Future Market Insights
Search Reports

Specialty Generics Market

Starting at US$ 5000

Buy Now
Companies
Industry Size (2022)
USD 61.8 Bn
Forecast (2032)
USD 130.5 Bn
CAGR (2022 to 2032)
7.7%

Specialty Generics Market Outlook (2022-2032)

[250 Pages Report] The global specialty generics market is expected to enjoy a valuation of US$ 61.8 Bn by the end of 2022, and further expand at a CAGR rate of 7.7% to reach a valuation of ~US$ 130.5 Bn in 2032. According to a recent study, the injectable route of administration led the market with a share of about 48.4% in the year 2021, globally.

Specialty generics can be small compounds generated using conventional pharmaceutical production techniques or large, injectable, protein-based molecules produced by a biotechnology process. Specialty generics are widely used in treatments for diseases such as multiple sclerosis, cancer, pulmonary hypertension, haemophilia, and hepatitis C treating complex disorders.

With rising cancer cases across the globe, the need for specialty generics oral and injectable is expected to surge rapidly over the forecast period (2022-2032). According to the American Cancer Society, by 2040, the global burden of cancer is expected to grow nearly double, reaching 27.5 million new cancer cases from 17 million in 2018. To curb the global burden of such diseases, key players are introducing a variety of specialty generics.

For instance, in April 2022, a leading healthcare professional, Dr. Reddy’s Laboratories announced the launch of a methylprednisolone sodium succinate injection for the pateints with blood disorders, certain type of cancers, and arthritis in the U.S.

Specialty Generics Market
Specialty Generics Market
Attributes Key Insights
Specialty Generics Market Market Value 2021 US$ 57.4 Bn
Market Value 2022 US$ 61.8 Bn
Market Value 2032 US$ 130.5 Bn
CAGR 2022-2032 7.7%
Market Share of Top 5 Countries 61.7%

Sales Analysis of Specialty Generics from 2017 to 2021 Vs Market Outlook for 2022 to 2032

As per Future Market Insights (FMI), the market value for specialty generics was approximately 14.2% of the overall ~US$ 404.7 Bn of global generics market in 2021. Sales of specialty generics surged at a CAGR of 7.3% from 2017 to 2021, owing to the rising prevalence of chronic and infectious diseases.

The demand for specialty generic medications is predicted to grow profitably as the number of off-patent specialty drugs rises. Preference for specialty generics is expected to surge as these drugs act on cancer treatment and central nervous system, and other therapeutic areas. Hence, biopharma businesses are switching their focus to complex generic drugs, which deliver more value by attending to new unmet needs. Further, the market is predicted to expand due to rise in incidence of neurological disorders, epilepsy, etc.

According to American Action Forum 2020, about 6 percent of children in the U.S. have more than one chronic ailment. While, about 27% of children in the country suffer from at least one chronic condition. Adults, on the other hand, experience at least one chronic ailment in 60% of cases, and multiple chronic conditions in 42% of cases.

Thus, owing to the aforementioned factors, the global specialty generics market is expected to grow at a CAGR rate value of 7.7% during the forecast period from 2022 to 2032. As per FMI, sales in the market are expected to increase by 2.1x, reaching US$ 130.5 Bn by 2032.

specialty generics market
specialty generics market

What are the Key Trends Propelling the Sales in the Market?

Asia Pacific to be a Hotspot for Sepcialty Generics Companies through 2022 & beyond

With development in healthcare infrastructure in India, China, and Japan, key players are eyeing the Asia Pacific specialty generics market to generate lucrative revenues. Growing patient pool, and affordable development and manufacturing, will draw international biopharmaceuticals to Asia with the emphasis on strengthening the R&D landscape, particularly for biologics.

In addition to the oversupply of simple generic products on the market, biopharma companies are focusing on developing complex generic medications that address additional unmet needs and provide greater value to patients.

As per the United Nations, in 2019, there were 703 million people worldwide who were 65 or older. In 2050, it is expected that there will be 1.5 billion people falling under the elderly age group. In the entire world, the percentage of people 65 and older rose from 6% in 1990 to 9% in 2019. By 2050, that percentage is expected to increase to 16%, meaning that one in six persons worldwide would be 65 or older. This is expected to provide lucrative opportunities for growth in the overall specialty generics market.

What are the Factors Restraining the Demand for Specialty Generics?

Regulatory requirements play a significant role in limiting the growth as the FDA Office of Generic Drugs (OGD) typically guides the endpoints and data necessary for the U.S. approval of simple generics as part of their clear development roadmap.

Set regulatory guidelines are not available for the process flow for the production of such differentiated generic formulations. This will increase uncertainty and risk in the planning and design process. In addition to this, according to the Global Health Journal, 2019, specialty medications are excessively expensive in the U.S.

Patients are at risk of not being able to pay for crucial and life-saving medications for complicated illnesses throughout a range of therapeutic classes, such as multiple sclerosis, cancer, inflammatory conditions, and Hepatitis C, due to high cost.

Even though only 2% of American prescriptions are for specialty medications, they accounted for roughly 45% of all drugs purchased in the country in 2018, and this is steadily increasing. The expected increase in U.S. pharmaceutical spending from US$ 485 billion in 2018 to around US$ 655 billion in 2023 due to rising expenditures for high-cost specialty and biologics.

Country-wise Insights

What Makes China a Highly Lucrative Market for Specialty Generics?

Development in China Pharmaceutical Industry to Push Demand in the Market

China held approximately 33.3% share in the East Asia market in 2021 and is projected to display growth at a CAGR of 4.5% during the forecast period. China is one of the largest pharmaceutical marketplaces in the world, this is expected to boost the market over the forecast period.

Owing to the rising prevalence of chronic illnesses and presence of regulatory approvals in the country, the demand for oral and injectable specialty generics. As per FMI, China is expected to spearhead the growth in East Asia market over the upcoming decade.

Why is the Demand for Specialty Generics Increasing in the U.S.?

Availability of Programs in Therapeutic Areas to Augment the Growth in the Market

The U.S. dominated the North America specialty generics market with a share of about 92.0% in 2021. Growth in the market is expected to continue to witness same growth over the forecast period. The U.S. is considered to be one of the largest pharmaceutical sectors, which is fueling the growth in specialty generics market.

Also, rising incidence of fatal diseases, including cancer and HIV, is driving the specialty generics market in the U.S. Additionally, increasing research and development in therapeutic areas will boost specialty generics market.

Furthermore, the U.S. Food and Drug Administration (FDA) successful programmes, such as Breakthrough Therapy, which attempts to increase and streamline patients' access to these medications, is one of the key industry trends driving the growth of the specialty generics market.

What is the Demand Outlook for Germany Specialty Generics Market?

Rising Prevalence of Chronic Illnessses to Increase the Sales in Germany Market

Germany is set to exhibit a CAGR growth at 5.6% CAGR in the Europe specialty generics market during the forecast period. Emergence of new therapeutic alternatives is raising patient survival rates for numerous chronic illnesses, including cancer, multiple sclerosis, rheumatoid arthritis, and HIV/AIDS.

This is pushing for pharmaceutical patent amendments to prevent expiry, improving the demand in the market. Due to these advances in the medical industry, demand for specialty generics market is increasing, boosting the market in Germany.

Category-wise Insights

Which is the Most Preferred Route of Administration in Specialty Generics Market?

Nearly 2/5th of Sales are Concentrated in Oncology Segment through 2022 & beyond

The injectable route of administration is expected to present high growth at a CAGR of 8.2% during the forecast period, with a share of about 48.4% in 2021. This is owing to its property of instant dosage distribution in the body, prolonged effect, and rapid absorption.

In terms of application, the oncology segment held a revenue share of around 38.4% in 2021. Sales in the oncology segment are expected to surge at a CAGR of 8.0% over the assessment period. According to the National Cancer Institute, 2020, cancer is the leading cause of death worldwide. By 2040, the rate of cancer cases will project to 29.5 million with cases of mortality up to 16.4 million.

Which is the Leading Distribution Channel in the Specialty Generics Market?

Hospital Pharmacies to Account for Half of the Sales in the Market

Hospital pharmacies held the highest market share value for specialty generics, holding around 48.2% share in 2021. Growing prevalence of chronic and infectious diseases, as well as the increasing treatment rate and dispensing of prescription medicines, have driven the demand in the segment, propelling sales in specialty generics market.

Competitive Landscape

With the presence of established players in the specialty generics market, the overall market is highly consolidated. To meet the growing demand and expand their customer base, these companies are implementing methods such as mergers and acquisitions, partnerships and collaborations, and new product launches.

Instances of key developmental strategies by the industry players in the specialty generics market are given below:

  • In October 2020, Teva introduced ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablets, the first generic versions of these HIV-1 treatments in the U.S. 
  • In May 2019, Mallinckrodt revised its plans for spinning off its Specialty Generics/Active Pharmaceutical Ingredients (Specialty Generics) division as a new company to shareholders of Mallinckrodt plc. One company will be focused on cutting-edge specialty branded pharmaceuticals, while the other will be primarily focused on manufacturing specialty generic products and APIs.

Report Scope as per Specialty Generics Industry Analysis

Attribute

Details

Market Value 2022

US$ 61.8 Bn

Market Value 2032

US$ 130.5 Bn

CAGR 2022-2032

7.7%

Forecast Period

2017-2021

Historical Data Available for

2022-2032

Market Analysis

US$ Mn for Value

Key Regions Covered

North America, Latin America, Europe, South Asia, East Asia, Oceania, and Middle East & Africa

Key Countries Covered

U.S., Canada, Brazil, Mexico, Argentina, U.K., Germany, Italy, Russia, Spain, France, BENELUX, Rest of Europe, India, Thailand, Indonesia, Malaysia, Japan, China, South Korea, Australia, New Zealand, Turkey, GCC, North Africa, and South Africa

Key Market Segments Covered

Route of Administration, Application, Distribution Channel, and Region

Key Companies Profiled

Key Market Segments Covered in Specialty Generics Industry Research

By Route of Administration:

  • Injectable
  • Oral
  • Others

By Application:

  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Others

By Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East and Africa (MEA)

Frequently Asked Questions

How much is the specialty generics market currently worth?

The global specialty generics market was worth US$ 57.4 Bn in 2021 and is set to expand 2.1X over the next ten years.

What is the sales forecast for specialty generics through 2032?

The specialty generics market is expected to reach US$ 130.5 Bn by end of 2032 at a CAGR of 7.7%.

What are the trends driving the demand outlook of the global specialty generics market?

The growing burden of chronic and infectious disease, rising awareness regarding high-level therapeutics and sustainable production methods, and the adoption of complex generics, are some of the key trends in this market.

Which region has the highest market share in the global specialty generics market?

North America has the highest market share of about 36.7% by value in 2021 in the global specialty generics market.

How likely is the specialty generics market to grow in India?

India accounts for about 45.8% of the market share in 2021 in the South Asia specialty generics market and is projected to grow with a CAGR of 4.9% in the forecast period.

Which are the top five countries driving demand for the specialty generics market?

India, the U.S., China, the U.K, and Germany are the top five countries, which are expected to drive demand in the specialty generics market.

Who are the key manufacturers in the specialty generics market?

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 are some of the key players in the specialty generics industry.

What is the demand outlook for China specialty generics market?

China accounted for 33.3% market share by value in 2021 within the region of East Asia. The specialty generics market in China is expected to grow at a 4.5% CAGR value during the forecast period.

What is the outlook of Japan in the specialty generics market?

Japan displays a share of around 43.0% in 2021 within East Asia and is set to present a lucrative CAGR growth rate of 5.8% during the forecast period.

Preview the report firsthand - request a free sample

Get Sample

Get the brochure for pricing and purchase details.

Future Market Insights

Specialty Generics Market