Biopharmaceutical Excipient Manufacturing Market by Type of Biologics, Type of Excipient, Scale of Operation and Key Geographies: Industry Trends and Global Forecasts, 2022-2035

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 therapies), 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 excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Furthermore, excipients 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 biopharmaceutical excipients has grown considerably. However, 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. 

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. 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. It is worth highlighting that biopharmaceutical excipient manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances, enhance their respective manufacturing capabilities in order to meet the growing demand for excipients used in 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 COVID-19 vaccines. With outsourcing being increasingly accepted as a viable and beneficial business model within this field, we anticipate the biopharmaceutical excipient manufacturing market to grow at a steady pace in the coming years.

Scope of the Report

The ‘Biopharmaceutical Excipient Manufacturing Market 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, MENA, and RoW): Industry Trends and Global Forecasts, 2022-2035’ report features an extensive study of companies engaged in manufacturing of biopharmaceutical excipients. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

Amongst other elements, the report features:

• 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.
  
• Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) engaged in this domain. 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 this domain, 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).
  

One of the key objectives of the report was to evaluate the current opportunity and the future potential of the biopharmaceutical excipient manufacturing market, over the next 15 years. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of biologics (antibodies, vaccines, cell therapies and other biologics), [B] type of excipient (carbohydrates, polymers, solubilizers / surfactants, polyols, proteins / amino acids and others), [C] company size (small, mid-sized, large / very large), [D] scale of operation (preclinical, clinical and commercial) and [E] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and rest of the world). 

In order to account for future uncertainties in the market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

Key Questions Answered

• Who are the key players engaged in biopharmaceutical excipient manufacturing?
  
• Which global regions are considered as key hubs for biopharmaceutical excipient manufacturing?
  
• What type of partnership models are commonly adopted by stakeholders in this industry?
  
• What kind of expansion initiatives have been undertaken by biopharmaceutical excipient manufacturers? 
  
• What is current, global biopharmaceutical excipient manufacturing capacity of contract manufacturers?
  
• How is the current and future market opportunity likely to be distributed across key market segments?