Biopharmaceutical Excipients Market Size, Share & Segmentation By Product (Solubilizes & Surfactants/Emulsifiers (Triglycerides, Esters, Others), Polyols (Mannito, Sorbitol, Others), Carbohydrates (Sucrose, Dextrose, Starch, Others), By Regions and Global Forecast 2024-2031

Biopharmaceutical Excipients Market Report Scope & Overview:

The Biopharmaceutical Excipients Market Size was valued at USD 2.7 billion in 2023 and is expected to reach USD 4.17 billion by 2031, and grow at a CAGR of 5.6% over the forecast period 2024-2031.

Increasing R&D investments in biosimilars, coupled with the patent expiration of top-selling biologics, are projected to propel the market. The chemical and physical instability of biopharmaceuticals and stringent manufacturing requirements need to be fulfilled for consistent yield of biologics and to ensure high cell viability are boosting the market. Furthermore, a growing adoption of multifunctional excipients, expiry of bioactive patents and increasing focus by pharmaceutical manufacturers on the Generic Market. In addition, to preserve the stability of medicinal products, new biotechnological excipients are being developed by operational players. In addition, Roquette launched the new excipient PEARLITOL ProTec in Europe in May 2023. It is a unique, plant based, processed blend of maize starch and mannitol, which can be used for the stabilisation of probiotics and for the protection of sensitive active ingredients such as mannitol.

Get more information on Biopharmaceutical Excipients Market - Request Sample Report

Biopharmaceutical excipients, which are inactive compounds used as carriers, must be coupled with the active pharmaceutical ingredients in order to achieve an appropriate formulation that is able to prolong its shelf life. The stability of the product must be improved by careful use of a combination of excipients, given that biopharma molecules are prone to instability.

MARKET DYNAMICS

DRIVERS

• The rapid development of the legal environment for production of biosimilars

• Increasing prevalence of cancer and infectious diseases

As cancer incidence increases, the need for diverse biological treatment is increasing. Biopharma companies, both large and small, are still looking for the molecular causes of cancer as well as developing drugs to stop tumor cells from growing. A number of aspects of the oncology market have therefore been shaped by the biopharma industry. Moreover, there is a significant burden of communicable diseases in industrialized and developing countries. Especially in low- and middle-income nations, contagious diseases, including HIV/AIDS, TB, malaria, and many others, cause a high mortality rate.

RESTRAINTS

• The market growth rate will slow down because of the lack of common treatments

• Regulatory issues in the manufacture of biopharmaceutical ingredients

The quality and safety of medicinal products is one of the most important issues for regulators. Regulators have become more stringent in their stance against the adulteration of pharmaceuticals with excipients and APIs due to a number of strict measures adopted last few years. However, there is a need for an independent excipient approval pathway to limit the entry of new excipients and new drugs into the market in the current regulatory environment. Moreover, due to uncertainty as to whether the new excipient will be accepted into a regulatory review which hinders market growth, manufacturers and producers of products are hesitant to invest significant resources and time in its development.

OPPORTUNITIES

• A growing demand for novel excipients in the development of medicines

New excipients are essential to ensure that new, better and safer drugs can be developed for the biopharma market. The majority of approved products are made up of conventional, well studied compendial excipients; therefore, the use of novel excipients is not necessary to formulate certain advanced products. Moreover, more companies are choosing to use sophisticated and innovative formulations containing new ingredients. A novel excipient is defined by the FDA as an excipient that has not been used in an FDA approved medicinal product. Therefore, there is no indication of any use in food.

CHALLENGES

• Lack of awareness of the biopharmaceutical excipients

Impact of Russia-Ukraine War

Many of the Ukraine-based clinical trial sites have collapsed, as the Russian invasion has destroyed hospitals and research facilities. In Russia, biopharma companies are stopping enrolling in a number of clinical studies. Several pharmaceutical and biotechnology companies acknowledged the likelihood of delays in trials in Ukraine and Russia, as well as difficulties to produce vaccines and medicinal products that are required for these countries. The instability in the region may lead to currency depreciation, trade tariffs and export restrictions that could have a negative impact on biopharma excipient prices from affected regions. This uncertainty could lead to disruption of market dynamics and pricing strategies for pharmaceuticals, which would have a negative impact on their bottom lines as well as the possible increase in consumer costs. In addition, the approval and certification of pharmaceutical products and excipients by disrupting regulatory processes and controls. As a result, companies may seek alternative sources of supply which could lead to changes in market dynamics and competition due to the resulting uncertainty regarding compliance with regulatory requirements.

Impact of Economic Slowdown

During economic slowdowns, excipient manufacturers and suppliers may encounter difficulties accessing financing, which could hamper their capacity expansion, technology upgrades, and product development efforts. Consequently, this may result in supply chain constraints and potential shortages of essential excipients in the market. In addition, during economic downturns, regulatory agencies may face budgetary constraints or prioritise the use of resources to address immediate public health issues in order to speed up approval processes for new excipients or updates affecting existing excipients.

In spite of these challenges, the market for biotherapeutic excipients may also present opportunities such as to reduce costs, pharmaceutical companies may be more focused on the development of generic or biogeneric versions of currently available biopharmaceuticals and this could lead to an increase in excipient demand from such formulations.

Market segmentation

By Product

• Solubilizes & Surfactants/Emulsifiers

  • Triglycerides

  • Esters

  • Others

• Polyols

  • Mannitol

  • Sorbitol

  • Others

• Carbohydrates

  • Sucrose

  • Dextrose

  • Starch

  • Others

In 2023, carbohydrates accounted for 36.2% of the market's revenue and this trend is expected to be maintained over the forecast period. In particular, the dominant share of this segment can be attributed to the extensive use of starch, sucrose and dextrose in different medicinal products. The rapid adoption of high-purity carbohydrates like trehalose in biosimilar development is driven by their capacity to boost final product yield, stabilize biologics, prevent aggregation, and enhance the overall biopharmaceutical manufacturing process. Additionally, the growing acceptance of carbohydrates as bulking agents for lyophilizing biomolecules, such as proteins, further contributes to segment growth.

The polyol segment is anticipated to grow at a faster compound annual growth rate over the forecast period. Polyols are sugar alcohols in some fruits, vegetables and sugars free sweeteners. The growing demand for protein therapeutic products is a reason for the growth in this segment. In order to enhance the tonic and stability of proteins, phenols are added. In addition, they have been shown to provide greater thermodynamic stability, which is essential for protein-based formulations.

Regional Analysis:

In 2023, North America had the largest market share at 32.3%. Several large pharmaceutical manufacturing companies operating in this region are likely to be responsible for the growth. In addition, there has been a significant demand for Biopharmaceutical production in this region and the need to maintain high quality raw materials used as development ingredients. Therefore, the use of biopharma excipients that comply with regulatory standards has been required by a number of regional excipient manufacturers in order to achieve the necessary production scale. Moreover, new studies are being carried out by companies active in the region to develop efficient excipient solutions.  

Asia Pacific market is expected to grow at a faster rate of around 6 % during the forecast period due to the presence of major CMOs involved in drug development. The development of biosimilars is largely driven by countries in this region, such as South Korea, India, and China. There are many reasons for the widespread development of biosimilars, including their large patient base, cost advantages, affordability and favourable legal framework. There are many biopharma companies active in Asian countries that could be potential customers on the market. As a result of the substantial cost advantages provided by the value chain, international biopharma companies are involved in relocating their manufacturing and research and development operations to these countries. In turn, the demand for novel excipients is increasing as a result of the increasing demand for biosimilars.

REGIONAL COVERAGE:

North America

• US

• Canada

• Mexico

Europe

• Eastern Europe

  • Poland

  • Romania

  • Hungary

  • Turkey

  • Rest of Eastern Europe

• Western Europe

  • Germany

  • France

  • UK

  • Italy

  • Spain

  • Netherlands

  • Switzerland

  • Austria

  • Rest of Western Europe

Asia Pacific

• China

• India

• Japan

• South Korea

• Vietnam

• Singapore

• Australia

• Rest of Asia Pacific

Middle East & Africa

• Middle East

  • UAE

  • Egypt

  • Saudi Arabia

  • Qatar

  • Rest of the Middle East

• Africa

  • Nigeria

  • South Africa

  • Rest of Africa

Latin America

• Brazil

• Argentina

• Colombia

• Rest of Latin America

KEY PLAYERS:

Some of the major key players are Associated British Foods, BASF SE, Colorcon, Clariant, DFE Pharma, Evonik Industries AG, IMCD, Sigachi Industries Pvt. Ltd., Merck KGaA, J. RETTENMAIER & SOHNE GmbH + Co KG, Roquette Freres, Signet Chemical Corporation Pvt, Ltd. and Other Players.

Evonik Industries AG-Company Financial Analysis

Recent Developments:

• In December 2022- BASF SE and StePac Ltd have collaborated to design the next generation of environmentally friendly packaging for the fresh produce sector. Utilizing BASF's delivery of Ultramid Cycled TM, a chemically recycled polyamide 6, StePac aims to enhance contact-sensitive package designs to meet more sustainable standards within the circular economy.

• In September 2022- Spectrum Chemical Mfg. Corp., renowned for its provision of specialty, fine, and cGMP chemicals, along with laboratory equipment and supplies worldwide, has established a new U.S. distribution partnership with DFE Pharma, a prominent global provider of excipient solutions for pharmaceutical and nutraceutical industries.