Global Active Pharmaceutical Ingredients (APIs) Market Growth, Share, Size, Trends and Forecast (2024 - 2030)
By Business Mode;
Captive APIs and Merchant APIs.By Synthesis Type;
Synthetic and Biotech.By Type of Drug;
Generic and Branded.By Application;
Cardiovascular Disease, Oncology, Neurological Disorders, Orthopedic Disorders, Endocrinology, Pulmonology, Gastrointestinal Disorders, Nephrology, and Ophthalmology.By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2020 - 2030).Introduction
Global Active Pharmaceutical Ingredients (APIs) Market (USD Million), 2020 - 2030
In the year 2023, the Global Active Pharmaceutical Ingredients (APIs) Market was valued at USD 199,557.39 million. The size of this market is expected to increase to USD 292,417.33 million by the year 2030, while growing at a Compounded Annual Growth Rate (CAGR) of 5.6%.
Global Active Pharmaceutical Ingredients (APIs) Market is a vital component of the pharmaceutical industry, serving as the foundation for the production of various types of drugs and medications. APIs are the biologically active components in pharmaceutical products that produce the intended effects. They are crucial in determining the safety, efficacy, and quality of medications.
With the increasing prevalence of chronic diseases and the growing demand for novel therapies, the API market is witnessing significant growth. Factors such as technological advancements, expanding research and development activities, and the rise in generic drug usage are driving this growth. Additionally, the trend towards outsourcing API manufacturing to reduce costs and focus on core competencies is further propelling market expansion.
Geographically, the API market is spread across regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Each region has its unique market dynamics, influenced by factors such as regulatory policies, healthcare infrastructure, and the presence of key market players. Overall, the Global Active Pharmaceutical Ingredients (APIs) Market is poised for continued growth, driven by innovation, increasing healthcare expenditure, and the rising demand for effective medications.
Global Active Pharmaceutical Ingredients (APIs) Market Recent Developments & Report Snapshot
Recent Developments:-
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In August 2023, EUROAPI announced a strategic agreement to acquire BianoGMP, a move aimed at bolstering its Contract Development and Manufacturing Organization (CDMO) capabilities, particularly in the high-growth field of oligonucleotide manufacturing.
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In April 2023, Eli Lilly announced a substantial investment of USD 1.6 billion in the U.S.-based LEAP Innovation Park, bringing its total investment in the facility to USD 3.7 billion. This significant financial commitment is aimed at expanding the company's capacity to manufacture complex active pharmaceutical ingredients (APIs), particularly for advanced therapies such as genetic medicines.
Parameters | Description |
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Market | Global Active Pharmaceutical Ingredients (APIs) Market |
Study Period | 2020 - 2030 |
Base Year (for Active Pharmaceutical Ingredients (APIs) Market Size Estimates) | 2023 |
Drivers |
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Restraints |
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Opportunities |
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Segment Analysis
The Global Active Pharmaceutical Ingredients (APIs) Market is experiencing substantial growth, driven by the increasing demand for high-quality pharmaceuticals and the rise in chronic diseases globally. APIs are crucial components in drug formulation, as they are the biologically active substances responsible for a drug's therapeutic effects. The market is segmented by type into synthetic APIs, biologics, and other categories. Synthetic APIs dominate the market due to their widespread use in conventional drug formulations, while biologics are gaining traction due to advancements in biotechnology and the growing trend towards personalized medicine. This shift highlights the need for more complex and effective therapeutic solutions that biologics can provide, reflecting the market's evolving landscape.
In terms of application, the APIs market is categorized into therapeutic segments, including cardiovascular, oncology, anti-diabetic, and others. The oncology segment is particularly notable, driven by the increasing prevalence of cancer and the rising demand for targeted therapies. The anti-diabetic segment is growing rapidly due to the global rise in diabetes cases, prompting pharmaceutical companies to develop new and innovative treatments. The demand for APIs in these therapeutic areas underscores the importance of continuous research and development efforts aimed at discovering novel compounds and improving existing formulations.
North America holds a significant share of the API market, bolstered by its robust pharmaceutical industry, strong regulatory framework, and substantial investment in research and development. However, the Asia-Pacific region is emerging as a key player, driven by lower production costs, a large pool of skilled labor, and an increasing number of contract manufacturing organizations (CMOs). Countries like India and China are becoming major hubs for API production, catering to both domestic and international markets. As the industry evolves, challenges such as regulatory compliance, quality control, and the need for sustainable manufacturing practices will be critical for stakeholders to address in order to ensure long-term growth and competitiveness in the global API market.
Global Active Pharmaceutical Ingredients (APIs) Segment Analysis
In this report, the Global Active Pharmaceutical Ingredients (APIs) Market , Segmented by Business Mode, Synthesis Type, Type of Drug, Application and Geography.
Global Active Pharmaceutical Ingredients (APIs) Market, Segmentation by Type of Business Mode
Global Active Pharmaceutical Ingredients (APIs) Market , Segmentation by Type of Business Mode into Captive APIs and Merchant APIs.
Captive APIs are produced by pharmaceutical companies for their internal use in manufacturing finished pharmaceutical products. These companies have their manufacturing facilities and produce APIs exclusively for their own products. Captive APIs provide companies with better control over quality, cost, and supply chain management.
On the other hand, Merchant APIs are produced by third-party manufacturers, also known as contract manufacturers, and are sold to pharmaceutical companies for use in their products. Merchant APIs offer flexibility to pharmaceutical companies by allowing them to source APIs from multiple suppliers based on cost, quality, and other factors. This segment of the market is driven by the increasing trend of outsourcing API manufacturing to specialized manufacturers.
The choice between Captive APIs and Merchant APIs depends on various factors such as the scale of operations, cost considerations, regulatory requirements, and strategic objectives of pharmaceutical companies. While Captive APIs offer control and exclusivity, Merchant APIs provide flexibility and cost advantages. Both segments play a crucial role in the Global Active Pharmaceutical Ingredients (APIs) Market, contributing to the development and production of a wide range of pharmaceutical products.
Global Active Pharmaceutical Ingredients (APIs) Market, Segmentation by Synthesis Type
Global Active Pharmaceutical Ingredients (APIs) Market, Segmented by Synthesis Type into Synthetic and Biotech.
Synthetic APIs are chemically synthesized compounds that are manufactured through various chemical processes. These APIs are typically produced from petrochemicals or other chemical raw materials and are widely used in the pharmaceutical industry due to their cost-effectiveness and well-established manufacturing processes.
On the other hand, Biotech APIs are produced using biotechnological processes, such as fermentation, recombinant DNA technology, and cell culture. These APIs are derived from biological sources, such as microorganisms, plants, or animal cells, and are known for their high specificity and efficacy. Biotech APIs are often used in the production of biologics, including vaccines, monoclonal antibodies, and therapeutic proteins.
The choice between Synthetic and Biotech APIs depends on factors such as the complexity of the molecule, production scalability, regulatory requirements, and market demand. While Synthetic APIs dominate the market in terms of volume and widespread use, Biotech APIs are gaining prominence due to their ability to produce complex molecules with high specificity and efficacy. Both segments contribute significantly to the Global Active Pharmaceutical Ingredients (APIs) Market, catering to the diverse needs of the pharmaceutical industry.
Global Active Pharmaceutical Ingredients (APIs) Market, Segmentation by Type of Drug
Global Active Pharmaceutical Ingredients (APIs) Market ,Segmented by Type of Drug into Generic and Branded.
Generic APIs are identical or bioequivalent versions of branded drugs that are no longer protected by patents. These APIs are typically sold at lower prices than their branded counterparts and are widely used due to their cost-effectiveness. Generic APIs play a crucial role in reducing healthcare costs and increasing access to essential medications.
On the other hand, Branded APIs are the active ingredients in drugs that are protected by patents and marketed under a specific brand name. These APIs are often developed by pharmaceutical companies through extensive research and development efforts. Branded APIs are known for their high quality, innovation, and brand recognition, which allows them to command higher prices in the market.
The choice between Generic and Branded APIs depends on various factors such as cost, efficacy, availability, and patient preference. While Generic APIs dominate the market in terms of volume and affordability, Branded APIs cater to specific therapeutic needs and offer unique formulations and delivery mechanisms. Both segments contribute significantly to the Global Active Pharmaceutical Ingredients (APIs) Market, serving the diverse needs of healthcare providers and patients worldwide.
Global Active Pharmaceutical Ingredients (APIs) Market, Segmentation by Application
Global Active Pharmaceutical Ingredients (APIs) Market, Segmented by Application into Cardiovascular Disease, Oncology, Neurological Disorders, Orthopedic Disorders, Endocrinology, Pulmonology, Gastrointestinal Disorders, Nephrology and Ophthalmology.
APIs used in the treatment of cardiovascular diseases such as hypertension, coronary artery disease, and heart failure.APIs used in the treatment of various types of cancers, including breast cancer, lung cancer, and leukemia. APIs used in the treatment of neurological disorders such as Alzheimer's disease, Parkinson's disease, and epilepsy.APIs used in the treatment of orthopedic disorders such as arthritis, osteoporosis, and joint pain.APIs used in the treatment of endocrine disorders such as diabetes, thyroid disorders, and hormonal imbalances.APIs used in the treatment of pulmonary disorders such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis. APIs used in the treatment of gastrointestinal disorders such as acid reflux, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).APIs used in the treatment of kidney disorders such as chronic kidney disease, kidney stones, and renal failure.APIs used in the treatment of eye disorders such as glaucoma, macular degeneration, and diabetic retinopathy.
Each of these segments represents a significant portion of the Global Active Pharmaceutical Ingredients (APIs) Market, catering to the diverse therapeutic needs of patients worldwide.
Global Active Pharmaceutical Ingredients (APIs) Market, Segmentation by Geography
In this report, the Global Active Pharmaceutical Ingredients (APIs) Market ,Segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Active Pharmaceutical Ingredients (APIs) Market Share (%), by Geographical Region, 2023
North America and Europe are considered mature markets, characterized by well-established pharmaceutical industries and high healthcare expenditures. The Asia Pacific region, led by countries like India and China, is experiencing rapid growth driven by factors such as increasing demand for generic drugs and a growing population with access to healthcare. In contrast, the Middle East and Africa, along with Latin America, are considered emerging markets with expanding healthcare infrastructure and rising investments in pharmaceuticals, presenting significant growth opportunities for API manufacturers.
Each region presents unique challenges and opportunities for API manufacturers. North America and Europe, while mature, offer a stable market with high quality standards and stringent regulatory requirements. In the Asia Pacific region, manufacturers can benefit from lower production costs and access to a skilled workforce. They may also face challenges related to regulatory compliance and intellectual property protection. The Middle East and Africa, as well as Latin America, offer untapped markets with growing demand for pharmaceuticals, but manufacturers need to navigate challenges such as political instability and infrastructure limitations.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Active Pharmaceutical Ingredients (APIs) Market. These factors include; Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunities Analysis
Drivers:
- Increasing Demand for Generic Drugs
- Technological Advancements in API Manufacturing
- Growing Pharmaceutical Outsourcing
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Rising Investment in Research and Development:- One of the key drivers propelling the Global Active Pharmaceutical Ingredients (APIs) Market is the rising investment in research and development (R&D) by pharmaceutical companies. As the demand for innovative and effective medications grows, pharmaceutical companies are increasing their R&D efforts to develop new drugs and therapies. This includes the development of new APIs or the enhancement of existing ones to improve efficacy, safety, and patient outcomes.
The investment in R&D is driven by the need to address unmet medical needs, such as the treatment of rare diseases or the development of personalized medicines. Additionally, pharmaceutical companies are focusing on developing APIs for niche markets or specialty drugs, which command higher prices and offer better profit margins. The rising investment in R&D is expected to drive innovation in the API market, leading to the development of novel drugs and therapies that can address a wide range of medical conditions.
Restraints:
- Stringent Regulatory Requirements
- Supply Chain Disruptions
- Increasing Competition
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Patent Expiry and Price Erosion:- One of the key restraints impacting the Global Active Pharmaceutical Ingredients (APIs) Market is the patent expiry of branded drugs, leading to price erosion. When patents for branded drugs expire, generic versions become available in the market at significantly lower prices. This can lead to a decline in sales of branded APIs, as healthcare providers and patients switch to the more affordable generic alternatives. As a result, API manufacturers may experience reduced revenues and profit margins.
Price erosion due to patent expiry also intensifies competition in the API market, as multiple manufacturers produce generic versions of the same drug. This can further impact the profitability of API manufacturers, especially if they are unable to differentiate their products or if they face challenges in scaling up production to meet market demand. Additionally, price erosion can lead to consolidation in the API market, as smaller manufacturers may struggle to compete with larger, more established companies.
Opportunities:
- Expansion in Emerging Markets
- Focus on Specialty APIs
- Rise in Contract Manufacturing
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Development of Biopharmaceuticals:- The development of biopharmaceuticals presents significant opportunities for the Global Active Pharmaceutical Ingredients (APIs) Market. Biopharmaceuticals, which are derived from biological sources such as living cells or microorganisms, offer unique therapeutic benefits and are used in the treatment of various diseases, including cancer, autoimmune disorders, and genetic diseases.
As the demand for biopharmaceuticals continues to rise, there is a growing need for APIs that can support the production of these complex molecules. API manufacturers can capitalize on the development of biopharmaceuticals by expanding their capabilities to produce biologically derived APIs. This may involve investing in specialized manufacturing processes, such as fermentation or cell culture, and developing expertise in biotechnology. By offering APIs for biopharmaceuticals, manufacturers can tap into a lucrative market segment and establish themselves as key suppliers in the growing field of biologics.
Competitive Landscape Analysis
Key players in Global Active Pharmaceutical Ingredients (APIs) Market include:
- Novartis AG
- Sanofi
- Pfizer Inc.
- Johnson & Johnson Private Limited
- Abbott
- Teva Pharmaceutical Industries Ltd.
- Bausch Health Companies Inc.
- Sunovion Pharmaceuticals Inc.
- Jazz Pharmaceuticals, Inc.
- AstraZeneca
- GSK plc
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Business Mode
- Market Snapshot, By Synthesis Type
- Market Snapshot, By Type of Drug
- Market Snapshot, By Application
- Market Snapshot, By Region
- Global Active Pharmaceutical Ingredients (APIs) Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Demand for Generic Drugs
- Technological Advancements in API Manufacturing
- Growing Pharmaceutical Outsourcing
- Rising Investment in Research and Development
- Restraints
- Stringent Regulatory Requirements
- Supply Chain Disruptions
- Increasing Competition
- Patent Expiry and Price Erosion
- Opportunities
- Expansion in Emerging Markets
- Focus on Specialty APIs
- Rise in Contract Manufacturing
- Development of Biopharmaceuticals
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Active Pharmaceutical Ingredients (APIs) Market, By Business Mode, 2020 - 2030 (USD Million)
- Captive APIs
- Merchant APIs
- Global Active Pharmaceutical Ingredients (APIs) Market, By Synthesis Type, 2020 - 2030 (USD Million)
- Synthetic
- Biotech
- Global Active Pharmaceutical Ingredients (APIs) Market, By Type of Drug , 2020 - 2030 (USD Million)
- Generic
- Branded
- Global Active Pharmaceutical Ingredients (APIs) Market, By Application, 2020 - 2030 (USD Million)
- Cardiovascular Disease
- Oncology
- Neurological Disorders
- Orthopedic Disorders
- Endocrinology
- Pulmonology
- Gastrointestinal Disorders
- Nephrology and Ophthalmology
- Global Active Pharmaceutical Ingredients (APIs) Market, By Geography, 2020 - 2030 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Active Pharmaceutical Ingredients (APIs) Market, By Business Mode, 2020 - 2030 (USD Million)
- Competitive Landscape
- Company Profiles
- Novartis AG
- Sanofi
- Pfizer Inc.
- Johnson & Johnson Private Limited
- Abbott
- Teva Pharmaceutical Industries Ltd.
- Bausch Health Companies Inc.
- Sunovion Pharmaceuticals Inc.
- Jazz Pharmaceuticals, Inc.
- AstraZeneca
- GSK plc
- Company Profiles
- Analyst Views
- Future Outlook of the Market