With this updated active pharmaceutical ingredients market analysis FPS Pharma wants to share light on the continuously evolving landscape of the API and HPAPI pharmaceutical industry by providing you free insights such as driving factors and challenges, data and forecasts from 2023 to 2033.
The analysis is based on both historical macro and micro data available from institutional sources per Country while forecasts are based on metrics average of most reliable sources.

Global Pharmaceutical API Market Dynamics and Future Projections

As of 2023, the global sales of the small molecule API market are estimated at approximately $206.44 billions USD (according to data from future market insights), with an anticipated Compound Annual Growth Rate (CAGR) ranging from 4% up to 6% from 2023 to 2033.

Key drivers include the impactful rise of personalized medicine, driven by breakthroughs in genomics and targeted therapies.
The escalating demand for High Potency Active Pharmaceutical Ingredients (HPAPIs), especially in oncology drugs, has necessitated stringent containment measures.
In response, as anticipated above, pharmaceutical companies are increasingly turning to Contract Development and Manufacturing Organizations (cDMOs) for API manufacturing, placing emphasis on strict compliance with regulatory guidelines from authorities such as the U.S. FDA and the European Medicines Agency (EMA).

Continuous manufacturing, sustainability initiatives, and environmental protection have emerged as focal points in API manufacturing. The adoption of green chemistry principles to minimize emissions, waste, and hazardous materials in API synthesis has gained traction.

Factors Driving Growth:

The factors propelling this growth:

Market Restraints and Challenges:

However, the small molecule APIs market faces challenges such as:

Market Segmentation and Trends

Additional Sub-Markets insights

The global API and HPAPI market features sub-markets based on therapeutic application and drug type, including infectious diseases, cancer treatments, ophthalmology, cardiovascular disorders, neurological treatments, pulmonary disorders, orthopedics, and sub-segments like branded prescription drugs, generic prescription drugs, and over-the-counter (OTC) medications.
Advancements in API manufacturing, the growth of the biopharmaceutical sector, and an increase in the geriatric population are identified as key drivers. The outsourcing of APIs and HPAPIs has become profitable, with a trend toward dual sourcing for risk mitigation.


The small molecule API and HPAPI market shows a dynamic landscape and is set for prosperity, fueled by trends in personalized medicine, new molecules discoveries, sustainability practices, and unwavering adherence to regulatory guidelines. 
This segment is also positively affected by advancements in API manufacturing processes and technologies, the increase of chronic diseases and population aging (senior citizens).
Navigating stringent regulatory processes and addressing the demand for specialized APIs HPAPIs in personalized medicine are critical considerations.  
Pharmaceutical companies reveal a tendency to outsourcing APIs since it has become profitable and mitigate supply chain risks.
Being innovators, especially in integrating forefront process technologies and AI into R&D will allow pharmaceutical companies not only to optimize production but also to deliver the most effective and safe Active Pharmaceutical Ingredients (API and HPAPI) and drugs.

Discover FPS Pharma technologies and bring your pharmaceutical processes at a new level.

FPS is pleased to confirm its presence at CPHI Milan

Date: 08-10 october

Venue: Milan (Italy)

Hall: 18

Stand: 18D67

Contact our team and schedule a meeting: marketing@fps-pharma.com

FPS is pleased to confirm its presence at GMP-PharmaCongress

Date: 19-20 march

Venue: Wiesbaden (Germany)

Stand: B24

Contact our team and schedule a meeting: marketing@fps-pharma.com

Filter Dryer Isolators are commonly installed on the discharge port of the Filter Dryer. The main goal is to protect the operators during the discharge operations of potent compounds.

This can be acceptable for OEB3 and OEB4 products. It requires special procedures and PPEs for activities such as filter vacuum or filter plate/cloth replacement after CIP, as well as a cleaning inspection inside the Filter Dryer.

Does that work for a containment down to 10ng/m3?

No, this CPT (Containment Performance Target) requires more containment, for example while dropping the filter base. FPS is very familiar with this application and its special isolator design allows you to get access to the filter baseplate under full containment through the gloves. This makes the cleaning inspection and filter cloth replacement smoother and much faster. This results in a more efficient process, while shortening process time and increasing productivity.

The FPS special design allows the operators to get the access:

The vertical set up and discharge give you much more flexibility and reduce the operator fatigue (no need to move heavy bags on a horizontal path).

Pushbuttons are provided and full communication with a centralized DCS allows the remote control of CIP, alarms monitoring and status of the machine.

Customer needs:

FPS custom solution:

We are thrilled to announce our presence at ASSCA Day held at Novotel Milano Ca’ Granda in Milan.

Join us on the 13rd Novmber for this incredible event. We will be the sponsor event.

Stay connected with us!

 We are thrilled to announce our presence at Contamination Control Strategy in a Light of Annex 1 Implementation workshop held at Università Campus Biomedico in Rome.

Join us on November 20-21 for this incredible event. Stefano Butti, our Technical Sales Director, will be the speaker.

He will speak about the Design of Aseptic Isolators handling Toxic powder/liquid.

Stay connected with us!

Customer needs

CDMOs need a high level of flexibility when milling and/or micronizing High Potent APIs. Those APIs require different milling technologies  (mechanical or jet milling) and different mills. Also a high level of cleanability is a must. 

In addition CDMOs must provide the best ergonomic conditions for operators whose height difference can reach 50 cm (almost 2 feet) between the shortest and the tallest person. 

FPS solution 

FPS multi-milling Isolator features interchangeable mills (through interchangeable heads). ConeMill, PinMill, HammerMill, Loop Mill and Jet Mill can be used in the same Isolator chamber (one or two at a time, depending on the configuration). 

Also a fully-integrated foldable platform is provided so that operators of all sizes can work at the perfect height. This platform is light and easy to be deployed when needed. Once the work is completed, it can quickly be folded and slid under the isolator, minimizing the footprint of the equipment. 

The milling system and the heads set are provided with an automatic gravimetric feeder which provides a constant feed rate. This assures a constant and uniform particle size at the output. 

To assure the high level of ergonomic, a full wooden mockup test was performed at the End User site. Inside all the equipment (various mills, feeders, cyclones) were 3D printed to better simulate all the activities (Operations, Cleaning, Maintenance).  

FPS is pleased to confirm its presence at Achema.

Date: 10-14 June

Venue: Frankfurt (Germany)

Stand: Hall 3.1 Stand E49

Contact our team and schedule a meeting: marketing@fps-pharma.com

FPS is pleased to confirm its presence at Solids.

Date: 05-06 June

Venue: Parma (Italy)

Stand: E40

Contact our team and schedule a meeting: marketing@fps-pharma.com

FPS is pleased to confirm its presence at 9th Annual Markets and Markets High Potent Medicine Conference.

Date: 24th May

Venue: Fiorenzuola d’Arda (Italy)

FPS Factory

Contact our team and schedule a meeting: marketing@fps-pharma.com