Introduction to Tbo-Filgrastim
Tbo-filgrastim, a recombinant DNA-derived granulocyte colony-stimulating factor (G-CSF), is a biologic drug used to treat conditions such as neutropenia, particularly chemotherapy-induced neutropenia. It was approved in the United States in 2012 as a biologic, rather than a biosimilar, due to the absence of the FDA biosimilar approval pathway at that time[2].
Market Size and Growth
The global filgrastim market, which includes tbo-filgrastim, is projected to reach $953.4 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 8% during the forecast period. This growth is driven by several key factors, including an increase in the aging population and the rising incidence of chronic diseases such as cancer[1].
Key Drivers of Market Growth
Increase in Aging Population
The global increase in the geriatric population is a significant driver for the demand of biopharmaceuticals like tbo-filgrastim. Older individuals are more susceptible to chronic diseases, which often require treatments that can lead to neutropenia, a condition where tbo-filgrastim is particularly effective[1].
Growing Cases of Chronic Diseases
Chronic diseases, especially cancer, are on the rise globally. Cancer treatments often cause neutropenia, making tbo-filgrastim a crucial component in patient care. The increasing prevalence of these diseases fuels the demand for G-CSF treatments like tbo-filgrastim[1].
Cost Savings and Economic Implications
Comparative Cost Analysis
Tbo-filgrastim offers significant cost savings compared to the original filgrastim product. The wholesale acquisition cost of tbo-filgrastim is approximately 20% less than filgrastim, making it an attractive option for health systems and patients seeking to reduce healthcare costs[2].
Impact on Healthcare Spending
The introduction of biosimilars like tbo-filgrastim is expected to reduce drug costs, although to a lesser degree than seen with small-molecule generic drugs. Between 2013 and 2014, spending on specialty drugs, including biologics, increased by 32.4%, while spending on small-molecule drugs increased by only 6.8%. Biosimilars are anticipated to account for 4% to 10% of the global biologics market by 2020, providing a much-needed cost-saving measure[3].
Adoption and Uptake
Provider Differences
Studies have shown that the adoption rate of biosimilar filgrastim, including tbo-filgrastim, varies among different types of healthcare providers. Office-based providers have a higher adoption rate compared to outpatient hospital-based providers. After three years, biosimilar filgrastim claims rose to 60% among office-based providers and 49% among outpatient hospital providers[4].
Market Share
Tbo-filgrastim has gained significant market share since its introduction. It captured more than a 34% share of the short-acting G-CSF hospital market in the first 17 months after its US launch and is covered by more than 95% of payers. This rapid uptake is attributed to its existing clinical experience and lower cost[3].
Regulatory Environment
Approval Process
The approval process for biosimilars like tbo-filgrastim is complex and stringent. Different countries have different approval processes, which can be challenging for pharmaceutical companies. However, the FDA's biosimilar approval pathway has streamlined the process, allowing more biosimilars to enter the market[1].
Clinical Efficacy and Safety
Ensuring the efficacy and safety of biosimilars is a critical aspect of their adoption. Studies have shown that tbo-filgrastim is as effective and safe as the original filgrastim, which has helped in its widespread acceptance. For instance, a retrospective review of engraftment data for tbo-filgrastim versus filgrastim in patients undergoing high-dose chemotherapy showed comparable outcomes[5].
Regional Outlook
Global Market
The filgrastim market, including tbo-filgrastim, is analyzed across various regions such as North America, Europe, Asia Pacific, and Latin America, Middle East, and Africa (LAMEA). North America is the leading region, driven by developed healthcare infrastructure, supportive reimbursement policies, and the availability of research grants and funding. The Asia Pacific region is anticipated to display the fastest growth rate due to the rising number of cancer patients in emerging nations like China and India[1].
Challenges and Barriers
Stringent Government Regulations
One of the major challenges facing the market is the stringent government regulations and policies surrounding the approval of biosimilars. These regulations require extensive evidence to prove the efficacy and safety of the products, which can be a barrier to entry for new biosimilars[1].
Financial Implications
Despite the cost savings, the financial implications of adopting biosimilars can be complex. High-deductible health plans and increasing patient cost share can influence the decision to switch from branded agents to biosimilars. Payers must carefully consider the economic implications and potential cost-effectiveness of biosimilars in clinical practice[3].
Future Outlook
Increasing Adoption
The adoption of biosimilars like tbo-filgrastim is expected to increase as more biologic patents expire and regulatory guidelines become clearer. By 2020, several biologic product patents are scheduled to expire, paving the way for multiple biosimilars to enter the US market[3].
Economic Predictions
Biosimilars are predicted to account for a significant portion of the global biologics market, offering much-needed cost savings. The economic implications of biosimilars will continue to shape the market, with payers and providers refining their plan designs and formulary structures to incorporate these cost-effective alternatives[3].
Key Takeaways
- Market Growth: The global filgrastim market, including tbo-filgrastim, is expected to reach $953.4 million by 2027, driven by an aging population and rising chronic diseases.
- Cost Savings: Tbo-filgrastim offers a 20% cost reduction compared to filgrastim, making it an attractive option for cost-conscious health systems.
- Adoption Rates: Office-based providers have higher adoption rates of biosimilar filgrastim compared to outpatient hospital-based providers.
- Regulatory Environment: Stringent regulations pose a challenge, but the FDA's biosimilar approval pathway has facilitated the entry of more biosimilars.
- Future Outlook: Increasing adoption and expiring biologic patents will continue to drive the market for biosimilars like tbo-filgrastim.
FAQs
Q: What is the expected market size of the global filgrastim market by 2027?
A: The global filgrastim market is expected to reach $953.4 million by 2027[1].
Q: How does tbo-filgrastim compare in cost to filgrastim?
A: Tbo-filgrastim is approximately 20% less expensive than filgrastim in terms of wholesale acquisition cost[2].
Q: Which region is expected to display the fastest growth rate for the filgrastim market?
A: The Asia Pacific region is anticipated to display the fastest growth rate due to the rising number of cancer patients in emerging nations like China and India[1].
Q: What are the main drivers of the filgrastim market growth?
A: The main drivers include an increase in the aging population and the growing incidence of chronic diseases such as cancer[1].
Q: How does the adoption rate of biosimilar filgrastim vary among different healthcare providers?
A: Office-based providers have a higher adoption rate of biosimilar filgrastim compared to outpatient hospital-based providers[4].
Sources
- KBV Research: Filgrastim Market Size & Share, Trends Industry Trends, 2027.
- AJMC: The Switch From Filgrastim to a Cheaper Alternative: Tbo-Filgrastim.
- AJMC: The Economic Implications of Biosimilars.
- AJMC: Provider Differences in Biosimilar Uptake in the Filgrastim Market.
- FDA: Biosimilar Adoption & Barriers to Success: Current and Future Considerations.
