Global Pharmaceutical Excipients Market - Segmented by Product, Delivery Mode, Functionality, and Geography - Growth, Trends, and Forecast (2018 - 2023)
The global pharmaceutical excipients market is expected to register a CAGR of 7% during the forecast period of 2018–2023. Pharmaceutical excipients are combined with active pharmaceutical ingredients to prepare the final dosage of drugs. The excipients provide bulk to the formulation, facilitate drug absorption, provide stability, and prevent denaturation. They are feasible, cost-effective, and stable for handling and inert. The main advantages of using excipients are to improve the wetting property, increase the bulk of the drug, providing stability, and enhancing organoleptic properties. Excipients are used in a variety of medicinal products like tablets, capsules, oral liquids, transdermal patches, implants, and inhalers.
Recent Patent Expiries Driving the Demand for Pharmaceutical Excipients
Many ‘blockbuster’ drugs are on the verge of losing their patents. The patent cliff (the period between 2011–2016) resulted in hundreds of billions of dollars’ worth of brand drug sales losing patent protection. Another patent cliff is expected in the coming years. When patents expire, generic drug companies are free to create their replicas, and these can cost up to 80% less than the original, which inevitably leads to a sharp and sudden loss in sales for the companies that developed them. Over 300 drug patents expired in the year 2017. For example, the effect of patent expiration can be seen on Roche Holdings. The company’s major revenue was generated through oncology drugs, such as Avastin, Herceptin, and MabThera/Rituxan, which are about to expire in 2020, 2019, and 2018 respectively. This has encouraged pharmaceutical companies to try and extend patents by using functionality excipients.
Also, factors such as increasing demand for functionality excipients, rapid advancements in nanotechnology, and the emergence of new excipients for the pharmaceutical industry are driving the pharmaceutical excipients market.
Stringent Regulatory Framework
Excipients can offer solutions to problems like new drug candidates possessing larger molecular weights, which in turn, reduces their solubility. This has encouraged pharmaceutical companies to invest in developing better excipients to incorporate into drugs. Despite this trend, excipients lack independent approval processes separate from the drug. This is restraining innovations in the field. Although a lot of people would be interested in developing them, it is a major issue for people to accept them without some approval from the regulatory authorities. So the drug companies are reluctant to use excipients in their products, which have not been approved. However, the FDA will not approve an excipient unless it has been included in an approved drug product. This leaves the organizations with little or no incentive to invest in the non-active part of the drug. The development pipeline for new excipients, when considered on top of the development timeline for the drug, are too lengthy. Also, depending on the type of pharmaceutical, the excipient could well be out of patent-life before it reaches commercial sales. This stringent regulatory framework, along with the decline in R&D investments are hindering the growth of the pharmaceutical excipients market.
United States Leads the Market in North America
The United States pharmaceutical excipients market held the largest market share in 2017 in North America due to the presence of high-quality healthcare system and the presence of numerous pharmaceutical companies. Asia-Pacific is one of the upcoming markets due to the advancements in the technology of manufacturing new excipients.
Key Developments in the Market