北米の遺伝子治療市場 – 2030 年までの業界動向と予測

北米の遺伝子治療市場の分析と洞察

北米の遺伝子治療市場は、市場プレーヤーの増加と高度なサービスや製品の利用可能性により、予測年度に成長すると予想されています。これに伴い、メーカーは市場に新しい製品を投入するための研究開発活動に取り組んでいます。

遺伝子治療とその技術および開発に関する研究の増加により、市場の成長がさらに促進されると予想されます。ただし、この方法を実行する際の倫理的および安全性の懸念により、予測期間中の北米の遺伝子治療市場の成長が妨げられると予想されます。遺伝子工学とヘルスケアの新興かつ先進的な分野である遺伝子治療の需要の増加により、市場に治療および診断アプローチを強化する機会がもたらされると予想されます。

がんや遺伝性疾患に対するより質の高い医療への需要の高まりが、市場の成長を後押しすると予想されます。しかし、診断コストの高さと熟練した資格のある専門家の不足が、市場の成長を阻むと予想されます。

Data Bridge Market Research の分析によると、北米の遺伝子治療市場は、予測期間中に 18.8% の CAGR で成長し、2030 年までに 134 億 1,896 万ドルに達すると予想されています。診断および治療におけるエキソソーム研究製品の使用が増加しているため、製品は市場で最も重要なタイプのセグメントを占めています。

北米遺伝子治療市場の定義

Gene therapy is a medical strategy that addresses the underlying genetic issue in order to treat or prevent disease. Instead of utilising drugs or surgery, gene therapy procedures allow doctors to treat a problem by changing a person's genetic composition. A select few disorders, including an eye condition called Leber congenital amaurosis and a muscle condition called spinal muscular atrophy, are being treated with gene therapy. To ensure that they will be secure and efficient, many other gene therapies are undergoing study. Medical professionals aim to soon apply the promising technique of genome editing to cure human illnesses.

The ability to successfully transport a therapeutic gene to a target cell is the most important prerequisite for gene therapy to be successful. Once transported, that gene must go to the cell wall's nucleus, where it will serve as a model for making protein molecules. The principal therapeutic action is then produced by the protein. For instance, cell destruction might be used in the treatment of tumours, whereas cell preservation might be used in the case of neurodegenerative illness. However, strict regulations and standards for the approval and commercialization of products is expected to restrain the market growth.

North America Gene Therapy Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:    

Drivers

• Novel approaches of gene therapy

Gene therapy has brought permanent cures for ailments that were previously simply temporary treatments. For a very long period, gene therapy did not work; however, in recent years, effective and long-lasting treated cases have been recorded. For a wide range of hereditary illnesses, including blood abnormalities, immunological deficiencies, vision issues, nerve cell regeneration, metabolic disorders, and different types of cancer, promising outcomes have been attained.

With more specificity and fewer side effects, gene therapy has the potential to be a customized medicine that can "cure" a variety of diseases. Gene therapy generally refers to the transfer of genetic material to treat an illness, or at the very least, to enhance a patient's clinical condition. Using viruses as genetic vectors to deliver the desired gene to the target cells is one method of how gene therapy functions. These vectors are classified as RNA-based or DNA-based viral vectors depending on the type of genome they contain.

The majority of experts concur that gene therapy has the potential to be the most intriguing use of DNA research to date. A simple intravenous injection of a gene transfer agent may one day be used to administer genes as medicine, seeking out target cells for stable, site-specific chromosomal integration and subsequent gene expression. It is predicted that there would be a need for gene therapy using revolutionary techniques that are being tested by researchers around the world and incorporated into conventional treatment is expected to act as driver for the growth of North America gene therapy market

• Increasing prevalance of genetic disorders

A sizable share of prenatal and neonatal mortality in several nations in the Region is caused by genetic and congenital diseases. Many multifactorial ailments are often caused by genetic factors as well. Gene alterations that are essentially present in every cell in the body cause many hereditary diseases. These illnesses thus frequently impact many bodily systems, and the majority cannot be treated.

For instance,

• The Department of Health indicated that roughly six out of ten people will be impacted by an ailment that has some genetic ties, according to the Government of Western Australia. Genetic disorders can range from minor to very severe. Between 3 and 5% of newborns born in Western Australia have genetic disorders or birth abnormalities

Mutations, exposure to chemicals and radiation, among other things, can all result in genetic disorders. Although some ailments have been treated with gene therapy, the majority of treatment plans for genetic disorders do not change the underlying genetic abnormality. For this, the prevalence of genetic abnormalities is significantly rising across all age groups and practically all geographic areas are expected to act as a driver for the growth of North America gene therapy market.

Restraint

• High cost of gene therapy

A new line of medical treatments called gene therapy involves replacing, deleting, or introducing genetic information into a patient's genome in order to treat a condition. Even though it is still in its infancy, gene therapy has already shown tremendous promise for the treatment and even cure of once-intractable illnesses. Gene therapy pricing is still highly uncontrolled and determined on a case-by-case basis in many nations, frequently focusing on a single upfront payment.

For instance,

• According to a news article published in Web MD in February 2023, Hemgenix is breaking records but is hardly an anomaly. In September 2022, Skysona, a medication for a rare neurological condition, went on sale for $3 million. Just one month prior, Zynteglo, a gene treatment for a genetic blood condition, made its market debut for $2.8 million. A cure for the genetic condition spinal muscular atrophy, which kills infants and young children, called Zolgensma cost $2.1 million in 2019.

Even if they are not always fully curative, gene therapies can be really transforming. The main barrier to accessing gene therapy is cost. The treatment landscape for many rare genetic illnesses will undergo significant change as additional gene therapy products become available, providing patients with potentially curative alternatives for the first time. The difficulty of making sure that all patients, not just a small group with financial means and privileged access to technology, may benefit from these cutting-edge therapies must be addressed by healthcare systems around the world. However, due to the high cost of the treatments

Opportunity

• Rise in strategic acquisition and partnership among organizations

Recently, different organizations are stepping forward for partnership and collaboration to develop various gene therapy products that are essential for detecting genetic disorders. Not only this, with the help of partnerships and agreements both the companies can develop a new suite of technologies and platforms that will help to detect diseases.

With the help of a long-term agreement, both companies can provide dimensional pricing of gene therapy products in response to consumer demand in the market. Such partnership and mutual agreement not only benefit both the companies but are also creating a lot of opportunities for the market to grow.

For instance,

• In July 2022, Novartis Pharmaceuticals UK announces the launch of the Novartis Biome UK Heart Health Catalyst 2022, in a world-first investor partnership with Medtronic ltd, RYSE Asset Management, and Chelsea and Westminster Hospital NHS Foundation Trust and its official charity CW+

Therefore, a rise in collaboration & partnerships is further expected to create a lot of opportunities for the market to grow

Challenge

• Stringent regulations for gene therapy products

The use of gene therapy across the globe is rapidly increasing, with the growth of the aged population and several chronic diseases which are preventable by early diagnosis and timely treatments. At the same time, the players of the gene therapy in the market have to follow certain regulations to get approval from the upper authorities for the launching of the product in a region. These stringent guidelines need to be followed, and this is one of the most difficult tasks among all the steps. The pre-market approval of various gene therapy products varies from one country to another.

For instance,

• In 2022, according to the information provided by Food and Drug Administration (FDA), the Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

Hence, stringent regulations for gene therapy products is different for different countries which is expected to act as a challenge in the market growth.

Recent Developments

• In December 2022 Kite Pharma, Inc., and Daiichi Sankyo Co., Ltd. announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the initial treatment of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma. Only patients who have not previously had a transfusion of CAR T cells directed against the CD19 antigen should be treated with Yescarta
• In December, Ferring Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. This has helped the company to expand their product portfolio

North America Gene Therapy Market Scope

The North America gene therapy market is segmented into four notable segments based on vector type, method, application, and end user. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

BY VECTOR TYPE

• Viral Vector
• Non-Viral Vector

On the basis of vector type, the North America gene therapy market is segmented into viral and non-viral vector.

BY METHOD

• Ex-Vivo
• In-Vivo

On the basis of method, the North America gene therapy market is segmented into ex vivo and in vivo.

BY APPLICATION

• Oncological Disorders
• Cardiovascular Diseases
• Infectious Disease
• Rare Diseases
• Neurological Disorders
• Other Diseases

On the basis of application, the North America gene therapy market is segmented into oncological disorders, cardiovascular diseases, infectious diseases, rare diseases, neurological disorders, and other diseases.

BY END USER

• Cancer Institutes
• Hospitals
• Research Institutes
• Others

On the basis of end user, the North America gene therapy market is segmented into cancer institutes, hospitals, research institutes, and others.

North America Gene Therapy Market Regional Analysis/Insights

The North America gene therapy market is segmented into four notable segments based on vector type, method, application, and end user.

The countries covered in this market report are U.S., Canada, and Mexico.

U.S. is expected to grow due to rise in technological advancement in gene therapy products market.

The U.S. dominates North America region due to strong presence of key players Novartis AG, Kite Pharma. Germany dominates Europe region due to the mass production of gene therapy products and increasing demand from emerging markets and expansion. China dominates Asia-Pacific region due to due to increasing customer inclinations towards minimally invasive medical processes.

レポートの国別セクションでは、市場の現在および将来の傾向に影響を与える国内市場における個別の市場影響要因と規制の変更も提供しています。新規販売、交換販売、国の人口統計、規制行為、輸出入関税などのデータ ポイントは、各国の市場シナリオを予測するために使用される主要な指標の一部です。また、国別データの予測分析を提供する際には、北米ブランドの存在と可用性、地元および国内ブランドとの競争が激しいか少ないために直面​​する課題、販売チャネルの影響も考慮されます。

競争環境と北米の遺伝子治療市場シェア分析

北米遺伝子治療市場の競争状況では、競合他社ごとに詳細が提供されます。詳細には、会社概要、会社の財務状況、収益、市場の可能性、研究開発への投資、新しい市場への取り組み、生産拠点と施設、会社の強みと弱み、製品の発売、製品の承認、製品の幅と幅、アプリケーションの優位性、製品タイプのライフライン曲線が含まれます。提供されている上記のデータ ポイントは、北米遺伝子治療市場への会社の重点にのみ関連しています。

北米の遺伝子治療市場で活動している主要企業には、ノバルティスAG、カイトファーマ（ギリアド・サイエンシズの子会社）、ユニキュアNV、オックスフォード・バイオメディカ、スパーク・セラピューティクス、SIBONO、ブルーバード・バイオ、上海サンウェイ・バイオテック、バイオジェン、デンドレオン・ファーマシューティカルズLLC、アムジェン、アンジェス、エンジヴァント・セラピューティクスGmbH、オーデュボン・バイオサイエンスなどがあります。

SKU-69929