Global Synthetic API Market - 2023-2030

Global Synthetic API Market - 2023-2030

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
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
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