Tapi's 2019 assumptions
By Jordan Rudner, Director, Head of Global Business Analysis and Sales Support
The global market for the manufacture and supply of API’s is changing rapidly and there are many factors influencing these changes. But precisely what are the major trends you should know and be aware of, and how can you use them to your advantage? In this article TAPI gives you the latest overview.
Trend #1 – More API growth
Fuelled by the aging population and an increase in global access to treatment the pharmaceutical market is growing. Financial and efficiency incentives are driving the pharma industry to outsource an increasingly large share of their API production, whether it is for generic or innovative API.
- Insights: API market is expected to grow 5% annually reaching approximately $219 billion by 2023
Trend #2 – More complex API
The newest generation of API’s being developed are extremely complex, these include peptides, high potency API, oligonucleotides, and sterile API. This means that the R&D and certification processes themselves have also become longer and more complicated.
- Insights: The category of biological APIs is growing the most1
Trend #3 – More competitive API market place
A multitude of small producers, specializing in manufacturing niche API’s has led to more intense competition despite the growing market.
- Insights: 50% of the global supply of API’s are produced in ASIA and is expected to grow at a faster pace than the overall pace of market growth1
Trend #4 – More regulatory & quality demands on API
As the volume of API production from Asia increases, unfortunately so has the number of major issues with quality and compliance. This had led to an increase in regulatory demands primarily from the US, European and Japanese authorities.
- Insights: The FDA commissioner announced an enhanced focus to bolster API drug safety and quality
Being aware of these trends is important, but perhaps what is even more important is how to leverage the opportunities they bring. Of course it depends on your current engagement in API sourcing … are you already fully engaged, or are you at the stage of considering a change?
Here is a range of recommendations on how to best use the current trends to your benefit.
The advantages of API sourcing
As the global demand for pharmaceutical solutions is growing, more and more drug companies are feeling the pressure to bring drugs to the market faster and more cost effectively.
API sourcing is often a way to fast track these opportunities by exploring and the leveraging the skills, capacity, knowledge and experiences of the API suppliers.
Perhaps the most far-reaching trend we have witnessed in the market is the move by pharmaceutical companies away from manufacturing their own API’s and a move to outsourcing their API manufacture to third party expert producers.
When selecting an API partner it is important to choose a supplier that has the competencies, scalability and dynamics to meet the increasing demands from authorities throughout the collaboration process.
TAPI has established procedures and tools to support customers throughout the sourcing process, including access to a dedicated account manager as well as access to thousands of regulatory files needed during the sourcing process via TAPI Online – TAPI's customer platform.
Even complex API’s are being sourced
A key trend in the global API market is increasing focus on innovative formulations in generics development. Demanding conditions call for advanced treatments using complex molecules.
API is no longer constrained to commodity treatments, and leading API manufacturers are pivoting to highly complex technologies such as peptides, oligonucleotides and sterile API.
TAPI is investing heavily in new technologies to create products used to treat complex medical conditions such as cancer and immunological conditions and other rare diseases.
Buying API’s produced in Asia has its pitfalls
More and more of the world supply of API’s will be manufactured in Asia, where the talent pool of engineers and scientists is high and where the cost structure for manufacturing, labor, materials and equipment is relatively low.
There are a number of issues already rising from this eastward migration. Concerns over quality have lead the US FDA and the European authorities to issue fines and import bans due to major issues concerning the quality and most worryingly the falsification of manufacturing and testing data.
Looking at statistics from the past five years, the number of API suppliers to come under scrutiny by the US FDA has increased. As there is a steady increase of API volume there is also an increase of suppliers who like to qualify for the worldwide market leading to, an increase in the number of critical issues found, mostly due to fact that the quality systems of these companies are not yet matured.
Flight to quality
One clear result of the regulatory issues surrounding API production in Asia has been a “flight to quality”, meaning that many pharmaceutical companies have turned to trusted partners like TAPI, to produce their API’s. Until full compliance is possible, most pharmaceutical companies are expected to place their business with API manufacturers who are already used and dedicated to worldwide standards and processes and to resolve issues in the region.
How will these trends influence the future of API production?
These trends may seem rather chaotic. However TAPI sees these trends inevitably meaning closer partnerships between API producers and the pharmaceutical companies. R&D expertise, quality control and product purity are the result of know-how, hard work and common understanding. Data integrity requires the sharing of technologies and customised software. New API’s no matter what technology is used to develop and manufacture, require API producers to enter into very close working partnerships with the pharma companies in order to develop methods of Api production, R&D, certification and product launch. The more complex the nature of the API, the closer the understanding and co-operation between producer and customer has to be. At the core of this relationship is partnership, trust, open communication, a dedication to quality and regulatory compliance and data integrity.
To find out more about TAPI’s global leadership in these fields please click onto your topic of interest to read more:
TAPI have a dedicated team of experts on hand to help you with your API needs. We cannot of course predict the future, and the trends we bring here are a result and analysis of our global presence and the support we provide to most of the leading pharmaceutical companies, but we have outlined in broad terms how we see the market trending. For a more detailed analysis of your particular area of API manufacture, compliance or data integrity please contact us.
About the author
Jordan Rudner has a Masters degree in economics from Concordia University in Canada. Jordan has been working at TAPI’s commercial group for over 3 years, and is currently head of the Global Business Analyst Team and Competitive Intelligence Team. His previous roles have included: Manager, Business Analytics at McKesson Corporation, and consultant at IMS (now IQVIA), and Health Economist at Brogan Inc. (acquired by IMS).
 The FDA commissioner Scott Gottlieb on Twitter
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