US Advanced Therapy Medicinal Products (ATMPs) Market Analysis

US Advanced Therapy Medicinal Products (ATMPs) Market Executive Summary

It is anticipated that the US Advanced Therapy Medicinal Products (ATMPs) market will increase from $4.3 Bn in 2022 to $9.8 Bn by 2030, recording a CAGR of 11% over the forecast period of 2022-30.

Innovative therapies known as advanced therapy medicinal products (ATMPs) employ living cells, tissues, or genes to treat or cure illness. Due to the fact that they provide a fresh approach to treating complicated and life-threatening illnesses, these treatments are gaining popularity in the US. One of the major markets for ATMPs in the world, the US market is anticipated to expand dramatically over the coming few years.

The rising incidence of chronic illnesses including cancer, diabetes, and cardiovascular diseases is one of the main factors boosting the US ATMPs market. ATMPs provide a promising novel therapeutic strategy for the treatment of many disorders, which frequently require long-term care. Likewise, the potential for ATMPs to treat genetic abnormalities has expanded as a result of developments in gene editing tools like CRISPR/Cas9.

By establishing a regulatory environment that promotes the development of these treatments, the US Food and Drug Administration (FDA) has also significantly contributed to the expansion of the ATMPs industry. The FDA has expedited the approval procedure for these treatments and created a specialized office to supervise the creation and approval of ATMPs.

The US ATMPs market is divided into 3 product categories:

• Tissue engineering
• Cell therapy, and
• Gene therapy

The largest category is gene therapy, which has the ability to treat genetic illnesses by changing or replacing defective genes. Cell therapy, which uses live cells to replace or repair damaged tissues, is another important subsegment.

Notwithstanding the potential advantages of ATMPs, the US market faces a number of difficulties. Several of these medicines require specific manufacturing procedures, and their development is frequently time-consuming and costly. Access to these treatments may also be hampered by their high cost, and certain ATMPs' long-term effectiveness and safety have been questioned.

As these novel medicines provide a fresh approach to treating complicated and life-threatening illnesses, the US ATMPs market is anticipated to expand significantly over the next years. To guarantee the long-term viability of these medicines, the industry will need to solve a number of issues.

Market Dynamics

Market Growth Drivers

1. Chronic diseases are becoming more common: One of the main factors propelling the market for ATMPs is the increased incidence of chronic illnesses including cancer, diabetes, and cardiovascular conditions. A potential new method of treating these disorders is provided by ATMPs.
2. Improvements in gene editing technologies: The market is expanding as a result of the greater potential for ATMPs to treat genetic illnesses brought about by advances in gene editing technologies like CRISPR/Cas9
3. Support from the FDA: The FDA has created a legal framework that promotes the creation of ATMPs, which is fueling the market expansion
4. Rising R&D expenditures: The market is anticipated to rise as a result of rising R&D expenditures on ATMPs

Competitive Landscape

Key Players

• Novartis International AG
• Gilead Sciences, Inc.
• Bluebird Bio, Inc.
• Spark Therapeutics, Inc.
• Kite Pharma, Inc.
• Celgene Corporation
• Editas Medicine, Inc.
• Sangamo Therapeutics, Inc.
• Intellia Therapeutics, Inc.
• CRISPR Therapeutics AG

These companies are among the leading developers and manufacturers of advanced therapy medicinal products in the United States. They are involved in the development of innovative treatments for a variety of diseases and conditions using cutting-edge technologies such as gene therapy, cell therapy, and gene editing. These companies are also investing heavily in research and development to bring new treatments to market and meet the growing demand for advanced therapies

Healthcare Policies and Regulatory Landscape

The American healthcare regulatory and policy environment is complicated and ever-changing. The following are some crucial elements of the healthcare policy and regulatory environment.

1. Affordable Care Act (ACA): To increase access to healthcare and lower healthcare costs, the Affordable Care Act, popularly known as Obamacare, was passed in 2010. It contains clauses like the individual mandate, which makes it mandatory for people to obtain health insurance and the creation of health insurance marketplaces.
2. Both Medicaid and Medicare Millions of Americans are covered by the government-funded healthcare programs Medicare and Medicaid. Although Medicaid covers low-income individuals and families, Medicare covers the elderly and those with certain impairments.
3. FDA guidelines: To assure their efficacy and safety, the FDA oversees pharmaceuticals, medical devices, and other healthcare items. Obtaining FDA clearance might take a while and be expensive, but it is required to launch innovative medications.
4. The Health Insurance Portability and Accountability Act (HIPAA), which was passed in 1996, establishes guidelines for safeguarding the confidentiality and privacy of patient health information. Moreover, it has clauses that address patient notification in the case of a data breach.
5. Value-based care is a type of healthcare delivery that places an emphasis on enhancing patient outcomes while cutting costs. It entails leveraging data to enhance the delivery of care and matching provider incentives with patient results.