Summary

Overview
Global Synthetic API Market reached US$ XX billion in 2022 and is expected to reach US$ XX million by 2030 growing at a CAGR of XX% during the forecast period 2023-2030.
An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or affects the structure or any function of the body of human.
Synthetic API drugs are manufactured under stringent conditions to maintain consistency and minimize the risk of contamination. The registration of an active pharmaceutical ingredient (API) is complex and very time-consuming and the success of the final drug product strongly depends on the API's quality and performance.
Market Dynamics
Increasing prevalence of chronic diseases
The increasing prevalence of chronic diseases acts as a significant driver for market growth. The burden of chronic diseases is increasing worldwide which makes synthetic API manufacturers help to grow the market.
For instance, according to American Cancer Society Reports 2023, around 1,958,310 new cancer cases and 609,820 cancer deaths are projected to occur in the United States. Cancer incidence increased for prostate cancer by 3% annually after two decades.
Also, according to the World Health Organization Report, about 422 million people worldwide have diabetes, the majority living in low-and middle-income countries, and 1.5 million deaths are directly attributed to diabetes each year. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
Furthermore, significant growth drivers such as the rising geriatric population, and advancements in synthetic API manufacturing units are expected to drive the market in the forecast period.
Drug price control policies
The high manufacturing cost of APIs is one of the major challenges faced by market players. Manufacturers often have to make costly investments for improvements in their manufacturing facilities to ensure compliance with standards such as the cGMP. This includes the renovation of production facilities, inculcating familiarity with qualification requirements and processes, and building a dossier of product efficacy and safety tests that meet the requirements of regulatory authorities.
The costs of obtaining regulatory approvals are relatively higher for firms with small volumes. The chemical synthesis of APIs also often requires expensive and uncommon building blocks and raw materials, which further adds to API manufacturing costs. These factors are hampering the growth of the market in the forecast period.
Segment Analysis
The global synthetic API market is segmented based on type, manufacturer type, application, and region.
The captive API manufacturer segment accounted for approximately 67.5% of the market share
The captive API manufacturer segment is expected to hold the largest market share over the period forecast. It is specialized in the production of active substances in pharmaceutical drugs and plays a crucial role in the pharmaceutical industry by producing high quality and consitent active ingredients.
For instance, in November 2023, Cadila Pharma launched an API manufacturing plant at Dahej. The facility is set up with an investment of Rs 200 crore and is equipped with the latest Distributed Control System (DCS) automation technology.
Additionally, in May 2023, Boehringer Ingelheim raised a $315 million in-house plant at its German headquarters that produces active pharmaceutical ingredients and drugs for clinical trials.
Also, in November 2023, Rusan Pharma launched the API manufacturing facility with an investment of around 300 crores. Hence, due to the above factors, the segment is expected to hold the largest market share.
Geographical Analysis
North America is expected to hold a significant position in the global synthetic API market share
North America has maintained a significant market proportion due to factors such as the rising prevalence of chronic diseases like cancer, diabetes, neurological disorders, and increasing healthcare expenditure, this trend is anticipated to continue throughout the forecast period.
For instance, in Canada, about 2.4 million Canadian adults aged 20 years and older live with diagnosed ischemic heart disease, including 578,000 with a history of a heart attack. Also, 40 years and older live with diagnosed heart failure in Canada.
Also, in January 2023, Eurofins CDMO Alphora Inc. declared that the company had moved to a new location in Ontario, Canada, and expanded its API development laboratory. Additionally, in June 2023, Apex Labs Ltd. secured Health Canada’s endorsement for its secondary US-based supplier of psilocybin Active Pharmaceutical Ingredient (API).
COVID-19 Impact Analysis
The COVID-19 pandemic has had a significant impact on the global synthetic API market. The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular diagnoses, treatment, product launches, and consultations worldwide. With the outbreak of the pandemic, many pharmaceutical or medical device manufacturing units faced labor shortages and were unable to travel to work due to lockdown restrictions. Therefore, owing to the above factors, the synthetic API market is expected to be moderately affected over the forecast period.
Market Segmentation
By Type
• Innovative Synthetic API
• Generic Synthetic API
By Treatment
• Captive API Manufacturer
• Merchant API Manufacturer
By Application
• Cardiology
• Pulmonology
• Oncology
• Ophthalmology
• Neurology
• Orthopedic
• Other
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o U.K.
o France
o Spain
o Italy
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Competitive Landscape
The major global players in the market include Pfizer Inc., Sanofi SA, Boehringer Ingelheim, Bristol-Myers Squibb, AstraZeneca Plc, Viatris Inc., Teva Pharmaceutical Industries Ltd, BASF SE, Dr Reddy's Laboratories Ltd, and Merck & Co Inc among others.
Key Developments
• In March 2021, Piramal Pharma Ltd. acquired a 100% Stake in Hemmo Pharmaceuticals which is a leading Indian manufacturer of peptide APIs.
• In September 2023, Celigo expanded the existing API Capabilities to support the full API lifecycle by adding new policy management and API developer portal support.
• In June 2023, API manufacturer C2 PHARMA declared the approval of a C-DMF for Digoxin, an API by the company's Polish manufacturing partner Nobilus Ent.
Why Purchase the Report?
• To visualize the global synthetic API market segmentation based on type, manufacturer type, application and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of global synthetic API market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global synthetic API market report would provide approximately 61 tables, 59 figures, and 185 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

ページTOPに戻る

Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Type
3.2. Snippet by Manufacturer Type
3.3. Snippet by Application
3.4. Snippet by Region
4. Market Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increasing prevalence of chronic diseases
4.1.1.2. XX
4.1.2. Restraints
4.1.2.1. Drug price control policies
4.1.2.2. XX
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
7.1.2. Market Attractiveness Index, By Type
7.2. Innovative Synthetic API*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Generic Synthetic API
8. By Manufacturer Type
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
8.1.2. Market Attractiveness Index, By Manufacturer Type
8.2. Captive API Manufacturer *
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.2.3. Merchant API Manufacturer
9. By Application
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
9.1.2. Market Attractiveness Index, By Application
9.2. Cardiology*
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Pulmonology
9.4. Oncology
9.5. Ophthalmology
9.6. Neurology
9.7. Orthopedic
9.8. Other
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.6.1. U.S.
10.2.6.2. Canada
10.2.6.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.6.1. Germany
10.3.6.2. UK
10.3.6.3. France
10.3.6.4. Italy
10.3.6.5. Spain
10.3.6.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.6.1. Brazil
10.4.6.2. Argentina
10.4.6.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.6.1. China
10.5.6.2. India
10.5.6.3. Japan
10.5.6.4. Australia
10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Manufacturer Type
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Pfizer Inc.
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Sanofi SA
12.3. Boehringer Ingelheim
12.4. Bristol-Myers Squibb
12.5. AstraZeneca
12.6. Viatris Inc.
12.7. Teva Pharmaceutical Industries Ltd
12.8. BASF SE
12.9. Dr Reddy's Laboratories Ltd
12.10. Merck & Co Inc.
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us