Hyaluronidase Market - Growth Drivers and Challenges
Growth Drivers
- Rise in chronic conditions: The increasing international incidence of autoimmune, retinopathy, diabetic, and cancer diseases is expanding the patient pool directly, which is positively driving the market globally. According to an article published by the CDC in October 2024, 3 in 4 adults in America are affected with at least 1 chronic disease, and more than half have 2 or more conditions. Besides, adults aged over 65 years constitute 90% of almost 1 chronic disorder, more than 75% midlife adults aged between 35 to 64 years have over 1 such condition, and 60% adults aged 18 to 34 years also comprise 1 condition, thus suitable for increasing the market’s demand.
- Containment in healthcare expenses: The presence of subcutaneous administration has reduced the burden on hospital-based infusion facilities, resulting in lowered overhead expenses, which is also uplifting the hyaluronidase market across different nations. For instance, as per the June 2025 PIB Government data report, in India, the Ayushman Bharat- Pradhan Mantri Jan Arogya Yojana (PM-JAY) readily caters to 55 crore people, with the provision of over 2.6 lakhs treatment options, amounting to Rs. 496 crores. This particularly caters to the elderly population, thereby determining a massive growth opportunity for the market.
- Tactical pharma-based partnerships: The aspect of licensing drug delivery platforms proprietary by large-scale pharmaceutical organizations is also escalating the market’s development and commercialization. For instance, in March 2024, Zencore Biologics Co., Ltd. as well as Apeloa Pharmaceutical Co., Ltd entered into a strategic cooperation-based deal. This agreement deliberately covers collaborative research and development, suitable for initiating production in the Antibody-drug Conjugates (ADCs) field.
Payer’s Pricing Inputs of Different Drugs Uplifting the Hyaluronidase Market (2025)
|
Drug Type |
Commercial Price |
Medicare Price |
|
Daratumumab FASPRO (1,800 mg/15 mL) |
USD 5.8 per mg |
USD 5.1 per mg |
|
Lenalidomide (25 mg) |
USD 35.6 |
USD 35.6 |
|
Lenalidomide (10 mg; maintenance) |
USD 89.1 |
USD 89.1 |
|
Bortezomib (3.5 mg) |
USD 57.8 |
USD 22.2 |
Source: JMCP
Challenges
- Complicated manufacturing and high costs: The stable, consistent, and high-purity hyaluronidase production, especially the recombinant variant, is considered a technically capital-intensive and complex process. It demands strict quality controls, maintains adherence to good manufacturing practice standards, and a sophisticated biotechnology infrastructure, which has created an entry barrier in the hyaluronidase market. This directly contributes to the increased cost of the finalized product, thereby impacting the cost-effectiveness. For healthcare payers and systems, particularly in budget-based environments, these increased expenses can emerge as a significant barrier to widespread adoption and reimbursement.
- Reimbursement uncertainty and administrative obstacles: The regulatory pathway for the market, particularly when utilized as a drug delivery enhancement for the newest biologic, is regarded to be complex and varies significantly across different regions. Agencies, such as the EMA and FDA, demand expanded data to prove that hyaluronidases do not alter the efficiency, safety, or pharmacokinetics of the primary medication. Moreover, the aspect of achieving standard reimbursement is a major challenge, causing a hindrance in the market’s upliftment. In this regard, payers frequently struggle with classifying and paying for these combination therapies.
Hyaluronidase Market: Key Insights
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
15.2% |
|
Base Year Market Size (2025) |
USD 1.8 billion |
|
Forecast Year Market Size (2035) |
USD 6.4 billion |
|
Regional Scope |
|
Browse key industry insights with market data tables & charts from the report:
Frequently Asked Questions (FAQ)
In the year 2025, the industry size of the hyaluronidase market was over USD 1.8 billion.
The market size for the hyaluronidase market is projected to reach USD 6.4 billion by the end of 2035 expanding at a CAGR of 15.2% during the forecast period i.e., between 2026-2035.
The major players in the market are Roche AG, LG Chem Ltd., JW Life Science, Croma-Pharma GmbH, Gufic Biosciences Ltd., and others.
In terms of the product segment, the recombinant segment is anticipated to garner the largest market share of 68.7% by 2035 and display lucrative growth opportunities during 2026-2035.
The market in North America is projected to hold the largest market share of 38.2% by the end of 2035 and provide more business opportunities in the future.