The Active Pharmaceutical Ingredient Market Size was valued at USD 237.5 billion in 2023 and is expected to reach USD 372.8 billion by 2031, and grow at a CAGR of 5.8% over the forecast period 2024-2031.
The growth of the market is driven by a growing incidence of infectious diseases and infections in hospitals. Moreover, it is expected that the high impact of market growth will be driven by rising incidences of heart disease, genetics and neurological disorders. Cardiovascular diseases (CVDs) are the most prevalent causes of death globally. 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.
Get More Information on Active Pharmaceutical Ingredient Market - Request Sample Report
During the COVID-19 pandemic, the API industry has transitioned from relying on single outsourcing to multiple suppliers across various regions to mitigate supply chain risks. Major companies are capitalizing on this trend by pursuing acquisitions to boost their capabilities. For example, EUROAPI's partnership with Biano GMP in August 2023 aims to enhance oligonucleotide manufacturing expertise, aligning with its vertical integration strategy.
DRIVERS
Innovation can speed up the development of medicines, which could change the drug business.
Focus on precision medicine
The variability of the environment, genes, and lifestyle of each individual is taken into account in precision medicine. This approach has made it possible to predict more accurately the prevention and treatment strategies of a specific disease in an individual population. This approach ensures that the benefits are maximized and costs and complications are minimised by targeting therapeutic or preventive interventions to patients.
To reduce the market's turn of events, drugs are evaluated.
Unfavorable drug price control policies
Most of the nation’s control pharmaceutical manufacturer prices, either directly (France and Italy) or indirectly (Germany and Japan), through restrictions on reimbursement or profits (UK). It is generally accepted that countries with strict price controls have lower drug prices than those which are more lenient and do not regulate, such as UK or US.
OPPORTUNITIES
The pharmaceutical companies use small atoms to deliver new treatments.
Emerging biosimilars market
The key factors driving the growth of the biosimilars market are a growing incidence of various diseases, an increased number of off patent biologic drugs, positive results from Ongoing Clinical Studies for Biosimilars and Growing Demand for Bio generics in Different Therapeutic Applications Such as Rheumatoid Arthritis and Blood Disorders. Biosimilars are generic versions of patented biologic drugs so, they do not need to comply with the stringent requirements of various regulatory authorities (making them cost-effective as compared to patented biologics). The opportunity for biosimilars to enter the market is expected to be opened by the expiry of patents and other intellectual property rights on originator biologics over the next ten years.
CHALLENGES
Increasing the use of counterfeit medicines
The ingredients of bad or toxic quality in the wrong dosage forms are included in falsified or counterfeit medicines. Counterfeit medicines account for 10% of all medicines, according to the World Health Organisation. In countries with more stringent legislation and control over the supply of medicinal products, there is reported to be an incidence of counterfeiting amounting to about 1% of all medicines. But the rate of counterfeiting medicines increases to about 50% in low- and medium-income countries.
The challenge of obtaining APIs is directly related to the production of pharmaceutical products, with price fluctuations, import dependency and lack of raw materials. The global supply chain has been interrupted by pandemics and the war in Ukraine, which have increased transport costs and raw material expenses that affect medicinal products as well as packaging. The US imports approximately 70% of the APIs. China accounts for roughly 10.0%–15.0% of the U.S. API market, while the EU, amid the Russia-Ukraine conflict, providing 20.1%–25.1% of API manufacturing facilities, leading to supply chain disruptions and raw material shortages. In order to achieve a consistent and equitable availability of medicines, effective mitigation strategies and resilience in the supply chain are essential.
To reduce reliance on suppliers located in conflict affected regions, pharmaceutical companies may review their API sourcing strategies. Diversification of supply sources, greater investment in domestic production capacity or imports from other countries could emerge as a consequence. Moreover, the research and development activities in the pharmaceutical sector may also be affected by this war. The challenges of conducting clinical trials or obtaining scientific expertise, which could delay the development of new drugs, may be encountered by pharmaceutical companies operating and cooperating in the Russia and Ukraine.
In the economic downturn, pharmaceutical companies may adapt their inventories to manage cash flows and lower working capital requirements. This could result in a decrease of API orders as well as reduced production volumes for the producers concerned. In addition, as companies seek to improve efficiency and reduce costs, the economic downturn could lead to consolidation in the pharmaceutical industry. This may lead to a reduction in the number of API suppliers and an increase in competition for other suppliers.
By Type of Synthesis
Biotech
Biotech APIs Market, By Type
Generic APIs
Innovative APIs
Biotech APIs Market, By Product
Monoclonal Antibodies
Hormones
Cytokines
Recombinant Proteins
Therapeutic Enzymes
Vaccines
Blood Factors
Synthetic
Synthetic APIs Market, By Type
Generic APIs
Innovative APIs
Synthetic segment held the highest revenue share of 70.7% in 2023 owing to high demand for generic drugs is a major driver of the synthetic API market. For synthetic and chemical API producers, APIs used in the development of generic drugs are a major source of income. As a result, CDMOs working in this sector have a wide range of opportunities. Due to an increase in outsourcing trend, as companies seek improved profitability by cutting production costs, opportunities for CDMOs on the synthetic API market are becoming increasingly profitable. In October 2023, Cambrex announced completion of its USD 38.0 million small molecule API manufacturing facility. This investment has doubled the production capacity of the company, thereby increasing its ability to attract new customers in order to keep pace with changing needs.
Captive APIs
Merchant APIs
Captive APIs segment held the highest market share in 2023. More companies are investing in the problem solving and development of new chemical ways to produce APIs from scratch. It also helps to reduce the cost and risk of contamination. It is expected that with more control of the process, protein synthesis and Artificial Intelligence will speed up development. In addition, a strong preference for inhouse production over outsourcing has been shown by the recent initiatives and developments of key stakeholders.
Get Customized Report as per your Business Requirement - Request For Customized Report
By Type
Generic APIs
Innovative APIs
By Type of Drug
Prescription
OTC
By Application
Cardiovascular Diseases
Oncology
CNS and Neurology
Orthopedic
Endocrinology
Pulmonology
Gastroenterology
Nephrology
Ophthalmology
Others
In 2023, due to rising incidences of cardiovascular disease worldwide, the cardiology segment accounted for a revenue share of an API market that amounted to USD 2.6 billion. According to the World Heart Report 2023, over half a billion people worldwide are affected by CVDs, causing approximately 20.6 million deaths in 2021 almost a third of global deaths and an increase from the previously estimated 122 million CVD-related deaths. Cardiovascular disease is one of the world's biggest public health challenges, which has led to a great deal of research on APIs in this area. AstraZeneca also uses rosuvastatin calcium as a further API to treat heart disease.
The North American API market accounted for 38.3% in 2023, due to the rising incidence of cardiovascular disease, genetics and other diseases as a result of increased research on developing drugs. Also, presence of market key players is positively influencing growth. For example, Viatris received FDA approval in February 2022 for the generic formulation of Restasis, a cyclosporine ophthalmic emulsion, for the treatment of dry eye disease. The region has high value production areas, such as complicated & highly potent APIs, gene therapy and biologicals which are forecast to grow at a relatively moderate rate. In addition, the region has seen a significant expansion of innovation and CDMOs, which has led to an increased advantage in the manufacture and commercialisation of APIs.
The Asia Pacific API market is expected to grow at the fastest rate in the coming years. Due to the fact that most of the API production takes place in countries in the region with high export rates, the market is experiencing a strong growth. The largest API producer in the world is China, which makes more than 1,600 varieties of chemicals APIs. In addition, the region is becoming a hub of several major players from around the world. The growth of the overall API market is also being driven by increasing investment and initiatives to promote and improve manufacturing facilities.
North America
US
Canada
Mexico
Europe
Eastern Europe
Poland
Romania
Hungary
Turkey
Rest of Eastern Europe
Western Europe
Germany
France
UK
Italy
Spain
Netherlands
Switzerland
Austria
Rest of Western Europe
Asia Pacific
China
India
Japan
South Korea
Vietnam
Singapore
Australia
Rest of Asia Pacific
Middle East & Africa
Middle East
UAE
Egypt
Saudi Arabia
Qatar
Rest of the Middle East
Africa
Nigeria
South Africa
Rest of Africa
Latin America
Brazil
Argentina
Colombia
Rest of Latin America
The Key players are Aurobindo Pharma, Bristol Myers Squibb, Eli Lilly and Company, BASF SE, Cipla, Abbvie Inc., Boehringer Ingelheim GmbH, Dr. Reddy’s Laboratories Ltd, Albemarle Corporation, Viatris Inc and Other Players
In July 2023, with a possible sale of its API unit on the table, Teva Pharmaceutical Industries Ltd. has drawn up a new development strategy. The API manufacturing facility is worth USD 2.0 billion.
In April 2023, The US based LEAP Innovation Park was the subject of a USD 1.6 billion investment by Eli Lilly. The total investment in the production of innovative APIs for products like genetic medicine has increased to USD 3.7 billion.
In February 2023, In Switzerland, Lonza has completed the production of its plant. The capacity of HPAPI production at the company's High Potent Active Pharmaceutical Ingredient HPAPI has been increased.
Report Attributes | Details |
Market Size in 2023 |
US$ 237.5 Billion |
Market Size by 2031 |
US$ 372.8 Billion |
CAGR |
CAGR of 5.8% From 2024 to 2031 |
Base Year |
2022 |
Forecast Period |
2024-2031 |
Historical Data |
2020-2022 |
Report Scope & Coverage |
Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
Key Segments |
• By Type (Innovative APIs, Generic APIS) |
Regional Analysis/Coverage |
North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East], Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia, Rest of Latin America) |
Company Profiles |
Aurobindo Pharma, Bristol Myers Squibb, Eli Lilly and Company, BASF SE, Cipla, Abbvie Inc., Boehringer Ingelheim GmbH, Dr. Reddy’s Laboratories Ltd, Albemarle Corporation, Viatris Inc |
Key Drivers |
• Reception of organ on chip models in drug improvement |
Opportunities |
• Drug organizations are utilizing little atoms to convey new treatments. |
The size of the Active Pharmaceutical Ingredient market was 237.5 illion by 2023.
Five steps are followed while doing the research process. First is secondary research, the second is primary research, third is data bank validation, the fourth QA/QC process, and the fifth final QC/QA process.
Drugs are assessed to bring down the market's turn of events, and Holistic drug price control is the restraint of the market.
North America held the greatest proportion of the active pharmaceutical ingredients market, followed by Europe and the Asia Pacific.
Yes, the data validation process is followed in this report.
TABLE OF CONTENTS
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Industry Flowchart
3. Research Methodology
4. Market Dynamics
4.1 Drivers
4.2 Restraints
4.3 Opportunities
4.4 Challenges
5. Impact Analysis
5.1 Impact of Russia-Ukraine Crisis
5.2 Impact of Economic Slowdown on Major Countries
5.2.1 Introduction
5.2.2 United States
5.2.3 Canada
5.2.4 Germany
5.2.5 France
5.2.6 UK
5.2.7 China
5.2.8 Japan
5.2.9 South Korea
5.2.10 India
6. Value Chain Analysis
7. Porter’s 5 Forces Model
8. Pest Analysis
9. Active Pharmaceutical Ingredient Market, By Type of Synthesis
9.1 Introduction
9.2 Trend Analysis
9.3 Biotech
9.3.1 Biotech APIs Market, By Type
9.3.1.1 Generic APIs
9.3.1.2 Innovative APIs
9.3.2 Biotech APIs Market, By Product
9.3.2.1 Monoclonal Antibodies
9.3.2.2 Hormones
9.3.2.3 Cytokines
9.3.2.4 Recombinant Proteins
9.3.2.5 Therapeutic Enzymes
9.3.2.6 Vaccines
9.3.2.7 Blood Factors
9.4 Synthetic
9.4.1 Synthetic APIs Market, By Type
9.4.1.1 Generic APIs
9.4.1.2 Innovative APIs
10. Active Pharmaceutical Ingredient Market, by Type of Manufacturer
10.1 Introduction
10.2 Trend Analysis
10.3 Captive APIs
10.4 Merchant APIs
11. Active Pharmaceutical Ingredient Market, by Type
11.1 Introduction
11.2 Trend Analysis
11.3 Generic APIs
11.4 Innovative APIs
12. Active Pharmaceutical Ingredient Market, by Type of Drug
12.1 Introduction
12.2 Trend Analysis
12.3 Prescription
12.4 OTC
13. Active Pharmaceutical Ingredient Market, by Application
13.1 Introduction
13.2 Trend Analysis
13.3 cardiovascular diseases
13.4 Oncology
13.5 CNS and Neurology
13.6 Orthopedic
13.7 Endocrinology
13.8 Pulmonology
13.9 Gastroenterology
13.10 Nephrology
13.11 Ophthalmology
13.12 Others
14. Regional Analysis
14.1 Introduction
14.2 North America
14.2.1 USA
14.2.2 Canada
14.2.3 Mexico
14.3 Europe
14.3.1 Eastern Europe
14.3.1.1 Poland
14.3.1.2 Romania
14.3.1.3 Hungary
14.3.1.4 Turkey
14.3.1.5 Rest of Eastern Europe
14.3.2 Western Europe
14.3.2.1 Germany
14.3.2.2 France
14.3.2.3 UK
14.3.2.4 Italy
14.3.2.5 Spain
14.3.2.6 Netherlands
14.3.2.7 Switzerland
14.3.2.8 Austria
14.3.2.9 Rest of Western Europe
14.4 Asia-Pacific
14.4.1 China
14.4.2 India
14.4.3 Japan
14.4.4 South Korea
14.4.5 Vietnam
14.4.6 Singapore
14.4.7 Australia
14.4.8 Rest of Asia Pacific
14.5 The Middle East & Africa
14.5.1 Middle East
14.5.1.1 UAE
14.5.1.2 Egypt
14.5.1.3 Saudi Arabia
14.5.1.4 Qatar
14.5.1.5 Rest of the Middle East
14.5.2 Africa
14.5.2.1 Nigeria
14.5.2.2 South Africa
14.5.2.3 Rest of Africa
14.6 Latin America
14.6.1 Brazil
14.6.2 Argentina
14.6.3 Colombia
14.6.4 Rest of Latin America
15. Company Profiles
15.1 Aurobindo Pharma
15.1.1 Company Overview
15.1.2 Financial
15.1.3 Products/ Services Offered
15.1.4 SWOT Analysis
15.1.5 The SNS View
15.2 Bristol Myers Squibb
15.2.1 Company Overview
15.2.2 Financial
15.2.3 Products/ Services Offered
15.2.4 SWOT Analysis
15.2.5 The SNS View
15.3 Eli Lilly and Company
15.3.1 Company Overview
15.3.2 Financial
15.3.3 Products/ Services Offered
15.3.4 SWOT Analysis
15.3.5 The SNS View
15.4 BASF SE
15.4.1 Company Overview
15.4.2 Financial
15.4.3 Products/ Services Offered
15.4.4 SWOT Analysis
15.4.5 The SNS View
15.5 Cipla
15.5.1 Company Overview
15.5.2 Financial
15.5.3 Products/ Services Offered
15.5.4 SWOT Analysis
15.5.5 The SNS View
15.6 Abbvie Inc.
15.6.1 Company Overview
15.6.2 Financial
15.6.3 Products/ Services Offered
15.6.4 SWOT Analysis
15.6.5 The SNS View
15.7 Boehringer Ingelheim GmbH
15.7.1 Company Overview
15.7.2 Financial
15.7.3 Products/ Services Offered
15.7.4 SWOT Analysis
15.7.5 The SNS View
15.8 Dr. Reddy’s Laboratories Ltd
15.8.1 Company Overview
15.8.2 Financial
15.8.3 Products/ Services Offered
15.8.4 SWOT Analysis
15.8.5 The SNS View
15.9 Albemarle Corporation
15.9.1 Company Overview
15.9.2 Financial
15.9.3 Products/ Services Offered
15.9.4 SWOT Analysis
15.9.5 The SNS View
15.10 Viatris Inc
15.10.1 Company Overview
15.10.2 Financial
15.10.3 Products/ Services Offered
15.10.4 SWOT Analysis
15.10.5 The SNS View
16. Competitive Landscape
16.1 Competitive Benchmarking
16.2 Market Share Analysis
16.3 Recent Developments
16.3.1 Industry News
16.3.2 Company News
16.3.3 Mergers & Acquisitions
17. Use Case and Best Practices
18. Conclusion
An accurate research report requires proper strategizing as well as implementation. There are multiple factors involved in the completion of good and accurate research report and selecting the best methodology to compete the research is the toughest part. Since the research reports we provide play a crucial role in any company’s decision-making process, therefore we at SNS Insider always believe that we should choose the best method which gives us results closer to reality. This allows us to reach at a stage wherein we can provide our clients best and accurate investment to output ratio.
Each report that we prepare takes a timeframe of 350-400 business hours for production. Starting from the selection of titles through a couple of in-depth brain storming session to the final QC process before uploading our titles on our website we dedicate around 350 working hours. The titles are selected based on their current market cap and the foreseen CAGR and growth.
The 5 steps process:
Step 1: Secondary Research:
Secondary Research or Desk Research is as the name suggests is a research process wherein, we collect data through the readily available information. In this process we use various paid and unpaid databases which our team has access to and gather data through the same. This includes examining of listed companies’ annual reports, Journals, SEC filling etc. Apart from this our team has access to various associations across the globe across different industries. Lastly, we have exchange relationships with various university as well as individual libraries.
Step 2: Primary Research
When we talk about primary research, it is a type of study in which the researchers collect relevant data samples directly, rather than relying on previously collected data. This type of research is focused on gaining content specific facts that can be sued to solve specific problems. Since the collected data is fresh and first hand therefore it makes the study more accurate and genuine.
We at SNS Insider have divided Primary Research into 2 parts.
Part 1 wherein we interview the KOLs of major players as well as the upcoming ones across various geographic regions. This allows us to have their view over the market scenario and acts as an important tool to come closer to the accurate market numbers. As many as 45 paid and unpaid primary interviews are taken from both the demand and supply side of the industry to make sure we land at an accurate judgement and analysis of the market.
This step involves the triangulation of data wherein our team analyses the interview transcripts, online survey responses and observation of on filed participants. The below mentioned chart should give a better understanding of the part 1 of the primary interview.
Part 2: In this part of primary research the data collected via secondary research and the part 1 of the primary research is validated with the interviews from individual consultants and subject matter experts.
Consultants are those set of people who have at least 12 years of experience and expertise within the industry whereas Subject Matter Experts are those with at least 15 years of experience behind their back within the same space. The data with the help of two main processes i.e., FGDs (Focused Group Discussions) and IDs (Individual Discussions). This gives us a 3rd party nonbiased primary view of the market scenario making it a more dependable one while collation of the data pointers.
Step 3: Data Bank Validation
Once all the information is collected via primary and secondary sources, we run that information for data validation. At our intelligence centre our research heads track a lot of information related to the market which includes the quarterly reports, the daily stock prices, and other relevant information. Our data bank server gets updated every fortnight and that is how the information which we collected using our primary and secondary information is revalidated in real time.
Step 4: QA/QC Process
After all the data collection and validation our team does a final level of quality check and quality assurance to get rid of any unwanted or undesired mistakes. This might include but not limited to getting rid of the any typos, duplication of numbers or missing of any important information. The people involved in this process include technical content writers, research heads and graphics people. Once this process is completed the title gets uploader on our platform for our clients to read it.
Step 5: Final QC/QA Process:
This is the last process and comes when the client has ordered the study. In this process a final QA/QC is done before the study is emailed to the client. Since we believe in giving our clients a good experience of our research studies, therefore, to make sure that we do not lack at our end in any way humanly possible we do a final round of quality check and then dispatch the study to the client.
In 2022, The Dental Prosthetics Market size amounted to USD 11.25 Billion & is estimated to reach USD 29.25 Billion by 2030 and increase at a compound annual growth rate of 12.2% between 2023 and 2030.
The Cell Reprogramming Market size is projected to grow from $374.2 million in 2022 to $720.2 million by 2030, at a CAGR of 8.53% during the forecast period.
The Breathalyzers Market Size was valued at USD 876.25 million in 2022 and is expected to reach USD 1.65 billion by 2030, and grow at a CAGR of 8.3% over the forecast period 2023-2030.
The Immunology Market is estimated to be valued at US$ 91,851 Million in 2022 and is expected to reach US$ 156,378.3 million by 2030, at a CAGR of 9% during the forecast period (2023–2030).
The Healthcare Supply Chain Management Market is expected to reach USD 4.67 billion by 2030, and Size was valued at USD 2.52 billion in 2022, and grow at a CAGR of 8.0 % over the forecast period 2023-2030.
The Dentures Market size was valued at USD 1.7 Bn in 2022 and is estimated to reach USD 3.05 Bn by 2030, with a CAGR of 7.5 % over the forecast period of 2023-2030.
Hi! Click one of our member below to chat on Phone