Gene Therapy Market Size, Share & COVID-19 Impact Analysis, By Application (Oncology, Neurology, and Others), By Vector Type (Viral and Non-viral), By Distribution Channel (Hospitals, Clinics, and Others), and Regional Forecast, 2020-2027

The global gene therapy market size was valued at USD 3.61 billion in 2019 and is projected to reach USD 35.67 billion by 2027, exhibiting a CAGR of 33.6% during the forecast period. U.S. dominated the global gene therapy market with a share of 59.83% in 2019.

The market is estimated to undergo a tremendous growth of 33.6% CAGR growing to the advancements in the CRISPR-Cas9 and CAR-T base gene editing technology. Gene therapy provides hope to individuals suffering from rare untreatable genetic disorders.

The technology is primarily based on injecting functional genes through viral or non-viral vectors into the patients in order to correct a faulty, non-functional, or absent gene in their body. Gene editing can either be carried in the somatic cell or germ line cell. The discovery of the technology has paved the way for a new approach towards curing an untreatable chronic disease such as cancer and spinal muscular atrophy (SMA). This kind of therapy is largely branded as a single dose cure as it helps correct the disease at the source DNA.

COVID-19 Pandemic Impacting Research in This Advancing Field

According to various sources, there hasn’t been a significant impact on the sale of gene therapy medicine due to the coronavirus pandemic. However, the major impact is exhibited in the ongoing research in this field. As per Wilson Brayan, director of Office of Tissues and Advanced Therapy at the U.S FDA, there hasn’t been an increase in the application of new drugs in gene therapies. However, he states that owing to the pandemic, the officials are prioritizing coronavirus related discoveries and approvals. This could impact the response of Investigational New Drug application of gene therapies filed to the U.S Food and Drug Administration (FDA). The U.S FDA official also mentions that there are cell therapies undergoing research to discover a cure for coronavirus, however the success rate of the treatment is still not known.

LATEST TRENDS

Shift towards Advanced Treatment Options to Cure Chronic Diseases is a Prominent Trend

The developed countries are utilizing advanced treatment options for chronic diseases. Thus, it is leading to a shift in the adoption of this treatment from conventional treatment options such as chemotherapy that have severe side effects and long term implications. There is also a shift towards the adoption of viral vectors that provides high immunogenicity and lower toxicity for the development of such therapies.

DRIVING FACTORS

Rising Prevalence of Oncology and Neurological Disorders to Bolster Market Growth

Worldwide, there is an increasing prevalence of rare genetic disorders among the population. According to the National Organization for Rare Diseases (NORD), the estimated incidence of spinal muscular atrophy is 1 in 10,000 live births in the U.S annually. Technological advancements in the field have facilitated the treatment of such diseases that were previously deemed untreatable. On the other hand, cancer is one of the most prevalent diseases globally. 

According to the recent estimates by the World Health Organization (WHO) and Globocan, the total five-year prevalence of cancer is around 43 million globally. Such gene therapies help prevent certain types of cancer among patients who are highly predisposed to acquiring the disorder through genetic mutation passed down from the previous generation.

Increasing Products under Pipeline is Propelling Growth of Market

The increasing research studies and innovations in the field are expected to have a huge impact on the market. The U.S Food and Drug Administration (FDA) expects to receive more than 200 applications of the therapy type by 2020. There are around 208 companies operating in this market in North America. 

According to the Alliance for Regenerative Medicine, as of 2018, there are around 259 candidates in Phase I clinical trials around the globe. The highest percentage of research is undertaken in oncology application. Additionally, the recent product approvals of such drugs are estimated to augment the growth of the market. For instance, In June 2018, Spark Therapeutics received the FDA approval for LUXTURNA for the treatment of RPE65-mediated inherited retinal disease.

RESTRAINING FACTORS

Exorbitant Costs of Treatment Method is Estimated to Restrain Market Growth

Regardless of the increasing prevalence of chronic disorders such as SMA and cancer, the treatment method is extremely expensive. The method is majorly advertised as a single dose treatment regime that reverses the genetic dysfunction in the patient’s body. According to Novartis AG, a single dose of Kymriah, the therapy cancer drug costs a whopping USD 475,000. The same drug is priced at USD 306,000 in Japan.

This high cost of this expensive therapy has also encouraged reluctance to reimburse the treatment method by some insurance companies. These factors could largely impact the growth of the market of gene therapy in the coming years.

SEGMENTATION

By Application Analysis

Neurology Segment to Hold Highest Market Share Backed by Expensive Nature of Drugs

On the basis of application, the market includes oncology, neurology, and others. The neurology segment held the highest gene therapy market share in 2019 owing to the high cost of the drug combined with larger adoption of the treatment type among neurology patients suffering from spinal muscular atrophy.

However, the oncology segment is expected to grow at a significant CAGR during the forecast period due to the increasing number of market players engaged in the developing treatment and cure for different types of cancer. The higher number of pipeline products in clinical and preclinical stages would augment the growth of the segment in the forthcoming years.

By Vector Type Analysis

Viral Vector Segment Dominated the Market in 2019 Owing to Rising Development of Therapies

This therapy market by vector is bifurcated into viral vectors and non-viral vectors. The viral vectors segment dominated the market in 2019. According to the analysis from clinicaltrials.gov, around 58% of gene therapies under development are utilizing viral vectors. The most used viral vector is Adeno-Associated Virus (AAD) owing to its low immunogenicity, safety, and long-term transient expression. The non-viral vector segment that includes bacterial vectors and plasmid DNA is estimated to grow at a slower pace, as compared to the viral vector segment in the coming years.

By Distribution Channel Analysis

Hospitals to Register a Higher CAGR Fueled by Rising Accessibility of Treatment Methods

In terms of distribution channel, the gene therapy market is segmented into hospitals, clinics, and others. The hospitals segment is expected to have the highest share in the market during the forecast period. The dominance is due to the high availability and accessibility of the treatment methods in such facilities. This segment is projected to maintain its dominance in the market during the forecast period. The clinics segment is also anticipated to experience growth owing to the increasing number of stand-alone clinics offering advanced therapies for cancer and neurological conditions.

REGIONAL INSIGHTS

The market size of the U.S. stood at USD 2.16 billion in 2019. The dominance of this country is attributable to the high prevalence of chronic disorders and increasing acceptance of advanced therapies for the treatment of rare disease. Favorable guidelines and reimbursement policies would also aid in the market growth in the country. This treatment method is not yet legalized in several developing countries and hence, the major market players are focusing on launching products in the U.S market.

Similarly, Europe is highly receptive towards advanced treatment options of untreatable diseases. Higher research funding in such fields would drive the market growth in the region. For instance, according to the Alliance for Regenerative Medicine, there are more than 100 companies involved in the market in the region. On the other hand, Asia Pacific holds significantly lower the market revenue share. The predominant reason for this is the lower adoption of this treatment type due to its high cost. Developing countries such as India are establishing guidelines for marketing and releasing of such products in the country.

KEY INDUSTRY PLAYERS

Market is Consolidated with Only Few Player Offering This Treatment Type

The market is consolidated with players such as Novartis AG, Amgen, GSK, and Spark Therapeutics among others. There are only around 14 drugs currently approved world-wide for the treatment of genetic disorders. This has led to the dominance of such key players in the market. However, several candidates of other key pharmaceutical companies are under clinical and preclinical stages that are yet to be approved by the regulatory authorities.

LIST OF KEY COMPANIES PROFILED:

• Novartis AG


• Spark Therapeutics, Inc.


• Biogen


• Gilead Sciences, Inc


• Amgen, Inc.


• Jazz Pharmaceuticals, Inc.


• Sarepta Therapeutics


• GlaxoSmithKline plc


• Other Prominent Players     

KEY INDUSTRY DEVELOPMENTS:

• June 2021 – Biogen Inc. announced positive results from their Phase 3 STAR study for their timrepigene emparvovec (BIIB111/AAV2-REP1), which is an investigational gene therapy for the treatment of choroideremia.


• February 2021 – Spark Therapeutics announces that the first study participant has been dosed in the U.S. region as a part of international gene therapy clinical trial related to Pompe Disease.


• December 2020 – Jazz Pharmaceuticals plc. And their partner PharmaMar announced positive result for their ATLANTIS Phase 3 study for Zepzelca in combination with Doxorubicin for patients with small cell lung cancer.

REPORT COVERAGE

The gene therapy market research report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the gene therapy market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the advanced market over the recent years.

Report Scope & Segmentation