Biopharmaceutical Excipients Market

Biopharmaceutical Excipients Market: Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Biologics (Antibodies, Vaccines, Cell Therapies and Other Biologics), Type of Excipient (Carbohydrates, Polymers, Solubilizers / Surfactants, Polyols, Proteins / Amino Acids and Others), Company Size (Small, Mid-sized, Large / Very Large), Scale of Operation (Preclinical, Clinical and Commercial) and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World)

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Biopharmaceutical Excipients Market Size Overview

The global biopharmaceutical excipients market size is estimated to grow from USD 2.73 billion in 2024 to USD 4.58 billion by 2035, representing a CAGR of 4.8% during the forecast period 2024-2035. 

Biopharmaceutical Excipients Market, By Type of Biologics (USD Billion)

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Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapy), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide. Given the evident benefits of biologics over small molecule drugs (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is poised to witness continued and consistent growth over the next several years.

However, biological therapeutics are inherently less stable than small molecules and, hence, more prone to degradation by several physical and chemical degradation mechanisms. Therefore, a variety of pharmaceutical excipients for biologics, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Furthermore, pharmaceutical excipients for biologics play a critical role in biologics development by enhancing the solubility and bioavailability, controlling pH and tonicity of the active pharmaceutical ingredients (APIs). Additionally, biopharmaceutical excipients act as bulking agents, antioxidants or preservatives. As a result, the demand for pharmaceutical excipients for biologics has grown considerably. With outsourcing being increasingly accepted as a viable and beneficial business model, we anticipate the biopharmaceutical excipients market to witness steady market growth during the forecast period.

Biopharmaceutical Excipients Market Scope

The market research report presents an in-depth analysis of the various companies that are engaged in the global market for biopharmaceutical excipients, across different segments, as defined in the table below:

Global Biopharmaceutical Excipients Market: Report Attributes / Market Segmentations

Key Report Attribute Details
Historical Trend 2018-2022
Base Year 2023
Forecast Period 2024-2035
Market Size 2024 $ 2.7 Billion
CAGR 4.8%
Type of Biologics
  • Antibodies
  • Vaccines
  • Cell Therapies
  • Other Biologics
Type of Excipient
  • Carbohydrates
  • Polymers
  • Solubilizers / Surfactants
  • Polyols, Proteins / Amino Acids
  • Others
Company Size
  • Small, 
  • Mid-sized
  • Large / Very Large
Scale of Operation
  • Preclinical
  • Clinical
  • Commercial
Key Geographies
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middel East and North Africa
  • Rest of the World
Key Companies Profiled
  • ABITEC
  • Avantor
  • BASF Pharma
  • Corden Pharma
  • DFE Pharma
  • Evonik
  • Kirsch Pharma
  • Merck KGaA
  • Pfanstiehl
  • Roquette
  • Spectrum Chemical Manufacturing
  • SPI Pharma 
(Full list of 70+ companies captured is available in the report)
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  • Market Landscape Analysis
  • Company Competitiveness Analysis
  • Partnerships and Collaborations
  • Recent Expansions
  • Capacity Analysis
  • Market Forecast and Opportunity Analysis

One of the key objectives of this market report was to estimate the current market size, opportunity and the future market growth potential of biopharmaceutical excipients market, over the forecast period. We have provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the current and forecasted opportunity across various segments, such as type of biologics (antibodies, vaccines, cell therapies and other biologics), type of excipient (carbohydrates, polymers, solubilizers / surfactants, polyols, proteins / amino acids and others), company size (small, mid-sized, large / very large), scale of operation (preclinical, clinical and commercial) and key geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World).

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the biopharmaceutical excipients market growth.

All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Insights of Biopharmaceutical Excipients Market

The “Biopharmaceutical Excipients Market: Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Biologics (Antibodies, Vaccines, Cell Therapies and Other Biologics), Type of Excipient (Carbohydrates, Polymers, Solubilizers / Surfactants, Polyols, Proteins / Amino Acids and Others), Company Size (Small, Mid-sized, Large / Very Large), Scale of Operation (Preclinical, Clinical and Commercial) and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World)” market report features an extensive study of the current market landscape, market size, market share, market analysis, market forecast and future opportunities for the biopharmaceutical excipient manufacturers. The report highlights the efforts of several players engaged in this rapidly emerging market segment of the pharmaceutical industry. Key takeaways of the biopharmaceutical excipients market analysis are briefly discussed below.

Current Biopharmaceuticals Excipients Market Landscape

Presently, there are several contract manufacturers that claim to have the required capabilities to manufacture a variety of biopharmaceutical excipients, including lipids, lactose, trehalose, mannitol, succinate, Tween 20 and benzyl alcohol. These companies are increasingly focusing on the development of co-processed multifunctional biopharmaceutical excipients to improve the stability and effectiveness of novel biotherapeutics.

At present, North America emerged as the hub for manufacturers engaged in the biopharmaceutical excipients market, with over 35% of the players established in the region.

Market Drivers Analysis: Increasing Complexity of Biologics is Driving Demand for Novel Excipients

For some of the biopharmaceutical excipients, such as lipids, the associated manufacturing processes are highly complex, capital-intensive and fraught with multiple challenges. Some of the major issues related to the production of GMP grade biopharmaceutical excipients include the need for specialized expertise, lack of facilities with the necessary infrastructure and capacity to produce the required quality of substances, as well as concerns related to storage, safety and efficacy. Additionally, as the drug modalities are becoming more complex, so is the need for novel excipients. The excipient manufacturers are stepping up to meet the industry demand. In October 2023, Clariant launched a new range of excipients at CPHI Barcelona. The excipients are aimed at improving stability and solubility of APIs.

Considering the technical and routine operations-related challenges, an increasing number of biologics developers are increasingly relying on biopharmaceutical excipient manufacturers.  The benefits of engaging such third-party service providers are numerous; for instance, contracting a supplier for medical grade biopharmaceutical excipients enables sponsors to leverage specialty biopharmaceutical excipients (available with the manufacturers), access larger capacities and achieve greater operational flexibility.

Biopharmaceutical Excipients Market Trends Analysis: Strategic Alliances are Driving the Overall Partnership Activity

It is worth highlighting that biopharmaceutical excipient manufacturers are actively trying to consolidate their presence in biopharmaceutical excipient market by entering into strategic alliances. They are striving to enhance their respective manufacturing capabilities in order to meet the growing demand for pharmaceutical excipients for biologics. In fact, recently, a number of deals were inked between vaccine developers and biopharmaceutical excipient manufacturers in order to cater to the urgent need for lipids for the formers’ respective coronavirus preventive vaccines (COVID-19 vaccines).

Market Size Analysis: As a Hub for Biopharmaceutical Excipient Manufacturers, North America Will Continue to Hold the Largest Market Share

The global opportunity for biopharmaceutical excipient manufacturers is projected to reach $4.58 billion by 2035. As mentioned before, 35% of the manufacturers are based in North America. This will ensure the dominance of this region in the overall market. A number of biopharmaceutical excipient manufacturers based in the region are also expanding their manufacturing capacities to meet the rising demand. In May 2023, Croda broke ground on a new manufacturing facility for pharmaceutical excipients in Lamar, Pennsylvania. A few months before, in March 2023, Evonik, a lipid CMO, began construction of a pharmaceutical lipid manufacturing facility in Indiana, US to increase the global supply of functional excipients for RNA medicines.

Key Companies Involved in Biopharmaceuticals Excipients Market

Examples of key biopharmaceutical excipients industry (which have also been profiled in this market report; the complete list of companies is available in the full report) include ABITEC, Avantor, BASF Pharma, Corden Pharma, DFE Pharma, Evonik, Kirsch Pharma, Merck KGaA, Pfanstiehl, Roquette, Spectrum Chemical Manufacturing and SPI Pharma. This market report includes an easily searchable excel database of all the biopharmaceutical excipients market companies, worldwide.

Biopharmaceutical Excipients Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market research report includes:

  • A preface providing an introduction to the full report, Biopharmaceutical Excipients Market: Industry Trends and Global Forecasts, till 2035.
This image highlights the context of Biopharmaceutical Excipient Manufacturing Market report. The demand for biopharmaceutical excipients has grown considerably in the past few years; they play a critical role in biologics development by enhancing the solubility and bioavailability, controlling pH and tonicity of the active pharmaceutical ingredients (APIs) This image provides list of Biopharmaceutical Excipient Manufacturers. Presently, around 45 players claim to provide various types of biopharmaceutical excipients to biologic developers; these companies operate in compliance to global regulatory standards This image presents the geographical distribution of the players engaged in the Biopharmaceutical Excipient Manufacturing Market. In order to cater to the evolving needs of sponsors, companies offering biopharmaceutical excipients have established their presence in various geographical regions

 

  • An outline of the systematic research methodology adopted to conduct the study on biopharmaceutical excipients, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An executive summary of the key insights captured during our research, offering a high-level view on the current landscape of the biopharmaceutical excipients market and their likely evolution in the short to mid and long term.
  • A detailed assessment of the current landscape of engaged in offering biopharmaceutical excipients, along with information on their year of establishment, company size (in terms of employee count), location of headquarters, location of manufacturing facilities, type of excipient (based on chemical composition (carbohydrates, polyols, polymers, proteins / amino acids, salts, lipids, and others), based on function (surfactants, stabilizers, tonicity modifiers, bulking agents, buffering agents, solubility enhancers, drug delivery system, chelators, antimicrobials, antioxidants and others), based on chemical structure (organic and inorganic)), scale of operation (preclinical, clinical and commercial),  type of formulation (liquid or parenteral and solid), type of biologic (vaccines, proteins / peptides, cell therapies, antibodies and blood products) and global regulatory compliance (United States Pharmacopoeia / United States Pharmacopoeia-National Formulary, European Pharmacopoeia, Japanese Pharmacopoeia, British Pharmacopoeia, China Pharmacopoeia, American Chemical Society grade, Indian Pharmacopoeia, Food Chemical Codex and Taiwan FDA).
  • An in-depth competitiveness analysis of the biopharmaceutical excipient manufacturers, based on supplier power (in terms of years of experience), company competitiveness (type of excipient based on chemical composition, function, chemical structure, and based on scale of operation, type of formulation, type of biologic, global regulatory compliance) and number of manufacturing facilities.
This image highlights the current market trend of the Biopharmaceutical Excipient Manufacturing Market. The market landscape is fragmented, featuring the presence of both established players and new entrants involved in the manufacturing of excipients for different types of biologics This image presents the competitive landscape of the players engaged in the Biopharmaceutical Excipient Manufacturing domain. Companies are steadily expanding their existing capabilities in order to enhance their respective portfolios and drive compliance to evolving industry benchmarks This image highlights the partnership activities of this domain. A rise in partnerships, focused on biopharmaceutical excipients, validate the growing interest in this domain; maximum number of such deals were signed in 2021

 

  • Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) engaged in biopharmaceutical excipients market. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key executives), financial information (if available), details related to its biopharmaceutical excipients portfolio, manufacturing facilities, recent developments, and an informed future outlook.
  • An analysis of recent partnerships inked between stakeholders engaged in biopharmaceutical excipients market, during the period 2016-2021, covering distribution agreements, acquisitions, supply agreements, product development agreements, asset acquisitions, research and development agreements, manufacturing agreements, service alliances and other related agreements.
  • A detailed analysis of the recent expansions undertaken by various biopharmaceutical excipient manufacturers, based on several relevant parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), company size (small, mid-sized, large and very large companies), location of headquarters, location of expanded facility, type of excipient, type of drug molecule, most active players (in terms of number of recent expansions) and geographical distribution (region-wise and country-wise).
  • 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 company size (small, mid-sized, large and very large companies), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, and Asia-Pacific).
  • A detailed biopharmaceutical excipients market forecast analysis in order to estimate the existing market size and future opportunity during the forecast period. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the forecast period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of type of biologics (antibodies, vaccines, cell therapies and other biologics), type of excipient (carbohydrates, polymers, solubilizers / surfactants, polyols, proteins / amino acids and others), company size (small, mid-sized, large / very large), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and rest of the world).
This image highlights the estimate of the global installed capacity for biopharmaceutical excipients. The supply-side of this market is driven by mid-sized and large biopharmaceutical excipient manufacturers; interestingly, close to 40% of the currently available capacity is installed in production plants located in Europe This image presents the likely growth scenario of Biopharmaceutical Excipient Manufacturing domain. With the growing focus on biologics based therapeutic interventions, the biopharmaceutical excipients market is likely to grow at a steady pace over the next decade This image highlights the market segments of Biopharmaceutical Excipient Manufacturing domain. The opportunity is expected to be segregated across a variety of biologics, scales of operation and key geographical regions


Recent Developments in Biopharmaceutical Excipients Market

Several recent developments have taken place in the biopharmaceuticals excipients industry, some of which have been outlined below.

  • In July 2023, Roquette acquired Qualicaps with an aim to strengthen its knowledge and expertise in the development of pharmaceutical excipients. 
  • In June 2023, Lubrizol Corporation entered into a licensing agreement with Welton Pharma in order to allow Welton to use the Apisolex excipient across the various regions with an aim to develop and commercialize a novel formulation of SN-38 to treat colorectal and associated gastro-intestinal cancers. 
  • In March 2023, Evonik announced the expansion of its global-scale production facility for pharmaceutical specialty lipids in Lafayette, US, with an aim to secure the industry’s access to critical excipients needed for mRNA vaccines and other nucleic acid therapies.

 

Frequently Asked Questions

Question 1: What are biopharmaceutical excipients?

Answer: Biopharmaceutical excipients are organic molecules which are formulated along with various biopharmaceuticals, including monoclonal antibodies, recombinant proteins, vaccines and gene therapies, in order to improve stability of the therapeutic.

Question 2: How big is the biopharmaceutical excipients market?

Answer: The biopharmaceutical excipient market size is estimated to be worth $2.73 billion in 2024.

Question 3: What is the projected market growth of the biopharmaceutical excipients market?

Answer: The biopharmaceutical excipients industry is expected to grow at compounded annual growth rate (CAGR) of 4.8% during the forecast period 2024 - 2035.

Question 4: Who are the leading manufacturers in the biopharmaceutical excipients industry?

Answer: ABITEC, Avantor, BASF Pharma, Corden Pharma, DFE Pharma, Evonik, Kirsch Pharma, Merck KGaA, Pfanstiehl, Roquette, Spectrum Chemical Manufacturing and SPI Pharma are some key companies engaged in biopharmaceutical excipient manufacturing.

Question 5: Which region has the maximum capacity of biopharmaceutical excipient manufacturing across the globe?

Answer: Presently, companies based in Europe capture close to 40% of the global biopharmaceutical excipient manufacturing capacity.

Question 6: Which region is the hub for biopharmaceutical excipient manufacturers?

Answer: North America emerged as the hub for manufacturers engaged in the biopharmaceutical excipients market, with over 35% of the players established in the region.

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