USD 210.01 Billion
Active Pharmaceutical Ingredients (API) Market Size, Share, Growth Analysis, By Type(Generic APIs, and Innovative APIs), By Synthesis(Synthetic APIs (Generic APIs, Innovative APIs), Biotech (Type {Generic APIs and Innovative APIs}, Product {Monoclonal Antibodies), By Drug(Prescription, and Over-the-Counter Drugs (OTC)), By Potency(Traditional APIs, and High Potency APIs), By Therapeutic applications(Communicable Diseases, Oncology, Cardiovascular Diseases, Orthopaedic), By End User(Pharmaceutical and Biotechnological Industry, Contact Research Organization, Contract Manufacturing Organization, Others), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35I2125 |
Region:
Global |
Published Date: July, 2024
Pages:
248
|Tables:
189
|Figures:
79
Active Pharmaceutical Ingredients (API) Market Insights
Active Pharmaceutical Ingredients (API) Market size was valued at USD 210.01 Billion in 2022 and is poised to grow from USD 222.4 Billion in 2023 to USD 351.81 Billion by 2031, growing at a CAGR of 5.9% in the forecast period (2024-2031).
In recent years, the global Active Pharmaceutical Ingredient market has been changing consumer preferences and demands due to the increasing incidence rates of chronic illnesses, high uptakes of generics, and intensification of R&D activities in recent years. Furthermore, the technology is changing a great deal, specifically at manufacturing levels and with respect to biotechnological methods which is contributing to the market growth. There are growing calls towards the outsourcing of API manufacturing especially CMOs with an emphasis on quality and safety. Consequently, this empowers pharmaceutical companies to focus only on their core functions while manoeuvring intricate regulatory policies. China and India in the Asia Pacific have become significant centres of production of APIs because of low costs and a strong foundation for pharmaceutical manufacturers. The market dynamics are also driven by regulatory reforms as well as attempts to ease up the approval process. Active pharmaceutical ingredients are becoming popular since they act as a key ingredient.
The single active pharmaceutical ingredients are used to make single dose medication, whereas several active pharmaceutical medians are used to make fixed-dose medicines. In every medicine API is present only in required amount due to its requirement in medicines is less to produce the effect. The medicine, which produces intended therapeutic effects, inculcates active paracetamol ingredients. For instance, in painkillers, the active ingredients relieve pain. In the OTC drug crocin, the API is paracetamol. API is used in high quality drugs that treat diseases pertaining to oncology, cardiology, CNS and neurology, orthopaedic, pulmonology, gastroenterology, nephrology, ophthalmology, and endocrinology. Through innovations of products and technological advancement APIs can potentially create a healthcare system which will be more sustainable.
US Active Pharmaceutical Ingredients Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Cardiology
Fastest Growth
Oncology
Growth Rate
5.9% CAGR
Global Active Pharmaceutical Ingredients Market ($ Bn)
Country Share for North America Region (%)
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Active Pharmaceutical Ingredients (API) Market Segmental Analysis
The global active pharmaceutical ingredient market is segmented based on type, synthesis, drug, potency, therapeutic applications, end user, and region. Based on type, the market is segmented into generic APIs, and innovative APIs. Based on synthesis, the market is segmented into synthetic APIs (generic APIs, innovative APIs), biotech (type {generic APIs, innovative APIs}, product {monoclonal antibodies, hormones, cytokines, recombinant proteins, therapeutic enzymes, vaccines, blood factors}, expression systems (mammalian expression system, microbial expression system, yeast expression system, insect expression system, others). Based on drug, the market is segmented into prescription, and over-the-counter drugs (OTC). Based on potency, the market is segmented into traditional APIs, high potency APIs. Based on therapeutic applications, the market is segmented into communicable diseases, oncology, cardiovascular diseases, orthopaedic, cardiology, endocrinology, pulmonology, gastroenterology, nephrology, ophthalmology, and others. Based on end user, the market is segmented into pharmaceutical and biotechnological industry, contact research organization, contract manufacturing organization, and others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Analysis by Offering
The synthetic API segment is the largest segment in the global active pharmaceutical ingredient market by offering and is having the revenue share of about 69.7%. The development of the generic drugs is contributing to the highest revenue share for synthetic and chemical API manufacturing companies and is contributing for creating huge number of opportunities. Some companies want to reduce cost of manufacturing such as CDMOs, therefore making it even more profitable option. For instance, in October 2023, completed its USD 37 million small molecule API manufacturing facility. Just help them in contributing to meet the evolving needs of the people and doubled their size of companies manufacturing facility.
On the other hand, the biotech API segment is the fastest growing segment by offering in the active pharmaceutical ingredient market. The rising investments in the biopharmaceutical sector contributes towards the growth of the market. This leads to the innovation of new molecules that provide treatment of many diseases such as cancer and others. There has been higher revenue generation and profitability in the biotech API segment which drives the companies and manufacturers attention leading towards their adoption. For instance, in May 2023, the OLON group entered the ADC API businesses located in Italy. The company invested approximately USD 23 million with containment level of OEB6.
Analysis by Therapeutic Applications
The cardiology segment in the global active pharmaceutical ingredient market by therapeutic application is having the largest share. It is due to the reason of the prevalence of the cardiovascular diseases globally. Based on SkyQuest Analysis, the world health report 2023 concludes that more than half of the billion people around the world are affected by cardiovascular diseases which has caused about 20 million deaths in the year 2021 which is 1/3rd of the global deaths and there has seen in the rise in deaths. It requires extensive research in this field due to its related serious health issues. Simvastatin, which is used in the treatment of dyslipidaemia, is a cholesterol controlling drug.
On the other hand, the oncology segment is the fastest growing segment in the market. The companies worldwide are collaborating, and investments helps in the development of the drugs, contributing towards its growth. The world has witnessed an escalating trend of cancer cases and as such, oncology is likely to be a leading API market. Demand for APIs used in treating cancers like chemotherapy and targeted therapies is still there. The progress made in cancer research as well as the availability of modern oncology drugs is what has made this therapeutic area progressing at a faster rate.
Global Active Pharmaceutical Ingredients Market By Therapeutic Applications
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Active Pharmaceutical Ingredients (API) Market Regional Insights
North America is dominating the API marketplace due to its superior healthcare infrastructure, strong research and improvement talents, and a high call for progressive prescribed drugs. It holds a share of about 37.8% of the revenue. The rising occurrence of cardiovascular diseases and other chronic diseases along with the growing research in the field, contributes to the development of the market. For instance, in February 2022, Viatris was granted FDA approval for generic restasis for the treatment of dry eye disease. The region is domestic to many major pharmaceutical businesses, contributing to a strong presence in API production. Stringent regulatory standards and a focal point on technological advancements similarly bolster North America's dominance in the global API marketplace.
Asia-Pacific is the fastest-growing region, in the main push via the growing contribution of nations like India and China to international pharmaceutical production. China is the largest producer of APIs producing more than 1500 varieties of chemical APIs. Furthermore, this increase in investments and government initiatives is propelling the growth in this region as it will lead to the development of the drugs. Cost advantages, a big and numerous affected person populace, and a developing emphasis on studies and improving sports are key factors. The vicinity's evolving regulatory panorama and improvements in pharmaceutical manufacturing technology contribute to its speedy boom within the API marketplace.
Global Active Pharmaceutical Ingredients Market By Region
- Largest
- Fastest
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Active Pharmaceutical Ingredients (API) Market Dynamics
Active Pharmaceutical Ingredients Market Drivers
Increasing Prevalence of Chronic Diseases
- Increasing incidence of chronic diseases and corresponding rise in demand for therapeutic drugs are important drivers of market growth as population ages and healthcare needs intensify. From their perspective focus more on API development and manufacturing for various therapeutic areas. In addition, contributing to R&D initiatives broadly, the global push for cost-effective healthcare solutions, especially in emerging markets, is driving drug delivery is the demand for organic products has increased, further stimulating the API market.
The Manufacturing Capacity Expansion of APIs in Pharmaceutical Companies
- The increase in production capacity of biopharmaceutical and pharmaceutical companies globally contributes to the demand for active pharmaceutical ingredients. These are achieved by the investments made by the government in this sector. For instance, in November 2023, Novo Nordisk expanded its manufacturing capacity by building API production unit in Denmark. It enhanced the capacity i.e. from API production to its packaging.
Restraints
High Regulatory Complexity and Excessive Stages of Regulatory Approvals
- One of the important marketplace constraints is regulatory complexity and excessive stages of regulatory approvals, which have an impact on growth and expenditure marks over the years, intellectual belongings retention and market markets affected by the alternate of the skeleton. They make their Environmental considerations additionally vicinity regulations on API commercial enterprise strategies, and it is essential to design inexperienced chemical compounds which are environmentally friendly
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Active Pharmaceutical Ingredients (API) Market Competitive Landscape
The competitive surroundings of the active pharmaceutical ingredient marketplace are dynamic and marked by using severe contention and strategic dynamics amongst key players. Major pharmaceutical companies, both multinational organizations and specialised manufacturers, vie for marketplace share via improvements, product portfolio expansions, and strategic collaborations. Contract manufacturing agencies (CMOs) also play a pivotal role, offering specialised API production offerings to pharmaceutical companies. Regulatory compliance, exceptional standards, and the capability to adapt to evolving healthcare wishes are vital factors shaping competitiveness.
Active Pharmaceutical Ingredients Market Top Player’s Company Profiles
- Boehringer Ingelheim (Germany)
- Lonza Group AG (Switzerland)
- Dr. Reddy's Laboratories Ltd. (India)
- Merck Group (Germany)
- Pfizer Inc. (US)
- Sandoz International GmbH (Switzerland)
- Teva Pharmaceutical Industries Ltd. (Israel)
- Mylan N.V. (US)
- F. Hoffmann-La Roche AG (Switzerland)
- Catalent Pharma Solutions (US)
- Samsung Biologics (South Korea)
- WuXi AppTec (China)
- Dishman Carbogen Amcis Ltd. (India)
- Jubilant Life Sciences Limited (India)
- Divi's Laboratories Ltd. (India)
- Aurobindo Pharma Limited (India)
- Zydus Cadila Healthcare Ltd. (India)
- Sun Pharmaceutical Industries Ltd. (India)
- Cipla Limited (India)
- Hikma Pharmaceuticals PL. (UK)
Active Pharmaceutical Ingredients Market Recent Developments
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In February 2024, Alembic Pharmaceuticals, a Vadodara-based company, is planning to launch five to six products quarterly in the US. The company has launched 11 new products during the third quarter of the current financial year.
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In September 2023, the Nirma Group prolonged it attain beyond chemical substances and building substances through making a big entry into the pharmaceutical sector. This enlargement is marked through the group's agreement to acquire a seventy-five% stake in Glenmark Life Sciences, amounting to a company price of about Rs 7,500 crore.
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In November 2023, Roquette, a prominent player in plant-based ingredients and pharmaceutical excipients worldwide, revealed its intent to acquire Qualicaps. This move is geared towards strengthening Roquette's standing as a significant supplier to the pharmaceutical industry. The amalgamation of these two entities is poised to play a pivotal role in advancing Roquette's strategic growth plan, fostering fresh opportunities for both Roquette and Qualicaps' clientele and workforce.
Active Pharmaceutical Ingredients (API) Key Market Trends
- Rising Demand for Specialty APIs: The elevated demand for uniqueness of APIs tailored to unique patient populations. Biopharmaceuticals, together with monoclonal antibodies and gene therapies, hold to benefit prominence, reflecting a developing trend in the industry. Therefore, contributing towards the development of the new APIs. Additionally, the combination of superior technology along with artificial intelligence and facts analytics in API improvement approaches is on the upward thrust, streamlining manufacturing and improving efficiency. This is achieved by the increasing investments in this sector made by companies and government organizations. Outsourcing of API production to settlement manufacturing organizations (CMOs) is growing, permitting pharmaceutical groups to focus on middle skills and agility.
Active Pharmaceutical Ingredients (API) Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
Global active pharmaceutical ingredient market analysis reveals a dynamic marketplace with several standout trends and difficulties. The marketplace is propelled by the increasing occurrence of persistent illnesses, demand for personalized medicinal drugs, and a surge in biopharmaceutical improvements. The adoption of the growing expenditure and generic drugs is further driving the market. The advancement in APIs and the growth in biopharmaceutical sector is leading towards the ongoing development, therefore driving the market. However, stringent regulatory procedures and patent expirations pose demanding situations. Therapeutic Applications kinds, inclusive of cardiology as having highest share and oncology as the quickly growing, are diversifying. North America dominates due to advanced healthcare infrastructure, while the Asia-Pacific area reports a fast boom fuelled by fee benefits. One major trend is the rising demand for specialty APIs which contributes to the growth. Key traits contain technological integration, sustainability practices, and the rising prominence of agreement manufacturing. The API market displays a dynamic panorama fashioned through health trends, regulatory dynamics, and evolving research paradigms.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 210.01 Billion |
| Market size value in 2031 | USD 351.81 Billion |
| Growth Rate | 5.9% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Active Pharmaceutical Ingredients (API) Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Active Pharmaceutical Ingredients (API) Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Active Pharmaceutical Ingredients (API) Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Active Pharmaceutical Ingredients (API) Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Active Pharmaceutical Ingredients (API) Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Active Pharmaceutical Ingredients (API) Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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