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Active Pharmaceutical Ingredient Market Report Scope & Overview:

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.

Active Pharmaceutical Ingredient Market Revenue Analysis

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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.

MARKET DYNAMICS

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.

RESTRAINTS

  • 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.

Impact of Russia-Ukraine War

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.

Impact of Economic Downturn

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.

Market Segmentation:

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.

Active Pharmaceutical Ingredient Market Segment By Type of Sinthesis

By Type of Manufacturer

  • 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.

Active Pharmaceutical Ingredient Market Segment By manufacturer

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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.

Regional Analysis:

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.

Active-Pharmaceutical-Ingredient-Market By-Region

REGIONAL 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 the Middle East

  • Africa

    • Nigeria

    • South Africa

    • Rest of Africa

Latin America

  • Brazil

  • Argentina

  • Colombia

  • Rest of Latin America

Key Players:

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

Abbvie Inc-Company Financial Analysis

 

Recent Developments:

  • 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.

Active Pharmaceutical Ingredient Market Report Scope:
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)
• By Type of Synthesis (Synthetic, Biotech)
• By Application (Communicable Diseases, Oncology,   Diabetes, Cardiovascular Disease, Pain management,   respiratory diseases)

 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
 • Work out for the dynamic drug fixing industry

 Opportunities

 • Drug organizations are utilizing little atoms to convey new treatments.
 • Creating status of generics in the worldwide dynamic.

 

Frequently Asked Questions

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

  1.  

9.2 Trend Analysis

9.3 Biotech

    1.  

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  

  1.  

10.1 Introduction

10.2 Trend Analysis

  1.  

10.3 Captive APIs

10.4 Merchant APIs

11. Active Pharmaceutical Ingredient Market, by Type

  1.  

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.

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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.

Secondary Research

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.

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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.

Primary Research

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Data Bank Validation

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