Breakthrough Therapy Designation Market by Applications (Rare Diseases, Oncology, Autoimmune Diseases, Infectious Diseases, Neurology Diseases, Pulmonary Diseases, and Others) and Regions (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021-2028

The global breakthrough therapy designation market size is estimated to expand at a significant CAGR during the forecast period, 2021-2028. The growth of the market is attributed to increase in demand for cancer treatment and requirement for treatment drugs for rare diseases along with rise in the number of molecules achieving breakthrough therapy status. Moreover, the increase in the incidence of cancer cases is also expected to boost the growth of the market.

Breakthrough therapy is a process originated to accelerate the development and evaluation of new drugs in order to treat a significant health condition and determines whether the trials conducted prior to phase I trials are effective or not. The effectiveness of the therapy is dependent on a key factor on what duration the therapy is effective and the final outcome of the therapy. In order to achieve success by breakthrough therapy, the trials conducted in the research phase is required to show a clear advantage over the other therapies that are available and currently in use.

The US Food and Drugs Administration (FDA) has approved numerous drugs over the years but several of these drugs as breakthrough therapy have failed in the last stages of the trials as they were unable to provide desirable results. For example, a tylenol-sized capsule named SER 109 was granted as breakthrough therapy in 2015 for the treatment of Clostridium Difficile Infection (CDI) but has failed in the phase II trials for the prevention of recurring of the infection. There is a large share of the market for generic medicines in developing countries such as China and India attributed to shallow spending on healthcare and unfavorable IP laws. Whereas, South Africa and Saudi Arabia have profitable markets for breakthrough therapy drugs attributed to high spending power as compared to other countries.

The outbreak of COVID-19 had a negative impact on the market as the process of approval and launch of a product is delayed due to the reduction in the approval of non-COVID therapies by FDA. The process of research and development has been also slowed down along with trials in order to reduce the spread of infection among the participants.

Market Trends, Drivers, Restraints, and Opportunities

• Increase introduction of new and innovative drugs providing effective and show quick results is a major factor propelling the market growth.
• Rise in the drugs approval by several regulatory bodies especially FDA for the treatment of rare disease and oncology is expected to boost the growth of the market.
• Development of Intellectual Property (IP) rights and laws along with increase in expenditure for healthcare are anticipated to drive the market expansion.
• Increase in the number of healthcare initiatives taken by various governments to create awareness regarding breakthrough therapy designation is another key driving factor of the market.
• Low success rate of clinical trials for breakthrough therapy designation is expected to hamper the market growth and prove to be a major restraining factor of the market.

Scope of the Report

The report on the global breakthrough therapy designation market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Rare disease segment is estimated to grow at a rapid pace

On the basis of applications, the breakthrough therapy designation market is segmented into rare diseases, oncology, autoimmune diseases, infectious diseases, neurology diseases, pulmonary diseases, and others. The infectious disease segment held a major share of the market in 2019 owing to a rise in sales of breakthrough therapy drugs such as Sovaldi and Harvoni. Moreover, several anti-infective drugs are achieving the title of breakthrough therapy status. However, a great competition is taking place in the hepatitis C market and a decline has also been observed in the sales of such drugs that are expected to hinder the infectious disease segment. The oncology segment, on the other hand, is anticipated to exhibit a healthy growth rate during the forecast period owing to increase in number of anti-cancer drugs achieving the breakthrough therapy status. As per the statistics of 2016, the anti-cancer drugs were the most in number in achieving the breakthrough therapy status, which is anticipated to propel the oncology segment in the coming years.

Meanwhile, the rare disease segment is estimated to grow at a rapid pace during the forecast period owing to an increase in the number of molecules authorized for rare diseases. Those drugs developed for the rare diseases treatment, if able to analyze, treat or prevent the disease, are given the title of Orphan Drug and are also given 50% of tax credit in the U.S. The most selling medicine for rare disease was Asfotase Alfa in 2016. The rare disease segment does not consist of rare cancer diseases as they are already covered in the oncology segment. A report by FDA entitled, “Insights into Rare Disease Drug Approval: Trends and Recent Developments” states that 23% of the total breakthrough therapy is accounted for rare diseases that do not include rare cancer diseases.

Asia Pacific is anticipated to exhibit a high CAGR

In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America held a dominant share of the market in 2019 due to the existing favorable legislative frameworks and Intellectual Property (IP) laws. Other major driving factors for the regional market growth are the increasing incidence of chronic diseases, improving healthcare access, and rising demand for innovative drugs by consumers in the region. Europe is the second-largest market for breakthrough therapy and is projected to hold a considerable market share in the coming years owing to favorable reimbursement policies and better infrastructure in the region.

However, the market Asia Pacific is anticipated to exhibit a high CAGR during the forecast period owing to the build-up of profitable Intellectual Property (IP) laws and increase in expenditure for healthcare. One of the challenges in India and China in the growth of innovative medicines is the inclination of consumers towards generic medicines.

Segments

• Rare Diseases
• Oncology
• Autoimmune Diseases
• Infectious Diseases
• Neurology Diseases
• Pulmonary Diseases
• Others

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

• F. Hoffmann-La Roche Ltd.
• Gilead
• Novartis AG
• Pfizer Inc.
• AbbVie Inc.
• Janssen Global Services LLC
• Bristol-Myers Squibb Co.
• Eli Lilly and Co.
• Sanofi
• Regeneron
• Acadia Pharmaceuticals Inc.
• Boehringer Ingelheim GmbH
• Amgen Inc.
• AstraZeneca
• GlaxoSmithKline plc

Competitive Landscape

Key players competing in the global breakthrough therapy designation market are F. Hoffmann-La Roche Ltd.; Gilead; Novartis AG; Pfizer Inc.; AbbVie Inc.; Janssen Global Services LLC; Bristol-Myers Squibb Co.; Eli Lilly and Co.; Sanofi; Regeneron; Acadia Pharmaceuticals Inc.; Boehringer Ingelheim GmbH; Amgen Inc.; AstraZeneca; and GlaxoSmithKline plc. Many of these players have adopted business strategies such as the development of new drugs, introducing new technology, merger, partnership, and production capacity expansion to increase their market position and expand their consumer base globally. Most number of breakthrough therapy drugs is produced in the market by F. Hoffmann-La Roche Ltd.