The global biologic excipient market is projected to be appraised at USD 2,241.8 million by 2034, up from USD 1500 million in 2024, advancing at a CAGR of 4.10% from 2024 to 2034.
The stabilization, solubilization, and improvement of biologic molecules' bioavailability are vital functions of biologic excipients, guaranteeing their safety and effectiveness during the production process and product lifespan.
Biotechnology breakthroughs, the growing biopharmaceutical pipeline, and the rising incidence of chronic illnesses are the main factors propelling the growth of the biologic excipients market.
The need for specialized excipients to improve the formulation and distribution of biologic drugs-which provide tailored therapy with fewer side effects-is being driven by the growing demand for these medications.
| Attributes | Key Insights |
|---|---|
| Market Size in 2024 | USD 1,500 million |
| Market Value in 2034 | USD 2,241.8 million |
| Value-based CAGR from 2024 to 2034 | 4.10% |
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From 2019 to 2023, the biologic excipient market experienced a CAGR of 3.90%. Over the projected period, a robust growth rate is anticipated in the biologic excipients market. This is because, among other things, excipients are frequently used in the creation of novel treatments and have the ability to increase the solubility of active ingredients in pharmaceuticals.
Furthermore, two key factors that are anticipated to fuel the expansion of the biologic excipients market during the projected period are the ongoing advancements in drug delivery technology and the prevalence of inflammatory and autoimmune diseases.
The development of new regulations, more financing opportunities, and more public-private collaborations drive the expansion of creative collaborative research prospects in pediatric formulations.
The development of flexible, dispersible, and multifunctional biologic excipients for use in pediatric oral solid and liquid formulations has taken precedence.
In addition, it is anticipated that in the upcoming years, demand for these excipients and oral formulations will be driven by pediatricians' continuous emphasis on unmet medical requirements. Projections indicate that the global biologic excipient market is expected to experience a CAGR of 4.10% from 2024 to 2034.
| Historical CAGR from 2019 to 2023 | 3.90% |
|---|---|
| Forecast CAGR from 2024 to 2034 | 4.10% |
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This section will detail the biologic excipient markets in key countries, including the United States, Germany, the United Kingdom, China, and India. This sector will emphasize the various reasons propelling the growth of the biologic excipient market in the countries mentioned below.
| Countries | Forecast CAGRs from 2024 to 2034 |
|---|---|
| The United States | 3.70% |
| Germany | 4.50% |
| The United Kingdom | 4.0% |
| China | 3.40% |
| India | 3.90% |
The biopharmaceutical sector in the United States is thriving, with many businesses producing, developing, and researching biologic medications. The need for specialized excipients to enhance the formulation and administration of biologic medicines is being driven by the rise in biotechnology investment and the number of biopharmaceutical businesses.
The biologic excipient market in the United States is expected to grow at a positive 3.70% CAGR over the assessment period.
Biologic medications are becoming more and more popular in the United States because of their ability to treat a wide range of complicated and chronic illnesses, including cancer, autoimmune diseases, and inflammatory problems.
Biologic medications are becoming more and more popular because they provide tailored therapy with fewer adverse effects than conventional small-molecule drugs. This has increased the demand for biologic excipients.
The United Kingdom is expected to surge at a 4.0%CAGR throughout the forecast period. In the fields of biotechnology and pharmaceuticals, scientific research and innovation are led by the United Kingdom.
United Kingdom companies and research organizations are actively developing novel excipients and drug delivery systems to enhance the efficacy and performance of biological medications.
Cutting-edge drug delivery technologies, including liposomes, nanoparticles, and polymer-based carriers, are driving up demand for specific excipients with special uses. The country's need for biologic excipients to enable the formulation and administration of biologic treatments is fueled in part by rising healthcare costs.
Germany is expected to surge at a 4.50%CAGR throughout the forecast period.
The growing aging population, the prevalence of chronic illnesses, and the availability of reputable facilities that offer high-quality care are the main factors driving the growth of the biologic excipients market in the country.
Furthermore, the German market will see a rise in demand for innovative excipients due to advantageous regulatory environments and rising investments in the development of biologics and sophisticated dosage forms.
The Chinese market is anticipated to hold a CAGR of 3.40% during the forecast period. The primary drivers of growth in China are the rise in R&D, instantaneously treating medications' availability, the healthcare sector's development, and the growing need for safe, effective medical practices and other therapies.
In addition, China has internal market influences, favorable government policies, changing regulations, and increasing funding, all of which impact both present and future market trends.
Biologic therapies are becoming increasingly well-liked among patients and healthcare professionals since they deliver customized treatments with better efficacy and safety profiles than traditional medications. The need for excipients that are specifically suited to their unique formulation needs is being driven by the growing market for biological medicines.
India's biologic excipient drug market is anticipated to hold a CAGR of 3.90% during the forecast period. The need for specialized excipients to enhance formulation and distribution has increased due to the rise of Indian biotech companies concentrating on developing biological drugs.
India's middle-class population and fast-increasing healthcare sector are driving up healthcare spending and driving up demand for novel cures.
Investment in biologic medications and excipients is fueled by government initiatives to increase insurance coverage and access to healthcare services. Excipients are in high demand as a means of facilitating the formulation and delivery of biologic medicines as a result of India's rising healthcare spending.
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The section below shows the leading segment. The polymers segment is expected to account for a market share of 30.10% in 2024. Based on application, the electricity segment is expected to have a share of 34.50%.
| Category | Market Share |
|---|---|
| Polymers | 30.10% |
| Biopharmaceutical Manufacturers | 65.70% |
The polymers segment emerged as the dominant force in the biologic excipient market, commanding 30.10% of the total market share in 2024. Because polymer excipients can be customized to fit the unique needs of biological medicinal products, they provide formulation designers with a great deal of versatility.
Polymers are useful for a variety of biological formulations because they can be tailored to provide a range of capabilities, including enhanced solubility, controlled release, stability of proteins, and protection against degradation.
By altering the pharmacokinetics and release profile of biologic medications, polymer excipients allow for more regulated and prolonged drug delivery. Targeted delivery to particular tissues or organs can be achieved by adding polymers into drug formulations, extending the therapeutic impact and lowering the dosing frequency.
Based on end-users, the biopharmaceutical manufacturers segment is expected to account for a market share of 65.70% in 2024. Biopharmaceutical producers use excipients to enhance biologic drug pharmacokinetics and biodistribution, as well as to optimize drug delivery systems.
Excipients have the potential to increase tissue targeting, reduce systemic adverse effects, and modify the kinetics of drug release, all of which can improve patient compliance and therapeutic outcomes.
The development of cutting-edge drug delivery systems, such as sustained-release formulations, liposomal carriers, and nanoparticle formulations, depends heavily on biologic excipients. To guarantee product safety, efficacy, and quality, regulatory bodies like the FDA and EMA place strict restrictions on the use of excipients in biologic medication formulations.
Manufacturers of biopharmaceuticals are required to choose excipients that meet regulatory requirements and provide proof of their compatibility through extensive testing and validation procedures.
Faster market entry and commercialization are made possible by excipients with known safety profiles and regulatory approvals, which streamline the regulatory approval process for biologic therapeutic products.
Companies in the biologic excipients industry are actively looking to bolster their positions through collaborations and acquisitions with established and up-and-coming competitors. Excipients are being produced in large quantities at local facilities by the manufacturers, who then sell them to biological drug producers at extremely low costs.
Leading companies in the field are concentrating on developing biologic excipients. Adopting IPEC principles is anticipated to encourage adherence to protocols, improving medicine efficacy and product safety in manufacturing and distribution.
| Attributes | Details |
|---|---|
| Estimated Market Size in 2024 | USD 1,500 million |
| Projected Market Valuation in 2034 | USD 2,241.8 million |
| Value-based CAGR 2024 to 2034 | 4.10% |
| Forecast Period | 2024 to 2034 |
| Historical Data Available for | 2019 to 2023 |
| Market Analysis | Value in USD million |
| Key Regions Covered | North America; Latin America; Western Europe; Eastern Europe; South Asia and Pacific; East Asia; The Middle East and Africa |
| Key Market Segments Covered | Excipients Type, End Users, Region |
| Key Countries Profiled | The United States, Canada, Brazil, Mexico, Germany, The United Kingdom, France, Spain, Italy, Russia, Poland, Czech Republic, Romania, India, Bangladesh, Australia, New Zealand, China, Japan, South Korea, GCC countries, South Africa, Israel |
| Key Companies Profiled | FMC Corporation; Wacker Chemie AG; Evonik Industries AG; Ashland Global Holdings Inc.; Archer-Daniels-Midland Co.; Roquette Freres S.A.; The Dow Chemical Company; Colorcon Inc.; Signet Chemical Co. Pvt. Ltd.; Sun Pharmaceutical Industries Ltd |
As of 2024, the market for biologic excipient is expected to be valued at USD 1,500 million.
By 2034, the market value of biologic excipient is expected to reach USD 2,214.8 million.
From 2024 to 2034, the biologic excipient market is expected to flourish at a CAGR of 4.10%.
The polymers segment is expected to account for a market share of 30.10% in 2024.
Germany is likely the top-performing markets, with a CAGR of 4.50%.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2019 to 2023 and Forecast, 2024 to 2034 5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Excipient Type 5.1. Polymers 5.2. Sugar Alcohols 5.3. Polysorbates 5.4. Inorganic Salts 5.5. Amino Acids 5.6. Surfactants 5.7. Others 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By End User 6.1. Biopharmaceutical Manufacturers 6.2. Contract Research Organizations 6.3. Contract Manufacturing Organizations 6.4. Research Organizations 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region 7.1. North America 7.2. Latin America 7.3. Western Europe 7.4. Eastern Europe 7.5. South Asia and Pacific 7.6. East Asia 7.7. Middle East and Africa 8. North America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 9. Latin America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 10. Western Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 11. Eastern Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 12. South Asia and Pacific Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 13. East Asia Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 14. Middle East and Africa Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 15. Key Countries Market Analysis 16. Market Structure Analysis 17. Competition Analysis 17.1. FMC Corporation 17.2. Wacker Chemie AG 17.3. Evonik Industries AG 17.4. Ashland Global Holdings Inc. 17.5. Archer-Daniels-Midland Co. 17.6. Roquette Freres S.A. 17.7. The Dow Chemical Company 17.8. Colorcon Inc. 17.9. Signet Chemical Co. Pvt. Ltd. 17.10. Sun Pharmaceutical Industries Ltd 18. Assumptions & Acronyms Used 19. Research Methodology
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Biologic Excipient Market
