis Processes
Expression Systems Covered:
• Mammalian Expression Systems
• Microbial Expression Systems
• Yeast Expression Systems
• Insect Expression Systems
• Other Expression Systems
Applications Covered:
• Cardiovascular Disorders
• Oncology
• Central Nervous System Disorders
• Anti-Infective
• Gastrointestinal Disorders
• Metabolic Disorders
• Other Applications
End Users Covered:
• Contract Manufacturing Organizations (CMOs)
• Pharmaceutical Companies
• Research Organizations
• Other End Users
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 2021, 2022, 2023, 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
o 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 End User Analysis
3.9 Emerging Markets
3.10 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 Active Pharmaceutical Ingredient Market, By Product
5.1 Introduction
5.2 Hormones
5.3 Monoclonal Antibodies
5.4 Cytokines
5.5 Recombinant Proteins
5.6 Therapeutic Enzymes
5.7 Vaccines
5.8 Blood Factors
5.9 Other Products
6 Global Active Pharmaceutical Ingredient Market, By Type
6.1 Introduction
6.2 Synthetic Active Pharmaceutical Ingredient
6.3 Biotech Active Pharmaceutical Ingredient
6.4 High Potency Active Pharmaceutical Ingredient
6.5 Other Types
7 Global Active Pharmaceutical Ingredient Market, By Synthesis Process
7.1 Introduction
7.2 Chemical Synthesis
7.3 Biotechnological Synthesis
7.4 Fermentation
7.5 Extraction
7.6 Other Synthesis Processes
8 Global Active Pharmaceutical Ingredient Market, By Expression System
8.1 Introduction
8.2 Mammalian Expression Systems
8.3 Microbial Expression Systems
8.4 Yeast Expression Systems
8.5 Insect Expression Systems
8.6 Other Expression Systems
9 Global Active Pharmaceutical Ingredient Market, By Application
9.1 Introduction
9.2 Cardiovascular Disorders
9.3 Oncology
9.4 Central Nervous System Disorders
9.5 Anti-Infective
9.6 Gastrointestinal Disorders
9.7 Metabolic Disorders
9.8 Other Applications
10 Global Active Pharmaceutical Ingredient Market, By End User
10.1 Introduction
10.2 Contract Manufacturing Organizations (CMOs)
10.3 Pharmaceutical Companies
10.4 Research Organizations
10.5 Other End Users
11 Global Active Pharmaceutical Ingredient Market, By Geography
11.1 Introduction
11.2 North America
11.2.1 US
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 Italy
11.3.4 France
11.3.5 Spain
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.2 China
11.4.3 India
11.4.4 Australia
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.1 Argentina
11.5.2 Brazil
11.5.3 Chile
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.2 UAE
11.6.3 Qatar
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.4 Expansions
12.5 Other Key Strategies
13 Company Profiling
13.1 Abbott
13.2 AbbVie Inc.
13.3 AstraZeneca
13.4 Bausch Health Companies Inc.
13.5 Cadila Pharmaceuticals
13.6 Cipla Inc.
13.7 Dr. Reddy’s Laboratories Ltd
13.8 GSK plc
13.9 H. Lundbeck A/S
13.10 Jazz Pharmaceuticals, Inc.
13.11 Johnson & Johnson Private Limited
13.12 Mylan N.V.
13.13 Novartis AG
13.14 Pfizer Inc.
13.15 Sanofi
13.16 Sumitomo Dainippon Pharma Co., Ltd
13.17 Sun Pharmaceutical Industries Ltd
13.18 Sunovion Pharmaceuticals Inc
13.19 Takeda Pharmaceutical Company Limited
13.20 Teva Pharmaceutical Industries Ltd.
List of Tables
1 Global Active Pharmaceutical Ingredient Market Outlook, By Region (2021-2030) ($MN)
2 Global Active Pharmaceutical Ingredient Market Outlook, By Product (2021-2030) ($MN)
3 Global Active Pharmaceutical Ingredient Market Outlook, By Hormones (2021-2030) ($MN)
4 Global Active Pharmaceutical Ingredient Market Outlook, By Monoclonal Antibodies (2021-2030) ($MN)
5 Global Active Pharmaceutical Ingredient Market Outlook, By Cytokines (2021-2030) ($MN)
6 Global Active Pharmaceutical Ingredient Market Outlook, By Recombinant Proteins (2021-2030) ($MN)
7 Global Active Pharmaceutical Ingredient Market Outlook, By Therapeutic Enzymes (2021-2030) ($MN)
8 Global Active Pharmaceutical Ingredient Market Outlook, By Vaccines (2021-2030) ($MN)
9 Global Active Pharmaceutical Ingredient Market Outlook, By Blood Factors (2021-2030) ($MN)
10 Global Active Pharmaceutical Ingredient Market Outlook, By Other Products (2021-2030) ($MN)
11 Global Active Pharmaceutical Ingredient Market Outlook, By Type (2021-2030) ($MN)
12 Global Active Pharmaceutical Ingredient Market Outlook, By Synthetic Active Pharmaceutical Ingredient (2021-2030) ($MN)
13 Global Active Pharmaceutical Ingredient Market Outlook, By Biotech Active Pharmaceutical Ingredient (2021-2030) ($MN)
14 Global Active Pharmaceutical Ingredient Market Outlook, By High Potency Active Pharmaceutical Ingredient (2021-2030) ($MN)
15 Global Active Pharmaceutical Ingredient Market Outlook, By Other Types (2021-2030) ($MN)
16 Global Active Pharmaceutical Ingredient Market Outlook, By Synthesis Process (2021-2030) ($MN)
17 Global Active Pharmaceutical Ingredient Market Outlook, By Chemical Synthesis (2021-2030) ($MN)
18 Global Active Pharmaceutical Ingredient Market Outlook, By Biotechnological Synthesis (2021-2030) ($MN)
19 Global Active Pharmaceutical Ingredient Market Outlook, By Fermentation (2021-2030) ($MN)
20 Global Active Pharmaceutical Ingredient Market Outlook, By Extraction (2021-2030) ($MN)
21 Global Active Pharmaceutical Ingredient Market Outlook, By Other Synthesis Processes (2021-2030) ($MN)
22 Global Active Pharmaceutical Ingredient Market Outlook, By Expression System (2021-2030) ($MN)
23 Global Active Pharmaceutical Ingredient Market Outlook, By Mammalian Expression Systems (2021-2030) ($MN)
24 Global Active Pharmaceutical Ingredient Market Outlook, By Microbial Expression Systems (2021-2030) ($MN)
25 Global Active Pharmaceutical Ingredient Market Outlook, By Yeast Expression Systems (2021-2030) ($MN)
26 Global Active Pharmaceutical Ingredient Market Outlook, By Insect Expression Systems (2021-2030) ($MN)
27 Global Active Pharmaceutical Ingredient Market Outlook, By Other Expression Systems (2021-2030) ($MN)
28 Global Active Pharmaceutical Ingredient Market Outlook, By Application (2021-2030) ($MN)
29 Global Active Pharmaceutical Ingredient Market Outlook, By Cardiovascular Disorders (2021-2030) ($MN)
30 Global Active Pharmaceutical Ingredient Market Outlook, By Oncology (2021-2030) ($MN)
31 Global Active Pharmaceutical Ingredient Market Outlook, By Central Nervous System Disorders (2021-2030) ($MN)
32 Global Active Pharmaceutical Ingredient Market Outlook, By Anti-Infective (2021-2030) ($MN)
33 Global Active Pharmaceutical Ingredient Market Outlook, By Gastrointestinal Disorders (2021-2030) ($MN)
34 Global Active Pharmaceutical Ingredient Market Outlook, By Metabolic Disorders (2021-2030) ($MN)
35 Global Active Pharmaceutical Ingredient Market Outlook, By Other Applications (2021-2030) ($MN)
36 Global Active Pharmaceutical Ingredient Market Outlook, By End User (2021-2030) ($MN)
37 Global Active Pharmaceutical Ingredient Market Outlook, By Contract Manufacturing Organizations (CMOs) (2021-2030) ($MN)
38 Global Active Pharmaceutical Ingredient Market Outlook, By Pharmaceutical Companies (2021-2030) ($MN)
39 Global Active Pharmaceutical Ingredient Market Outlook, By Research Organizations (2021-2030) ($MN)
40 Global Active Pharmaceutical Ingredient Market Outlook, By Other End Users (2021-2030) ($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
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
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