Dublin, April 20, 2026 (GLOBE NEWSWIRE) — The “Biopharmaceutical Excipients Market (2nd Edition): Industry Trends and Global Forecasts: Distribution by Scale of Operation, Type of Modality, Type of Excipient, Chemical Components, Company Size, Source of Manufacturing, End User and Geographical Regions” report has been added to ResearchAndMarkets.com’s offering.
The global biopharmaceutical excipients market is estimated to grow from USD 3.6 billion in the current year to USD 6.3 billion by 2035, at a CAGR of 6.4% during the forecast period, till 2035
Over the years, the increasing popularity of biologics has resulted in a significant shift within the healthcare sector. In the past ten years, the annual rate of biopharmaceutical approvals (which includes monoclonal antibodies, recombinant proteins, vaccines, and gene therapies) by the USFDA has consistently risen, with biologics accounting for over 40% of all newly approved drugs.
As of October 2024, there are more than 12,700 biologic products undergoing clinical trials globally, emphasizing the level of innovation in this area. Considering their unique advantages over small molecules such as improved efficacy, precise targeting, and better safety profiles, biologics are projected to continue propelling advancements in treatments for cancer, autoimmune diseases, rare disorders, and genetic conditions. Nevertheless, biologics possess a complex structure and are naturally less stable than small molecules, making them susceptible to physical degradation (such as aggregation, precipitation, and denaturation) and chemical degradation (including oxidation, deamidation, and hydrolysis).
To overcome these challenges, various biopharmaceutical excipients, such as sugars (including sucrose and trehalose), amino acids (such as arginine), surfactants (for example, polysorbates), and polymeric agents (like PEGs), are employed to stabilize formulations, increase solubility, regulate pH and tonicity, and enhance overall bioavailability. In fact, more than 70% of marketed biologics depend on polysorbates as stabilizing agents, while bulking agents, antioxidants, and preservatives enhance their functional effectiveness.
Further, excipients have become essential for facilitating advanced drug product formats, including lyophilized vials, prefilled syringes, and ready-to-use liquid formulations. Ongoing innovations, especially in lipid-based excipients for mRNA vaccines and therapeutics, are expanding the landscape of excipients even further. Combined with the increasing tendency towards outsourcing and enhanced regulatory support for innovative excipients, the application of biopharmaceutical excipients is set for continued market growth throughout the forecast period.
BIOPHARMACEUTICAL EXCIPIENTS MARKET: KEY SEGMENTS
Commercial Scale of Operation Accounts for the Largest Share of Biopharmaceutical Excipients Market
In terms of scale of operation, the biopharmaceutical excipients market is segmented across preclinical / clinical and commercial scale. In the current year, the commercial scale segment occupies the higher biopharmaceutical excipients market share (close to 90%) and is likely to grow at a higher CAGR (6.8%) during the forecast period. This dominance is fueled by the increased demand for biologics, necessitating substantial amounts of excipients to maintain product stability, solubility, and efficacy during large-scale production. With an increasing number of biologic drugs moving into commercial manufacturing phases, the demand for excipients rises significantly, leading to a larger market share for commercial-scale operations.
Solid Tumors Segment to Hold the Highest Revenue in the Biopharmaceutical Excipient Market
In the current year, antibodies segment constitutes most of the biopharmaceutical excipient market size (around 50%) and is likely to grow at a higher CAGR (8.7%) during the forecast period. This results from the swift expansion and mass manufacturing of monoclonal antibodies and antibody-driven therapies, necessitating various excipients to maintain the stability, solubility, and safety of these intricate biologics.
Europe Accounts for the Largest Share of the Biopharmaceutical Excipients Market
In terms of geographical regions, Europe is likely to capture majority (35%) of the biopharmaceutical excipients market share in the current year, and this trend is unlikely to change in the future as well. This results from the significant presence of well-established biotech and pharmaceutical firms in the sector. The focus of major industry leaders drives substantial funding and speeds up the integration of AI technologies in pharmaceutical production. Further, this sector gains advantages from its developed pharmaceutical ecosystem, strong R&D capacities, and favorable regulatory framework, which enhances its leading position. Significantly, the Asia-Pacific market is expected to expand to the highest CAGR (7.7%) throughout the forecast period until 2035.
BIOPHARMACEUTICAL EXCIPIENTS MARKET: KEY INSIGHTS
- The current market landscape features the presence of close to 60 manufacturers that claim to offer services for biopharmaceutical excipients across the world; of these, majority (40%) are headquartered in Europe.
- Close to 50% of the companies manufacture polymer-based biopharmaceutical excipients; of these, majority (~65%) of the excipients are being used as stabilizers in drug formulations.
- Stakeholders are actively upgrading their existing capabilities in order to enhance their respective portfolios and gain a competitive edge over other players active in the biopharmaceutical excipients manufacturing domain.
- Majority of the deals inked in this domain were distribution agreements, indicating a strategic focus on expanding market reach and ensuring broad availability of specialized excipients across diverse geographic regions.
- Driven by the growing demand for biologics, CMOs have significantly expanded their existing capacities and capabilities; notably, majority of the expansion initiatives have been undertaken by players based in Europe.
- Our proprietary framework serves as a strategic tool for developers, enabling them to evaluate vendors based on their specific requirements for biopharmaceutical excipients manufacturing.
- Driven by the growing adoption of biologic therapies, innovations in multifunctional excipients, the biopharmaceutical excipients market is anticipated to witness robust growth in the coming years.
- Currently, majority of the market share is captured by antibodies subsegment owing to the widespread use of monoclonal antibodies, which play a vital role in targeted therapies for cancer, autoimmune, and infectious diseases.
- Carbohydrates sub-segment is estimated to capture most of the market share in the current year, due to the extensive use of starch, sucrose, and dextrose in drug formulations as stabilizers and bulking agents for biologics.
REASONS TO BUY THIS REPORT
- The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
- Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
- The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
COMPANIES FEATURED
- A&C Bio Buffer
- ABITEC
- Actylis
- Additive Manufacturing Customized Machines (AMCM)
- Aditya Chemicals
- ADM
- Advancion (formerly known as ANGUS Chemical)
- AmpTec
- Apothecon Pharmaceuticals
- Asahi Kasei
- Ashland
- Avanti Research
- Avantor
- Azelis
- Barentz
- BASF Pharma
- BENEO
- BIOGRUND
- BioNTech
- BioSpectra
- BOC Sciences
- Bonumose
- Brenntag
- Budenheim
- Cascade Chemistry (acquired by Actylis)
- CG Chemkalien
- c-LEcta
- Cole-Parmer
- Colorcon
- Corden Pharma
- CPI
- Crest Cellulose
- Croda
- DFE Pharma
- DKSH
- Dr. Paul Lohmann
- DuPont
- DURECT
- Enmex
- Erkang Pharmaceutical
- Evonik
- Finar
- Fuji Chemical
- Gangwal Healthcare
- Gattefosse
- Gelita
- Harro Hofliger
- Hawkins
- HOPAX
- Hosokawa Micron
- Ideal Cures
- IFF Pharma Solutions
- IMCD
- IMCoPharma
- Indchem International
- InnoCore Pharmaceuticals
- International Flavors & Fragrances
- InVitria
- Itacel
- JRS Pharma
- Kerry
- Kirsch Pharma
- KLK Kolb
- Kuraray
- Larodan
- Lazuline Biotech
- LBB Specialties
- Lipoid
- Lubrizol
- LyoHUB
- Maas Pharma Chemicals
- Meggle
- Merck KGaA
- Mitushi Biopharma
- Moderna
- Nagase Viita
- National Institute of Bioprocessing Research and Training (NIBRT)
- Nordic Bioproducts
- Nordmann
- PanReac AppliChem
- PCAS
- Pfanstiehl
- Pfizer
- Polykon Manufacturing
- Qualicaps
- ReForm Biologics
- Roquette
- Seppic
- Shanghai Huamao Pharmaceutical
- Shin-Etsu Chemical
- Sigachi
- Spectrum Chemical Manufacturing
- SPI Pharma
- Stanford University
- Sudeep Pharma
- TaBlitz
- Thermo Fisher Scientific
- Tomita
- TTY Biopharm
- Univar Solutions
- VAV Life Sciences
- Vikram Thermo
- Wilshire Technologies
MARKET SCOPE
Scale of Operation
- Preclinical / Clinical Scale
- Commercial Scale
Type of Modality
- Antibodies
- Vaccines
- Cell and Gene Therapies
- Proteins / Peptides
- Other Biologics
Type of Excipients
- Buffering Agents
- Lyoprotectant Agents
- Solubilizers and Surfactants
- Tonicity Agents
- pH Adjusting Agents
- Others
Chemical Components
- Carbohydrates
- Polymers
- Polyols
- Proteins / Amino Acids
- Others
Company Size
- Small Players
- Mid-sized Players
- Large and Very Large Players
Source of Manufacturing
- In-house
- Outsourcing
End User
- Contract Manufacturers
- Drug Developers
- Hybrid Players
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Middle East and North Africa
- Latin America
ADDITIONAL BENEFITS
- Complimentary PPT Insights Packs
- Complimentary Excel Data Packs Covering All Analytical Modules
- Up to 15% Complimentary Content Customization
- In-Depth Report Walkthrough with the Research Team
- Complimentary Report Update if the Report is 6+ Months Old
For more information about this report visit https://www.researchandmarkets.com/r/qhe5xz
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