Pharmaceutical Excipients Market

The global market for pharmaceutical excipients, in terms of revenue, was estimated to be $8.6 billion in 2022 and is projected to reach $11.5 billion by 2030 growing at a CAGR of 5.9% from 2023to 2030. A new research study has been conducted, analyzing industry trends, pricing, patents, conferences and webinars, key stakeholders, and market buying behavior. The growth of the pharmaceutical market, supported by functional excipients, the rise of generics, increased adoption of biopharmaceuticals, and the utilization of orphan drugs, are key drivers for the market. Additionally, the market presents significant growth opportunities for players in the near future, thanks to multifunctional excipients, the shift of pharmaceutical manufacturing to emerging countries, and the growth of the biosimilars market. However, the market may face constraints due to increasing regulatory requirements for drug and excipient approvals, as well as the time and cost involved in the drug development process.

Pharmaceutical Excipients Market Dynamics

Driver: Surge in the Generics Market

The generics market is experiencing significant growth due to cost-effectiveness and comparable therapeutic effectiveness and safety profiles compared to branded drugs. The lower cost of generics has contributed to the popularity of this market segment. In the United States, for example, the healthcare system saved $265 billion in 2017 and over $1.67 trillion in the last decade through the use of generic drugs, according to the Association for Accessible Medicines. Medicare and Medicaid also experienced substantial savings, with $82.7 billion and $40.6 billion saved, respectively. Governments in various countries are promoting the use of generic drugs due to these advantages. Globally, the adoption of generics is on the rise. In the United States, generics accounted for 90% of prescriptions dispensed in 2020, as reported by the Association for Accessible Medicines. This is driven by drugs going off-patent and healthcare reforms favoring generics. According to the National Pharmaceutical Services report, 47 drugs are expected to face patent expiration between 2019 and 2022, including important medications from major players like Merck, Novartis, Bristol-Myers Squibb, and Eli Lilly.

Industry experts anticipate significant revenue and volume losses for the branded drug industry due to generic erosion. This opens up opportunities for cheaper generic alternatives to enter the market, resulting in increased sales volume. The growing affordability and healthcare expenditure in emerging economies further contribute to the sales volume of generics, which positively impacts the growth of the pharmaceutical excipients market.

Restraint: Cost and time-intensive drug development process

According to the California Biomedical Research Association (CBRA), it takes an average of 12 years for a drug to go from the research lab to the patient, including 1 to 6 years dedicated to toxicology studies alone. Additionally, only 1 out of every 5,000 drugs that undergo preclinical testing successfully advances to human testing, and ultimately, only one drug is approved for human usage. The Tufts Center for the Study of Drug Development (CSDD) reports that the cost of developing a drug that obtains market approval is approximately $2.6 billion, with an additional $312 million spent on post-approval development for testing new indications, formulations, and dosage strengths. This results in a total cost of $1.7 billion for the development of a single prescription drug over a span of 10 to 12 years. Moreover, failures in late-stage drug development increase research and development (R&D) costs and impact the profit margins of pharmaceutical companies. The increasing regulations related to excipient and drug quality and safety necessitate the upgrade of current manufacturing and quality assurance practices, which further adds to the overall manufacturing cost. Despite significant advancements in excipient and drug production in recent years, the high capital investments required are expected to impede market growth during the forecast period.

Opportunity: Increase in multifunctional excipients

The emergence of multifunctional excipients represents a promising solution to address the time and cost constraints associated with bringing a drug to the market, a process that typically takes 10 to 12 years. Multifunctional excipients enhance the drug manufacturing process by improving flowability, compressibility, bioavailability, and particle size distribution. They offer several advantages, including improved efficiency, cost-effectiveness, reduced production time, facilitation of new chemical entities' development, and formulation of orally disintegrating tablets (ODT). The introduction of multifunctional excipients will aid in resolving formulation development challenges and streamlining optimization studies. Many market players are now focused on introducing new grades of existing excipients to enhance their performance for specific applications, such as excipients tailored for controlled-release formulations, immediate-release applications, topical formulations, and orally disintegrating tablets. This trend creates lucrative growth opportunities in the market.

Challenge: Safety and quality concerns

Despite the increasing use of excipients in the pharmaceutical industry, ensuring compliance with the quality expectations of regulators, end users, drug manufacturers, and patients poses a challenge. Variations in excipient production can impact the drug's performance and its critical quality attributes. Supplier-to-supplier or batch-to-batch variations in excipients can influence the interaction between the excipient and the drug, thereby affecting the drug's efficacy. A significant portion of pharmaceutical excipient manufacturing is outsourced to smaller manufacturers in low-cost countries, which can lead to limited control over the manufacturing process and quality of excipients. As a result, there is a growing need for enhanced process transparency across the entire supply chain. However, achieving immediate streamlining and maximum transparency in supply chain activities presents challenges for both drug manufacturers and excipient manufacturers.

The organic chemicals segment is expected to have the dominant share of the pharmaceutical excipients market.

The market is divided into three main categories: organic chemicals, inorganic chemicals, and other chemicals. Among these, the organic chemicals segment holds the largest market share and is projected to exhibit the highest compound annual growth rate (CAGR) during the forecast period. This is primarily due to the non-toxic nature of organic chemicals and their effectiveness as excipients in oral drug formulations. The organic chemicals market is further segmented into five major segments: oleochemicals, carbohydrates, petrochemicals, proteins, and other organic chemicals, with the oleochemicals segment occupying the largest share of the organic chemicals market.

Europe was the most important region of the pharmaceutical excipients market.

The market is categorized into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2021, Europe held the largest market share. This can be attributed to the presence of numerous pharmaceutical giants with extensive production capacities, resulting in high consumption of excipients. The increasing focus on superior pharmaceutical products, generics, and biosimilars has also contributed to the rising demand for innovative excipients, thereby stimulating market growth.

Key players in the pharmaceutical excipients market include Ashland Global Holdings, Inc (US), BASF SE (Germany), International Flavors & Fragrances, Inc. (US), Evonik Industries AG (Germany), and Roquette Frères (France).

This report provides a categorization of the pharmaceutical excipients market to forecast revenue and analyze trends in each of the following submarkets.

By Product

• Organic Chemicals
• Oleochemicals
  • Fatty Alcohols
  • Metal Stearates
  • Glycerin
  • Other Oleochemicals
• Carbohydrates
  • Sugars
    • Actual Sugars
    • Sugar Alcohols
    • Artificial Sweetners
  • Cellulose
    • Microcrystalline cellulose
    • Cellulose ethers
    • Carboxymethyl cellulose (CMC) and croscarmellose sodium
    • Cellulose esters
  • Starches
    • Modified Starch
    • Dried Starch
    • Converted Starch
• Petrochemicals
  • Glycols
  • Povidones
  • Mineral Hydrocarbons
  • Acrylic Polymers
  • Other Petrochemical Excipients
• Proteins
• Other Organic Chemicals
• Inorganic Chemicals
• Calcium Phosphate
• Metal Oxides
• Halites
• Calcium Carbonate
• Calcium Sulphate
• Other Inorganic Chemicals
• Other Chemicals

By Functionality

• Fillers & Diluents
• Suspending & Viscosity Agents
• Coating Agents
• Binders
• Flavoring Agents & Sweeteners
• Disintegrants
• Colorants
• Lubricants & Glidants
• Preservatives
• Emulsifying Agents
• Other Functionalities

By End User

• Oral Formulations
• Tablets
• Capsules
  • Hard-gelatin Capsules
  • Soft-gelatin Capsules
• Liquid Formulations
• Topical Formulations
• Parenteral Formulations
• Other Formulations

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • Italy
  • Spain
  • UK
  • RoE
• Asia Pacific
  • China
  • Japan
  • India
  • Rest of Asia Pacific
• Latin America
• Middle East & Africa

Recent Developments

• Ashland introduced the Aquaflow NMS 460E rheology modifier, a nonionic synthetic associative thickener, in May 2019.
• Colorcon released STARTAB, a starch tableting excipient specifically designed for the direct compression process, in May 2019.