Introduction

Active pharmaceutical ingredients (APIs) are the substances within a pharmaceutical drug or therapeutic that are the main source of beneficial health effects labelled by the drug [i]. As global events continue to shape the pharmaceutical landscape, key players in the industry are left wondering how such events will affect API sourcing and pricing [ii].

With an increase in demand for therapeutics to manage rising incidences of oncological, cardiovascular, and related lifestyle diseases such as diabetes, as well as the expiration of various drug patents, various reports predict an increase in API prices over the coming years due to increased difficulty of their sourcing and transportation, something already felt in various sectors of the pharmaceutical industry [ii]. While different companies with specific focuses will evidently be affected in different ways by increasing API prices, more and more effort has been shifted towards relieving the pressures of rising prices. These challenges are compounded by an increasing demand for shortened development time, reduced cost of development, process design, and new regulations and quality standards. The COVID-19 pandemic and subsequent vaccine effort have not helped to relieve the mounting pressures within the market. These create domino effects that trickle down from the sourcing of APIs, straight through to patients and consumers.

A well-rounded, flexible strategy will prove beneficial for all parties affected by recent challenges in API sourcing and prices. This Trend Report will focus on small molecule APIs and the various sectors of the pharmaceutical industry likely to see their processes affected by fluctuating prices. We will also analyse the results of our API Trend Report survey in which members of the CPHI Online community were invited to share their thoughts on the current outlook for API prices, manufacturing, and sourcing.

As global events continue to shape the pharmaceutical landscape, key players in the industry are left wondering how such events will affect API sourcing and pricing [ii].

Trend Overview

Public Opinion: Survey Analysis

Key Learnings: What the Recent Past has Taught Us

Future Trends: Can We Predict the Market?

Contributors

Ammar Badwy, Pharmaoffer

Over the past 10 years, Ammar Badwy has worked in various departments within pharma companies. Currently, as one of the founders and CEO of Pharmaoffer, he is disrupting the traditional API market with a digital platform that shows all qualified API suppliers in one place. With his series of explainer videos, Ammar is making difficult pharma topics accessible to anyone.

René Zoetmulder, 4SCENERGY

René Zoetmulder holds a BSc in chemistry. With more than 20 years of experience at Philips, he was responsible for operations and later procurement with a focus on outsourcing and supplier development in China. He worked for 10 years at DSM as Global Category Director and was responsible for some of the core materials for different business groups. He spent over 3 years at Aspen API where he redesigned the organization and optimized the availability of pharmaceutical starting materials for the in-house production of APIs and intermediates. He has been a partner at 4SCENERGY for 2 years, cooperating with Nanjing Chemphar International to further enhance the security of supplying pharmaceutical starting materials and key fine chemicals from China for end-users in countries outside China. Since 2021, he has been a member of the Strategic Advisory board of CPHI.

Stefan Schmidinger, KEMIEX

Stefan is the Chief Economist at global API procurement and intelligence platform KEMIEX. Before joining KEMIEX, a globally leading and the only GDP-certified information and procurement software provider for Active Pharmaceutical Ingredients (API) and related chemicals, he was a strategy and business development director at UBS, the global investment bank. Prior he held roles servicing global institutional clients at Credit Suisse and as supply chain management analyst in the Swiss retail sector.

Dr. MD. Abu Zafor Sadek

Dr. Zafor is the former short-term Consultant at The World Bank, and researcher in the pharmaceutical industry.

Gabriele Rebuzzini, ANSA SpA

Gabriele Rebuzzini is Managing Director at AMSA SpA, a CFM group company. He is also a member of the Managing Committee for the Chemical Pharmaceutical Generic Association CPA, which represents Italian manufacturers of Active Pharmaceutical Ingredients. He joined the CFM group in 2010, covering various roles in R&D and Business Development in the API field. Before that, he had carried out his MSc and PhD work in Industrial Biotechnology at UniMIB and DiaSorin, focusing on recombinant protein expression for biocatalysis and immunodiagnostics.