Specialty Generics Market

The global specialty generics market size is estimated to expand at a significant CAGR during the forecast period, 2021–2028. The growth of the market is attributed to the increase in number of chronic diseases such as hepatitis C, multiple sclerosis, cancer, and others.

Specialty generics are the generic types of specialty pharmaceutical drugs. They are economical as compared with branded versions as there is no need of costly marketing and development costs. Specialty generics include blood derived products, biopharmaceuticals, and complex molecules. These drugs are used to treat chronic health conditions such as autoimmune diseases, cancer, HIV, Hepatitis, epilepsy, rheumatoid arthritis, and multiple sclerosis. 

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As per the World Health Organization (WHO), the new cancer cases is going to rise from 18 million in 2018 to 29.4 million by 2040. WHO furthers reports that liver cancer is caused mainly due to hepatitis, which is responsible for nearly 80% of all the liver cancer cases reported globally and nearby 1.5 million deaths every year.

The reports also states that about 310 chronic cases are recorded worldwide. As per the U.S. Department of Health & Human Services, around 37% of newly chronic hepatitis C cases were recorded of the people aged between 20 to 30 years in 2018 and this is anticipated to surge during the forecast period. As per the Multiple Sclerosis Foundation 2015 report, around 400,000 in the U.S. and 2.5 million people around the globe were reported with multiple sclerosis.

About 10,000 new cases of the disease are detected every year, as presented by MultipleSclerosis.net. These prevailing numbers of chronic diseases shows the importance of developing inexpensive medicine in the coming future. The COVID-19 pandemic brought positive impact on the market as the pandemic forced the world to speed up the requirement of affordable medicine across the nations.

As the treatment was costly and caused troubles for the patients from low economic class, this has resulted into rising death of people. Considering the prevailing healthcare burden caused by the pandemic, governments across the globe realize the need for the development of inexpensive medicines for various disease treatment. The pandemic has pushed doctors to start recommending and opting for generic medicine.

Market Trends, Drivers, Restraints, and Opportunities

• Rising government interest in the development of low-price medicine and developing new strategies for the production of advanced generic drugs are projected to boost the market growth.  
• Favorable reimbursement policies and expansion of clinical laboratories for testing drugs and drugs discovery experiments are key factors driving the market expansion in the coming time.
• Increasing geriatric population along with high prevalence of chronic diseases among the aging population are proving to be key factors that boost the demand for cost-effective medicines during the forecast period.
• Development of specialty generics is a complicated process which needs skilled professionals and availability of raw materials. These factors can restrict the growth of the market in the near future.
• Several specialty medicines are getting patent expiration, which increase the opportunities for the specialty generic medicines expansion during the forecast period.

Scope of Specialty Medicines Market Report

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

Specialty Medicines Market Segment Insights

Injectables segment is expected to grow at a rapid pace

Based on generic types, the global specialty generics market is divided into injectables, oral drugs, and others. The injectables segment is expected to grow at a rapid pace in the coming years due to long duration of action, quick absorption, and immediate dose distribution of the medicine type. 

Furthermore, the rising demand for self-administration by patients is boosting the segment expansion and is projected to fuel the further growth of the segment in the coming years. Moreover, several development strategies of mass production of injectables adopted by some of the major players such as Sun Pharma; Pfizer, Inc.; and Teva are developing different strategic initiatives are likely to spur the segment growth.

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The oral drugs segment, however, is anticipated to exhibit considerable growth in the near future owing to wide availability of oral medicines for the prevention and treatment of growing incidences of cancer, arthritis, and chronic diseases along with easy of availability and self-administration.

Oncology segment is projected to expand at a considerable CAGR

On the basis of applications, the market is segregated into oncology, inflammatory conditions, multiple sclerosis, hepatitis C, and others. The oncology segment is projected to expand at a considerable CAGR during the projected period owing to growing cases of different types of cancer such as melanoma, colon cancer, prostate cancer, lung cancer, breast cancer, and leukemia.

Death rate due to cancer is greater in developing and underdeveloped countries as compared to developed countries. The high price of cancer drugs and treatment along with inadequate advanced healthcare infrastructure in the countries are some of the major factors responsible for high mortality rate globally. This increases the demand for cost-effective generic medicines that are less expensive as well as highly effective against the branded drugs.

The inflammatory segment, meanwhile, is projected to expand at a robust growth rate in the coming years attributed to the high frequency of asthma, arthritis, Crohn’s disease, and tuberculosis. As per the Centre for Disease Control and Diagnosis (CDC), nearly 54 million cases in the US were reported with lupus, gout, and arthritis during the period, 2013-2015.

Specialty pharmacy segment is anticipated to account for a key market share

Based on end-users, the global specialty generics market is classified as specialty pharmacy, retail pharmacy, and hospital pharmacy. The specialty pharmacy segment is anticipated to account for a key market share during the forecast period due to wide distribution of the specialty medicines through these pharmacies by the manufacturers.

However, these medicines are expensive, highly complex, and requires careful handling. Additionally, increasing healthcare awareness and accessibility of advanced therapeutics for the treatment of several chronic diseases are driving the segment growth at a fast rate.

The retail pharmacy segment, however, is projected to register a high CAGR during the projected period due to the easy availability of retail stores and the drugs are sold in lower and discounted prices. Meanwhile, the hospital pharmacy segment is showing a promising growth attributed to rising number of patients with diseases like multiple sclerosis, cancer, hepatitis C, and inflammatory conditions, which require patient to get admitted to hospitals. 

North America is anticipated to dominate the market

In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. The market of North America is anticipated to dominate the market owing to advance healthcare facilities as well as government initiatives in the region with high funding from public and private organizations.

Additionally, healthcare organizations are widely involved in preparing policies such as the National Cancer Control Programs. These are key factors expected to increase the growth of the market in this region.

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The market of Europe is expected to expand significantly during the targeted period due to the advancements in technology in the region for the treatment of chronic diseases as well as well-developed healthcare facilities in countries such as the UK, France, Switzerland, and Germany. Meanwhile, Asia Pacific is a fast-growing market and is anticipated to constitute a major share of the total revenue of the market during the forecast period owing to high chronic disease cases and rising government initiatives for the inexpensive medicines with high efficacy in the region.

Additionally, growing disposable income of a large number of the population and gradual development of healthcare services are proving the market growth of the region.

Segments

The global specialty generics market has been segmented on the basis of

Generics

• Injectables
• Oral Drugs
• Others

Applications

• Oncology
• Inflammatory Conditions
• Multiple sclerosis
• Hepatitis C
• Others

End-users

• Specialty pharmacy
• Retail pharmacy
• Hospital pharmacy

Regions

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

Key Players

• Teva Pharmaceuticals Industries
• Akorn Inc.
• Mylan N.V.
• Mallinckrodt
• Sandoz International GmbH
• Pfizer Inc.
• Sun Pharmaceutical Industries Ltd.
• Valeant Pharmaceuticals
• Apotex Corp.
• Endo International plc

Competitive Landscape

Key players competing in the global specialty generics market are Pfizer Inc.; Teva Pharmaceuticals Industries; Mylan N.V.; Sandoz International GmbH; Akorn Inc.; Valeant Pharmaceuticals; Sun Pharmaceutical Industries Ltd.; Apotex Corp.; Mallinckrodt; and Endo International plc. Pfizer, Inc.; Teva Pharmaceuticals USA; Mylan N.V.; Novartis; and Sun Pharmaceutical Industries Ltd. are the major players that has oral therapeutics for the treatment of chronic diseases.

Teva Pharmaceutical Industries Ltd. had announced the release of the generic form of abacavir and lamivudine (Epzicom1) tablets in the U.S. in September 2016. In other event, Mylan N.V. made an agreement with Medicines Patent Pool (MPP) in 2016 with a goal of smoothing access to chronic hepatitis C drugs in developing countries. With this agreement, Mylan received the licenses of producing a generic form of daclatasvir tablets.