The biopharmaceutical excipients market size was exhibited at USD 3.15 billion in 2023 and is projected to hit around USD 5.39 billion by 2033, growing at a CAGR of 5.52% during the forecast period 2024 to 2033.
| Report Coverage | Details |
| Market Size in 2024 | USD 3.32 Billion |
| Market Size by 2033 | USD 5.39 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 5.52% |
| Base Year | 2023 |
| Forecast Period | 2024-2033 |
| Segments Covered | Product, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Country scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Key Companies Profiled | U.S.; Canada; Germany; U.K.; France; Italy; Spain; Denmark; Sweden; Norway; China; Japan; India; South Korea; Australia; Thailand; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
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. Moreover, the increasing adoption of multifunctional excipients, patent expiry of biological actives, and growing focus of pharmaceutical players on the generic market are factors expected to offer lucrative opportunities in the market for biopharmaceutical excipients during the forecast period.
COVID-19 Impact: Vital role of excipients in therapeutics is set to propel market demand. Pandemic Impact Post COVID Outlook Multi-functional excipients have gained significant popularity in recent years, expected to drive the market. Biopharmaceutical excipients are expected to gain traction post the pandemic outbreak, with high demand across re-purposing existing drugs & vaccine development for the management of SARS-COV-2 infection. Market participants are focusing on the development of co-processed multifunctional excipient formulations anticipated to propel market expansion. An array of effective excipient formulations are being introduced for the stabilization of vaccines and biologics during storage & processing, which is set to offer new opportunities to the market players, particularly post the pandemic outbreak.
Biopharmaceutical manufacturers are engaged in improving the administration of biologics as compared to conventional dosage forms (currently available in parental formulations). Growing demand for excipients with improved properties for biologic formulations drives the market. Polyols, glycerol, surfactants, and buffers are the most used excipients for the formulation of biologics. Moreover, companies operating in the market are developing new process development technologies.
For instance, in June 2020, Evonik launched the RESOMER Precise platform for custom manufacturing of functional polymeric excipients to allow pharmaceutical companies to control the release of their parenteral drug products with accuracy and precision. The process technology will help in optimizing drug product stability, which will reduce regulatory risk for a wide range of parenteral drug products.
Moreover, operating players are launching innovative biopharmaceutical excipients to maintain the stability of pharmaceutical products. For instance, in May 2023, Roquette introduced the novel excipient PEARLITOL ProTec in Europe . It is a unique, plant-based co-processed blend of maize starch & mannitol and can be used for stabilizing and protecting sensitive active ingredients such as probiotics.
Furthermore, an increasing number of programs to advance innovative biopharmaceutical excipients are expected to open new avenues for the market. For instance, in September 2023, the Office of New Drugs and the Center for Drug Evaluation and Research launched a voluntary Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). This program is intended to allow biopharmaceutical manufacturers to obtain FDA review of novel excipients. Such initiatives are driving the biopharmaceutical excipients market.
The sudden outbreak of COVID-19 led vaccine manufacturers to extend their collaboration to continue the supply of excipients for vaccine development. For instance, in May 2020, CordenPharma and Moderna extended their manufacturing services agreement to supply lipid excipients used to develop the vaccine for SARS-CoV-2. In addition, the companies further extended the supply relationship by expanding their agreement that was signed in 2016. The new agreement now included CordenPharma Colorado and CordenPharma Chenôve for larger-scale production of lipid excipients to meet Moderna's increasing demand for vaccine development. Thus, the COVID-19 pandemic had a positive impact on the global market for biopharmaceutical excipients.
Carbohydrate-based excipient products dominated the market in 2023 with a revenue share of 36.81%, and this trend is expected to continue through the forecast period. The extensive use of starch, sucrose, and dextrose in various drug formulations can be primarily attributed to the dominant share of the segment.
High-purity carbohydrates such as trehalose are being rapidly adopted in the development of biosimilars due to their ability to enhance the yield of the final product, stabilize various biologics, prevent aggregation, and improve the entire process of biopharmaceutical manufacturing. In addition, the increasing adoption of carbohydrates as bulking agents for assisting in the process of lyophilization for biomolecules such as proteins is further contributing to segment growth.
The polyols segment is expected to witness the fastest CAGR over the forecast period. Polyols are sugar alcohols found in certain fruits, vegetables, and sugar-free sweeteners. The growth of this segment can be attributed to the increasing demand for protein therapeutics. Polyols are added in protein formulations for increasing tonicity and stability. Moreover, they have also been shown to offer greater thermodynamic stability, which is essential for protein-based formulations.
Most therapies based on biomolecules are lyophilized to prevent aggregation and degradation. All lyophilized formulations use one or the other polyol. Sorbitol (polysorbate 80 & polysorbate 20) and mannitol are the most widely used polyols. In October 2023, Roquette introduced two next-generation mannitol excipients, PEARLITOL 200 GT and PEARLITOL CR-H, for direct compression and controlled release of mini tabs and tablets.
North America accounted for the largest market share of 32.85 % in 2023. The regional growth can be attributed to several large-scale pharmaceutical manufacturing companies operating in this region. The region has witnessed a significant demand for biopharmaceutical production, along with the need to maintain the quality of high-grade raw materials used to develop biopharmaceuticals. This has compelled several regional excipient manufacturers to achieve the required production scalability by using biopharmaceutical excipients that comply with the regulatory standards.
Furthermore, companies operating in the region are conducting new studies for developing efficient excipient solutions. For instance, in February 2021, Innophos released a whitepaper that focused on co-processed multifunctional excipients for enhancing compressibility, increasing manufacturing efficiency, simplifying labels, and reducing tablet size. This technology will continue to grow as it helps in reducing ingredients on the label without compromising efficacy and will help in reducing operational costs for manufacturers.
The Asia Pacific market is anticipated to witness the fastest growth rate of around 6.0% during the projection period, owing to the presence of large CMOs involved in drug development. Countries in this region such as South Korea, India, and China are majorly involved in the advancement of biosimilars. There are numerous reasons for the extensive development of biosimilars, including the presence of a large patient pool, cost advantages, affordability, and favorable regulatory framework.
Numerous biopharmaceutical manufacturers, who are potential customers for the market, have their manufacturing units in Asian countries. International biopharma players are involved in shifting their manufacturing and R&D operation sites to these countries owing to the significant cost advantages offered in the value chain. The spiraling demand for biosimilars is, in turn, bolstering the demand for novel excipients. These factors are expected to propel the Asia Pacific region’s growth in the near future.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the biopharmaceutical excipients market
Product
Regional
Chapter 1 Biopharmaceutical Excipients Market: Research Methodology And Scope
1.1 Market Segmentation And Scope
1.1.1 Segment Definitions
1.1.1.1 Product Segment
1.2 Regional Scope
1.3 Estimates And Forecast Timeline
1.4 Objectives
1.4.1 Objective - 1
1.4.2 Objective - 2
1.4.3 Objective - 3
1.5 Research Methodology
1.6 Information Procurement
1.6.1 Purchased Database
1.6.2 Internal Database
1.6.3 Secondary Sources
1.6.4 Primary Research
1.7 Information Or Data Analysis
1.7.1 Data Analysis Models
1.8 Market Formulation & Validation
1.9 Model Details
1.9.1 Commodity Flow Analysis
1.10 List of Secondary Sources
1.11 List of Abbreviations
Chapter 2 Biopharmaceutical Excipients Market: Executive Summary
2.1 Market Outlook
2.2 Product Snapshot
2.3 Competitive Landscape Snapshot
Chapter 3 Biopharmaceutical Excipients Market: Market Variables, Trends & Scope
3.1 Market Lineage Outlook
3.1.1 Related/Ancillary Market Outlook
3.2 Market Dynamics
3.2.1 Market Drivers Analysis
3.2.1.1 Chemical And Physical Instability Of Biopharmaceuticals Is Boosting The Development Of Excipients
3.2.1.2 Increase In Focus Of Pharmaceutical Players On Biogeneric Market
3.2.1.3 Cost Effective And Competency Of Manufacturers
3.2.1.4 Patent Expiry Of Biological Actives
3.2.1.5 Rising Adoption Of Multifunctional Excipients
3.2.2 Market Restraint Analysis
3.2.2.1 Challenges In Development Of Excipients For Biologics
3.2.2.2 Issues Pertaining To Supply Chain In Biopharmaceutical Industry
3.3 Industry Analysis Tools
3.3.1 Porter’s Five Forces Analysis
3.3.2 Pestel Analysis
Chapter 4 Biopharmaceutical Excipients Market: Product Business Analysis
4.1 Biopharmaceutical Excipients Market: Product Movement Analysis
4.2 Solubilizes & Surfactants/Emulsifiers
4.2.1 Solubilizes & Surfactants/Emulsifiers Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.2.2 Triglycerides
4.2.2.1 Triglycerides Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.2.3 Esters
4.2.3.1 Esters Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.2.4 Others
4.2.4.1 Others Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.3 Polyols
4.3.1 Polyols Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.3.2 Mannitol
4.3.2.1 Mannitol Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.3.3 Sorbitol
4.3.3.1 Sorbitol Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.3.4 Others
4.3.4.1 Others Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.4 Carbohydrates
4.4.1 Carbohydrates Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.4.2 Dextrose
4.4.2.1 Dextrose Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.4.3 Sucrose
4.4.3.1 Sucrose Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.4.4 Starch
4.4.4.1 Starch Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.4.5 Others
4.4.5.1 Others Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
4.5 Specialty Excipients
4.5.1 Specialty Excipients Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
Chapter 5 Biopharmaceutical Excipients Market: Regional Business Analysis
5.1 Regional Market Snapshot
5.2 North America
5.2.1 North America Biopharmaceutical Excipients Market Estimates And Forecast, 2021 - 2033 (USD Million) (Volume In Tons)
5.2.2 U.S.
5.2.2.1 U.S. Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.2.2.2 Key Country Dynamics
5.2.2.3 Regulatory Framework
5.2.2.4 Reimbursement Scenario
5.2.3 Canada
5.2.3.1 Canada Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.2.3.2 Key Country Dynamics
5.2.3.3 Regulatory Framework
5.2.3.4 Reimbursement Scenario
5.3 Europe
5.3.1 Europe Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.2 UK
5.3.2.1 UK Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.2.2 Key Country Dynamics
5.3.2.3 Regulatory Framework
5.3.2.4 Reimbursement Scenario
5.3.3 Germany
5.3.3.1 Germany Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.3.2 Key Country Dynamics
5.3.3.3 Regulatory Framework
5.3.3.4 Reimbursement Scenario
5.3.4 Spain
5.3.4.1 Spain Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.4.2 Key Country Dynamics
5.3.4.3 Regulatory Framework
5.3.4.4 Reimbursement Scenario
5.3.5 France
5.3.5.1 France Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.5.2 Key Country Dynamics
5.3.5.3 Regulatory Framework
5.3.5.4 Reimbursement Scenario
5.3.6 Italy
5.3.6.1 Italy Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.6.2 Key Country Dynamics
5.3.6.3 Regulatory Framework
5.3.6.4 Reimbursement Scenario
5.3.7 Denmark
5.3.7.1 Denmark Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.7.2 Key Country Dynamics
5.3.7.3 Regulatory Framework
5.3.7.4 Reimbursement Scenario
5.3.8 Sweden
5.3.8.1 Sweden Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.8.2 Key Country Dynamics
5.3.8.3 Regulatory Framework
5.3.8.4 Reimbursement Scenario
5.3.9 Norway
5.3.9.1 Norway Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.3.9.2 Key Country Dynamics
5.3.9.3 Regulatory Framework
5.3.9.4 Reimbursement Scenario
5.4 Asia Pacific
5.4.1 Asia-Pacific Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.2 Japan
5.4.2.1 Japan Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.2.2 Key Country Dynamics
5.4.2.3 Regulatory Framework
5.4.2.4 Reimbursement Scenario
5.4.3 CHINA
5.4.3.1 China Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.3.2 Key Country Dynamics
5.4.3.3 Regulatory Framework
5.4.3.4 Reimbursement Scenario
5.4.4 India
5.4.4.1 India Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.4.2 Key Country Dynamics
5.4.4.3 Regulatory Framework
5.4.4.4 Reimbursement Scenario
5.4.5 South Korea
5.4.5.1 South Korea Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.5.2 Key Country Dynamics
5.4.5.3 Regulatory Framework
5.4.5.4 Reimbursement Scenario
5.4.6 Thailand
5.4.6.1 Thailand Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.6.2 Key Country Dynamics
5.4.6.3 Regulatory Framework
5.4.6.4 Reimbursement Scenario
5.4.7 Australia
5.4.7.1 Australia Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.4.7.2 Key Country Dynamics
5.4.7.3 Regulatory Framework
5.4.7.4 Reimbursement Scenario
5.5 Latin America
5.5.1 Latin America Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.5.2 Brazil
5.5.2.1 Brazil Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.5.2.2 Key Country Dynamics
5.5.2.3 Regulatory Framework
5.5.2.4 Reimbursement Scenario
5.5.3 Mexico
5.5.3.1 Mexico Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.5.3.2 Key Country Dynamics
5.5.3.3 Regulatory Framework
5.5.2.4 Reimbursement Scenario
5.5.4 Argentina
5.5.4.1 Argentina Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.5.4.2 Key Country Dynamics
5.5.4.3 Regulatory Framework
5.5.4.4 Reimbursement Scenario
5.6 MEA
5.6.1 MEA Biopharmaceutical Excipients Market 2021 - 2033 (USD Million) (Volume In Tons)
5.6.2 South Africa
5.6.2.1 South Africa Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.6.2.2 Key Country Dynamics
5.6.2.3 Regulatory Framework
5.6.2.4 Reimbursement Scenario
5.6.3 Saudi Arabia
5.6.3.1 Saudi Arabia Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.6.3.2 Key Country Dynamics
5.6.3.3 Regulatory Framework
5.6.3.4 Reimbursement Scenario
5.6.4 UAE
5.6.4.1 UAE Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.6.4.2 Key Country Dynamics
5.6.4.3 Regulatory Framework
5.6.2.4 Reimbursement Scenario
5.6.5 Kuwait
5.6.5.1 Kuwait Biopharmaceutical Excipients Market, 2021 - 2033 (USD Million) (Volume In Tons)
5.6.5.2 Key Country Dynamics
5.6.5.3 Regulatory Framework
5.6.5.4 Reimbursement Scenario
Chapter 6 Biopharmaceutical Excipients Market: Competitive Landscape
6.1 Company Categorization
6.2 Strategy Mapping
6.2.1 New product launch
6.2.2 Partnerships
6.2.3 Acquisition
6.2.4 Collaboration
6.2.5 Funding
6.3 Company Market Share Analysis, 2022
6.4 Company Profiles
6.4.1 MERCK KGAA
6.4.1.1 Company overview
6.4.1.2 Financial performance
6.4.1.3 Product benchmarking
6.4.1.4 Strategic initiatives
6.4.2 SIGNET EXCIPIENTS PVT. LTD.
6.4.2.1 Company overview
6.4.2.2 Financial performance
6.4.2.3 Product benchmarking
6.4.2.4 Strategic initiatives
6.4.3 Sigachi Industries Pvt. Ltd
6.4.3.1 Company overview
6.4.3.2 Financial performance
6.4.3.3 Product benchmarking
6.4.3.4 Strategic initiatives
6.4.4 ASSOCIATED BRITISH FOODS
6.4.4.1 Company overview
6.4.4.2 Financial performance
6.4.4.3 Product benchmarking
6.4.4.4 Strategic initiatives
6.4.5 SPECTRUM CHEMICAL MANUFACTURING CORP.
6.4.5.1 Company overview
6.4.5.2 Financial performance
6.4.5.3 Product benchmarking
6.4.5.4 Strategic initiatives
6.4.6 ROQUETTE FRÈRES
6.4.6.1 Company overview
6.4.6.2 Financial performance
6.4.6.3 Product benchmarking
6.4.6.4 Strategic initiatives
6.4.7 DFE PHARMA
6.4.7.1 Company overview
6.4.7.2 Financial performance
6.4.7.3 Product benchmarking
6.4.7.4 Strategic initiatives
6.4.8 CLARIANT
6.4.8.1 Company overview
6.4.8.2 Financial performance
6.4.8.3 Product benchmarking
6.4.8.4 Strategic initiatives
6.4.9 COLORCON
6.4.9.1 Company overview
6.4.9.2 Financial performance
6.4.9.4 Product benchmarking
6.4.9.5 Strategic initiatives
6.4.10 RETTENMAIER & SÖHNE GMBH + CO KG
6.4.10.1 Company overview
6.4.10.2 Financial performance
6.4.10.3 Product benchmarking
6.4.10.4 Strategic initiatives
6.4.11 BASF SE
6.4.11.1 Company overview
6.4.11.2 Financial performance
6.4.11.3 Product benchmarking
6.4.11.4 Strategic initiatives
6.4.12 EVONIK INDUSTRIES AG
6.4.12.1 Company overview
6.4.12.2 Financial performance
6.4.12.3 Product benchmarking
6.4.12.4 Strategic initiatives
6.4.13 IMCD
6.4.12.1 Company overview
6.4.12.2 Financial performance
6.4.12.3 Product benchmarking
6.4.12.4 Strategic initiatives
Chapter 7 KOL Recommendations/Analyst Perspective
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
(Upto 5 With No Cost)
Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers