Biopharmaceutical Excipients Market: Overview
As per Roots Analysis, the global biopharmaceutical excipients market is estimated to grow from USD 3.3 billion in the current year to USD 6.3 billion by 2035, at a CAGR of 6.6% during the forecast period, till 2035.
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
End User
- Contract Manufacturers
- Drug Developers
- Hybrid Players
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Middle East and North Africa
- Latin America
Biopharmaceutical Excipients Market: Growth and Trends
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 Insights
The report delves into the current state of the biopharmaceutical excipients market and identifies potential growth opportunities within the industry. Some key findings from the report include:
- 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.
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.
Example Players in the Biopharmaceutical Excipients Market
- Avantor
- Spectrum Chemical Manufacturing
- Actylis
- Pfanstiehl
- Biospectra
- BOC Sciences
- Merck KGaA
- CG Chemkalien
- Evonik
- BASF Pharma
- Mass Chemicals
- Gangwal
- Mitushi Biopharma
- Nagase Vitta
Biopharmaceutical Excipients Market: Research Coverage
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the biopharmaceutical excipients market, focusing on key market segments, including [A] type of modality, [B] type of excipient, [C] chemical components, [D] company size, [E] source of manufacturing, [F] end user and [G] key geographical regions.
- Market Landscape: A comprehensive evaluation of biopharmaceutical excipients companies, considering various parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] location of manufacturing facilities, [E] type of excipient, [F] scale of operation, [G] type of formulation, [H] type of biologic and [I] global regulatory compliance.
- Company Profiles: In-depth profiles of companies engaged in the manufacturing of biopharmaceutical excipients headquartered in North America, Europe and Asia-Pacific focusing on [A] company overview, [B] biopharmaceutical excipient offering, [C] recent developments and [D] an informed future outlook.
- Company Competitiveness Analysis: A comprehensive competitive analysis of biopharmaceutical manufacturers, examining factors, such as supplier strength, service strength and number of manufacturing facilities.
- Partnerships and Collaborations: A detailed analysis of the partnerships inked between stakeholders in the biopharmaceutical excipients market based on several relevant parameters, such as [A] year of partnership, [B] type of partnership, [C], year and type of partnership and [D], geographical distribution of partnership activity.
- Recent Expansions: A detailed analysis of the recent expansions undertaken by various biopharmaceutical excipient manufacturers, based on several relevant parameters, such as [A] year of expansion, [B] type of expansion, [C] type of excipient, [D] type of expansion (region and country), [E] location of expanded facility (region), [F] location of expanded facility (country), [G] most active players (in terms of number of recent expansions) and [H] geographical distribution (region and country).
- Capacity Analysis: An estimate of the global installed capacity for biopharmaceutical excipients taking into consideration the capacities of various biopharmaceutical excipient manufacturers, along with information on the distribution of available global biopharmaceutical excipient production capacity based on several relevant parameters, such as [A] company size, [B] scale of operation and [C] key geographical regions.
- Vendor Selection Framework: An insightful vendor selection framework highlighting the parameters that should be considered when outsourcing biopharmaceutical excipients manufacturing operations.
- Market Impact Analysis: In-depth analysis of the factors that can impact the growth of the biopharmaceutical excipients market. It also features identification and market analysis of [A] key drivers, [B] potential restraints, [C] emerging opportunities, and [D] existing challenges.
Key Questions Answered in this Report
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
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.
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- 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.
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