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
- August 2017: Straumann Group acquired ClearCorrect.
Reasons to Purchase the Report
- Follow the current and future pharmaceutical excipients market in the developed and emerging markets.
- Analyzing various perspectives of the market with the help of Porter’s
- Five Forces Analysis.
- Identify the segment that is expected to dominate the market.
- Identify the regions that are expected to witness the fastest growth during the forecast period.
- Identify the latest developments, market shares, and strategies employed by the major market players.
- 3-month analyst support along with the Market Estimate sheet (in Excel).
This report can be customized to meet your requirements.
1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Products and Services
5.2.5 Competitive Rivalry within the Industry
6. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
6.1.1 Increasing Demand for Functionality Excipients
6.1.2 Recent Patents Expiries Driving the Demand for Pharmaceutical Excipients
6.1.3 Rapid Advancements in Nanotechnology
6.1.4 Emergence of New Excipients for the Pharmaceutical Industry
6.2.1 Stringent Regulatory Framework
6.2.2 Decline in R&D Investments
6.4 Key Challenges
7. Market Segmentation
7.1 By Products
7.1.1 Inorganic Chemicals
7.1.2 Organic Chemicals
7.2 By Delivery Mode
7.2.1 Oral Formulations
184.108.40.206 Liquid Formulations
7.2.2 Topical Formulations
7.2.3 Parenteral Formulations
7.2.4 Advance Delivery Systems
7.3 By Functionality
7.3.1 Fillers & Diluents
7.3.3 Suspension and Viscosity Agents
7.3.5 Flavoring Agents
7.3.7 Lubricants & Glidants
7.4 By Geography
7.4.1 North America
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
126.96.36.199 Australia & New Zealand
188.8.131.52 South Korea
184.108.40.206 Rest of Asia-Pacific
7.4.4 Middle East & Africa
220.127.116.11 South Africa
18.104.22.168 Rest of the Middle East & Africa
7.4.5 South America
22.214.171.124 Rest of South America
8. Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches
9. Key Players
9.1 Archer Daniels Midland Company
9.2 Ashland Inc.
9.3 Associated British Foods PLC
9.4 BASF SE
9.5 Croda International PLC
9.6 Evonik Industries AG
9.7 FMC Corporation
9.8 Roquette Group
9.9 The DOW Chemical Company
9.10 The Lubrizol Corporation
*List not Exhaustive
10. Future of the Market
- Ashland Inc.
- BASF SE
- The Dow Chemical Company
- FMC Corporation
- Roquette Group
- Evonik Industries AG
- Associated British Foods PLC
- The Lubrizol Corporation
- Archer Daniels Midland Company
- Croda International PLC